chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Burns second degree, Cyanosis, Exercise tolerance decreased, Fatigue
Clinical narrative: Brainstem stroke occurred on 5/13/17. Was recovering well from stroke. Flu shot received on 11/1/2017. On 11/19/17 I took a motorcycle ride. It was cold and I was using heated gloves while on the bike. At the end of the ride, I removed my gloves and noticed that I had a second degree burn on my right hand and my left foot was blue. I had no sense of feeling in either my right hand or left foot.  Since that time, the lack of feeling has spread up to my right shoulder, left elbow, left knee and up to the right hip. I have become increasingly fatigued, and was prior to the flu shot, able to walk 3-4 miles/day, and now am able to only walk 1-2 miles before I become totally exhausted. I have had to stop my physical therapy, since I am so fatigued as well. As a result of my worsening condition, I sought medical advice at Clinic.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Neurological examination, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Sensory loss
Clinical narrative: Brainstem stroke occurred on 5/13/17. Was recovering well from stroke. Flu shot received on 11/1/2017. On 11/19/17 I took a motorcycle ride. It was cold and I was using heated gloves while on the bike. At the end of the ride, I removed my gloves and noticed that I had a second degree burn on my right hand and my left foot was blue. I had no sense of feeling in either my right hand or left foot.  Since that time, the lack of feeling has spread up to my right shoulder, left elbow, left knee and up to the right hip. I have become increasingly fatigued, and was prior to the flu shot, able to walk 3-4 miles/day, and now am able to only walk 1-2 miles before I become totally exhausted. I have had to stop my physical therapy, since I am so fatigued as well. As a result of my worsening condition, I sought medical advice at Clinic.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site erythema, Pain in extremity
Clinical narrative: Redness at injection site, sore arm upset stomach--on first shot has chills and fever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Influenza, Muscular weakness
Clinical narrative: Symptoms of a severe flu (headaches, body aches, sweats, chills, muscle weakness) stated about 6 hours after the injection and last about 36 hours. Gradual recovery but not fully recovered until 4 days afterwards.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Symptoms of a severe flu (headaches, body aches, sweats, chills, muscle weakness) stated about 6 hours after the injection and last about 36 hours. Gradual recovery but not fully recovered until 4 days afterwards.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV, TDAP
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain, X-ray limb normal
Clinical narrative: Two weeks after these 3 vaccines given on same arm, patient started feeling electrical wave type of pain radiating into shoulder and elbow joint. A few weeks after that, pain progressed to the point that patient couldn't move her arm to do daily activities. She took some Ibuprofen which tend to help somewhat. She discussed it with her doctor on 01.30.18, and doctor recommended to do some exercise. Pain still didn't go away. On 04.05.18, doctor ordered X-ray of the arm and shoulder. On 05.31.18, patient brought it to pharmacy's attention the first time.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and injection site swelling. On an unknown date, the outcome of the influenza-like symptoms and injection site swelling were unknown. The reporter considered the influenza-like symptoms and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. All questions were asked, field representative provided limited information.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 67-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 21st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 24th May 2018, 3 days after receiving SHINGRIX, the patient experienced local swelling and erythema of extremities. On an unknown date, the outcome of the local swelling and erythema of extremities were not recovered/not resolved. The reporter considered the local swelling and erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that, she had a patient that had SHINGRIX on Monday, 21st May 2018 (discrepant information was reported for the vaccination date which was corrected from 21st May 2008 to 21st May 2018). The patient came the day before the date of reporting to the pharmacy with red lumps on her arm where she received the injection. The red lumps were no tiny bumps, they were actual lumps. They were midway down the arm, not exactly at the injection site. There were about 3 to 4 lumps. The lumps were not itchy. The pharmacist did not want to provide name of medication. She said the patient had been on the same medication for a while. Clarification had been raised for the confirmation of the reporter's qualification (consumer or pharmacist).
