chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal disorder, Myalgia, Nausea, Vision blurred
Clinical narrative: Injection site very swollen and hot to the touch. Couldn't use left arm for 3 days, Extreme joint and muscle soreness. Light headed. Blurred Vision. Very Dizzy. No depth of field. Severe muscle cramps all over legs, arms and torso including neck. Headaches. Insomnia. Chronic Diarrhea. Nausea. Vomited. Severe hot and cold sweats. Not steady when I walk. It'll be a week tomorrow and I'm still in bed trying to recoup. I really don't want to get the second follow up shot in 2-6 months, I can't do this again.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Injection site very swollen and hot to the touch. Couldn't use left arm for 3 days, Extreme joint and muscle soreness. Light headed. Blurred Vision. Very Dizzy. No depth of field. Severe muscle cramps all over legs, arms and torso including neck. Headaches. Insomnia. Chronic Diarrhea. Nausea. Vomited. Severe hot and cold sweats. Not steady when I walk. It'll be a week tomorrow and I'm still in bed trying to recoup. I really don't want to get the second follow up shot in 2-6 months, I can't do this again.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry mouth, Gait inability, Headache, Heart rate abnormal
Clinical narrative: Patient started having headache, paced heartrate, shivering, dry mouth, couldn't even walk, or do anything. Muscle aches and about 24 hours later, she is feeling better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient started having headache, paced heartrate, shivering, dry mouth, couldn't even walk, or do anything. Muscle aches and about 24 hours later, she is feeling better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Chills, Fatigue, Headache, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 16th January 2018, refer case US2018051224). Concurrent medical conditions included drug allergy (the patient was allergic to FLAGYL and MACRODANTIN). Concomitant products included levothyroxine. On 25th March 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced chills, tiredness, headache, fever, pain in arm and sleeplessness. On 27th March 2018, the patient experienced rash and tachycardia. On an unknown date, the outcome of the chills, tiredness and fever were recovering/resolving and the outcome of the headache was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the sleeplessness, rash and tachycardia were unknown. The reporter considered the chills, tiredness, headache and pain in arm to be almost certainly related to SHINGRIX. The reporter considered the fever, rash and tachycardia to be possibly related to SHINGRIX. It was unknown if the reporter considered the sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The events arm soreness, chills, fever, tiredness and headache began approximately 6 hours after the injection. Less than a day after receiving vaccination, the patient also reported a sleepless night due to events. Two days after receiving vaccination, the patient developed a rash on her face on the left mandible area above the left nare and right maxilla and the patient also had a small eruption on her chest that resembles a pimple. The patient also had tachycardia and felt feverish. The patient had denied permission to contact their physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash, Tachycardia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 16th January 2018, refer case US2018051224). Concurrent medical conditions included drug allergy (the patient was allergic to FLAGYL and MACRODANTIN). Concomitant products included levothyroxine. On 25th March 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced chills, tiredness, headache, fever, pain in arm and sleeplessness. On 27th March 2018, the patient experienced rash and tachycardia. On an unknown date, the outcome of the chills, tiredness and fever were recovering/resolving and the outcome of the headache was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the sleeplessness, rash and tachycardia were unknown. The reporter considered the chills, tiredness, headache and pain in arm to be almost certainly related to SHINGRIX. The reporter considered the fever, rash and tachycardia to be possibly related to SHINGRIX. It was unknown if the reporter considered the sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The events arm soreness, chills, fever, tiredness and headache began approximately 6 hours after the injection. Less than a day after receiving vaccination, the patient also reported a sleepless night due to events. Two days after receiving vaccination, the patient developed a rash on her face on the left mandible area above the left nare and right maxilla and the patient also had a small eruption on her chest that resembles a pimple. The patient also had tachycardia and felt feverish. The patient had denied permission to contact their physician.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 18-year-old male patient who received BEXSERO. On 29th January 2018, the patient received the 1st dose of BEXSERO. On 29th January 2018, less than a day after receiving BEXSERO, the patient experienced influenza-like symptoms, chills and myalgia. On an unknown date, the outcome of the influenza-like symptoms, chills and myalgia were recovered/resolved. The reporter considered the influenza-like symptoms, chills and myalgia to be related to BEXSERO. Additional information was received as follows: This case was reported by the patient's mother. The case has been linked to the case US2018051277, reported for same patient. The case has been linked to the case US2018051278 and US2018GSK057910 (brother's case), reported by same reporter for the patient from same family.