chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Insomnia, Pain, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Concomitant products included citalopram and lisinopril. On 7th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 5 days after receiving SHINGRIX, the patient experienced shingles, itchy rash and pain. In June 2018, the patient experienced sleep decreased. On an unknown date, the outcome of the shingles, pain and sleep decreased were unknown and the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the shingles, itchy rash, pain and sleep decreased to be related to SHINGRIX. Additional details were provided as follows: The patient  was the technician who works at the facility of administration. The concomitant medications were not new. The patient received SHINGRIX in the right upper arm (right deltoid). The patient experienced the itching and burning painful rash started on the right side of her back. On 13th June 2018, the patient went to a doctor's appointment because of the symptoms, after another pharmacist at the pharmacy suggested that she go ahead and go to see the doctor about the symptoms. On the same day the doctor diagnosed the symptoms as being shingles. when asked to the reporter that if the symptoms were disabling, the reporter responded that the patient had missed 45 minutes of work due to the doctor's appointment. The itchiness and pain of the rash keeps her awake. The doctor gave her a medication which did not seem to help, but the rash was still itching and was spreading to different spots. On the day of reporting, the patient said the rash was on the right side of her back from below her braline all the way down further to below her waistline. At the time of reporting there were total ten patches of rash in that area. She had about eight spots of the rash at the time of the doctor's appointment and at the reporting the patient had about one or two new areas since her Wednesday doctor office visit. The reporter agreed to contact for further follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Concomitant products included citalopram and lisinopril. On 7th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 5 days after receiving SHINGRIX, the patient experienced shingles, itchy rash and pain. In June 2018, the patient experienced sleep decreased. On an unknown date, the outcome of the shingles, pain and sleep decreased were unknown and the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the shingles, itchy rash, pain and sleep decreased to be related to SHINGRIX. Additional details were provided as follows: The patient  was the technician who works at the facility of administration. The concomitant medications were not new. The patient received SHINGRIX in the right upper arm (right deltoid). The patient experienced the itching and burning painful rash started on the right side of her back. On 13th June 2018, the patient went to a doctor's appointment because of the symptoms, after another pharmacist at the pharmacy suggested that she go ahead and go to see the doctor about the symptoms. On the same day the doctor diagnosed the symptoms as being shingles. when asked to the reporter that if the symptoms were disabling, the reporter responded that the patient had missed 45 minutes of work due to the doctor's appointment. The itchiness and pain of the rash keeps her awake. The doctor gave her a medication which did not seem to help, but the rash was still itching and was spreading to different spots. On the day of reporting, the patient said the rash was on the right side of her back from below her braline all the way down further to below her waistline. At the time of reporting there were total ten patches of rash in that area. She had about eight spots of the rash at the time of the doctor's appointment and at the reporting the patient had about one or two new areas since her Wednesday doctor office visit. The reporter agreed to contact for further follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, 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 60-year-old 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 week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she received SHINGRIX vaccine between her elbow and her shoulder last Tuesday or Wednesday. The patient experienced arm was sore, red, hard and big as a grapefruit at the injection site. The patient noted that she received the vaccine and was concerned the vaccine was given too low. The caller refused any other questions. The caller was referred to her physician, but declined, so she was then referred back to the pharmacy where product was received. The caller was seeking to know if the reaction was normal and due to the vaccine. The prescribing information was reviewed with the caller on the reactions seen in clinical trials. The health care professional declined and did not want to report.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Varicella
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chickenpox in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a teenager). Concomitant products included SHINGRIX, thyroxine sodium (Levothyroxine) and metoprolol. On 4th June 2018, the patient received the 2nd dose of SHINGRIX. On 8th June 2018, 4 days after receiving SHINGRIX, the patient experienced chickenpox (serious criteria other: as per the reporter) and generalized rash (serious criteria other: as per reporter). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the chickenpox and generalized rash were not recovered/not resolved. The reporter considered the chickenpox and generalized rash to be probably related to SHINGRIX. Additional details were provided as follows: The patient had the first dose of SHINGRIX on 24th May 2018. The patient received SHINGRIX in the left arm. The physician had a patient received 2nd dose of SHINGRIX and experienced a rash which started on her left arm and generalized from there. The rash had progressed and the physician diagnosed the patient with chickenpox in June 2018.