chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 14th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced sleeplessness and pain. On 15th August 2018, the patient experienced rash, swelling, erythematous rash, fever and skin warm. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the rash, swelling, erythematous rash and fever were not recovered/not resolved and the outcome of the sleeplessness and skin warm were unknown and the outcome of the pain was recovering/resolving.  It was unknown if the reporter considered the rash, sleeplessness, swelling, erythematous rash, pain, fever and skin warm to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient herself. At evening, the patient had SHINGRIX vaccine. The patient could not sleep that night because of the pain which made her twist and turn all night. The next morning, she noticed a rash about 3 to 2 inches in width which appeared about 2 inches below the injection site. It was a bit swollen and was red and warm to the touch. She took Motrin at morning and at evening, the day before reporting day, so the pain has improved a little but the rash seems to be worsening. The patient was transferred for additional assistance.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pruritus, Injection site swelling, Lip swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 56-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site bruising and injection site swelling. On 15th August 2018, the patient experienced injection site itching, lip swelling and facial swelling. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and epinephrine (Epi Pen). On an unknown date, the outcome of the injection site bruising, injection site itching, lip swelling, injection site swelling and facial swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site bruising, injection site itching, lip swelling, injection site swelling and facial swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient had the SHINGRIX vaccine and immediately experienced bruising and a big large swelling at the injection site. Overnight the patient experienced facial and lip swelling. The patient also experienced itching at the injection site. On the day of reporting, the patient went to the doctor and had series of cortisone injections and an epi pen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 56-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site bruising and injection site swelling. On 15th August 2018, the patient experienced injection site itching, lip swelling and facial swelling. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and epinephrine (Epi Pen). On an unknown date, the outcome of the injection site bruising, injection site itching, lip swelling, injection site swelling and facial swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site bruising, injection site itching, lip swelling, injection site swelling and facial swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient had the SHINGRIX vaccine and immediately experienced bruising and a big large swelling at the injection site. Overnight the patient experienced facial and lip swelling. The patient also experienced itching at the injection site. On the day of reporting, the patient went to the doctor and had series of cortisone injections and an epi pen.
Age: 70.0
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 70-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th April 2019) for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX(intramuscular) .5 ml. On 1st August 2018, 105 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with Antiviral. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient developed shingles. The patient was just finished her antiviral medication. The patient has denied permission to contact their physician. The pharmacist was transferred for additional assistance.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Shingrix for prophylaxis. On 2nd August 2018, the patient received the 1st dose of Shingrix. On 2nd August 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. Limited information was provided. The patient want to remain anonymous. The patient did not wanted to answer any further question and disconnected the call. The patient had also denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Shingrix for prophylaxis. On 2nd August 2018, the patient received the 1st dose of Shingrix. On 2nd August 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. Limited information was provided. The patient want to remain anonymous. The patient did not wanted to answer any further question and disconnected the call. The patient had also denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain 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 pain, malaise and injection site pain. On an unknown date, the outcome of the pain, malaise and injection site pain were unknown. It was unknown if the reporter considered the pain, malaise and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient had reported experiencing malaise, feeling achy and that the vaccine was painful. Five out of 3 patients experienced the same events. This case has been linked with case US2018GSK152862 and US2018GSK152863 reported by the same reporter.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 81-year-old female patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included Shingrix. On 13th August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th August 2018, immediately after receiving Shingrix, the patient experienced injection site pain. On 14th August 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, nausea, influenza-like symptoms and chills. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain, headache, nausea, influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain, headache, nausea, influenza-like symptoms and chills to be related to Shingrix. Additional information was reported as follows: On 12th June 2018, the patient was vaccinated with the 1st dose of Shingrix and she had not experienced any adverse events. After the injection the patient's arm was sore, but the next morning she had pain, redness and swelling at the injection site. She also had chills, nausea, flu-like symptoms and headache. The swelling had gotten to 4-5 inches in diameter. The patient saw her doctor and was instructed to ice the swelling.