chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received SHINGRIX. Concomitant products included vitamin D, Vitamin C and Aspirin Baby. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 9th April 2018, the outcome of the injection site pain was recovered/resolved. In April 2018, the outcome of the injection site erythema was recovered/resolved. The reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported on behalf of her husband (patient). Concomitant medication included Multivitamin. The caller stated that the patient received the SHINGRIX vaccine last Monday before the date of reporting and later that day he experienced adverse events. The caller stated that the patient's redness went away immediately, however, the soreness lasted approximately 5 days then resolved. The patient has denied permission to contact their physician. This case has been linked with case US2018067040 (for patient's wife), reported by the same reporter.
Age: 80.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever 105. Admitted hospital 04/24-04/27. Headache, Myalgia and Fever.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Paraesthesia, Swelling
Clinical narrative: Patient reports tingling, reddened area from upper arm to mid-forearm. Stiffness and swelling. He reports it is getting better.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Cold sweat, Headache, Pain, Pyrexia
Clinical narrative: Woke with cold sweats, headache, fever, body aches. First day.
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The patient did not have a reaction to this vaccine. I reported this to HD and they stated that this can be counted this 1 time as a tetanus dose.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Vomiting
Clinical narrative: Inconsolable fussiness, crying, and vomiting x 3 days after receiving the vaccines.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Blood immunoglobulin E, Diarrhoea, Differential white blood cell count, Full blood count, Headache
Clinical narrative: Follow up labs, Employee Health, new hire screening. 4/12/18. Went to ER, 4/20/18. 4/23/18 complaint of rash, fever, diarrhea. Seen at Employee Health 4/23/18. Generalized rash, fever, diarrhea, headache. Appointment scheduled Infectious Disease 4/25/18.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Hepatitis B virus test, Measles antibody, Metabolic function test, Mumps antibody test, Platelet count
Clinical narrative: Follow up labs, Employee Health, new hire screening. 4/12/18. Went to ER, 4/20/18. 4/23/18 complaint of rash, fever, diarrhea. Seen at Employee Health 4/23/18. Generalized rash, fever, diarrhea, headache. Appointment scheduled Infectious Disease 4/25/18.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash generalised, Rubella antibody test, Varicella virus test
Clinical narrative: Follow up labs, Employee Health, new hire screening. 4/12/18. Went to ER, 4/20/18. 4/23/18 complaint of rash, fever, diarrhea. Seen at Employee Health 4/23/18. Generalized rash, fever, diarrhea, headache. Appointment scheduled Infectious Disease 4/25/18.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Fatigue, Oropharyngeal pain, Petechiae, Rash
Clinical narrative: Extreme fatigue, sore throat, petechial rash to face and chest, loss of appetite.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Lymph node by left clavicle got painful and swollen, I returned to pharmacy and spoke with man that gave me the shot, he made notes in my file. Lump went away in about a month. My arm has tender at injection site. I took ibuprofen for pain, used ice and heat. My arm and muscles are still hurting and keeps me awake at night, very painful. This was only the second flu shot in my life, the last one was over 20 years ago. I received a pneumonia shot on January 22, 2018, first pneumonia shot in my life, Dr. talked me into getting this shot. Injection shot hurt for over 2 weeks and now I have right arm pain in the muscles and it hurts all day off and on and aches a lot at night. I have told my primary care physician and also a second Doctor in the same office, on 2 different visits.  I now have been in constant pain since November 2017 and I have trouble sleeping at night and it hurts to raise my arms and do much of anything during the day without pain. I have been to PT, although Dr. only put my back pain on form for PT, she did not address arm pain, back pain has since gone, I believe it was a pinched nerve but both arms are still very painful. I have tried ice, heat, TENS treatments, prescription Diclofenac Sodium Topical Gel 1%,  prescribed by Dr., Ibuprofen, ALEVE, prescription ALEVE, bought 2 new different bed pillows to try and relieve pain in arms and shoulders, hot baths, Epsom salts, Chiropractor, Massage therapy weekly. 4 days ago I tried CBD oil, 1 drop a day for 2 days and 2 drops yesterday.  I will be seeing an orthopedist tomorrow. Running out of ideas for this constant pain!!
