chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injected limb mobility decreased, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain. On an unknown date, the outcome of the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain were unknown. It was unknown if the reporter considered the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Due to time constraints the reporter declined to answer specific questions for the form. After being vaccinated, patient had horrible pain up and down that arm and into her shoulder. Her pharmacist told her to contact poison control. Poison Control did not handle her inquiry, so her pharmacist told her to contact GSK. The patient called GSK on the day of reporting to inquiry as to what to do for these symptoms. The patient saw her physician. Her physician thought it was muscular and told her to use a heating pad. The patient used a heating pad but said that her physician was wrong and that it was not muscular. The patient did not think her health care professional diagnosed her symptoms correctly. The patient was currently in pain and can barely use that arm and was inquiring to GSK why she was having this extended period of pain that was just going all over that side now, her upper right torso, shoulder, neck, and back. The patient was referred to contact her health care professional as soon as possible on the day of reporting to address her inquiries and discuss her current symptoms. It would be okay to contact the reporter via letter for further details. The patient said she needed to end the call and was going to contact her health care professional and have her health care professional contact GSK to further discuss. No further information could be clarified or was obtained beyond what was documented above due to time constraints. The patient did not mention the specific arm, but the context of the call was that it would be the arm in which she received the vaccination to which she was likely referring. It was unclear to which part of her body she referred or what she meant by saying all over that side now.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain. On an unknown date, the outcome of the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain were unknown. It was unknown if the reporter considered the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Due to time constraints the reporter declined to answer specific questions for the form. After being vaccinated, patient had horrible pain up and down that arm and into her shoulder. Her pharmacist told her to contact poison control. Poison Control did not handle her inquiry, so her pharmacist told her to contact GSK. The patient called GSK on the day of reporting to inquiry as to what to do for these symptoms. The patient saw her physician. Her physician thought it was muscular and told her to use a heating pad. The patient used a heating pad but said that her physician was wrong and that it was not muscular. The patient did not think her health care professional diagnosed her symptoms correctly. The patient was currently in pain and can barely use that arm and was inquiring to GSK why she was having this extended period of pain that was just going all over that side now, her upper right torso, shoulder, neck, and back. The patient was referred to contact her health care professional as soon as possible on the day of reporting to address her inquiries and discuss her current symptoms. It would be okay to contact the reporter via letter for further details. The patient said she needed to end the call and was going to contact her health care professional and have her health care professional contact GSK to further discuss. No further information could be clarified or was obtained beyond what was documented above due to time constraints. The patient did not mention the specific arm, but the context of the call was that it would be the arm in which she received the vaccination to which she was likely referring. It was unclear to which part of her body she referred or what she meant by saying all over that side now.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain. On an unknown date, the outcome of the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain were unknown. It was unknown if the reporter considered the pain, injected limb mobility decreased, pain in arm, shoulder pain, muscle pain, neck pain and back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Due to time constraints the reporter declined to answer specific questions for the form. After being vaccinated, patient had horrible pain up and down that arm and into her shoulder. Her pharmacist told her to contact poison control. Poison Control did not handle her inquiry, so her pharmacist told her to contact GSK. The patient called GSK on the day of reporting to inquiry as to what to do for these symptoms. The patient saw her physician. Her physician thought it was muscular and told her to use a heating pad. The patient used a heating pad but said that her physician was wrong and that it was not muscular. The patient did not think her health care professional diagnosed her symptoms correctly. The patient was currently in pain and can barely use that arm and was inquiring to GSK why she was having this extended period of pain that was just going all over that side now, her upper right torso, shoulder, neck, and back. The patient was referred to contact her health care professional as soon as possible on the day of reporting to address her inquiries and discuss her current symptoms. It would be okay to contact the reporter via letter for further details. The patient said she needed to end the call and was going to contact her health care professional and have her health care professional contact GSK to further discuss. No further information could be clarified or was obtained beyond what was documented above due to time constraints. The patient did not mention the specific arm, but the context of the call was that it would be the arm in which she received the vaccination to which she was likely referring. It was unclear to which part of her body she referred or what she meant by saying all over that side now.