chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included no adverse effect. On 12th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced joint pain, influenza and injection site pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the influenza and injection site pain were recovered/resolved. It was unknown if the reporter considered the joint pain, influenza and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. At vaccination night or the day after vaccination, the arm where she received the shot hurt and she also felt like she was coming down with the flu. It lasted a day. However, about the following week she started noticing severe joint pain. She has joint pain in her knuckles of both hands and both knees. She said that she was not recovered till the time of reporting and the pain was about the same since then. The patient was concerned about getting her second SHINGRIX dose. She did not have her physician's name with her at the time of the call.
Sex: F
Vaccine: VARZOS
Symptoms: Back disorder, Condition aggravated
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back disorder in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back disorder (patient had back problem at least 20 times a year). On 8th August 2018, the patient received the 2nd dose of SHINGRIX. On 8th August 2018, less than a day after receiving SHINGRIX, the patient experienced back disorder. On an unknown date, the outcome of the back disorder was unknown. It was unknown if the reporter considered the back disorder to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient mentioned that after taking the vaccine the day of reporting, as she was leaving the pharmacy, her back went out. She stated that the problem with her back was not uncommon. The patient had this problem at least 20 times a year. She said that it had nothing to do with the vaccine. The patient name was already in the system, but it was missed confirming the address. This was all of the information provided.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Myalgia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 69-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received SHINGRIX (intramuscular) 50 ug. On 6th August 2018, less than a day after receiving SHINGRIX, the patient experienced muscle soreness and influenza-like symptoms. On 8th August 2018, the patient experienced rash and injection site erythema. On an unknown date, the outcome of the muscle soreness and influenza-like symptoms were recovered/resolved and the outcome of the rash and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the muscle soreness, rash, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient experienced muscle soreness and flu like symptoms on the first and second day, but they had resolved. On 8th August 2018, the patient developed a rash around his neck, and on his stomach and chest. He also developed redness around the injection site and inside his elbow.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of myalgia (For tolerance to the 1st dose received on 20th March 2018, refer case US2018GSK149449). On 1st June 2018, the patient received the 2nd dose of SHINGRIX. On 2nd June 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, nausea, vomiting and fatigue. On 5th June 2018, the outcome of the muscle pain, nausea, vomiting and fatigue were recovered/resolved. It was unknown if the reporter considered the muscle pain, nausea, vomiting and fatigue to be related to SHINGRIX. Additional details were provided as follows: The next day after vaccination, the patient experienced muscle pain, fatigue, nausea, and vomiting. The events were resolved after 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site swelling, erythema of extremities and incomplete course of vaccination. On an unknown date, the outcome of the injection site swelling and erythema of extremities were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in physician's office. On 2nd February 2018, the patient received 1st dose and was already late for her 2nd dose at the time of reporting, which led to incomplete course of vaccination. After 1st dose of SHINGRIX, the patient had swelling around the injection site and redness that went down her arm almost to her elbow. Both symptoms resolved within 2 to 3 days. The reporter was unable to provide any additional details. The reporter's call was transferred to Medical Information.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But it could be 78 or 79 years old. The patient did not know the date of administration, but stated that she received SHINGRIX a few weeks ago. The patient experienced a rash on the front of her body. She stated that the rash was interspersed and did not completely cover the area of her skin. The patient declined to give phone number or other personal information.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a female patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced feeling hot, tiredness, headache and pain. On an unknown date, the outcome of the feeling hot, tiredness, headache and pain were not recovered/not resolved. It was unknown if the reporter considered the feeling hot, tiredness, headache and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The day before reporting, the patient received a dose of SHINGRIX and was feeling feverish or warm, achy, tired and had a headache at the time of reporting. The patient did not wish to provide any additional information regarding the event and stated that she did not want to file a report as she expected these side effects.