chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received and experience adverse event refer linked case US2018GSK141983). On 11th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported for the reporter's brother. The age at vaccination was not reported. On Wednesday, 11th July 2018, the patient received 2nd dose of SHINGRIX shot. The patient experienced arm soreness. Arm soreness was still a little sore but not as sore as after the first Shingles shot but still worse than any other shot (example Tetanus). The patient noticed it most at night as he can not sleep on the shoulder that received the shot.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, 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 76-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, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: About 5 to 6 months prior to the date of reporting, the patient received her 1st dose of SHINGRIX on the left arm, the exact date for vaccination was not provided. The patient noted soreness to arm. The soreness was described as, she was unable to sleep on the arm for well over a week. The soreness completely resolved on the 3rd week after the vaccination, the exact date for recovery was not provided. The reporter did not have batch number, expiry date or dose of the SHINGRIX vaccine. The patient had denied permission to contact their physician. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK140958.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-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, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: About 5 to 6 months prior to the date of reporting, the patient received her 1st dose of SHINGRIX on the left arm, the exact date for vaccination was not provided. The patient noted soreness to arm. The soreness was described as, she was unable to sleep on the arm for well over a week. The soreness completely resolved on the 3rd week after the vaccination, the exact date for recovery was not provided. The reporter did not have batch number, expiry date or dose of the SHINGRIX vaccine. The patient had denied permission to contact their physician. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK140958.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 5 to 6 months prior to the reporting date. For tolerance, refer case US2018136216). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than an hour after receiving SHINGRIX, the patient experienced extremities hot feeling of, itchy upper limbs and erythema of extremities. On an unknown date, the outcome of the extremities hot feeling of, itchy upper limbs and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the extremities hot feeling of, itchy upper limbs and erythema of extremities to be related to SHINGRIX. Additional information was reported as follows: Over a week before the date of reporting, the patient received the 2nd dose of SHINGRIX on right arm, the exact date for vaccination was not provided. Within an hour after receiving SHINGRIX, the patient experienced redness, heat and itchiness. The redness, heat and itchiness was described as a big red square which itched like a mosquito bite. The patient noted no problem to move her arm. It was reported that, the events had not improved or worsened. The reporter did not have batch number, expiry date or dose of the SHINGRIX vaccine. The patient had denied permission to contact their physician.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 5 to 6 months prior to the reporting date. For tolerance, refer case US2018136216). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than an hour after receiving SHINGRIX, the patient experienced extremities hot feeling of, itchy upper limbs and erythema of extremities. On an unknown date, the outcome of the extremities hot feeling of, itchy upper limbs and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the extremities hot feeling of, itchy upper limbs and erythema of extremities to be related to SHINGRIX. Additional information was reported as follows: Over a week before the date of reporting, the patient received the 2nd dose of SHINGRIX on right arm, the exact date for vaccination was not provided. Within an hour after receiving SHINGRIX, the patient experienced redness, heat and itchiness. The redness, heat and itchiness was described as a big red square which itched like a mosquito bite. The patient noted no problem to move her arm. It was reported that, the events had not improved or worsened. The reporter did not have batch number, expiry date or dose of the SHINGRIX vaccine. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, 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 81-year-old male patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site discomfort. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site discomfort were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination could be 81 or 82 years. The patient himself reported the case, who received second dose of SHINGRIX and experienced injection site reaction including arm soreness and redness. The reporter stated that his arm was still sore, till the time of reporting and felt uncomfortable at night when sleeping on his side. This case was linked with case US2018136352, reported by the same reporter.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Neurological symptom
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of neurological symptom in a 54-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 24th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st March 2018, 36 days after receiving SHINGRIX, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was unknown. It was unknown if the reporter considered the neurological symptom to be related to SHINGRIX. Additional information was reported as follows: This case was previously reported to the physician. The reporter was the patient himself, after vaccination with SHINGRIX, he experienced neurological symptoms and till the time of reporting, the patient was still experiencing the events. The reporter provided permission to contact his physician. The reporter did not want to take time to elaborate on the neurological symptoms. The reported batch number 324KL, does not exist in the sales database, so it was replaced and corrected with the correct batch number as 3Z4KL. It was unable to obtain further information.