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2018) for prophylaxis. On 5th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 7th June 2018, the patient experienced injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site swelling and injection site erythema were unknown. The reporter considered the injection site pain, injection site warmth, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter had a consumer that received the Shingrix vaccination on June 5, 2018 at approximately 4:30pm on right deltoid. The next day, on 6th June, 2018, when she woke up, she noted that it was sore and red at the injection site. On the day of reporting 7th June, 2018, she had noticed that the redness was spreading and the injection site was now, also, swollen and had heat. The reporter indicated that she left a message with the consumer's physician regarding what the consumer has experienced.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fatigue in a 60-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were unknown. It was unknown if the reporter considered the fatigue and pain to be related to SHINGRIX. Additional details were provided as follows: The patient complained of fatigue and achiness that lasted about 2 to 3 days and then resolved. No further information was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, generalized aching and fatigue. On an unknown date, the outcome of the injection site pain, generalized aching and fatigue were unknown. It was unknown if the reporter considered the injection site pain, generalized aching and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient complained about local pain at the injection site, fatigue and overall achiness that lasted about 2 to 3 days and then resolved. No further information was provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site oedema, Injection site rash, Injection site urticaria, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site edema in a 63-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019) for prophylaxis. Concurrent medical conditions included reaction to drug preservatives. Concomitant products included amlodipine + benazepril and tretinoin. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, local swelling and localized erythema. In June 2018, the patient experienced injection site edema, injection site rash and injection site hives. On an unknown date, the outcome of the injection site edema, injection site rash and injection site hives were not recovered/not resolved and the outcome of the muscle pain, local swelling and localized erythema were not reported. The reporter considered the injection site edema, injection site rash, injection site hives, muscle pain, local swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: Pharmacist did not speak to the patient directly. She read a note left by another pharmacist. The patient called and said that she had the SHINGRIX shot on arm and experienced redness, muscle aches and swelling since the day of vaccination. She still had rash and hives around the injection area without itching. The patient had has no fever nor breathing issues. The edema hat was 2 by 4 rectangular on her arm around the injection site. Pharmacist recommended taking BENADRYL to treat the symptoms. The call was transferred to Medical Information for questions.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site edema in a 63-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019) for prophylaxis. Concurrent medical conditions included reaction to drug preservatives. Concomitant products included amlodipine + benazepril and tretinoin. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, local swelling and localized erythema. In June 2018, the patient experienced injection site edema, injection site rash and injection site hives. On an unknown date, the outcome of the injection site edema, injection site rash and injection site hives were not recovered/not resolved and the outcome of the muscle pain, local swelling and localized erythema were not reported. The reporter considered the injection site edema, injection site rash, injection site hives, muscle pain, local swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: Pharmacist did not speak to the patient directly. She read a note left by another pharmacist. The patient called and said that she had the SHINGRIX shot on arm and experienced redness, muscle aches and swelling since the day of vaccination. She still had rash and hives around the injection area without itching. The patient had has no fever nor breathing issues. The edema hat was 2 by 4 rectangular on her arm around the injection site. Pharmacist recommended taking BENADRYL to treat the symptoms. The call was transferred to Medical Information for questions.