chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like side effects; Muscle pain; Dizziness; Weakness; Extreme tiredness; Chills; Stomach issues; Headaches; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In October 2019, 4 days after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a lot of flu like side effects, lots of muscle pain, dizziness, weakness, extreme tiredness, chills, stomach issues and headaches after vaccination. The patient asked whether it is normal to start events 4 to 5 days after shot and how many days does it usually last. The patient asked will experience the same side effects with the 2nd dose. The patient stated that her husband needs to get the shot but he cannot be out of work for 4 days. The patient asked how many days after shot and for how long events occur and why do people suffer from side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Severe grade 3 swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 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 a year after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the greater than 50 years of age patient received the first dose of Shingrix at an unspecified date in 2019 and she developed what he described as severe grade 3 swelling at the injection site. The reporter had no further information about the adverse event.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Pain, Pyrexia, Skin burning sensation
Clinical narrative: Shivers; Burning skin; Aches; Stomach pain; Low grade temp; This case was reported by a consumer via sales rep and described the occurrence of shivers in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, 15 hrs after receiving Shingrix, the patient experienced shivers, burning skin, pain, stomach pain and low grade fever. On an unknown date, the outcome of the shivers, burning skin, pain, stomach pain and low grade fever were unknown.   It was unknown if the reporter considered the shivers, burning skin, pain, stomach pain and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient had shivers, burning skin, aches, stomach pain and low grade temperature after receiving vaccine. The patient stated that rarely ever get sick. The patient asked whether the event will be worse after the 2nd dose of vaccine.      Lab Comments: on an unknown date body temperature was recorded
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Feeling drunk, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; drunk/dizzy feeling; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient had large golf ball or softball sized welt, hot to touch, swollen, at the injection site, drunk and dizzy feeling, after vaccinated with Fluarix Quadrivalent 2019-2020 season. This case linked with US2019AMR181651, US2019AMR181432 and US2019AMR181652, reported by same reporter.
Sex: U
Vaccine: UNK
Symptoms: Dizziness, Feeling drunk, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; drunk feeling; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, dizziness and feeling drunk. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, dizziness and feeling drunk were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, dizziness and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient had large golf ball or softball sized welt, hot to touch, swollen, at the injection site, drunk and dizzy feeling, after vaccinated with Fluarix Quadrivalent 2019-2020 season. This case linked with US2019AMR181650, US2019AMR181432 and US2019AMR181652, reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Feeling drunk, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; feeling dizzy; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient had large golf ball or softball sized welt, hot to touch, swollen, at the injection site, drunk and dizzy feeling, after vaccinated with Fluarix Quadrivalent 2019-2020 season. This case linked with US2019AMR181651, US2019AMR181432 and US2019AMR181650, reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Nausea, Vomiting
Clinical narrative: facial flushing; nausea; vomiting; felt faint; This case was reported by a physician via sales rep and described the occurrence of facial flushing in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number GD44Z, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced facial flushing, nausea, vomiting and felt faint. On an unknown date, the outcome of the facial flushing, nausea, vomiting and felt faint were unknown.   It was unknown if the reporter considered the facial flushing, nausea, vomiting and felt faint to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. GlaxoSmithKline sales professional called in and stated her colleague had already reported this adverse event but the GlaxoSmithKline staff who is the reporter today got to speak to the physician on 4th October 2019 morning and obtained clarifications.  The patient identifiers were not available. Around 1st October 2019, the patient received Flulaval vaccine 2019-2020. The patient had facial flushing, they felt faint and also had nausea and vomiting. There were no hospitalization required.  Additional information was not provided.  The reporter consented to follow up. This is 1 of 5 cases reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Nausea, Vomiting
Clinical narrative: facial flushing; nausea; vomiting; felt faint; This case was reported by a physician via sales rep and described the occurrence of facial flushing in a adult patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number GD44Z, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced facial flushing, nausea, vomiting and felt faint. On an unknown date, the outcome of the facial flushing, nausea, vomiting and felt faint were unknown.   It was unknown if the reporter considered the facial flushing, nausea, vomiting and felt faint to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. GlaxoSmithKline sales professional called in and steted her colleague had already reported this adverse event but the GlaxoSmithKline staff who is the reporter today got to speak to the physician on 4th october 2019 morning and obtained clarifications.  The patient identifiers were not available. Around 1st October 2019, the patient received Flulaval vaccine 2019-2020. The patient had facial flushing, they felt faint and also had nausea and vomiting. There were no hospitalization required.  Additional information was not provided.  The reporter consented to follow up. This is 1 of 5 cases reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Nausea, Vomiting
