chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2010, the patient was treated by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-SEP-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2014, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Dysstasia, Headache, Joint swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug hypersensitivity (medicines) and multiple allergies. On 19th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced difficulty in standing. On 19th June 2018, the patient experienced knee pain. On 21st June 2018, the patient experienced swelling of knees, nausea, headache and dizziness. On an unknown date, the outcome of the swelling of knees was not recovered/not resolved and the outcome of the nausea, headache, knee pain, dizziness and difficulty in standing were unknown. The reporter considered the swelling of knees to be probably related to SHINGRIX. It was unknown if the reporter considered the nausea, headache, knee pain, dizziness and difficulty in standing to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. At 10:30, the patient received SHINGRIX on the left arm. Less than a day after vaccination, the patient experienced soreness. Two days after vaccination, the patient experienced swelling, nausea, headache and dizziness. The patient stated that even though her knee felt a little better, she was unable to stand on it for extended periods of time.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug hypersensitivity (medicines) and multiple allergies. On 19th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced difficulty in standing. On 19th June 2018, the patient experienced knee pain. On 21st June 2018, the patient experienced swelling of knees, nausea, headache and dizziness. On an unknown date, the outcome of the swelling of knees was not recovered/not resolved and the outcome of the nausea, headache, knee pain, dizziness and difficulty in standing were unknown. The reporter considered the swelling of knees to be probably related to SHINGRIX. It was unknown if the reporter considered the nausea, headache, knee pain, dizziness and difficulty in standing to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. At 10:30, the patient received SHINGRIX on the left arm. Less than a day after vaccination, the patient experienced soreness. Two days after vaccination, the patient experienced swelling, nausea, headache and dizziness. The patient stated that even though her knee felt a little better, she was unable to stand on it for extended periods of time.
Age: 72.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Back pain, Insomnia, Middle insomnia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of paresthesia of fingers in a 72-year-old female patient who received SHINGRIX (batch number LN9TL, expiry date unknown) for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On 3rd May 2018 15:00, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, several hours after receiving SHINGRIX, the patient experienced back pain. On 4th May 2018, the patient experienced paresthesia of fingers. In May 2018, the patient experienced nocturnal awakening. On an unknown date, the outcome of the paresthesia of fingers was recovering/resolving and the outcome of the back pain was recovered/resolved and the outcome of the nocturnal awakening was unknown. The reporter considered the paresthesia of fingers and back pain to be related to SHINGRIX. It was unknown if the reporter considered the nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: The patient experienced paresthesia presented the following night (1 day after vaccination) after the vaccination with SHINGRIX. The back pain presented same night but was more severe the next day of vaccination. It was keeping sometimes wakes her up at night and sometimes keep her up at night. She also felt Paresthesia at the base of her thumbs momentarily a few weeks later. The patient said she could not remember exactly when. The patient mentioned that she was very medication sensitive and always has flu like symptoms and chills following flu shots. The patient did not have a physician because she was very healthy and her husband was a retired physician. She provided permission to follow up with her. This case has been linked with US2018GSK121406, reported by the same for the same patient.
Age: 72.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of paresthesia of fingers in a 72-year-old female patient who received SHINGRIX (batch number LN9TL, expiry date unknown) for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On 3rd May 2018 15:00, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, several hours after receiving SHINGRIX, the patient experienced back pain. On 4th May 2018, the patient experienced paresthesia of fingers. In May 2018, the patient experienced nocturnal awakening. On an unknown date, the outcome of the paresthesia of fingers was recovering/resolving and the outcome of the back pain was recovered/resolved and the outcome of the nocturnal awakening was unknown. The reporter considered the paresthesia of fingers and back pain to be related to SHINGRIX. It was unknown if the reporter considered the nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: The patient experienced paresthesia presented the following night (1 day after vaccination) after the vaccination with SHINGRIX. The back pain presented same night but was more severe the next day of vaccination. It was keeping sometimes wakes her up at night and sometimes keep her up at night. She also felt Paresthesia at the base of her thumbs momentarily a few weeks later. The patient said she could not remember exactly when. The patient mentioned that she was very medication sensitive and always has flu like symptoms and chills following flu shots. The patient did not have a physician because she was very healthy and her husband was a retired physician. She provided permission to follow up with her. This case has been linked with US2018GSK121406, reported by the same for the same patient.
