chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Brain oedema, Cardio-respiratory arrest, Electroencephalogram abnormal, Endotracheal intubation, Full blood count
Clinical narrative: She was born a beautiful and perfectly healthy baby. She did receive her vitamin K shot being I had been on blood thinners for clotting. She suffered a bit from jaundice but at 4 days old she received her hep b. Her temp stayed lower than normal which they kept saying was normal being born at 36.5 weeks GA. At her 2 week check up she was found to be doing well and her temp had come up to 99.0 degrees. Well we took her home to have her temp spike within 8 hrs of her check up to 101.7. I thought it was my thermometer so I tried a bath, skin to skin and a tad bit of TYLENOL trying to help her. It came down to 99.8 which was better for me so we went to sleep for 3 hrs. When I retook it at 4am on December 14th, it was 101.4 so we took her to the ER. They did a lot of blood work and tried to get a lumbar puncture that ended as a failed try. They transferred us to another hospital where she started having respiratory issues and they ended up transferring us yet again. This time to another hospital's PICU. By the 15th she had crashed into a full cardiac/respiratory arrest which ended in her being intubated. They kept her intubated for 3.5 days until the morning of the 18th and they ended up bagging her within 5 minutes of extubated. Within the 7 days we were there, she was bagged 7 more times. Her last MRI showed her to have brain damage due to cerebral hypoxia, fluid on the brain, a collection on her spine as well as an abnormal 24 hr EEG.
Sex: U
Vaccine: HEP
Symptoms: Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging brain abnormal, Respiratory disorder, Spinal cord oedema
Clinical narrative: She was born a beautiful and perfectly healthy baby. She did receive her vitamin K shot being I had been on blood thinners for clotting. She suffered a bit from jaundice but at 4 days old she received her hep b. Her temp stayed lower than normal which they kept saying was normal being born at 36.5 weeks GA. At her 2 week check up she was found to be doing well and her temp had come up to 99.0 degrees. Well we took her home to have her temp spike within 8 hrs of her check up to 101.7. I thought it was my thermometer so I tried a bath, skin to skin and a tad bit of TYLENOL trying to help her. It came down to 99.8 which was better for me so we went to sleep for 3 hrs. When I retook it at 4am on December 14th, it was 101.4 so we took her to the ER. They did a lot of blood work and tried to get a lumbar puncture that ended as a failed try. They transferred us to another hospital where she started having respiratory issues and they ended up transferring us yet again. This time to another hospital's PICU. By the 15th she had crashed into a full cardiac/respiratory arrest which ended in her being intubated. They kept her intubated for 3.5 days until the morning of the 18th and they ended up bagging her within 5 minutes of extubated. Within the 7 days we were there, she was bagged 7 more times. Her last MRI showed her to have brain damage due to cerebral hypoxia, fluid on the brain, a collection on her spine as well as an abnormal 24 hr EEG.
