chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included MS (had for 40 years but not ambulatory). On 22nd February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband who was retired physician. The patient never had shingles before. The patient received a dose of SHINGRIX on the left arm. Within 2 days after vaccination, the patient's injection site had been moderately to severely painful at the injection site and it was radiating down perhaps 4 inches down the site of injection on her upper arm. The reporter did not want the company to contact the patient's physician. This case has been linked with the case US2019063878, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 64-year-old male patient who received SHINGRIX (batch number 3735X, expiry date unknown) for prophylaxis. Previously administered products included ZOSTAVAX (received the dose in 2014). Concomitant products included CLOZARIL. On 29th March 2019, the patient received the 1st dose of CLOZARIL. On 3rd April 2019, 5 days after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not reported. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that the SHINGRIX dose was administered at the pharmacy and she has limited access to further details. The patient broke-out in a shingles-like rash on his torso. The pharmacist thought that the CLOZARIL lowered the immune response to the SHINGRIX dose. The nurse noted that a VAERS report has been filed.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 76-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 8th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th April 2019, less than a day after receiving SHINGRIX, the patient experienced blister, pruritus and rash. On an unknown date, the outcome of the blister, pruritus and rash were not recovered/not resolved. It was unknown if the reporter considered the blister, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. The patient experienced bumps, blisters, and itching on her right wrist (opposite arm of the injection site). On 9th April 2019, the patient experienced bumps on her back. In outcome of the events bumps, blisters, and itching were not recovered/not resolved, however in source document the outcome of this events was reported as recovering/resolving.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of sickness in a 64-year-old female patient who received SHINGRIX (batch number T5242, expiry date unknown) for prophylaxis. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX on left deltoid. Initially the patient did not get the second dose due to the product stock issue, however an appointment was scheduled when the product was in stock and the patient cancelled the appointment due to being sick. The nurse does not have further details available regarding the statement sick, as the patient had spoken to the receptionist at the time. Till the time of reporting, the patient did not receive the second dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not reported. The reporter considered the pain in arm to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The patient reported that in October 2018, her first dose of SHINGRIX caused very minor arm pain. The patient did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-MAR-2015, at age 62, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-APR-2017, at age 65, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 hr after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a patient's wife. The age at vaccination was not reported. One or Two hours after receiving SHINGRIX, the patient developed hives mainly on his back, some around on his abdomen and upper arms. The reporter had pictures of reaction and would send if needed.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain, fever and unwell. On an unknown date, the outcome of the influenza-like symptoms, fever and unwell were recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, fever and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About 3 weeks ago, from the date of reporting, the patient received 1st dose of SHINGRIX on an unknown arm. The patient felt ill with flu like symptoms for a few days with a fever of around 101 degree F. the patient also had a very sore arm at injection site to touch. The reporter wants to know if patient should receive the 2nd dose. The reporter agreed to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included fibromyalgia. Concomitant products included hydrocodone. On 6th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th April 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and skin warm. The patient was treated with ADVIL and Ice Pack (NOS). On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and skin warm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional case details were provided as follows: The patient received concomitantly hydrocodone for fibromyalgia but, it did not help. The patient received dose of SHINGRIX on Saturday and on the next day the patient experienced arm was red, warm, swollen and very sore. The reaction on the patient's arm was about the size of a pickle jar top. The patient has given the consent for follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 54-year-old male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2019) for prophylaxis. On 1st March 2019, the patient received the 1st dose of SHINGRIX. On 1st March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, fatigue and feeling miserable. On 2nd March 2019, the outcome of the influenza-like symptoms, fever, chills, fatigue and feeling miserable were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, fatigue and feeling miserable to be related to SHINGRIX. Additional case details were provided as follows: The case was reported by the medical assistant. The patient received the dose of SHINGRIX and on the same night the patient experienced the side effects such as fever, chills, fatigue, flu-like, feeling miserable. All the events were resolved on next day of vaccination. No additional data was provided.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of foggy feeling in head in a 78-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included non-Hodgkin's lymphoma (9 years ago from the date of reporting). Concurrent medical conditions included neuropathy (Permanent, due to chemotherapy treatment). In February 2019, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced foggy feeling in head and erythromacular rash. On an unknown date, the outcome of the foggy feeling in head was recovered/resolved and the outcome of the erythromacular rash was not recovered/not resolved. It was unknown if the reporter considered the foggy feeling in head and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The patient was currently cancer-free. The patient received the dose of SHINGRIX on left arm. Roughly a week later after receiving SHINGRIX, the patient developed red spots on both of his lower legs that have not resolved. The red spots were about 6 inches below his kneecaps on the same area on both legs. The patient stated that it was not a rash, not oozing, not itching, and not painful. When the area was wet, such as in the shower, the red spots appear darker, but when they are dry they lighten up again. The patient also mentioned that he felt foggy for a few days initially after the vaccination. The reporter consented to follow up. In core outcome of the event fogginess was recovered/resolved and the outcome of the red spots was not recovered/not resolved, however in source document the outcome of the fogginess was recovered/resolved with sequel and the outcome of the red spots was recovering/resolving.