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone swelling, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bone swelling in a 60-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th July 2018, 2 days after receiving SHINGRIX, the patient experienced bone swelling. On an unknown date, the outcome of the bone swelling was not recovered/not resolved. It was unknown if the reporter considered the bone swelling to be related to SHINGRIX. Additional information was reported as follows: On 29th July 2018, one day before the date of reporting, the patient came to the pharmacist and stated that she experienced swelling on her collar bone at the base of her neck and on the same side where she was vaccinated. The swelling was getting worse. The patient was referred to health care provider. No further details were provided by the pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site dryness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. This case was previously not reported to anyone. The reporter received the SHINGRIX vaccine approximately two weeks before the day of reporting. The patient noted that two hours after the vaccination she felt exhausted. The next day after the vaccination she noted that she had a red circle at the injection site approximately three inches across. The red circle began to itch. Over the time it became raised and swollen, and felt warm to the touch. Currently it was resolving but was still red and the skin looked dry. The reporter did not want to provide additional information and ended the call.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. This case was previously not reported to anyone. The reporter received the SHINGRIX vaccine approximately two weeks before the day of reporting. The patient noted that two hours after the vaccination she felt exhausted. The next day after the vaccination she noted that she had a red circle at the injection site approximately three inches across. The red circle began to itch. Over the time it became raised and swollen, and felt warm to the touch. Currently it was resolving but was still red and the skin looked dry. The reporter did not want to provide additional information and ended the call.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia, Thirst
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included influenza. On 10th July 2018 16:00, the patient received the 1st dose of SHINGRIX. In July 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, pain, thirst and shivering. In July 2018, the outcome of the fever, pain, thirst and shivering were recovered/resolved. It was unknown if the reporter considered the fever, pain, thirst and shivering to be related to SHINGRIX. Additional details were received as follows: This case was previously reported to the physician. On 10th July 2018, at 4 pm or 5pm the patient was vaccinated with a dose of SHINGRIX. On 11th July 2018, at 2 am, the patient went to bed experienced shivering with a fever. The fever was recorded as 99.9 Degree F. The patient was experienced aching like she did the last time she had flu. On 11th July 2018, at 9:00am after 17 hours she woke up experienced very thirsty. All symptoms were resolved by later that afternoon.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site rash and fever were recovered/resolved. It was unknown if the reporter considered the injection site rash and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the arm. After receiving SHINGRIX, the patient developed a rash that radiated from the injection site down to her elbow that lasted about 7-10 days and a low grade fever.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 52-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced 15 or 20 years ago). On 27th July 2018, the patient received the 1st dose of SHINGRIX In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site reaction and pain in arm. On an unknown date, the outcome of the injection site reaction and pain in arm were unknown. It was unknown if the reporter considered the injection site reaction and pain in arm to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The age at vaccination can be 52 or 53 years. The reporter was the patient's father who received the 1st dose of SHINGRIX and experienced injection site reaction including arm soreness and pain. The reporter also stated that, the patient did not have redness but had arm pain that was moving down into the fingers at the time of reporting. This case was linked to case US2018136222, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received 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 unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age group was not reported, but was captured as adult as per the vaccine indication. The reporter received the adverse event reporting, that was received by her from a healthcare provider. The reporter stated that the healthcare professional stated that, SHINGRIX vaccine hurts. The healthcare professional had not mentioned any specific patient or any other details.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 73-year-old female patient who received Boostrix (batch number 54B74, expiry date 14th September 2020) for prophylaxis. On 8th May 2018, the patient received the 1st dose of Boostrix (intramuscular). In June 2018, 30 days after receiving Boostrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved. It was unknown if the reporter considered the vesicular rash to be related to Boostrix. Additional details reported as follows: The healthcare professional stated the patient received Boostrix and a month later developed a shingles like rash (unconfirmed) on her neck that ran down to her breast area. It was really mild, not really pronounced. The healthcare professional agreed to be re-contacted if necessary.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Immediate post-injection reaction, Incorrect route of drug administration, Injection site discolouration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 68-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 25th July 2018 15:00, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discoloration. On 25th July 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth, injection site burning, injection site induration and intramuscular formulation administered by other route. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site burning were recovering/resolving and the outcome of the injection site erythema and injection site induration were recovered/resolved and the outcome of the injection site discoloration and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth, injection site burning, injection site induration, injection site discoloration and intramuscular formulation administered by other route to be related to SHINGRIX. Additional details reported as follows: The patient was administered the vaccine subcutaneously on left arm, which led to incorrect route of vaccine administration. The patient experienced burning immediately following the injection. The burning became worse the night of vaccination. There was extreme redness and swelling in a 4 inch wide by 5 inch long area with a hard part and it was hot to touch and itchy. The itchiness started to resolve Sunday and then late in the day yesterday it started again. The extreme redness was gone but there was still some discoloration.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 68-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 25th July 2018 15:00, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discoloration. On 25th July 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth, injection site burning, injection site induration and intramuscular formulation administered by other route. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site burning were recovering/resolving and the outcome of the injection site erythema and injection site induration were recovered/resolved and the outcome of the injection site discoloration and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching, injection site warmth, injection site burning, injection site induration, injection site discoloration and intramuscular formulation administered by other route to be related to SHINGRIX. Additional details reported as follows: The patient was administered the vaccine subcutaneously on left arm, which led to incorrect route of vaccine administration. The patient experienced burning immediately following the injection. The burning became worse the night of vaccination. There was extreme redness and swelling in a 4 inch wide by 5 inch long area with a hard part and it was hot to touch and itchy. The itchiness started to resolve Sunday and then late in the day yesterday it started again. The extreme redness was gone but there was still some discoloration.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (hardness and soreness after receiving 1st dose in April 2018, refer case US2018132476). On 20th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site burning, injection site swelling and injection site itching. On 20th July 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site burning, injection site swelling, injection site itching and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site burning, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: Four days before the reporting date, the patient received SHINGRIX subcutaneously on the backside of her left arm about 3 inches below her shoulder, which led to incorrect route of vaccination. The patient stated that the area at the injection and around it was swollen, itching and burning along the outer side of her arm and it was lasting longer than her previous site reactions. The patient stated that she knew it should have been given into the deltoid muscle, as was her first dose. The patient received injections at different pharmacies. The patient had not reported these events to her physician or this last concern of subcutaneous injection back to the pharmacy. The patient was concerned if she would need another injection. The patient had a concern if the subcutaneous injection of 2nd dose would be as effective as intramuscular injection of 1st dose. The patient was asking if she should receive another dose properly administered. The patient had been referred to her physician. She had provided contact details of the physician as well.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In February 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced product availability issue and incomplete course of vaccination. On an unknown date, the outcome of the fever, product availability issue and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient had a reaction of a high fever at the night of vaccination day and missed work next day. With having a reaction and starting a new job and being out of town a lot she had to put off getting 2nd vaccine until previous week of reporting date. At the reporting time, the patient found out there was a shortage. She was on a waiting list at pharmacy. Other local pharmacy had a list as well. On 9th August 2018 it would be 6 months. She was enquiring about what was the outlook for this shortage and what would happen if vaccine was not available by then.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of leg pain in a 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 leg pain. On an unknown date, the outcome of the leg pain was unknown. It was unknown if the reporter considered the leg pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the nurse who herself was patient. The patient's date of birth was unknown. The age at vaccination was not reported. The nurse agreed to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of general body pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on an unknown date. For tolerance, refer case US2018GSK140288.). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and polymyalgia. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the general body pain and polymyalgia were not recovered/not resolved. The reporter considered the general body pain and polymyalgia to be related to SHINGRIX. Additional information was reported as follows: The nurse thought, the patient did not had any other concomitant vaccines. The patient received the 2nd dose of SHINGRIX at a pharmacy. The patient had general pain and myalgia all over his body for 11 days so far, at the time of reporting. The patient would wait for 1 more week to see if the pain resolves and see a doctor if it had not. The nurse thought that, the pain was due to the vaccine. The patient felt, the pain with the 2nd dose was worse than expected with the 1st dose of SHINGRIX. The reporter could not remember any other details at the time of reporting. The nurse agreed to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms 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, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue and fever. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the fatigue and fever were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a practice manager. The age at vaccination was not reported. The patient experienced fatigue and fever for about 24 hours. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pain in extremity, Pruritus, Skin warm
