chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Incorrect route of product administration, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a male patient who received SHINGRIX (batch number MG42F, expiry date unknown) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dizziness, injection site pain, headache and intramuscular formulation administered by other route. On an unknown date, the outcome of the dizziness, injection site pain, headache and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the dizziness, injection site pain and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX, subcutaneously, which led to incorrect route of vaccine administration. The reported batch number MG72F updatded to MG42F as per sales data sheet.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 51-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 17th November 2018, the patient received the 1st dose of SHINGRIX. On 17th November 2018, less than a day after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved.  It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: On the day of vaccine administration, the patient had reaction and redness developed. The pharmacist reported that the redness was the only thing which was out of the ordinary. No further details provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cardiac stress test normal, Chills, Colonoscopy normal, Decreased appetite
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose was received on 31st October 2018 (refer case US2019025047)). Concurrent medical conditions included drug allergy ( allergic to penicillin, iodine and sulfa). On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 5 hrs after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), fainting (serious criteria GSK medically significant), sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration. On an unknown date, the patient experienced fall and weakness. On an unknown date, the outcome of the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration were recovered/resolved and the outcome of the fall and weakness were unknown. The reporter considered the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration to be related to SHINGRIX. It was unknown if the reporter considered the fall and weakness to be related to SHINGRIX. Additional details were received as follows: At noon, the patient received SHINGRIX vaccine in the left arm but she was not sure. By the evening, 5 hours later, she was really sick, much worst than the first time she received the vaccine, very achy, shaking, weak, shivering, fever, was in bed for 2 to 3 days and did not want to get out of bed, nor did she want to eat or drink. The first night, she got up to use the bathroom, had diarrhea and while on the toilet, passed out twice. The patient was laying on the cool tile floor, but not hitting any body parts with force when she fell. She then crawled back to bed. She felt stronger after 3 days, started to eat small amounts of food and after her symptoms resolved, she drove back home. She went to home after her symptoms resolved. She was staying at her daughter's home when she was ill after the second vaccine. When she was at home, the following day she noticed some blood in her stool, went to her gastroenterologist and had two colonoscopies, one in the office, the second one under anesthesia, both were unremarkable and within normal limits. The patient's cardiologist was concerned she fainted twice, so she wore a heart holter monitor for 2 weeks and the results were essentially normal. The patient then had a Stress test done and that was essentially within normal limits . She believes she was very dehydrated after the second vaccine and that is why she fainted.  She is allergic to penicillin, iodine and sulfa. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Diarrhoea, Electrocardiogram ambulatory normal, Fall, Haematochezia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose was received on 31st October 2018 (refer case US2019025047)). Concurrent medical conditions included drug allergy ( allergic to penicillin, iodine and sulfa). On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 5 hrs after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), fainting (serious criteria GSK medically significant), sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration. On an unknown date, the patient experienced fall and weakness. On an unknown date, the outcome of the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration were recovered/resolved and the outcome of the fall and weakness were unknown. The reporter considered the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration to be related to SHINGRIX. It was unknown if the reporter considered the fall and weakness to be related to SHINGRIX. Additional details were received as follows: At noon, the patient received SHINGRIX vaccine in the left arm but she was not sure. By the evening, 5 hours later, she was really sick, much worst than the first time she received the vaccine, very achy, shaking, weak, shivering, fever, was in bed for 2 to 3 days and did not want to get out of bed, nor did she want to eat or drink. The first night, she got up to use the bathroom, had diarrhea and while on the toilet, passed out twice. The patient was laying on the cool tile floor, but not hitting any body parts with force when she fell. She then crawled back to bed. She felt stronger after 3 days, started to eat small amounts of food and after her symptoms resolved, she drove back home. She went to home after her symptoms resolved. She was staying at her daughter's home when she was ill after the second vaccine. When she was at home, the following day she noticed some blood in her stool, went to her gastroenterologist and had two colonoscopies, one in the office, the second one under anesthesia, both were unremarkable and within normal limits. The patient's cardiologist was concerned she fainted twice, so she wore a heart holter monitor for 2 weeks and the results were essentially normal. The patient then had a Stress test done and that was essentially within normal limits . She believes she was very dehydrated after the second vaccine and that is why she fainted.  