Sex: U
Vaccine: HEP
Symptoms: X-ray
Clinical narrative: She was born a beautiful and perfectly healthy baby. She did receive her vitamin K shot being I had been on blood thinners for clotting. She suffered a bit from jaundice but at 4 days old she received her hep b. Her temp stayed lower than normal which they kept saying was normal being born at 36.5 weeks GA. At her 2 week check up she was found to be doing well and her temp had come up to 99.0 degrees. Well we took her home to have her temp spike within 8 hrs of her check up to 101.7. I thought it was my thermometer so I tried a bath, skin to skin and a tad bit of TYLENOL trying to help her. It came down to 99.8 which was better for me so we went to sleep for 3 hrs. When I retook it at 4am on December 14th, it was 101.4 so we took her to the ER. They did a lot of blood work and tried to get a lumbar puncture that ended as a failed try. They transferred us to another hospital where she started having respiratory issues and they ended up transferring us yet again. This time to another hospital's PICU. By the 15th she had crashed into a full cardiac/respiratory arrest which ended in her being intubated. They kept her intubated for 3.5 days until the morning of the 18th and they ended up bagging her within 5 minutes of extubated. Within the 7 days we were there, she was bagged 7 more times. Her last MRI showed her to have brain damage due to cerebral hypoxia, fluid on the brain, a collection on her spine as well as an abnormal 24 hr EEG.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain
Clinical narrative: Patient received SHINGRIX dose 1 on 9/5/18 at 221P NDC # 58160081912 in left arm and states he had soreness from shot waited 3 weeks then got his flu vaccine. On 1/26/19 the pharmacy called to let him know his second dose of SHINGRIX was in and he was due for it. That's when he stated he is still having arm pain from his shot(s). He's not sure which one caused it. He thought pain after SHINGRIX was getting better but then after flu shot states it felt the same so he's not sure if it ever went away. It is now 4 months since both shots and he's stating he still has pain. He has an appointment with his PCP middle of Feb 2019 and he states he will report it to the doctor and see if the doctor still recommends that he get the second dose of SHINGRIX.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Erythema, Rash
Clinical narrative: Rash and chills, sore armpit, redness on chest and neck.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Joint injection, Loss of personal independence in daily activities
Clinical narrative: When I got the shot there was a deep sharp pain, much worse than my many previous ones, it did not get better in 3 or 4 days as previous ones did. The injection site stayed painful, but the pain changed to a very sore spot and is still there to this day. Additionally the pain spread through the upper arm and into the shoulder joint over the next months. My family physician did nothing, but my Orthopedic doc, gave me a series of shots into the joint, which appeared at first to help, but the problems returned after a few days. He said that was all he could do for me. I am very limited in range of motion and any movement is painful. I have difficulty caring for my body and my home and in constant pain.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, X-ray
Clinical narrative: When I got the shot there was a deep sharp pain, much worse than my many previous ones, it did not get better in 3 or 4 days as previous ones did. The injection site stayed painful, but the pain changed to a very sore spot and is still there to this day. Additionally the pain spread through the upper arm and into the shoulder joint over the next months. My family physician did nothing, but my Orthopedic doc, gave me a series of shots into the joint, which appeared at first to help, but the problems returned after a few days. He said that was all he could do for me. I am very limited in range of motion and any movement is painful. I have difficulty caring for my body and my home and in constant pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Pain
Clinical narrative: I became ill with fever, chills, nausea. The swelling on my arm at the injection site kept getting larger. On the fourth day, I went to Urgent Care and was diagnosed with cellulitis. The swollen, red, burning painful area was immediately around the injection site and extended 6 inches around and 4 inches up and down. The injection site was below the deltoid. I do not know if it was given in a muscle or under the skin. It was not in the deltoid. There are two numbers on my receipt Rx; 056581333823 and NDC: 58160-0823-11
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Injection site pain, Injection site swelling, Malaise
Clinical narrative: I became ill with fever, chills, nausea. The swelling on my arm at the injection site kept getting larger. On the fourth day, I went to Urgent Care and was diagnosed with cellulitis. The swollen, red, burning painful area was immediately around the injection site and extended 6 inches around and 4 inches up and down. The injection site was below the deltoid. I do not know if it was given in a muscle or under the skin. It was not in the deltoid. There are two numbers on my receipt Rx; 056581333823 and NDC: 58160-0823-11