Age: 72.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Fatigue, Insomnia, Middle insomnia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of paresthesia of fingers in a 72-year-old female patient who received SHINGRIX (batch number LN9TL, expiry date unknown) for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On 3rd May 2018 15:00, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, several hours after receiving SHINGRIX, the patient experienced back pain. On 4th May 2018, the patient experienced paresthesia of fingers. In May 2018, the patient experienced nocturnal awakening. On an unknown date, the outcome of the paresthesia of fingers was recovering/resolving and the outcome of the back pain was recovered/resolved and the outcome of the nocturnal awakening was unknown. The reporter considered the paresthesia of fingers and back pain to be related to SHINGRIX. It was unknown if the reporter considered the nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: The patient experienced paresthesia presented the following night (1 day after vaccination) after the vaccination with SHINGRIX. The back pain presented same night but was more severe the next day of vaccination. It was keeping sometimes wakes her up at night and sometimes keep her up at night. She also felt Paresthesia at the base of her thumbs momentarily a few weeks later. The patient said she could not remember exactly when. The patient mentioned that she was very medication sensitive and always has flu like symptoms and chills following flu shots. The patient did not have a physician because she was very healthy and her husband was a retired physician. She provided permission to follow up with her. This case has been linked with US2018GSK121406, reported by the same for the same patient.
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Back pain, Insomnia, Middle insomnia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Influenza vaccine Quadrivalent for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved. The reporter considered the influenza-like symptoms and chills to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient was very medication sensitive and always had flu like symptoms and chills following flu shots. The patient did not have a physician because she was very healthy and her husband was a retired physician. She provided permission to follow up with her. This case has been linked with US2018115098, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Influenza vaccine Quadrivalent for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved. The reporter considered the influenza-like symptoms and chills to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient was very medication sensitive and always had flu like symptoms and chills following flu shots. The patient did not have a physician because she was very healthy and her husband was a retired physician. She provided permission to follow up with her. This case has been linked with US2018115098, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Fatigue, Insomnia, Middle insomnia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Influenza vaccine Quadrivalent for prophylaxis. Concurrent medical conditions included drug hypersensitivity. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved. The reporter considered the influenza-like symptoms and chills to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient was very medication sensitive and always had flu like symptoms and chills following flu shots. The patient did not have a physician because she was very healthy and her husband was a retired physician. She provided permission to follow up with her. This case has been linked with US2018115098, reported by the same reporter for the same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Feeling hot, Headache, Insomnia
Clinical narrative: This case was reported by a non-health professional via call center representative and described the occurrence of feeling unwell in a 63-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th June 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, sleeplessness, feeling hot, feeling cold, headache, pain in arm and erythema. On 19th June 2018, the outcome of the headache was recovered/resolved. On 21st June 2018, the outcome of the erythema was recovered/resolved. On an unknown date, the outcome of the feeling unwell, sleeplessness, feeling hot, feeling cold and pain in arm were unknown. It was unknown if the reporter considered the feeling unwell, sleeplessness, feeling hot, feeling cold, headache, pain in arm and erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. The patient called the office to report how she felt after receiving the SHINGRIX vaccine. The patient felt ill, could not sleep, had headache for 1 day, redness for 4 days and sore arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: This case was reported by a non-health professional via call center representative and described the occurrence of feeling unwell in a 63-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th June 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, sleeplessness, feeling hot, feeling cold, headache, pain in arm and erythema. On 19th June 2018, the outcome of the headache was recovered/resolved. On 21st June 2018, the outcome of the erythema was recovered/resolved. On an unknown date, the outcome of the feeling unwell, sleeplessness, feeling hot, feeling cold and pain in arm were unknown. It was unknown if the reporter considered the feeling unwell, sleeplessness, feeling hot, feeling cold, headache, pain in arm and erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. The patient called the office to report how she felt after receiving the SHINGRIX vaccine. The patient felt ill, could not sleep, had headache for 1 day, redness for 4 days and sore arm.