She is allergic to penicillin, iodine and sulfa. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise, Pain, Pyrexia, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose was received on 31st October 2018 (refer case US2019025047)). Concurrent medical conditions included drug allergy ( allergic to penicillin, iodine and sulfa). On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 5 hrs after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), fainting (serious criteria GSK medically significant), sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration. On an unknown date, the patient experienced fall and weakness. On an unknown date, the outcome of the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration were recovered/resolved and the outcome of the fall and weakness were unknown. The reporter considered the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration to be related to SHINGRIX. It was unknown if the reporter considered the fall and weakness to be related to SHINGRIX. Additional details were received as follows: At noon, the patient received SHINGRIX vaccine in the left arm but she was not sure. By the evening, 5 hours later, she was really sick, much worst than the first time she received the vaccine, very achy, shaking, weak, shivering, fever, was in bed for 2 to 3 days and did not want to get out of bed, nor did she want to eat or drink. The first night, she got up to use the bathroom, had diarrhea and while on the toilet, passed out twice. The patient was laying on the cool tile floor, but not hitting any body parts with force when she fell. She then crawled back to bed. She felt stronger after 3 days, started to eat small amounts of food and after her symptoms resolved, she drove back home. She went to home after her symptoms resolved. She was staying at her daughter's home when she was ill after the second vaccine. When she was at home, the following day she noticed some blood in her stool, went to her gastroenterologist and had two colonoscopies, one in the office, the second one under anesthesia, both were unremarkable and within normal limits. The patient's cardiologist was concerned she fainted twice, so she wore a heart holter monitor for 2 weeks and the results were essentially normal. The patient then had a Stress test done and that was essentially within normal limits . She believes she was very dehydrated after the second vaccine and that is why she fainted.  She is allergic to penicillin, iodine and sulfa. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Viral test
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose was received on 31st October 2018 (refer case US2019025047)). Concurrent medical conditions included drug allergy ( allergic to penicillin, iodine and sulfa). On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 5 hrs after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), fainting (serious criteria GSK medically significant), sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration. On an unknown date, the patient experienced fall and weakness. On an unknown date, the outcome of the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration were recovered/resolved and the outcome of the fall and weakness were unknown. The reporter considered the blood in stool, fainting, sickness, pain, shivering, tremor, fever, diarrhea, appetite lost and dehydration to be related to SHINGRIX. It was unknown if the reporter considered the fall and weakness to be related to SHINGRIX. Additional details were received as follows: At noon, the patient received SHINGRIX vaccine in the left arm but she was not sure. By the evening, 5 hours later, she was really sick, much worst than the first time she received the vaccine, very achy, shaking, weak, shivering, fever, was in bed for 2 to 3 days and did not want to get out of bed, nor did she want to eat or drink. The first night, she got up to use the bathroom, had diarrhea and while on the toilet, passed out twice. The patient was laying on the cool tile floor, but not hitting any body parts with force when she fell. She then crawled back to bed. She felt stronger after 3 days, started to eat small amounts of food and after her symptoms resolved, she drove back home. She went to home after her symptoms resolved. She was staying at her daughter's home when she was ill after the second vaccine. When she was at home, the following day she noticed some blood in her stool, went to her gastroenterologist and had two colonoscopies, one in the office, the second one under anesthesia, both were unremarkable and within normal limits. The patient's cardiologist was concerned she fainted twice, so she wore a heart holter monitor for 2 weeks and the results were essentially normal. The patient then had a Stress test done and that was essentially within normal limits . She believes she was very dehydrated after the second vaccine and that is why she fainted.  She is allergic to penicillin, iodine and sulfa. The reporter did not consent to follow up.