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Headache, Heart rate increased, Malaise, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On 6th June 2018, several hours after receiving SHINGRIX, the patient experienced taste metallic. On 7th June 2018, the patient experienced heart rate increased, headache, pain in arm, facial swelling, red blotches and feeling unwell. On an unknown date, the outcome of the taste metallic, heart rate increased, headache, pain in arm, facial swelling, red blotches and feeling unwell were unknown. It was unknown if the reporter considered the taste metallic, heart rate increased, headache, pain in arm, facial swelling, red blotches and feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient did not experience any reaction after receiving the 1st dose of SHINGRIX previously. A day before the reporting day, the patient had a dose of SHINGRIX in an unknown arm. Few hours after vaccination, the patient had a funny taste in her mouth which described as a metallic and very unfamiliar taste. It did not go away. One day after vaccination, at the reporting day, when the patient woke up in morning experienced swollen face, red blotches on her face, headache, pain from shoulder down to fingertips in the arm where the vaccine was administered and heart rate in the 80's range when it was usually in 50's. The patient described this symptoms as non-life-threatening and that was monitored by herself. The patient called GlaxoSmithKline (GSK) to inquire if these were symptoms that had been associated with SHINGRIX. The Product Information (PI) was discussed.  The reporter declined to answer any questions for the CAMEL form. The patient stated that she was not feeling well and was referred to her heath care professional (HCP) to discuss current symptoms before the call ended.
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On 6th June 2018, several hours after receiving SHINGRIX, the patient experienced taste metallic. On 7th June 2018, the patient experienced heart rate increased, headache, pain in arm, facial swelling, red blotches and feeling unwell. On an unknown date, the outcome of the taste metallic, heart rate increased, headache, pain in arm, facial swelling, red blotches and feeling unwell were unknown. It was unknown if the reporter considered the taste metallic, heart rate increased, headache, pain in arm, facial swelling, red blotches and feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient did not experience any reaction after receiving the 1st dose of SHINGRIX previously. A day before the reporting day, the patient had a dose of SHINGRIX in an unknown arm. Few hours after vaccination, the patient had a funny taste in her mouth which described as a metallic and very unfamiliar taste. It did not go away. One day after vaccination, at the reporting day, when the patient woke up in morning experienced swollen face, red blotches on her face, headache, pain from shoulder down to fingertips in the arm where the vaccine was administered and heart rate in the 80's range when it was usually in 50's. The patient described this symptoms as non-life-threatening and that was monitored by herself. The patient called GlaxoSmithKline (GSK) to inquire if these were symptoms that had been associated with SHINGRIX. The Product Information (PI) was discussed.  The reporter declined to answer any questions for the CAMEL form. The patient stated that she was not feeling well and was referred to her heath care professional (HCP) to discuss current symptoms before the call ended.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Oropharyngeal discomfort, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 53-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced headache, chills, pharynx strange sensation of and fever. On an unknown date, the outcome of the headache, chills, pharynx strange sensation of and fever were unknown. It was unknown if the reporter considered the headache, chills, pharynx strange sensation of and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter had a consumer that received the second dose of the SHINGRIX one day earlier than the schedule. The patient was experiencing funny feeling in her throat. The reporter did not want to continue to answer questions and wanted to be transferred to MI.  Unable to obtain additional information as he said he can provide additional information when GlaxoSmithKline contacts him via letter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Erythema, Fatigue, Induration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 80-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included nebivolol hydrochloride (Bystolic), omeprazole (Prilosec), levothyroxine sodium (Synthroid) and lisinopril. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced erythema and induration. On 14th May 2018, the patient experienced influenza like illness, tiredness, fever, weakness and upset stomach. The patient was treated with antihistamine. On an unknown date, the outcome of the erythema, influenza like illness, tiredness, fever, weakness, upset stomach and induration were recovered/resolved. The reporter considered the erythema, influenza like illness, tiredness, fever, weakness, upset stomach and induration to be related to SHINGRIX. Additional details were provided as follows: On Friday the patient received SHINGRIX. And that day her arm started turning red and was hard to the touch. The patient's arm became red from shoulder to wrist and was hard as a rock. On 14th May 2018 Monday, 3 days after vaccination the patient developed a fever, which was 99.9 on Tuesday. For the rest of the week the patient felt very sick like she had the flu. She was weak, tired and had an upset stomach and fever. By Saturday, on 19th May 2018, the patient finally felt better. The patient saw her doctor during that week because she felt so sick and she was recommended to take an antihistamine, and the redness and hardness in her arm did improve after that.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 80-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included nebivolol hydrochloride (Bystolic), omeprazole (Prilosec), levothyroxine sodium (Synthroid) and lisinopril. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced erythema and induration. On 14th May 2018, the patient experienced influenza like illness, tiredness, fever, weakness and upset stomach. The patient was treated with antihistamine. On an unknown date, the outcome of the erythema, influenza like illness, tiredness, fever, weakness, upset stomach and induration were recovered/resolved. The reporter considered the erythema, influenza like illness, tiredness, fever, weakness, upset stomach and induration to be related to SHINGRIX. Additional details were provided as follows: On Friday the patient received SHINGRIX. And that day her arm started turning red and was hard to the touch. The patient's arm became red from shoulder to wrist and was hard as a rock. On 14th May 2018 Monday, 3 days after vaccination the patient developed a fever, which was 99.9 on Tuesday. For the rest of the week the patient felt very sick like she had the flu. She was weak, tired and had an upset stomach and fever. By Saturday, on 19th May 2018, the patient finally felt better. The patient saw her doctor during that week because she felt so sick and she was recommended to take an antihistamine, and the redness and hardness in her arm did improve after that.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Cardiac function test normal, Cardiac stress test normal, Discomfort, Electrocardiogram normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included blood pressure, lymphoma (non-hodgkin's) (Recovered), chemotherapy and splenectomy. Concomitant products included nebivolol hydrochloride (Bystolic), thyroxine sodium (Levothyroxine) and progesterone (Prometrium). On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On 3rd June 2018, the patient experienced discomfort. On 4th June 2018, the patient experienced breast pain. On 5th June 2018, the patient experienced rash, skin lesion and skin irritation. The patient was treated with acyclovir, lidocaine and hydrocodone bitartrate + paracetamol (Vicodin). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the discomfort, breast pain, skin lesion and skin irritation were unknown. The reporter considered the injection site erythema, injection site swelling, injection site pain, rash, breast pain and skin lesion to be related to SHINGRIX. It was unknown if the reporter considered the discomfort and skin irritation to be related to SHINGRIX. Additional details were provided as follows: The patient stated that in the past she had non hodkigns lymphoma and had her spleen removed in February 2017. In 2017, the patient went through 6 rounds of chemotherapy. At 14:30, the patient received SHINGRIX on left deltoid. The patient stated that she experienced redness, swelling and pain at the injection site which started the next day after receiving the vaccine. The symptoms were got worse for next 5 days and resolved completely after 7 days from the beginning of symptoms. On 3rd June 2018, the patient felt discomfort beneath her breast under the first rib. On 4th June 2018, the patient experienced stabbing pain beneath her breast on the left side and she visited her Cardiologist on same day where EKG (electrocardiogram) was performed and it was negative. On 4th June 2018, the patient was then sent to the emergency room at Hospital. The patient had a full work up done for her heart including treadmill test, x-ray, and left quadrant test and all tests were negative. On the same day, at 4:30 pm, the patient was discharged with pain medication and lidocaine patch to place underneath her breast.  The patient was told to leave the lidocaine patch on for about 12 hours and take it off next morning. On 5th June 2018, when the patient woke up and took the patch off the area underneath was red and irritated and noticed bright red lesions on the left side of her back and spreading to lower first rib area underneath her breast.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Exercise electrocardiogram normal, 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 erythema in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included blood pressure, lymphoma (non-hodgkin's) (Recovered), chemotherapy and splenectomy. Concomitant products included nebivolol hydrochloride (Bystolic), thyroxine sodium (Levothyroxine) and progesterone (Prometrium). On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On 3rd June 2018, the patient experienced discomfort. On 4th June 2018, the patient experienced breast pain. On 5th June 2018, the patient experienced rash, skin lesion and skin irritation. The patient was treated with acyclovir, lidocaine and hydrocodone bitartrate + paracetamol (Vicodin). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the discomfort, breast pain, skin lesion and skin irritation were unknown. The reporter considered the injection site erythema, injection site swelling, injection site pain, rash, breast pain and skin lesion to be related to SHINGRIX. It was unknown if the reporter considered the discomfort and skin irritation to be related to SHINGRIX. Additional details were provided as follows: The patient stated that in the past she had non hodkigns lymphoma and had her spleen removed in February 2017. In 2017, the patient went through 6 rounds of chemotherapy. At 14:30, the patient received SHINGRIX on left deltoid. The patient stated that she experienced redness, swelling and pain at the injection site which started the next day after receiving the vaccine. The symptoms were got worse for next 5 days and resolved completely after 7 days from the beginning of symptoms. On 3rd June 2018, the patient felt discomfort beneath her breast under the first rib. On 4th June 2018, the patient experienced stabbing pain beneath her breast on the left side and she visited her Cardiologist on same day where EKG (electrocardiogram) was performed and it was negative. On 4th June 2018, the patient was then sent to the emergency room at Hospital. The patient had a full work up done for her heart including treadmill test, x-ray, and left quadrant test and all tests were negative. On the same day, at 4:30 pm, the patient was discharged with pain medication and lidocaine patch to place underneath her breast.  The patient was told to leave the lidocaine patch on for about 12 hours and take it off next morning. On 5th June 2018, when the patient woke up and took the patch off the area underneath was red and irritated and noticed bright red lesions on the left side of her back and spreading to lower first rib area underneath her breast.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin irritation, Skin lesion, X-ray normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included blood pressure, lymphoma (non-hodgkin's) (Recovered), chemotherapy and splenectomy. Concomitant products included nebivolol hydrochloride (Bystolic), thyroxine sodium (Levothyroxine) and progesterone (Prometrium). On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On 3rd June 2018, the patient experienced discomfort. On 4th June 2018, the patient experienced breast pain. On 5th June 2018, the patient experienced rash, skin lesion and skin irritation. The patient was treated with acyclovir, lidocaine and hydrocodone bitartrate + paracetamol (Vicodin). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the discomfort, breast pain, skin lesion and skin irritation were unknown. The reporter considered the injection site erythema, injection site swelling, injection site pain, rash, breast pain and skin lesion to be related to SHINGRIX. It was unknown if the reporter considered the discomfort and skin irritation to be related to SHINGRIX. Additional details were provided as follows: The patient stated that in the past she had non hodkigns lymphoma and had her spleen removed in February 2017. In 2017, the patient went through 6 rounds of chemotherapy. At 14:30, the patient received SHINGRIX on left deltoid. The patient stated that she experienced redness, swelling and pain at the injection site which started the next day after receiving the vaccine. The symptoms were got worse for next 5 days and resolved completely after 7 days from the beginning of symptoms. On 3rd June 2018, the patient felt discomfort beneath her breast under the first rib. On 4th June 2018, the patient experienced stabbing pain beneath her breast on the left side and she visited her Cardiologist on same day where EKG (electrocardiogram) was performed and it was negative. On 4th June 2018, the patient was then sent to the emergency room at Hospital. The patient had a full work up done for her heart including treadmill test, x-ray, and left quadrant test and all tests were negative. On the same day, at 4:30 pm, the patient was discharged with pain medication and lidocaine patch to place underneath her breast.  The patient was told to leave the lidocaine patch on for about 12 hours and take it off next morning. On 5th June 2018, when the patient woke up and took the patch off the area underneath was red and irritated and noticed bright red lesions on the left side of her back and spreading to lower first rib area underneath her breast.