chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pain, Protein total normal
Clinical narrative: This case was reported by a nurse and described the occurrence of chest pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In November 2018, the patient experienced fatigue, skin warm, pain, headache, malaise and shivering. On 16th November 2018, the patient experienced chest pain, dizziness and ringing in ears. In November 2018, the outcome of the fatigue, headache, malaise, shivering and dizziness were recovered/resolved. On 16th November 2018, the outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, skin warm, pain and ringing in ears were unknown. It was unknown if the reporter considered the chest pain, fatigue, injection site erythema, injection site swelling, skin warm, pain, headache, malaise, shivering, dizziness and ringing in ears to be related to SHINGRIX. Additional details were received as follows: This case was reported by nurse who herself was the patient. After vaccination with SHINGRIX, the patient had many of the common and uncommon side effects. The patient presented with vaccination site redness and swelling which happened within 12 hours after vaccination with SHINGRIX. Within 24 hours after vaccination, a large red streak, measured approximately 3 by 1 inch, developed about 3 inches below the injection site. It was hot, swollen red and painful. The patient presented with headache (HA), malaise, shivering, fatigue which lasted for 36 hours. Four days after vaccination with SHINGRIX, the patient developed pain in chest that lasted for approximately 25 minutes and felt like she was going to faint, dizziness and ringing in her ears. The patient never felt this events before. The patient was taken by ambulance to the emergency department (ED). In ED, the patient had done 2 EKGs (electrocardiogram) and  2 troponins test which showed results stable normal vital signs. Everything was normal and the patient did not have a heart attack. Two days later, the patient had a 100 percent normal stress test. The patient had not told to her coworkers about her chest pain or feelings of faint. The patient asked if GlaxoSmithKline (GSK) had any reports of chest pain or fainting symptoms after receiving SHINGRIX vaccine and if it was recommended to receive the follow up of SHINGRIX in 2 months. This case was linked with case US2018GSK219275 (master case), reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Tinnitus, Troponin normal
Clinical narrative: This case was reported by a nurse and described the occurrence of chest pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In November 2018, the patient experienced fatigue, skin warm, pain, headache, malaise and shivering. On 16th November 2018, the patient experienced chest pain, dizziness and ringing in ears. In November 2018, the outcome of the fatigue, headache, malaise, shivering and dizziness were recovered/resolved. On 16th November 2018, the outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, skin warm, pain and ringing in ears were unknown. It was unknown if the reporter considered the chest pain, fatigue, injection site erythema, injection site swelling, skin warm, pain, headache, malaise, shivering, dizziness and ringing in ears to be related to SHINGRIX. Additional details were received as follows: This case was reported by nurse who herself was the patient. After vaccination with SHINGRIX, the patient had many of the common and uncommon side effects. The patient presented with vaccination site redness and swelling which happened within 12 hours after vaccination with SHINGRIX. Within 24 hours after vaccination, a large red streak, measured approximately 3 by 1 inch, developed about 3 inches below the injection site. It was hot, swollen red and painful. The patient presented with headache (HA), malaise, shivering, fatigue which lasted for 36 hours. Four days after vaccination with SHINGRIX, the patient developed pain in chest that lasted for approximately 25 minutes and felt like she was going to faint, dizziness and ringing in her ears. The patient never felt this events before. The patient was taken by ambulance to the emergency department (ED). In ED, the patient had done 2 EKGs (electrocardiogram) and  2 troponins test which showed results stable normal vital signs. Everything was normal and the patient did not have a heart attack. Two days later, the patient had a 100 percent normal stress test. The patient had not told to her coworkers about her chest pain or feelings of faint. The patient asked if GlaxoSmithKline (GSK) had any reports of chest pain or fainting symptoms after receiving SHINGRIX vaccine and if it was recommended to receive the follow up of SHINGRIX in 2 months. This case was linked with case US2018GSK219275 (master case), reported by the same reporter.