Age: 37.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Cellulitis, Erythema, Fatigue, Injected limb mobility decreased, Injection site joint erythema
Clinical narrative: 4/12/19 AT 1700hrs, felt fatigued 4/13/19 @ 0700hrs began severe left arm pain and continued fatigue, by 1000hrs pt experienced redness, swelling, of left shoulder joint, unable to move left arm d/t pain, erythema and severe fatigue, fever of 101.6F. Fever broke 4/13/19 evening w/ Tylenol throughout the day. Sunday, 4/14/19 pt experienced progressing redness, swelling into upper left arm. Progression continued 4/15/19 and pt went to ER at 2330hrs. Per pt, diagnosed w/ left arm cellulitis by ER, started on Clindamycin 300mg four times a day, lactobacillus reuteri capsules.
Age: 37.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site joint swelling, Pain in extremity, Pyrexia
Clinical narrative: 4/12/19 AT 1700hrs, felt fatigued 4/13/19 @ 0700hrs began severe left arm pain and continued fatigue, by 1000hrs pt experienced redness, swelling, of left shoulder joint, unable to move left arm d/t pain, erythema and severe fatigue, fever of 101.6F. Fever broke 4/13/19 evening w/ Tylenol throughout the day. Sunday, 4/14/19 pt experienced progressing redness, swelling into upper left arm. Progression continued 4/15/19 and pt went to ER at 2330hrs. Per pt, diagnosed w/ left arm cellulitis by ER, started on Clindamycin 300mg four times a day, lactobacillus reuteri capsules.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster oticus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. In or around 02 FEB 2015, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX vaccine, the patient suffered facial paralysis (considered a symptom of Bell's Palsy or Ramsay Hunt Syndrome), Bell's palsy, and Ramsay Hunt Syndrome. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient experienced serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Treatment and outcome of events was not recovered. Causality assessment was related. Upon internal review, Bell's palsy and Ramsay Hunt Syndrome were determined to be medical significant. Bell's palsy and Ramsay Hunt Syndrome were considered to be disabling. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately age 66, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-NOV-2007, at age 64, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tendon pain (past 2007, the patient had rare tendon and ligament leg and arm severe pain after taking CIPRO few times that year for different reasons.), ligament pain, pain in arm (after taking LUNSETA) and leg pain. On 6th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that by the evening of the same day, she had severe pain in the underside of her upper arm. This pain has continued for over 1 month. The patient also started getting similar pain in her right arm a couple of weeks ago. The pain was not continual. It was usually worse in the evening. The patient has not been able to attribute this ripping pain to any other activity, other than the SHINGRIX shot. The patient also had leg and arm pain after taking LUNESTA, and my doctor took me right off the medication. The SHINGRIX was so strong a medicine, the patient asked could this be a severe reaction, since the patient seem to be prone to ligament and tendon pain. The patient asked do you advise me still getting a 2nd shot.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Axillary pain, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tendon pain (past 2007, the patient had rare tendon and ligament leg and arm severe pain after taking CIPRO few times that year for different reasons.), ligament pain, pain in arm (after taking LUNSETA) and leg pain. On 6th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that by the evening of the same day, she had severe pain in the underside of her upper arm. This pain has continued for over 1 month. The patient also started getting similar pain in her right arm a couple of weeks ago. The pain was not continual. It was usually worse in the evening. The patient has not been able to attribute this ripping pain to any other activity, other than the SHINGRIX shot. The patient also had leg and arm pain after taking LUNESTA, and my doctor took me right off the medication. The SHINGRIX was so strong a medicine, the patient asked could this be a severe reaction, since the patient seem to be prone to ligament and tendon pain. The patient asked do you advise me still getting a 2nd shot.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Inflammation, Injection site pain, Joint noise, Muscle tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tendon pain (past 2007, the patient had rare tendon and ligament leg and arm severe pain after taking CIPRO few times that year for different reasons.), ligament pain, pain in arm (after taking LUNSETA) and leg pain. On 6th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that by the evening of the same day, she had severe pain in the underside of her upper arm. This pain has continued for over 1 month. The patient also started getting similar pain in her right arm a couple of weeks ago. The pain was not continual. It was usually worse in the evening. The patient has not been able to attribute this ripping pain to any other activity, other than the SHINGRIX shot. The patient also had leg and arm pain after taking LUNESTA, and my doctor took me right off the medication. The SHINGRIX was so strong a medicine, the patient asked could this be a severe reaction, since the patient seem to be prone to ligament and tendon pain. The patient asked do you advise me still getting a 2nd shot.