chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache, tiredness, influenza-like symptoms, pain in arm, weakness, joint pain and nausea. On an unknown date, the outcome of the headache, tiredness, influenza-like symptoms, pain in arm, weakness, joint pain and nausea were recovered/resolved. It was unknown if the reporter considered the headache, tiredness, influenza-like symptoms, pain in arm, weakness, joint pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the 1st dose about 2 months before the reporting date. The patient reported that she had a lot of side effects after receiving the SHINGRIX. The patient had not received the 2nd dose at the time of reporting. The patient said that she had both pain at the injection site and pain in the whole arm where she has received the injection. The patient did not want to share her address. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache, tiredness, influenza-like symptoms, pain in arm, weakness, joint pain and nausea. On an unknown date, the outcome of the headache, tiredness, influenza-like symptoms, pain in arm, weakness, joint pain and nausea were recovered/resolved. It was unknown if the reporter considered the headache, tiredness, influenza-like symptoms, pain in arm, weakness, joint pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the 1st dose about 2 months before the reporting date. The patient reported that she had a lot of side effects after receiving the SHINGRIX. The patient had not received the 2nd dose at the time of reporting. The patient said that she had both pain at the injection site and pain in the whole arm where she has received the injection. The patient did not want to share her address. The patient had denied permission to contact their physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Incorrect route of product administration, 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 erythema in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included denosumab (Prolia). On 5th October 2018 10:30, the patient received the 1st dose of SHINGRIX (subcutaneous). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness and intramuscular formulation administered by other route. On 6th October 2018, the patient experienced injection site erythema, shivering, injection site warmth and extensive swelling of vaccinated limb. On 7th October 2018, the patient experienced injection site itching. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)) and medication unknown (Anti-Itch Medication). On an unknown date, the outcome of the injection site erythema, injection site itching, injection site warmth and extensive swelling of vaccinated limb were not recovered/not resolved and the outcome of the shivering and injection site tenderness were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site itching, shivering, injection site tenderness, injection site warmth and extensive swelling of vaccinated limb to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, she got SHINGRIX and it was administered subcutaneously, which led to Inappropriate route of vaccination. The injection site was tender on same day of vaccination. One day after receiving SHINGRIX (next morning), the patient woke up with an egg size area that was red, swollen and hot to the touch. It continued to grow that day and she also experienced some shivering. On 6th October 2018, she felt like she was coming down with a cold. On 7th October 2018, 2 days after receiving SHINGRIX, when patient woke up she felt fine except for the redness and swelling at the injection site which was the size of a baseball. On 7th October 2018,  2 days after receiving SHINGRIX, the patient started getting itching at the injection site as well. On 8th October 2018, she saw her doctor and the redness and swelling was about 6 inches long by 4 inches wide. The patient had been prescribed an antibiotic and anti-itch medication.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included denosumab (Prolia). On 5th October 2018 10:30, the patient received the 1st dose of SHINGRIX (subcutaneous). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness and intramuscular formulation administered by other route. On 6th October 2018, the patient experienced injection site erythema, shivering, injection site warmth and extensive swelling of vaccinated limb. On 7th October 2018, the patient experienced injection site itching. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)) and medication unknown (Anti-Itch Medication). On an unknown date, the outcome of the injection site erythema, injection site itching, injection site warmth and extensive swelling of vaccinated limb were not recovered/not resolved and the outcome of the shivering and injection site tenderness were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site itching, shivering, injection site tenderness, injection site warmth and extensive swelling of vaccinated limb to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, she got SHINGRIX and it was administered subcutaneously, which led to Inappropriate route of vaccination. The injection site was tender on same day of vaccination. One day after receiving SHINGRIX (next morning), the patient woke up with an egg size area that was red, swollen and hot to the touch. It continued to grow that day and she also experienced some shivering. On 6th October 2018, she felt like she was coming down with a cold. On 7th October 2018, 2 days after receiving SHINGRIX, when patient woke up she felt fine except for the redness and swelling at the injection site which was the size of a baseball. On 7th October 2018,  2 days after receiving SHINGRIX, the patient started getting itching at the injection site as well. On 8th October 2018, she saw her doctor and the redness and swelling was about 6 inches long by 4 inches wide. The patient had been prescribed an antibiotic and anti-itch medication.