Sex: F
Vaccine: MNQ
Symptoms: Exposure via eye contact, Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case ID 2018SA322129 (another female office staff, same reporter). This case involves a female patient (office staff) who was exposed to vaccine MENACTRA (Batch number: U6016AA, expiration date: 09 Oct 2019, dose) on an unspecified date. It was a case of occupational exposure as it was reported that female office staff drew the MENACTRA from a multi-dose vial (with their syringe and needle) and the needle cracked and sprayed the vaccine on her. It was also reported that vaccine was splashed in the eyes and face. (Occupational exposure to product via eye and exposure via skin contact). It was also a case of product issue. The MENACTRA was not given. It was unknown if patients had adverse event due to this. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Irritability, Restlessness, Swelling face
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 26 months old male patient who experienced an anaphylactic reaction, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE QUADRIVALENT first dose on 25-SEP-2018 with lot number UT6259JA. The patient's past medical history, medical treatment(s) and family history were not provided. No concomitant vaccines were given. On 28-Nov-2018, the patient received a 0.25 ml second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259JA and Exp. Date 30-JUN-2019 via intramuscular route in the left (thigh) vastus laterallis. On an unknown date, around 4 pm the patient developed an anaphylactic reaction (anaphylactic reaction) with symptoms of face was swollen and unrecognizable (swelling face), hives (urticaria), became fussy and was not settling down (irritability) and was not breathing well (dyspnoea), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, after receiving the vaccine, later that night, while in bed the child became fussy and was not settling down when the mother turned on the light and pulled down the cover he was covered in hives, his face was swollen and unrecognizable. He was not breathing well. Details of lab data not provided. Final diagnosis was developed an anaphylactic reaction. The patient was dosed with oral steroids and taking oral fluids and then released home with order for continued steroids and an EPI PEN. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a young patient who presented with anaphylactic reaction after vaccination with FLUZONE QUADRIVALENT. The time to onset is not known and the events are expected with this vaccine. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 26 months old male patient who experienced an anaphylactic reaction, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE QUADRIVALENT first dose on 25-SEP-2018 with lot number UT6259JA. The patient's past medical history, medical treatment(s) and family history were not provided. No concomitant vaccines were given. On 28-Nov-2018, the patient received a 0.25 ml second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259JA and Exp. Date 30-JUN-2019 via intramuscular route in the left (thigh) vastus laterallis. On an unknown date, around 4 pm the patient developed an anaphylactic reaction (anaphylactic reaction) with symptoms of face was swollen and unrecognizable (swelling face), hives (urticaria), became fussy and was not settling down (irritability) and was not breathing well (dyspnoea), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, after receiving the vaccine, later that night, while in bed the child became fussy and was not settling down when the mother turned on the light and pulled down the cover he was covered in hives, his face was swollen and unrecognizable. He was not breathing well. Details of lab data not provided. Final diagnosis was developed an anaphylactic reaction. The patient was dosed with oral steroids and taking oral fluids and then released home with order for continued steroids and an EPI PEN. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a young patient who presented with anaphylactic reaction after vaccination with FLUZONE QUADRIVALENT. The time to onset is not known and the events are expected with this vaccine. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Fever, chills, localized erythema w/significant pain, and itching.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Fever of greater than 101 for three days. Upset stomach. Chills and headache. Muscle aches. Tenderness at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of greater than 101 for three days. Upset stomach. Chills and headache. Muscle aches. Tenderness at injection site.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Was given a pediatric dose to a 14 year old. Patient was instructed to come back in for second injection.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Injection site is still swollen and very sore day 3 post shot given. Full body muscle soreness and headache has kept me 80% bedridden. I have no temperature but the grapefruit size red knot on my arm is warm to touch. I have taken BENADRYL, MUCINEX, ALLEGRA and ibuprofen. Still experiencing side effects to date.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nodule, Skin warm
