chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Headache, Influenza like illness, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza like illness in a 79-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, several hours after receiving SHINGRIX, the patient experienced influenza like illness, woozy, headache, general body pain and difficulty breathing. In July 2018, the outcome of the influenza like illness, woozy, headache, general body pain and difficulty breathing were recovered/resolved. It was unknown if the reporter considered the influenza like illness, woozy, headache, general body pain and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received the SHINGRIX vaccine. Overnight the patient felt like he was getting the flu. The patient felt woozy, had a headache and body aches and briefly felt short of breath. Within 3 to 4 hours, all of these symptoms were resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that patient received the SHINGRIX in the office and before leaving the office the physician saw a rash and diagnosed her with Shingles. No additional information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included irritable bowel syndrome (IBS) and IBD (inflammatory bowel disease). In February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash. On an unknown date, the outcome of the fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash were recovered/resolved. It was unknown if the reporter considered the fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she experienced a red rash and burning on the face, under the nose on both sides, and the site of injection. The patient had swelling and soreness at the site of injection and also felt tired and had a fever. The patient stated that this started after a week and lasted till the end of March 2018. The patient visited her primary care doctor, and dermatologist for the symptoms she experienced.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included irritable bowel syndrome (IBS) and IBD (inflammatory bowel disease). In February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash. On an unknown date, the outcome of the fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash were recovered/resolved. It was unknown if the reporter considered the fever, burning sensation in face, injection site pain, erythematous rash, tiredness, injection site swelling, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she experienced a red rash and burning on the face, under the nose on both sides, and the site of injection. The patient had swelling and soreness at the site of injection and also felt tired and had a fever. The patient stated that this started after a week and lasted till the end of March 2018. The patient visited her primary care doctor, and dermatologist for the symptoms she experienced.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 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 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 SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The reporter was reporting arm pain that he experienced (for tolerance see case US2018152723) and mentioned that his doctor's wife (patient) also had the injection and that she had arm pain in the injected arm as well. Did not probe for additional information.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in face in a 74-year-old female patient who received SHINGRIX (batch number 2453L, expiry date unknown) for prophylaxis. The patient's past medical history included dizzy spells (experienced a dizzy episode on 6th August 2018 prior to getting the injection). On 15th August 2018 16:00, the patient received the 1st dose of SHINGRIX. On 15th August 2018, 1 hr after receiving SHINGRIX, the patient experienced burning sensation in face. On 16th August 2018, the patient experienced heart racing and dizziness. The patient was treated with BENADRYL. On an unknown date, the outcome of the burning sensation in face, heart racing and dizziness were recovered/resolved. It was unknown if the reporter considered the burning sensation in face, heart racing and dizziness to be related to SHINGRIX. Additional details were provided as follows: The lot number listed in this report was the lot number provided by the patient. The patient had asked the pharmacy for the lot number but she did not get the expiry date. An hour after receiving SHINGRIX, the patient experienced burning on a small portion of her face near her mouth. The patient received BENADRYL and it was resolved. Next day after receiving SHINGRIX, the patient experienced dizziness and her heart was racing, which was resolved. A day before the date of reporting, the patient had dizziness again but no heart racing. The patient estimated experiencing 10 dizzy episodes with 2 hours yesterday. The patient had denied permission to contact their physician.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a 74-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was unknown. The reporter considered the heart rate increased to be unrelated to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The healthcare professional reported that her patient experienced an elevated heart rate after receiving SHINGRIX. It was lasted for around 24 hours. The healthcare professional did not believe it was related to vaccination. The reported batch number M7784 for SHINGRIX did not exist and was updated to M77B4 as per the sales database.
Sex: U
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The case was reported via pharmacy technician. The patient had reaction which included swelling from their shoulder to wrist after receiving unknown brand of Tdap. The reaction was mentioned by caller after they were transferred to medical information system (MIS) for an escalated call. No other information was obtained.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 50-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache, nausea, injection site pain, fever, fatigue and myalgia. On an unknown date, the outcome of the headache, nausea, injection site pain, fever, fatigue and myalgia were unknown. It was unknown if the reporter considered the headache, nausea, injection site pain, fever, fatigue and myalgia to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left deltoid. The patient came into the doctor's office on 22nd August 2018, 11 am and reports common reactions such as, local pain at injection site. No additional information provided. The healthcare professional called representative (MI), and would like to know if the patient should receive the 2nd dose. The representative escalated the call to medical expert (MES).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 50-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache, nausea, injection site pain, fever, fatigue and myalgia. On an unknown date, the outcome of the headache, nausea, injection site pain, fever, fatigue and myalgia were unknown. It was unknown if the reporter considered the headache, nausea, injection site pain, fever, fatigue and myalgia to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left deltoid. The patient came into the doctor's office on 22nd August 2018, 11 am and reports common reactions such as, local pain at injection site. No additional information provided. The healthcare professional called representative (MI), and would like to know if the patient should receive the 2nd dose. The representative escalated the call to medical expert (MES).
