chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: nausea; sweat; body ache; Chest pain/ 3 episodes of Chest pain in 24 hrs; Chills; Localized Swelling; dizziness; This case was reported by a physician via call center representative and described the occurrence of local swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced local swelling, dizziness, nausea, sweating, general body pain, chest pain and chills. On an unknown date, the outcome of the local swelling, dizziness, nausea, sweating, general body pain and chest pain were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the local swelling, dizziness, nausea, sweating, general body pain, chest pain and chills to be related to Shingrix.  Additional details were reported as follows: The physician reported that patient presented localized swelling, 4 days of dizziness, nausea , sweat and chills, body ache, 3 episodes of chest pain in 24 hours after the first dose of Shingrix. The reporter consented to follow up. This case is linked with case US2020222218, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222218:(Deleted- No GSK product)
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: blisters / blisters are "bigger and leaking pus."; blisters / blisters are "bigger and leaking pus."; pain; rash; Shingles; numbness or tingling in his left arm; numbness or tingling in his left arm / tingling spread to his chest and arm pit; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received Shingrix (intramuscular). On 4th November 2020, 2 days after receiving Shingrix, the patient experienced shingles, numbness and tingling. On 5th November 2020, the patient experienced rash. On 6th November 2020, the patient experienced pain. On 7th November 2020, the patient experienced blister. On 9th November 2020, the patient experienced abscess. On an unknown date, the outcome of the shingles, numbness, tingling and rash were not recovered/not resolved and the outcome of the pain, blister and abscess were unknown.   It was unknown if the reporter considered the shingles, numbness, tingling, rash, pain, blister and abscess to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself and his partner The patient received Shingrix in the left arm. Two days later, he stated that he felt a numbness or tingling in his left arm.  Three days later, the tingling spread to his chest and arm pit and developed into a rash.  He stated he developed rash and blisters 7th November 2020. On 9th November 2020, 7 days later the blisters were bigger and leaking pus. The patient stated this was shingles and his partner was going to the medical doctor for evaluation. The patient went to a dermatologist on 9th November 2020 and was diagnosed with shingles which still exists. The reporter consented to follow up. There was discrepancy in the reported event onset dates by different reporters. The patient reported latency of 2 days for numbness and tingling, 3 days for rash. However, the patient's partner reported latency of 4 days for numbness, and tingling (onset date 6th November 2020) and 5 days for rash (onset date 7th November 2020).
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: blisters / blisters are "bigger and leaking pus."; blisters / blisters are "bigger and leaking pus."; pain; rash; Shingles; numbness or tingling in his left arm; numbness or tingling in his left arm / tingling spread to his chest and arm pit; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received Shingrix (intramuscular). On 4th November 2020, 2 days after receiving Shingrix, the patient experienced shingles, numbness and tingling. On 5th November 2020, the patient experienced rash. On 6th November 2020, the patient experienced pain. On 7th November 2020, the patient experienced blister. On 9th November 2020, the patient experienced abscess. On an unknown date, the outcome of the shingles, numbness, tingling and rash were not recovered/not resolved and the outcome of the pain, blister and abscess were unknown.   It was unknown if the reporter considered the shingles, numbness, tingling, rash, pain, blister and abscess to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself and his partner The patient received Shingrix in the left arm. Two days later, he stated that he felt a numbness or tingling in his left arm.  Three days later, the tingling spread to his chest and arm pit and developed into a rash.  He stated he developed rash and blisters 7th November 2020. On 9th November 2020, 7 days later the blisters were bigger and leaking pus. The patient stated this was shingles and his partner was going to the medical doctor for evaluation. The patient went to a dermatologist on 9th November 2020 and was diagnosed with shingles which still exists. The reporter consented to follow up. There was discrepancy in the reported event onset dates by different reporters. The patient reported latency of 2 days for numbness and tingling, 3 days for rash. However, the patient's partner reported latency of 4 days for numbness, and tingling (onset date 6th November 2020) and 5 days for rash (onset date 7th November 2020).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Each time was after getting a flu shot; Initial information was received on 24-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient with unknown demography who each time experienced flu was after getting INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  There will be no information on the batch number for this case.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Syringe issue, Underdose