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: neck pain; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 68-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 3rd October 2018, the patient received the 1st dose of SHINGRIX .5 ml. In October 2018, 14 hrs after receiving SHINGRIX, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was recovering/resolving. It was unknown if the reporter considered the neck pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX at around 1:00 PM in the afternoon. On 4th October 2018 at 3:00 AM, the patient woke up with neck pain. The patient made an appointment with her physician about for the neck pain. It was little bit better, but not recovered. Still the patient could not turn her head to the back without pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Pain, Pruritus, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th October 2018, 2 days after receiving SHINGRIX, the patient experienced pain, skin scaly, pimples, skin irritation, pruritus and erythema. On an unknown date, the outcome of the pain, skin scaly, pimples, skin irritation, pruritus and erythema were not recovered/not resolved. It was unknown if the reporter considered the pain, skin scaly, pimples, skin irritation, pruritus and erythema to be related to SHINGRIX. Additional details were provided as follows: At around 10:00 AM, the patient received a dose of SHINGRIX on left arm. The patient was at a football game and all of the sudden the patient had a breakout on her elbow that the patient described as a patchy section which was red, pimply looking area, irritated and scaly. This area was about 3 to 4 inches and 1 to 2.5 inches wide. The patient had concern about that, she might have shingles based on the appearance of the area but the patient was unsure. The patient was planning on see her physician on 10th October 2018.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th October 2018, 2 days after receiving SHINGRIX, the patient experienced pain, skin scaly, pimples, skin irritation, pruritus and erythema. On an unknown date, the outcome of the pain, skin scaly, pimples, skin irritation, pruritus and erythema were not recovered/not resolved. It was unknown if the reporter considered the pain, skin scaly, pimples, skin irritation, pruritus and erythema to be related to SHINGRIX. Additional details were provided as follows: At around 10:00 AM, the patient received a dose of SHINGRIX on left arm. The patient was at a football game and all of the sudden the patient had a breakout on her elbow that the patient described as a patchy section which was red, pimply looking area, irritated and scaly. This area was about 3 to 4 inches and 1 to 2.5 inches wide. The patient had concern about that, she might have shingles based on the appearance of the area but the patient was unsure. The patient was planning on see her physician on 10th October 2018.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced red blotches. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain and red blotches were recovered/resolved. It was unknown if the reporter considered the injection site pain and red blotches to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on left arm. The patient felt pain immediately upon receiving the injection which lasted for few days. The patient reported that, that pain was the most painful shot she ever received. Four days after vaccination with SHINGRIX, the patient had red blotches on her left arm between her shoulder and elbow. The blotches was treated with BENADRYL and the blotches were gone away the next day. This case has been linked with the case US2018182772, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. 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 details were provided as follows: The age at vaccination was not reported for the patients. The age group was not reported, but was selected adult as per vaccine indication. The reporter's physician informed her that, some of the other patients reported to the physician that the SHINGRIX vaccine was painful. The reporter did not have any additional details. This case has been linked with the case US2018182771, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult male patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site rash and injection site muscle pain. On an unknown date, the outcome of the injection site rash and injection site muscle pain were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was a physician. The age at vaccination was not reported. The patient received a dose of SHINGRIX on an unknown deltoid. The patient experienced tenderness at injection site. The patient was provided the limited information to the reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Product administered at inappropriate site
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fatigue in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 1st dose of SHINGRIX. On 4th October 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 5th October 2018, the patient experienced injection site pain. On 6th October 2018, the patient experienced fatigue, headache and muscle pain. On an unknown date, the outcome of the fatigue, headache, injection site pain and muscle pain were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the fatigue, headache, injection site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiry date were not reported. The patient received SHINGRIX at another site, which led to vaccine administered at inappropriate site. After receiving SHINGRIX, the patient experienced fatigue, severe muscle pain, headache and pain at injection site. No further information was provided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 7th October 2018, the patient received the 1st dose of SHINGRIX. On 8th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, erythema, chest pain and injection site warmth. On an unknown date, the outcome of the injection site pain, erythema, chest pain and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, erythema, chest pain and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at right deltoid at 14:00. The patient was experiencing pain at the injection site that extends to her hand and the site was hot.