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site warmth in a adult female patient who received Herpes SHINGRIX (batch number 539A2, expiry date 30th March 2020) 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 warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that her pharmacist vaccinated SHINGRIX into the fat instead of intramuscular, which led to inappropriate route of vaccination. The vaccination site was swollen up, quite red and hot.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of axillary lymph nodes enlarged in a adult female 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 axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was not recovered/not resolved. It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. In 2018, the patient experienced swollen lymph nodes above the collarbone and under her arm after vaccination (on the same side as the vaccine). The patient received the vaccine at a different location so she didn't have any further information to provide to us. The patient called the office the day of reporting to report the reaction.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included breast cancer (radiation treatment). On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced light headedness and injection site pain. SHINGRIX was continued with no change. On an unknown date, the outcome of the light headedness and injection site pain were recovered/resolved. It was unknown if the reporter considered the light headedness and injection site pain to be related to SHINGRIX. Additional details reported as follows: The patient planned to follow-up with her physician on an unknown date.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, 2 days after receiving SHINGRIX, the patient experienced headache, pain in arm, fatigue and generalized muscle aches. In July 2018, the outcome of the headache, pain in arm, fatigue and generalized muscle aches were recovered/resolved. It was unknown if the reporter considered the headache, pain in arm, fatigue and generalized muscle aches to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The patient experienced muscle aches all over the body, headaches, arm pain and fatigue. It was stated that, all the symptoms started on the 2nd or 3rd day and lasted for total of 2 days. The patient gave permission to contact her physician. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of SHINGRIX and had two days worth of flu like symptoms following administration. Nurse did not recall lot number or date of administration. The reporter did not agree to follow up. The reporter did believe the adverse event to be related to the product and resolved with no further complications.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year 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 were provided as follows: The age at vaccination was not applicable for this report. The patient's age group was taken based on the product indication as no other patient details were provided. The unspecified number of patients received SHINGRIX and experienced flu like symptoms with the 2nd dose of SHINGRIX, but no other issues with the second dose. This case has been linked with case US2018GSK152349 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, 1 days after receiving SHINGRIX, the patient experienced fever, shivering and headache. On an unknown date, the outcome of the fever, shivering and headache were unknown. It was unknown if the reporter considered the fever, shivering and headache to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received her second half of shingle shot the day before reporting. The day of reporting, the patient experienced fever of 99.5 degree F. The patient asked how long these side effects would last.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a 63-year-old 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 headache, fever, chills and fatigue. On an unknown date, the outcome of the headache, fever, chills and fatigue were recovered/resolved. It was unknown if the reporter considered the headache, fever, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headache, fever, chills and fatigue after receiving SHINGRIX vaccination. The symptoms resolved in 2 to 3 days. The reporter agreed to contact for follow up. This case has been linked with case US2018GSK153148, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and adverse event. On an unknown date, the outcome of the fever and adverse event were unknown. It was unknown if the reporter considered the fever and adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. SHINGRIX dose number was unknown in series. Lot number as not given in reporter's practice. Vaccination date and duration was not provided. The customer heard about one of her physician's wife experienced low fever and systemic side effects. The physician's wife not hospitalized, side effects were resolved. The customer's knowledge was secondhand. The reporter agree to follow up. This case was linked with cases US2017GSK170696 and US2018GSK153190, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. When the patient was at the clinic to receive the 2nd dose, it was reported that, after the 1st dose, the patient experienced pain and swelling at the site of injection for three weeks. The reporter did not agree for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Epigastric discomfort, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced weakness, influenza and pain. On 20th August 2018, the patient experienced injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills and joint pain. On an unknown date, the outcome of the injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills, joint pain, weakness, influenza and pain were unknown. It was unknown if the reporter considered the injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills, joint pain, weakness, influenza and pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX this Monday at the conclusion of my annual physical. The patient had all of the listed side effects and then some, requiring me to lose a full day from work. On 20th August 2018, 1 day after vaccination, the patient experienced injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills and joint pain. On Monday afternoon, the patient had a sore arm at the injection site that spread to my entire upper arm, painful to even touch, with some numbness in the patient's hand. But the night of vaccination, the patient was awake with a fever that peaked at 101 degree F, a pounding headache, tightness in the patient's gut, sweating and chills, and aching in joints in the patient's arms and legs and had never had before. It was like the worst flu patient ever had. The patient was in bed for a day. The fever finally broke about 36 hours later and the patient was still weakened and sore from this episode. The patient had never had a reaction to any other vaccinations in my lifetime. The patient's doctor was questioning whether he should do the second shot in a few months, and he obviously don't want to go through this again. The patient asked happens if the second one was missed. Is it less effective, ineffective, or does it made me even more vulnerable to shingles? Is it reasonable to assume the second shot would be just as reactive as the first?