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: I became ill with fever, chills, nausea. The swelling on my arm at the injection site kept getting larger. On the fourth day, I went to Urgent Care and was diagnosed with cellulitis. The swollen, red, burning painful area was immediately around the injection site and extended 6 inches around and 4 inches up and down. The injection site was below the deltoid. I do not know if it was given in a muscle or under the skin. It was not in the deltoid. There are two numbers on my receipt Rx; 056581333823 and NDC: 58160-0823-11
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Red, swollen, warm, painful arm. Diffuse mylagias, fevers about 2 hours after receiving vaccine.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Red, swollen, warm, painful arm. Diffuse mylagias, fevers about 2 hours after receiving vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysuria, Fatigue, Headache, Moaning
Clinical narrative: Approximately 6 -8  hours post vaccine I began with chills that were so severe I could physically not stop shaking, had burning skin that was felt through my clothes, pain urinating, horrendous headache, sore skin where it was painful to even lay down, nausea, and overwhelming tiredness.  My husband reported that I was continually groaning in my sleep. This continued for 24-36 hours.  On the 25th I woke up feeling fine. This duplicates the symptoms of my first vaccine but at that time I had begun with a cold which my M.D. felt was probably the reason. I now believe that I had an adverse reaction both times.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Nausea, Pain of skin, Skin burning sensation, Skin ulcer
Clinical narrative: Approximately 6 -8  hours post vaccine I began with chills that were so severe I could physically not stop shaking, had burning skin that was felt through my clothes, pain urinating, horrendous headache, sore skin where it was painful to even lay down, nausea, and overwhelming tiredness.  My husband reported that I was continually groaning in my sleep. This continued for 24-36 hours.  On the 25th I woke up feeling fine. This duplicates the symptoms of my first vaccine but at that time I had begun with a cold which my M.D. felt was probably the reason. I now believe that I had an adverse reaction both times.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Chills, and body aches beginning at 11:30 PM on the day of injection, slept until 4:30 AM, then had fever of 101 necessitated missing work. Took TYLENOL and slept most of the day, awakened around 7:00 PM (fever at 100) and stayed up for few hours, then slept through the night. Felt better the following day.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Patient states that at the site of injection still (after 3 months) feels like a charlie horse, or muscle knot.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Erythema, Headache, Swelling
Clinical narrative: Patient reported having chest pain the morning following the second dose of SHINGRIX vaccine lasting several minutes. Other symptoms reported include arm redness and swelling as well as headache.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Headache, Impaired work ability, Lethargy
Clinical narrative: She woke up the following morning (Thursday) with soreness in the arm, which then spread through her chest into the right shoulder/arm and up into the neck. She then experienced general muscle and joint pain throughout the body and a headache. She also felt lethargic. After going into to work that day she decided to leave work early and went home to rest. She also missed a day of work the next day so in total was out of work for more than one day.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: She woke up the following morning (Thursday) with soreness in the arm, which then spread through her chest into the right shoulder/arm and up into the neck. She then experienced general muscle and joint pain throughout the body and a headache. She also felt lethargic. After going into to work that day she decided to leave work early and went home to rest. She also missed a day of work the next day so in total was out of work for more than one day.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Limb discomfort, Malaise
Clinical narrative: She woke up the following morning (Thursday) with soreness in the arm, which then spread through her chest into the right shoulder/arm and up into the neck. She then experienced general muscle and joint pain throughout the body and a headache. She also felt lethargic. After going into to work that day she decided to leave work early and went home to rest. She also missed a day of work the next day so in total was out of work for more than one day.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: She woke up the following morning (Thursday) with soreness in the arm, which then spread through her chest into the right shoulder/arm and up into the neck. She then experienced general muscle and joint pain throughout the body and a headache. She also felt lethargic. After going into to work that day she decided to leave work early and went home to rest. She also missed a day of work the next day so in total was out of work for more than one day.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Epistaxis, Headache, Injection site erythema, Injection site pain
