chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mg. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On 16th February 2018, the patient experienced headache. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, headache and rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, headache and rash to be related to SHINGRIX. Additional details were provided as follows: At 14:00 hours, the patient received SHINGRIX in right arm. After vaccination the patient had pain at the site for 6 days and redness for 7 days. She also had swelling in about a 3 inch circle around the injection site. On 16th February 2018, she woke up with headache that lasted for 24 hours. A few days after the injection she had a rash on her right arm where she got the injection, about 10 small red dots down her arm to her wrist. This lasted for about 5 days. About a week later her left arm developed the same rash. The patient has denied permission to contact their physician. This case has been linked US2018GSK135577, reported for further dose of SHINGRIX. This is 1 of the 5 cases reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mg. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On 16th February 2018, the patient experienced headache. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, headache and rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, headache and rash to be related to SHINGRIX. Additional details were provided as follows: At 14:00 hours, the patient received SHINGRIX in right arm. After vaccination the patient had pain at the site for 6 days and redness for 7 days. She also had swelling in about a 3 inch circle around the injection site. On 16th February 2018, she woke up with headache that lasted for 24 hours. A few days after the injection she had a rash on her right arm where she got the injection, about 10 small red dots down her arm to her wrist. This lasted for about 5 days. About a week later her left arm developed the same rash. The patient has denied permission to contact their physician. This case has been linked US2018GSK135577, reported for further dose of SHINGRIX. This is 1 of the 5 cases reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 15th February 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mg. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX.  Additional information was reported as follows: The patient experienced pain at injection site for a period of 3 days and redness starting and subsiding, the third day. The batch number for SHINGRIX was unknown. For tolerance to next dose, refer case US2018GSK135762.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling 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 swelling, fatigue, rash and pain. On an unknown date, the outcome of the swelling, fatigue, rash and pain were unknown. It was unknown if the reporter considered the swelling, fatigue, rash and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The reporter stated that she was speaking with her pharmacist and pharmacist had a patient who experienced adverse events after receiving a dose of SHINGRIX. This was one of five cases which were reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction 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, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had reaction (unspecified adverse event) to SHINGRIX. This is one of the 5 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that she was talking with her pharmacist and her pharmacist had a patient who had a reaction to SHINGRIX. This case was reported for 2nd patient. This is one of five cases, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of papular rash in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of pain in extremity (refer case US2018GSK135722). On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, pain in arm and erythema of extremities. On 20th July 2018, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the papular rash and itchy rash were not recovered/not resolved and the outcome of the swelling arm, pain in arm and erythema of extremities were unknown. It was unknown if the reporter considered the papular rash, itchy rash, swelling arm, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received the first dose of SHINGRIX on the day before reporting and she experienced redness, swelling and soreness in the arm in which she received the vaccine. The patient states that this afternoon she noticed an itchy, bumpy, rash that was on the upper part of her left shoulder, on her upper back and on the right shoulder blade. The physician information was added. This case has been linked with US2018GSK135722, reported for the same patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of papular rash in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of pain in extremity (refer case US2018GSK135722). On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, pain in arm and erythema of extremities. On 20th July 2018, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the papular rash and itchy rash were not recovered/not resolved and the outcome of the swelling arm, pain in arm and erythema of extremities were unknown. It was unknown if the reporter considered the papular rash, itchy rash, swelling arm, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient received the first dose of SHINGRIX on the day before reporting and she experienced redness, swelling and soreness in the arm in which she received the vaccine. The patient states that this afternoon she noticed an itchy, bumpy, rash that was on the upper part of her left shoulder, on her upper back and on the right shoulder blade. The physician information was added. This case has been linked with US2018GSK135722, reported for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Fatigue, Heart rate decreased, Influenza like illness, Injection site inflammation