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 81-year-old female patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included Shingrix. On 13th August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th August 2018, immediately after receiving Shingrix, the patient experienced injection site pain. On 14th August 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, nausea, influenza-like symptoms and chills. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain, headache, nausea, influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain, headache, nausea, influenza-like symptoms and chills to be related to Shingrix. Additional information was reported as follows: On 12th June 2018, the patient was vaccinated with the 1st dose of Shingrix and she had not experienced any adverse events. After the injection the patient's arm was sore, but the next morning she had pain, redness and swelling at the injection site. She also had chills, nausea, flu-like symptoms and headache. The swelling had gotten to 4-5 inches in diameter. The patient saw her doctor and was instructed to ice the swelling.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and citric acid + corn syrup + quinine + water (Tonic Water). On 12th August 2018, the patient received the 2nd dose of SHINGRIX. On 13th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue. In August 2018, the patient experienced feeling hot, pruritus, erythema and swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the feeling hot, pruritus, erythema and swelling were not recovered/not resolved. It was unknown if the reporter considered the fatigue, feeling hot, pruritus, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: In early June 2018, the patient received 1st dose of SHINGRIX (for tolerance to 1st dose refer linked case US2018GSK153574). The patient was drinking a lot of tonic water, prior to getting the shot (24 ounces of tonic water everyday), as recommended by her physician. The patient waited for more than 2 months between doses. Less than a day after receiving SHINGRIX, the patient experienced swelling, heat, redness and itching close to the injection site. The patient said that it was not exactly where she got the injection, but slightly below, like three inches below her band aid from the shot. The patient also felt wiped out with fatigue on the following day after receiving the injection with both injections. The noticed that her symptoms were heightened, as they seem to linger a long time. The patient wonders if tonic water might interact with SHINGRIX. The patient wanted to report these observations in case other people notice the same thing. This case has been linked with US2018149466 and US2018GSK153538, reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and citric acid + corn syrup + quinine + water (Tonic Water). On 12th August 2018, the patient received the 2nd dose of SHINGRIX. On 13th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue. In August 2018, the patient experienced feeling hot, pruritus, erythema and swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the feeling hot, pruritus, erythema and swelling were not recovered/not resolved. It was unknown if the reporter considered the fatigue, feeling hot, pruritus, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: In early June 2018, the patient received 1st dose of SHINGRIX (for tolerance to 1st dose refer linked case US2018GSK153574). The patient was drinking a lot of tonic water, prior to getting the shot (24 ounces of tonic water everyday), as recommended by her physician. The patient waited for more than 2 months between doses. Less than a day after receiving SHINGRIX, the patient experienced swelling, heat, redness and itching close to the injection site. The patient said that it was not exactly where she got the injection, but slightly below, like three inches below her band aid from the shot. The patient also felt wiped out with fatigue on the following day after receiving the injection with both injections. The noticed that her symptoms were heightened, as they seem to linger a long time. The patient wonders if tonic water might interact with SHINGRIX. The patient wanted to report these observations in case other people notice the same thing. This case has been linked with US2018149466 and US2018GSK153538, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 64-year-old male patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received 23rd May 2018, refer linked case US2018GSK153111). On 13th August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th August 2018, immediately after receiving Shingrix, the patient experienced injection site pain. On 14th August 2018, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix. Additional information was reported as follows: The patient experienced pain in arm immedaitely after the vaccination. The patient also commented that it hurted a little more when compared to the first dose. There was no change in the injection technique for the first and the second dose. The next day after vaccination, the patient expereinced swelling at the injection site. The swelling had reached about 2 inches in diameter.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, 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 muscle pain in a 87-year-old male patient who received Shingrix for prophylaxis. Concomitant products included Shingrix. On 12th August 2018, the patient received the 2nd dose of Shingrix. On 13th August 2018, 1 days after receiving Shingrix, the patient experienced fatigue. In August 2018, the patient experienced injection site muscle pain and injection site erythema. On an unknown date, the outcome of the injection site muscle pain and fatigue were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, fatigue and injection site erythema to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient's wife. In early June 2018, the patient received 1st dose of Shingrix (for tolerance to 1st dose refer linked case US2018GSK153538). Less than a week after receiving 2nd dose of Shingrix, the patient experienced muscle pain close to the injection site with both injections and redness close to the injection site with his second dose. The redness close to the injection site was almost gone. The patient also felt wiped out with fatigue the following day after receiving both shots. This case has been linked with US2018149464, reported by the same reporter.