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm, pain in arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities was unknown and the outcome of the skin warm and pain in arm were recovered/resolved and the outcome of the itchy upper limbs was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin warm, pain in arm and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine 5 days prior to the day of reporting. The patient had a local reaction which was described as arm was red, warm and very tender. At the time of reporting, the patient's arm was no longer sore or hot but still itched. The patient was fine and had seen worse but worried about the 2nd dose reaction. The reporter did not agree to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm, pain in arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities was unknown and the outcome of the skin warm and pain in arm were recovered/resolved and the outcome of the itchy upper limbs was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin warm, pain in arm and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine 5 days prior to the day of reporting. The patient had a local reaction which was described as arm was red, warm and very tender. At the time of reporting, the patient's arm was no longer sore or hot but still itched. The patient was fine and had seen worse but worried about the 2nd dose reaction. The reporter did not agree to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site cellulitis
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site cellulitis in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis and intramuscular formulation administered by other route. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site cellulitis and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX vaccine subcutaneously instead of intramuscular route by mistake, which led to incorrect route of vaccine administration. The patient received the SHINGRIX vaccine at the reporter's office, late last week from the date of reporting. The patient went to emergency room (ER) over the weekend and diagnosed with cellulitis at the injection site. The patient was given prescription for antibiotic. The patient asked if it was needed to repeat the 1st dose and if so, when it could be given.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles 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, less than a week after receiving SHINGRIX, the patient experienced shingles, rash and pain. On an unknown date, the outcome of the shingles, rash and pain were unknown. It was unknown if the reporter considered the shingles, rash and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received a dose of SHINGRIX in the office, within a week the patient returned as a follow up with rash on side and back. The reporting nurse diagnosed it as Shingles. The patient stated there was a slight pain at the rash site. No patient details were provided. The nurse agreed to be contacted for 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 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 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 provided as follows: This case was reported for the reporter's brother. The age at vaccination was not reported. The patient experienced soreness of arm at injection site for 3 to 4 days after 1st dose of SHINGRIX. For tolerance of 2nd dose refer linked case US2018136202, for same the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site nodule, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever 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, less than a year after receiving SHINGRIX, the patient experienced fever and injection site nodule. On an unknown date, the outcome of the fever and injection site nodule were unknown. It was unknown if the reporter considered the fever and injection site nodule to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had fist size knots at injection site and fever. Because of adverse reaction, the patient was advised by the reporter's office that not to get 2nd dose. This case linked to US2018GSK137728, reported by the same reporter.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse via phone on 31-Jul-2018. This case is linked to 2018SA212665, 2018SA212615, 2018SA212638 and 2018SA212627 (Same reporter). This case involves a 6 months old male patient who experienced received third dose of vaccine PENTACEL lot number C5529AA (expiry date: 04-Oct-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE RHBSAG (HEPA-B) for Immunisation; PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of Pentacel and the reporter was unsure which one of the 5 patients who recieved doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Inflammation, Injection site reaction, Rash, Rash macular
Clinical narrative: Patient experienced redness (splotches) on cheeks of face, neck, chest, back, and around injection site starting 1-2 days after both vaccinations. This redness lasted approximately 1 week and went away on its own. The redness had a warmth to it, but it did not itch. She did not experience and swelling in throat. The patient went to see her dermatologist Dr. for a routine office visit after her second dose where she was told to take CLARITIN in the morning and 1/2 of a levocetirizine tablet in the evening. She stated she did this for a couple days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient experienced redness (splotches) on cheeks of face, neck, chest, back, and around injection site starting 1-2 days after both vaccinations. This redness lasted approximately 1 week and went away on its own. The redness had a warmth to it, but it did not itch. She did not experience and swelling in throat. The patient went to see her dermatologist Dr. for a routine office visit after her second dose where she was told to take CLARITIN in the morning and 1/2 of a levocetirizine tablet in the evening. She stated she did this for a couple days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pyrexia, Vomiting