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Myalgia, Neck pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tendon pain (past 2007, the patient had rare tendon and ligament leg and arm severe pain after taking CIPRO few times that year for different reasons.), ligament pain, pain in arm (after taking LUNSETA) and leg pain. On 6th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that by the evening of the same day, she had severe pain in the underside of her upper arm. This pain has continued for over 1 month. The patient also started getting similar pain in her right arm a couple of weeks ago. The pain was not continual. It was usually worse in the evening. The patient has not been able to attribute this ripping pain to any other activity, other than the SHINGRIX shot. The patient also had leg and arm pain after taking LUNESTA, and my doctor took me right off the medication. The SHINGRIX was so strong a medicine, the patient asked could this be a severe reaction, since the patient seem to be prone to ligament and tendon pain. The patient asked do you advise me still getting a 2nd shot.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Poor quality sleep, Rheumatoid arthritis, Rotator cuff syndrome, Sjogren's syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tendon pain (past 2007, the patient had rare tendon and ligament leg and arm severe pain after taking CIPRO few times that year for different reasons.), ligament pain, pain in arm (after taking LUNSETA) and leg pain. On 6th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that by the evening of the same day, she had severe pain in the underside of her upper arm. This pain has continued for over 1 month. The patient also started getting similar pain in her right arm a couple of weeks ago. The pain was not continual. It was usually worse in the evening. The patient has not been able to attribute this ripping pain to any other activity, other than the SHINGRIX shot. The patient also had leg and arm pain after taking LUNESTA, and my doctor took me right off the medication. The SHINGRIX was so strong a medicine, the patient asked could this be a severe reaction, since the patient seem to be prone to ligament and tendon pain. The patient asked do you advise me still getting a 2nd shot.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Spinal X-ray, Ultrasound scan, X-ray limb normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tendon pain (past 2007, the patient had rare tendon and ligament leg and arm severe pain after taking CIPRO few times that year for different reasons.), ligament pain, pain in arm (after taking LUNSETA) and leg pain. On 6th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that by the evening of the same day, she had severe pain in the underside of her upper arm. This pain has continued for over 1 month. The patient also started getting similar pain in her right arm a couple of weeks ago. The pain was not continual. It was usually worse in the evening. The patient has not been able to attribute this ripping pain to any other activity, other than the SHINGRIX shot. The patient also had leg and arm pain after taking LUNESTA, and my doctor took me right off the medication. The SHINGRIX was so strong a medicine, the patient asked could this be a severe reaction, since the patient seem to be prone to ligament and tendon pain. The patient asked do you advise me still getting a 2nd shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Hyperhidrosis, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2019, the patient received the 1st dose of SHINGRIX. On 5th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, sweating and shivers. On 6th April 2019, the patient experienced neck pain, shoulder pain and upset stomach. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm, neck pain, shoulder pain and upset stomach were unknown and the outcome of the sweating and shivers were not recovered/not resolved. The reporter considered the pain in arm, sweating, shivers, neck pain, shoulder pain and upset stomach to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX and experienced typical Pain around area following injection. In the middle of night, the pain increased in arm. The patient also had experienced sweat or shivers which was present on the day of reporting. On Saturday, the patient experienced body aches in base of neck and body shoulder area and also experienced sweat at night. In the noon of Saturday, the patient had stomach upset. The batch number was not reported. The patient believes that the events were related to the vaccine. The reporter agreed to follow up from GSK.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2019, the patient received the 1st dose of SHINGRIX. On 5th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, sweating and shivers. On 6th April 2019, the patient experienced neck pain, shoulder pain and upset stomach. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm, neck pain, shoulder pain and upset stomach were unknown and the outcome of the sweating and shivers were not recovered/not resolved. The reporter considered the pain in arm, sweating, shivers, neck pain, shoulder pain and upset stomach to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX and experienced typical Pain around area following injection. In the middle of night, the pain increased in arm. The patient also had experienced sweat or shivers which was present on the day of reporting. On Saturday, the patient experienced body aches in base of neck and body shoulder area and also experienced sweat at night. In the noon of Saturday, the patient had stomach upset. The batch number was not reported. The patient believes that the events were related to the vaccine. The reporter agreed to follow up from GSK.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Patient reported terrible headache and pain up shoulder into neck. Reported symptoms to doctor. After a day of rest, acetaminophen, and ice there was no improvement. Doctor referred patient to ER where blood work was done. This came back normal and the patient was released.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site pain, Pain, Pyrexia