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rash in a 58-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, several days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left deltoid. Few days after receiving 2nd dose of SHINGRIX, the patient experienced a rash on left arm and across his abdomen.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 63-year-old male patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 9th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) 50 ug. On 9th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were reported as follows: Right after receiving the SHINGRIX, the patient started to have pain in the deltoid where he received the injection. The pain did not improve over the past 2 weeks. The patient did not have this pain with the 1st dose. The batch number reported 459CM for SHINGRIX was not found and changed to AS9CM as per sales data.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 18-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. On 27th June 2018, the patient received the 1st dose of BEXSERO .5 ml. On 28th June 2018, 1 days after receiving BEXSERO the patient experienced vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful. On an unknown date, the outcome of the vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful were unknown. It was unknown if the reporter considered the vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO on right deltoid. The patient vomited 4 times in one day but it subsided at evening on the day before the reporting date. The patient felt weak like she had been run over. The patient had no fever or diarrhea.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 18-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. On 27th June 2018, the patient received the 1st dose of BEXSERO .5 ml. On 28th June 2018, 1 days after receiving BEXSERO the patient experienced vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful. On an unknown date, the outcome of the vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful were unknown. It was unknown if the reporter considered the vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO on right deltoid. The patient vomited 4 times in one day but it subsided at evening on the day before the reporting date. The patient felt weak like she had been run over. The patient had no fever or diarrhea.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Soreness/ Pain; Redness; Swelling; Muscle Pain; Tiredness; Chills; Upset Stomach; 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 Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2018, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, chills and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, chills and upset stomach were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, chills and upset stomach to be related to Shingrix.  Additional details were provided as follows: At 12:00, the patient received Shingrix in the left arm. On the same day, she started experiencing sore arm, redness and swelling at injection site along with muscle pain, tiredness, chills, and upset stomach. On day 3 and 4, the patient's symptoms got worse, and at the time of reporting she was recovering. The patient had denied permission to contact their physician. No further details were provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Soreness/ Pain; Redness; Swelling; Muscle Pain; Tiredness; Chills; Upset Stomach; 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 Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2018, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, chills and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, chills and upset stomach were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, chills and upset stomach to be related to Shingrix.  Additional details were provided as follows: At 12:00, the patient received Shingrix in the left arm. On the same day, she started experiencing sore arm, redness and swelling at injection site along with muscle pain, tiredness, chills, and upset stomach. On day 3 and 4, the patient's symptoms got worse, and at the time of reporting she was recovering. The patient had denied permission to contact their physician. No further details were provided.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Erythema, Headache, Injection site induration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 20-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. On 27th June 2018, the patient received the 2nd dose of BEXSERO .5 ml. On 27th June 2018, less than a day after receiving BEXSERO, the patient experienced vomiting, chills, headache, pain in arm, skin warm, injection site swelling, nausea, fever, injection site pain and injection site induration. On 28th June 2018, the patient experienced erythema of extremities and dizziness. On an unknown date, the outcome of the vomiting was recovered/resolved and the outcome of the chills, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the vomiting, chills, headache, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration to be related to BEXSERO. Additional details were provided as follow: The patient received BEXSERO in right deltoid. The patient had a horrible headache and severe sore arm that was painful and hot to touch and was larger the 50 cent piece and was getting larger. The patient had fever and chills all night. The patient had nausea and vomiting all day and a severe headache that was rated as a 5 or 6. On 28th June 2018, 1 day after receiving vaccination, she woke up with dizziness and redness on arm. The patient had increasing arm pain, redness and tenderness. She was fine and drinking water on the reporting date with no vomiting. The headache was persists and the injection site was swollen, hard and painful. The patient was not experiencing confusion or light sensitivity.