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 67-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 21st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 24th May 2018, 3 days after receiving SHINGRIX, the patient experienced local swelling and erythema of extremities. On an unknown date, the outcome of the local swelling and erythema of extremities were not recovered/not resolved. The reporter considered the local swelling and erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that, she had a patient that had SHINGRIX on Monday, 21st May 2018 (discrepant information was reported for the vaccination date which was corrected from 21st May 2008 to 21st May 2018). The patient came the day before the date of reporting to the pharmacy with red lumps on her arm where she received the injection. The red lumps were no tiny bumps, they were actual lumps. They were midway down the arm, not exactly at the injection site. There were about 3 to 4 lumps. The lumps were not itchy. The pharmacist did not want to provide name of medication. She said the patient had been on the same medication for a while. Clarification had been raised for the confirmation of the reporter's qualification (consumer or pharmacist).
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash and headache. On an unknown date, the outcome of the rash was unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the rash and headache to be related to SHINGRIX. Additional details were provided as follows: The patient did mention during the call that her pharmacist reported this event to her doctor and CDC (center of disease control and prevention). The age at vaccination was not reported. The patient called to ask about how long did the headache last after receiving SHINGRIX. The patient mentioned that she developed a rash next morning, and she also had a headache. The reporter gave medical disclaimer, provided information from prescribing information. The call had disconnected before asking any questions in the CAMEL template, attempted to call back the patient but got no answer.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Antibody test negative, Ataxia, Cerebellar ataxia, Immunology test normal, Laboratory test normal
Clinical narrative: This vaccine combo was given in a pharmacy 3 to 4 weeks before the onset of ataxia. Our current diagnosis is acute cerebellar midline ataxia. This patient has also been evaluated by a neurologist and ENT specialist and another internist. He has had a negative workup for other causes of ataxia, to include (viral, AB studies, nutritional/vitamin deficiencies and autoimmune disease). The ataxia is not getting better or worse since its onset which was 4/30/2018. It would be nice to talk to a real MD and not have to fill out this form!!
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Viral test negative
Clinical narrative: This vaccine combo was given in a pharmacy 3 to 4 weeks before the onset of ataxia. Our current diagnosis is acute cerebellar midline ataxia. This patient has also been evaluated by a neurologist and ENT specialist and another internist. He has had a negative workup for other causes of ataxia, to include (viral, AB studies, nutritional/vitamin deficiencies and autoimmune disease). The ataxia is not getting better or worse since its onset which was 4/30/2018. It would be nice to talk to a real MD and not have to fill out this form!!
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nervous system disorder, Neurological symptom, Vertigo CNS origin
Clinical narrative: This vaccine combo was given in a pharmacy 3 to 4 weeks before the onset of ataxia. Our current diagnosis is acute cerebellar midline ataxia. This patient has also been evaluated by a neurologist and ENT specialist and another internist. He has had a negative workup for other causes of ataxia, to include (viral, AB studies, nutritional/vitamin deficiencies and autoimmune disease). The ataxia is not getting better or worse since its onset which was 4/30/2018. It would be nice to talk to a real MD and not have to fill out this form!!
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Back pain, Cerebellar ataxia, Gait disturbance, Neuromuscular pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This vaccine combo was given in a pharmacy 3 to 4 weeks before the onset of ataxia. Our current diagnosis is acute cerebellar midline ataxia. This patient has also been evaluated by a neurologist and ENT specialist and another internist. He has had a negative workup for other causes of ataxia, to include (viral, AB studies, nutritional/vitamin deficiencies and autoimmune disease). The ataxia is not getting better or worse since its onset which was 4/30/2018. It would be nice to talk to a real MD and not have to fill out this form!!
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal normal
Clinical narrative: This vaccine combo was given in a pharmacy 3 to 4 weeks before the onset of ataxia. Our current diagnosis is acute cerebellar midline ataxia. This patient has also been evaluated by a neurologist and ENT specialist and another internist. He has had a negative workup for other causes of ataxia, to include (viral, AB studies, nutritional/vitamin deficiencies and autoimmune disease). The ataxia is not getting better or worse since its onset which was 4/30/2018. It would be nice to talk to a real MD and not have to fill out this form!!
