chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: After administration of Tdap, MENACTRA and Hep A patient immediately began to feel light headed, skin clammy/sweaty, nauseous. Condition progressed to patient complaining of tongue and throat feeling swollen, shortness of breath, numbness to extremities, pain to touch of skin, felt that eyes and nasal passages felt swollen. Patient was laid down on table, assessed by nurse, given cold compresses to head and arms. EMS was notified and responded for transport to the hospital.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Muscle spasms, Pain in extremity
Clinical narrative: Chills the first evening starting at around Nd 9:00 PM. At 4:30 in the morning excruciating pain similar to a muscle cramp running down my right leg tried to get up but could not lasted about five minutes. Returned at 2:20 PM. Felt like shock wave traveling through the bone or nerve again lasted for about five minutes. It was like nerve spasms.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection. Treated with a topical anti-itch cream. Rash is resolving nicely.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Hypersomnia, Inappropriate schedule of drug administration
Clinical narrative: Second round of GARDASIL shot was injected approximately 12PM on 7/23/2018. This is one month earlier than the general vaccine schedule, as the first round was given on 6/21/2018. The suggested schedule for vaccine is for the 2nd vaccination to occur 2 months after the first vaccination and the 3rd to occur 6 months after the first vaccination. Patient was extremely fatigued from 7/24/2018-7/25/2018, and could hardly leave the bed or stay awake. Patient slept approximately 12 hours the night of 7/24/2018, got up for work and made breakfast and shortly returned to bed sleeping 3 more hours. Patient is starting to feel slightly better, but still fairly fatigued as of 3:30PM 7/25/2018.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats
Clinical narrative: She received her second dose of SHINGRIX, approximately 80 days after her first dose. She reported excessive night sweating for the first 2 nights after receiving the second dose of SHINGRIX. She stated this side effect did not happen after her first dose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Dysgeusia, Fatigue
Clinical narrative: Received 1st SHINGRIX 50 MCG 7/18/2018 about 9:30 AM. By that evening, noticed muscle aches, then chills and extreme fatigue. Then experienced extreme anorexia which lasted for 3 days. Barely able to force down water. Mild diarrhea. Metallic taste in mouth. Gradually recovered 7/21-7/23.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Received 1st SHINGRIX 50 MCG 7/18/2018 about 9:30 AM. By that evening, noticed muscle aches, then chills and extreme fatigue. Then experienced extreme anorexia which lasted for 3 days. Barely able to force down water. Mild diarrhea. Metallic taste in mouth. Gradually recovered 7/21-7/23.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Hypophagia, Malaise, Pain
Clinical narrative: Received 1st SHINGRIX 50 MCG 7/18/2018 about 9:30 AM. By that evening, noticed muscle aches, then chills and extreme fatigue. Then experienced extreme anorexia which lasted for 3 days. Barely able to force down water. Mild diarrhea. Metallic taste in mouth. Gradually recovered 7/21-7/23.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Headache, Nausea, Pain in extremity
Clinical narrative: I had a shingles vaccination Friday. I had a fever, nausea, diarrhea, headache the next day. 3 days later my arm is swollen, rash, red and hurts really bad.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: I had a shingles vaccination Friday. I had a fever, nausea, diarrhea, headache the next day. 3 days later my arm is swollen, rash, red and hurts really bad.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient received one dose of SHINGRIX on 4/9/18 and represented to provider's office on 4/10/18 with symptoms of pain to area and the reaction site was warm to touch.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 20-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot # R006220 and expiration date reported as 29-FEB-2020 (dose, strength, frequency and route of administration were unknown. No adverse effects were reported. It was reported that the vaccine had a temperature excursion of -9°C to 8°C during 9 hours and 32 minutes. No previous temperature excursions were reported. Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Herpes zoster, Hypoaesthesia, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-AUG-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date in August 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient developed a painful rash on his left arm accompanied by redness, burning, and numbness. In response to these complaints, the patient presented to a medical center and was diagnosed as suffering from shingles. Thereafter, on 19-AUG-2016, the patient had a follow-up appointment and was diagnosed as suffering from post-herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-AUG-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date in August 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient developed a painful rash on his left arm accompanied by redness, burning, and numbness. In response to these complaints, the patient presented to a medical center and was diagnosed as suffering from shingles. Thereafter, on 19-AUG-2016, the patient had a follow-up appointment and was diagnosed as suffering from post-herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irrigation, Eye irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in eye in a female patient who intended to administer SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 17th July 2018, the patient received SHINGRIX. On 17th July 2018, immediately after receiving SHINGRIX, the patient experienced burning sensation in eye, inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the burning sensation in eye was not recovered/not resolved and the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown. It was unknown if the reporter considered the burning sensation in eye to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the adjuvant accidently squirted into her eyes when attempting to mix the SHINGRIX vaccine, which led to inadvertent exposure to vaccine, and exposure via eye contact. She felt some burning and rinsed with water. After rinsing she still felt a little burning feeling. The reporting registered pharmacist called immediately following the event requesting information from Medical Information (MI). Her call was transferred to MI.