Clinical narrative: A pregnant patient was administered with FLUZONE QUADRIVALENT 0.5 mL prefilled syringe and some of it leaked out where the needle was connecting to the syringe with no AE; some of it leaked out where the needle was connecting to the syringe. They are unable to determine how much vaccine that the patient has received with no AE; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 32 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 0.5 ml prefilled syringe and some of it leaked out where the needle was connecting to the syringe and they are unable to determine how much vaccine that the   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  They are unable to determine how much vaccine that the patient has received with no AE occurred at 35 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 35 weeks of pregnancy, during third pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 08-Feb-2020.  The estimated due date is 07-Dec-2020.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On 12-Oct-2020, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [lot UT7058JA and expiration date via intramuscular route in the left deltoid for prophylactic vaccination.  On same day, some of it leaked out where the needle was connecting to the syringe (Device connection issue) they are unable to determine how much vaccine that the patient has received (Underdose) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No adverse event was reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Not Applicable for both events.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Cold sweat, Dizziness, Electrocardiogram, Eye movement disorder
Clinical narrative: Shortly after receiving the vaccine, the patient became lightheaded, dizzy, pale, clammy, and diaphoretic.  Patient was laying on exam table and  patient's eyes rolled into the back of his head, became unconscious for about 30 seconds, foam noted from mouth. EMS was activated. Pt alert upon transport to ER. When EMS arrived and patient moved to gurney, he vomited a small amount of clear fluid twice. He was evaluated in the ER and diagnosed with Vasovagal Syncope.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Foaming at mouth, Full blood count, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Shortly after receiving the vaccine, the patient became lightheaded, dizzy, pale, clammy, and diaphoretic.  Patient was laying on exam table and  patient's eyes rolled into the back of his head, became unconscious for about 30 seconds, foam noted from mouth. EMS was activated. Pt alert upon transport to ER. When EMS arrived and patient moved to gurney, he vomited a small amount of clear fluid twice. He was evaluated in the ER and diagnosed with Vasovagal Syncope.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope, Troponin, Vomiting
Clinical narrative: Shortly after receiving the vaccine, the patient became lightheaded, dizzy, pale, clammy, and diaphoretic.  Patient was laying on exam table and  patient's eyes rolled into the back of his head, became unconscious for about 30 seconds, foam noted from mouth. EMS was activated. Pt alert upon transport to ER. When EMS arrived and patient moved to gurney, he vomited a small amount of clear fluid twice. He was evaluated in the ER and diagnosed with Vasovagal Syncope.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vertigo, Vision blurred, Visual impairment
Clinical narrative: Patient woke up and had visual trouble. It was hard to focus. I sat up and was very dizzy. I had to walk slowly due to extreme vertigo. I had trouble walking down stairs. The vertigo was severe and lasted approximately 5 hrs. It has since resolved. The visual disturbances are also resolved. I have been receiving the Flu vaccine for over 20 years and I have never had a reaction. I am attributing the incident of vertigo and visual disturbances the morning after the vaccine to a reaction. I have no other symptoms. I didn't f/up with a Dr since the sxs have resolved. It was a scary reaction. I am a RN and thought that I should notify VAERS of the incident. Please feel free to contact me for any additional information.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Described the beginning of a red dot about size of a dime with painful to the touch beginning on 11/15/20 and reported to us on the 16th. Spoke with patient again on 11/17/20 doing better regarding pain in the area but with some redness still in area of injection. Patient will call if any further problems occur.