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received influenza vaccine quadrivalent at an unknown dose. On an unknown date, unknown after receiving influenza vaccine quadrivalent, the patient experienced Guillain Barre Syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to influenza vaccine quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) had no documentation of when or what flu shot the patient received.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of dizziness in a male patient who received SHINGRIX. Previously administered products included SHINGRIX (received 1st dose on an unspecified date). On 23rd May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced dizziness and chills. On an unknown date, the outcome of the dizziness and chills were unknown. The reporter considered the dizziness and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician noted that the patient reported on the reporting date that he experienced dizziness, light headedness and chills. The reporter stated that no additional details were available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Chills, Extensive swelling of vaccinated limb, Feeding disorder, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, general body pain, pain in arm, injection site erythema and chills. On 23rd May 2018, the patient experienced feeling unwell and unable to eat. On 24th May 2018, the patient experienced vivid dreams and sweating. On 25th May 2018, the patient experienced fever blister. The patient was treated with TYLENOL. On 24th May 2018, the outcome of the fever, general body pain and chills were recovered/resolved. On an unknown and the outcome of the extensive swelling of vaccinated limb, feeling unwell and unable to eat were unknown and the outcome of the vivid dreams, pain in arm, fever blister, injection site erythema and sweating were unchanged. The reporter considered the extensive swelling of vaccinated limb, fever, general body pain, vivid dreams, pain in arm, fever blister, injection site erythema, chills and sweating to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell and unable to eat to be related to SHINGRIX. Additional details were provided as follows: On 22nd May 2018, at 10:30, the patient received SHINGRIX in the left deltoid. On the same day, 12 hours and 30 minutes after receiving SHINGRIX, the patient experienced 102 degree fever, chills and body aches around 11 pm on the day of vaccination. The patient took two TYLENOL to help with her fever and drank a lot of water. The patient stated that her arm was swollen, sore and red since the day of vaccination. The redness and swelling was about the size of 6 inches by 3 inches which starts from the injection site and radiates down below the site. One day after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101. 5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101.5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient woke up very wet with perspiration and had vivid dreams that night. The patient felt a little energetic since her fever was gone that day. Three days after receiving SHINGRIX, the patient again woke up with perspiration and vivid dreams along with a fever blister on lower left lip of the face. The patient had denied permission to contact their physician. All questions were asked, no further details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise, Oral herpes, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, general body pain, pain in arm, injection site erythema and chills. On 23rd May 2018, the patient experienced feeling unwell and unable to eat. On 24th May 2018, the patient experienced vivid dreams and sweating. On 25th May 2018, the patient experienced fever blister. The patient was treated with TYLENOL. On 24th May 2018, the outcome of the fever, general body pain and chills were recovered/resolved. On an unknown and the outcome of the extensive swelling of vaccinated limb, feeling unwell and unable to eat were unknown and the outcome of the vivid dreams, pain in arm, fever blister, injection site erythema and sweating were unchanged. The reporter considered the extensive swelling of vaccinated limb, fever, general body pain, vivid dreams, pain in arm, fever blister, injection site erythema, chills and sweating to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell and unable to eat to be related to SHINGRIX. Additional details were provided as follows: On 22nd May 2018, at 10:30, the patient received SHINGRIX in the left deltoid. On the same day, 12 hours and 30 minutes after receiving SHINGRIX, the patient experienced 102 degree fever, chills and body aches around 11 pm on the day of vaccination. The patient took two TYLENOL to help with her fever and drank a lot of water. The patient stated that her arm was swollen, sore and red since the day of vaccination. The redness and swelling was about the size of 6 inches by 3 inches which starts from the injection site and radiates down below the site. One day after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101. 