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in November 2007). On 30th May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 7 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were reported as follows: Seven days later was seen by the physician and was diagnosed with a confirmed case of zoster. The patient was not immunosuppressed. The physician granted permission for GlaxoSmithKline to follow up. No further details known by representative.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chalazion, Cyst, Eyelid operation, Eyelid pain, Eyelids pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chalazion in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included scab. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 15 days after receiving SHINGRIX, the patient experienced chalazion. On an unknown date, the patient experienced eyelid pain, eyelids pruritus and cyst. SHINGRIX was discontinued (Dechallenge was positive). On an unknown date, the outcome of the chalazion and eyelid pain were recovering/resolving and the outcome of the eyelids pruritus and cyst were recovered/resolved. It was unknown if the reporter considered the chalazion, eyelid pain, eyelids pruritus and cyst to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient received SHINGRIX on left deltoid. The patient stated that she did not have any discomfort, pain, or swelling, but within days, her left eyelid had soreness and the root of her eyelash started to itch. By 17th May 2018, the patient had a big bump there and she saw her ophthalmologist on the 18th May 2018 and he diagnosed her as having a chalazion cyst and informed her to use hot compresses on it and to return in a week if it did not go away. It did not go away and the patient had to have a procedure where they cut and cleaned out the area. On 8th June 2018, the patient had begun to have the same symptoms in the right eyelid area that resulted in having the same procedure on 5th July 2018. The patient's ophthalmologist recommended that she had to see her internist when her right eye became involved to make sure it was not anything systemic, as the ophthalmologist felt that it was unusual to have the same occurrences in both eyes, in exactly the same place. The ophthalmologist's internist tested the patient and ruled her out for diabetes, staph and cholesterol related issues. On 17th July 2018, the patient was due for her 2nd dose of SHINGRIX, but her pharmacist did not feel comfortable administering it, so she had not received it. The patient stated that, her both eyes were healing, but there are scabs there from the procedures on the reporting date. The patient stated that at first she did not associate her incidences with the vaccine, but began to look at the timeline in addition to ruling out other causes, and thought that they might be indeed associated. The patient had given permission to contact their physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chalazion in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included scab. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 15 days after receiving SHINGRIX, the patient experienced chalazion. On an unknown date, the patient experienced eyelid pain, eyelids pruritus and cyst. SHINGRIX was discontinued (Dechallenge was positive). On an unknown date, the outcome of the chalazion and eyelid pain were recovering/resolving and the outcome of the eyelids pruritus and cyst were recovered/resolved. It was unknown if the reporter considered the chalazion, eyelid pain, eyelids pruritus and cyst to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient received SHINGRIX on left deltoid. The patient stated that she did not have any discomfort, pain, or swelling, but within days, her left eyelid had soreness and the root of her eyelash started to itch. By 17th May 2018, the patient had a big bump there and she saw her ophthalmologist on the 18th May 2018 and he diagnosed her as having a chalazion cyst and informed her to use hot compresses on it and to return in a week if it did not go away. It did not go away and the patient had to have a procedure where they cut and cleaned out the area. On 8th June 2018, the patient had begun to have the same symptoms in the right eyelid area that resulted in having the same procedure on 5th July 2018. The patient's ophthalmologist recommended that she had to see her internist when her right eye became involved to make sure it was not anything systemic, as the ophthalmologist felt that it was unusual to have the same occurrences in both eyes, in exactly the same place. The ophthalmologist's internist tested the patient and ruled her out for diabetes, staph and cholesterol related issues. On 17th July 2018, the patient was due for her 2nd dose of SHINGRIX, but her pharmacist did not feel comfortable administering it, so she had not received it. The patient stated that, her both eyes were healing, but there are scabs there from the procedures on the reporting date. The patient stated that at first she did not associate her incidences with the vaccine, but began to look at the timeline in addition to ruling out other causes, and thought that they might be indeed associated. The patient had given permission to contact their physician.