Age: 7.0
Sex: F
Vaccine: FLU4, HEPA, IPV
Symptoms: Rash generalised
Clinical narrative: 3:50 PM pt. presented a rash all over the body, after vaccine administration. She was evaluated by the Dr who ordered BENADRYL 5ml stat PO given at 4:30pm and was left for observation. At 4:50pm the doctor reevaluated the patient and observed the rash had disappeared and discharged her with instructions to continue treatment with BENADRYL 12.5mg/5ml PO Q6hrs and to go to the ER if worsen.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Acute decrease in vision clarity 6 months after 1 dose of SHINGRIX. Pt has not received 2nd dose. Pt states that she would guess that her vision as decreased by 20% in the last month, requiring more light and magnification. She has not been evaluated by a specialist yet, but has an appointment to investigate her concerns.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Injection site erythema, Pain
Clinical narrative: VERY sore even two days later. Woke Sunday early morning (shot was on Saturday afternoon) with chills/shivering, upset stomach, dry heaves from the stomach, and headache. Vaccination site still red (about a two inch circumference), and warm and sore.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Vaccination site pain, Vaccination site warmth
Clinical narrative: VERY sore even two days later. Woke Sunday early morning (shot was on Saturday afternoon) with chills/shivering, upset stomach, dry heaves from the stomach, and headache. Vaccination site still red (about a two inch circumference), and warm and sore.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills for 12 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms, headache, fever, body/muscle aches, stomach upset, nausea, fatigue, dizzy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms, headache, fever, body/muscle aches, stomach upset, nausea, fatigue, dizzy.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on half upper right thigh, patient will try hydrocortisone 1% and BENDARYL 25mg to suppress symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Developed a herpes zoster infection in her eye several hours after the shot.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Measles antibody, Measles post vaccine, Pyrexia, Rash, Rubella antibody negative
Clinical narrative: Measles rash and fever.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Impaired driving ability, Peripheral swelling, Vision blurred
Clinical narrative: First, redness and swelling in left arm for about a week. Followed by blurred vision in right eye.  Difficulty in driving. Cornea transplant in 2011. Followed by December and February doctor appointments and prescriptions. Has improved, but still under Dr care.  Will see again in March.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache
Clinical narrative: Feeling dizzy and headache shortly after taking the flu shot, and the symptoms lasted 4-5 days.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Mobility decreased, Pain
Clinical narrative: Big time flu symptoms. Couldn't move for over 48 hours. Severe body pain.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Product supply issue
Clinical narrative: Big time flu symptoms. Couldn't move for over 48 hours. Severe body pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician, referring to himself, a 66 year-old male patient. The patient did not have any concomitant medications or medical history were not disclosed. Past drug reactions included Parsonage Turner Syndrome developed after the vaccination with an unspecified flu vaccine, on an unspecified date in September 2018. On 21-JAN-2019, the patient received a dose of PNEUMOVAX 23 (route, dose, frequency, lot # and expiration date were unknown) in the left arm, for prophylaxis. He reported that the vaccine was painful when administered (injection site pain) and later that day, he had soreness at the injection site and chills, but no fever. The next day, on 22-JAN-2019, the patient felt that pain traveled to the bicep (pain in extremity), and there was macular redness at injection site (injection site erythema). Afterwards, on 23-JAN-2019, the patient experienced some distal swelling (peripheral swelling) and noticed that the redness spread to size of 4.5 inches by 3 inches (erythema). The patient reported that he received treatment due to these events and sought medical attention with a primary care physician, but it was not specified further. No Lab diagnostics or studies were performed. At the time of this report, the outcome of pain in extremity, chills, injection site erythema, injection site pain, peripheral swelling and erythema was reported as not recovered. Causality assessment between PNEUMOVAX 23 and the aforementioned events was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2019, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N0306956 and expiration date: 25-AUG-2019) single dose, once, orally, for prophylaxis. The administered doses of the vaccines experienced a temperature of 50.92 Fahrenheit for 20 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dyspepsia, Headache, Injection site erythema