5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101.5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient woke up very wet with perspiration and had vivid dreams that night. The patient felt a little energetic since her fever was gone that day. Three days after receiving SHINGRIX, the patient again woke up with perspiration and vivid dreams along with a fever blister on lower left lip of the face. The patient had denied permission to contact their physician. All questions were asked, no further details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, general body pain, pain in arm, injection site erythema and chills. On 23rd May 2018, the patient experienced feeling unwell and unable to eat. On 24th May 2018, the patient experienced vivid dreams and sweating. On 25th May 2018, the patient experienced fever blister. The patient was treated with TYLENOL. On 24th May 2018, the outcome of the fever, general body pain and chills were recovered/resolved. On an unknown and the outcome of the extensive swelling of vaccinated limb, feeling unwell and unable to eat were unknown and the outcome of the vivid dreams, pain in arm, fever blister, injection site erythema and sweating were unchanged. The reporter considered the extensive swelling of vaccinated limb, fever, general body pain, vivid dreams, pain in arm, fever blister, injection site erythema, chills and sweating to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell and unable to eat to be related to SHINGRIX. Additional details were provided as follows: On 22nd May 2018, at 10:30, the patient received SHINGRIX in the left deltoid. On the same day, 12 hours and 30 minutes after receiving SHINGRIX, the patient experienced 102 degree fever, chills and body aches around 11 pm on the day of vaccination. The patient took two TYLENOL to help with her fever and drank a lot of water. The patient stated that her arm was swollen, sore and red since the day of vaccination. The redness and swelling was about the size of 6 inches by 3 inches which starts from the injection site and radiates down below the site. One day after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101. 5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient was not feeling well all day and she was hardly able to eat anything. The patient's body temperature at night on 23rd May 2018 was recorded as around 101.5 degrees F, she took some TYLENOL extra strength that night. Two days after receiving SHINGRIX, the patient woke up very wet with perspiration and had vivid dreams that night. The patient felt a little energetic since her fever was gone that day. Three days after receiving SHINGRIX, the patient again woke up with perspiration and vivid dreams along with a fever blister on lower left lip of the face. The patient had denied permission to contact their physician. All questions were asked, no further details were provided.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 80-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 17th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The health care professional reported that the patient experienced redness and soreness at injection site after receiving initial dose of SHINGRIX. The pain subsided after a few days however redness persisted. No treatment had been received. The patient was currently recovering with no further reports of incident regarding the event.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Received first of two SHINGRIX injections on 5/26. The next day experienced a significant stiff neck on the side of the injection site. Each day since, the pain has increased to the point where I cannot lie down or sit upright without NAPROSYN.
Sex: M
Vaccine: HPV4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Have pain, chills, and fever after HPV vaccine.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt had swelling, redness and extreme soreness at injection site. Also experience extreme chills for 24 hours. Low grade fever this morning at 99 degrees. Given antibiotics to help treat.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Oxygen saturation decreased, Oxygen therapy, Unresponsive to stimuli
Clinical narrative: Nurse went through the consent with the patient prior to administration of vaccinations. Patient denied any medical history; allergies; and did state that she had eaten this morning. Nurse was administering immunizations to the patient who was sitting in a chair. Patient was holding a conversation the entire time with the nurse during the administration. Nurse administered all three vaccinations and as the nurse went to place a Band-Aid on the last injection site the patient fell back abruptly in the chair. Patient was completely unresponsive, however patient had a pulse. Nurse initiated Health Department protocol by using her whistle to call for assistance twice. After the second whistle was blown the patient started to regain consciousness and asked "Am I in a Basketball game?" Assistance came and vitals were taken. Patient was slowly still regaining consciousness and stated the she "felt funny'. 911 call was made by the Nurse Manager. Vitals were as follows: 8:05am Pulse: 49BP: 102/70; O2: 84% RA Oxygen was placed on patient at 2L. 8:06am Pulse: 60 O2: 99% with 2L of oxygen. 8:07am Pulse 50 O2: 99% with 2 L of oxygen, patient given Mountain Dew (sugar source); 8:08am Pulse 78 O2 99% oxygen removed; 8:11am Pulse: 70 BP: 120/70 O2:99% RA: paramedics arrived and evaluated patient. At this time patient was able to sit up on her own and stated the she "did not want to go to the hospital". Paramedics reviewed and agreed with nurses that patient should not drive today. Patients mother was called and confirmed that she would come pick the patient up. Patient stayed in the immunizations room until mother came and picked her up. Patient's final vitals were: Pulse: 65 BP: 120/72 O2 99 RA. Patient was able to stand up and walk on her own.