Age: 60.0
Sex: F
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 60-year-old female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received SHINGRIX. On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. On 18th July 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. 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 was given the SHINGRIX in her upper arm, a day before the reporting date and noticed pinkish area around the site of the injection about 3 to 8 inches in diameter later that day. On the reporting date, 1 day after vaccination, the patient noticed a 2nd area about 1 to 2 inch below the injection site that was again pinkish but was more like an inch in diameter and very painful. She had a call into her physician's office. A product information (PI) was being sent to the patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Cough, Disturbance in attention, Fatigue, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple allergies and asthma. Concomitant products included FLONASE, SINGULAIR and FLOVENT. On 5th May 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced tinnitus, injection site discoloration, tiredness, attention impaired, cough, nasal congestion, allergy aggravated and runny nose. On an unknown date, the outcome of the tinnitus, tiredness and attention impaired were recovering/resolving and the outcome of the injection site discoloration, cough and nasal congestion were recovered/resolved and the outcome of the allergy aggravated and runny nose were unknown. It was unknown if the reporter considered the tinnitus, injection site discoloration, tiredness, attention impaired, cough, nasal congestion, allergy aggravated and runny nose to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she experienced tinnitus within 24 to 30 hours post vaccination. The patient used to hear loud noises that woke her up in the middle of night and it had decreased over time but she did still hears buzzing in her ears time to time. The patient had allergies and asthma. After receiving the vaccine her allergies were exaggerated since she started coughing a lot of fluid and felt congested. When the patient woke up in the morning as she put her head down, fluid started coming out of her nose, felt tired and her attention was impaired. At the time of reporting, the patient had recovered from her congestion and coughing now but she was still recovering from tiredness and impaired attention. Due to her tinnitus she was referred to see otolaryngology (ENT) specialist by her doctor on 6th June 2018. The patient had a blue and black mark at the injection site which lasted for total of 10 days. The patient had denied permission to contact their physician and her regular physician was on vacation. The patient would follow up with her physician. No further details were provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Nasal congestion, Rhinorrhoea, Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple allergies and asthma. Concomitant products included FLONASE, SINGULAIR and FLOVENT. On 5th May 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced tinnitus, injection site discoloration, tiredness, attention impaired, cough, nasal congestion, allergy aggravated and runny nose. On an unknown date, the outcome of the tinnitus, tiredness and attention impaired were recovering/resolving and the outcome of the injection site discoloration, cough and nasal congestion were recovered/resolved and the outcome of the allergy aggravated and runny nose were unknown. It was unknown if the reporter considered the tinnitus, injection site discoloration, tiredness, attention impaired, cough, nasal congestion, allergy aggravated and runny nose to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she experienced tinnitus within 24 to 30 hours post vaccination. The patient used to hear loud noises that woke her up in the middle of night and it had decreased over time but she did still hears buzzing in her ears time to time. The patient had allergies and asthma. After receiving the vaccine her allergies were exaggerated since she started coughing a lot of fluid and felt congested. When the patient woke up in the morning as she put her head down, fluid started coming out of her nose, felt tired and her attention was impaired. At the time of reporting, the patient had recovered from her congestion and coughing now but she was still recovering from tiredness and impaired attention. Due to her tinnitus she was referred to see otolaryngology (ENT) specialist by her doctor on 6th June 2018. The patient had a blue and black mark at the injection site which lasted for total of 10 days. The patient had denied permission to contact their physician and her regular physician was on vacation. The patient would follow up with her physician. No further details were provided.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nasal irritation in a 78-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included nasal operation (a few weeks before receiving the SHINGRIX). On 27th June 2018, the patient received SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced nasal irritation. On an unknown date, the outcome of the nasal irritation was not recovered/not resolved. The reporter considered the nasal irritation to be possibly related to SHINGRIX. Additional details were provided as follows: The patient complained of irritation on the bridge of their nose about 1 week later receiving vaccination. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, muscle pain, chills, pain and bedridden. On an unknown date, the outcome of the fever, muscle pain, chills, pain and bedridden were unknown. It was unknown if the reporter considered the fever, muscle pain, chills, pain and bedridden to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced fever, chills, pain, muscle ache, and she was in bed for over 24 hours after SHINGRIX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced headache, stomach discomfort, chills and feeling bad. On an unknown date, the outcome of the headache, stomach discomfort, chills and feeling bad were recovered/resolved. It was unknown if the reporter considered the headache, stomach discomfort, chills and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The following day after vaccination, the patient experienced a horrible headache chills and was sick to her stomach. The patient said that the first full day of having the symptoms, she had to lay down. She did not know how she made it to work because it was bad. The patient was afraid of getting the second dose of SHINGRIX. The symptoms lasted a couple of days. The patient had denied permission to contact their physician.