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Condition aggravated, Feeling abnormal, Heart rate increased, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of heart rate increased in a 81-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure high and blood cholesterol increased. On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, less than a day after receiving SHINGRIX, the patient experienced heart rate increased (serious criteria disability and life threatening), increased blood pressure (serious criteria disability and life threatening), feels awful and shaking. The patient was treated with beta blocker nos (Beta Blocker). On an unknown date, the outcome of the heart rate increased, increased blood pressure, feels awful and shaking were recovering/resolving. The reporter considered the heart rate increased, increased blood pressure, feels awful and shaking to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitiant medicine included blood pressure medication and cholesterol. In morning, the patient's blood pressure 126 systolic and diastolic was in the 74 The patient received SHINGRIX on left arm. The patient stated that, 10 minutes after receiving the SHINGRIX, while he and his wife were on the way home, he started feeling terrible and shaking. The patient stated that when he got home, he took his blood pressure and his blood pressure had increased to 170 systolic and his diastolic was in the 90's. The patient did not remember the exact number. The patient stated that his heart rate was increased to 118 bpm, possibly higher, and his pulse is normally around 54 bpm. The patient reported that that he laid down in trendelenburg position and took 12.5mg of a beta blocker. The patient reported that approximately 10 minutes later, emergency medical service (EMS) arrived and his heart rate and blood pressure were starting to return to normal. The patient did not go to the hospital but had called his physician and was waiting for his physician to call him back. The patient reported that he was completely disabled during this episode and at the time felt like this event was life threatening. The patient had denied contacting their physician. Lab comments: On 20th May 2018 in morning the patient's blood pressure was 126 systolic and diastolic was in the 74 On the same day. the patient blood pressure was increased to 170 systolic and his diastolic was in the 90.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 48-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. Concomitant products included SHINGRIX. On 1st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st May 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. In May 2018, the patient experienced injection site pain, injection site swelling, injection site erythema and malaise. The patient was treated with ibuprofen and Ice Pack. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and malaise were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the injection site pain, injection site swelling, injection site erythema and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The nurse practitioner came to the pharmacy to inject the vaccine to the patient. The patient received SHINGRIX vaccine at 48 years of age, which led to inappropriate age at vaccination. The patient experienced similar symptoms which were experienced after 1st injection (refer case US2018077569), but it was worse. The patient tried Ibuprofen and placing ice on the injection site, which did not help. This case is also linked to case US2018077566 (husband's case), reported by the same reporter. Follow up was received by the pharmacist on 15th June 2018: The patient's demographic details were updated. The reporter wanted the refund for the cost of the vaccine as the patient experienced pain and suffering. The VAERS details were updated. Sender's Comments: US2018GSK087683: Previous VAERS submission in paper format.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Diarrhoea, Laboratory test abnormal, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 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 day after receiving SHINGRIX, the patient experienced fever, diarrhea and adverse reaction. The patient was treated with Ice Pack. On an unknown date, the outcome of the fever and adverse reaction were recovered/resolved and the outcome of the diarrhea was recovering/resolving. It was unknown if the reporter considered the fever, diarrhea and adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a temperature of 102 the first night and another spike in fever the next day. The arm reaction was acute. The treatment required icing for three days and a total of six days to fully resolve. The patient experienced acute, violent diarrhea which did not fully resolve for a week. The patient had some abnormal blood chemistries 10 days after the vaccine was administered.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of flu symptoms in a 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 day after receiving SHINGRIX, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was unknown. It was unknown if the reporter considered the flu symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter saw unspecified flu symptoms in the first 24 hours in about I5 percent of the patients who received SHINGRIX. The lot number and expiration date was unspecified. This information had not been reported to the FDA. No further details were provided.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of general body pain in a 55-year-old male patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020) for prophylaxis. On 13th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain. On 15th April 2018, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced extreme body ache or pain. The patient did not provide permission for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an adult 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. This case is one of 8 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of headache in a 51-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved. The reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 50 or 51 years old. The onset time or duration of the headache was unknown. The caller did not have any additional details. This case has been linked with case US2018107613, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling at injection site, very itchy, from a few hours after injection till date.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site swelling, Local reaction
Clinical narrative: Patient with swelling on left upper deltoid and initially had numbness in her deltoid down to her fingers.  Numbness resolved one hour after taking ibuprofen about 4 hours after vaccine had been given;  Patient seen in office with localized reaction.
