chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, 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 75-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 25th September 2018, 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, chills and localized erythema. On an unknown date, the outcome of the pain in arm, chills and localized erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient reported chills, arm soreness, and significant localized redness expanding up to the shoulder. The symptoms resolved after a few days. This case was linked to the case US2018184659, reported by the same reporter for the different patient who also experienced same symptoms with the same lot number.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 4-year-old male patient who received FLULAVAL QUADRIVALENT (batch number TL72B, expiry date 26th June 2019) for prophylaxis. On 9th October 2018, the patient received FLULAVAL QUADRIVALENT (intramuscular). In October 2018, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: It was reported that, the patient received FLULAVAL and experienced a fever of 102.4.
Age: 75.0
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 76-year-old male patient who received SHINGRIX for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case reported by the patient's wife. The patient received a dose of SHINGRIX on the left arm. The event was lasted for 2 days. This case has been linked with case US2018185583 and US2018GSK187827, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Middle insomnia, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, itchy upper limbs and nocturnal awakening. On an unknown date, the outcome of the injection site swelling, itchy upper limbs and nocturnal awakening were unknown. It was unknown if the reporter considered the injection site swelling, itchy upper limbs and nocturnal awakening to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient experienced swelling at injection site and it was just bigger than a 50-cent piece. The patient also had itching on both arms that caused her to wake up at night. The contact details of the physician was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, malaise, fever and injection site erythema. On an unknown date, the outcome of the injection site pain, malaise, fever and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, malaise, fever and injection site erythema 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 reported through online chat that, the patient's received SHINGRIX dose induced a bunch of the typical side effects (4 days of site pain and erythema, 1 to 2 days of malaise and low grade fever). The reporter wanted to known that, whether the patient would likely to have a similar post-vaccination course for the second dose as well. The reporter did not had time to provide more information. Due to imminent time constraints, reporter appreciated an answer to his question. The reporter did not had much time to provide additional background information at the time of reporting. He could provide it later.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 74-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown. It was unknown if the reporter considered the localized erythema and local swelling to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient experienced a localized reaction of redness and swelling. No further details were provided regarding the patient's experience.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 79-year-old female patient who received SHINGRIX (batch number D3L5G, expiry date 30th June 2019) for prophylaxis. On 7th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema. In September 2018, the patient experienced shingles. On an unknown date, the outcome of the shingles and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the shingles and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: Shortly after receiving the dose of SHINGRIX, in the first week of June, the patient developed a red mark at the injection site which looks like a Shingles sore. A few months (3 months) later, the patient was diagnosed with a Shingles outbreak. Shingles outbreak was not directly related to the red mark- the patient developed additional Shingles symptoms (details unknown) besides the injection site reaction, which led to the diagnosis. This diagnosis was made within the last month (September / October). Reporter was uncertain of vaccination date (states first week in June) and uncertain when the red mark first appeared, just that it was soon after that first dose. There had been no improvement in the red mark over the past 4 months, as far as the reporter was aware.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin eruption in a elderly female patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received SHINGRIX. On 8th October 2018, 14 days after receiving SHINGRIX, the patient experienced skin eruption and shingles. On an unknown date, the outcome of the skin eruption and shingles were unknown. It was unknown if the reporter considered the skin eruption and shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Monday or Tuesday of this reporting week, the patient experienced breaking out. The call center representative asked for the health care professional information, but the patient stated that the health care professional was going to give GlaxoSmithKline a call.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 79-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) 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 erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at administration was 79 years. The healthcare professional reported that the patient experienced redness and itching.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, 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 adult male patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix. In June 2018, 2 hrs after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and pain in arm. The patient was treated with oxycodone. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient reported injection site pain, arm pain, and could not raise his arm. The patient went to an emergency department and was prescribed oxycodone. After 1 month, the events resolved. The patient had denied permission to contact their physician. The reporter was the wife of the patient and she had to end the call.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Muscular dystrophy, X-ray normal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscular dystrophy in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced muscular dystrophy. On an unknown date, the outcome of the muscular dystrophy was not recovered/not resolved. It was unknown if the reporter considered the muscular dystrophy to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left arm approximately 2 months ago. The patient reported to the pharmacist that shortly after receiving the vaccine, she experienced muscle dystrophy in her left arm. The patient reported that her left arm looked smaller than her right arm. The patient went to see her physician and had an X-ray and the physician did not see anything unusual on the X-ray. The reporter did not have patients initials, patient's date of birth or lot number at the time of the call, however, he stated that he would call back tomorrow and provide this information.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pruritus in a elderly male patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received SHINGRIX. On 12th October 2018, 1 days after receiving SHINGRIX, the patient experienced pruritus, swelling and erythema. On an unknown date, the outcome of the pruritus, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the pruritus, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he experienced itching, redness, and a bump on his left foot. The patient reported that he contacted his physician's office. On 12th October 2018, at 1:38 AM, the patient contacted via after hours voicemail.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Shingrix for prophylaxis. On 5th October 2018, the patient received Shingrix. On 5th October 2018, unknown after receiving Shingrix, the patient experienced extra dose administered. In October 2018, the patient experienced fever, general body pain, headache and fatigue. On an unknown date, the outcome of the fever, general body pain, headache, fatigue and extra dose administered were unknown. It was unknown if the reporter considered the fever, general body pain, headache and fatigue to be related to Shingrix. Additional details were provided a follows: The patient reported that a couple days later after receiving Shingrix vaccine the Medical doctor office called to tell her that they mistakenly had given her a third dose of Shingrix at that time, which led to extra dose administered. Less than a week after receiving vaccination, the patient had experienced headache, extreme fatigue, body ache and fever. The reporter was unable to provide phone number or address for a physician since she was driving. The reporter was also unable to give dates of the first two doses of Shingrix.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product supply issue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 8th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and product supply issue. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever over 102 degree F. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 8th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and product supply issue. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever over 102 degree F. The patient had denied permission to contact their physician.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received Shingrix (batch number 3NY5G, expiry date 8th March 2021) for prophylaxis. On 4th October 2018, the patient received Shingrix (intramuscular). In October 2018, less than a month after receiving Shingrix, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix. Additional details were reported as follows: The patient received a dose of Shingrix on the left deltoid. On 11th October 2018, the patient stated that, she experienced redness and soreness on her arm. The reporter was not sure when the adverse events were started. The reported lot number (3NY56) for Shingrix did not exist and was updated to 3NY5G, according to sales datasheet.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pyrexia
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 10th October 2018, the patient received the 2nd dose of Shingrix .5 ml. In October 2018, less than a week after receiving Shingrix, the patient experienced fever, injection site erythema, injection site warmth, injection site swelling and injection site lump. On an unknown date, the outcome of the fever, injection site erythema, injection site warmth, injection site swelling and injection site lump were unknown. It was unknown if the reporter considered the fever, injection site erythema, injection site warmth, injection site swelling and injection site lump to be related to Shingrix. Additional details were provided as follows: The caller was retired nurse who received 2nd dose of Shingrix on left arm. The caller reported that she experienced fever and swelling, redness and warm to the touch at the injection site. The caller described a knot of about the size of a half-dollar at the injection site. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a adult patient who received Shingrix (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 5th October 2018, the patient received the 1st dose of Shingrix (intramuscular). In October 2018, less than a week after receiving Shingrix, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash 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 adult as per vaccine indication. The patient received Shingrix on an unknown arm. After receiving Shingrix, the patient experienced red rash started around the injection site which moved to the entire upper arm. The pharmacist did not provide the patient information.