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia, Influenza, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced weakness, influenza and pain. On 20th August 2018, the patient experienced injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills and joint pain. On an unknown date, the outcome of the injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills, joint pain, weakness, influenza and pain were unknown. It was unknown if the reporter considered the injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills, joint pain, weakness, influenza and pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX this Monday at the conclusion of my annual physical. The patient had all of the listed side effects and then some, requiring me to lose a full day from work. On 20th August 2018, 1 day after vaccination, the patient experienced injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills and joint pain. On Monday afternoon, the patient had a sore arm at the injection site that spread to my entire upper arm, painful to even touch, with some numbness in the patient's hand. But the night of vaccination, the patient was awake with a fever that peaked at 101 degree F, a pounding headache, tightness in the patient's gut, sweating and chills, and aching in joints in the patient's arms and legs and had never had before. It was like the worst flu patient ever had. The patient was in bed for a day. The fever finally broke about 36 hours later and the patient was still weakened and sore from this episode. The patient had never had a reaction to any other vaccinations in my lifetime. The patient's doctor was questioning whether he should do the second shot in a few months, and he obviously don't want to go through this again. The patient asked happens if the second one was missed. Is it less effective, ineffective, or does it made me even more vulnerable to shingles? Is it reasonable to assume the second shot would be just as reactive as the first?
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced weakness, influenza and pain. On 20th August 2018, the patient experienced injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills and joint pain. On an unknown date, the outcome of the injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills, joint pain, weakness, influenza and pain were unknown. It was unknown if the reporter considered the injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills, joint pain, weakness, influenza and pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX this Monday at the conclusion of my annual physical. The patient had all of the listed side effects and then some, requiring me to lose a full day from work. On 20th August 2018, 1 day after vaccination, the patient experienced injection site pain, tenderness, numbness in hand, fever, headache, epigastric discomfort, sweating, chills and joint pain. On Monday afternoon, the patient had a sore arm at the injection site that spread to my entire upper arm, painful to even touch, with some numbness in the patient's hand. But the night of vaccination, the patient was awake with a fever that peaked at 101 degree F, a pounding headache, tightness in the patient's gut, sweating and chills, and aching in joints in the patient's arms and legs and had never had before. It was like the worst flu patient ever had. The patient was in bed for a day. The fever finally broke about 36 hours later and the patient was still weakened and sore from this episode. The patient had never had a reaction to any other vaccinations in my lifetime. The patient's doctor was questioning whether he should do the second shot in a few months, and he obviously don't want to go through this again. The patient asked happens if the second one was missed. Is it less effective, ineffective, or does it made me even more vulnerable to shingles? Is it reasonable to assume the second shot would be just as reactive as the first?
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, fatigue, shivering and myalgia. On an unknown date, the outcome of the fever, fatigue, shivering and myalgia were unknown. It was unknown if the reporter considered the fever, fatigue, shivering and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was running a fever, fatigue, shivering and myalgia and missed a days work. The reporter agreed for follow up. This case has been linked with case US2018GSK153229, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Impaired work ability, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, pain and contusion. On an unknown date, the outcome of the fever, chills, pain and contusion were recovered/resolved. It was unknown if the reporter considered the fever, chills, pain and contusion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient had a 103 degree fahrenheit fever, chills, aches and dark bruises that lasted for around four days. The patient was sent to home from work as well. The reporter agreed to be contacted for follow up. Lab Comments: On an unknown date, the patient's body temperature was recorded as 103 degree F.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling arm in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than an hour after receiving SHINGRIX, the patient experienced swelling arm, light headedness and erythema. In August 2018, the outcome of the swelling arm, light headedness and erythema were recovered/resolved. It was unknown if the reporter considered the swelling arm, light headedness and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness, swollen arm, light headed, and dizziness within 20 minutes of receiving the SHINGRIX, which lasted 2 hours and recovered within 24 hours. The healthcare professional (HCP) stated that, the patient did not experience wheezing. The healthcare professional did not have lot number or expiry date of the vaccine.