Age: 38.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Mobility decreased, Sleep disorder
Clinical narrative: I had a very active day Friday 10/23 after receiving the shot and didn?t feel any adverse effects. By the night time my right arm began to become very achy. I later woke up in the middle of the night with much deeper arm pain. By morning I could no longer lift my arm or use my arm/hand. This continued until I woke up on Monday morning 10/26. The entire weekend I had to hold my arm against my body while walk or moving in order to stay comfortable and the pain was so intense and deep that I got very little sleep. By Monday 10/26 I was able to move and lift my arm again and the pain gradually subsided. I get a flu shot every winter and I?ve experienced arm muscle pain following the shot each time but nothing like this has ever happened to me. I was completely incapable of moving my entire arm for 2 1/2 days.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Body aches and other flu-like symptoms that were quite severe.  Slight headache Symptoms started within 4 hours of vaccination.  This is second day since the shot.  Still have symptoms but they are not as severe.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Altered state of consciousness, Chills, Delirium, Dysgeusia, Feeding disorder
Clinical narrative: after vax, same day, had very odd chemical taste in mouth while driving home. Call clinic to report her symptoms. About 5 hours later, extreme chills, shuttering and shaking. Had on a lot of clothes to keep from being so cold. Had aching in all muscles in body. Hands wouldn't move in middle of the night Became delirium and did not feel conscious, had more of an onset of a fever last night 11.18.20.  Was nauseous and couldn't eat. Had very bad headache, couldn't get up to use bathroom. Lasted 36-48 hours. When had first shingrix dose on 08.23.20 , it produced increased heart rate. Second dose, was not bad with heart rate.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling cold, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: after vax, same day, had very odd chemical taste in mouth while driving home. Call clinic to report her symptoms. About 5 hours later, extreme chills, shuttering and shaking. Had on a lot of clothes to keep from being so cold. Had aching in all muscles in body. Hands wouldn't move in middle of the night Became delirium and did not feel conscious, had more of an onset of a fever last night 11.18.20.  Was nauseous and couldn't eat. Had very bad headache, couldn't get up to use bathroom. Lasted 36-48 hours. When had first shingrix dose on 08.23.20 , it produced increased heart rate. Second dose, was not bad with heart rate.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: after vax, same day, had very odd chemical taste in mouth while driving home. Call clinic to report her symptoms. About 5 hours later, extreme chills, shuttering and shaking. Had on a lot of clothes to keep from being so cold. Had aching in all muscles in body. Hands wouldn't move in middle of the night Became delirium and did not feel conscious, had more of an onset of a fever last night 11.18.20.  Was nauseous and couldn't eat. Had very bad headache, couldn't get up to use bathroom. Lasted 36-48 hours. When had first shingrix dose on 08.23.20 , it produced increased heart rate. Second dose, was not bad with heart rate.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Altered state of consciousness, Delirium, Fine motor skill dysfunction, Gait disturbance, Headache
Clinical narrative: after vax, same day, had very odd chemical taste in mouth while driving home. Call clinic to report her symptoms. About 5 hours later, extreme chills, shuttering and shaking. Had on a lot of clothes to keep from being so cold. Had aching in all muscles in body. Hands wouldn't move in middle of the night Became delirium and did not feel conscious, had more of an onset of a fever last night 11.18.20.  Was nauseous and couldn't eat. Had very bad headache, couldn't get up to use bathroom. Lasted 36-48 hours. When had first shingrix dose on 08.23.20 , it produced increased heart rate. Second dose, was not bad with heart rate.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hyperhidrosis, Hypokinesia, Loss of personal independence in daily activities, Muscular weakness, Myalgia
Clinical narrative: after vax, same day, had very odd chemical taste in mouth while driving home. Call clinic to report her symptoms. About 5 hours later, extreme chills, shuttering and shaking. Had on a lot of clothes to keep from being so cold. Had aching in all muscles in body. Hands wouldn't move in middle of the night Became delirium and did not feel conscious, had more of an onset of a fever last night 11.18.20.  Was nauseous and couldn't eat. Had very bad headache, couldn't get up to use bathroom. Lasted 36-48 hours. When had first shingrix dose on 08.23.20 , it produced increased heart rate. Second dose, was not bad with heart rate.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia, Tremor
Clinical narrative: after vax, same day, had very odd chemical taste in mouth while driving home. Call clinic to report her symptoms. About 5 hours later, extreme chills, shuttering and shaking. Had on a lot of clothes to keep from being so cold. Had aching in all muscles in body. Hands wouldn't move in middle of the night Became delirium and did not feel conscious, had more of an onset of a fever last night 11.18.20.  Was nauseous and couldn't eat. Had very bad headache, couldn't get up to use bathroom. Lasted 36-48 hours. When had first shingrix dose on 08.23.20 , it produced increased heart rate. Second dose, was not bad with heart rate.