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Gastrooesophageal reflux disease, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included coronary artery disease, gastroesophageal reflux disease, urinary tract disorder (urological difficulties) and arthritis. Concomitant products included omeprazole. On 7th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 7th August 2018, 7 hrs after receiving SHINGRIX, the patient experienced fatigue, gastroesophageal reflux, injection site pain, fever and chills. On an unknown date, the patient experienced tremor and feeling abnormal. The patient was treated with ibuprofen. On an unknown date, the outcome of the fatigue, fever and chills were recovered/resolved and the outcome of the gastroesophageal reflux and injection site pain were not recovered/not resolved and the outcome of the tremor and feeling abnormal were unknown. It was unknown if the reporter considered the fatigue, gastroesophageal reflux, injection site pain, fever, chills, tremor and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: At 9 AM, the patient received SHINGRIX. Around 4 PM, 7 hours after receiving SHINGRIX the patient felt fatigued. He often was fatigued in the afternoon, but this time he laid down for about 1 hour and when he got up did not feel any better. He also felt like his stomach was acting up around this time. By 9 PM, 12 hours after receiving SHINGRIX, the patient had chills and a fever of about 102.5 F. He took 600 mg of ibuprofen, but it was difficult for him to open the bottle because he was shaking so hard. He went to bed and over the course of the night his fever went down and by morning it was 89.9 F. The patient also had soreness at the injection site, but no redness or swelling. On 8th and 9th August 2018, the patient's stomach had continued to cause him problems and he had prominent reflux when eating. This case is 1 of the 4 cases reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included coronary artery disease, gastroesophageal reflux disease, urinary tract disorder (urological difficulties) and arthritis. Concomitant products included omeprazole. On 7th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 7th August 2018, 7 hrs after receiving SHINGRIX, the patient experienced fatigue, gastroesophageal reflux, injection site pain, fever and chills. On an unknown date, the patient experienced tremor and feeling abnormal. The patient was treated with ibuprofen. On an unknown date, the outcome of the fatigue, fever and chills were recovered/resolved and the outcome of the gastroesophageal reflux and injection site pain were not recovered/not resolved and the outcome of the tremor and feeling abnormal were unknown. It was unknown if the reporter considered the fatigue, gastroesophageal reflux, injection site pain, fever, chills, tremor and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: At 9 AM, the patient received SHINGRIX. Around 4 PM, 7 hours after receiving SHINGRIX the patient felt fatigued. He often was fatigued in the afternoon, but this time he laid down for about 1 hour and when he got up did not feel any better. He also felt like his stomach was acting up around this time. By 9 PM, 12 hours after receiving SHINGRIX, the patient had chills and a fever of about 102.5 F. He took 600 mg of ibuprofen, but it was difficult for him to open the bottle because he was shaking so hard. He went to bed and over the course of the night his fever went down and by morning it was 89.9 F. The patient also had soreness at the injection site, but no redness or swelling. On 8th and 9th August 2018, the patient's stomach had continued to cause him problems and he had prominent reflux when eating. This case is 1 of the 4 cases reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Flatulence, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Crohn's disease (bad bout last year, currently in remission) and small intestinal resection (had about 2 feet removed). Concomitant products included Vitamin B12 and ENTYVIO. On 7th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, stomach pain and gas. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved and the outcome of the injection site erythema and stomach pain were recovering/resolving and the outcome of the gas was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, stomach pain and gas to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. At 9 AM, the patient received SHINGRIX. The next day after receiving SHINGRIX, the patient had pain, redness and swelling at the injection site. The patient also experienced stomach pain which might be related to gas. The stomach pain lasted about 12 hours. On 9th August 2018, on the reporting date, the stomach pain was much better and the injection site was less red, but it was still tender and swollen. The swelling was greater than 2 inches in diameter. This case is 1 of the 4 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via out of hour services and described the occurrence of general body pain in a adult female patient who received SHINGRIX for prophylaxis. On 9th August 2018, the patient received the 2nd dose of SHINGRIX. On 10th August 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, fever and joint pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the general body pain, fever and joint pain were not recovered/not resolved. It was unknown if the reporter considered the general body pain, fever and joint pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by nurse practitioner for herself. The age group was not reported but was selected as adult as per vaccine indication. On Thursday, 9th August 2018, the patient received 2nd dose of SHINGRIX. On 10th August 2018, the patient experienced body aches and joint aches. The patient was also reporting a fever of 100 degrees F. The patient took 800 mg of Ibuprofen with no effect alleviating her symptoms. At time of message, symptoms were not resolved. A VM was left on Friday, 10th August 2018, at 9:12 PM. The contact person filed the adverse reaction as discussed on the voice mail. He would call back later in the day to ask additional questions. There might be a follow up report as a result. This adverse events has been corrected by agent. The contact person attempted a second call back and the patient did not answer; only voicemail was left. The patient was given a number to reference, if she desires to call back.