Clinical narrative: I started to get a headache after the first hour or two. Overnight my headache got much worse, I had indigestion, dizziness, body aches and was shivering off and on. The next day (Sunday) the headache was bad, but manageable with TYLENOL and shivering had stopped. I mostly had to stay in bed. Today- Monday- I still need the TYLENOL but feel more like myself. The redness/swelling at the injections site is a bit larger than a silver dollar. My husband got a shot at same time but only had a slight headache and his arm, while sore, looks nothing like mine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: I started to get a headache after the first hour or two. Overnight my headache got much worse, I had indigestion, dizziness, body aches and was shivering off and on. The next day (Sunday) the headache was bad, but manageable with TYLENOL and shivering had stopped. I mostly had to stay in bed. Today- Monday- I still need the TYLENOL but feel more like myself. The redness/swelling at the injections site is a bit larger than a silver dollar. My husband got a shot at same time but only had a slight headache and his arm, while sore, looks nothing like mine.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chest X-ray normal, Cough, Injection site erythema, Injection site infection
Clinical narrative: 2/6/19 C/O head congestion. 2/7 started with low grade temp. MOTRIN/TYLENOL/HALLS lozenges/ MUCINEX, 2/7/19 8:31 temp of 102.2, 2/8/19 nasal congestion & cough, Temp 102.9, Diagnosed with UTI, MACROBID started. Low sodium, IV fluids (NS) started and CXR done (no acute cardiopulmonary disease), 2/9 R deltoid skin infection, redness, tender, 10-15 cm in diameter, site of pneumonia vaccine on 2/6/19. WBC increased, MACROBID discontinued, KEFLEX & BACTRIM started to cover both UTI and skin infection.  Infection continued to improve until 2/16/19 when it was completely resolved.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nasal congestion, Upper respiratory tract congestion, Urinary tract infection, White blood cell count increased
Clinical narrative: 2/6/19 C/O head congestion. 2/7 started with low grade temp. MOTRIN/TYLENOL/HALLS lozenges/ MUCINEX, 2/7/19 8:31 temp of 102.2, 2/8/19 nasal congestion & cough, Temp 102.9, Diagnosed with UTI, MACROBID started. Low sodium, IV fluids (NS) started and CXR done (no acute cardiopulmonary disease), 2/9 R deltoid skin infection, redness, tender, 10-15 cm in diameter, site of pneumonia vaccine on 2/6/19. WBC increased, MACROBID discontinued, KEFLEX & BACTRIM started to cover both UTI and skin infection.  Infection continued to improve until 2/16/19 when it was completely resolved.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Blister, Blood test normal, Chills, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Next morning, felt so fatigued & out of it, went back to bed. By the next evening, had extreme flu-like symptoms - vomiting, diarrhea, fever, chills, headache, body aches. Was in bed until the next evening, when I got up realized I had very blurry vision, couldn't read or focus, still had headache and nausea and was very dizzy. Felt like I was drunk. Was sent to the ER because of the blurry vision. Two days later, I developed a painful sore on my lower buttock, and about 4" of  red patches on my right arm. I looked at the one on my butt with a mirror & saw that it looked like it had lots of little blisters on it, so I was concerned I had shingles or herpes or something. So I went and had a doctor look at it.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Diarrhoea, Dizziness, Electrocardiogram normal, Erythema, Fatigue
Clinical narrative: Next morning, felt so fatigued & out of it, went back to bed. By the next evening, had extreme flu-like symptoms - vomiting, diarrhea, fever, chills, headache, body aches. Was in bed until the next evening, when I got up realized I had very blurry vision, couldn't read or focus, still had headache and nausea and was very dizzy. Felt like I was drunk. Was sent to the ER because of the blurry vision. Two days later, I developed a painful sore on my lower buttock, and about 4" of  red patches on my right arm. I looked at the one on my butt with a mirror & saw that it looked like it had lots of little blisters on it, so I was concerned I had shingles or herpes or something. So I went and had a doctor look at it.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Feeling abnormal, Feeling drunk, Headache, Influenza like illness, Musculoskeletal pain
Clinical narrative: Next morning, felt so fatigued & out of it, went back to bed. By the next evening, had extreme flu-like symptoms - vomiting, diarrhea, fever, chills, headache, body aches. Was in bed until the next evening, when I got up realized I had very blurry vision, couldn't read or focus, still had headache and nausea and was very dizzy. Felt like I was drunk. Was sent to the ER because of the blurry vision. Two days later, I developed a painful sore on my lower buttock, and about 4" of  red patches on my right arm. I looked at the one on my butt with a mirror & saw that it looked like it had lots of little blisters on it, so I was concerned I had shingles or herpes or something. So I went and had a doctor look at it.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Nausea, Pain, Pyrexia, Skin ulcer, Vision blurred