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold sores lip in a male patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. On 9th October 2018, 1 days after receiving SHINGRIX, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown. It was unknown if the reporter considered the cold sores lip to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The next morning after receiving SHINGRIX, the patient developed a cold sore on his lip. The patient has denied permission to contact their physician.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 58-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, extremities hot feeling of, swelling and pruritus. On an unknown date, the outcome of the erythema, extremities hot feeling of, swelling and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema, extremities hot feeling of, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by other healthcare professional via chat for herself. After receiving SHINGRIX, the patient experienced redness, swelling and her arm was hot which lasted a week.The patient also felt very itchy like she wanted to reach inside and scratch it. The itching lessened as time went on but it lasted a week. Toward the end it would just itch occasionally, all of a sudden. The patient had not answered if this was first time reporting or follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 58-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 3rd October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced pruritus, feels awful and erythema. On an unknown date, the outcome of the pruritus, feels awful and erythema were unknown. It was unknown if the reporter considered the pruritus, feels awful and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. After receiving SHINGRIX, the patient experienced redness, feels terrible and itching. The patient actually felt so bad that she went to walk in clinic day before reporting to see someone. The reporter had not answer if this was first time reporting or follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: 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 female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved. It was unknown if the reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. During the summer of 2018, the patient received SHINGRIX on an unknown arm. After receiving SHINGRIX, the patient experienced achiness (entire body) and a sore arm which only lasted 1 day. The reporter did not have any additional information regarding the event and did not feel comfortable providing patient initials or date of birth.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, 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 71-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced pain in arm and pain in joint involving forearm. The patient was treated with prednisone. On an unknown date, the outcome of the pain in arm and pain in joint involving forearm were unknown. It was unknown if the reporter considered the pain in arm and pain in joint involving forearm to be related to SHINGRIX. Additional details were provided as follows: This case was reported via online chat. The patient had a possible adverse events. Two weeks after vaccination, the patient experienced a lot of pain in right arm (from wrist to elbow) and described it as the pain at skin surface. The pain was severe enough that her primary care provider prescribed prednisone to treat it. The patient had pain for over a week. The patient was wondered if this could had been from SHINGRIX and should she receive the 2nd dose of SHINGRIX.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Skin lesion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, pruritus and skin lesion. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles and skin lesion were recovering/resolving and the outcome of the pruritus was recovered/resolved. It was unknown if the reporter considered the shingles, pruritus and skin lesion to be related to SHINGRIX. Additional details were reported as follows: Less than 20 hours after vaccination, the patient experienced shingles and itching. The patient was treated with antiviral for itching. The contact details of the physician was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis.  On 3rd October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, touch sensitivity increased, blotchy, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, touch sensitivity increased and injection site erythema were recovering/resolving and the outcome of the blotchy and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, touch sensitivity increased, blotchy, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: On 3rd October 2018 at approximately 3:00 PM, the patient received SHINGRIX on the outside of her right arm. After vaccination, the patient experienced tremendous pain at the injection site and could not touch that area. It was sensitive to the touch and red for all days. At the time of reporting, the area looked large and red but it was itchy and the redness was faint. Initially the injection site area was a fire red color and had blotches. By the 4th or 5th day after vaccination, the redness became a faint red pink. The patient had denied permission to contact her a physician.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 92-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 11th June 2018; batch number: 3AF9E, expiry date: 2nd February 2021). On 1st October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reports a patient was diagnosed as having shingles after receiving their second dose in series of SHINGRIX. It was reported that the patient was seen and treated by their a physician, however patient's current condition was unknown. No further details were reported regarding the event.
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of infection 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, 2 days after receiving SHINGRIX, the patient experienced infection and generalized erythema. On an unknown date, the outcome of the infection and generalized erythema were recovered/resolved. It was unknown if the reporter considered the infection and generalized erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the patient used to normally get red when she used to recover from an infection. The patient stated that with example, if the patient was recovering from a sinus infection then she turns all red. Two to three days after vaccination, the patient looked all red like a boiled lobster. The patient assumed that, she was recovering from an infection from the SHINGRIX vaccine. The patient spoke with her a physician and the physician advised her not to receive the 2nd dose of SHINGRIX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, 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 61-year-old female patient who received SHINGRIX for prophylaxis.  On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On 3rd October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 5th October 2018, the patient experienced generalized aching, chills, headache and nausea. On 6th October 2018, the patient experienced tiredness. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, generalized aching, chills, injection site erythema, headache, nausea and tiredness were unknown. It was unknown if the reporter considered the injection site pain, generalized aching, chills, injection site erythema, headache, nausea and tiredness to be related to SHINGRIX. Additional details were reported as follows: This case was reported via online chat. The batch number and expiry date were not reported. One day after receiving vaccination, the patient experienced some soreness and redness around the injection site. The patient thought, she was good but not. On 5th October 2018, the patient also experienced severe headache, severe chills and aching all over. The patient felt nauseous and went to bed after taken the ibuprofen. On 6th October 2018, the patient felt very achy and tired. On 7th October 2018, the patient had intermittent episodes of chills.  On 8th October 2018, in the evening the patient had again another episode of chills. The patient was concerned about that, whether she should receive a 2nd dose in next 2 to 6 months. The patient not looking forward to a repeat of this for next dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis.  On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On 3rd October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 5th October 2018, the patient experienced generalized aching, chills, headache and nausea. On 6th October 2018, the patient experienced tiredness. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, generalized aching, chills, injection site erythema, headache, nausea and tiredness were unknown. It was unknown if the reporter considered the injection site pain, generalized aching, chills, injection site erythema, headache, nausea and tiredness to be related to SHINGRIX. Additional details were reported as follows: This case was reported via online chat. The batch number and expiry date were not reported. One day after receiving vaccination, the patient experienced some soreness and redness around the injection site. The patient thought, she was good but not. On 5th October 2018, the patient also experienced severe headache, severe chills and aching all over. The patient felt nauseous and went to bed after taken the ibuprofen. On 6th October 2018, the patient felt very achy and tired. On 7th October 2018, the patient had intermittent episodes of chills.  On 8th October 2018, in the evening the patient had again another episode of chills. The patient was concerned about that, whether she should receive a 2nd dose in next 2 to 6 months. The patient not looking forward to a repeat of this for next dose.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. 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 unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2018, the patient received a dose of SHINGRIX. No further details were provided. This case has been linked with case US2018GSK186075 (vaccinated with same lot number), reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No further details were provided.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Flu unspecified (Influenza vaccine). On 17th September 2018 02:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fatigue, general body pain, headache, shivering, feeling cold and influenza like illness. On an unknown date, the outcome of the pain in arm, fatigue, general body pain, headache, shivering, feeling cold and influenza like illness were recovered/resolved. It was unknown if the reporter considered the pain in arm, fatigue, general body pain, headache, shivering, feeling cold and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient was also given a flu shot at the same time that day. The patient experienced a sore arm after receiving the injection. A headache followed soon after. A couple of hours later, she felt chills, body aches and fatigue. The patient spent the next 24 hours in bed. All symptoms lasted approximately 24 hours. Less than a day after receiving SHINGRIX, the patient described it as feeling like she had the flu. The patient was very cold when she went to bed and had to put socks on and blankets.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: 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 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Flu unspecified (Influenza vaccine). On 17th September 2018 02:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fatigue, general body pain, headache, shivering, feeling cold and influenza like illness. On an unknown date, the outcome of the pain in arm, fatigue, general body pain, headache, shivering, feeling cold and influenza like illness were recovered/resolved. It was unknown if the reporter considered the pain in arm, fatigue, general body pain, headache, shivering, feeling cold and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient was also given a flu shot at the same time that day. The patient experienced a sore arm after receiving the injection. A headache followed soon after. A couple of hours later, she felt chills, body aches and fatigue. The patient spent the next 24 hours in bed. All symptoms lasted approximately 24 hours. Less than a day after receiving SHINGRIX, the patient described it as feeling like she had the flu. The patient was very cold when she went to bed and had to put socks on and blankets.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 77-year-old female patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 2nd October 2018 10:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd October 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, the patient did not feel good, kind of sick feeling after receiving SHINGRIX. This case has been linked to the case US2018183676, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell 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 reporter stated that, another pharmacist told her that, the patient experienced not feeling good after Shingrix and even worse after the second dose. The reporter did not had additional details about this report, as she mentioned she heard from another pharmacist. For tolerance to next dose, refer case US2018GSK186788. This case has been linked with the case US2018183672, reported by same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old male patient who received Shingrix for prophylaxis. In August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced tiredness and weird feeling. On an unknown date, the outcome of the tiredness and weird feeling were recovered/resolved. It was unknown if the reporter considered the tiredness and