Age: 65.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated his Right Deltoid became swollen, red, warm to touch by next day 6/20/18. Presented to office on 6/22/18 to have arm checked. No fever, child, increased pulse, or increased blood pressure. Just localized swelling, warmth, soreness, and redness at area of injection. Both injections within 2 inches on R. Deltoid.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache, Injection site erythema, Injection site pain
Clinical narrative: Friday 6/1/18 Woke with headache during the night about 1am. Took ALEVE and went back to sleep- arm hurting and not laying on this arm. Woke with really hurting arm at injection site and red swelling of injection site about 3" circle. Took BC Green Aspirin about 6am. At 8 am still with Bad Headache-Arm Hurting-Body just Sore- Upset stomach (maybe from severe headache). Took 2-ALEVE and within 45 minutes started to feel better. Continued to take 2 ALEVE every 12 hours for 2 days with the continuing injection site soreness and swelling/red. Monday went back to the Pharmacy where administered vaccine and talked with the Pharmacist. I was told that it is common for these reactions and as long as reactions not getting worse continue to take the over counter pain medicine. It was 14 days for the soreness and red swelling at injection site to completely stop. Even with this reaction I will still get the 2nd shot knowing the reaction I will probably have to keep from getting Shingles!
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: Friday 6/1/18 Woke with headache during the night about 1am. Took ALEVE and went back to sleep- arm hurting and not laying on this arm. Woke with really hurting arm at injection site and red swelling of injection site about 3" circle. Took BC Green Aspirin about 6am. At 8 am still with Bad Headache-Arm Hurting-Body just Sore- Upset stomach (maybe from severe headache). Took 2-ALEVE and within 45 minutes started to feel better. Continued to take 2 ALEVE every 12 hours for 2 days with the continuing injection site soreness and swelling/red. Monday went back to the Pharmacy where administered vaccine and talked with the Pharmacist. I was told that it is common for these reactions and as long as reactions not getting worse continue to take the over counter pain medicine. It was 14 days for the soreness and red swelling at injection site to completely stop. Even with this reaction I will still get the 2nd shot knowing the reaction I will probably have to keep from getting Shingles!
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Anxiety, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Patient was very anxious about receiving vaccines. Had a near syncopal episode within a couple minutes after vaccines were administered. She became pale and diaphoretic but did not lose consciousness. Patient was allowed to lay down and was given some fluids to drink. Symptoms resolved in about 15 minutes.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Initial swelling....then pain and tingling down arm...followed up with family physician. MD gave steroid shot...as of 6/25/18 pt still experiencing intermittent tingling.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Inflammation, Pain in extremity
Clinical narrative: I received the second dose of SHINGRIX on Friday, June 22, 2018. All day on Saturday, I ran a 103 degree temperature. I took TYLENOL and ADVIL during the day on Saturday with no results. The area continues to be very inflamed. I finally put a cool rag over my head and the temperature went down to 101 degrees. When I woke up on Sunday, I was still running a 101 degree temperature. On Sunday afternoon, my temperature went down to 100 degrees, and I felt much better. I woke up this morning (Monday) feeling like my temperature was going back up. It was 101 degrees. It is now 5:15 on 6/25/2018. My arm is still extremely sore. I have no fever.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, hot, raised patch on arm.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dyskinesia, Hypotonia, Syncope
Clinical narrative: Approximately 3 minutes after the shot was given we were walking out of the facility, in the parking lot, and patient said she felt light headed and she began to sway. I put my arms around her so she would not fall and asked her what she was feeling. Her body started making jerking movements and her head went backwards and her eyes went wide open but she was not blinking and didn't seem to be aware and she did not answer my questions. She then went limp. I screamed for help and they brought a wheelchair out to take her inside. They said to not worry that she had just fainted. They took her blood pressure and gave her some juice. Asked if she had eaten breakfast. Told them that she had. They observed her for 10-15 minutes and then said we were fine to go home. No symptoms since then. She did not flinch or wince when they gave her the shot/did not express any pain. However, she does not remember leaving the office and has a vague, dreamlike memory of the reaction. Not sure if this was fainting or a seizure.