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Lymph node by left clavicle got painful and swollen, I returned to pharmacy and spoke with man that gave me the shot, he made notes in my file. Lump went away in about a month. My arm has tender at injection site. I took ibuprofen for pain, used ice and heat. My arm and muscles are still hurting and keeps me awake at night, very painful. This was only the second flu shot in my life, the last one was over 20 years ago. I received a pneumonia shot on January 22, 2018, first pneumonia shot in my life, Dr. talked me into getting this shot. Injection shot hurt for over 2 weeks and now I have right arm pain in the muscles and it hurts all day off and on and aches a lot at night. I have told my primary care physician and also a second Doctor in the same office, on 2 different visits.  I now have been in constant pain since November 2017 and I have trouble sleeping at night and it hurts to raise my arms and do much of anything during the day without pain. I have been to PT, although Dr. only put my back pain on form for PT, she did not address arm pain, back pain has since gone, I believe it was a pinched nerve but both arms are still very painful. I have tried ice, heat, TENS treatments, prescription Diclofenac Sodium Topical Gel 1%,  prescribed by Dr., Ibuprofen, ALEVE, prescription ALEVE, bought 2 new different bed pillows to try and relieve pain in arms and shoulders, hot baths, Epsom salts, Chiropractor, Massage therapy weekly. 4 days ago I tried CBD oil, 1 drop a day for 2 days and 2 drops yesterday.  I will be seeing an orthopedist tomorrow. Running out of ideas for this constant pain!!
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Pain, Pain in extremity
Clinical narrative: I have had many shots and am familiar with "sore arm" sometimes afterwards. This was a total surprise. About 4 hrs. after the shot my arm was extremely sore and by 6pm I had only about 10% range of  motion (front, back, side). The pain was significant if I moved my arm at all, interfered with sleep that night. Saw MD next day and was prescribed MOBIC. Symptoms gradually resolved after 3 days and were gone by 6 days. My arm was not hot or swollen. I have NEVER experienced pain like this from any kind of shot in my arm. It was very unusual thought you should know.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Blood electrolytes normal, Crying, Full blood count normal, Muscle contractions involuntary, Opisthotonus
Clinical narrative: Patient received Hep A vaccine 4/26/18 10:27 am. On 4/28/18 at 9:00 pm, child awoke crying and was then noted to have whimpering and arching of his back, non responsive, flexed arms held firmly to his side and shaking of legs. No fever. 911 called and went to ER. Normal exam there. Follow up with Neuro pending. Episode lasted about six minutes total.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Patient received Hep A vaccine 4/26/18 10:27 am. On 4/28/18 at 9:00 pm, child awoke crying and was then noted to have whimpering and arching of his back, non responsive, flexed arms held firmly to his side and shaking of legs. No fever. 911 called and went to ER. Normal exam there. Follow up with Neuro pending. Episode lasted about six minutes total.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Malaise
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Malaise
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reported for the patient's who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reported for the patient's who experienced adverse events after receiving SHINGRIX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 60-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness, malaise, cold and fatigue. On an unknown date, the outcome of the muscle soreness, malaise, cold and fatigue were recovered/resolved. It was unknown if the reporter considered the muscle soreness, malaise, cold and fatigue to be related to SHINGRIX. Additional information was received as follows: The patient experienced terrible muscle soreness, felt out of sorts (reporter thought they implied malaise). These adverse events were lasted for about 24 hours. This case has been linked to the case US2018GSK072110, reported for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Malaise
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main though was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main though was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Pain