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) for prophylaxis. Additional patient notes included None. On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th February 2018, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain and headache. On 17th February 2018, the outcome of the chills, general body pain and headache were recovered/resolved. It was unknown if the reporter considered the chills, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The reported adverse events were not associated with medical history or concurrent illness, erroneous administration, suspected transmission of an infectious agent via medicinal product and lack of effect.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of SHINGRIX. On 20th July 2018, not applicable after receiving SHINGRIX and immediately after receiving SHINGRIX, the patient experienced pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The caller stated that the patient received the SHINGRIX adjuvant in left deltoid without being reconstituted with the antigen which, led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The caller stated that once this was discovered, the patient received a dose of the reconstituted vaccine and the patient reported that she felt soreness in her arm immediately following the injection of the reconstituted vaccine. The patient experienced soreness in the left arm for 2 days before the symptoms resolved. The caller stated that one of his fellow colleagues reported this event; however, an agent was not able to locate this report.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Malaise, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, fever, malaise, pain and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, malaise, pain and fatigue were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, malaise, pain and fatigue to be related to SHINGRIX. Additional details reported as follows: The doctor did not provide any demographics. The reporter had an elderly female patient in good health who had SHINGRIX shot two months ago and experienced a severe, but not threatening reaction. She had a very large red area surrounding the injection site with concomitant swelling, fever of 99.8 for two days, malaise, aching, fatigue, etc. She had asked to the reporter if she could apply heat or cold to the injection site and reporter was  not sure how to advise her.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, fever, malaise, pain and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, malaise, pain and fatigue were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, malaise, pain and fatigue to be related to SHINGRIX. Additional details reported as follows: The doctor did not provide any demographics. The reporter had an elderly female patient in good health who had SHINGRIX shot two months ago and experienced a severe, but not threatening reaction. She had a very large red area surrounding the injection site with concomitant swelling, fever of 99.8 for two days, malaise, aching, fatigue, etc. She had asked to the reporter if she could apply heat or cold to the injection site and reporter was  not sure how to advise her.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 20th March 2018, the patient received the 1st dose of SHINGRIX. On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain. On 21st March 2018, the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported muscle pain, which only lasted a day. This case was linked to the case US2018144763, reported by the same reporter for the same patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness at injection site. Increasing in intensity over 2 days.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cold sweat, Diarrhoea, Myalgia, Vomiting
Clinical narrative: Diarrhea, vomitting, muscle pain, cold sweats.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect product formulation administered
Clinical narrative: Only diluent was given, no active vaccine. No adverse side effects, family had to return for active vaccine.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect product formulation administered
Clinical narrative: Only diluent was given, without mixing in vaccine. Thus patient had to return for the vaccine. No side effects.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Only diluent was given, without mixing in vaccine. Thus patient had to return for the vaccine. No side effects.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: PT called and left a message reporting subjective fever, chills, soreness around site injection and fatigue. He stated that is fever last from the evening of the shot until 0930 this morning of 8/17/18.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle tightness, Pain, X-ray
Clinical narrative: No pain after and during injection. Soreness started 2-3 days post injection. After that 3 days, no pain improvement/worsening. Since then, lingering pain occurs whenever he tries to lift his arm up, but pain stops 30 seconds after he puts his arm down. The pain located on the back of his left upper arm. Per pt, he was given shot (unsure of what that is) to relieve the muscle tension which was diagnosed by his doctor at the time. He's given X-ray as well and still waiting for the result.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Vaccination site mass