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypotension, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 17th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, fever, fatigue, injection site erythema and malaise. On 18th July 2018, the patient experienced low blood pressure. On an unknown date, the outcome of the injection site warmth, injection site pain, fever, fatigue, injection site erythema and malaise were recovering/resolving and the outcome of the low blood pressure was recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site pain, low blood pressure, fever, fatigue, injection site erythema and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The pharmacist stated the patient called and said that the injection site was red, warm and sore. The patient was also experiencing malaise, fatigue and fever. The day after getting the vaccine she had low blood pressure, which resolved. The patient was recovering at the time of reporting.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 17th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, fever, fatigue, injection site erythema and malaise. On 18th July 2018, the patient experienced low blood pressure. On an unknown date, the outcome of the injection site warmth, injection site pain, fever, fatigue, injection site erythema and malaise were recovering/resolving and the outcome of the low blood pressure was recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site pain, low blood pressure, fever, fatigue, injection site erythema and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The pharmacist stated the patient called and said that the injection site was red, warm and sore. The patient was also experiencing malaise, fatigue and fever. The day after getting the vaccine she had low blood pressure, which resolved. The patient was recovering at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Viral infection
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, muscle pain, fatigue and viral infection. On an unknown date, the outcome of the injection site pain, injection site erythema, muscle pain, fatigue and viral infection were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, muscle pain and fatigue to be related to SHINGRIX. The reporter considered the viral infection to be unrelated to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient presented local redness pain at site, common, severe muscle aches and fatigue lasted for weeks then got viral bug that felt unrelated but they were having a hard time determining if should give second dose of SHINGRIX vaccine. The side effects, lasted for 2 to 3 weeks.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX. On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and feeling of warmth. On an unknown date, the outcome of the influenza-like symptoms, general body pain and feeling of warmth were unknown. The reporter considered the influenza-like symptoms, general body pain and feeling of warmth to be probably related to SHINGRIX. Additional details were reported as follows: The reporter was sister of the patient who provided this information. The patient experienced flu like symptoms, body aches and warm all over. The health care professional did not consider the events to be life threatening. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. Health care professional did not consider the event(s) to result in persistent or significant disability/incapacity. The patient did not experience fatal adverse event and the patient had no congenital anomaly or birth defect. The patient did not require surgical or medical intervention to prevent one of the outcomes described in preceding questions. She was willing to take a call to follow-up on the resolution or any other details needed. Her cell phone was included.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 49-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Previously administered products included SHINGRIX (On an unknown date received 1st dose). On 16th July 2018, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were not recovered/not resolved. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced fever and vomiting. This has not yet resolved. This was a follow up to previously reported adverse event.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old male patient who received SHINGRIX (batch number 7N227 ?, expiry date 21st February 2021) for prophylaxis. On 9th July 2018, the patient received the 2nd dose of SHINGRIX. On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced flu like symptoms after the 2nd dose of SHINGRIX. No symptoms were reported for 1st dose of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of welts in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 23rd March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th March 2018, 1 days after receiving SHINGRIX, the patient experienced welts. The patient was treated with TYLENOL. On an unknown date, the outcome of the welts was recovering/resolving. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The patients received their SHINGRIX vaccine in the office. On 24th March 2018, the patient woke up on with welts on his back and the back of his right leg. On 25th March 2018, the welts were almost gone. The patient was scheduled to receive his 2nd dose on 3rd July 2018 but the office cancelled until they found out if the reaction was due to the vaccine. Agency was contacted. The office felt comfortable giving the patient his 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX  (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache. On an unknown date, the outcome of the pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache were recovered/resolved. The reporter considered the pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The patient's age was over 70 years. The patient received immunization at a local retail pharmacy. The patient had a lot of arm swelling and pain. Other symptoms were everything referencing safety profile in SHINGRIX Visual Aid except for shivering, fever and gastrointestinal issue. Symptoms lasted for 2 weeks. The reporter did not agree to follow up from GlaxoSmithKline. The healthcare professional strongly encouraged patient to get 2nd dose of SHINGRIX even in light of experienced side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX  (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache. On an unknown date, the outcome of the pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache were recovered/resolved. The reporter considered the pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The patient's age was over 70 years. The patient received immunization at a local retail pharmacy. The patient had a lot of arm swelling and pain. Other symptoms were everything referencing safety profile in SHINGRIX Visual Aid except for shivering, fever and gastrointestinal issue. Symptoms lasted for 2 weeks. The reporter did not agree to follow up from GlaxoSmithKline. The healthcare professional strongly encouraged patient to get 2nd dose of SHINGRIX even in light of experienced side effects.