Clinical narrative: facial flushing; nausea; vomiting; felt faint; This case was reported by a physician via sales rep and described the occurrence of facial flushing in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number GD44Z, expiry date 30th June 2020) for prophylaxis.   On 1st October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced facial flushing, nausea, vomiting and felt faint. On an unknown date, the outcome of the facial flushing, nausea, vomiting and felt faint were unknown.   It was unknown if the reporter considered the facial flushing, nausea, vomiting and felt faint to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The Glaxosmithkline sales professional called in stating that her colleague had already reported this adverse event but the Glaxosmithkline staff who was the reporter today got to speak to the physician. The patient experienced facial flushing, they felt faint and also had nausea and vomiting.  There were no hospitalizations. Additional information not provided.  The patient identifiers not available. The reporter consented to follow up. This case is 1 of the 5 linked cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: Bullous pemphigoid lession on abdominal area; This case was reported by a physician via call center representative and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 3rd October 2019, 1 days after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and next morning on Thursday, had bullous pemphigoid lesion on his abdominal area. The patient would like to had fedback if this was a possible adverse effect that you are aware of. The reporter consented for follow up.
Sex: U
Vaccine: FLU4
Symptoms: Pharyngeal swelling
Clinical narrative: throat swelling; This case was reported by a physician via sales rep and described the occurrence of throat swelling in a adult patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number GD44Z, expiry date 30th June 2020) for prophylaxis.   On 1st October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced throat swelling. On an unknown date, the outcome of the throat swelling was recovered/resolved.   It was unknown if the reporter considered the throat swelling to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that a patient after receiving the Flulaval vaccine 2019-2020, the patient had a throat swelling. There was no hospitalization.  Additional information was not provided.   The patient identifiers were not available. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: feels like he always ends up getting the flu; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. When the patient got the flu vaccine, he felt like he always ends up getting the flu. The reporter did not consent for follow up.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Nausea, Vomiting
Clinical narrative: facial flushing; nausea; vomiting; felt faint; This case was reported by a physician via sales rep and described the occurrence of facial flushing in a adult patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number GD44Z, expiry date 30th June 2020) for prophylaxis.   On 1st October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced facial flushing, nausea, vomiting and felt faint. On an unknown date, the outcome of the facial flushing, nausea, vomiting and felt faint were unknown.   It was unknown if the reporter considered the facial flushing, nausea, vomiting and felt faint to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: GlaxoSmithKline sales professional called in and steted her colleague had already reported this adverse event but the GlaxoSmithKline staff who is the reporter today got to speak to the physician on 4th October 2019 morning and obtained clarifications.  The patient identifiers were not available. Around 1st October 2019, the patient received Flulaval vaccine 2019-2020. The patient had facial flushing, they felt faint and also had nausea and vomiting. There were no hospitalization required.  Additional information was not provided.  The reporter consented to follow up. This is 1 of 5 cases reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On 13th September 2019, 1 days after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), chills (serious criteria hospitalization) and muscle pain (serious criteria hospitalization). On 16th September 2019, the outcome of the fever, chills and muscle pain were recovered/resolved.   It was unknown if the reporter considered the fever, chills and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. The patient received Shingrix and following day, she woke up with fever, chills and muscle aches. On 14th September 2019, the patient's fever rose to 103.2 degrees F, so prompted an emergency room visit (ER) and the patient was admitted that day and stayed three days. On 17th September 2019, the patient was discharged with all symptoms resolved. The reporter consented to follow up.
Age: 86.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Bacterial infection, Hypoaesthesia, Laboratory test, Mobility decreased, Pain in extremity
Clinical narrative: Wife states that his arm was so sore that he could not lift it up, then it became numb. The patient went to the hospital where some tests were run (wife did not know what tests) and the outcome was that he had a bacterial infection.