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported to be sore right after the injection. On June 24th, 3 days after the vaccination, patient swelling and redness at the site of injection and described it as big as the size of her palm. She also stated that it progressed to be itchy and hot when touched. Patient took a total 3 doses of 50 mg BENADRYL since June 24th to June 25th and patient had noticed a significant improvement with the swelling, redness, and itchiness. Patient will follow up and discuss this reaction furthermore with her doctor in August to consult about getting the second dose.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reported to be sore right after the injection. On June 24th, 3 days after the vaccination, patient swelling and redness at the site of injection and described it as big as the size of her palm. She also stated that it progressed to be itchy and hot when touched. Patient took a total 3 doses of 50 mg BENADRYL since June 24th to June 25th and patient had noticed a significant improvement with the swelling, redness, and itchiness. Patient will follow up and discuss this reaction furthermore with her doctor in August to consult about getting the second dose.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Foreign body aspiration, Oral administration complication, Respiratory arrest
Clinical narrative: Patient aspirated the rotavirus and stopped breathing when she was given the vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Neck pain, Pain
Clinical narrative: Pain starting within several hours of vaccine. No redness, warmth or swelling. Just pain that extended into head neck and became so severe patient considered going to the ED. Pain then began to fade and within 12 hrs of pain starting it went away and has not returned.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Exposure during pregnancy, Pain, Uterine contractions during pregnancy
Clinical narrative: Pregnancy is normal no problems, EDD is 07/11/2018. On 6/22 vision was blocked by sparkles in eyes like bright lights that float accompanied by lightheadedness. Those symptoms continued until 6/23 at 5:00pm when symptoms of vomiting, diarrhea, contractions and body pain were added to the blurry vision and dizziness. Symptoms of vomiting/diarrhea subsided at 10:30pm on 6/23 and contractions stopped at 11:40 pm 6/23.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred, Visual field defect, Vitreous floaters, Vomiting
Clinical narrative: Pregnancy is normal no problems, EDD is 07/11/2018. On 6/22 vision was blocked by sparkles in eyes like bright lights that float accompanied by lightheadedness. Those symptoms continued until 6/23 at 5:00pm when symptoms of vomiting, diarrhea, contractions and body pain were added to the blurry vision and dizziness. Symptoms of vomiting/diarrhea subsided at 10:30pm on 6/23 and contractions stopped at 11:40 pm 6/23.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: SNYCOPE AFTER ADMINISTRATION - 3 MINUTES AFTER.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Moderate arm muscle pain (4 days). Moderate swelling at the injection site (8 days). Redness at the injection site (4 days). Mild itching of the injected arm (8 days). Mild headache (day of vaccine), mild shivering (day of vaccine), mild fatigue (day of vaccine).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pruritus
Clinical narrative: Moderate arm muscle pain (4 days). Moderate swelling at the injection site (8 days). Redness at the injection site (4 days). Mild itching of the injected arm (8 days). Mild headache (day of vaccine), mild shivering (day of vaccine), mild fatigue (day of vaccine).
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt developed a blistering rash on neck and shoulder/back on left side of body. It developed 2 days after vaccine was given. Pt went to his doctor who prescribed Valtrex 1gm 1 tablet every 8 hours for 7 days. Patient is to follow up with doctor in about 3 weeks to see how the rash progresses and to see if he should get the 2nd dose once the rash clears.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The day after the injection she noticed her arm was very red and warm around the injection site. It is a large area that is about 5 inches in diameter. On day 4 post-injection it was the same size.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient stated that she went to ugent care on Saturday 6/23 due to her arm swelling up the size of a baseball and was diagnosed with cellulitis. Patient presented back to pharmacy on 6/25 and the area was no longer noticeably red or swollen. Patient states it began to get better on Sunday.