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Induration, Pain, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 16-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019). Concomitant products included MENACTRA. On 24th April 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 24th April 2018, less than a day after receiving BEXSERO, the patient experienced swelling, induration and pain. On 1st May 2018, the outcome of the swelling, induration and pain were recovered/resolved. It was unknown if the reporter considered the swelling, induration and pain to be related to BEXSERO. Additional details were provided as follows: This case was reported by the Physician's Assistant (PA). On 24th April 2018, the patient received MENACTRA (batch number U5766AE and expiry date 2nd December 2018) concomitantly. The patient was administered BEXSERO in the left deltoid.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Red, itchy, hives on upper arm where injection was given.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Impaired work ability, Influenza like illness, Nasopharyngitis
Clinical narrative: Red, itchy, hives on upper arm where injection was given.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Red, itchy, hives on upper arm where injection was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Localised oedema, Pruritus, Rash, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site muscle pain. On 18th May 2018, the patient experienced rash, localized itching, skin warm, localized erythema and local swelling. On an unknown date, the outcome of the rash, localized itching, skin warm, localized erythema, injection site muscle pain and local swelling were recovered/resolved. The reporter considered the rash, localized itching, skin warm, localized erythema, injection site muscle pain and local swelling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The patient received SHINGRIX in the right deltoid. The patient experienced muscle soreness at the injection, right after receiving the vaccination with SHINGRIX. Three days after receiving the vaccination the patient noticed that the area approximately one inch below the injection site had a rash, was hot, itchy, red and swollen. There was no redness at the injection site. These symptoms were resolved after three days. The patient gave permission for her physician to be contacted and provided the details for the same.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site muscle pain. On 18th May 2018, the patient experienced rash, localized itching, skin warm, localized erythema and local swelling. On an unknown date, the outcome of the rash, localized itching, skin warm, localized erythema, injection site muscle pain and local swelling were recovered/resolved. The reporter considered the rash, localized itching, skin warm, localized erythema, injection site muscle pain and local swelling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The patient received SHINGRIX in the right deltoid. The patient experienced muscle soreness at the injection, right after receiving the vaccination with SHINGRIX. Three days after receiving the vaccination the patient noticed that the area approximately one inch below the injection site had a rash, was hot, itchy, red and swollen. There was no redness at the injection site. These symptoms were resolved after three days. The patient gave permission for her physician to be contacted and provided the details for the same.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PNEUMOVAX reaction (MERCK & CO Lot # R000579) temperature to 100.2, body aches, myalgias. Red swollen arm hot and painful from top of shoulder down to elbow. Headache.
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Myalgia, Pain
Clinical narrative: PNEUMOVAX reaction (MERCK & CO Lot # R000579) temperature to 100.2, body aches, myalgias. Red swollen arm hot and painful from top of shoulder down to elbow. Headache.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Oral herpes
Clinical narrative: Large cold sore (herpes blisters) left side-lower lip 6 days after vaccine-never had this before only once on upper lip right side 20 yrs. ago. I was very healthy when I received this vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient developed swelling and redness and extreme pain in left upper arm at the site of vaccination. Persistent for 10 days. She also developed a red rash on chest.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Decreased appetite, Rash erythematous, Rash generalised
Clinical narrative: Loss of appetite, red bumps on her face, that spread all over her body within 5 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: I received SHINGRIX 1st shot and about 3 hours later began to feel ill. Experienced chills, nausea, low grade fever, very tired with no energy, whole body ached, headache, pain and discomfort in shoulders and joints, developed rash on buttocks, no appetite, exhausted, trouble sleeping. These severe symptoms lasted about 3 days with gradual improvement, for me it took an entire week to feel back to normal. I am hopeful that when I receivedthe second shot in 4 months that my side effects will be less severe. The symptoms I experienced made me feel the sickest and unwell I have felt in years. Even when I have experienced flu like symptoms I did not feel as ill as I did after receiving this injection. The injection was also very painful, not the needle stick but the length of time to inject the product. It felt like someone was trying to inject a thick substance into my arm and very painful during that process. Arm at injection site lump and very sore for a few days. Worst experience I ever had with getting a injection. I am 70 years old male and relatively healthy, not obese and very mobile. I was very unprepared for the side effects I experienced and believe caregivers should better prepare patients on what to expect regarding the severity of possible symptoms and the length of time until the adverse reactions subside. I only report my experience to forewarn, for I will gladly tolerate the side effects if it protects one from getting shingles. This shot should not be given to sissys for they will think they are dying and rush to the ER or be calling the undertaker.