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 female patient who received Shingrix for prophylaxis. In June 2018, the patient received Shingrix. On an unknown date, several days 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 provided as follows: The age at the vaccination was not reported. The patient experienced Shingles a few days after vaccination. No additional information was provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received Shingrix (batch number 4492P, expiry date unknown) for prophylaxis. On 13th April 2018, the patient received the 1st dose of Shingrix. In April 2018, less than a day after receiving Shingrix, the patient experienced rash. In April 2018, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: The patient experienced a rash on half of the face within 24 hours after vaccination that lasted one week. The healthcare professional would like to know if there were any reports of these reactions and if the patient should receive the 2nd dose. No additional information was provided. Escalation to vaccine specialist was done. The reported batch number 44929 for Shingrix did not exist and was updated as 4492P as per sales database.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Lethargy, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 81-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles and pain. On 9th August 2018, the patient received Shingrix (intramuscular) 50 ug. On 10th August 2018, 1 days after receiving Shingrix, the patient experienced tiredness, upset stomach, lethargy and headache. In August 2018, the patient experienced pain localized and skin irritation. On an unknown date, the outcome of the tiredness, pain localized, upset stomach, lethargy and headache were not recovered/not resolved and the outcome of the skin irritation was unknown. It was unknown if the reporter considered the tiredness, pain localized, upset stomach, lethargy, headache and skin irritation to be related to Shingrix. Additional details were provided as follows: The next day after receiving vaccine the patient started experiencing bad headaches, she is tired and lethargic and her stomach did not feel well. She was experiencing these symptoms at the time of reporting. After getting Shingrix, the patient had a feeling in the area where she previously had shingles. It was not like last time, only a little painful and really just an annoyance. She did not have a rash. She thought that it felt like shingles but much less severe.
Age: 80.0
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 tiredness in a 81-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles and pain. On 9th August 2018, the patient received Shingrix (intramuscular) 50 ug. On 10th August 2018, 1 days after receiving Shingrix, the patient experienced tiredness, upset stomach, lethargy and headache. In August 2018, the patient experienced pain localized and skin irritation. On an unknown date, the outcome of the tiredness, pain localized, upset stomach, lethargy and headache were not recovered/not resolved and the outcome of the skin irritation was unknown. It was unknown if the reporter considered the tiredness, pain localized, upset stomach, lethargy, headache and skin irritation to be related to Shingrix. Additional details were provided as follows: The next day after receiving vaccine the patient started experiencing bad headaches, she is tired and lethargic and her stomach did not feel well. She was experiencing these symptoms at the time of reporting. After getting Shingrix, the patient had a feeling in the area where she previously had shingles. It was not like last time, only a little painful and really just an annoyance. She did not have a rash. She thought that it felt like shingles but much less severe.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site cellulitis in a 17-year-old male patient who received Bexsero for prophylaxis. On 16th July 2018, the patient received Bexsero. On 16th July 2018, immediately after receiving Bexsero, the patient experienced injection site cellulitis and injection site pain. On an unknown date, the outcome of the injection site cellulitis and injection site pain were unknown. It was unknown if the reporter considered the injection site cellulitis and injection site pain to be related to Bexsero. Additional details were provided as follows: The patient received Bexsero on an unknown arm. The healthcare professional (HCP) reported that the patient was vaccinated with Bexsero and immediately had pain in arm at injection site. Three days later, the patient was diagnosed with cellulitis in the injected arm. The sales representative did not have any additional details to provide.