Clinical narrative: Injection site is still swollen and very sore day 3 post shot given. Full body muscle soreness and headache has kept me 80% bedridden. I have no temperature but the grapefruit size red knot on my arm is warm to touch. I have taken BENADRYL, MUCINEX, ALLEGRA and ibuprofen. Still experiencing side effects to date.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, chills, vomiting, muscle aches, headache on day 1. On day 2, fever, fatigue, and headache. Dose site is extremely sore and red and hot and over 3-4 inches. It is still very sore on December 10, 2018.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting, muscle aches, headache on day 1. On day 2, fever, fatigue, and headache. Dose site is extremely sore and red and hot and over 3-4 inches. It is still very sore on December 10, 2018.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode lasting less than 10s. Recovered quickly.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-SEP-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 25-DEC-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received on 03-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In 2012, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is unknown. The causality of the events is related. Upon internal review, severe varicella pneumonia was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received on 03-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 29-MAY-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 28-APR-2016, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is unknown. The causality of the events is related. Upon internal review, severe varicella pneumonia was determined to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Lethargy, Paraesthesia
Clinical narrative: Had the second vaccine shot SHINGRIX on Friday, 12/7 at 1:30pm On Saturday I was extremely lethargic and my arm was tender and sore where the shot was given. On Sunday 12/9 my left hand started a tingling sensation under my ring, I removed my ring, washed my hands really good thinking that the juice from a jalapeno pepper, not the case! The burning sensation continue through the night and covered my whole hand. To relieve the tingling I took two ALEVE and used an ice pack all night. This morning the sensation has dissipated to the palm and seems to slowly getting better.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Anion gap, Asthenia, Basophil count decreased, Basophil percentage decreased, Blood chloride normal
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatinine normal, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea normal
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Calcium ionised normal, Carbon dioxide normal, Computerised tomogram thorax normal, Dizziness, Dyspnoea
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Eosinophil count normal, Eosinophil percentage, Fibrin D dimer normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Neutrophil count normal
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Neutrophil percentage increased, Paraesthesia, Platelet count normal, Presyncope, Red blood cell count normal
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Red cell distribution width normal, Troponin I, Urticaria, White blood cell count normal
Clinical narrative: Near Vasovagal syncope within approximately 2-3 minutes of receiving the vaccine; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing; This lasted about 20 minutes; Hives subsided; Taken to the ER via EMS; Secondary episode 11/21/2018, ER visit with the same symptoms; Hives on the neck, fast heartbeat, dizziness, weakness, tingling of the entire body, slight difficulty breathing.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had a red swollen area at the site of the injection that was tender to the touch. Patient thought it was more than just a typical injection site reaction. Had a similar reaction with the first shot that went away after a week or so. I followed up with the patient on 12/10/2018 at 11:20 AM and verified that the reaction had cleared up and was not causing any additional concerns.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Anxiety, Choking, Crying, Cyanosis