Clinical narrative: 7:00AM, MORNING AFTER SHOT HAD BAD HEADACHE IN BACK OF HEAD. 12:00PM STARTED ALL OVER BODY ACHES AND SWIMMY HEAD. 3:00PM SO MUCH BODY PAIN, DIDN'T WANT TO MOVE AT ALL. 1:00AM, WOKE UP WITH HEAD FEELING LIKE IT WAS GOING TO BLOW UP DUE TO HEADACHE. BLEW NOSE AND BLOOD CAME OUT OF EACH NOSTRIL. HURT IN BODY AND HEAD UNTIL 6:00PM. FELT BETTER ATER THAT. ALSO, INJECTION SITE IS RED, SWOLLEN, AND VERY PAINFUL.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: 7:00AM, MORNING AFTER SHOT HAD BAD HEADACHE IN BACK OF HEAD. 12:00PM STARTED ALL OVER BODY ACHES AND SWIMMY HEAD. 3:00PM SO MUCH BODY PAIN, DIDN'T WANT TO MOVE AT ALL. 1:00AM, WOKE UP WITH HEAD FEELING LIKE IT WAS GOING TO BLOW UP DUE TO HEADACHE. BLEW NOSE AND BLOOD CAME OUT OF EACH NOSTRIL. HURT IN BODY AND HEAD UNTIL 6:00PM. FELT BETTER ATER THAT. ALSO, INJECTION SITE IS RED, SWOLLEN, AND VERY PAINFUL.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient reported a rash about 8 inches in diameter that felt warm and was sore for about 3-4 days after the shot was given. She did report to her family doctor who recommended BENADRYL and ibuprofen and that the patient wait the full 6 months before getting the second dose in the opposite arm. She did come in on 12/31/18 for her second dose and got it in her right arm. I followed up with her on 1/2/19 and she reported a 2 inch rash but that the pain from the shot was already gone, she had been using BENADRYL and ibuprofen again post shot.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram, Encephalitis, Fontanelle bulging, Laboratory test, Lethargy
Clinical narrative: Encephalitis, lathargic, bulging of soft spot.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Encephalitis, lathargic, bulging of soft spot.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient filled out consent form to receive BOOSTRIX. He verbally verified he wanted BOOSTRIX with 2 pharmacy staff members. After receiving the shot, he told the pharmacist he just received BOOSTRIX at the Dr's office the same day and actually wanted Flu.
Age: 59.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Hypersensitivity, Myalgia
Clinical narrative: Patient stated he had all over muscle and joint pain. This amount of pain caused him to go the the doctor on 1/14/19. The doctor informed him it was an allergic reaction to the second SHINGRIX dose and that something in the serum had changed. Patient received a steroid shot and he said he felt a lot better.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: PATIENT CALLED THE NEXT DAY AFTER VACCINATION TO REPORT A SORE ARM WILL SWELLING AT INJECTION SITE AND REDNESS.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Nuclear magnetic resonance imaging
Clinical narrative: Major stroke in the right side of brain.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia, Vomiting
Clinical narrative: Intense shivers, headache, upset stomach, vomited many times all night, muscle pain, couldn't take medicine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever to 101.1 (temporal artery) chills, diffuse myalgias, nausea, headache lasting 24 hours. Local pain and tenderness at vaccination site lasting 48 hours.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Fever to 101.1 (temporal artery) chills, diffuse myalgias, nausea, headache lasting 24 hours. Local pain and tenderness at vaccination site lasting 48 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Site and arm swelling, nausea, headache, body ache, chills, weak, fatigue, fever, near fainting, diarrhea.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain, Peripheral swelling, Presyncope
Clinical narrative: Site and arm swelling, nausea, headache, body ache, chills, weak, fatigue, fever, near fainting, diarrhea.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Site and arm swelling, nausea, headache, body ache, chills, weak, fatigue, fever, near fainting, diarrhea.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Feeling abnormal, Hypoaesthesia, Influenza like illness, Injection site swelling
Clinical narrative: Flu like symptoms, upper arm swelled at injection site, slightly disoriented, and then both hands went numb and stiffened this last part lasted about 40 minutes. Didn't feel good the next day pretty much just stayed in bed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Flu like symptoms, upper arm swelled at injection site, slightly disoriented, and then both hands went numb and stiffened this last part lasted about 40 minutes. Didn't feel good the next day pretty much just stayed in bed.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Pain in extremity, Sneezing
Clinical narrative: Pt called pharmacy complaining of sneezing, sore arm, headache, and a cold feeling day after receiving second SHINGRIX shot - pt concerned may be allergy to vaccine- advised pt to speak to primary doctor. These may be more common symptoms following vaccine administration. If allergy may see relief with BENADRYL or cold medicine for other symptoms. If persists or worsens follow up with physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Peripheral swelling