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever and injection site inflammation. On 16th July 2018, the patient experienced vomiting, pain in arm, blood sugar increased, pulse decreased and oxygen saturation decreased. On 17th July 2018, the patient experienced influenza-like symptoms, pain, fatigue and nausea. On an unknown date, the outcome of the vomiting, influenza-like symptoms and fever were recovering/resolving and the outcome of the pain in arm, pain, fatigue, nausea and injection site inflammation were not recovered/not resolved and the outcome of the blood sugar increased, pulse decreased and oxygen saturation decreased were unknown. It was unknown if the reporter considered the vomiting, pain in arm, influenza-like symptoms, pain, fatigue, nausea, fever, injection site inflammation, blood sugar increased, pulse decreased and oxygen saturation decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that about 2 hours after receiving SHINGRIX the patient began vomiting. The patient also reported that the patient had a blood sugar spike, her oxygen saturation decreased and her pulse decreased, her arm pain was pretty severe and extremely tender to touch. On the second day after receiving the vaccine patient stated that she had some pretty severe flu like symptoms, she was extremely achy, very fatigued, nauseas. A fever was reported as well. On the day of reporting on 18th July 2018 she stated that she felt a little better than she had been feeling the last two days except for the continued fatigue, achy feeling and a very tender arm or inflamed injection site, the patient reported that her symptoms were so bad that she did not want to get the second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Oxygen saturation decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever and injection site inflammation. On 16th July 2018, the patient experienced vomiting, pain in arm, blood sugar increased, pulse decreased and oxygen saturation decreased. On 17th July 2018, the patient experienced influenza-like symptoms, pain, fatigue and nausea. On an unknown date, the outcome of the vomiting, influenza-like symptoms and fever were recovering/resolving and the outcome of the pain in arm, pain, fatigue, nausea and injection site inflammation were not recovered/not resolved and the outcome of the blood sugar increased, pulse decreased and oxygen saturation decreased were unknown. It was unknown if the reporter considered the vomiting, pain in arm, influenza-like symptoms, pain, fatigue, nausea, fever, injection site inflammation, blood sugar increased, pulse decreased and oxygen saturation decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that about 2 hours after receiving SHINGRIX the patient began vomiting. The patient also reported that the patient had a blood sugar spike, her oxygen saturation decreased and her pulse decreased, her arm pain was pretty severe and extremely tender to touch. On the second day after receiving the vaccine patient stated that she had some pretty severe flu like symptoms, she was extremely achy, very fatigued, nauseas. A fever was reported as well. On the day of reporting on 18th July 2018 she stated that she felt a little better than she had been feeling the last two days except for the continued fatigue, achy feeling and a very tender arm or inflamed injection site, the patient reported that her symptoms were so bad that she did not want to get the second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever and injection site inflammation. On 16th July 2018, the patient experienced vomiting, pain in arm, blood sugar increased, pulse decreased and oxygen saturation decreased. On 17th July 2018, the patient experienced influenza-like symptoms, pain, fatigue and nausea. On an unknown date, the outcome of the vomiting, influenza-like symptoms and fever were recovering/resolving and the outcome of the pain in arm, pain, fatigue, nausea and injection site inflammation were not recovered/not resolved and the outcome of the blood sugar increased, pulse decreased and oxygen saturation decreased were unknown. It was unknown if the reporter considered the vomiting, pain in arm, influenza-like symptoms, pain, fatigue, nausea, fever, injection site inflammation, blood sugar increased, pulse decreased and oxygen saturation decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that about 2 hours after receiving SHINGRIX the patient began vomiting. The patient also reported that the patient had a blood sugar spike, her oxygen saturation decreased and her pulse decreased, her arm pain was pretty severe and extremely tender to touch. On the second day after receiving the vaccine patient stated that she had some pretty severe flu like symptoms, she was extremely achy, very fatigued, nauseas. A fever was reported as well. On the day of reporting on 18th July 2018 she stated that she felt a little better than she had been feeling the last two days except for the continued fatigue, achy feeling and a very tender arm or inflamed injection site, the patient reported that her symptoms were so bad that she did not want to get the second dose.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX (batch number 759E9, expiry date 25th April 2020) for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The healthcare professional reported that the patient had flu-like symptoms after receiving SHINGRIX on left arm. This case has been linked with US2018128734, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 52-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient's age was around 52 years. The age at vaccination was not reported. The patient received a dose of SHINGRIX in his facility in April 2018. The patient stated that his arm hurt for about 3 days after the shot and he had some flu-like symptoms. The patient still plans to get the second dose. The reporter gave consent for follow up. At the time of reporting, the patient planned to get the second dose.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atopy (the patient carries an EPIPEN). Concomitant products included EPIPEN. On 27th June 2018, the patient received the 1st dose of SHINGRIX. On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness and nausea. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness, nausea and headache were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness, nausea and headache to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she was vaccinated with the initial dose SHINGRIX vaccine as recommended by her primary care physician. The patient asked the nurse, that if the vaccine would hurt and the nurse said no. The patient also stated that, she was very active 73 year old female and also later on same day after vaccination she swam her usual laps. She realized then that she could not raise her arm that had been injected without a lot of pain, but she kept on thinking that the pain would work its way out, however it didn't. After carrying out a 40 min swim she felt dizzy and was thankful that she had not fallen onto the cement. Thereafter she felt slightly nauseous, headachy and lethargic. By the next day of the vaccination most of her symptoms were resolved, but the site of the injection continued to be very painful, red and somewhat swollen for three days. The patient was handed with a flyer at the time of injection and she warned that side effects could be mild to moderate. Whereas, the patient described the side effects as moderate to severe. The patient never had that degree of pain after vaccination. She went online and read a lot of reports of the same side effects that she had, which reassured her that the reactions that she had experienced were normal for the vaccine. The patient had two questions towards GlaxoSmithKline that were stated as, why don't you warn patients about the moderate to severe side effects in your flyer? Also, as the patient was atopic and she carried a EPIPEN, so the patient inquired that is it recommended for her to take the second part of the immunization which she was scheduled to receive in a few months, before the date of reporting.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Nausea, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atopy (the patient carries an EPIPEN). Concomitant products included EPIPEN. On 27th June 2018, the patient received the 1st dose of SHINGRIX. On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness and nausea. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness, nausea and headache were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site erythema, injection site swelling, injection site pain, lethargy, dizziness, nausea and headache to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she was vaccinated with the initial dose SHINGRIX vaccine as recommended by her primary care physician. The patient asked the nurse, that if the vaccine would hurt and the nurse said no. The patient also stated that, she was very active 73 year old female and also later on same day after vaccination she swam her usual laps. She realized then that she could not raise her arm that had been injected without a lot of pain, but she kept on thinking that the pain would work its way out, however it didn't. After carrying out a 40 min swim she felt dizzy and was thankful that she had not fallen onto the cement. Thereafter she felt slightly nauseous, headachy and lethargic. By the next day of the vaccination most of her symptoms were resolved, but the site of the injection continued to be very painful, red and somewhat swollen for three days. The patient was handed with a flyer at the time of injection and she warned that side effects could be mild to moderate. Whereas, the patient described the side effects as moderate to severe. The patient never had that degree of pain after vaccination. She went online and read a lot of reports of the same side effects that she had, which reassured her that the reactions that she had experienced were normal for the vaccine. The patient had two questions towards GlaxoSmithKline that were stated as, why don't you warn patients about the moderate to severe side effects in your flyer? Also, as the patient was atopic and she carried a EPIPEN, so the patient inquired that is it recommended for her to take the second part of the immunization which she was scheduled to receive in a few months, before the date of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were unknown. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient called the Pharmacy complaining about her arm being sore and red following the injection. The patient felt the injection was administered lower on the deltoid muscle than usual. This was all the information the sales representative received. The reporter agreed to be contacted for follow up.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 20-year-old female patient who received BEXSERO (batch number 16D601, expiry date unknown) for prophylaxis. On 12th June 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by an office staff. The patient received BEXSERO on the left arm. The reporter agreed to be contacted for follow up. For tolerance to next dose, refer case US2018GSK134428.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of allergic reaction in a adult male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included salbutamol sulphate (Ventolin Hfa) inhaler for chronic obstructive pulmonary disease. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and Ventolin Hfa 90 µg daily. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Ventolin Hfa, the patient experienced allergic reaction. The action taken with Ventolin Hfa was unknown (Dechallenge was unknown). Rechallenge with Ventolin Hfa was unknown. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season and Ventolin Hfa. Additional details were provided as follows: This case was received from the non healthcare provider via the patient assistance program. The age at vaccination was not reported. The patient stated that he went to the hospital on 6th July 2018 because he had allergic reaction from the Flu shot. The patient stated he was taking the Ventolin HFA at the time of the reaction. No further details regarding hospital visit was provided. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Depressed mood, Headache, Impaired work ability, Influenza
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a male 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 influenza, feeling down and headache. On an unknown date, the outcome of the influenza, feeling down and headache were unknown. It was unknown if the reporter considered the influenza, feeling down and headache to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, he was not sure if he had flu after administration with the first dose of SHINGRIX. The healthcare professional additional reported that, after receiving the first dose, he could not work for the next day after receiving the vaccine and he also stated that the vaccine knocked him so low. The events were updated after call review. This case was linked with case US2018129628, reported by the same reporter for the same patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 21st February 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose (batch number LT533) received on 4th May 2018, refer linked case US2018128734). On 9th July 2018, the patient received the 2nd dose of SHINGRIX. On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid (the batch number was reported as TN227, which was corrected to ZN22Z as per sales data sheet). This case has been linked with US2018GSK129131, US2018GSK129134 and US2018GSK129168 reported by same reporter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: 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 17-year-old female patient who received BEXSERO (batch number 165801, expiry date 30th October 2018) for prophylaxis. On 14th June 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 14th June 2018, less than a day after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of BEXSERO about a month ago in the left arm and experienced local arm pain. This case has been linked with case US2018129638 (for 2nd dose), reported by the same reporter for the same patient.