Age: 86.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swollen are, redness, pain. Patient states that it is getting worse and she feels like it's infected.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Genital swelling, Lip swelling, Peripheral swelling
Clinical narrative: WeOn August 11, 2019 I had the 2nd shot of the Shingix vaccination at the same location as I had the 1st shot - Pharmacy store. I can't absolutely say the adverse reaction is from the Shingrix vaccination but I suspect it might. Over the course of the next month I noticed swelling that was not normal but I wouldn't call it severe. My lip was swollen for 3 days which is unusual. My tongue swelled a little bit for a day or two and that is unusual. The back of my left hand swelled but I thought I might have hit it as I did yard work. In the corner of the same hand on the back between my thumb and forefinger it swelled and I thought it could be a bug bite. The severe reactions I experienced began sometime overnight Wednesday, September 18, 2019 into Thursday, September 19, 2019.  I woke up and my genitals had swollen a bit. We took note of it and, as it was the first day of a trip, went about our day. That night I stopped to use the restroom and it had become more severe to include my penis. I went to Emergency Room. I was never admitted and they treated me and had me check in with the Urologist at the end of my stay and all seemed well. However, that last day, Monday, September 23, 2019 I remember biting my lip but not very hard when I ate breakfast. Through the day my lip became more and more swollen and when I entered my plane my entire bottom lip was swollen over my top lip. The next day I began experiencing hives. I did go to my primary doctor on Tuesday, September 24, 2019 to check in with her about it. That Saturday, September 28, 2019 I experienced a swollen tongue and went to emergency room for treatment. Thru today, Monday, October 14, 2019, when not on steroids, I have experienced severe hives and swelling to include my entire face with my eyes swollen shut.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face, Swelling of eyelid, Swollen tongue, Ultrasound scan, Urine analysis
Clinical narrative: WeOn August 11, 2019 I had the 2nd shot of the Shingix vaccination at the same location as I had the 1st shot - Pharmacy store. I can't absolutely say the adverse reaction is from the Shingrix vaccination but I suspect it might. Over the course of the next month I noticed swelling that was not normal but I wouldn't call it severe. My lip was swollen for 3 days which is unusual. My tongue swelled a little bit for a day or two and that is unusual. The back of my left hand swelled but I thought I might have hit it as I did yard work. In the corner of the same hand on the back between my thumb and forefinger it swelled and I thought it could be a bug bite. The severe reactions I experienced began sometime overnight Wednesday, September 18, 2019 into Thursday, September 19, 2019.  I woke up and my genitals had swollen a bit. We took note of it and, as it was the first day of a trip, went about our day. That night I stopped to use the restroom and it had become more severe to include my penis. I went to Emergency Room. I was never admitted and they treated me and had me check in with the Urologist at the end of my stay and all seemed well. However, that last day, Monday, September 23, 2019 I remember biting my lip but not very hard when I ate breakfast. Through the day my lip became more and more swollen and when I entered my plane my entire bottom lip was swollen over my top lip. The next day I began experiencing hives. I did go to my primary doctor on Tuesday, September 24, 2019 to check in with her about it. That Saturday, September 28, 2019 I experienced a swollen tongue and went to emergency room for treatment. Thru today, Monday, October 14, 2019, when not on steroids, I have experienced severe hives and swelling to include my entire face with my eyes swollen shut.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: WeOn August 11, 2019 I had the 2nd shot of the Shingix vaccination at the same location as I had the 1st shot - Pharmacy store. I can't absolutely say the adverse reaction is from the Shingrix vaccination but I suspect it might. Over the course of the next month I noticed swelling that was not normal but I wouldn't call it severe. My lip was swollen for 3 days which is unusual. My tongue swelled a little bit for a day or two and that is unusual. The back of my left hand swelled but I thought I might have hit it as I did yard work. In the corner of the same hand on the back between my thumb and forefinger it swelled and I thought it could be a bug bite. The severe reactions I experienced began sometime overnight Wednesday, September 18, 2019 into Thursday, September 19, 2019.  