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patients who experienced adverse events after receiving SHINGRIX.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX. The patient's past medical history included fibromyalgia (since 2006), arthritis (since 2012), shingles (in 8th grade), chickenpox and herpes zoster. Concurrent medical conditions included diabetes. Concomitant products included amlodipine, Furosemide, lamotrigine, Levothyroxine, Losartan, pantoprazole, Pravastatin, calcium, VOLTAREN, sertraline, etodolac, HUMALOG, TOUJEO and zafirlukast. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 14th April 2018, the patient experienced tiredness, shivers, sweating and swelling arm. On 15th April 2018, the patient experienced erythema of extremities. In April 2018, the patient experienced headache and skin warm. On an unknown date, the outcome of the pain in arm, skin warm and swelling arm were not recovered/not resolved and the outcome of the erythema of extremities was unchanged and the outcome of the headache was unknown and the outcome of the tiredness was recovering/resolving and the outcome of the shivers and sweating were recovered/resolved. The reporter considered the pain in arm, erythema of extremities, tiredness, shivers, sweating, skin warm and swelling arm to be related to SHINGRIX. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX at 1:15 PM on left arm. The patient reported that after receiving SHINGRIX, she experienced a hurt arm which was red, warm and swollen. She was tired after the injection and slept for 12 hours. The patient quickly mentioned headache at the beginning of the call but there was a bad connection and the physician forgot to inquire about her headache statement.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX. The patient's past medical history included fibromyalgia (since 2006), arthritis (since 2012), shingles (in 8th grade), chickenpox and herpes zoster. Concurrent medical conditions included diabetes. Concomitant products included amlodipine, Furosemide, lamotrigine, Levothyroxine, Losartan, pantoprazole, Pravastatin, calcium, VOLTAREN, sertraline, etodolac, HUMALOG, TOUJEO and zafirlukast. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 14th April 2018, the patient experienced tiredness, shivers, sweating and swelling arm. On 15th April 2018, the patient experienced erythema of extremities. In April 2018, the patient experienced headache and skin warm. On an unknown date, the outcome of the pain in arm, skin warm and swelling arm were not recovered/not resolved and the outcome of the erythema of extremities was unchanged and the outcome of the headache was unknown and the outcome of the tiredness was recovering/resolving and the outcome of the shivers and sweating were recovered/resolved. The reporter considered the pain in arm, erythema of extremities, tiredness, shivers, sweating, skin warm and swelling arm to be related to SHINGRIX. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX at 1:15 PM on left arm. The patient reported that after receiving SHINGRIX, she experienced a hurt arm which was red, warm and swollen. She was tired after the injection and slept for 12 hours. The patient quickly mentioned headache at the beginning of the call but there was a bad connection and the physician forgot to inquire about her headache statement.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Malaise
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Pt states arm of injection site is sore next day and still sore today, she also has a headache. Counsel on placing cold compress to area and take TYLENOL for pain and headache. Soreness has subsided.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site scab, Local reaction
Clinical narrative: On 05/01/2018 Patient reported a local adverse reaction with a red, itchy area approximately 70 MM. in diameter at injection site of first VARIVAX injection, no systemic reaction reported. There remains a round hyper-pigmented area at the injection site about 5 mm. in diameter. Patient also noted that a scab had formed that she scratched off.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Fever followed by macular rash of chest and abdomen.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left arm spreading redness and tenderness.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Headache, Hyperhidrosis, Immediate post-injection reaction, Muscle contractions involuntary
Clinical narrative: Immediately following administration of vaccines (TDaP, Menveo and HPV respectively), patient slumped in chair, eyes rolled back, patient because shaking and arms contracted for approx. 20 seconds. Patient 2 person assisted to exam table to lay down. patient was diaphoretic and pale, requested for lights to be turned down as she c/o headache. Patient able to recite back her name, age, her whereabouts and the date. Vital signs obtained and RN in to care for patient. Patient seen my MD, and received a full exam. Discharged home via wheelchair with mother approx. 1 hour later (patient's brother in clinic for well check).