Sex: M
Vaccine: FLUX
Symptoms: Narcolepsy
Clinical narrative: Initial information received from a physician. This case involves a male patient (reported as vaccinated at 7-8 years) who experienced narcolepsy, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s) and vaccination(s) were not provided. Family history includes both parents carry the narcolepsy gene. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious narcolepsy (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that both parents carry the narcolepsy gene so the patient would have developed narcolepsy at some point anyway. The patient was 7 or 8 years old when he got the vaccine and the parents state he developed narcolepsy soon afterwards. The physician states that because of this, they are now refusing other vaccines for their son (patient). (Other relevant tests included No lab data.) Final diagnosis was narcolepsy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for narcolepsy. List of documents held by sender: none. Sender's Comments: This case involves a child who presented with narcolepsy post vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, medical condition at the time of vaccination, laboratory investigations excluding other etiology would be needed to fully assess this case. Moreover, reporting physician states that both parents carry the narcolepsy gene so the patient would have developed narcolepsy at some point anyway. Based on available information the role of vaccine cannot be assessed.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle aches, fever (101.1), shivering and fatigue lasting about 24 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Very red, warm, and swollen 4 inch area around the site of injection - has been putting ice on area and moving arm around; recommended that patient continue doing what she is doing and that this has been a common reaction to the second dose of SHINGRIX. Advised her that if it became unbearable, to either call us or go to urgent care for further treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LOCALIZED REDNESS AND SWELLING AT INJECTION SITE OF KINRIX ON RA THAT BEGAN WITHIN 24HR OF VACCINE AND LASTED 2-3 DAYS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Severe inflammation, redness, pain at injection site. Increasing in size over 24 hours after injection. Patient called Doctor's office where injection was given. Primary Care Doctor prescribed prednisone, though the swelling had become severe so patient was advised to go to Urgent care where it was diagnosed that she had cellulitis and given antibiotic. It was verified with patient and staff that injection site was cleaned twice with alcohol wipes.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, warmth, and swelling at and surrounding the injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Patient reports 3" red circle. Hot and hard.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Oropharyngeal pain, Pain
Clinical narrative: Patient stated that he started to have dull headache, body ache and general discomfort on Tuesday after vaccination on Monday, and symptoms improved over 3 days. Then on Thursday he started experiencing mild sore throad. Patient was able to ean and drink normally. Patient checked body temperature and stated no fever.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Syncope, Vomiting
Clinical narrative: Patient received vaccines and was instructed to remain seated for 15 minutes after administration. Approx. 3 minutes after vaccines were given, patient became very pale and faint, followed by vomiting. A cool compress was placed on her neck and she was laid flat. Dr. was notified and she checked her immediately after this episode began. Patient remained lying flat for approx. 20 minutes and then was given a Coke to sip on. She was able to leave the office without difficulty.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Approximately 12 hours following administration pt noted fever- (not eval. by thermometer), and tenderness to site. Self-medicated with TYLENOL- 1/2tab. Awoke 4:30 am with fever "broken", sweaty. Noted redness to injection site of 3"x2". 3:00p - No further fever, or lethargy, redness remains but is resolving.
Age: 0.83
Sex: M
Vaccine: HIBV
Symptoms: Seizure, Urticaria
Clinical narrative: My son had a severe seizure in the parking lot of the doctors office. He broke out in hives on his body raised all over. He was seen by the doctor and we were told it wasnt an allergic reaction just a normal reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling around the injection site in the a.m., by noon, having some chills, fever of 99.9, headache and some body aches. Took two acetaminophen this morning, some better now (3 pm).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness and swelling around the injection site in the a.m., by noon, having some chills, fever of 99.9, headache and some body aches. Took two acetaminophen this morning, some better now (3 pm).