I woke up and my genitals had swollen a bit. We took note of it and, as it was the first day of a trip, went about our day. That night I stopped to use the restroom and it had become more severe to include my penis. I went to Emergency Room. I was never admitted and they treated me and had me check in with the Urologist at the end of my stay and all seemed well. However, that last day, Monday, September 23, 2019 I remember biting my lip but not very hard when I ate breakfast. Through the day my lip became more and more swollen and when I entered my plane my entire bottom lip was swollen over my top lip. The next day I began experiencing hives. I did go to my primary doctor on Tuesday, September 24, 2019 to check in with her about it. That Saturday, September 28, 2019 I experienced a swollen tongue and went to emergency room for treatment. Thru today, Monday, October 14, 2019, when not on steroids, I have experienced severe hives and swelling to include my entire face with my eyes swollen shut.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red and swelling to left arm ,
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Feeling hot, Haemorrhage, Mobility decreased, Orthosis user
Clinical narrative: Patient describes waking up the next morning and tried to stretch and couldn't move her arm.  She states her arm is bruised  and cant lift her arm and it radiates up her shoulder.  arm has been hot and cold.  She is wearing a brace.   She did bleed after receiving shot.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral coldness, Skin warm
Clinical narrative: Patient describes waking up the next morning and tried to stretch and couldn't move her arm.  She states her arm is bruised  and cant lift her arm and it radiates up her shoulder.  arm has been hot and cold.  She is wearing a brace.   She did bleed after receiving shot.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: It has been 3 weeks since I received the flu vaccine (I am unsure which one so listed both above) in my left deltoid. Upon injection it was fairly pain-free, however about an hour following injection the pain, soreness and stiffness increased significantly. I have been self treating with my own conservative therapy (active range of motion, active-assisted range of motion, light isometrics, ice, heat, and naproxen BID). Now that it has been three weeks overall it has not improved and my range of motion has decreased. The symptoms are reflective of possible bursitis, tendonitis of the rotator cuff and impingement. These symptoms are worse in the morning upon awakening. The symptoms are impacting my every day activities and my job. I work as a pediatric physical therapist and am having difficulty lifting children up.
Age: 1.08
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No complaints of adverse effects- Vaccine given to a incorrect age group
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red and swelling to right arm
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient experienced unusual soreness, inflammation and fever at injection site that is three to four inches in diameter, low grade fever starting Sat (highest 100) that lasted over 24 hours (fever free as of 10/14/19).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Feeling cold, Pain, Pyrexia
Clinical narrative: Patient's mother called 3 hours after patient received vaccine stating that patient has a fever of 101 degrees and is very cold and crying in pain.  After reporting the adverse reaction, mother stated that they would monitor patient before presenting to Dr or ER.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Blister rupture, Burning sensation, Erythema, Pruritus
Clinical narrative: Burning sensation in the arm when showering, made 2 blisters in the arm which popped, itching.  8 days later pt still has the red marks on his arm.  No issue with mobility in the arm.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Altered state of consciousness, Dyskinesia, Head injury, Loss of consciousness, Postictal state
Clinical narrative: Patient rec'd the vaccines at approx 1200 noon, waited approx 10-15 minutes sitting in exam room.  Return to waiting room and said she was going to pass out.  Her forehead hit a chair, she was unconscious for about 15 seconds, was helped up to the chair.  Eyes were open then her head flopped and she began to have slight jerking movements.  She appeared to be post icthal and the decision was made to transport to local ED via ambulance.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Posture abnormal
Clinical narrative: Patient rec'd the vaccines at approx 1200 noon, waited approx 10-15 minutes sitting in exam room.  Return to waiting room and said she was going to pass out.  Her forehead hit a chair, she was unconscious for about 15 seconds, was helped up to the chair.  Eyes were open then her head flopped and she began to have slight jerking movements.  She appeared to be post icthal and the decision was made to transport to local ED via ambulance.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia
Clinical narrative: Developed fever of 102 and muscle aches in both legs eight hours after receiving vaccine. Symptoms have now improved.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve injury, Pain
Clinical narrative: Patient complained of pain & nerve damage in left arm & hand. Patient did not seek medical attention.