Sex: M
Vaccine: MENB
Symptoms: Chills, Discomfort, Extra dose administered, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received BEXSERO for prophylaxis. Concomitant products included BEXSERO. On 22nd August 2018, the patient received the 3rd dose of BEXSERO. On 22nd August 2018, unknown after receiving BEXSERO, the patient experienced extra dose administered. On 23rd August 2018, the patient experienced headache, fever, chills and sensation of pressure. On an unknown date, the outcome of the headache, fever, chills and sensation of pressure were not recovered/not resolved and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the headache, fever, chills and sensation of pressure to be related to BEXSERO. Additional information was received as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The patient received the second dose in June 2018, but the nurse apparently misread the chart and mistakenly administered a third dose of BEXSERO, which led to extra dose administered. At the time of reporting the patient had fever, chills, headache and pressure all over. The patient's body temperature was recorded as 100.6. The reporter reported this to the physician and asked that what information did they have about the effects of mistaken third doses of BEXSERO.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain 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 day after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The age at vaccination was not reported, the patient was in his 60's. The physician stated that after he received his first injection of SHINGRIX he had pain within the first 24 hours, which went away. This case has been linked with US2018GSK154784, reported by the same reporter for different patients.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and pain, refer the case for 1st dose US2018107211). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad, pain, fever, headache and muscle pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the feeling bad, pain, fever, headache and muscle pain were unknown. It was unknown if the reporter considered the feeling bad, pain, fever, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient had awful reactions and again had fever, aches, headache, and muscle pain. The patient had the same side effects. The patient was in bed all day but feel like turned the corner. This was 1 of 2 cases, reported by the same reporter for same patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and pain, refer the case for 1st dose US2018107211). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad, pain, fever, headache and muscle pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the feeling bad, pain, fever, headache and muscle pain were unknown. It was unknown if the reporter considered the feeling bad, pain, fever, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient had awful reactions and again had fever, aches, headache, and muscle pain. The patient had the same side effects. The patient was in bed all day but feel like turned the corner. This was 1 of 2 cases, reported by the same reporter for same patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever of 103.1 post vaccines 1 day.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient felt lightheaded, and nausea. She took 50 mg diphenhydramine by mouth while still at the pharmacy. Went home after 15 minutes of sitting in pharmacy waiting area. Patient states she vomited when she got home, and immediately felt better after emesis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dysgeusia, Fatigue
Clinical narrative: Flu-like symptoms that became increasingly severe. By morning, I was too weak to get out of bed, was achy all over, had chills, had a screaming headache, felt nauseous, and eventually threw up. I sipped on a glass of water, and managed to eat a peeled apple that day. I slept on and off all day and through the next night. The next day, I began eating more substantially, but everything tasted bitter, I continued to feel nauseous, and experienced some diarrhea. The next day, I was able to take my morning walk and eat a little more, but had much worse diarrhea, and was fatigued and weak. The following day I was better, but still fatigued, and had a loose, but normal BM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Nausea, Pain, Vomiting
Clinical narrative: Flu-like symptoms that became increasingly severe. By morning, I was too weak to get out of bed, was achy all over, had chills, had a screaming headache, felt nauseous, and eventually threw up. I sipped on a glass of water, and managed to eat a peeled apple that day. I slept on and off all day and through the next night. The next day, I began eating more substantially, but everything tasted bitter, I continued to feel nauseous, and experienced some diarrhea. The next day, I was able to take my morning walk and eat a little more, but had much worse diarrhea, and was fatigued and weak. The following day I was better, but still fatigued, and had a loose, but normal BM.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient called the pharmacy on 8/30 and reported to the pharmacist that she had to go to the emergency department the day before, some time after the vaccination was administered. The patient was very brief and didn't give much detail about why she went to the emergency room other than that her arm was in a lot of pain after receiving the shot. She said on the phone that she believed it hurt more than the first time she received the shot. She also said on the phone that the emergency department staff said the vaccine was "under the muscle" as opposed to "in the muscle" which was the reason she was experiencing pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: LARGE RED WELT, WARM TO THE TOUCH.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Injection site reaction, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Feeling of Nerve Pain (feeling of electric impulses) from the injection site all the way to the elbow. Right hand Fifth digit (Pinky) was hurting and moving involuntarily.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen, red, painful, indurated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Maculopapular erythematous rash to bilat upper and lower extremities, trunk and neck.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Patient experienced body aches and "flu-like" symptoms for approximately 24 hours requiring her to rest in bed.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Lip swelling, Ocular hyperaemia, Upper-airway cough syndrome