Clinical narrative: Mild fever, feeling cold, tired, sore all over the body and the area of vaccine injection
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Itching developed at site of injection within 5 minutes. Developed 6 cm erythematous area at site and a 2 mm raised erythematous welt at injection site.  A second 2 cm erythematous area was noted superior to primary urticarial site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Bruising surrounded by redness/swelling on left thigh. 12.5cm by 10cm. Prescription for Keflex TID x 10 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Stiff neck, swollen joints, headache, flu like symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-DEC-2010, at age 63, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post-herpetic neuralgia; Shingles; 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. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 18-MAY-2012, at age 61, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles and post-herpetic neuralgia. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles and post-herpetic neuralgia is unknown.  Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Malaise, Pyrexia, Rash macular, Swelling face
Clinical narrative: malaise; pyrexia; rash macular; swelling face; This case was reported by a consumer via other manufacturer and described the occurrence of malaise in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 29th March 2019, the patient received Pediarix. On an unknown date, less than a month after receiving Pediarix, the patient experienced malaise, fever, macular rash and facial swelling. On an unknown date, the outcome of the malaise, fever, macular rash and facial swelling were unknown.   It was unknown if the reporter considered the malaise, fever, macular rash and facial swelling to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced malaise, fever, macular rash and facial swelling.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and local reaction. On an unknown date, the outcome of the fever and local reaction were not recovered/not resolved. It was unknown if the reporter considered the fever and local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that the patient had a reaction including high fever and local reaction. It has been a month and a week, and patient continues to have issues. The physician stated that he already reported this to GlaxoSmithKline a month ago and filled out the requested paperwork and the patient declined to provide additional details during this call. The specialist was completing adverse event documentation at the time of reporting, since the physician stated that the patient continues to have issues, and agent was unable to verify patient details with physician in order to complete a follow up adverse event report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX. On 25th March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, fatigue and feeling miserable. On 26th March 2019, the outcome of the influenza-like symptoms, fever, chills, fatigue and feeling miserable were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, fatigue and feeling miserable to be related to SHINGRIX. Additional details were provided as follows: The patient experienced side effects fever, chills, fatigue, flu-like and feeling miserable. The patient experienced symptoms on the same night after 1st injection and resolved the next day. No additional data provided.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of forehead swelling in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (about 3 to 4 years ago). In February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced forehead swelling. On an unknown date, the outcome of the forehead swelling was not recovered/not resolved. It was unknown if the reporter considered the forehead swelling to be related to SHINGRIX. Additional details were provided as follows: The caller stated that he received SHINGRIX in early February and about 2 days afterwards he had swelling of his forehead and cheeks. He stated it was just very slight but he noticed it, there was no pain. He stated that he did report it to his physician but the physician stated he could not tell there was swelling and offered no treatment recommendations. The patient stated the swelling was still present at the same degree, he had his 2nd SHINGRIX shot three days ago even though the swelling was still present but has not had any increase or worsening since receiving the 2nd dose. The reporter did not consent to follow-up. The health care professional declined to provided information and follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Received vaccine AM of 4/9/19. That evening had pain and local reaction at site (L) deltoid. Woke in AM with sore throat, vomiting, diarrhea. Came to office approximately 4 pm on 4/10/19. All symptoms resolved except feels ill and (L) arm hurts. (L) deltoid greater than 1/2 dollar size erythema, tender and indurate at site of injection.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: Received vaccine AM of 4/9/19. That evening had pain and local reaction at site (L) deltoid. Woke in AM with sore throat, vomiting, diarrhea. Came to office approximately 4 pm on 4/10/19. All symptoms resolved except feels ill and (L) arm hurts. (L) deltoid greater than 1/2 dollar size erythema, tender and indurate at site of injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Cough, Dehydration, Dry mouth, Dyspepsia