Age: 19.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Extra dose administered
Clinical narrative: Child profile and EHR vaccine records did not match. I was using the child profile for looking up the immunization needed for the pt. I later figured out that I had given extra vaccination that she already took (MMR & Hep B).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Swelling, rash, soreness at injection site starting at 5pm 06/20/18. Fever of 102F starting at 3:00am 06/21/18, uncontrolled shaking 3:00-5:00am. Fever decreased and resolved by 9:00am. Soreness, swelling, rash continued until 06/24/18.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: Received vaccine on 06/12/2018 and symptoms developed 06/16/2018: pustules (pencil-eraser-tip size), green, 6 inside mouth, and 1 outside mouth (larger on the outside of lip). 4-5 days they persisted, and then gone. Did not come back after.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Malaise, Musculoskeletal pain, Pain
Clinical narrative: Blistery rash occurred 10d after 1st dose of SHINGRIX, painful and red on opposite shoulder of injection, lasting 5 days- This is unusual as this is inactive vaccine - when receiving second dose 3 months later, pt had fever and felt sick GI upset and diffuse body aches within hours of the shot and lasted 5 hr.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Blistery rash occurred 10d after 1st dose of SHINGRIX, painful and red on opposite shoulder of injection, lasting 5 days- This is unusual as this is inactive vaccine - when receiving second dose 3 months later, pt had fever and felt sick GI upset and diffuse body aches within hours of the shot and lasted 5 hr.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site rash, Pain
Clinical narrative: Meningitis B vaccine given. The following day it was not swelling but it was severe pain, followed by a streak like red rash moving upwards and downwards from the injection site. Flu like symptoms followed except no fever. She has never had a reaction to any vaccinations. Ever. The concern lies in that it took an antibiotic to clear it up and now two weeks later she has a reoccurring side effect. Light swelling, very much red, and very hot and is spreading up and down her arm. This child is 18 never has reactions or illnesses. Something is wrong she never responds like this.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm, Swelling
Clinical narrative: Meningitis B vaccine given. The following day it was not swelling but it was severe pain, followed by a streak like red rash moving upwards and downwards from the injection site. Flu like symptoms followed except no fever. She has never had a reaction to any vaccinations. Ever. The concern lies in that it took an antibiotic to clear it up and now two weeks later she has a reoccurring side effect. Light swelling, very much red, and very hot and is spreading up and down her arm. This child is 18 never has reactions or illnesses. Something is wrong she never responds like this.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Limb mass, Nervousness, Oral pain
Clinical narrative: Patient reported issue with SHINGRIX. Patient had fever, pain in inside of her mouth, stomach hurt, lump feeling in the arm, headache and shaky.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported issue with SHINGRIX. Patient had fever, pain in inside of her mouth, stomach hurt, lump feeling in the arm, headache and shaky.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: I had a PNEUMOVAX 23 injection and the pain in my arm kept me awake that night. The next day was just as bad and the pain moved to the underside of my arm. I am very fatigued.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Erythema, Fatigue, Headache
Clinical narrative: I am reporting these side effects because: This is a new vaccine. I am 76 years old and have never had a reaction to a vaccine. I did not have a reaction to the first injection in the series which I had on 03/27/2018 along with Tdap. The morning after the second injection I was extremely tired upon awakening and struggled to stay awake. The injection site was red and sore and there was an irregularly shaped 5 x 7 inch red patch about 2 inches below the injection site which was not sore and did not itch. I slept for the better part of 2 days which is unusual. The information sheet provided listed "feeling tired or weak", "belly pain" and "headache". Belly pain and headache were intermittent for 2 days. The irregularly shaped red patch disappeared after a week.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: I am reporting these side effects because: This is a new vaccine. I am 76 years old and have never had a reaction to a vaccine. I did not have a reaction to the first injection in the series which I had on 03/27/2018 along with Tdap. The morning after the second injection I was extremely tired upon awakening and struggled to stay awake. The injection site was red and sore and there was an irregularly shaped 5 x 7 inch red patch about 2 inches below the injection site which was not sore and did not itch. I slept for the better part of 2 days which is unusual. The information sheet provided listed "feeling tired or weak", "belly pain" and "headache". Belly pain and headache were intermittent for 2 days. The irregularly shaped red patch disappeared after a week.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Full blood count normal, Pyrexia, Urine analysis normal
Clinical narrative: Pt developed high fever 105 degrees F at home-accord to parents at 3-4 hrs after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Severe body aches. Fever. Light headed/dizzy.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Oral herpes
Clinical narrative: Patient developed shingles 1 week after receiving the vaccines. Shingles outbreak in the mouth, eye, and the body.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate decreased, Hypotension, Presyncope
Clinical narrative: Near syncope, low blood pressure, decreased heart rate.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness on left thigh, vaccines given Wed, onset insidious, severity: moderate. Cephalexin 250mg/5mL, 4.5 mL, po, QID, 10 days for cellulitis.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dyspepsia
Clinical narrative: Pt began feeling dizzy 15 min after immunization. Pt felt light headed over the weekend along with heart burn. Pt still feels dizzy without vertigo.