Clinical narrative: Patient received her AFLURIA influenza vaccination at around 9am today 8/31/2018. She said that between the hours of 12pm-1pm the same day she experienced sudden onset of swollen, red, itchy eyes as well as some swelling of her lips with what also felt like post nasal drip.  She reported no swelling of her tongue or throat and had no difficulty talking or breathing and hadn't experienced any wheezing or chest tightness. She also reported no pain or numbness. She has had influenza vaccinations in the past with no reactions. I recommended that she take over-the-counter BENADRYL and to contact her primary care physician (PCP). She said that she had already contacted her PCP and was able to make an appointment to be seen today at 3pm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Severe myalgias and flu-like symptoms for about 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Severe myalgias and flu-like symptoms for about 3 days.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccine administered IM instead of SQ. No adverse events noted.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 5 Minutes post administration patient started the get hives at the site of the injection.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came to the pharmacy and her left arm/deltoid region appears to have an Injection Site Reaction after vaccine administration. Vaccine was administrated 3 days ago. Sx/sx: redness, tenderness, warmth and pain area. Patient exptect to visit the clinic.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Influenza like illness, Injection site erythema
Clinical narrative: The next morning after the shot I had a sore arm with mild or moderate pain, redness and swelling where I got the shot. Later in the day around 4:00 PM I began to feel tired, my body ached all over kind of like when you have the flu. (Which I Do Not Have) muscle pain, 99.4 fever, some stomach pain, and a shooting pain in my right big toe that began about 5:00 PM this evening. My body felt light and also like it had a led weight attached to it, just not feeling well.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Myalgia, Pain
Clinical narrative: The next morning after the shot I had a sore arm with mild or moderate pain, redness and swelling where I got the shot. Later in the day around 4:00 PM I began to feel tired, my body ached all over kind of like when you have the flu. (Which I Do Not Have) muscle pain, 99.4 fever, some stomach pain, and a shooting pain in my right big toe that began about 5:00 PM this evening. My body felt light and also like it had a led weight attached to it, just not feeling well.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The next morning after the shot I had a sore arm with mild or moderate pain, redness and swelling where I got the shot. Later in the day around 4:00 PM I began to feel tired, my body ached all over kind of like when you have the flu. (Which I Do Not Have) muscle pain, 99.4 fever, some stomach pain, and a shooting pain in my right big toe that began about 5:00 PM this evening. My body felt light and also like it had a led weight attached to it, just not feeling well.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Pyrexia, Rash, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever of over 102 for three days as of now. Rash that started over his eye and spread to his lower face area, chest, abdomen, back, and buttocks. Severe congestion. Copious amounts of clear nasal drainage. Treated with ibuprofen.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Body aches and low fever (99-100) for 48 hours. Felt like beginning of flu, but resolved in two days (recommend this shot on a Friday). Symptoms manageable with TYLENOL. 2nd dose today about two hours ago. So far no symptoms.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Laboratory test, Tremor
Clinical narrative: 101 temp./chills/shaking.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported having a swollen arm, every and feeling lethargic. Patient took TYLENOL and reported marked improvement after with fever and swelling of the arm.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: THE PATIENT DEVELOPED A BLISTER WITH CLEAR FLUID AT THE SITE OF INJECTION. AFTER HER DOCTOR EXAMINED THE BLISTER IT CHANGED COLOR AND THEN POPPED. SHE WAS INSTRUCTED TO APPLY ANTIBIOTIC OINTMENT TO THE SITE UNTIL THE AREA HEALED AND TO INFORM HER DOCTOR IF THERE ARE ANYMORE COMPLICATIONS.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Injected limb mobility decreased, Pyrexia
Clinical narrative: Extreme chilling which started around 5 p.m. and lasted throughout the night. Fever next day which precluded having allergy serum administered. Inability to raise right arm over head the next day. Also some light headedness.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Pruritus
Clinical narrative: Pt reported arm redness during first series dose. After 2nd shot was administered, pt experienced anaphylaxis, itching, and was sent to the emergency room where they administered epinephrine and antihistamine. Pt was also prescribed oral steroid.