chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Balance disorder, Headache, Immediate post-injection reaction, Malaise, Musculoskeletal discomfort
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of photophobia in a 18-year-old female patient who received BEXSERO (batch number 16A901, expiry date 28th February 2019) for prophylaxis. Previously administered products included BEXSERO with an associated reaction of pain in extremity (1st dose received on 14th June 2018, for tolerance see case US2018GSK134400). On 18th July 2018 09:30, the patient received the 2nd dose of BEXSERO (intramuscular). On 18th July 2018, immediately after receiving BEXSERO, the patient experienced photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever. The patient was treated with MOTRIN. On an unknown date, the outcome of the photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever were recovering/resolving. It was unknown if the reporter considered the photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left arm. On 18th July 2018, in the morning around 9:30-10, the patient received a dose of BEXSERO and immediately after receiving vaccine experienced headache, light sensitivity, vomiting, fever, and her balance was off. The patient stopped back to HCP's (healthcare profession) office around lunch and looked pale and sick. The doctor did a neurological assessment and the patient looked better from a neurological perspective, with the exception of the headache and light sensitivity. The patient's balance was better, as per the physician when the physician bent the patient's neck, the patient did complain but it was not really stiff. On the same day around 4pm, during a phone conversation, it was revealed that the patient took 800mg of MOTRIN and was doing better and that her symptoms were improving. This case has been linked with case US2018GSK134400 (1st dose) reported by the same reporter for the same patient. Lab Comments: The patient looked better from a neurological perspective, with the exception of the headache and light sensitivity.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Neurological examination, Pallor, Photophobia, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of photophobia in a 18-year-old female patient who received BEXSERO (batch number 16A901, expiry date 28th February 2019) for prophylaxis. Previously administered products included BEXSERO with an associated reaction of pain in extremity (1st dose received on 14th June 2018, for tolerance see case US2018GSK134400). On 18th July 2018 09:30, the patient received the 2nd dose of BEXSERO (intramuscular). On 18th July 2018, immediately after receiving BEXSERO, the patient experienced photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever. The patient was treated with MOTRIN. On an unknown date, the outcome of the photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever were recovering/resolving. It was unknown if the reporter considered the photophobia, vomiting, neck discomfort, balance disorder, looked pale, sickness, headache and fever to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left arm. On 18th July 2018, in the morning around 9:30-10, the patient received a dose of BEXSERO and immediately after receiving vaccine experienced headache, light sensitivity, vomiting, fever, and her balance was off. The patient stopped back to HCP's (healthcare profession) office around lunch and looked pale and sick. The doctor did a neurological assessment and the patient looked better from a neurological perspective, with the exception of the headache and light sensitivity. The patient's balance was better, as per the physician when the physician bent the patient's neck, the patient did complain but it was not really stiff. On the same day around 4pm, during a phone conversation, it was revealed that the patient took 800mg of MOTRIN and was doing better and that her symptoms were improving. This case has been linked with case US2018GSK134400 (1st dose) reported by the same reporter for the same patient. Lab Comments: The patient looked better from a neurological perspective, with the exception of the headache and light sensitivity.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a year after receiving SHINGRIX, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were not recovered/not resolved. It was unknown if the reporter considered the general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For further tolerance, refer case US2018GSK135599.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Anxiety, Chest discomfort, Fatigue, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included open heart surgery. Concurrent medical conditions included angina pectoris and post-traumatic stress disorder (PTSD). Concomitant products included amlodipine, Aspirin, Atorvastatin, Bupropion, Buspirone Hcl, fenofibrate, Losartan, Magnesium, Meclizine, Montelukast, omeprazole, ranitidine hydrochloride, ZYRTEC, Calcium+D3, clonidine, Fluticasone Nasal Spray, hydrochlorothiazide, Insulin, KLOR CON, melatonin, metoprolol, NITRO-PATCH, primidone, TRESIBA and TYLENOL. On 19th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm. On an unknown date, the outcome of the fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient planned to follow-up with her physician on an unknown date. The patient has given consent to contact their physician.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included open heart surgery. Concurrent medical conditions included angina pectoris and post-traumatic stress disorder (PTSD). Concomitant products included amlodipine, Aspirin, Atorvastatin, Bupropion, Buspirone Hcl, fenofibrate, Losartan, Magnesium, Meclizine, Montelukast, omeprazole, ranitidine hydrochloride, ZYRTEC, Calcium+D3, clonidine, Fluticasone Nasal Spray, hydrochlorothiazide, Insulin, KLOR CON, melatonin, metoprolol, NITRO-PATCH, primidone, TRESIBA and TYLENOL. On 19th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm. On an unknown date, the outcome of the fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the fatigue, memory loss, skin discoloration, chest discomfort, anxiety and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient planned to follow-up with her physician on an unknown date. The patient has given consent to contact their physician.