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In September 2018, the patient received the 1st dose of Shingrix. In September 2018, 1 day after receiving Shingrix, the patient experienced muscle pain, loss of energy, injection site erythema and fever. On an unknown date, the outcome of the muscle pain, loss of energy, injection site erythema and fever were recovered/resolved. It was unknown if the reporter considered the muscle pain, loss of energy, injection site erythema and fever to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix sometime in September 2018 exact date was not known. He had muscle aches, fever and no energy. The symptoms began 1 day after the dose and lasted for 4 to 5 days. The patient had a big red spot on the injection site the resolved after 3 days. The patient had denied permission to contact their physician. This case has been linked with case US2018186350, reported for his wife.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly female patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix. In July 2018, 1 day after receiving Shingrix, the patient experienced muscle pain, loss of energy and fever. On an unknown date, the outcome of the muscle pain and fever were recovered/resolved and the outcome of the loss of energy was unknown. It was unknown if the reporter considered the muscle pain, loss of energy and fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Th patient received Shingrix sometime in July 2018, and received 2nd dose in September 2018 exact dates not known. She reported muscle aches, fever, and no energy. The symptoms began 1 day after 1st dose of Shingrix and lasted for 2 to 3 days. This case has been linked with the case US2018186348, reported by her husband.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Shingrix for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix. On 9th October 2018, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site lump and injection site induration. On 11th October 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site lump and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site lump and injection site induration to be related to Shingrix. Additional details were reported as follows: After vaccination, the patient developed two lumps at the injection site which was hard and swollen.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Shingrix (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 10th October 2018, the patient received the 2nd dose of Shingrix 1 dosage form(s). In October 2018, less than a week after receiving Shingrix, the patient experienced rash and generalized pruritus. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the generalized pruritus was not recovered/not resolved. It was unknown if the reporter considered the rash and generalized pruritus to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rash down her arm and itching all over.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a adult female patient who received Shingrix for prophylaxis. In September 2018, the patient received the 1st dose of Shingrix (intramuscular). In September 2018, 1 day after receiving Shingrix, the patient experienced eye swelling. On an unknown date, the outcome of the eye swelling was recovered/resolved. It was unknown if the reporter considered the eye swelling to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. Approximately 6 weeks ago from the date of reporting, the patient received Shingrix. The day after receiving Shingrix, the patient had swelling around her right eye which resolved in approximately 3 days. The patient reported the event to her doctor via email. The reporter had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injury associated with device
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a female patient who intended to vaccinate the patient with Shingrix (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. It was unknown if the reporter considered the needle injury to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable. The reporter had a nursing student that was helping to administer vaccinations, she pricked her finger on the syringe that contained the adjuvant suspension. The product was not administered to a consumer.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 58-year-old female patient who received Shingrix (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2018, less than a week after receiving Shingrix, the patient experienced tiredness and erythema. On an unknown date, the outcome of the tiredness was unknown and the outcome of the erythema was not recovered/not resolved. It was unknown if the reporter considered the tiredness and erythema to be related to Shingrix. Additional details were reported as follows: After vaccination, the patient experienced redness 4 inches below the injection site. The reported lot number (D2945) for Shingrix did not exist and was updated to D294J, according to sales datasheet.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Vertigo