Clinical narrative: Patient was brought in to urgent care for "bumps on both arms". Mother states he received immunizations in the leg and each arm 6 days ago. Provider documents 0.5cm intramuscular mass in right deltoid under vaccination site. Mother was instructed to apply warm compresses and follow up in the clinic in 2-3 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Very achy all over to the point of causing nausea from booster though the first round did not result in hardly any reaction despite being coupled with tetanus booster.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid began to swell and become red at bedtime the evening the shot was given. Patient called pharmacy the next morning. Injection site not red or inflamed - but the rest of the arm. Recommended she call her physician and do warm compresses and BENADRYL. Patient went to MD and got a script for Triamcinolone and was told to take OTC ALEVE and BENADRYL for the next 2 days. MD did not believe any infection but just an allergic reaction.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, fever, large red and very swollen and sore area at injection spot, itchy at injection spot, weak and extremely tired. Today is day 3 and my arm is still super swollen, red and painful.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Headache, fever, large red and very swollen and sore area at injection spot, itchy at injection spot, weak and extremely tired. Today is day 3 and my arm is still super swollen, red and painful.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Electrocardiogram, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient had syncopal episode a few minutes post vaccination administration and fell to floor striking his head. Loss of consciousness for 30 seconds and then proceeded to vomit x's 1. Vitals signs normal. Blood sugar normal. Complained of neck pain and decided by mother to go for evaluation to local ED. Was evaluated at ED and nothing further needed evaluated. Seen in our office for a ED follow-up and patient was better but still complaining of mild neck strain.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle strain, Neck pain, Spinal X-ray, Syncope, Vomiting
Clinical narrative: Patient had syncopal episode a few minutes post vaccination administration and fell to floor striking his head. Loss of consciousness for 30 seconds and then proceeded to vomit x's 1. Vitals signs normal. Blood sugar normal. Complained of neck pain and decided by mother to go for evaluation to local ED. Was evaluated at ED and nothing further needed evaluated. Seen in our office for a ED follow-up and patient was better but still complaining of mild neck strain.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Presyncope.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: Pt reported mild swelling at the site of TRUMENBA injection on R delt, redness, no pain or itching, noticed 1 day after the vaccine by pt's mother, 6cm diameter, felt slighlty warm to touch. Pt was seen on 8/17/18, noted decreased swelling and redness. Was advised to ice it 2-3 times/day, to call if no improvement or worsening.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema, pain to injection site of posterior upper left arm that was non-responsive to analgesics within 24 hours and ice so client went to ER for further evaluation/care related to what the ER physician described to her as "allergic reaction" and advised her to not receive vaccination again.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles, Local reaction
Clinical narrative: Erythema, edema, pain to injection site of posterior upper left arm that was non-responsive to analgesics within 24 hours and ice so client went to ER for further evaluation/care related to what the ER physician described to her as "allergic reaction" and advised her to not receive vaccination again.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: L arm cellulitis.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Lethargy
Clinical narrative: Patient states feelings of lethargy since receiving the vaccination. Also states that he sometimes experiences dizziness. He is concerned about the length of time these symptoms have lasted.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Erythema, Limb discomfort, Malaise, Pain in extremity
Clinical narrative: Patient contacted pharmacy on 8/17/18 stating, her arm was sore and red, she did not feel well and had diarrhea. I advised her to contact MD and come to pharmacy for me to check arm. I also advised her to use an ice pack on the arm and take TYLENOL or ibuprofen for the discomfort. She arrived at pharmacy at 10 am, I looked at arm and it was tender to the touch, warm and somewhat red. Patient did appear not to feel well. I contacted Dr. office and spoke with nurse and explained her symptoms. I gave nurse information as to what vaccines were given and arranged for MD to see patient at 11:30am. I left my name and phone # and asked nurse to have MD call me with any questions or concerns.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Patient contacted pharmacy on 8/17/18 stating, her arm was sore and red, she did not feel well and had diarrhea. I advised her to contact MD and come to pharmacy for me to check arm. I also advised her to use an ice pack on the arm and take TYLENOL or ibuprofen for the discomfort. She arrived at pharmacy at 10 am, I looked at arm and it was tender to the touch, warm and somewhat red. Patient did appear not to feel well. I contacted Dr. office and spoke with nurse and explained her symptoms. I gave nurse information as to what vaccines were given and arranged for MD to see patient at 11:30am. I left my name and phone # and asked nurse to have MD call me with any questions or concerns.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Chills, Feeling hot, Headache, Musculoskeletal stiffness