Age: 0.17
Sex: U
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix at months 2 and 4 while under his care; Kinrix at months 2 and 4 while under his care; Kinrix at months 2 and 4 while under his care; was unwell; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and malaise. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and malaise were unknown.   It was unknown if the reporter considered the malaise to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Kinrix at months 2 and 4 while under his care (nurse administered doses), but then left the practice.  The reporter was not at all forthcoming with patient information, but stated that the patient's father was threatening to sue the practice and alluded to the fact that the patient was unwell.  He did not share how long ago the patient received Kinrix.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Skin exfoliation
Clinical narrative: Scalp is very itchy; Broken out in big whelps of flaky skin; whelps skin; This case was reported by a consumer via interactive digital media and described the occurrence of itchy scalp in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy scalp, flaking scalp and welts. On an unknown date, the outcome of the itchy scalp, flaking scalp and welts were unknown.   It was unknown if the reporter considered the itchy scalp, flaking scalp and welts to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient itself. The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient's scalp was very itchy and has broken out in big whelps of flaky skin. The patient asked question, could this be from the injection.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Significant arm pain upon first dose; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in right arm. The patient experienced significant arm pain upon 1st dose. The reporter did believe pain was related Shingrix administration. For tolerance to 2nd dose, refer linked case US2020AMR226401, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR226401:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Condition aggravated
Clinical narrative: CHF symptoms worsened; This case was reported by a nurse via sales rep and described the occurrence of congestive cardiac failure aggravated in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included congestive heart failure.   On 16th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced congestive cardiac failure aggravated (serious criteria GSK medically significant). On an unknown date, the outcome of the congestive cardiac failure aggravated was unknown.   It was unknown if the reporter considered the congestive cardiac failure aggravated to be related to Shingrix.  Additional details were provided as follows: Congestive heart failure symptoms worsened after 1st dose and was reported 4th November to Doctor.  If symptoms were related to vaccine was unknown and they did not know if symptoms resolved.  2nd dose had not been administered. Consent to follow up granted.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Flu shot and still got the flu / Suspected vaccination failure; Got the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the flu shot and still got the flu. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: We are all Dtaped. Aka vaccinated/Suspected vaccination failure; Think i have whopping cough; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (DTaP vaccine) for prophylaxis.  On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient thought he or she had whopping cough right now.  The patient stated he or she got whopping cough from his/her son who was in daycare. He whooped last night. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming whopping cough were not provided. No further information was provided. This case linked with US2020AMR227460, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR227460:son's case
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Hyperhidrosis, Injection site pain
Clinical narrative: Bright red rash on her torso; patch; chills; sweating; nausea; fever; Pain in her joints / pain which radiated up to her neck and down her shoulder; pain; pain in her joints, back; pain in her joints, back, feet and hands; pain which radiated up to her neck; intense pain around the injection site; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included FLU VACCINE with an associated reaction of fatigue (Annual flu shots,case US2020AMR224679) and Zostavax.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, less than a day after receiving Shingrix, the patient experienced pain. On 7th November 2020, the patient experienced chills, sweating, nausea, fever and joint pain. On 8th November 2020, the patient experienced red rash and patchy rash. In November 2020, the patient experienced back pain, foot pain, neck pain and injection site pain. On an unknown date, the outcome of the red rash was not recovered/not resolved and the outcome of the chills, sweating, nausea, fever, joint pain and pain were recovered/resolved and the outcome of the back pain, foot pain, neck pain, injection site pain and patchy rash were unknown.   