Clinical narrative: The patient is a healthy 4-year-old who received influenza vaccine #5 and 26 October 2018. MOP reports he had complained his head hurt to receipt of vaccine about 1 hour prior and had been given TYLENOL. States he received the vaccine without immediate incident and they waited the required 15 minutes and then left. A few minutes later he complained of GI pain. At about 20 minutes post vaccine receipt they were at store, and he continued to complain of GI pain he was given a snack of a 'lunchable' at about 40 minutes post vaccine receipt. About 60 minutes post vaccine receipt she had him in a warm shower and he experienced an episode of emesis, gagging, choking, spitting, and facial flushing and complained of cold. She denies noting facial swelling pruritus, urticaria, or dyspnea. She did state he was 'blue at his lips' and his eyes were 'blotchy'. They returned to clinic where he was very distressed, crying, voice very soft, anxious, and refused to speak or open his mouth. He was treated with BENADRYL and IM steroid and went to sleep. He was discharged to home and continued his GI pain complaint for another 1-2 hours. He had an episode of diarrhea at some point during this event, but MOP does not recall exactly when. About 3 PM his father came home and he immediately perked up and was at baseline. He had no further symptoms, no fever no urticaria no pruritus, ate well, took fluids and was playing normally. Provider note reports positive erythema and edema to eyelids, eyes, throat pain, and refusal to talk or eat. Physical exam notes tachycardia heart rate at 158 and hypertension 147/95. Lung exam clear to auscultation and no urticaria is documented.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Diet refusal, Emotional distress, Erythema of eyelid, Eye oedema
Clinical narrative: The patient is a healthy 4-year-old who received influenza vaccine #5 and 26 October 2018. MOP reports he had complained his head hurt to receipt of vaccine about 1 hour prior and had been given TYLENOL. States he received the vaccine without immediate incident and they waited the required 15 minutes and then left. A few minutes later he complained of GI pain. At about 20 minutes post vaccine receipt they were at store, and he continued to complain of GI pain he was given a snack of a 'lunchable' at about 40 minutes post vaccine receipt. About 60 minutes post vaccine receipt she had him in a warm shower and he experienced an episode of emesis, gagging, choking, spitting, and facial flushing and complained of cold. She denies noting facial swelling pruritus, urticaria, or dyspnea. She did state he was 'blue at his lips' and his eyes were 'blotchy'. They returned to clinic where he was very distressed, crying, voice very soft, anxious, and refused to speak or open his mouth. He was treated with BENADRYL and IM steroid and went to sleep. He was discharged to home and continued his GI pain complaint for another 1-2 hours. He had an episode of diarrhea at some point during this event, but MOP does not recall exactly when. About 3 PM his father came home and he immediately perked up and was at baseline. He had no further symptoms, no fever no urticaria no pruritus, ate well, took fluids and was playing normally. Provider note reports positive erythema and edema to eyelids, eyes, throat pain, and refusal to talk or eat. Physical exam notes tachycardia heart rate at 158 and hypertension 147/95. Lung exam clear to auscultation and no urticaria is documented.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Eyelid oedema, Feeling cold, Flushing, Gastrointestinal pain, Hypertension
Clinical narrative: The patient is a healthy 4-year-old who received influenza vaccine #5 and 26 October 2018. MOP reports he had complained his head hurt to receipt of vaccine about 1 hour prior and had been given TYLENOL. States he received the vaccine without immediate incident and they waited the required 15 minutes and then left. A few minutes later he complained of GI pain. At about 20 minutes post vaccine receipt they were at store, and he continued to complain of GI pain he was given a snack of a 'lunchable' at about 40 minutes post vaccine receipt. About 60 minutes post vaccine receipt she had him in a warm shower and he experienced an episode of emesis, gagging, choking, spitting, and facial flushing and complained of cold. She denies noting facial swelling pruritus, urticaria, or dyspnea. She did state he was 'blue at his lips' and his eyes were 'blotchy'. They returned to clinic where he was very distressed, crying, voice very soft, anxious, and refused to speak or open his mouth. He was treated with BENADRYL and IM steroid and went to sleep. He was discharged to home and continued his GI pain complaint for another 1-2 hours. He had an episode of diarrhea at some point during this event, but MOP does not recall exactly when. About 3 PM his father came home and he immediately perked up and was at baseline. He had no further symptoms, no fever no urticaria no pruritus, ate well, took fluids and was playing normally. Provider note reports positive erythema and edema to eyelids, eyes, throat pain, and refusal to talk or eat. Physical exam notes tachycardia heart rate at 158 and hypertension 147/95. Lung exam clear to auscultation and no urticaria is documented.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Retching, Tachycardia, Vomiting