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 20-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. On 27th June 2018, the patient received the 2nd dose of BEXSERO .5 ml. On 27th June 2018, less than a day after receiving BEXSERO, the patient experienced vomiting, chills, headache, pain in arm, skin warm, injection site swelling, nausea, fever, injection site pain and injection site induration. On 28th June 2018, the patient experienced erythema of extremities and dizziness. On an unknown date, the outcome of the vomiting was recovered/resolved and the outcome of the chills, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the vomiting, chills, headache, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration to be related to BEXSERO. Additional details were provided as follow: The patient received BEXSERO in right deltoid. The patient had a horrible headache and severe sore arm that was painful and hot to touch and was larger the 50 cent piece and was getting larger. The patient had fever and chills all night. The patient had nausea and vomiting all day and a severe headache that was rated as a 5 or 6. On 28th June 2018, 1 day after receiving vaccination, she woke up with dizziness and redness on arm. The patient had increasing arm pain, redness and tenderness. She was fine and drinking water on the reporting date with no vomiting. The headache was persists and the injection site was swollen, hard and painful. The patient was not experiencing confusion or light sensitivity.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 20-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. On 27th June 2018, the patient received the 2nd dose of BEXSERO .5 ml. On 27th June 2018, less than a day after receiving BEXSERO, the patient experienced vomiting, chills, headache, pain in arm, skin warm, injection site swelling, nausea, fever, injection site pain and injection site induration. On 28th June 2018, the patient experienced erythema of extremities and dizziness. On an unknown date, the outcome of the vomiting was recovered/resolved and the outcome of the chills, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the vomiting, chills, headache, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration to be related to BEXSERO. Additional details were provided as follow: The patient received BEXSERO in right deltoid. The patient had a horrible headache and severe sore arm that was painful and hot to touch and was larger the 50 cent piece and was getting larger. The patient had fever and chills all night. The patient had nausea and vomiting all day and a severe headache that was rated as a 5 or 6. On 28th June 2018, 1 day after receiving vaccination, she woke up with dizziness and redness on arm. The patient had increasing arm pain, redness and tenderness. She was fine and drinking water on the reporting date with no vomiting. The headache was persists and the injection site was swollen, hard and painful. The patient was not experiencing confusion or light sensitivity.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 24th June 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, around 2 months ago from the reporting date, the patient received SHINGRIX. The patient experienced Shingles rash. No additional information was available.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 7th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were received as follows: The patient reported that she felt tired for 2 days after vaccinating with SHINGRIX.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: At 11:58 hours, the patient received SHINGRIX on left arm. The patient's left arm at the injection site was red, itchy and hot to the touch. The area measures 4cc by 4cc.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Condition aggravated, Erythema, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (1st dose received and experienced swelling in arm and pain in arm refer linked case US2018GSK121411). Concurrent medical conditions included tinnitus. On 26th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 12 hrs after receiving SHINGRIX, the patient experienced myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated. On an unknown date, the outcome of the myalgia, arthralgia and fever were recovered/resolved and the outcome of the facial swelling and red face were not recovered/not resolved and the outcome of the tinnitus aggravated was recovering/resolving. It was unknown if the reporter considered the myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced side effects after her second SHINGRIX dose in the series. About 12 hours after the injection the patient experienced myalgia, arthralgia, fever (the patient's body temperature was recorded as to 101 degrees). The patient was recovered from those symptoms as well as from swelling of face, redness on the face. The patient was recovering from worsening tinnitus in her right ear. Patient said that the only symptoms that she had with the first dose in the series was pain in the arm, swelling in the arm (refer case US2018GSK121411). The physician did not know exactly where the patient received the vaccine and he thought that probably at her pharmacy.