Clinical narrative: Shortly after getting home, the patient started to experience swelling in the left arm, then approx 2-3PM the same day it became red, and felt like it was burning. She started to take EXCEDRIN EXTRA STRENGTH at home right away. It was from the elbow to the shoulder. She called the pharmacy and spoke with somebody on the following day 1/26/19 at 12:58PM. The patient was advised to use cold compresses, BENADRYL, and a pain reliever and if situation got worse to seek medical attention. The patient used cold compresses and continued using the EXCEDRIN every four hours until about 10:30PM on 1/26/19. The patient has stated that it is much improved today 1/27/19. She hasn't used any therapies since last night 1/26/19.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness, Nausea, Seizure, Vomiting
Clinical narrative: Right after adminstration patient felt dizzy, then went into a quick seizure where she lost conciousness for a brief time. After coming back to concious patient felt nauseated and vomited.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient reports ongoing pain in arm for about 3 weeks. Potential bursitis.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Nausea, Pain
Clinical narrative: Nausea, headache, body aches that worsened as the day progressed.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling of the injection site with warm sensation -  round area about 3 inch diameter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Developed a line of blisters under both breasts.
Age: 55.0
Sex: F
Vaccine: FLUC4, HEPA, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 689195), concerns a 55-year-old, adult, female patient. The patient's historical condition, allergies and concomitant medications were not reported. The patient had not current illness. On 30-Mar-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 185284 and expiry date: not reported), non-company suspect product HAVRIX (route of administration: intramuscular, anatomical location: left arm, batch number: 544EG, anatomical location: unknown and expiry date: not reported) and ADACEL (route of administration: intramuscular, anatomical location: left arm, batch number U5489AA, anatomical location: unknown and expiry date: not reported). On the same day, after vaccination, the patient experienced swelling, redness in upper left arm and redness distributed over the lateral aspect of the upper arm from elbow to shoulder. The patient also experienced pain (unspecified and received TYLENOL). The patient did not experience itching. On 03-Apr-2017, the patient went to the clinic and stated that, swelling and redness were improving. It was reported that, patient planned a tuberculin skin test (TST) at an urgent care. No lab investigations were performed. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Vaccine did not prevent shingles as intended; Ongoing painful rash which was diagnosed as shingles; Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is alleged that the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) vaccine on or about 26-SEP-2014 at a health clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-MAY-2015, the patient was treated at the same facility for an ongoing painful rash which was diagnosed by her physician as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages.  Follow-up (F/U) information has been received regarding a case in litigation from a lawyer concerning a 71 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-SEP-2014, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider at a clinic (lot number, dosage and route of administration not provided). On or about 26-MAY-2015, the patient was treated by a physician at the clinic for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claims damages including: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles was considered to be not recovered.  Additional information has been requested
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Decreased appetite, Dizziness, Loss of personal independence in daily activities, Nausea, Vertigo
Clinical narrative: This is non-serious spontaneous case, reported by healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 707280), concerns a 38-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. On 05-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), batch number: 195214, route of administration: intramuscular, anatomical location: left arm). On 06-Aug-2017, 1 day after administration of vaccine, the patient reported signs and symptoms of nausea with vomiting (every 15 minutes for a while). It was reported that, the patient also experienced vertigo, dizziness and loss of appetite. The patient reported that he rarely gets sick and believed that it was due to flu shot. It was stated that the patient had to miss the work which he did not miss in a very long time. The patient's lab data was not reported. On an unknown date, the patient had recovered from all the events. Update 03-Jul-2018: Non-significant case correction was performed with IRD 19-May-2018: The sentence was corrected from 'every minute for a while' to 'every 15 minutes for a while' and 'the patient felt that he was rarely sick' to 'the patient reported that he rarely gets sick' in the narrative.