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Insomnia, Malaise, Musculoskeletal discomfort
Clinical narrative: I received SHINGRIX 1st shot and about 3 hours later began to feel ill. Experienced chills, nausea, low grade fever, very tired with no energy, whole body ached, headache, pain and discomfort in shoulders and joints, developed rash on buttocks, no appetite, exhausted, trouble sleeping. These severe symptoms lasted about 3 days with gradual improvement, for me it took an entire week to feel back to normal. I am hopeful that when I receivedthe second shot in 4 months that my side effects will be less severe. The symptoms I experienced made me feel the sickest and unwell I have felt in years. Even when I have experienced flu like symptoms I did not feel as ill as I did after receiving this injection. The injection was also very painful, not the needle stick but the length of time to inject the product. It felt like someone was trying to inject a thick substance into my arm and very painful during that process. Arm at injection site lump and very sore for a few days. Worst experience I ever had with getting a injection. I am 70 years old male and relatively healthy, not obese and very mobile. I was very unprepared for the side effects I experienced and believe caregivers should better prepare patients on what to expect regarding the severity of possible symptoms and the length of time until the adverse reactions subside. I only report my experience to forewarn, for I will gladly tolerate the side effects if it protects one from getting shingles. This shot should not be given to sissys for they will think they are dying and rush to the ER or be calling the undertaker.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain, Pyrexia, Rash
Clinical narrative: I received SHINGRIX 1st shot and about 3 hours later began to feel ill. Experienced chills, nausea, low grade fever, very tired with no energy, whole body ached, headache, pain and discomfort in shoulders and joints, developed rash on buttocks, no appetite, exhausted, trouble sleeping. These severe symptoms lasted about 3 days with gradual improvement, for me it took an entire week to feel back to normal. I am hopeful that when I receivedthe second shot in 4 months that my side effects will be less severe. The symptoms I experienced made me feel the sickest and unwell I have felt in years. Even when I have experienced flu like symptoms I did not feel as ill as I did after receiving this injection. The injection was also very painful, not the needle stick but the length of time to inject the product. It felt like someone was trying to inject a thick substance into my arm and very painful during that process. Arm at injection site lump and very sore for a few days. Worst experience I ever had with getting a injection. I am 70 years old male and relatively healthy, not obese and very mobile. I was very unprepared for the side effects I experienced and believe caregivers should better prepare patients on what to expect regarding the severity of possible symptoms and the length of time until the adverse reactions subside. I only report my experience to forewarn, for I will gladly tolerate the side effects if it protects one from getting shingles. This shot should not be given to sissys for they will think they are dying and rush to the ER or be calling the undertaker.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced shingles, discomfort and painful rash. On an unknown date, the outcome of the shingles, discomfort and painful rash were unknown. It was unknown if the reporter considered the shingles, discomfort and painful rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient contacted via call back and stated that after receiving SHINGRIX vaccine, he had a full case of shingles. This rash was exceptionally uncomfortable and painful. The patient was very unhappy that there was no warning that he would actually got shingles from this vaccination. It was not mentioned as a side effect on any documentation. The patient provided the vial kit number and asked to contact him and advice on next step. The patient was contacted and the phone rang and rang and disconnected itself. Limited information was available.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Contusion, Crying, Fall, Pain, Rash erythematous
Clinical narrative: Thirty minutes after vaccine he was running and continuously falling. Experienced leg bruising. Night after vaccine he was painfully crying. Today is day two-quarter size spot and red spot all over legs. Patient may be seen by office today. (Note: History of AE's. As a baby he experienced high fever and and jaundice discoloration. Taken to hospital).