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Listless, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (After 1st dose patient experienced illness and body ache (refer case US2018GSK107382)). Concomitant products included Influenza vaccine Quadrivalent. On 4th June 2018, the patient received the 2nd dose of SHINGRIX. On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell and shivering. On 5th June 2018, the patient experienced listless. In June 2018, the patient experienced general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the feeling unwell, shivering, general body pain and listless were unknown. It was unknown if the reporter considered the feeling unwell, shivering, general body pain and listless to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient got her 2nd shot on Monday of this week late in the afternoon, and at about 11 pm she was awoken from sleep shivering and ill feeling. The patient stated her body ached. The patient noted she had also had similar issues with her first dose of SHINGRIX, but she was ten times worse with this shot. The patient noted she was not even able to stay out of bed yesterday. The patient stated Tuesday afternoon she was down for the count, just listless. The patient stated she took a 30 minute walk yesterday morning and the body aches were just too bad so she went back to bed. She didn't have lot and expiration date of her products. She noted she had spoken with her physician about the symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysstasia, Pain
Clinical narrative: chills; difficulty standing; pain; This case was reported by a consumer via call center representative and described the occurrence of chills in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received SHINGRIX. On 7th June 2018, 1 days after receiving SHINGRIX,  the patient experienced chills, difficulty in standing and pain. On an unknown date, the outcome of the chills, difficulty in standing and pain were unknown. The reporter considered the chills, difficulty in standing and pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported but it could be 78 or 79 years old. The patient was at the doctor's office at the time reporting. The reporter terminated the call.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Petechiae, Rash erythematous, Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of erythema in a 9-month-old female patient who received PEDIARIX for prophylaxis. In June 2018, the patient received PEDIARIX. On an unknown date, less than a week after receiving PEDIARIX, the patient experienced erythema, petechia and swelling. On an unknown date, the outcome of the erythema, petechia and swelling were unknown. It was unknown if the reporter considered the erythema, petechia and swelling to be related to PEDIARIX. Additional details were reported as follows: The age at vaccination was not reported. The PEDIARIX was administered on approximately 1st June 2018. On 6th June 2018, the redness, swelling, petechiae reported by parents to health care provide. The reporter told that one of their patient experienced unusual red spots on her legs after administration of PEDIARIX vaccine. The parents of the patient were suspecting it could be due to the latex. No additional details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Insomnia, Lethargy, Malaise, Product preparation error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 31st May 2018, the patient received SHINGRIX. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, insomnia, lethargy, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the feeling unwell, insomnia and lethargy were recovering/resolving and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the feeling unwell, insomnia and lethargy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient received only the adjuvant portion of the SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that later that night they were lethargic, felt like they were getting sick, and experienced insomnia. The health care professional was certain the patient only received the adjuvant for the SHINGRIX. The patient insists they received the complete vaccine because of the side effects experienced. The patient did not want to come back to be revaccinated with the complete vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site hyperaesthesia, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included high blood pressure. On 23rd March 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 25th March 2018, the patient experienced injection site itching, injection site blisters and diarrhea. On an unknown date, the patient experienced nerve pain, injection site hyperesthesia and injection site pain. The patient was treated with gabapentin, MOTRIN and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the nerve pain, injection site hyperesthesia and injection site pain were not recovered/not resolved and the outcome of the injection site itching, injection site erythema, injection site blisters, injection site swelling and diarrhea were recovered/resolved. The reporter considered the nerve pain, injection site itching, injection site hyperesthesia, injection site erythema, injection site blisters, injection site swelling, diarrhea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving blood pressure medication. The patient was administered SHINGRIX in the left arm. On 24th March 2018, one day after receiving vaccination, the patient developed a big orange size circle on her upper left arm, which was very red, raised and swollen. On 25th March 2018, 2 days after receiving vaccination, the patient also developed itching in the area along with tiny red blisters and diarrhea. The patient's arm was very sensitive to touch and was very painful. The swelling in the area lasted for about 7 to 10 days. The redness went down after two and half weeks. The red blisters went away after 2 to 3 days. The itchiness and diarrhea lasted for total of 2 to 3 days. The patient had still not recovered from the pain and sensitivity to touch. The patient stated she visited her doctor office sometimes in the end of April to follow up with her health care physician. The patient take MOTRIN for pain and use hot pack or ice pack as needed in the area. The patient was referred to her Neurologist, which she visited on 7th June 2018. The patient neurologist had recommended her to see allergist and dermatologist to see if there was anything underlying from the vaccine that was adding to the pain she was experiencing.