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Device failure, Dizziness, Fall, Head injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fall in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, less than a year after receiving SHINGRIX, the patient experienced fall, head injury, dizziness and denture failure. On an unknown date, the outcome of the fall, head injury, dizziness and denture failure were unknown. It was unknown if the reporter considered the fall, head injury, dizziness and denture failure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the daughter of the patient. In 2018, at 4 PM, the patient received a dose of SHINGRIX. The patient stated that her mother said that she had fallen since she had the injection. The reporter said she received a call from her mother in morning of day of reporting, her mother said that she had just been able to get phone call from her daughter. The patient said that she had fallen 3 times, was dizzy, heat her head and had broken her denture. The reporter said that she did not know all the details since she had not gone to see her mother yet but was on her way.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Complication associated with device, Contusion, Fall, Head injury, Injection site bruising
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fall in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, less than a year after receiving SHINGRIX, the patient experienced fall, head injury, dizziness and denture failure. On an unknown date, the outcome of the fall, head injury, dizziness and denture failure were unknown. It was unknown if the reporter considered the fall, head injury, dizziness and denture failure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the daughter of the patient. In 2018, at 4 PM, the patient received a dose of SHINGRIX. The patient stated that her mother said that she had fallen since she had the injection. The reporter said she received a call from her mother in morning of day of reporting, her mother said that she had just been able to get phone call from her daughter. The patient said that she had fallen 3 times, was dizzy, heat her head and had broken her denture. The reporter said that she did not know all the details since she had not gone to see her mother yet but was on her way.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip injury, Oral contusion, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fall in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, less than a year after receiving SHINGRIX, the patient experienced fall, head injury, dizziness and denture failure. On an unknown date, the outcome of the fall, head injury, dizziness and denture failure were unknown. It was unknown if the reporter considered the fall, head injury, dizziness and denture failure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the daughter of the patient. In 2018, at 4 PM, the patient received a dose of SHINGRIX. The patient stated that her mother said that she had fallen since she had the injection. The reporter said she received a call from her mother in morning of day of reporting, her mother said that she had just been able to get phone call from her daughter. The patient said that she had fallen 3 times, was dizzy, heat her head and had broken her denture. The reporter said that she did not know all the details since she had not gone to see her mother yet but was on her way.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discomfort. On 20th July 2018, the patient experienced erythema. On an unknown date, the outcome of the injection site discomfort and erythema were unknown. It was unknown if the reporter considered the injection site discomfort and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. The age at vaccination was not reported. After receiving SHINGRIX, the patient initially had some discomfort at the injection site. Three days after receiving SHINGRIX, the patient developed redness on her hands, face and thighs. The patient did not have any swelling of the face or throat. This case has been linked with case US2018130266, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a male patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX,  the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had some discomfort at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthritis, Chills, Condition aggravated, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 15th March 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills. On 19th March 2018, the outcome of the injection site tenderness was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient was in her mid sixties and reported the presentation of all symptoms. At 15:30, the patient received SHINGRIX on the left arm. The patient experienced very red left arm and swollen at the injection site, which was hot to touch and tender. The arthritis flare up was in the joints of her fingers. The patient described it as similar to the reaction to an insect sting. The tenderness subsided after the 4 days but the swelling and itchiness lasted over 3 weeks before it resolved. The patient refused to provide the demographics or date of birth.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 15th March 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills. On 19th March 2018, the outcome of the injection site tenderness was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient was in her mid sixties and reported the presentation of all symptoms. At 15:30, the patient received SHINGRIX on the left arm. The patient experienced very red left arm and swollen at the injection site, which was hot to touch and tender. The arthritis flare up was in the joints of her fingers. The patient described it as similar to the reaction to an insect sting. The tenderness subsided after the 4 days but the swelling and itchiness lasted over 3 weeks before it resolved. The patient refused to provide the demographics or date of birth.