Clinical narrative: Next morning, felt so fatigued & out of it, went back to bed. By the next evening, had extreme flu-like symptoms - vomiting, diarrhea, fever, chills, headache, body aches. Was in bed until the next evening, when I got up realized I had very blurry vision, couldn't read or focus, still had headache and nausea and was very dizzy. Felt like I was drunk. Was sent to the ER because of the blurry vision. Two days later, I developed a painful sore on my lower buttock, and about 4" of  red patches on my right arm. I looked at the one on my butt with a mirror & saw that it looked like it had lots of little blisters on it, so I was concerned I had shingles or herpes or something. So I went and had a doctor look at it.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Vomiting
Clinical narrative: Next morning, felt so fatigued & out of it, went back to bed. By the next evening, had extreme flu-like symptoms - vomiting, diarrhea, fever, chills, headache, body aches. Was in bed until the next evening, when I got up realized I had very blurry vision, couldn't read or focus, still had headache and nausea and was very dizzy. Felt like I was drunk. Was sent to the ER because of the blurry vision. Two days later, I developed a painful sore on my lower buttock, and about 4" of  red patches on my right arm. I looked at the one on my butt with a mirror & saw that it looked like it had lots of little blisters on it, so I was concerned I had shingles or herpes or something. So I went and had a doctor look at it.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Blood glucose abnormal, Dizziness, Laboratory test normal, Vision blurred
Clinical narrative: Next morning, felt so fatigued & out of it, went back to bed. By the next evening, had extreme flu-like symptoms - vomiting, diarrhea, fever, chills, headache, body aches. Was in bed until the next evening, when I got up realized I had very blurry vision, couldn't read or focus, still had headache and nausea and was very dizzy. Felt like I was drunk. Was sent to the ER because of the blurry vision. Two days later, I developed a painful sore on my lower buttock, and about 4" of  red patches on my right arm. I looked at the one on my butt with a mirror & saw that it looked like it had lots of little blisters on it, so I was concerned I had shingles or herpes or something. So I went and had a doctor look at it.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Blister, Blood test normal, Chills, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Pt. came in the store on 2/18/19 saying she went to the hospital secondary to getting blurred vision and dizzy a few days after receiving these 3 vaccines. She also admitted that her glucose levels were abnormal that week as well. Patient was convinced that her experience was due to the vaccines and told me she wanted her experience reported.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Diarrhoea, Dizziness, Electrocardiogram normal, Erythema, Fatigue
Clinical narrative: Pt. came in the store on 2/18/19 saying she went to the hospital secondary to getting blurred vision and dizzy a few days after receiving these 3 vaccines. She also admitted that her glucose levels were abnormal that week as well. Patient was convinced that her experience was due to the vaccines and told me she wanted her experience reported.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Feeling abnormal, Feeling drunk, Headache, Influenza like illness, Musculoskeletal pain
Clinical narrative: Pt. came in the store on 2/18/19 saying she went to the hospital secondary to getting blurred vision and dizzy a few days after receiving these 3 vaccines. She also admitted that her glucose levels were abnormal that week as well. Patient was convinced that her experience was due to the vaccines and told me she wanted her experience reported.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Nausea, Pain, Pyrexia, Skin ulcer, Vision blurred
Clinical narrative: Pt. came in the store on 2/18/19 saying she went to the hospital secondary to getting blurred vision and dizzy a few days after receiving these 3 vaccines. She also admitted that her glucose levels were abnormal that week as well. Patient was convinced that her experience was due to the vaccines and told me she wanted her experience reported.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Vomiting
Clinical narrative: Pt. came in the store on 2/18/19 saying she went to the hospital secondary to getting blurred vision and dizzy a few days after receiving these 3 vaccines. She also admitted that her glucose levels were abnormal that week as well. Patient was convinced that her experience was due to the vaccines and told me she wanted her experience reported.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13, VARZOS, FLUA3, PNC13, VARZOS
Symptoms: Blood glucose abnormal, Dizziness, Laboratory test normal, Vision blurred
Clinical narrative: Pt. came in the store on 2/18/19 saying she went to the hospital secondary to getting blurred vision and dizzy a few days after receiving these 3 vaccines. She also admitted that her glucose levels were abnormal that week as well. Patient was convinced that her experience was due to the vaccines and told me she wanted her experience reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Coma scale normal, Computerised tomogram normal, Dizziness, Ear pain