Clinical narrative: Patient began to have symptoms in the middle of the night 8-17-18. Symptoms consist of shivering, headache, stomach aches, stiffness of arm, and feeling hot all over. Mother of patient expressed that she had given patient ibuprofen to help with the body warmth but it did not seem to help. After consulting with MD regarding the reaction to vaccination, it was felt that patient should go to the ER to be evaluated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Pain
Clinical narrative: Large painful erythematous patch; he was given DEPO MEDROL 40mg and BENADRYL with relief.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pain
Clinical narrative: Nausea and vomiting, dizziness, achiness, chills and sweats.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea and vomiting, dizziness, achiness, chills and sweats.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Immediate post-injection reaction, Pyrexia
Clinical narrative: Child spiked a high fever immediately following vaccinations and lost all verbal communication. Almost two years later and he still cannot communicate verbally. Prior to vaccination, the child was beginning to speak in sentences and was thriving.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Rash
Clinical narrative: Patient vaccinated 8-13-18. Presented at the clinic today (8-17-18) with injection site being red, hot and swollen. She has a rash on her arm and torso and reported having a fever on and off. She said the symptoms started the evening after getting the injection. I advised the patient to go to Urgent Care   as Dr.is out of the office. Patient was treated at Urgent care with antibiotics and steroids.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient vaccinated 8-13-18. Presented at the clinic today (8-17-18) with injection site being red, hot and swollen. She has a rash on her arm and torso and reported having a fever on and off. She said the symptoms started the evening after getting the injection. I advised the patient to go to Urgent Care   as Dr.is out of the office. Patient was treated at Urgent care with antibiotics and steroids.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Patient vaccinated 8-13-18. Presented at the clinic today (8-17-18) with injection site being red, hot and swollen. She has a rash on her arm and torso and reported having a fever on and off. She said the symptoms started the evening after getting the injection. I advised the patient to go to Urgent Care   as Dr.is out of the office. Patient was treated at Urgent care with antibiotics and steroids.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Rash erythematous
Clinical narrative: Initially-red arm. 1 Week later-his leg developed red bumps and they spread. He went to his dr and he said that it was shingles.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Fever up to 104, (temp over 102 for about 48 hours), chills, sweats, malaise, better now, down to 99 now.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Injection site reaction, Injection site vesicles, Malaise
Clinical narrative: Blotchy skin redness at injection site, malaise, muscle aches, vesicle on left arm over bicep and left lower leg below knee. Vesicle on left arm healed. One on left lower leg was evaluated by Dr. and treated with BACTRIM with resolution of cellulitis. MRSA positive.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Rash macular, Staphylococcus test positive
Clinical narrative: Blotchy skin redness at injection site, malaise, muscle aches, vesicle on left arm over bicep and left lower leg below knee. Vesicle on left arm healed. One on left lower leg was evaluated by Dr. and treated with BACTRIM with resolution of cellulitis. MRSA positive.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient's wife said that the patient's arm is still swollen and warm to the touch after 5 days.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Pt received vaccine and was fine. After she witnessed her brother receive his vaccine she stated she felt dizzy and tired. She sat down and was white and sweaty then slumped off the chair. We put her in rescue position. She regained color immediately but didn't regain consciousness for about 15 seconds. She was coherent when she came to but did not remember fainting. She sat again and drank some juice but continued to feel dizzy so she lay on the ground in front of a fan and after about 10 minutes she felt well enough to walk out.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Posture abnormal
Clinical narrative: Pt received vaccine and was fine. After she witnessed her brother receive his vaccine she stated she felt dizzy and tired. She sat down and was white and sweaty then slumped off the chair. We put her in rescue position. She regained color immediately but didn't regain consciousness for about 15 seconds. She was coherent when she came to but did not remember fainting. She sat again and drank some juice but continued to feel dizzy so she lay on the ground in front of a fan and after about 10 minutes she felt well enough to walk out.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Swelling of the arm more than 2/3 of the size of the arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient received the vaccine right below the desired deltoid location. Site is red, swollen, painful. Patient reports flu like symptoms.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain in extremity
Clinical narrative: Very bad headache developed evening after his vaccine, several hours after vaccine per patient and parent. Headache resolved by the next day. Does not typically get headaches. Resolved by the next day. Note, also had a very sore arm for several days (known common vaccine reaction).