Age: 31.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Right arm area of injection induration redness tender - cellulitis.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Local reaction, Malaise, Skin warm
Clinical narrative: General malaise 4" round red, raised local reaction, hot to touch.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Pt received her shots, walked around the office to the waiting room where she began to fall down hit her head on desk and fainted for about 10-20 minutes.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: Dizzy, fast heart rate, weakness, felt weird.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose, Dizziness, Hyporesponsive to stimuli, Immediate post-injection reaction
Clinical narrative: Pt given SHINGRIX vaccine at 1:15PM 6/16/18. Immediately C/O lightheadedness and dizziness. Vaccine given while pt seated. When pt tried to stand had to sit down again D/T lightheadedness. Pt not in pain or have SOB. Two attempts to take BP unsuccessful. Pt became less responsive so called 911. Pt took deep breath when I asked he "are you ok". When EMT's arrived, pt was doing better with less dizziness and was able to talk. Pt walked out of pharmacy with help of husband's assistance at 1:50PM.
Age: 28.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 27-Mar-2018, concerning a 28-year-old, adult male patient. On 27-Mar-2018, the patient (under age of 65 year) was inadvertently administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported) instead of FLUCELVAX QIV. It was reported that, no adverse event was experienced by the patient. The reporter assessed the case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 708766), concerns a 71-year-old, elderly female patient.  The patient's concomitant medication included PLAVIX. On 07-Aug-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: unknown, anatomical location: right arm, batch number: 178502, expiry date: not reported) and PREVNAR 13 (dose: 1 DF, route of administration: unknown, anatomical location: left arm, batch number: R49357 (as reported), expiry date: not reported). On the same day, after 2 hours of vaccination, the patient developed red welt like event which increased in size and itching on left arm. The patient used over the counter (OTC) medication hydrocortisone cream 1 percent for itching, but was not effective. The welt size increased to quarter within 1 to 2 days and 3 inches in diameter and the shape changed from circle to oval. The outcome of the events was unknown. The reporter considered the case as non-serious.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 709121), concerns a 70-year-old, elderly, female patient. The patient's medical history, allergy and concomitant medication were not reported. On 12-Aug-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, batch number: 178303, anatomical location and expiry date: not reported). On the same day, after the vaccination, the patient developed rash on left thigh and administered EPIPEN injection. On an unspecified date, the patient had recovered from the event. The reporter assessed the event as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 710189), concerns a 69-year-old, elderly, female patient. The patient's current condition included diabetes (since an unspecified date). The patient had been allergic to codeine. The patient's concomitant medication was not reported. On 17-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, anatomical location: left arm, batch number: 178502, route of administration and expiry date: not reported). On 18-Aug-2017, after 1 day of vaccination, the patient had injection site redness, swelling and pain. The patient applied ice pack and received TYLENOL and recovered from the events. The reporter assessed the events as non-serious.