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend, who was also a physician. The age at vaccination was not reported. The batch number of the vaccine was unknown. The physician reported limited information and declined contact. The patient had denied permission to contact their physician. The physician did not want to be contacted for follow up information. All questions were asked, only information known is that provided.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Astrovirus test positive, Diarrhoea, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 18-year-old male patient who received BEXSERO. Concurrent medical conditions included ulcerative colitis. Concomitant products included APRISO, REMICADE and VSL Probiotic Sachets. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced sickness, diarrhea and astrovirus test positive. On an unknown date, the outcome of the sickness, diarrhea and astrovirus test positive were recovered/resolved. It was unknown if the reporter considered the sickness, diarrhea and astrovirus test positive to be related to BEXSERO. Additional details were provided as follows: The reporter was the mother of the patient. This was the report for the patient that was immune suppressed. In 2018, the patient received 2nd dose of BEXSERO. In 2018, the patient was sick for 24 hours and then it got better. Then the patient got horribly sick again and experienced severe diarrhea and came positive with astrovirus. This case has been linked to the case US2018051277 and US2018GSK056258 for another patient and linked to US2018051278 reported for the same patient.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt. rec'd. (PNVX-23) on 3/26/18 and called next day with redness spreading over R upper arm. He was seen on 3/28/18. Evidence of redness swelling extending from upper arm to elbow = Dx cellulitis after PNEUMOVAX 23 injection.
Age: 87.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Ocular hyperaemia, Pain in extremity, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old patient who received SHINGRIX. The patient's past medical history included leukemia. Concomitant products included IMBRUVICA. On 21st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 23rd March 2018, the patient experienced bloodshot eye. On 27th March 2018, the patient experienced injection site erythema and erythromacular rash. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the bloodshot eye was not recovered/not resolved and the outcome of the injection site erythema was unchanged and the outcome of the erythromacular rash was unknown. The reporter considered the pain in arm, bloodshot eye, injection site erythema and erythromacular rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received her first SHINGRIX injection at pharmacy. On day 2, 2 days after receiving SHINGRIX, the patient experienced left eye bloodshot and was unresolved at time of report. On day 6, 6 days after receiving SHINGRIX, the patient experienced the arm soreness returned with some red spots around the injection site and about 2 to 3 in total size of the arm area.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Pt symptoms are redness and swollen approximately 6cm x 6cm area -> improved some with warm compress.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Carpal tunnel decompression, Electromyogram abnormal, Grip strength decreased, Hypoaesthesia, Musculoskeletal disorder
Clinical narrative: Initial unsolicited report received from consumer on 26-Mar-2018. This case involves 53 years old female patient who was vaccinated intramuscularly with 0.5 ml dose of ADACEL (frequency: once, Batch number, expiration date, dose in series and site of administration were not reported) on 25-Oct-2017. The patient's medical history includes allergies to CLARITIN, clindamycin and lactose intolerant. Concomitant medication were not reported. On an unknown date (Within 24 to 48 hours after receiving the vaccine), following the vaccination patient experienced numbness and tingling in her right arm, one week after vaccination patient was seen in her physician office with numbness and tingling was becoming progressively worse and moving down the arm into the fingertips. Patient experienced much pain with this and was unable to hold anything in the right hand. Patient had an electromyogram (EMG) test which showed a decrease in the ability to use the arm down to a 3% usage and was scheduled for an immediate Carpal tunnel release surgery. It was reported that, patient was also seen by two different neurologists. Other laboratory investigations and corrective treatments were not reported. Outcome of the events was recovering. This case was reported as serious due to disability. List of documents held by sender: none. Sender's Comments: Patient developed Carpel tunnel syndrome after vaccination. Time to onset is compatible. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. The various other risk factors for Carpel tunnel syndrome need to be investigated like diabetes, hypertension, obesity or arthritis. Based on the available information the role of vaccine seems unlikely.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paraesthesia