Clinical narrative: Patient c/o fever was 101F, vomiting and SOB after injection of SHINGRIX vaccine on 8/2/2018.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Mom called the office on 8/4 to say that patient had a rash all over her body 10 days after receiving her vaccines. As of 8/8 the rash was much better and had mostly cleared up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Musculoskeletal stiffness, Peripheral swelling, Skin warm
Clinical narrative: Pt has  swelling in Lt arm 50mm that istarted day after receiving SHINGRIX. Pt states it is warm to touch, stiff arm with some discomfort. Pt denies having any further symptoms post vaccination. Pt was concerned since this is not a live vaccination.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: In the evening after vaccinations that morning, the child developed redness, heat, swelling, and pain to the left arm where PCV-13 shot was given. Child was seen by provider and Mother was told that reaction was an allergy to the vaccine and returned to the health department for VAERS reporting.  Redness and heat observed on  left deltoid extending to the child's elbow with child guarding his arm.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Staff gave Dtap instead of Tdap. No signs or symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated
Clinical narrative: Patient reports asthma symptoms that were previously under control, exacerbating since receiving the vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Muscular weakness
Clinical narrative: Patient c/o dizzy, weakness of lower extremities, fatigue and pain on the left deltoid.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Immediately following injection patient began to have localized swelling, redness, and warmth measuring 8x10cm on the right thigh where the MMR was placed. Patient also has the same immediate reaction to VARIVAX which was placed in the right arm. That localized reaction was measured at 5x6cm. Markers were placed on each localized reaction sites so we could watch for continual spreading. Patient was kept in office for observation an additional hour to ensure no further reaction symptoms presented themselves. An ice pack was provided for both sites and patient was given Tylenol for pain. Mother was advised to watch for additional localized reaction. She voiced understanding and we have scheduled a follow up appointment so we may continue to monitor this patients outcome.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Patient called and stated that after his second immunization he experienced a fever reaching 100.2 F the evening following his shot. He also experienced sweats and chills and stiffness across his neck and shoulders to the point of being unable to turn his head the evening following his shot. He reported this morning feeling somewhat better but still aches all over. He reported that he felt this after his first shot but thought he may have just been coming down with a cold.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient called and stated that after his second immunization he experienced a fever reaching 100.2 F the evening following his shot. He also experienced sweats and chills and stiffness across his neck and shoulders to the point of being unable to turn his head the evening following his shot. He reported this morning feeling somewhat better but still aches all over. He reported that he felt this after his first shot but thought he may have just been coming down with a cold.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PPSV23 on 8/7/18. The evening of the vaccine patient report swelling, pain, redness and hardened tissue below insertion site, mid upper arm. Co-workers marked the redness this morning. Redness continues to remain within the marked border. Patient notes swelling has decreased significantly overnight. Pain started on the medial side of the upper arm and is spreading underneath and to the lateral side. Marked area is red, warm and hard. Home cares; ice, elevate, TYLENOL/ibuprofen, compression.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Tremor
Clinical narrative: Patient received the above vaccines on exam table and ambulated across room to a chair. 3-5 minutes, while the patient was sitting in the chair, she was watching her brother get his vaccines and began shaking and became diaphoretic. Shaking subsided without intervention. Patient was observed in clinic. During which time she was given water to drink and ice pack. Patient was no longer shaky, ambulatory, acting appropriately, alert and oriented, without reports of vision changes prior to leaving clinic.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abnormal behaviour, Blood test normal, Computerised tomogram head normal, Confusional state, Crying
Clinical narrative: Severe migraine onset around 2:45 PM. Patient was screaming and crying. He said he couldn't see. His face and lips were swelling. He vomited 3 times. His behavior changed and he became erratic and confused. Left side of his body was in pain down due his thigh.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Lip swelling, Migraine, Pain, Screaming, Swelling face
Clinical narrative: Severe migraine onset around 2:45 PM. Patient was screaming and crying. He said he couldn't see. His face and lips were swelling. He vomited 3 times. His behavior changed and he became erratic and confused. Left side of his body was in pain down due his thigh.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urine analysis normal, Visual impairment, Vomiting
Clinical narrative: Severe migraine onset around 2:45 PM. Patient was screaming and crying. He said he couldn't see. His face and lips were swelling. He vomited 3 times. His behavior changed and he became erratic and confused. Left side of his body was in pain down due his thigh.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient experienced cellulitis (w/o abcess) reaction after a few days after receiving the SHINGRIX vaccine. Received BACTRIM DS to treat.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Joint swelling, Pyrexia
Clinical narrative: Diarrhea, swollen joints in my hands, the joints were purple, shivering, fatigue, and fever of 105.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Diarrhea, swollen joints in my hands, the joints were purple, shivering, fatigue, and fever of 105.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Migraine, Pyrexia
Clinical narrative: Fever of 102 degrees F; migraine headache 12 hours after injection lasting 24 hours.