Age: 13.0
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Visual impairment
Clinical narrative: A few minutes after receiving the flu vaccine, she reported to father that she "couldn't see" and felt dizzy. She laid supine on exam table for a few minutes & vitals stable. Then she was sitting for a few minutes. She said she felt much better. Vital stable. Walked out of office approximately 20 minutes after vaccine. She does have h/o feeling dizzy/faint after other vaccines.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Localized reaction - left thigh
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine administered 10/8 - patients mom noticed redness, swelling, minor bruising at/near injection site on Friday 10/11. Patient was taken to walk-in. No meds administered - MD stated that it could be an insect bite or an insect bite reaction to flu shot. Mom stated patients arm returned to normal within 1 day after applying ice.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Diarrhoea, Faeces discoloured, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Both legs are swollen and red w/fever. Vaccines given (10/9/19) fever started (10/10/19) green diarrhea (10/11/19)
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Injection site warmth, Limb discomfort, Muscular weakness, Pain
Clinical narrative: Received flu vaccine to right arm on 10/9/10. (R) arm feels heavy. Hurts to lay on it or move it. (R) arm seems a little week. Sensation & movement intact slight warmth at injection site with faint area of erythema.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Pain in extremity
Clinical narrative: Received flu vaccine to right arm on 10/9/10. (R) arm feels heavy. Hurts to lay on it or move it. (R) arm seems a little week. Sensation & movement intact slight warmth at injection site with faint area of erythema.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Patent states that she had a headache, and flu like symptoms and her arm and back were sore for a few days. She was informed that these are normal side effect symptoms of a flu shot but she wanted the pharmacy to report it anyway.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: Client vaccinated per protocol into left deltoid.  Client immediately complained of pain at site of injection.  Nurse stated that his muscle seemed to tense when vaccine was injected.  About one hour later the client returned to the nurse and reported continued pain in his whole arm as well as burning and numbness in his pinky and ring finger of the left hand.  Nurse recommended that if there was no improvement that he contact his PCP.  Client has no PCP so was recommended to go to Urgent Care.  No redness at site of injection.  It is unknown if client had medical visit.  Attempts to contact resulted in no return call from client.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Eye swelling, Full blood count normal, Headache, Injection site cellulitis
Clinical narrative: Day 1 (day of vaccine): arm pain and redness at the site;  Day 2(Thursday, day after vaccine): cellulitis at site, burning pain at site, generalized pain/back pain; Day 3(Friday, 2 days after vaccine): bilateral eye swelling, nasal congestion with drainage,  headache with photophobia
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Metabolic function test normal, Nasal congestion, Pain
Clinical narrative: Day 1 (day of vaccine): arm pain and redness at the site;  Day 2(Thursday, day after vaccine): cellulitis at site, burning pain at site, generalized pain/back pain; Day 3(Friday, 2 days after vaccine): bilateral eye swelling, nasal congestion with drainage,  headache with photophobia
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Photophobia, Rhinorrhoea
Clinical narrative: Day 1 (day of vaccine): arm pain and redness at the site;  Day 2(Thursday, day after vaccine): cellulitis at site, burning pain at site, generalized pain/back pain; Day 3(Friday, 2 days after vaccine): bilateral eye swelling, nasal congestion with drainage,  headache with photophobia
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dysphagia, Ear pain, Headache, Neck pain
Clinical narrative: Horrific pain 2 to 3 hours after vaccine.  Pain centered on right side - Neck, Throat, Head, Ear Could barely swollow.  Kept my head on ice off and on for 5 days.  The blisters finally started to break out on my neck and face on Saturday, October 5th.  By time I saw Dr on Monday, the 7th, they were coming down the side of my face, on my neck and they were all over my head.  Huge sores. Right side only. Visited Urgent Care the Friday before I saw Dr. (I went to regular doctor office 1st on Friday Oct. 4, 2019, but Friday is a shot day for them, so I was told to go to their Urgent Care instead.  I finally saw my doctor, Dr. on Monday, October 7, 2019) on Friday, October 3rd.  Explained my symptoms and the pain.  Since the blisters had not surfaced yet, they had no idea why I was in pain, even after telling them of the vaccine I had on October 1st.  I had my 15 month old grandson (he is in my care every Friday) and was afraid I would pass something to him.  I took Aleve every twelve hours and continued on.  The Aleve was not helping.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal pain, Skin ulcer