Age: 80.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Rash
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 710985), concerns an 80-year-old, elderly, female patient. The patient's current history included high blood pressure and back pain (since an unspecified date). The patient's concomitant medications included ALEVE, Vitamin D, biotin, Aspirin 81 mg. On 28-Aug-2017, the patient was administered with FLUAD (dose: 0.5, route of administration: intramuscular, anatomical location: left arm, batch number: 178301, and expiry date: not recommended) and PREVNAR 13 (route of administration: intramuscular, dose, manufacturer, anatomical location: right arm, manufacturer, trade name, batch number and expiry date: not reported). On 30-Aug-2017, after 2 days vaccination, the patient had a rash on her cheeks and over the nose. At the time of this report, the outcome of the event was recovered. The reporter considered the case as non-serious.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 711264), concerns an 83-year-old, elderly male patient. The patient's medical history was not reported. The patient had no known drug allergy (NKDA). The patient's concomitant medication included Propranolol. On 01-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178303 and expiry date: not reported). On 02-Sep-2017, after 1 day of vaccination, the patient experienced itching on the back and hands for couple of days. The patient received BENADRYL and recovered from the events. The reporter assessed the events as non-serious.
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 711763), concerns a 78-year-old, elderly, male patient. The patient's medical history, allergy and concomitant medication were not reported. On 01-Aug-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 178502 and expiry date: not reported). On 20-Aug-2017, after 3 weeks of vaccination, the patient had continued itching, slight soreness and redness at injection site. The patient also had slight radiating pain. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: Rash generalised
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 711781), concerns 82-year-old elderly male patient. The patient was allergic to iodine contrast dye. The patient's current condition included diabetes since an unspecified date. On 24-Aug-2017, the patient was administered with FLUAD (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178302A and expiry date: not reported). On 25-Aug-2017, 1 day after the administration of vaccine, the patient developed rash on the whole body. On 27-Aug-2017, the patient consulted the physician. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 712198), concerns a 70-year-old, elderly female patient.  The patient's concomitant medication included temazepam. On 02-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: unknown (as reported), anatomical location: left arm, batch number: 178601, expiry date: not reported) and PNEUMOVAX 23 (dose: 1 DF (as reported), route of administration: unknown (as reported), anatomical location: left arm, batch number: M038216, expiry date). On 05-Sep-2017, the patient developed swelling and redness at left arm deltoid muscle. At the time of this report, the patient had recovered from the events. The reporter considered the case as non-serious.
Age: 72.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 713057), concerns a 72-year-old, elderly, female patient. The patient's medical history and concomitant medication were not reported. The patient had no any allergy. On 11-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178623 and expiry date: not reported) and ZOSTAVAX (dose: 1 DF, route of administration: subcutaneous, anatomical location: left arm, batch number: M041511 and expiry date: not reported). On 13-Sep-2017, after 02 days of vaccination, the patient presented with a circular red, itchy patch at the injection site of left arm about half dollar size (as reported). No lab investigation was done. On 16-Sep-2017, at 12:50 pm, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 713062), concerns a 74-year-old, elderly, female patient. The patient current conditions included diabetes, depression, anxiety. The patient was allergic to codeine, hydrochlorothiazide, PERCOCET (since an unspecified date). The patient's concomitant medications included clonazepam, Metformin, LANTUS, NOVOLOG, Citalopram, amlodipine, glimepiride, rosuvastatin. On 12-Sep-2017, the patient was administered with FLUAD (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178303 and expiry date: not reported). On the same day, after vaccination, the patient had pain in hip and knee joints which lasted for 3 days. The patient recovered from the event. The reporter considered the case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 06-Mar-2018 by Seqirus from VAERS (VAERS ID: 713123), concerns a 65-year-old elderly female patient. The patient was allergic to amoxicillin, codeine, hydrocodone and latex. The patient's concurrent medications included ibuprofen. On 25-Aug-2017, the patient received FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 178323, expiry date: not reported) and PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, dose, manufacturer, trade, batch, and expiry date: not reported). On 26-Aug-2017, after 1 day of vaccination, the patient reported that after receiving the PNEUMOVAX vaccine, the injection site area became red, hard, swollen. After two days of vaccination the patient's whole arm from down to the wrist became red, hard and swollen. The patient did not mention about medical or laboratory tests related to adverse event, treatment or duration of swelling. The patient had recovered from the events (injection site erythema, induration and swelling). The reporter assessed the case as non-serious.