Clinical narrative: About 1 hour later, patient could not get out of bed because started coughing violently; cough productive with clear sputum. Patient reports cough has worsen and it has been like 7 days; the worst was the same day through 4/5 -4/6. Per wife, patient was delirious on first and second day. On 4/4 patient went to clinic and told them what was going on; told it was typical and would last like 3-5 days. Patient has been taking MUCINEX, sucking on cough drops, and drinking lots of water. Mouth is very dry so patient is a bit dehydrated. On 4/7, patient was concerned because started coughing blood. Patient may have irritated throat from coughing so much and has not happened since. Patient is wheezing, hard to catch breath but getting a little better. Patient cannot sleep well because coughing so much and drinking so much water. Patient feels burning on chest and stomach due to the cough probably. At night patient feels the need to have rag from sweat to wipe head--pillow is soaking wet. Patient has had no fever this whole time.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Haemoptysis, Hyperhidrosis, Poor quality sleep, Productive cough, Wheezing
Clinical narrative: About 1 hour later, patient could not get out of bed because started coughing violently; cough productive with clear sputum. Patient reports cough has worsen and it has been like 7 days; the worst was the same day through 4/5 -4/6. Per wife, patient was delirious on first and second day. On 4/4 patient went to clinic and told them what was going on; told it was typical and would last like 3-5 days. Patient has been taking MUCINEX, sucking on cough drops, and drinking lots of water. Mouth is very dry so patient is a bit dehydrated. On 4/7, patient was concerned because started coughing blood. Patient may have irritated throat from coughing so much and has not happened since. Patient is wheezing, hard to catch breath but getting a little better. Patient cannot sleep well because coughing so much and drinking so much water. Patient feels burning on chest and stomach due to the cough probably. At night patient feels the need to have rag from sweat to wipe head--pillow is soaking wet. Patient has had no fever this whole time.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: That same night and 48 hrs after that my whole body ached as if I had the worst flu I've ever had. The injection site was not only red, but my arm's upper half up tol the shoulder swelled considerably for several days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Arm sore at injection site first evening. Later that night started not feeling well, had really bad headache, severe body aches particularly muscles and joints, felt sick to stomach, felt very fatigued and stayed in bed several days. No fever.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Arm sore at injection site first evening. Later that night started not feeling well, had really bad headache, severe body aches particularly muscles and joints, felt sick to stomach, felt very fatigued and stayed in bed several days. No fever.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Blood test normal, Breath holding, Computerised tomogram normal, Crying, Diarrhoea
Clinical narrative: On 11/10/2017 his stools became watery and full of mucus. On 11/13/2017 Patient started waking up startled out of his sleep. He would curl up and stop breathing for a few seconds. He would do this on and off for a few minutes and he would be crying uncontrollably in between. This would happen in the middle of the night, up to 3 times a night as well as naps throughout the day. I thought something was just scaring him like having a bad dream but I had a really bad feeling about it. He stopped breastfeeding around this same time so I was feeding him pumped milk I had stored. He was projectile vomiting on 12/05 Doctors said it might be his reflux. I took him to the ER for the vomiting on 12/21/17. Doctors didn't say much. They told me to feed him smaller portions more often. He then developed a rash on his belly looked like eczema. On 12/26/17 I took Patient to the ER after I saw a video of infantile spasms on YouTube. He was then hospitalized for 20 days for having seizures.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Electroencephalogram abnormal, Epilepsy, Infantile spasms, Middle insomnia, Mucous stools
Clinical narrative: On 11/10/2017 his stools became watery and full of mucus. On 11/13/2017 Patient started waking up startled out of his sleep. He would curl up and stop breathing for a few seconds. He would do this on and off for a few minutes and he would be crying uncontrollably in between. This would happen in the middle of the night, up to 3 times a night as well as naps throughout the day. I thought something was just scaring him like having a bad dream but I had a really bad feeling about it. He stopped breastfeeding around this same time so I was feeding him pumped milk I had stored. He was projectile vomiting on 12/05 Doctors said it might be his reflux. I took him to the ER for the vomiting on 12/21/17. Doctors didn't say much. They told me to feed him smaller portions more often. He then developed a rash on his belly looked like eczema. On 12/26/17 I took Patient to the ER after I saw a video of infantile spasms on YouTube. He was then hospitalized for 20 days for having seizures.