The reporter considered the red rash, chills, sweating, nausea, fever, joint pain, pain, back pain, foot pain, neck pain, injection site pain and patchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the 1st dose of Shingrix.  Late that night she experienced intense pain around the injection site. She woke up in the middle of the night due to the pain which radiated up to her neck and down her shoulder. She also had pain in her joints, back, feet and hands. She woke up with nausea, sweating and chills. By yesterday she felt fine except she had a bright red rash on her torso which she said isn't unusual for her. The patches were about four in in diameter. The areas were not raised. They were worse this morning but she says they will go away based on her history. During the call she mentioned she gets the flu shot and experiences some tiredness afterwards but she could not provide any additional information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222199:same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Bright red rash on her torso; patch; chills; sweating; nausea; fever; Pain in her joints / pain which radiated up to her neck and down her shoulder; pain; pain in her joints, back; pain in her joints, back, feet and hands; pain which radiated up to her neck; intense pain around the injection site; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included FLU VACCINE with an associated reaction of fatigue (Annual flu shots,case US2020AMR224679) and Zostavax.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, less than a day after receiving Shingrix, the patient experienced pain. On 7th November 2020, the patient experienced chills, sweating, nausea, fever and joint pain. On 8th November 2020, the patient experienced red rash and patchy rash. In November 2020, the patient experienced back pain, foot pain, neck pain and injection site pain. On an unknown date, the outcome of the red rash was not recovered/not resolved and the outcome of the chills, sweating, nausea, fever, joint pain and pain were recovered/resolved and the outcome of the back pain, foot pain, neck pain, injection site pain and patchy rash were unknown.   The reporter considered the red rash, chills, sweating, nausea, fever, joint pain, pain, back pain, foot pain, neck pain, injection site pain and patchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the 1st dose of Shingrix.  Late that night she experienced intense pain around the injection site. She woke up in the middle of the night due to the pain which radiated up to her neck and down her shoulder. She also had pain in her joints, back, feet and hands. She woke up with nausea, sweating and chills. By yesterday she felt fine except she had a bright red rash on her torso which she said isn't unusual for her. The patches were about four in in diameter. The areas were not raised. They were worse this morning but she says they will go away based on her history. During the call she mentioned she gets the flu shot and experiences some tiredness afterwards but she could not provide any additional information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222199:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Herpes zoster, Pain, Scab, Swelling
Clinical narrative: Now has a large scab; Biopsy showed it to be a herpetic infection /  Confirmed to be herpes zoster (shingles; Bump below her left eyebrow / which grew upto a the size of a nickel; She was in lot of pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix. On 19th October 2020, 3 days after receiving Shingrix, the patient experienced shingles, local swelling and pain. On an unknown date, the patient experienced scab. The patient was treated with valaciclovir hydrochloride (Valacyclovir), doxycycline and ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the shingles and pain were unknown and the outcome of the local swelling was recovered/resolved and the outcome of the scab was not recovered/not resolved.   It was unknown if the reporter considered the shingles, local swelling, pain and scab to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and by 19th October 2020 she noticed a bump below her left eyebrow, on the left side of the bridge of the nose, a bump which grew up to a the size of a nickel. The patient was in lot of pain. The patient saw at least 3 dermatologist and was at the HCP office at least 6 times. Initially she was treated with doxycycline and then was given a local cortisone cream. The third dermatology took a biopsy and suggested on 31st October 2020 that the biopsy showed it to be a herpetic infection, and on 6th November 2020 it was confirmed to be herpes zoster (shingles) and was given valcyclovir orally. The bump had healed and the patient now had a large scab.  The patient stated she had to get stitches after the biopsy was done. The patient stated prior to this incident she has never had shingles before. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: redness and a rash around the trunk area.; rash around the trunk area; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 2nd April 2022) for prophylaxis.   On 6th November 2020, the patient received Shingrix (intramuscular). On 7th November 2020, 1 days after receiving Shingrix, the patient experienced erythema and rash. On an unknown date, the outcome of the erythema and rash were recovering/resolving.   It was unknown if the reporter considered the erythema and rash to be related to Shingrix.  Aditional details were provided as follows: The reporter stated that after Shingrix vacciaton, the patient had redness and a rash around the trunk area. The reporter stated redness and a rash around the trunk area were still ongoing currently but had gotten better. The reporter did not consent to follow up. This was 1 of 2 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020183487:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Atypical pneumonia, Bronchitis, Influenza
Clinical narrative: got the flu; Walking pneumonia; bronchitis; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.   This case is linked to cases 2020SA293945 and 2020SA293954. (same reporter)    This case involves a male patient (age unspecified) who got the flu (influenza) then came down with bronchitis (bronchitis) and walking pneumonia (atypical pneumonia), while he received INFLUENZA VACCINE [flu shot].  Ongoing medical condition included type 1 diabetic.  Past medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date (two years ago), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) then came down with bronchitis (bronchitis) and walking pneumonia (atypical pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for all reported events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.   This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310708, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old that was given Pentacel with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00296932) was received from a nurse and transmitted to Sanofi 01-Oct-2020.  This case involved a 17 year old male patient who was vaccinated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot not reported expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was reported that a patient, age 17 years, had never had vaccines and the doctor thought it would be okay to give the patient DTap along with PENTACEL AND IPOL. The reporter stated that she was not sure if the patient should have received ADACEL.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, patient had not experienced any adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cervical spinal stenosis, Hypoaesthesia, Intervertebral disc operation, Paraesthesia
Clinical narrative: cervical stenosis; numbness; tingling; Initial information regarding an unsolicited valid serious case received from a nurse via Information (Reference number- 00346068) and transmitted to Sanofi on 04-Nov-2020.  This case involves an elder female patient (age at onset was not reported) who had cervical stenosis (cervical spinal stenosis) with numbness (hypoaesthesia) and tingling (paraesthesia), after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].   The patient had received Flu shot (unspecified) on an unknown date in 2015 from pharmacy also, she had vaccinated with Fluzone High-Dose (with lot number 165703 and expiration date 01-Apr-2017) on 30-Sep-2016 and another dose of same vaccine on 02-Oct-2017 (with lot number UI884AB and expiration date was not reported) in the past for prophylactic vaccination.  The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.   On 07-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (prefilled syringe, lot UJ043AB and expiration date 22-May-2019) via an unknown route at an unknown administration site for prophylactic vaccination.  No information regarding flu vaccination in 2019 reported.  On an unknown date, the patient developed serious cervical stenosis (cervical spinal stenosis) with numbness (hypoaesthesia) and tingling (paraesthesia), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  After diagnosis, the patient had surgery on her cervical vertebrae C4 and C5 and was admitted to rehab after this surgery on 26-Sep-2020.  Details of laboratory data were not reported.  Final diagnosis was cervical spinal stenosis.   It was not reported if any other corrective treatment was received by the patient.  The patient was discharged on 06-Oct-2020 from the rehab facility.  At the time of reporting, the outcome of the events were not reported.; Sender's Comments: This case concerns an elder patient who had cervical spinal stenosis, after vaccination with FLUZONE HIGH DOSE. The time to onset is not unknown.  Also, patient had previous vaccination with same vaccines and no adverse events were reported to them at the time of reporting. The patient's medical condition at the time of vaccination, concomitant therapy and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Inflammation