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Tinnitus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (1st dose received and experienced swelling in arm and pain in arm refer linked case US2018GSK121411). Concurrent medical conditions included tinnitus. On 26th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 12 hrs after receiving SHINGRIX, the patient experienced myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated. On an unknown date, the outcome of the myalgia, arthralgia and fever were recovered/resolved and the outcome of the facial swelling and red face were not recovered/not resolved and the outcome of the tinnitus aggravated was recovering/resolving. It was unknown if the reporter considered the myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced side effects after her second SHINGRIX dose in the series. About 12 hours after the injection the patient experienced myalgia, arthralgia, fever (the patient's body temperature was recorded as to 101 degrees). The patient was recovered from those symptoms as well as from swelling of face, redness on the face. The patient was recovering from worsening tinnitus in her right ear. Patient said that the only symptoms that she had with the first dose in the series was pain in the arm, swelling in the arm (refer case US2018GSK121411). The physician did not know exactly where the patient received the vaccine and he thought that probably at her pharmacy.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (1st dose received and experienced swelling in arm and pain in arm refer linked case US2018GSK121411). Concurrent medical conditions included tinnitus. On 26th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 12 hrs after receiving SHINGRIX, the patient experienced myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated. On an unknown date, the outcome of the myalgia, arthralgia and fever were recovered/resolved and the outcome of the facial swelling and red face were not recovered/not resolved and the outcome of the tinnitus aggravated was recovering/resolving. It was unknown if the reporter considered the myalgia, arthralgia, fever, facial swelling, red face and tinnitus aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced side effects after her second SHINGRIX dose in the series. About 12 hours after the injection the patient experienced myalgia, arthralgia, fever (the patient's body temperature was recorded as to 101 degrees). The patient was recovered from those symptoms as well as from swelling of face, redness on the face. The patient was recovering from worsening tinnitus in her right ear. Patient said that the only symptoms that she had with the first dose in the series was pain in the arm, swelling in the arm (refer case US2018GSK121411). The physician did not know exactly where the patient received the vaccine and he thought that probably at her pharmacy.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Condition aggravated, Erythema, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported it could be 53 or 54 years. The patient experienced pain in the arm and swelling in the arm. For tolerance of 2nd dose of SHINGRIX refer linked case US2018116402.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Tinnitus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported it could be 53 or 54 years. The patient experienced pain in the arm and swelling in the arm. For tolerance of 2nd dose of SHINGRIX refer linked case US2018116402.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported it could be 53 or 54 years. The patient experienced pain in the arm and swelling in the arm. For tolerance of 2nd dose of SHINGRIX refer linked case US2018116402.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number XC534, expiry date unknown) and (batch number FY79G, expiry date unknown) for prophylaxis. Concomitant products included Pravastatin, Tamsulosin, ELIQUIS and TOPROL. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th April 2018, the 1st dose was an unknown dose. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, joint pain and fatigue. On 14th April 2018, the outcome of the injection site pain and joint pain were recovered/resolved. On 15th April 2018, the outcome of the fatigue was recovered/resolved. It was not reported if the reporter considered the injection site pain, joint pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported 2 batch numbers 1 of adjuvant and other of lyophilized powder. The patient received SHINGRIX in left arm. The health care professional reported that the patient received SHINGRIX and developed pain at the injection site, fatigue and achy joints within 6 hours of vaccination. This case has been linked with case US2018116406, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received SHINGRIX. On 28th June 2018, 28 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that the patient, a day before reporting, noticed a rash on his upper arm, which was the same arm he had gotten the SHINGRIX injection.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were reported as follows: On the day of vaccination, at night, the patient developed a bad injection site reaction. For tolerance after 2nd dose, refer case US2018GSK121414.