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Circumstance or information capable of leading to medication error, Hypoacusis, Syncope, Thirst
Clinical narrative: During injection for patient, the vein jumped and patient got anxious and moved arm, I removed the injection when I already injected half dose to avoid breaking the needle. Right after that, I changed new needle and completed the dose with another injection next to it IM - 1 dose with 2 injections on the same arm. Patient got fainting when he stood up after the injection. He described that he could not hear well and quiet surrounding around him, and he did not see well. I asked him to sit down at the consultation room for another 15 minutes. I brought patient water cups to drink because he said he is thirsty.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: During injection for patient, the vein jumped and patient got anxious and moved arm, I removed the injection when I already injected half dose to avoid breaking the needle. Right after that, I changed new needle and completed the dose with another injection next to it IM - 1 dose with 2 injections on the same arm. Patient got fainting when he stood up after the injection. He described that he could not hear well and quiet surrounding around him, and he did not see well. I asked him to sit down at the consultation room for another 15 minutes. I brought patient water cups to drink because he said he is thirsty.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt received his vaccine and 10 min later witnessed his sister faint. He stated he was dizzy and his father was able to get to him before he fell. He regained consciousness within 5 seconds and drank juice and rested for about 10 min. He was able to walk out on his own.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: Shivering about 4 hours, body aches, redness and swelling, tiredness weakness, no appetite, was in the bed 48 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Shivering about 4 hours, body aches, redness and swelling, tiredness weakness, no appetite, was in the bed 48 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 2-inch erythema at injection site. Warm and tender to the touch per aunt. Applied cool compress and water to the site. Acetaminophen given to the child. 8 hours later, symptoms are relieved. Mild redness and less tender, per aunt.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Both doses same reaction. Extremely painful at site of injection within 4 hours. Body aches and chills within 8 hours. Flu like symptoms for 2-3 days, bad enough to postpone normal activities.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Feeling hot, Tremor
Clinical narrative: Patient felt hot, lightheadedness, general weakness, and shaky.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received vaccine order from provider to give patient DTaP & IPV (KINRIX) due to the patient not being technically due for Hep B at the time. Double checked with another RN and they thought this was okay as well. Administered vaccine as requested. When documenting the vaccine in the computer I realized that this is not recommended for the age group. I immediately went to my Supervisor, and the provider, to tell them this. My supervisor called the Poison Control to find out information and they stated that it was not harmful to the patient. However, it was not effective and will not count. Patient will need to get another vaccination for it to be valid. Provider will contact patient's mother to let her know of this. Unknown if patient has had adverse effect.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chills, Headache, Injection site pain
Clinical narrative: Full body muscle aches, headache, neck stiffness, shivers, nausea, temperature registered at 101 degrees. Took ADVIL PM. Didn't get much sleep. Took regular ADVIL in this morning (8/17), symptoms improved as the day went on. Still have some back pain and pain at injection site (expected).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Full body muscle aches, headache, neck stiffness, shivers, nausea, temperature registered at 101 degrees. Took ADVIL PM. Didn't get much sleep. Took regular ADVIL in this morning (8/17), symptoms improved as the day went on. Still have some back pain and pain at injection site (expected).