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Neurological examination, Pallor, Photophobia, Posture abnormal, Tremor
Clinical narrative: Immediately following administration of vaccines (TDaP, Menveo and HPV respectively), patient slumped in chair, eyes rolled back, patient because shaking and arms contracted for approx. 20 seconds. Patient 2 person assisted to exam table to lay down. patient was diaphoretic and pale, requested for lights to be turned down as she c/o headache. Patient able to recite back her name, age, her whereabouts and the date. Vital signs obtained and RN in to care for patient. Patient seen my MD, and received a full exam. Discharged home via wheelchair with mother approx. 1 hour later (patient's brother in clinic for well check).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Sore arm, headache, nausea, fever of 101 degrees for 12+ hours, extreme fatigue--slept all day 4/27/18 and had to miss work.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm, headache, nausea, fever of 101 degrees for 12+ hours, extreme fatigue--slept all day 4/27/18 and had to miss work.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Myalgia, Pyrexia, Swelling
Clinical narrative: Redness, swelling, muscle pain progressing. Second day redness and swelling increased, traveling across and under arm. Second night fever, chills. Took Chlorpheniramine and applied Benedryl cream to area. Third day swelling, redness and pain continued, spreading further. Area was 5" by 3" at that point. Notified pharmacist and physician, adverse reaction confirmed. Swelling subsided by day 5, but still persists. Day 6 redness was diminished, but pain and some redness continues.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Occipital neuralgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of occipital neuralgia in a male patient who received SHINGRIX. Concomitant products included SHINGRIX. On 2nd March 2018, the patient received the 2nd dose of SHINGRIX. On 2nd March 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 15th April 2018, the patient experienced occipital neuralgia. On an unknown date, the outcome of the occipital neuralgia was not reported and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the occipital neuralgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 12th February 2018, the patient received 1st dose of SHINGRIX. On 2nd March 2018, the patient received 2nd dose of SHINGRIX earlier than the recommended schedule, which led to shortening of the vaccination schedule. The patient developed right sided occipital neuralgia. The healthcare professional did not provide his date of birth or any lot number or expiry date of the SHINGRIX dose he was given early.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 84-year-old male patient who received SHINGRIX. Concomitant products included ramipril. On 17th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th April 2018, 1 days after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. The patient received CREON as concomitant drug.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Malaise
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also post on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also post on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse events because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 62-year-old male patient who received SHINGRIX. Concomitant products included FLOMAX. In April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovering/resolving. The reporter considered the pruritus to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX vaccine approximately a week before the reporting date. The patient experienced medium amount of itching. Medical disclaimer was provided and patient was counseled to follow up with health care physician. The patient had denied permission to contact their physician. The patient provided limited information due to time constraint.
Sex: F
Vaccine: HEPAB
Symptoms: Immediate post-injection reaction, Injection site pain, Product preparation error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received TWINRIX. Previously administered products included TWINRIX with an associated reaction of pain (1st dose (refer case US2018068949)). On 19th April 2018, the patient received the 2nd dose of TWINRIX. On 19th April 2018, immediately after receiving TWINRIX, the patient experienced injection site pain and inappropriate reconstitution technique. On an unknown date, the outcome of the injection site pain and inappropriate reconstitution technique were unknown. It was unknown if the reporter considered the injection site pain to be related to TWINRIX. Additional details were reported as follows: Age at vaccination was not reported. After 2nd dose, the patient hurt like normal. She was concerned because she read the PI information about administering the vaccine prior to getting vaccine and how there may be 2 layers and the vaccine should be shaken until it had a uniform, hazy, white appearance. When she saw the dose that the medical assistant was about to administer to her she could clearly see a white layer and a separate clear layer still present in the syringe. She told the medical assistant that the vaccine needed to be shaken, and the medical assistant did shake it a little after that, but not as much as recommended in the PI. The dose was then administered. This led to inappropriate reconstitution technique. The patient was not sure if the vaccine was shaken enough, and does not know if the vaccine was ever shaken with the first dose. The caller declined to participate in the report.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Left arm pain since 3/19/18 after getting a Tdap. Pain is worse in the morning. She had significant pain when she raises her arms to put her hair in a ponytail. The pain is bad enough that she does not continue to put her hair up. She had no redness or swelling in the area. She has not had problems with a vaccine in the past. She had no pain in the shoulder prior to the shot. The pain she feels is deep. She had no other trauma to the area. No previous shoulder problems. She has tried heat and ADVIL without success.