Clinical narrative: Shortly after being given her 11yr old vaccines, Patient fell weak and dizzy. She was sitting on the exam table. She subsequently fell and hit the left side of her head. I heard the mother scream. MD was next door. MD immediately went to the next room. MD found her mother on the floor with her child in her arm who was uncounscous. MD checked her pulse which was in the 90's. MD called out her name and immediately woke up and opened her eyes. She was in a bit of daze. She was able to recognize me and her mother. MD have her an alcohol swab to smell as a noxious stimuli. MD activated EMS. We brought in the crash cart. MD asked the child to sit on the chair. She said she felt dizzy. MD performed a mini mental exam. She passed the test without any errors. Her GCS was 15. Shortly there after EMS and I gave them an update. We repeated the vital signs which were WNL. A bedside ECG was done which was normal. Given that she was feeling dizzy, MD counseled the mother that she should be evaluated in the ER. The EMT agreed to take her to ER.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Electrocardiogram abnormal, Fall, Feeling abnormal, Head injury, Headache
Clinical narrative: Shortly after being given her 11yr old vaccines, Patient fell weak and dizzy. She was sitting on the exam table. She subsequently fell and hit the left side of her head. I heard the mother scream. MD was next door. MD immediately went to the next room. MD found her mother on the floor with her child in her arm who was uncounscous. MD checked her pulse which was in the 90's. MD called out her name and immediately woke up and opened her eyes. She was in a bit of daze. She was able to recognize me and her mother. MD have her an alcohol swab to smell as a noxious stimuli. MD activated EMS. We brought in the crash cart. MD asked the child to sit on the chair. She said she felt dizzy. MD performed a mini mental exam. She passed the test without any errors. Her GCS was 15. Shortly there after EMS and I gave them an update. We repeated the vital signs which were WNL. A bedside ECG was done which was normal. Given that she was feeling dizzy, MD counseled the mother that she should be evaluated in the ER. The EMT agreed to take her to ER.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Shortly after being given her 11yr old vaccines, Patient fell weak and dizzy. She was sitting on the exam table. She subsequently fell and hit the left side of her head. I heard the mother scream. MD was next door. MD immediately went to the next room. MD found her mother on the floor with her child in her arm who was uncounscous. MD checked her pulse which was in the 90's. MD called out her name and immediately woke up and opened her eyes. She was in a bit of daze. She was able to recognize me and her mother. MD have her an alcohol swab to smell as a noxious stimuli. MD activated EMS. We brought in the crash cart. MD asked the child to sit on the chair. She said she felt dizzy. MD performed a mini mental exam. She passed the test without any errors. Her GCS was 15. Shortly there after EMS and I gave them an update. We repeated the vital signs which were WNL. A bedside ECG was done which was normal. Given that she was feeling dizzy, MD counseled the mother that she should be evaluated in the ER. The EMT agreed to take her to ER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Persistent left deltoid pain x 2 months after injection.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, headache, chills, diarrhea and muscle ache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Chills, muscle ache, fatigue, swelling and pain at injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain
Clinical narrative: PATIENT CALLED US ON 02/16/19 ON SATURDAY & WAS COMPLAINING PAIN ALL OVER BODY & HE HAS DIFFICULTY IN WALKING.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash erythematous, Swelling face
Clinical narrative: Red rash on both cheeks and lightly on arms - no complaint of itchiness or irritation. Mild fever (no higher than 99.1). Slightly swollen right cheek. No treatment given - temperature and skin tone were monitored. As of the submission of this report, it has been  4 days since noticing the rash. We plan on a doctor's visit in the next day or so.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Severe pain in injection site, chills, headache, fever and fatigue for 4 days.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling of right upper arm with rash the.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: She broke out in hives for 3 days following the vaccination. It was DTap but I am unsure of whether is was DAPTACEL or INFANRIX.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Migraine
Clinical narrative: Immediate muscle pain at the injection site, which quickly spread down my right arm and to my right shoulder, and has since limited my ability to use my right arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Chills, Headache, Fever, Fatigue, Muscle Aches, Swelling and redness at injection site and loss of taste buds.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Chills, Headache, Fever, Fatigue, Muscle Aches, Swelling and redness at injection site and loss of taste buds.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Cellulitis, Chills, Fatigue, Headache