Clinical narrative: Initial unsolicited report received from consumer on 26-Mar-2018. This case involves 53 years old female patient who was vaccinated intramuscularly with 0.5 ml dose of ADACEL (frequency: once, Batch number, expiration date, dose in series and site of administration were not reported) on 25-Oct-2017. The patient's medical history includes allergies to CLARITIN, clindamycin and lactose intolerant. Concomitant medication were not reported. On an unknown date (Within 24 to 48 hours after receiving the vaccine), following the vaccination patient experienced numbness and tingling in her right arm, one week after vaccination patient was seen in her physician office with numbness and tingling was becoming progressively worse and moving down the arm into the fingertips. Patient experienced much pain with this and was unable to hold anything in the right hand. Patient had an electromyogram (EMG) test which showed a decrease in the ability to use the arm down to a 3% usage and was scheduled for an immediate Carpal tunnel release surgery. It was reported that, patient was also seen by two different neurologists. Other laboratory investigations and corrective treatments were not reported. Outcome of the events was recovering. This case was reported as serious due to disability. List of documents held by sender: none. Sender's Comments: Patient developed Carpel tunnel syndrome after vaccination. Time to onset is compatible. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. The various other risk factors for Carpel tunnel syndrome need to be investigated like diabetes, hypertension, obesity or arthritis. Based on the available information the role of vaccine seems unlikely.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hot flush, Pharyngeal oedema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received SHINGRIX. On 19th February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm. In March 2018, the patient experienced ill-defined intestinal infections (serious criteria GSK medically significant) and gastrointestinal infection. On 28th March 2018, the patient experienced redness of legs, skin peeling and leg infection. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, esophageal candida (serious criteria GSK medically significant), oral thrush and thrush. The patient was treated with antibiotics nos. On an unknown date, the outcome of the vaccination failure, swelling arm, redness of legs, skin peeling and leg infection were unknown and the outcome of the shingles, esophageal candida, oral thrush and thrush were recovered/resolved and the outcome of the ill-defined intestinal infections and gastrointestinal infection were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, ill-defined intestinal infections, esophageal candida, gastrointestinal infection, oral thrush, thrush, swelling arm, redness of legs, skin peeling and leg infection to be related to SHINGRIX. Additional details were reported as follows: The reporter inquired about ingredients in SHINGRIX, provided information from the prescribing information. The patient received the  SHINGRIX on left arm. The patient experienced swelling of arm for the first two weeks after receiving the SHINGRIX vaccine. The patient also experienced thrush in her mouth, esophagus and stomach for one week. Since a week and a half from the date of reporting, the patient developed intestinal and colon infection. The patient had to go to emergency  room  (ER) and was prescribed antibiotics for intestinal infection. The antibiotics did not work for her. The patient developed Shingles on her arm which was later resolved. Since 28th March 2018 (past Wednesday), the patient experienced bright redness on her legs and looked like she shaved her legs without any soap and was thoroughly infected. The patient felt like her skin was peeled off. The reporter was in hurry to call her doctor and was not able to provide any additional information due to time constraint. This case was considered as suspected vaccination failure since completion status of the primary vaccination schedule and time to onset for the event were unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Candida infection, Enteritis infectious, Erythema, Gastrointestinal infection, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received SHINGRIX. On 19th February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm. In March 2018, the patient experienced ill-defined intestinal infections (serious criteria GSK medically significant) and gastrointestinal infection. On 28th March 2018, the patient experienced redness of legs, skin peeling and leg infection. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, esophageal candida (serious criteria GSK medically significant), oral thrush and thrush. The patient was treated with antibiotics nos. On an unknown date, the outcome of the vaccination failure, swelling arm, redness of legs, skin peeling and leg infection were unknown and the outcome of the shingles, esophageal candida, oral thrush and thrush were recovered/resolved and the outcome of the ill-defined intestinal infections and gastrointestinal infection were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, ill-defined intestinal infections, esophageal candida, gastrointestinal infection, oral thrush, thrush, swelling arm, redness of legs, skin peeling and leg infection to be related to SHINGRIX. Additional details were reported as follows: The reporter inquired about ingredients in SHINGRIX, provided information from the prescribing information. The patient received the  SHINGRIX on left arm. The patient experienced swelling of arm for the first two weeks after receiving the SHINGRIX vaccine. The patient also experienced thrush in her mouth, esophagus and stomach for one week. Since a week and a half from the date of reporting, the patient developed intestinal and colon infection. The patient had to go to emergency  room  (ER) and was prescribed antibiotics for intestinal infection. The antibiotics did not work for her. The patient developed Shingles on her arm which was later resolved. Since 28th March 2018 (past Wednesday), the patient experienced bright redness on her legs and looked like she shaved her legs without any soap and was thoroughly infected. The patient felt like her skin was peeled off. The reporter was in hurry to call her doctor and was not able to provide any additional information due to time constraint. This case was considered as suspected vaccination failure since completion status of the primary vaccination schedule and time to onset for the event were unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Localised infection, Oesophageal candidiasis, Oral candidiasis, Peripheral swelling, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received SHINGRIX. On 19th February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm. In March 2018, the patient experienced ill-defined intestinal infections (serious criteria GSK medically significant) and gastrointestinal infection. On 28th March 2018, the patient experienced redness of legs, skin peeling and leg infection. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, esophageal candida (serious criteria GSK medically significant), oral thrush and thrush. The patient was treated with antibiotics nos. On an unknown date, the outcome of the vaccination failure, swelling arm, redness of legs, skin peeling and leg infection were unknown and the outcome of the shingles, esophageal candida, oral thrush and thrush were recovered/resolved and the outcome of the ill-defined intestinal infections and gastrointestinal infection were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, ill-defined intestinal infections, esophageal candida, gastrointestinal infection, oral thrush, thrush, swelling arm, redness of legs, skin peeling and leg infection to be related to SHINGRIX. Additional details were reported as follows: The reporter inquired about ingredients in SHINGRIX, provided information from the prescribing information. The patient received the  SHINGRIX on left arm. The patient experienced swelling of arm for the first two weeks after receiving the SHINGRIX vaccine. The patient also experienced thrush in her mouth, esophagus and stomach for one week. Since a week and a half from the date of reporting, the patient developed intestinal and colon infection. The patient had to go to emergency  room  (ER) and was prescribed antibiotics for intestinal infection. The antibiotics did not work for her. The patient developed Shingles on her arm which was later resolved. Since 28th March 2018 (past Wednesday), the patient experienced bright redness on her legs and looked like she shaved her legs without any soap and was thoroughly infected. The patient felt like her skin was peeled off. The reporter was in hurry to call her doctor and was not able to provide any additional information due to time constraint. This case was considered as suspected vaccination failure since completion status of the primary vaccination schedule and time to onset for the event were unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received SHINGRIX. On 19th February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm. In March 2018, the patient experienced ill-defined intestinal infections (serious criteria GSK medically significant) and gastrointestinal infection. On 28th March 2018, the patient experienced redness of legs, skin peeling and leg infection. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, esophageal candida (serious criteria GSK medically significant), oral thrush and thrush. The patient was treated with antibiotics nos. On an unknown date, the outcome of the vaccination failure, swelling arm, redness of legs, skin peeling and leg infection were unknown and the outcome of the shingles, esophageal candida, oral thrush and thrush were recovered/resolved and the outcome of the ill-defined intestinal infections and gastrointestinal infection were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, ill-defined intestinal infections, esophageal candida, gastrointestinal infection, oral thrush, thrush, swelling arm, redness of legs, skin peeling and leg infection to be related to SHINGRIX. Additional details were reported as follows: The reporter inquired about ingredients in SHINGRIX, provided information from the prescribing information. The patient received the  SHINGRIX on left arm. The patient experienced swelling of arm for the first two weeks after receiving the SHINGRIX vaccine. The patient also experienced thrush in her mouth, esophagus and stomach for one week. Since a week and a half from the date of reporting, the patient developed intestinal and colon infection. The patient had to go to emergency  room  (ER) and was prescribed antibiotics for intestinal infection. The antibiotics did not work for her. The patient developed Shingles on her arm which was later resolved. Since 28th March 2018 (past Wednesday), the patient experienced bright redness on her legs and looked like she shaved her legs without any soap and was thoroughly infected. The patient felt like her skin was peeled off. The reporter was in hurry to call her doctor and was not able to provide any additional information due to time constraint. This case was considered as suspected vaccination failure since completion status of the primary vaccination schedule and time to onset for the event were unknown.