Clinical narrative: 5 x4 cm raised erythematous induration on left lateral thigh
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Pain in extremity
Clinical narrative: Red rash around site of injection, approximately size of my arm covered was 2" x 3" in size.  I did not notice it on the first day after injection, but on the second morning, I saw the rash on my arm.  Extremely red, slightly raised bumps, warm to the touch.  (I have pictures of my arm).   It is still visible today (3rd day after injection) but the redness has decreased and the area covered has also decreased.  The area is still slightly itchy and sensitive to the touch. This rash is in addition to having extreme fatigue, sore arm, pain when raising arm - which lasted about 24 hrs and now is gone.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Patient  experience extreme pain in the left arm of the injection site for a week and  pain in the top of head immediately after injection was completed.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperaemia, Influenza, Lymphadenopathy, Nodule, Ultrasound scan abnormal
Clinical narrative: I felt a hard nodule in my left clavicle on Saturday 14 Nov 2020 and when I looked in the mirror there was a pillowy lump above the area.   I went to a Clinic where the Dr. told me that the pillowy lump may be normal.  It is not.  Initially, she also claimed she could not feel the nodule until I insisted.  They did an X-ray there and said there was some deterioration of the left clavicle.     On Monday, 16 Nov 2020 I saw a Dr. filling in for my regular PCP.  She ordered an ultrasound and the results are:   Ultrasound soft tissue head and neck  CLINICAL INDICATION: Left supraclavicular lump.  Real-time ultrasound evaluation of the left side of the neck was performed in the supraclavicular region in the region of the palpable lump indicated by the patient.  In this region, there is a lymph node measuring 0.9 x 0.5 x 0.9 cm. The cortex of this lymph node is hypoechoic and thickened diffusely and demonstrates mild hyperemia. This most likely represents a reactive lymph node.  IMPRESSION:  The patient's palpable lump most likely represents a reactive lymph node.   I asked the Dr. if this could be an adverse event and she said maybe.  She did not ask for or take any information to report this.   I noticed today on the website for this specific flu vaccine that Lymphadenopathy is a post marketing experience so I thought my symptoms should be reported.  Although I have not completely recovered, the hard node is mostly gone.  The pillowy lump above the node area comes and go.  I feel like I have a mild flu.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: I felt a hard nodule in my left clavicle on Saturday 14 Nov 2020 and when I looked in the mirror there was a pillowy lump above the area.   I went to a Clinic where the Dr. told me that the pillowy lump may be normal.  It is not.  Initially, she also claimed she could not feel the nodule until I insisted.  They did an X-ray there and said there was some deterioration of the left clavicle.     On Monday, 16 Nov 2020 I saw a Dr. filling in for my regular PCP.  She ordered an ultrasound and the results are:   Ultrasound soft tissue head and neck  CLINICAL INDICATION: Left supraclavicular lump.  Real-time ultrasound evaluation of the left side of the neck was performed in the supraclavicular region in the region of the palpable lump indicated by the patient.  In this region, there is a lymph node measuring 0.9 x 0.5 x 0.9 cm. The cortex of this lymph node is hypoechoic and thickened diffusely and demonstrates mild hyperemia. This most likely represents a reactive lymph node.  IMPRESSION:  The patient's palpable lump most likely represents a reactive lymph node.   I asked the Dr. if this could be an adverse event and she said maybe.  She did not ask for or take any information to report this.   I noticed today on the website for this specific flu vaccine that Lymphadenopathy is a post marketing experience so I thought my symptoms should be reported.  Although I have not completely recovered, the hard node is mostly gone.  The pillowy lump above the node area comes and go.  I feel like I have a mild flu.
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Asthenia, Blood glucose, Electrocardiogram, Full blood count, Hypersensitivity
Clinical narrative: Patient felt weak and developed generalized rash on 10/21/2020 AM.  Patient's husband text patient's sign and symptoms and photo of skin rash.  Benadryl and Medrol dose pack oral were prescribed.  Patient had a vasovagal event at home 10/21/2020 in the afternoon after taken first 4mg  Medrol dose.  Patient had a video telemedicine with provider in the afternoon.  Patient was alert and orient sitting in the house.  Patient subsequently was brought to local ER by husband in the early evening, and received epinephrin, diphenhydramine  and methylprednisonlone sod succ (SOLUMEDROL) and IV fluid.  Patient discharged home with ER diagnosis acute allergic reaction, initial enounter and syncope and collapse.