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 23rd July 2018, 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, back pain and vertigo. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, back pain and vertigo were recovered/resolved. It was unknown if the reporter considered the pain in arm, back pain and vertigo to be related to Shingrix. Additional details were provided as follows: The patient had significant side effects such as 36 hours of arm, leg, and back pain which was somewhat ameliorated with Ibuprofen post vaccination. Following that, the patient had 5 days of vertigo. The patient wanted to know should she receive the second dose,  what side effects can she expect, how effective was the vaccine with just 1 dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a 68-year-old female patient who received Shingrix for prophylaxis. In August 2018, the patient received the 1st dose of Shingrix. In August 2018, 1 day after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to Shingrix. Additional details were reported as follows: A day after given dose of Shingrix, the patient broke out in rash on left hand and foot and then it proceeded to abdomen and was considered as suspected shingles. The office called CDC to advise whether or not to give patient 2nd dose. It was left clinically up to provider. The patient had not received 2nd dose till the time of reporting. The GlaxoSmithKline MI number was given to the reporter. The reporter agreed to be follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patients experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix. Additional information received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The 6 to 7 patients experienced large red fist size bulls eye at injection site. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a male patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, pain, chills and influenza-like symptoms. On an unknown date, the outcome of the fever, pain, chills and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the fever, pain, chills and influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter received the Shingrix shot personally. The patient experienced pain, low grade fever, chills and flu like symptoms, which resolved in about 24 hours. The reporter could not think of any other reason for the symptoms. The registered pharmacist did the reporter agree to follow up from Glaxosmithkline.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a adult 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 fever and diarrhea. On an unknown date, the outcome of the fever and diarrhea were unknown. It was unknown if the reporter considered the fever and diarrhea to be related to Shingrix. Additional details were reported as follows: The reporter said that the patient had fever and diarrhea severe enough to visit an urgent care after receiving a dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: 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 Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional information received 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 experienced low grade fever. On an unknown date, the patient's body temperature was recorded as 102 degree F. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter and also linked to the case US2018GSK186373, reported for the same event. Lab Comments: On an unknown date, the patient's body temperature was recorded as 102 degree F.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patients experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. Additional information received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The 2 to 3 patients experienced flu-like symptoms. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patients 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 information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The 5 to 6 patients experienced sore arm. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, 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 Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional information received 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 experienced low grade fever. On an unknown date, the patient's body temperature was recorded as 102 degree F. The reporter agreed to follow up from GlaxoSmithKline. This has been linked to the case US2018GSK186345, reported by the same reporter for the same event. Lab Comments: On an unknown date, the patient's body temperature was recorded as 102 degree F.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in a 75-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose 0.5ml, received on 6th July 2018, intramuscularly, for tolerance refer case US2018157103). On 21st September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix. Additional details were provided as follows: This case was reported by patient for himself. The patient experienced events without malaise or headache.
Sex: U
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Influenza vaccine Quadrivalent for prophylaxis. On 9th October 2018 10:00, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 9th October 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced extensive swelling of vaccinated limb and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site itching to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. After receiving Flu vaccine, the patient experienced itching and swelling over an 8 cm by 8 cm by 3 cm area at the injection. The reporter knew it was a GSK product but was unable to provide the name or any other information at the time of the call. The staff member would call back to provide additional information. This case was transferred to medical information. This case has been linked with the case US2018183707, US2018183712 and US2018GSK186850 reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 9th October 2018 10:00, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 9th October 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced extensive swelling of vaccinated limb and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site itching to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. After receiving Flu vaccine, the patient experienced itching and swelling over an 8cm by 8cm by 3cm area at the injection. The reporter knows it was a GSK product but was unable to provide the name or any other information at the time of the call. The staff member would call back to provide additional information. This case was transferred to medical information. This case has been linked with the case US2018183707, US2018183712 and US2018GSK186849 reported by same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Furuncle, Influenza like illness, Pruritus, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 1st June 2018, refer case US2018185583). Concurrent medical conditions included wet macular