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Peripheral swelling, Pseudomonas test positive
Clinical narrative: Was given PNEUMOVAX 23 Vaccine shot in right arm at 11:00 AM May 16, 2018. Started getting fever at 5:00 PM and pain swelling in arm. Fever up to 102 deg. F by 7:30 PM. Called Doctors office and was told to go to the Emergency Room. Went to Hospital, and was admitted. (White blood cell count was 17 on May 9 and 19 when the shot was given). Arm continued to swell and turn red. Was treated in hospital with MERREM, fever went down, but white blood cell count continued to go up to 26.2 by May 19, switched to Vancomycin for two days, white cell count dropped to 17, and fever dropped to normal but developed rash on back, so switched back to MERREM. Arm continued to swell until 5/21/18 then started going down. No fever, but white count started back up to 23.2 when discharged from the hospital on May 23. Mucus sample taken on May 17 contained Pseudomonas Aeruginosa. Went to ENT Doctor May 24, had MRI which showed left Maxillary sinus cavity full of ??. Swab sample sent to lab which showed Pseudomonas Aeruginosa. White blood cell count was 20.3 on May 30. Doctors still trying to determine cause of high white blood cell count. Could it be the Pseudomonas Aeruginosa in the Maxillary sinus cavity?
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash, Swelling, White blood cell count increased
Clinical narrative: Was given PNEUMOVAX 23 Vaccine shot in right arm at 11:00 AM May 16, 2018. Started getting fever at 5:00 PM and pain swelling in arm. Fever up to 102 deg. F by 7:30 PM. Called Doctors office and was told to go to the Emergency Room. Went to Hospital, and was admitted. (White blood cell count was 17 on May 9 and 19 when the shot was given). Arm continued to swell and turn red. Was treated in hospital with MERREM, fever went down, but white blood cell count continued to go up to 26.2 by May 19, switched to Vancomycin for two days, white cell count dropped to 17, and fever dropped to normal but developed rash on back, so switched back to MERREM. Arm continued to swell until 5/21/18 then started going down. No fever, but white count started back up to 23.2 when discharged from the hospital on May 23. Mucus sample taken on May 17 contained Pseudomonas Aeruginosa. Went to ENT Doctor May 24, had MRI which showed left Maxillary sinus cavity full of ??. Swab sample sent to lab which showed Pseudomonas Aeruginosa. White blood cell count was 20.3 on May 30. Doctors still trying to determine cause of high white blood cell count. Could it be the Pseudomonas Aeruginosa in the Maxillary sinus cavity?
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: After second dose of SHINGRIX, experienced mild fever and shivering as well as muscle pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Intense pain and immobility in entire right arm and shoulder into upper side. Lasted entire evening unable to sleep and resulting in missing part of work day. Taking OTC Ibuprofen, but pain is still present. Advised to call paramedics but didn't. Scheduled to see doctor on 6/4/18.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Peripheral swelling
Clinical narrative: Leg swelling.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient is here for immunizations per order of Dr dated 5/24/18. Vaccine information sheet(s) were given on 05/24/18. Verbal consent was obtained. Patient tolerated the immunization well without incident. 1532-Patient stated she felt fine to leave, went to front desk to set up apt and passed out. Denies hitting head, came too right away, FOA with patient, I came to the front of the office and got patient a cool cloth and FOA got water for her. We escorted her to a chair. Patient talking and laughing and drinking her water. Denies any pain or injury anywhere. Dr called, notified of incident, verbalizes understanding. No order given. 1546-Patient states she is feeling much better, has drank 2 cups of water, denies any discomfort or injury, states she has to go to work. Patient was advised to let us know if she had any issues or concerns, she verbalized understanding. Patient walked out of clinic with a steady gait, states she feels fine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: Arm very sore and painful - within a few hours, red, hot, swollen, sore to touch - sore even when not touched. The redness is subsiding - it is almost 2 weeks - not yet completely gone.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 6th March 2018 09:12, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, malaise and chills. The patient was treated with TYLENOL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, malaise and chills were recovered/resolved. It was unknown if the reporter considered the fever, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was a Medical Technologist. She called to report an adverse event as advised by a physician. The physician that asked reporter to call was also the patient himself. The patient received SHINGRIX vaccine and within 4 hours experienced fever, chills (teeth chattering chills) and malaise. The patient said that after TYLENOL it was better and lasted for a total of 5 hours. This case was linked to the case US2018GSK096014 (2nd dose), reported by the same reporter for the same patient.