Clinical narrative: Approx 15 hours post injection, (2/14/19) I awoke feeling sore at the site of the injection and also experienced a headache and fatigue. Throughout the next several hours I experienced a headache, fatigue, chills and nausea. Approx. 24 hours later I took my temperature and had a temperature of 100.6. On the morning of 2/15/19 I noticed a small red rash and slight swelling several inches below the injection site and to the inside of my upper right arm. I still was experiencing fatigue but fever was gone. The next 2 days the pain at the injection site decreased significantly but I noticed the rash and swelling had increased in size and felt warm to the touch. On Monday, 2/18/2019 all other symptoms have disappeared except for the rash and swelling that have increased significantly.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Approx 15 hours post injection, (2/14/19) I awoke feeling sore at the site of the injection and also experienced a headache and fatigue. Throughout the next several hours I experienced a headache, fatigue, chills and nausea. Approx. 24 hours later I took my temperature and had a temperature of 100.6. On the morning of 2/15/19 I noticed a small red rash and slight swelling several inches below the injection site and to the inside of my upper right arm. I still was experiencing fatigue but fever was gone. The next 2 days the pain at the injection site decreased significantly but I noticed the rash and swelling had increased in size and felt warm to the touch. On Monday, 2/18/2019 all other symptoms have disappeared except for the rash and swelling that have increased significantly.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Approx 15 hours post injection, (2/14/19) I awoke feeling sore at the site of the injection and also experienced a headache and fatigue. Throughout the next several hours I experienced a headache, fatigue, chills and nausea. Approx. 24 hours later I took my temperature and had a temperature of 100.6. On the morning of 2/15/19 I noticed a small red rash and slight swelling several inches below the injection site and to the inside of my upper right arm. I still was experiencing fatigue but fever was gone. The next 2 days the pain at the injection site decreased significantly but I noticed the rash and swelling had increased in size and felt warm to the touch. On Monday, 2/18/2019 all other symptoms have disappeared except for the rash and swelling that have increased significantly.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Patient experience pain and swelling red and blue at the injection site, couldn't sleep at night.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives, lasting about a week at this writing, maybe about over it.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain in extremity
Clinical narrative: 1ST DOSE 8/24/2018 MADE ME NAUSEOUS AND WITH FLU LIKE SYMPTOMS FOR AT LEAST 3 DAYS WITH SEVERE PAIN IN THE LEFT ARM WHICH SUBSIDED IN ABOUT A WEEK. 2ND DOSE 12/28/2018 HAS RESULTED IN HAVING SEVERE PAIN IN THE LEFT ARM WHICH HAS NOT GONE AWAY. IT HAS BEEN A MONTH AND A HALF AND A I STILL HAVE SEVERE PAIN IN MY ARM THAT FEELS LIKE NERVE DAMAGE OR MUSCLE DAMAGE.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Irritability, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Patient's mother is not sure when exactly the redness on left thigh started, if it was right after getting the vaccines or if it was later. She sent a message because she thought that the area looked more red and raised today than it had been yesterday or previously. Area on left thigh is about 0.5 inches by 0.25 in size. Pt didn't seem bothered by having the area touched. Pt had a low grade fever of 100 F overnight on 2/15/19. Later on Friday 2/15/19, Patient developed a fever and was fussy/irritable. Then developed rash all over body concomitant with the fever. Fever lasted about 24 hours. Today, 2/18/19 rash is fading but still present on chest/abdomen. Flat (macular) erythematous rash noted on abdomen and anterior chest. Left anterior thigh there is erythema without increased warmth or drainage. Patient noted to be scratching at area during exam. Size of erythema is 1-1.5 cm length, centrally there is induration ~ 5 mm size. No apparent Thrombotic Thrombocytopenia Purpura. Parent instructed to apply hydrocortisone cream to red area on left thigh twice daily for up to 14 days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash macular
Clinical narrative: Patient's mother is not sure when exactly the redness on left thigh started, if it was right after getting the vaccines or if it was later. She sent a message because she thought that the area looked more red and raised today than it had been yesterday or previously. Area on left thigh is about 0.5 inches by 0.25 in size. Pt didn't seem bothered by having the area touched. Pt had a low grade fever of 100 F overnight on 2/15/19. Later on Friday 2/15/19, Patient developed a fever and was fussy/irritable. Then developed rash all over body concomitant with the fever. Fever lasted about 24 hours. Today, 2/18/19 rash is fading but still present on chest/abdomen. Flat (macular) erythematous rash noted on abdomen and anterior chest. Left anterior thigh there is erythema without increased warmth or drainage. Patient noted to be scratching at area during exam. Size of erythema is 1-1.5 cm length, centrally there is induration ~ 5 mm size. No apparent Thrombotic Thrombocytopenia Purpura. Parent instructed to apply hydrocortisone cream to red area on left thigh twice daily for up to 14 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Erythema left thigh with induration. Not tender, slight warmth. Measures 7 X 8 cm.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness, Vomiting