Clinical narrative: The patient is a healthy 4-year-old who received influenza vaccine #5 and 26 October 2018. MOP reports he had complained his head hurt to receipt of vaccine about 1 hour prior and had been given TYLENOL. States he received the vaccine without immediate incident and they waited the required 15 minutes and then left. A few minutes later he complained of GI pain. At about 20 minutes post vaccine receipt they were at store, and he continued to complain of GI pain he was given a snack of a 'lunchable' at about 40 minutes post vaccine receipt. About 60 minutes post vaccine receipt she had him in a warm shower and he experienced an episode of emesis, gagging, choking, spitting, and facial flushing and complained of cold. She denies noting facial swelling pruritus, urticaria, or dyspnea. She did state he was 'blue at his lips' and his eyes were 'blotchy'. They returned to clinic where he was very distressed, crying, voice very soft, anxious, and refused to speak or open his mouth. He was treated with BENADRYL and IM steroid and went to sleep. He was discharged to home and continued his GI pain complaint for another 1-2 hours. He had an episode of diarrhea at some point during this event, but MOP does not recall exactly when. About 3 PM his father came home and he immediately perked up and was at baseline. He had no further symptoms, no fever no urticaria no pruritus, ate well, took fluids and was playing normally. Provider note reports positive erythema and edema to eyelids, eyes, throat pain, and refusal to talk or eat. Physical exam notes tachycardia heart rate at 158 and hypertension 147/95. Lung exam clear to auscultation and no urticaria is documented.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt's arm was red and sore around the spot of the shot for about 24 hours. She complained of pain in that arm but was able to do normal activities. After 24 hours, the redness and swollenness spread and grew to cover most of her upper arm, from below her shoulder to above her elbow. She said it itched really bad. It was hot to the touch.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Employee states with pain to upper (R) arm (injection site) on movement. Also with movement limitation - difficulty of dressing/undressing due to movement limitation and pain on movement.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: I was concerned by my reaction to the SHINGRIX vaccine. I got the vaccine at a hospital pharmacy on Monday, 10/29/2018, at 5pm. I felt some mild tiredness right away so I drove straight home. At 8pm I felt like I needed water, I had the chills and my teeth were chattering so I sat down with a blanket. From 9 to 11pm I felt very tired and wanted to go to bed but didn't have the strength to get up. At 11:30 I finally got up, drank more water and went to bed. I woke up at 2am Tuesday needing to go the bathroom but I was so cold that I waited as long as I could. When I finally got up I felt dizzy and stuffy and had a moderate headache. At 6am I again woke up. My feet and hands weren't normal. My feet could barely hold me up and my hands couldn't grip. I was much dizzier, stuffiness made it hard to breathe, and the splitting headache was the worst I've ever had. I finally stumbled to the kitchen, made a cup of tea and drank it. My feet and hands were working better but the headache and other symptoms were so bad that I went back to bed. At 12:30 pm I woke up with a moderate headache, dizziness, and nausea. I wrote down my symptoms and called the pharmacist who had administered the vaccine. She said my symptoms had been reported by other people and recommended that I get the second vaccine in two months. I then went back to bed. I woke up at 6pm with only minor headache and dizziness, was able to eat some chicken soup and watch TV. I went to bed at 11pm. The fever passed sometime in the night. I woke up Wednesday morning wet from sweat, and feeling weak. The head congestion drained that afternoon. On Thursday I still felt a little weak. Friday I felt back to normal. The FDA telephone number was on the paperwork from the pharmacy; I called and they gave me helpful info and said I should report to VAERS because of the severity of my symptoms. I also reported my symptoms to my doctor who prescribed the vaccine. She advised me not to get the second dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling cold, Gait disturbance, Grip strength decreased, Headache