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 15th March 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills. On 19th March 2018, the outcome of the injection site tenderness was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site tenderness, injection site itching, flare up of arthritis, fever, pain, upset stomach, tremor, injection site swelling and chills to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient was in her mid sixties and reported the presentation of all symptoms. At 15:30, the patient received SHINGRIX on the left arm. The patient experienced very red left arm and swollen at the injection site, which was hot to touch and tender. The arthritis flare up was in the joints of her fingers. The patient described it as similar to the reaction to an insect sting. The tenderness subsided after the 4 days but the swelling and itchiness lasted over 3 weeks before it resolved. The patient refused to provide the demographics or date of birth.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria, Pruritus generalised, Rash generalised, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), cetirizine hydrochloride (Zyrtec), omeprazole, rosuvastatin calcium (Rosuvastatin), vitamin d, ubidecarenone (Coq10), fish oil and raloxifene. On 8th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 9th June 2018, the patient experienced generalized pruritus, erythromacular rash and injection site hives. On an unknown date, the outcome of the injection site pain and injection site hives were recovered/resolved and the outcome of the generalized pruritus and erythromacular rash were not recovered/not resolved.  It was unknown if the reporter considered the injection site pain, generalized pruritus, erythromacular rash and injection site hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by reporter for herself. The patient was administered SHINGRIX in the left deltoid. One day after receiving vaccination, the patient experienced itching all over body, red dots all over body and hives around injection site. The patient planned to continue follow-up with her physician on an unknown date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 60-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 7th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, injection site swelling and influenza-like symptoms. On an unknown date, the outcome of the injection site rash, injection site pain, injection site swelling and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site pain, injection site swelling and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: SHINGRIX was administered in left arm. The pharmacist stated that the patient experienced pain, rash and swelling at the injection site. The patient also had flu like symptoms. All the events resolved in 5 days. No further details were provided.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site pain, Lethargy, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), calcium salt (Calcium Unknown), simvastatin, vitamin d and cetirizine hydrochloride (Zyrtec). On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, lethargy, fever, myalgia and shivering. On 26th April 2018, the outcome of the headache and lethargy were recovered/resolved. On 12th July 2018, the outcome of the injection site pain, fever and myalgia were recovered/resolved. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, lethargy, fever, myalgia and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left arm. The patient planned to continue follow-up with her physician on an unknown date. For the tolerability of 2nd dose, refer case US2018GSK135622 reported for same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), calcium salt (Calcium Unknown), simvastatin, vitamin d and cetirizine hydrochloride (Zyrtec). On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, lethargy, fever, myalgia and shivering. On 26th April 2018, the outcome of the headache and lethargy were recovered/resolved. On 12th July 2018, the outcome of the injection site pain, fever and myalgia were recovered/resolved. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, lethargy, fever, myalgia and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left arm. The patient planned to continue follow-up with her physician on an unknown date. For the tolerability of 2nd dose, refer case US2018GSK135622 reported for same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Nausea, 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 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), calcium salt (Calcium Unknown), simvastatin, vitamin d and cetirizine hydrochloride (Zyrtec). On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, lethargy, fever, myalgia and shivering. On 26th April 2018, the outcome of the headache and lethargy were recovered/resolved. On 12th July 2018, the outcome of the injection site pain, fever and myalgia were recovered/resolved. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, lethargy, fever, myalgia and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left arm. The patient planned to continue follow-up with her physician on an unknown date. For the tolerability of 2nd dose, refer case US2018GSK135622 reported for same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), calcium salt (Calcium Unknown), simvastatin, vitamin d and cetirizine hydrochloride (Zyrtec). On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, lethargy, fever, myalgia and shivering. On 26th April 2018, the outcome of the headache and lethargy were recovered/resolved. On 12th July 2018, the outcome of the injection site pain, fever and myalgia were recovered/resolved. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, lethargy, fever, myalgia and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left arm. The patient planned to continue follow-up with her physician on an unknown date. For the tolerability of 2nd dose, refer case US2018GSK135622 reported for same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site pain, Lethargy, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after 1st dose received on 25th April 2018, refer case US2018130290). Concomitant products included acetylsalicylic acid, calcium salt, simvastatin, vitamin D and ZYRTEC. On 11th July 2018, the patient received the 2nd dose of SHINGRIX. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, chills, vomiting and nausea. Rechallenge with SHINGRIX was positive. On 12th July 2018, the outcome of the fatigue, chills, vomiting and nausea were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, vomiting and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient planned to continue follow-up with her physician on an unknown date.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after 1st dose received on 25th April 2018, refer case US2018130290). Concomitant products included acetylsalicylic acid, calcium salt, simvastatin, vitamin D and ZYRTEC. On 11th July 2018, the patient received the 2nd dose of SHINGRIX. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, chills, vomiting and nausea. Rechallenge with SHINGRIX was positive. On 12th July 2018, the outcome of the fatigue, chills, vomiting and nausea were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, vomiting and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient planned to continue follow-up with her physician on an unknown date.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after 1st dose received on 25th April 2018, refer case US2018130290). Concomitant products included acetylsalicylic acid, calcium salt, simvastatin, vitamin D and ZYRTEC. On 11th July 2018, the patient received the 2nd dose of SHINGRIX. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, chills, vomiting and nausea. Rechallenge with SHINGRIX was positive. On 12th July 2018, the outcome of the fatigue, chills, vomiting and nausea were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, vomiting and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient planned to continue follow-up with her physician on an unknown date.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after 1st dose received on 25th April 2018, refer case US2018130290). Concomitant products included acetylsalicylic acid, calcium salt, simvastatin, vitamin D and ZYRTEC. On 11th July 2018, the patient received the 2nd dose of SHINGRIX. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, chills, vomiting and nausea. Rechallenge with SHINGRIX was positive. On 12th July 2018, the outcome of the fatigue, chills, vomiting and nausea were recovered/resolved. It was unknown if the reporter considered the fatigue, chills, vomiting and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient planned to continue follow-up with her physician on an unknown date.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 18th July 2018, the patient experienced tingling of extremity, numbness of upper extremities and erythema. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the tingling of extremity, numbness of upper extremities and erythema were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, tingling of extremity, numbness of upper extremities and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX vaccine on an unknown arm and her arm was sore and throbbing that first day and the evening of next day, she noticed a spot by her elbow on the arm where she received the injection was numb and sometimes tingling. The patient provided contact details of the physician.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Sciatica
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sciatica in a 75-year-old male patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. Concurrent medical conditions included sciatica (on right leg). On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced sciatica. On an unknown date, the outcome of the sciatica was unknown. It was unknown if the reporter considered the sciatica to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX vaccine in the left deltoid. The pharmacist had a patient who received the SHINGRIX vaccination a day before reporting and began to experience sciatica down his left leg.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 62-year-old male patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th July 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The health care professional (HCP) reported that the patient received a dose of SHINGRIX and then 2 days later developed a rash in the right groin area. The patient went to see a doctor for this event. The rash was itchy but it was not painful so they did not think it was a shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site oedema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site edema in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site edema. In May 2018, the outcome of the injection site edema was recovered/resolved.  It was unknown if the reporter considered the injection site edema to be related to SHINGRIX. Additional information was received as follows: The case was reported by the pharmacy intern. The age at vaccination was not reported. The reporter did not know the exact date of the vaccination but estimated it to be around 20th May 2018. The patient received SHINGRIX on the left arm. The patient experienced fluid build up at the injection site, the day following the injection. The build up also migrated a little down the arm. It lasted for approximately one week. The reporter did not have any additional details.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atopic dermatitis and allergy to feathers. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injected limb mobility decreased, injection site swelling, dizziness, injection site erythema, malaise and nausea. On 28th June 2018, the outcome of the injected limb mobility decreased, injection site swelling, dizziness, injection site erythema and malaise were recovered/resolved. On 30th June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, injection site swelling, dizziness, injection site erythema, malaise and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving EPIPEN as a concomitant medication. The patient stated after getting the vaccine her arm was in pain and she could hardly lift it. The patient also experienced malaise, dizziness and nausea. Along with swelling and redness at the injection site. The pain lasted for total of three days, and everything else was gone by the next morning post vaccination. The patient had denied permission to contact their physician. No further details were provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atopic dermatitis and allergy to feathers. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injected limb mobility decreased, injection site swelling, dizziness, injection site erythema, malaise and nausea. On 28th June 2018, the outcome of the injected limb mobility decreased, injection site swelling, dizziness, injection site erythema and malaise were recovered/resolved. On 30th June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, injection site swelling, dizziness, injection site erythema, malaise and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving EPIPEN as a concomitant medication. The patient stated after getting the vaccine her arm was in pain and she could hardly lift it. The patient also experienced malaise, dizziness and nausea. Along with swelling and redness at the injection site. The pain lasted for total of three days, and everything else was gone by the next morning post vaccination. The patient had denied permission to contact their physician. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Impaired work ability, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, fainting, shivering, fatigue, radiating pain, fever, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site swelling, injection site erythema, fatigue and radiating pain were not recovered/not resolved and the outcome of the fainting, shivering and fever were recovered/resolved and the outcome of the injection site warmth and injection site induration were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, fainting, shivering, fatigue, radiating pain, fever, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist said that this patient came back into the pharmacy to speak to the pharmacist about the side effects she experienced. The patient told the pharmacist that at the injection site, her skin was warm, red, swollen and hard. After the vaccination, the patient went back to work but had to leave because of more side effects. The patient said that she started shivering, had fever and felt like she might faint. There was pain that radiated from her arm around to the back of her neck. This information was all that the reporter had now. The reporter said she might reach out to the customer to get more information from her and possibly speak to medical information about the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, fainting, shivering, fatigue, radiating pain, fever, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site swelling, injection site erythema, fatigue and radiating pain were not recovered/not resolved and the outcome of the fainting, shivering and fever were recovered/resolved and the outcome of the injection site warmth and injection site induration were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, fainting, shivering, fatigue, radiating pain, fever, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist said that this patient came back into the pharmacy to speak to the pharmacist about the side effects she experienced. The patient told the pharmacist that at the injection site, her skin was warm, red, swollen and hard. After the vaccination, the patient went back to work but had to leave because of more side effects. The patient said that she started shivering, had fever and felt like she might faint. There was pain that radiated from her arm around to the back of her neck. This information was all that the reporter had now. The reporter said she might reach out to the customer to get more information from her and possibly speak to medical information about the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, fainting, shivering, fatigue, radiating pain, fever, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site swelling, injection site erythema, fatigue and radiating pain were not recovered/not resolved and the outcome of the fainting, shivering and fever were recovered/resolved and the outcome of the injection site warmth and injection site induration were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, fainting, shivering, fatigue, radiating pain, fever, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist said that this patient came back into the pharmacy to speak to the pharmacist about the side effects she experienced. The patient told the pharmacist that at the injection site, her skin was warm, red, swollen and hard. After the vaccination, the patient went back to work but had to leave because of more side effects. The patient said that she started shivering, had fever and felt like she might faint. There was pain that radiated from her arm around to the back of her neck. This information was all that the reporter had now. The reporter said she might reach out to the customer to get more information from her and possibly speak to medical information about the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema 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 erythema, swelling, pain and skin warm. On an unknown date, the outcome of the erythema, swelling, pain and skin warm were unknown. It was unknown if the reporter considered the erythema, swelling, pain and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not provide any more information at the time of reporting but stated that she would call back on Monday with more information about the patient. This case was linked with US2018GSK135707, reported by the same reporter.