Clinical narrative: Horrific pain 2 to 3 hours after vaccine.  Pain centered on right side - Neck, Throat, Head, Ear Could barely swollow.  Kept my head on ice off and on for 5 days.  The blisters finally started to break out on my neck and face on Saturday, October 5th.  By time I saw Dr on Monday, the 7th, they were coming down the side of my face, on my neck and they were all over my head.  Huge sores. Right side only. Visited Urgent Care the Friday before I saw Dr. (I went to regular doctor office 1st on Friday Oct. 4, 2019, but Friday is a shot day for them, so I was told to go to their Urgent Care instead.  I finally saw my doctor, Dr. on Monday, October 7, 2019) on Friday, October 3rd.  Explained my symptoms and the pain.  Since the blisters had not surfaced yet, they had no idea why I was in pain, even after telling them of the vaccine I had on October 1st.  I had my 15 month old grandson (he is in my care every Friday) and was afraid I would pass something to him.  I took Aleve every twelve hours and continued on.  The Aleve was not helping.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Headache, Neck pain, Pain, Pustule
Clinical narrative: Horrific pain 2 to 3 hours after vaccine.  Pain centered on right side - Neck, Throat, Head, Ear Could barely swollow.  Kept my head on ice off and on for 5 days.  The blisters finally started to break out on my neck and face on Saturday, October 5th.  By time I saw Dr on Monday, the 7th, they were coming down the side of my face, on my neck and they were all over my head.  Huge sores. Right side only. Visited Urgent Care the Friday before I saw Dr. (I went to regular doctor office 1st on Friday Oct. 4, 2019, but Friday is a shot day for them, so I was told to go to their Urgent Care instead.  I finally saw my doctor, Dr. on Monday, October 7, 2019) on Friday, October 3rd.  Explained my symptoms and the pain.  Since the blisters had not surfaced yet, they had no idea why I was in pain, even after telling them of the vaccine I had on October 1st.  I had my 15 month old grandson (he is in my care every Friday) and was afraid I would pass something to him.  I took Aleve every twelve hours and continued on.  The Aleve was not helping.
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Rash
Clinical narrative: stated she had a rash on arm and upper body
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site rash, Pain, Pain in extremity, Rash
Clinical narrative: stated she had a rash on arm and upper body
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Rash
Clinical narrative: Pain in arm. Unable to move it without pain for day and a half.  Next day rash on left shoulder close to injection site. Rash spread down arm and onto next arm two days later. It preadacros chest by third day and then down legs by fourth day. By fifth day it spread across back.
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site rash, Pain, Pain in extremity, Rash
Clinical narrative: Pain in arm. Unable to move it without pain for day and a half.  Next day rash on left shoulder close to injection site. Rash spread down arm and onto next arm two days later. It preadacros chest by third day and then down legs by fourth day. By fifth day it spread across back.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Contusion, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Mouth haemorrhage
Clinical narrative: ITP-  extreme low platelet count.  7k count at Hospital 8-22-2018.   Extreme bruising, bleeding in mouth, petechiae all over (mouth, neck, head, groin)  Bruising happened very quick-24hours
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Petechiae, Platelet count decreased, Transfusion
Clinical narrative: ITP-  extreme low platelet count.  7k count at Hospital 8-22-2018.   Extreme bruising, bleeding in mouth, petechiae all over (mouth, neck, head, groin)  Bruising happened very quick-24hours
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitus - cephalexin prescribed
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Fever (100 degrees Fahrenheit) and chills
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Symptoms present at the injection site: warmth, redness, swelling and arm pain. Patient reports potentially using Tylenol and a cool compress. Symptoms lasted 5-6 days. All symptoms resolved completely after the 5-6 days.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Hypoaesthesia, Pharyngeal swelling
Clinical narrative: Patient complained of chest feeling heavy and throat feeling swollen a few minutes after administration of vaccine. We therefore called 911 for an ambulance, and monitored patient to watch for signs of difficulty breathing. After paramedics arrived, they took her away on stretcher to ambulance to administer Benadryl. Patient later informed us that when she was in the ambulance, her entire body became numb.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: SEVERE CHILLS, FATIGUE, PAIN AND SWELLING IN ARM.  RASH ON SHOULDER/ARM.  FATIGUE LASTED 3 DAYS.  FEVER LASTED 2 DAYS.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: SEVERE CHILLS, FATIGUE, PAIN AND SWELLING IN ARM.  RASH ON SHOULDER/ARM.  FATIGUE LASTED 3 DAYS.  FEVER LASTED 2 DAYS.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: An expired dose of the flu vaccine was given on 10/12/19. Patient is being contacted to return to the office for an updated vaccination.