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Lip swelling, Swollen tongue
Clinical narrative: Right after vaccine, she feel like she is having trouble breathing, her lips feels like swelling and her tongue swelling, then I gave her EPIPEN and call 911 then few minutes after she said she feels better now, no hives, no dizziness as well, she was able to  talk, walk and drink water as well.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Epistaxis
Clinical narrative: Severe nose bleed 1 hour after shot.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Hypersensitivity, Injection site reaction, Injection site urticaria, Pruritus, Rash erythematous
Clinical narrative: Patient presented on 8/17/18 with red raised 'bumps' and hives around/at injection site of ADACEL 6 days after administration. Patient advised to use hydrocortisone cream/ointment for itching and diphenhydramine at bedtime for allergic reaction. Patient advised that if site becomes warm or hot to touch or develops fever to contact PCP for follow up.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: I administered both immunization into the patients right arm about 2 inches apart. The patient was nervous about getting the injections. Gave both fine and he was fine when finished. I advised to his mother that he hang around for 20 minutes in the store to make sure that he didn't have any issues with breathing or respiratory issues. Approximately 5 minutes after the injections he became lightheaded and pale and fainted. We rushed to him and evaluated the scene. He was conscious and gaining color back. He was lucid and I checked his pulse/bp which was 121/74 with a pulse of 94. He kept telling me he was fine but I kept him on the ground until ems arrived approximately 5 minutes later. They evaluated him again and he was lucid checked his bp/pulse and got him on his feet. He was still slightly pale but stated he felt fine. His mother transported to the hospital to make sure everything was ok.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperaesthesia, Injection site pain, Pyrexia, Tenderness
Clinical narrative: SEVERAL HOURS AFTER RECEIVING THE VACCINE PATIENT WAS ATTENDING A POOL PARTY WHEN HE STARTED TO HAVING CHILLS ALL THROUGHOUT HIS BODY THAT LASTED ABOUT 4-5 HOURS WHICH RESULTED IN A MILD FEVER LASTING ABOUT 2-3 HOURS AFTER. HE RETURNED HOME TO REST AND WOKE UP THE NEXT MORNING WITH EXTREME SENSITIVITY TO HIS SKIN THROUGHOUT HIS WHOLE BODY. HE STATES IS WAS VERY PAINFUL TO THE TOUCH. THESE SYMPTOMS IMPROVED AND HE FELT FULLY RECOVERED AFTER THE SECOND DAY. HE STATES THERE WERE SOME SORENESS IN THE ARM AT THE INJECTION SITE BUT FELT IT WAS SIMILAR TO THE PREVIOUS DOSE HE RECEIVED A FEW MONTHS PRIOR.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Patient came in a couple of hours after receiving vaccine with swollen lip and no reaction at injection site. No difficulty breathing.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Headache, Injection site erythema
Clinical narrative: Pain in neck and shoulder, headache, shivering, nausea, stomach pain, injection site redness and hot, and no appetite. Arm was sore for a week and two days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Musculoskeletal pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Pain in neck and shoulder, headache, shivering, nausea, stomach pain, injection site redness and hot, and no appetite. Arm was sore for a week and two days.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Feeling abnormal, Swelling face
Clinical narrative: The patient presented to me on 8/17/2018 stating that her injections gave her a feeling of unease. She said her face got puffy, but no other symptoms or sign of allergy. When she was speaking with me, she appeared normal and said the symptoms she had been feeling were gone. She had no site reaction on either arm.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Pt. had lower legs (knees down) bilaterally turn bright red and swell. Pt. was also not able to be comforted/eat bottle for 1 hour - constant crying. Then issues resolved.
Age: 25.0
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Local erythema (6 cm x 5 cm). Induration, pain, itching.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Inadvertently gave a dose of Tdap instead of pediatric Dtap.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blister, Butterfly rash, Condition aggravated, Erythema, Eyelid oedema
Clinical narrative: Exacerbation of butterfly rash on face. Bullae and vesicles scalp and L lateral canthus area. Erythema/edema (L) shoulder. Pt has had a butterfly rash since birth. Her work up had included a diagnosis of food allergies. She was Dx with lactose intolerance and formulas are being switched. Pt. mother PMH (positive), Sjogren's, RA, hypothyroid. On 8/8/18 she received vaccines as noted in the right and left thighs. By 8/9/18 patient had an exacerbation of butterfly rash, with increased erythema covering both cheeks. She had upper eyelid edema. Mother gave TYLENOL for fever. Patient developed small bullae on left malar cheek, erythema prominent over left shoulder. Patient then developed a large bullae covering entire vertex of scalp. This had very little serum in it on exam. The bullae on the left cheek were superficial and debrided with serous crust. Patient was referred to pediatric dermatologist 8/10/18 at 8:30 AM for further evaluation. No meds were given except for warm compresses. An unofficial consult was done with Dr., employee of CDC, expert in vaccinations. She confirmed this was not a common reaction.