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Blood test normal, Gastrointestinal pain, Hyperhidrosis, Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 77-year-old female patient who received SHINGRIX. On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 14th March 2018, several hours after receiving SHINGRIX, the patient experienced low blood pressure, clamminess, nausea, sweating and motion sickness. In March 2018, the patient experienced light headedness, pulse rate increased and fall. On an unknown date, the outcome of the light headedness, low blood pressure, pulse rate increased and nausea and were recovered/resolved and the outcome of the clamminess, sweating, motion sickness and fall were unknown. The reporter considered the light headedness, low blood pressure, pulse rate increased, clamminess, nausea and sweating to be related to SHINGRIX. It was unknown if the reporter considered the motion sickness and fall to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included high blood pressure medication. The patient was vaccinated at 2:30 pm with SHINGRIX. Thirteen hours thirty minutes after vaccination the patient woke up around 4:00 am and tried to get out of bed to go to the bathroom and she felt lightheaded and dizzy. After visiting the bathroom, her legs collapsed and she fell to the ground but her husband caught her. The patient's blood pressure was at 84/50 which it usually was controlled on medication at 120. Within an hour, the patient's blood pressure was in the 90's and around 11:00 AM it was normal for her again. She had a 99 resting pulse rated during that time. The patient claimed that she had some kind of reaction from the SHINGRIX shot and she woke up feeling sweaty, clammy and wet. The patient also felt nauseous which she described as motion sickness nausea similar to when you are on a boat.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urine analysis normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 77-year-old female patient who received SHINGRIX. On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 14th March 2018, several hours after receiving SHINGRIX, the patient experienced low blood pressure, clamminess, nausea, sweating and motion sickness. In March 2018, the patient experienced light headedness, pulse rate increased and fall. On an unknown date, the outcome of the light headedness, low blood pressure, pulse rate increased and nausea and were recovered/resolved and the outcome of the clamminess, sweating, motion sickness and fall were unknown. The reporter considered the light headedness, low blood pressure, pulse rate increased, clamminess, nausea and sweating to be related to SHINGRIX. It was unknown if the reporter considered the motion sickness and fall to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included high blood pressure medication. The patient was vaccinated at 2:30 pm with SHINGRIX. Thirteen hours thirty minutes after vaccination the patient woke up around 4:00 am and tried to get out of bed to go to the bathroom and she felt lightheaded and dizzy. After visiting the bathroom, her legs collapsed and she fell to the ground but her husband caught her. The patient's blood pressure was at 84/50 which it usually was controlled on medication at 120. Within an hour, the patient's blood pressure was in the 90's and around 11:00 AM it was normal for her again. She had a 99 resting pulse rated during that time. The patient claimed that she had some kind of reaction from the SHINGRIX shot and she woke up feeling sweaty, clammy and wet. The patient also felt nauseous which she described as motion sickness nausea similar to when you are on a boat.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Dizziness, Heart rate increased, Hypotension, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 77-year-old female patient who received SHINGRIX. On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 14th March 2018, several hours after receiving SHINGRIX, the patient experienced low blood pressure, clamminess, nausea, sweating and motion sickness. In March 2018, the patient experienced light headedness, pulse rate increased and fall. On an unknown date, the outcome of the light headedness, low blood pressure, pulse rate increased and nausea and were recovered/resolved and the outcome of the clamminess, sweating, motion sickness and fall were unknown. The reporter considered the light headedness, low blood pressure, pulse rate increased, clamminess, nausea and sweating to be related to SHINGRIX. It was unknown if the reporter considered the motion sickness and fall to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included high blood pressure medication. The patient was vaccinated at 2:30 pm with SHINGRIX. Thirteen hours thirty minutes after vaccination the patient woke up around 4:00 am and tried to get out of bed to go to the bathroom and she felt lightheaded and dizzy. After visiting the bathroom, her legs collapsed and she fell to the ground but her husband caught her. The patient's blood pressure was at 84/50 which it usually was controlled on medication at 120. Within an hour, the patient's blood pressure was in the 90's and around 11:00 AM it was normal for her again. She had a 99 resting pulse rated during that time. The patient claimed that she had some kind of reaction from the SHINGRIX shot and she woke up feeling sweaty, clammy and wet. The patient also felt nauseous which she described as motion sickness nausea similar to when you are on a boat.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness, Fall, Heart rate increased, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 77-year-old female patient who received SHINGRIX. On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 14th March 2018, several hours after receiving SHINGRIX, the patient experienced low blood pressure, clamminess, nausea, sweating and motion sickness. In March 2018, the patient experienced light headedness, pulse rate increased and fall. On an unknown date, the outcome of the light headedness, low blood pressure, pulse rate increased and nausea and were recovered/resolved and the outcome of the clamminess, sweating, motion sickness and fall were unknown. The reporter considered the light headedness, low blood pressure, pulse rate increased, clamminess, nausea and sweating to be related to SHINGRIX. It was unknown if the reporter considered the motion sickness and fall to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included high blood pressure medication. The patient was vaccinated at 2:30 pm with SHINGRIX. Thirteen hours thirty minutes after vaccination the patient woke up around 4:00 am and tried to get out of bed to go to the bathroom and she felt lightheaded and dizzy. After visiting the bathroom, her legs collapsed and she fell to the ground but her husband caught her. The patient's blood pressure was at 84/50 which it usually was controlled on medication at 120. Within an hour, the patient's blood pressure was in the 90's and around 11:00 AM it was normal for her again. She had a 99 resting pulse rated during that time. The patient claimed that she had some kind of reaction from the SHINGRIX shot and she woke up feeling sweaty, clammy and wet. The patient also felt nauseous which she described as motion sickness nausea similar to when you are on a boat.