Age: 1.33
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was given 2nd Havrix too soon, no harm to patient. Will need to be repeated
Age: 70.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: arm still red ,warm and slightly raised at injection site six days after
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given 2nd dose too early, no harm to patient per CDC. Will need to be repeated at age 16-18
Age: 24.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PATIENT GIVEN DTAP VACCINATION AT THE AGE OF 24. WAS TO RECEIVE TD VACCINE.
Age: 72.0
Sex: M
Vaccine: FLUA3, HEPA, TDAP, VARZOS
Symptoms: Body temperature increased, Hyperhidrosis, Rash, Urticaria
Clinical narrative: The night of 10/04/2019 patient's wife states that he had a rash that started on his back and "wasn't that bad" .  The next day it was also on his chest and belly and that night he had a 99.7 temp with sweating. He had slept in the morning and afternoon that day which is more than his usual.   On the 7th it was mostly on his belly.  On the 10th the hives were no better and benadryl did not help and steroid and prednison helped briefly. Friday patient went to the ER for worsening hives and was given a stronger dose of prednisone and steroid.  Today 10/14/19 patient is still not much better. He will be seeing his doctor this evening and may be having lab work.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pyrexia
Clinical narrative: Patient received flu shot on 10/04/19. Patient's mom states arm all red and got a fever 102.3  on next day of receiving flu shot 10/05/19. Unsure what time course patient had reaction.
Sex: M
Vaccine: TDAP
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Seizures; Stopped breathing; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than a week after receiving DTPa vaccine, the patient experienced seizure (serious criteria GSK medically significant) and breathing arrested (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Cardiopulmonary Resuscitation). On an unknown date, the outcome of the seizure and breathing arrested were unknown.   It was unknown if the reporter considered the seizure and breathing arrested to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine and had seizure, stopped breathing and had to be given cardiopulmonary resuscitation (CPR) in less than 48 hours. As per reporter it would not be easy to guilt people into profiting for you and why did not you let people knew that at the same time you were trying to portray them as predators. The VAERS details were already reported.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure, Syncope
Clinical narrative: Syncopal Seizure Event; Syncope; This case was reported by a nurse via call center representative and described the occurrence of seizure in a 18-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and syncope (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure and syncope were unknown.   It was unknown if the reporter considered the seizure and syncope to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 season on left deltoid. The patient experienced syncopal seizure event and was hospitalized due to it. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash
Clinical narrative: Rash measuring about 7cm x 7 cm
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient reports pain in arm that radiates into her back, reports that pain is so intense she can't move her arm
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, External ear inflammation, Fatigue, Headache, Laryngitis
Clinical narrative: Developed URI and middle ear infection after receiving flu vaccine  Vaccine was given on 10/7/2019  Developed symptoms 10/10/2019 Still symptomatic on 10/14/2019  Symptoms include: congestion, cough, runny nose, fatigue, sneezing, postnasal drip, fever, laryngitis, headache, increased phlegm, inflammation of ears, sinusitis
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Otitis media, Productive cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Developed URI and middle ear infection after receiving flu vaccine  Vaccine was given on 10/7/2019  Developed symptoms 10/10/2019 Still symptomatic on 10/14/2019  Symptoms include: congestion, cough, runny nose, fatigue, sneezing, postnasal drip, fever, laryngitis, headache, increased phlegm, inflammation of ears, sinusitis
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Sinusitis, Sneezing, Upper respiratory tract infection, Upper-airway cough syndrome
Clinical narrative: Developed URI and middle ear infection after receiving flu vaccine  Vaccine was given on 10/7/2019  Developed symptoms 10/10/2019 Still symptomatic on 10/14/2019  Symptoms include: congestion, cough, runny nose, fatigue, sneezing, postnasal drip, fever, laryngitis, headache, increased phlegm, inflammation of ears, sinusitis
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approx 18 hours after injection significant redness, warmth, swelling and pain developed involving whole extensor surface of right upper arm around injection site
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity, Shock symptom
Clinical narrative: After receiving the flu shot, her arm was abnormally painful, sore, and had experienced shock-like painful sensations down her left arm.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: syncope reaction
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Patient was seen in ED and dx'd with Cellulitis .  No treatment given, advised to follow up with pcp.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: After receiving the flu shot at a workplace flu clinic, she experienced prolonged arm pain. After being seen by a physician she has stated she had nerve damage from the administration of the flu shot.