weird feeling to be related to Shingrix. Additional details were provided as follows: The patient received the vaccine on his left shoulder mid day a couple of months ago. The patient reported that he felt a bit tired and weird after receiving Shingrix vaccine. The reaction happened one day after the vaccination and he felt that way for a day or so and then it resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incorrect route of product administration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Shingrix (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 4th October 2018, the patient received Shingrix (subcutaneous) .5 ml. On 4th October 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 7th October 2018, the patient experienced injection site erythema, injection site itching, extensive swelling of vaccinated limb and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching, extensive swelling of vaccinated limb and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site itching, extensive swelling of vaccinated limb and injection site warmth to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix subcutaneously, which led to inappropriate route of vaccination. Three days after receiving Shingrix, the patient complained that the site of injection was red, swollen, hot to the touch and itching. The patient said that the site of injection was raised 5 inches around it.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Feeling abnormal, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received Shingrix (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 14th June 2018, the patient received the 1st dose of Shingrix 50 µg. On 15th June 2018, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced extensive swelling of vaccinated limb and feeling bad. On an unknown date, the outcome of the fever, extensive swelling of vaccinated limb and feeling bad were recovered/resolved. It was unknown if the reporter considered the fever, extensive swelling of vaccinated limb and feeling bad to be related to Shingrix. Additional details were provided as follows: Less than a year after Shingrix, the patient stated that, she had arm swelling of 3 to 5 inches around at the site. The reporter also noted a fever that started the next day after the shot, it lasted for about 30 hours. The reporter noted she felt bad and stayed in bed for a day. The patient did treat the fever with over the counter medication.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Induration, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 70-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, several hours after receiving Shingrix, the patient experienced fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue. On an unknown date, the outcome of the fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue were unknown. It was unknown if the reporter considered the fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the healthcare professional for herself. The age at vaccination was not reported but it could be 69 or 70 years. In the evening on the day of vaccination, the patient experienced fever, shivering, fatigue and pain in the left arm. The following day, the patient noted a 2.25 inch by 2.5 inch area about 2 inches below the injection site which was red, swollen, hard, warm to the touch and slightly painful.   The healthcare professional declined to provide an address for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 70-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, several hours after receiving Shingrix, the patient experienced fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue. On an unknown date, the outcome of the fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue were unknown. It was unknown if the reporter considered the fever, skin warm, swelling arm, erythema of extremities, shivering, pain in arm, induration and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the healthcare professional for herself. The age at vaccination was not reported but it could be 69 or 70 years. In the evening on the day of vaccination, the patient experienced fever, shivering, fatigue and pain in the left arm. The following day, the patient noted a 2.25 inch by 2.5 inch area about 2 inches below the injection site which was red, swollen, hard, warm to the touch and slightly painful.   The healthcare professional declined to provide an address for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of alopecia in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was not reported. It was unknown if the reporter considered the alopecia to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The HCP (healthcare professional) reported information through chat, however the HCP was no longer responding to the chat so this was the only information that was provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Faeces discoloured, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 58-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Methotrexate (patient was on Methotrexate a couple of years before the reporting date she had the same reaction as the Shingrix). On 9th October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th October 2018, less than a day after receiving Shingrix, the patient experienced nausea, vomiting and stool discolored. On an unknown date, the outcome of the nausea, vomiting and stool discolored were not recovered/not resolved. It was unknown if the reporter considered the nausea, vomiting and stool discolored to be related to Shingrix. Additional details were provided as follows: The patient reported that she received the Shingrix vaccine on left arm around 1:45 pm and she was concerned because on her way home she became nauseous and her bowels were fluorescent yellow last night and next morning. The patient also vomited twice the same color.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site dryness, Injection site rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 59-year-old male patient who received BOOSTRIX (batch number X9YP3, expiry date 2nd October 2020) for prophylaxis. On 13th July 2018, the patient received BOOSTRIX .5 ml. On 16th July 2018, 3 days after receiving BOOSTRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to BOOSTRIX. Additional information received as follows: At 14:58, the patient received BOOSTRIX on the left deltoid. The patient experienced a dry rash at injection site. It was unknown how long it took to resolve.