degeneration and injection site pain. On 19th September 2018, the patient received the 2nd dose of Shingrix. On 19th September 2018, less than a day after receiving Shingrix, the patient experienced shivering, skin discoloration, boil in nose, itchy scalp and influenza-like symptoms. On 24th September 2018, the outcome of the shivering and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the skin discoloration, boil in nose and itchy scalp were not recovered/not resolved. It was unknown if the reporter considered the shivering, skin discoloration, boil in nose, itchy scalp and influenza-like symptoms to be related to Shingrix. Additional details were reported as follows: The patient was seen by her a physician. The patient planned to continue follow-up with her physician on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of rotator cuff tear in a female patient who received Shingrix for prophylaxis. In July 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rotator cuff tear and injection site pain. On an unknown date, the outcome of the rotator cuff tear and injection site pain were unknown. The reporter considered the rotator cuff tear and injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the day following injection, pain at the injection site was so severe that she went to the emergency room. The patient continued to have pain in her shoulder area since July 2018 injection and she was referred to an orthopedic physicians after an appointment with her primary care provider (PCP). The orthopedic surgeon informed the patient that it was the Shingrix vaccination that caused her rotator cuff to be torn (shortly after vaccination). The patient was threatening litigation against GlaxoSmithKline and the reporting pharmacist.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Shingrix for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix .5 ml. On 11th October 2018, 2 days after receiving Shingrix, the patient experienced shingles, painful rash and blister. On an unknown date, the outcome of the shingles, painful rash and blister were unknown. It was unknown if the reporter considered the shingles, painful rash and blister to be related to Shingrix. Additional details were provided as follows: The batch number was unknown. The patient experienced a painful blistering rash in a dermatomal pattern on the arm, chest and neck that did not cross the midline. This was verified as shingles by MD and by Dermatologist. Culture of blisters was not done at these visits but would be considered as follow up. The physician agreed to be contacted for follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in the right arm that traveled to the neck, tingling and numbness down the arm that spread down that entire right side of the body and to the right foot. Symptoms began to subside by the morning and by the time the patient called the pharmacy, tingling remained only in her foot.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-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 on 25th May 2018 and experienced injection site pain, refer case US2018185589). On 9th August 2018, the patient received the 2nd dose of Shingrix. On 9th August 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On 11th August 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were reported as follows: This case was reported by the patient's wife. The patient experienced injection site pain after receiving 2nd dose of Shingrix. The event was lasted for 2 days.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Feeling cold, Headache, Hypersensitivity, Injection site pain
Clinical narrative: Right deltoid pain started while still in office. Other symptoms lead to ED visit. 7:11 PM: Patient is a 16 YO male with history of allergies and asthma presents to the Emergency Room complaining of allergic reaction vaccination. Presents pediatrician's office today and received 2 - meningococcal vaccinations between 4 and 430. Approximately 1 hour later he began the 2 shiver, had a slow onset headache, felt cold, and had multiple bouts of nausea vomiting. He has no stridor drooling, no abnormal behavior, no new numbness or weakness, no shortness of breath or retractions, no chest pain, no angio or periorbital edema and in no acute distress.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: Right deltoid pain started while still in office. Other symptoms lead to ED visit. 7:11 PM: Patient is a 16 YO male with history of allergies and asthma presents to the Emergency Room complaining of allergic reaction vaccination. Presents pediatrician's office today and received 2 - meningococcal vaccinations between 4 and 430. Approximately 1 hour later he began the 2 shiver, had a slow onset headache, felt cold, and had multiple bouts of nausea vomiting. He has no stridor drooling, no abnormal behavior, no new numbness or weakness, no shortness of breath or retractions, no chest pain, no angio or periorbital edema and in no acute distress.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: Macular rash.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Impaired work ability, Pain, Pain in extremity
Clinical narrative: Pt stated arm was red swollen next day. Very painful unable to work for 2 days. Left work. Drove home. Not aware that he was driving home, got home. Left car running for two HRS. Had chills. But did not take temp or go to Emergency. Unable to contact pt for more Info. Left 2 message no return calls. Arm (R) still soar.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Pt stated arm was red swollen next day. Very painful unable to work for 2 days. Left work. Drove home. Not aware that he was driving home, got home. Left car running for two HRS. Had chills. But did not take temp or go to Emergency. Unable to contact pt for more Info. Left 2 message no return calls. Arm (R) still soar.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Swollen eyes. Pt contacted MD MD advised cold compress and Benadryl 50mg Q6 hours and to call 911 if breathing problems.