Clinical narrative: I was concerned by my reaction to the SHINGRIX vaccine. I got the vaccine at a hospital pharmacy on Monday, 10/29/2018, at 5pm. I felt some mild tiredness right away so I drove straight home. At 8pm I felt like I needed water, I had the chills and my teeth were chattering so I sat down with a blanket. From 9 to 11pm I felt very tired and wanted to go to bed but didn't have the strength to get up. At 11:30 I finally got up, drank more water and went to bed. I woke up at 2am Tuesday needing to go the bathroom but I was so cold that I waited as long as I could. When I finally got up I felt dizzy and stuffy and had a moderate headache. At 6am I again woke up. My feet and hands weren't normal. My feet could barely hold me up and my hands couldn't grip. I was much dizzier, stuffiness made it hard to breathe, and the splitting headache was the worst I've ever had. I finally stumbled to the kitchen, made a cup of tea and drank it. My feet and hands were working better but the headache and other symptoms were so bad that I went back to bed. At 12:30 pm I woke up with a moderate headache, dizziness, and nausea. I wrote down my symptoms and called the pharmacist who had administered the vaccine. She said my symptoms had been reported by other people and recommended that I get the second vaccine in two months. I then went back to bed. I woke up at 6pm with only minor headache and dizziness, was able to eat some chicken soup and watch TV. I went to bed at 11pm. The fever passed sometime in the night. I woke up Wednesday morning wet from sweat, and feeling weak. The head congestion drained that afternoon. On Thursday I still felt a little weak. Friday I felt back to normal. The FDA telephone number was on the paperwork from the pharmacy; I called and they gave me helpful info and said I should report to VAERS because of the severity of my symptoms. I also reported my symptoms to my doctor who prescribed the vaccine. She advised me not to get the second dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Nasal congestion, Nausea, Thirst
Clinical narrative: I was concerned by my reaction to the SHINGRIX vaccine. I got the vaccine at a hospital pharmacy on Monday, 10/29/2018, at 5pm. I felt some mild tiredness right away so I drove straight home. At 8pm I felt like I needed water, I had the chills and my teeth were chattering so I sat down with a blanket. From 9 to 11pm I felt very tired and wanted to go to bed but didn't have the strength to get up. At 11:30 I finally got up, drank more water and went to bed. I woke up at 2am Tuesday needing to go the bathroom but I was so cold that I waited as long as I could. When I finally got up I felt dizzy and stuffy and had a moderate headache. At 6am I again woke up. My feet and hands weren't normal. My feet could barely hold me up and my hands couldn't grip. I was much dizzier, stuffiness made it hard to breathe, and the splitting headache was the worst I've ever had. I finally stumbled to the kitchen, made a cup of tea and drank it. My feet and hands were working better but the headache and other symptoms were so bad that I went back to bed. At 12:30 pm I woke up with a moderate headache, dizziness, and nausea. I wrote down my symptoms and called the pharmacist who had administered the vaccine. She said my symptoms had been reported by other people and recommended that I get the second vaccine in two months. I then went back to bed. I woke up at 6pm with only minor headache and dizziness, was able to eat some chicken soup and watch TV. I went to bed at 11pm. The fever passed sometime in the night. I woke up Wednesday morning wet from sweat, and feeling weak. The head congestion drained that afternoon. On Thursday I still felt a little weak. Friday I felt back to normal. The FDA telephone number was on the paperwork from the pharmacy; I called and they gave me helpful info and said I should report to VAERS because of the severity of my symptoms. I also reported my symptoms to my doctor who prescribed the vaccine. She advised me not to get the second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-FEB-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient had her first shingles outbreak on 10-MAY-2016. On 21-OCT-2016, the patient was diagnosed with neuropathic disorder causing her pain and was prescribed gabapentin for the pain. As a direct result of the vaccine, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the ZOSTAVAX vaccine, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. Upon internal review, neuropathic disorder was determined to be medically significant. Shingles outbreak and neuropathic disorder were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-NOV-2011, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination were not reported. After vaccination, the patient had an outbreak. The patient wanted to know, how long did it take the 1st dose to start working. In 2018, the patient's physician had given prescription of Acyclovir. The call center representative asked to the patient, his date of birth and provider information if safety department would like to follow up with that provider.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that, the patient received SHINGRIX and flu vaccine together. The patient presented with fever and the reporter wanted to know whether it was normal.