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included high blood pressure. On 23rd March 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 25th March 2018, the patient experienced injection site itching, injection site blisters and diarrhea. On an unknown date, the patient experienced nerve pain, injection site hyperesthesia and injection site pain. The patient was treated with gabapentin, MOTRIN and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the nerve pain, injection site hyperesthesia and injection site pain were not recovered/not resolved and the outcome of the injection site itching, injection site erythema, injection site blisters, injection site swelling and diarrhea were recovered/resolved. The reporter considered the nerve pain, injection site itching, injection site hyperesthesia, injection site erythema, injection site blisters, injection site swelling, diarrhea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving blood pressure medication. The patient was administered SHINGRIX in the left arm. On 24th March 2018, one day after receiving vaccination, the patient developed a big orange size circle on her upper left arm, which was very red, raised and swollen. On 25th March 2018, 2 days after receiving vaccination, the patient also developed itching in the area along with tiny red blisters and diarrhea. The patient's arm was very sensitive to touch and was very painful. The swelling in the area lasted for about 7 to 10 days. The redness went down after two and half weeks. The red blisters went away after 2 to 3 days. The itchiness and diarrhea lasted for total of 2 to 3 days. The patient had still not recovered from the pain and sensitivity to touch. The patient stated she visited her doctor office sometimes in the end of April to follow up with her health care physician. The patient take MOTRIN for pain and use hot pack or ice pack as needed in the area. The patient was referred to her Neurologist, which she visited on 7th June 2018. The patient neurologist had recommended her to see allergist and dermatologist to see if there was anything underlying from the vaccine that was adding to the pain she was experiencing.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Skin discolouration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness in fingers in a 85-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On 11th May 2018 12:21, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 12th May 2018, 1 days after receiving SHINGRIX, the patient experienced numbness in fingers and skin discoloration. On an unknown date, the outcome of the numbness in fingers was not recovered/not resolved and the outcome of the skin discoloration was recovering/resolving. The reporter considered the numbness in fingers and skin discoloration to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 84 years or 85 years. The patient received SHINGRIX in the left deltoid. The reporter did not have the lot number from the box but provided the lot numbers from both the antigen (9AS39) and the adjuvant (A4X57) vials. One finger on the patient's left hand was numb and another on the same hand turned black and blue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 8th April 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. As per pharmacist the patient received her 1st dose of SHINGRIX and was still complaining of injection site soreness. The pharmacist was unsure of the lot number as it was hard to read.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Localised infection, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of swelling arm in a 83-year-old female patient who received BOOSTRIX (batch number 9XJ5L, expiry date 14th October 2018) for prophylaxis. On 2nd June 2018, the patient received BOOSTRIX .5 ml. In June 2018, less than a week after receiving BOOSTRIX, the patient experienced swelling arm (serious criteria hospitalization), infection (serious criteria hospitalization) and erythema of extremities (serious criteria hospitalization). The patient was treated with antibiotics NOS. On an unknown date, the outcome of the swelling arm, infection and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm, infection and erythema of extremities to be related to BOOSTRIX. Additional information was received as follows: The patient came back into pharmacy on 9th June 2018, to report that she was hospitalized for 3 days after the administration of vaccine because of an infection in her arm. The patient's arm was swollen and red. The pharmacist reported that the patient's arm had a marking which used for measuring cellulitis. The patient was on antibiotics that was given in the hospital. The patient reported that the physician in the hospital told her that the infection didn't look like a normal reaction that would be caused by the BOOSTRIX. The contact details of the patient was provided. The pharmacist did not have the name of patient's physician.