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 20-year-old female patient who received BEXSERO (batch number 16E601, expiry date unknown) for prophylaxis. Concomitant products included BEXSERO. On 13th July 2018, the patient received the 2nd dose of BEXSERO. In July 2018, less than a week after receiving BEXSERO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by an office staff. On 12th June 2018, the patient received the 1st dose of BEXSERO (batch number 16D601) and experienced pain and swelling at injection site (refer case US2018GSK130899). The patient received 2nd dose of BEXSERO on the left arm and experienced same adverse events. The reporter agreed to be contacted for follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient's injection site was sore, painful and she could hardly lift her arm. She had been taking MOTRIN. The patient's condition was getting worse. The patient gave permission to contact her physician. The patient would follow up with her physician in a week from the date of reporting. No further details were provided. This case has been linked with case US2018130283, reported by the same reporter (same patient for 1st dose).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2018130336 for further information). On 2nd July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On 3rd July 2018, the patient experienced fatigue and headache. In July 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, fatigue and headache were recovered/resolved and the outcome of the injection site swelling was unknown.  It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had pain at the injection site for 3 days and redness for 5 days. She again had the swelling in about a 3 inch circle around the injection site. On 3rd July 2018, she woke up with a headache and fatigue that lasted about 24 hours. The patient has denied permission to contact their physician. This is 1 of the 5 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose, refer case US2018130236). On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain and fever. On 19th July 2018, the patient experienced injection site itching, injection site induration, injection site tenderness and injection site erythema. On an unknown date, the outcome of the general body pain, injection site itching, injection site induration, injection site tenderness, fever and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the general body pain, injection site itching, injection site induration, injection site tenderness, fever and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 58 or 59 years of age. The patient experienced body aches, fever, and injection site reactions including red, hard starburst 2 to 3 inches in size, tender and itchy. On 19th July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site reactions.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose, refer case US2018130236). On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain and fever. On 19th July 2018, the patient experienced injection site itching, injection site induration, injection site tenderness and injection site erythema. On an unknown date, the outcome of the general body pain, injection site itching, injection site induration, injection site tenderness, fever and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the general body pain, injection site itching, injection site induration, injection site tenderness, fever and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 58 or 59 years of age. The patient experienced body aches, fever, and injection site reactions including red, hard starburst 2 to 3 inches in size, tender and itchy. On 19th July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site reactions.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling, pain and skin warm. On an unknown date, the outcome of the erythema, swelling, pain and skin warm were unknown. It was unknown if the reporter considered the erythema, swelling, pain and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not provide any more information at the time of reporting but stated that she would call back on Monday with more information about the patient. This case was linked with US2018130334, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
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 71-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) for prophylaxis. In October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The patient received flu vaccine on left arm. The patient also mentioned that sometimes when she gets the flu vaccine (unknown manufacturer), her arm gets a little sore for a few days. This case has been linked with US2018130341, reported for the same patient.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on 15th February 2018, the patient received 1st dose (refer case US2018130337)). On 2nd July 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd July 2018, 1 days after receiving SHINGRIX, the patient experienced headache and fatigue. In July 2018, the patient experienced pain. On an unknown date, the outcome of the headache and fatigue were unknown and the outcome of the pain was recovering/resolving. It was unknown if the reporter considered the headache, fatigue and pain to be related to SHINGRIX. Additional information was reported as follows: On 3rd July 2018, the patient woke up with the events headache and fatigue after vaccination. The batch number for SHINGRIX was unknown. This case was linked with case US2018130337 (1st dose), reported by the same reporter for the same patient.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Chest X-ray normal, Decreased appetite, Epistaxis, Laboratory test normal, Pyrexia