Sex: M
Vaccine: HEPA, HPV4, MENB
Symptoms: Hypoaesthesia, Multiple sclerosis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of multiple sclerosis in a 17-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included HAVRIX for prophylaxis and GARDASIL for prophylaxis. The patient's past medical history included seizure (had an episode of seizure at the age of 4 years old). On an unknown date, the patient received BEXSERO, HAVRIX and GARDASIL at an unknown dose. On an unknown date, 7 days after receiving BEXSERO and HAVRIX, the patient experienced multiple sclerosis (serious criteria GSK medically significant) and numbness generalized. On an unknown date, the outcome of the multiple sclerosis and numbness generalized were unknown. It was unknown if the reporter considered the multiple sclerosis and numbness generalized to be related to BEXSERO and HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO, HAVRIX and GARDASIL on the same day. After a week of vaccination, the patient ended up at emergency room with numbness throughout the body. The patient was diagnosed with multiple sclerosis at the hospital. Upon finding it was noticed that the plaque with multiple sclerosis was old. As per physician it was believed that the immune response of the vaccine might have triggered the multiple sclerosis that was dormant in the body. The physician was in contact with the neurology department and was waiting for the final results. There was no diagnosis of multiple sclerosis prior to receiving the vaccine. The patient had been discharged from the hospital (no further details provided). It was unknown if the reporter considered the multiple sclerosis and numbness to be related to GARDASIL as well. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Cold sweat, Computerised tomogram head abnormal, Deafness unilateral, Diarrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (a bad case of chickenpox as a child). Concurrent medical conditions included rheumatoid arthritis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 10 hrs after receiving SHINGRIX, the patient experienced sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing. On 20th August 2018, the patient experienced hearing loss (serious criteria GSK medically significant). The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing were unknown. It was unknown if the reporter considered the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was a friend of the reporter. Ten hours after vaccination, the patient had vomiting and diarrhea. The patient had inner ear fluid imbalance. The patient went to the emergency room from 5 PM to 11:30 PM.  The patient had a computed tomography (CT) scan and was diagnosed with a sinus infection. The patient had been prescribed an antibiotic for treatment. The patient had a hearing test on the reporting date and had been diagnosed with hearing loss in her left ear (latency twelve day). This case has been linked with US2018151138 and US2018151143, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysstasia, Inner ear disorder, Labyrinthitis, Sinusitis, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (a bad case of chickenpox as a child). Concurrent medical conditions included rheumatoid arthritis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 10 hrs after receiving SHINGRIX, the patient experienced sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing. On 20th August 2018, the patient experienced hearing loss (serious criteria GSK medically significant). The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing were unknown. It was unknown if the reporter considered the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was a friend of the reporter. Ten hours after vaccination, the patient had vomiting and diarrhea. The patient had inner ear fluid imbalance. The patient went to the emergency room from 5 PM to 11:30 PM.  The patient had a computed tomography (CT) scan and was diagnosed with a sinus infection. The patient had been prescribed an antibiotic for treatment. The patient had a hearing test on the reporting date and had been diagnosed with hearing loss in her left ear (latency twelve day). This case has been linked with US2018151138 and US2018151143, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram head abnormal, Deafness unilateral, Diarrhoea, Discomfort, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (a bad case of chickenpox as a child). Concurrent medical conditions included rheumatoid arthritis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 10 hrs after receiving SHINGRIX, the patient experienced sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing. On 20th August 2018, the patient experienced hearing loss (serious criteria GSK medically significant). The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing were unknown. It was unknown if the reporter considered the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was a friend of the reporter. Ten hours after vaccination, the patient had vomiting and diarrhea. The patient had inner ear fluid imbalance. The patient went to the emergency room from 5 PM to 11:30 PM.  The patient had a computed tomography (CT) scan and was diagnosed with a sinus infection. The patient had been prescribed an antibiotic for treatment. The patient had a hearing test on the reporting date and had been diagnosed with hearing loss in her left ear (latency twelve day). This case has been linked with US2018151138 and US2018151143, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Sinusitis, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (a bad case of chickenpox as a child). Concurrent medical conditions included rheumatoid arthritis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 10 hrs after receiving SHINGRIX, the patient experienced sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing. On 20th August 2018, the patient experienced hearing loss (serious criteria GSK medically significant). The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing were unknown. It was unknown if the reporter considered the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was a friend of the reporter. Ten hours after vaccination, the patient had vomiting and diarrhea. The patient had inner ear fluid imbalance. The patient went to the emergency room from 5 PM to 11:30 PM.  The patient had a computed tomography (CT) scan and was diagnosed with a sinus infection. The patient had been prescribed an antibiotic for treatment. The patient had a hearing test on the reporting date and had been diagnosed with hearing loss in her left ear (latency twelve day). This case has been linked with US2018151138 and US2018151143, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Computerised tomogram, Deafness unilateral, Nausea, Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (a bad case of chickenpox as a child). Concurrent medical conditions included rheumatoid arthritis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 10 hrs after receiving SHINGRIX, the patient experienced sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing. On 20th August 2018, the patient experienced hearing loss (serious criteria GSK medically significant). The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing were unknown. It was unknown if the reporter considered the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was a friend of the reporter. Ten hours after vaccination, the patient had vomiting and diarrhea. The patient had inner ear fluid imbalance. The patient went to the emergency room from 5 PM to 11:30 PM.  The patient had a computed tomography (CT) scan and was diagnosed with a sinus infection. The patient had been prescribed an antibiotic for treatment. The patient had a hearing test on the reporting date and had been diagnosed with hearing loss in her left ear (latency twelve day). This case has been linked with US2018151138 and US2018151143, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Haemorrhage