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypotension, Motion sickness, Muscular weakness, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 77-year-old female patient who received SHINGRIX. On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 14th March 2018, several hours after receiving SHINGRIX, the patient experienced low blood pressure, clamminess, nausea, sweating and motion sickness. In March 2018, the patient experienced light headedness, pulse rate increased and fall. On an unknown date, the outcome of the light headedness, low blood pressure, pulse rate increased and nausea and were recovered/resolved and the outcome of the clamminess, sweating, motion sickness and fall were unknown. The reporter considered the light headedness, low blood pressure, pulse rate increased, clamminess, nausea and sweating to be related to SHINGRIX. It was unknown if the reporter considered the motion sickness and fall to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included high blood pressure medication. The patient was vaccinated at 2:30 pm with SHINGRIX. Thirteen hours thirty minutes after vaccination the patient woke up around 4:00 am and tried to get out of bed to go to the bathroom and she felt lightheaded and dizzy. After visiting the bathroom, her legs collapsed and she fell to the ground but her husband caught her. The patient's blood pressure was at 84/50 which it usually was controlled on medication at 120. Within an hour, the patient's blood pressure was in the 90's and around 11:00 AM it was normal for her again. She had a 99 resting pulse rated during that time. The patient claimed that she had some kind of reaction from the SHINGRIX shot and she woke up feeling sweaty, clammy and wet. The patient also felt nauseous which she described as motion sickness nausea similar to when you are on a boat.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Rash, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pustule in a 62-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 5th March 2019). On 5th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, 3 days after receiving SHINGRIX, the patient experienced pustule. In March 2018, the patient experienced injection site erythema, crust and contusion. On an unknown date, the outcome of the pustule was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome of the crust and contusion were unknown. The reporter considered the pustule and injection site erythema to be possibly related to SHINGRIX. It was unknown if the reporter considered the crust and contusion to be related to SHINGRIX. Additional details were provided as follows: The patient was not taking any concomitant medications. Yesterday on 26th March 2018 the patient showed the pharmacist who had previously administered the patient's first dose of SHINGRIX vaccine into the muscle of her left upper arm a picture which was taken 3 days after having received the vaccination. The picture showed at the site of injection on the left upper arm a small red circle spot and there was a bigger red circled spot above the site of injection. Those symptoms were disappeared as of yesterday when the pharmacist examined the patient's left arm. Also, for about the past three weeks since about 3 days after receiving the vaccination, the patient had pustules which have arisen, crusted over, and then turned into bruises on her left lower arm, on her left wrist and backside of the left hand as well as the left side of her body chest area, and these symptoms have not yet resolved. When they appear, the pustules are not in a cluster but a couple will pop up and are described to appear more like zits. The grants permission to be contacted by agency. The call was transferred to the MI team regarding the reporter's inquiry as to whether or not these types of reactions have been reported beyond any information labeled in the PI.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site erythema, Rash pustular, Scab
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pustule in a 62-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 5th March 2019). On 5th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, 3 days after receiving SHINGRIX, the patient experienced pustule. In March 2018, the patient experienced injection site erythema, crust and contusion. On an unknown date, the outcome of the pustule was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome of the crust and contusion were unknown. The reporter considered the pustule and injection site erythema to be possibly related to SHINGRIX. It was unknown if the reporter considered the crust and contusion to be related to SHINGRIX. Additional details were provided as follows: The patient was not taking any concomitant medications. Yesterday on 26th March 2018 the patient showed the pharmacist who had previously administered the patient's first dose of SHINGRIX vaccine into the muscle of her left upper arm a picture which was taken 3 days after having received the vaccination. The picture showed at the site of injection on the left upper arm a small red circle spot and there was a bigger red circled spot above the site of injection. Those symptoms were disappeared as of yesterday when the pharmacist examined the patient's left arm. Also, for about the past three weeks since about 3 days after receiving the vaccination, the patient had pustules which have arisen, crusted over, and then turned into bruises on her left lower arm, on her left wrist and backside of the left hand as well as the left side of her body chest area, and these symptoms have not yet resolved. When they appear, the pustules are not in a cluster but a couple will pop up and are described to appear more like zits. The grants permission to be contacted by agency. The call was transferred to the MI team regarding the reporter's inquiry as to whether or not these types of reactions have been reported beyond any information labeled in the PI.