Clinical narrative: Pt was in for a well visit 3 days ago ( 7-27-18 ), had 3 vaccines and also diagnosis with BOM, Pt then was started on Cefdinir, and mom gave 2 doses so far, mom says his fever was 104 the next day do they went to the E/R, at Medical Center, where he had a nasal swab and CXR, which results were normal. Mom, giving TYLENOL or MOTRIN, with fair results. Temp today 105.8 rectal, Pt fusion past 2-3 days, appetite decreased, clear runny nose for 3 days, blood from the ear x 5 days - resolving.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rhinorrhoea
Clinical narrative: Pt was in for a well visit 3 days ago ( 7-27-18 ), had 3 vaccines and also diagnosis with BOM, Pt then was started on Cefdinir, and mom gave 2 doses so far, mom says his fever was 104 the next day do they went to the E/R, at Medical Center, where he had a nasal swab and CXR, which results were normal. Mom, giving TYLENOL or MOTRIN, with fair results. Temp today 105.8 rectal, Pt fusion past 2-3 days, appetite decreased, clear runny nose for 3 days, blood from the ear x 5 days - resolving.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Angiopathy, Blood creatinine normal, Blood culture negative, C-reactive protein increased, Chest X-ray normal
Clinical narrative: Patient reports 1 day after injection, she developed pain and expanding erythema at site of injection with rigors, fevers to 103 F, myalgias, transient numbness of hands and feet. She went to ED on 7/25 where she also had hypotension and tachycardia. Physician concerned for severe sepsis secondary to cellulitis vs post-pneumococcal severe hypersensitivity reaction. She was started on broad spectrum antibiotics cefazolin and transitioned to vancomycin and ZOSYN. After 24 hours, the rash had improved proximally with reduced erythema but had worsening erythema inferiomedially and distally not past the elbows. Pain at site of injection continued to be significant.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hypoaesthesia, Hypotension, Injection site erythema, Injection site pain
Clinical narrative: Patient reports 1 day after injection, she developed pain and expanding erythema at site of injection with rigors, fevers to 103 F, myalgias, transient numbness of hands and feet. She went to ED on 7/25 where she also had hypotension and tachycardia. Physician concerned for severe sepsis secondary to cellulitis vs post-pneumococcal severe hypersensitivity reaction. She was started on broad spectrum antibiotics cefazolin and transitioned to vancomycin and ZOSYN. After 24 hours, the rash had improved proximally with reduced erythema but had worsening erythema inferiomedially and distally not past the elbows. Pain at site of injection continued to be significant.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test normal, Myalgia, Neutrophil count increased, Oedema peripheral, Pyrexia
Clinical narrative: Patient reports 1 day after injection, she developed pain and expanding erythema at site of injection with rigors, fevers to 103 F, myalgias, transient numbness of hands and feet. She went to ED on 7/25 where she also had hypotension and tachycardia. Physician concerned for severe sepsis secondary to cellulitis vs post-pneumococcal severe hypersensitivity reaction. She was started on broad spectrum antibiotics cefazolin and transitioned to vancomycin and ZOSYN. After 24 hours, the rash had improved proximally with reduced erythema but had worsening erythema inferiomedially and distally not past the elbows. Pain at site of injection continued to be significant.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Red blood cells urine positive, Tachycardia, Ultrasound Doppler, Ultrasound scan abnormal
Clinical narrative: Patient reports 1 day after injection, she developed pain and expanding erythema at site of injection with rigors, fevers to 103 F, myalgias, transient numbness of hands and feet. She went to ED on 7/25 where she also had hypotension and tachycardia. Physician concerned for severe sepsis secondary to cellulitis vs post-pneumococcal severe hypersensitivity reaction. She was started on broad spectrum antibiotics cefazolin and transitioned to vancomycin and ZOSYN. After 24 hours, the rash had improved proximally with reduced erythema but had worsening erythema inferiomedially and distally not past the elbows. Pain at site of injection continued to be significant.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased, White blood cells urine positive
Clinical narrative: Patient reports 1 day after injection, she developed pain and expanding erythema at site of injection with rigors, fevers to 103 F, myalgias, transient numbness of hands and feet. She went to ED on 7/25 where she also had hypotension and tachycardia. Physician concerned for severe sepsis secondary to cellulitis vs post-pneumococcal severe hypersensitivity reaction. She was started on broad spectrum antibiotics cefazolin and transitioned to vancomycin and ZOSYN. After 24 hours, the rash had improved proximally with reduced erythema but had worsening erythema inferiomedially and distally not past the elbows. Pain at site of injection continued to be significant.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site, upper left arm: swollen, sore, reddened, pain in movement. General: chills, fever (up to 101.6), fatigue. Symptoms began within 6 hrs of receiving the vaccine on 07/23/2018. Symptoms continued until 07/28/2018. Symptoms were held in check with ibuprofen until symptoms subsided 07/28/2018. Contacted prescribing doctor via online practice portal, doctor phoned in prescription for antibiotics, in case the symptoms were as a result of cellulitis.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Injection site, upper left arm: swollen, sore, reddened, pain in movement. General: chills, fever (up to 101.6), fatigue. Symptoms began within 6 hrs of receiving the vaccine on 07/23/2018. Symptoms continued until 07/28/2018. Symptoms were held in check with ibuprofen until symptoms subsided 07/28/2018. Contacted prescribing doctor via online practice portal, doctor phoned in prescription for antibiotics, in case the symptoms were as a result of cellulitis.