Clinical narrative: This case was reported by a consumer and described the occurrence of accidental underdose in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that when the pharmacist withdrew the needle, some fluid ran down her arm, so she guessed that she did not get a full dose, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The patient was hoping that this was not a huge concern in the case of a booster dose. The patient did not think it was a huge amount, but it was more than a couple of drops. The patient reported that the pharmacist said that they had 80 doses left and that she had been giving about 20 vaccinations a day. One person also said that another nearby pharmacy had already run out of its supply. Follow up information received from consumer on 15th August 2018: As per the reporter, this was not an adverse event after all. Initially, the reporter thought that the fluid that dripped on her arm was vaccine, but upon closer inspection, it was clear that it was blood.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 80-year-old female patient who received Shingrix (batch number C523T, expiry date unknown) for prophylaxis. On 9th April 2018, the patient received Shingrix .5 ml. On 11th April 2018, 2 days after receiving Shingrix, the patient experienced fever, diarrhea and vomiting. On an unknown date, the outcome of the fever, diarrhea and vomiting were recovered/resolved. The reporter considered the fever, diarrhea and vomiting to be unrelated to Shingrix. Additional details were provided as follows: On 11th April 2018, in evening the patient experienced low grade fever, diarrhea lasting 10-14 days and vomiting. The patient was seen 10 days after vaccine administration for complaints of diarrhea. The patient was seen prescriber who did not believe events were related to product. The patient was seen again on 25th July 2018 and symptoms resolved but did not wish to receive 2nd dose. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain 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 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. The patient experienced local injection site pain lasting 2 days. The reporter agreed to be contacted for follow up. This case has been linked with US2018GSK153816, reported for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling hot in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling hot and pain. On an unknown date, the outcome of the feeling hot and pain were recovered/resolved. It was unknown if the reporter considered the feeling hot and pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient felt feverish and achy for approximately 6 hours post vaccination with Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. On 14th August 2018, 14 days 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 provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient received SHINGRIX at a pharmacy 2 weeks before the date of reporting and on the day of reporting the patient was diagnosed with shingles. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days 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 information was reported as follows: The age at vaccination was not reported. The patient experienced second round of Shingles after vaccination with Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of pain in arm 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 pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the pain in arm, swelling arm and erythema of extremities 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 captured as adult as per the vaccine indication. The case was received from other manufacturer's medical representative, who provided the information reported by the nurse. The nurse reported that the patient received Shingrix and experienced painful and red swelling on the arm. No additional information was provided. This case has been linked with case US2018GSK148212, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of pain in arm 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 pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the pain in arm, swelling arm and erythema of extremities 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 captured as adult as per the vaccine indication. The case was received from other manufacturer's medical representative, who provided the information reported by the nurse. The nurse reported that patient received Shingrix and experienced painful and red swelling on the arm. No additional information was provided. This case has been linked with case US2018GSK148210, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This case was reported by a consumer via other and described the occurrence of back pain in a male patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received SHINGRIX. On 21st July 2018, 2 days after receiving SHINGRIX, the patient experienced back pain. On an unknown date, the outcome of the back pain was unknown. It was unknown if the reporter considered the back pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The customer received a SHINGRIX vaccine and 2 days later he sustained severe lower back pain. He had been to the physician and had no relief.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 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 injection site pain, fever and myalgia. On an unknown date, the outcome of the injection site pain, fever and myalgia were unknown. It was unknown if the reporter considered the injection site pain, fever and myalgia 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.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Rash erythematous
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site rash in a 64-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concurrent medical conditions included adhesive tape allergy (the patient avoid adhesive). On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash, erythematous rash and raised rash. On an unknown date, the patient experienced tiredness. On 24th June 2018, the outcome of the injection site rash, erythematous rash and raised rash were recovered/resolved. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the injection site rash, erythematous rash, raised rash and tiredness to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced red, raised rash coming down from the site of injection 3 and half inches round. Less than a year after receiving SHINGRIX, the patient experienced tiredness. The patient iced and rested.