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, 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 58-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included Parkinson's disease. Concomitant products included carbidopa with levodopa. On 21st March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced worn out. On 21st March 2018, the patient experienced injection site swelling, injection site pain, injection site inflammation and injection site erythema. On 22nd March 2018, the patient experienced general body pain, neck pain, shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, general body pain, worn out, neck pain, shoulder pain, injection site pain and injection site inflammation were recovering/resolving and the outcome of the injection site erythema and influenza-like symptoms were unknown. The reporter considered the injection site swelling, general body pain, worn out, neck pain, injection site pain and injection site inflammation to be related to SHINGRIX. It was unknown if the reporter considered the shoulder pain, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received pain medication as concomitant drug. The pharmacist reported that she administered the SHINGRIX to a patient at 2:30 pm and the patient reported that her upper arm turned bright red and swollen and was sore immediately after injection. The patient experienced severe pain in her shoulder and neck but the pain subsided when the inflammation form the injection site went down. The patient had flu like symptoms that made her bed ridden and she had body aches the following day after injection. The pharmacist described her side effects as exaggerated side effects.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included Parkinson's disease. Concomitant products included carbidopa with levodopa. On 21st March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced worn out. On 21st March 2018, the patient experienced injection site swelling, injection site pain, injection site inflammation and injection site erythema. On 22nd March 2018, the patient experienced general body pain, neck pain, shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, general body pain, worn out, neck pain, shoulder pain, injection site pain and injection site inflammation were recovering/resolving and the outcome of the injection site erythema and influenza-like symptoms were unknown. The reporter considered the injection site swelling, general body pain, worn out, neck pain, injection site pain and injection site inflammation to be related to SHINGRIX. It was unknown if the reporter considered the shoulder pain, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received pain medication as concomitant drug. The pharmacist reported that she administered the SHINGRIX to a patient at 2:30 pm and the patient reported that her upper arm turned bright red and swollen and was sore immediately after injection. The patient experienced severe pain in her shoulder and neck but the pain subsided when the inflammation form the injection site went down. The patient had flu like symptoms that made her bed ridden and she had body aches the following day after injection. The pharmacist described her side effects as exaggerated side effects.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Fatigue, Immediate post-injection reaction, Influenza like illness, 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 58-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included Parkinson's disease. Concomitant products included carbidopa with levodopa. On 21st March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced worn out. On 21st March 2018, the patient experienced injection site swelling, injection site pain, injection site inflammation and injection site erythema. On 22nd March 2018, the patient experienced general body pain, neck pain, shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, general body pain, worn out, neck pain, shoulder pain, injection site pain and injection site inflammation were recovering/resolving and the outcome of the injection site erythema and influenza-like symptoms were unknown. The reporter considered the injection site swelling, general body pain, worn out, neck pain, injection site pain and injection site inflammation to be related to SHINGRIX. It was unknown if the reporter considered the shoulder pain, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received pain medication as concomitant drug. The pharmacist reported that she administered the SHINGRIX to a patient at 2:30 pm and the patient reported that her upper arm turned bright red and swollen and was sore immediately after injection. The patient experienced severe pain in her shoulder and neck but the pain subsided when the inflammation form the injection site went down. The patient had flu like symptoms that made her bed ridden and she had body aches the following day after injection. The pharmacist described her side effects as exaggerated side effects.