Clinical narrative: Patient states that she got the vaccine and 3 hours later was at the mall at the food court when she was eating. Patient suddenly had the feeling of her throat closing up. Patient stopped eating and had a bout of emesis. Symptoms resolved shortly after. Patient did not attempt to finish eating.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Hiccups, Nausea, Oesophageal discomfort, Oesophageal pain
Clinical narrative: Patient states that she got the vaccine and 3 hours later was at the mall at the food court when she was eating. Patient suddenly had the feeling of her throat closing up. Patient stopped eating and had a bout of emesis. Symptoms resolved shortly after. Patient did not attempt to finish eating.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Pain in extremity, Throat tightness, Vomiting
Clinical narrative: Patient states that she got the vaccine and 3 hours later was at the mall at the food court when she was eating. Patient suddenly had the feeling of her throat closing up. Patient stopped eating and had a bout of emesis. Symptoms resolved shortly after. Patient did not attempt to finish eating.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Ppatient had a red spot on the arm at the site of the injection, it was not raised or warm.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Angiotensin converting enzyme decreased, Anti-aquaporin-4 antibody negative, Antinuclear antibody negative, CSF oligoclonal band absent
Clinical narrative: At trampoline park 3 days prior to onset of sx. Onset of arm weakness and paresthesias about 12/29. Seen in local peds er 12/30 and seen again with progression/worsening on 12/31. Abnml spine MRI from C4 to T1, admitted to Hospital 12/31 with dx of transverse myelitis. Loss of grip in hands, arm weakness, numbness, and progression to truncal numbness/abd discomfort. Progression until unable to ambulate. Brain MRI nml, Given high dose steroids and plasmapharesis with gradual improvement. D/C home on 1/10/2019. F/U with neurologist dr. Still with bilateral upper ext weakness and numbness with slow improvement. Labs for systemic inflammatory illnesses neg. Aquaporin-4 antibody neg. Plan repeat labs and MRI in 3 months.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Grip strength decreased, Hypoaesthesia, Muscular weakness, Myelitis transverse
Clinical narrative: At trampoline park 3 days prior to onset of sx. Onset of arm weakness and paresthesias about 12/29. Seen in local peds er 12/30 and seen again with progression/worsening on 12/31. Abnml spine MRI from C4 to T1, admitted to Hospital 12/31 with dx of transverse myelitis. Loss of grip in hands, arm weakness, numbness, and progression to truncal numbness/abd discomfort. Progression until unable to ambulate. Brain MRI nml, Given high dose steroids and plasmapharesis with gradual improvement. D/C home on 1/10/2019. F/U with neurologist dr. Still with bilateral upper ext weakness and numbness with slow improvement. Labs for systemic inflammatory illnesses neg. Aquaporin-4 antibody neg. Plan repeat labs and MRI in 3 months.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Plasmapheresis
Clinical narrative: At trampoline park 3 days prior to onset of sx. Onset of arm weakness and paresthesias about 12/29. Seen in local peds er 12/30 and seen again with progression/worsening on 12/31. Abnml spine MRI from C4 to T1, admitted to Hospital 12/31 with dx of transverse myelitis. Loss of grip in hands, arm weakness, numbness, and progression to truncal numbness/abd discomfort. Progression until unable to ambulate. Brain MRI nml, Given high dose steroids and plasmapharesis with gradual improvement. D/C home on 1/10/2019. F/U with neurologist dr. Still with bilateral upper ext weakness and numbness with slow improvement. Labs for systemic inflammatory illnesses neg. Aquaporin-4 antibody neg. Plan repeat labs and MRI in 3 months.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Chills and shaking for 3 hours.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Chest pain, Computerised tomogram, Flank pain, Inflammation
Clinical narrative: The day my husband received the SHINGRIX vaccine he became ill. After 2 Dr. visits, he was sent to the ER and was admitted, there for 19 days. His symptoms kept changing and worsening. First, apparent pneumonia, then to critical care unit for respiratory failure.Then severe "migratory pain" starting in chest and ending in excruciating right flank pain. Drs ran LOTS of tests...Xrays,CT's, MRI, even a PET scan. His C-Reactive Protein was 299 (normal is less than 2). Found nothing to explain this "inflammatory cascade" and finally said it was probably a severe reaction to the SHINGRIX (I have more info, here and other #'s but Continuation Page won't work.).