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Cough, Ear pain, Fatigue
Clinical narrative: Low grade fever, headache, sore throat, tired, weak, insomnia, stomachache, nausea, vomiting, cough, sinus congestion, earache, hives.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Insomnia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Low grade fever, headache, sore throat, tired, weak, insomnia, stomachache, nausea, vomiting, cough, sinus congestion, earache, hives.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Sinus congestion, Streptococcus test negative, Urticaria, Viral test, Vomiting
Clinical narrative: Low grade fever, headache, sore throat, tired, weak, insomnia, stomachache, nausea, vomiting, cough, sinus congestion, earache, hives.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Neck pain, Rash generalised
Clinical narrative: Rash over entire body, head and neck pain and was seen by dr on 7/25/18 and given steroid injection and prescribed Prednisone orally.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Appetite disorder, Crying, Diet refusal, Eye swelling, Immediate post-injection reaction
Clinical narrative: As a first time mother, I should have been thoroughly explained each and every vaccination my two month old son was going to receive. However, I was not, and only given a white sheet with bare minimal information to read over on my own with no assistance from the medical professionals. My son was administered numerous vaccinations without me signing any type of paper work or receiving explanations on what type of adverse reactions to look for afterwards. Immediately after the vaccinations being administered my son cried and screamed of distress for almost 2 hours straight. After finally settling him down he refused to eat and he went into a deep sleep. After a 6 hour nap, I forced my son to wake up and his entire face and eyes were swollen immensely and had hives. He still would not eat (had been almost 9 hours since his last feeding). I immediately took my son to the emergency room where we stayed and were closely observed for hours and administered TYLENOL as his fever came down. He slept until we left the hospital, and were discharged with swelling and hives still present. After getting home, he still refused to eat and I administered more TYLENOL and he stayed asleep. He was not sleeping as he normally does, but rather a very deep sleep. He woke up at approximately 8 AM, and was still not interested in eating a bottle. I forced him to eat 2 oz as it had almost been 20 hours since his last feeding. He immediately projectile vomited all over himself, me, our clothes, and bed. I bathed him, he passed a large bowel movement, and he began to feel a tiny bit better. I got him into a new pediatrician and his hives and swelling were still noticeable. This pediatrician believes that he had a severe allergic reaction to vaccinations. However, he still has swelling and trouble with appetite and sleepiness over 24 hours later.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Screaming, Somnolence, Swelling face, Urticaria, Vomiting projectile
Clinical narrative: As a first time mother, I should have been thoroughly explained each and every vaccination my two month old son was going to receive. However, I was not, and only given a white sheet with bare minimal information to read over on my own with no assistance from the medical professionals. My son was administered numerous vaccinations without me signing any type of paper work or receiving explanations on what type of adverse reactions to look for afterwards. Immediately after the vaccinations being administered my son cried and screamed of distress for almost 2 hours straight. After finally settling him down he refused to eat and he went into a deep sleep. After a 6 hour nap, I forced my son to wake up and his entire face and eyes were swollen immensely and had hives. He still would not eat (had been almost 9 hours since his last feeding). I immediately took my son to the emergency room where we stayed and were closely observed for hours and administered TYLENOL as his fever came down. He slept until we left the hospital, and were discharged with swelling and hives still present. After getting home, he still refused to eat and I administered more TYLENOL and he stayed asleep. He was not sleeping as he normally does, but rather a very deep sleep. He woke up at approximately 8 AM, and was still not interested in eating a bottle. I forced him to eat 2 oz as it had almost been 20 hours since his last feeding. He immediately projectile vomited all over himself, me, our clothes, and bed. I bathed him, he passed a large bowel movement, and he began to feel a tiny bit better. I got him into a new pediatrician and his hives and swelling were still noticeable. This pediatrician believes that he had a severe allergic reaction to vaccinations. However, he still has swelling and trouble with appetite and sleepiness over 24 hours later.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Lip swelling, Myalgia, Urticaria
Clinical narrative: Mild muscle aches. Urticaria, mostly to face. Swollen lips
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Electroencephalogram normal, Laboratory test normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient describes developing sensation of shortness of breath the night prior to adverse event. On the next morning he woke, again with sensation of shortness of breath. At 11:30 AM he developed a seizure. He was taken to the hospital where he had another seizure while in ER. He was hospitalized and had multiple tests including MRI, EEG, Lumbar puncture, and lab test that failed to reveal any abnormality. As of today, patient has recovered, still in the hospital and will be discharged soon. Information provided by patient through a telephone call.