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: This is non-serious spontaneous case, reported by healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 707280), concerns a 38-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. On 05-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), batch number: 195214, route of administration: intramuscular, anatomical location: left arm). On 06-Aug-2017, 1 day after administration of vaccine, the patient reported signs and symptoms of nausea with vomiting (every 15 minutes for a while). It was reported that, the patient also experienced vertigo, dizziness and loss of appetite. The patient reported that he rarely gets sick and believed that it was due to flu shot. It was stated that the patient had to miss the work which he did not miss in a very long time. The patient's lab data was not reported. On an unknown date, the patient had recovered from all the events. Update 03-Jul-2018: Non-significant case correction was performed with IRD 19-May-2018: The sentence was corrected from 'every minute for a while' to 'every 15 minutes for a while' and 'the patient felt that he was rarely sick' to 'the patient reported that he rarely gets sick' in the narrative.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 709664), concerns a 48-year-old, adult, female patient. The patient had no medical history, current condition and concomitant medications. On 23-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported). On 24-Aug-2017, 1 day after vaccination, the patient experienced rash about 2 inches around the injection site. AT the time of this report, the outcome of the event was unknown.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 709845), concerns a 58-year-old, adult, female patient. The patient's medical history and current conditions were not reported. On 27-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195210, expiry date: not reported). On the same day, approximately 5 to 10 minutes after vaccination, the patient fainted. On an unspecified date, the patient had recovered from the event. The reporter assessed the event as non-serious.
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710219), concerns a 20-year-old, adult, male patient. The patient had no allergies, medical history, current illness or concomitant medications. On 13-Aug-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195213, expiry date: not reported). On 15-Aug-2018, 2 days after vaccination, the patient developed circular rash around injection site and rash on left side of trunk, chest, torso. The reporter suspected that, the reaction may be due to immunization or working outside in heat. The reporter assessed this case as non-serious.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Haemorrhage, Immediate post-injection reaction, Induration, Swelling
Clinical narrative: This spontaneous case, reported by pharmacist to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 710986), concerns a 40-year-old, adult, male patient. The patient medical history and the concomitant medications were not reported. On 03-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported). On the same day (03-Sep-2017), after vaccination, the patient experienced immediate swelling and a bump about a size of nickel which became very hard. The patient also experienced bleeding and the patient advised to sit for few minutes and immediately became lightheaded. After sitting a while and drinking the water, the patient felt better. The patient was monitored for 20 minutes. At the time of the report, the patient had recovered from the events (injection site haemorrhage, light-headedness, immediate post-injection reaction, injection site swelling and injection site induration). The reporter assessed the case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 711372), concerns a 48-year-old adult female patient. The patient's current conditions included hypertension, and major depressive disorders. The patient was allergic to ceftazidime and macrolides. The patient's concomitant medications were not reported. On 21-Aug-2017, 4 days after vaccination, the patient experienced shooting pain, occurred on raising the arm and persisted for 7 days after vaccination. It was reported that, the pain did not subside instead affected the range of motion. At the time of this report, the patient has not yet recovered from the events (joint range of motion decreased and pain). The reporter assessed this case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 711783) , concerns a 20-year-old, adult, female patient. The patient had no medical history and the concomitant medications. On 09-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195231 and expiry date: not reported). On the same day (09-Sep-2017), at 15:30 (as reported), the patient experienced warmth and noticed a red area about a size of half dollar (as reported). On 10-Sep-2017, the size of the area increased by 5 cm. The patient went to clinic and assessed by nurse and physician assistant (PA). The patient's vital signs (VS as reported) were stable, and lungs were clear. The patient was given EPIPEN and BENADRYL 50 mg as precaution. No lab investigations were performed. At the time of the report, the outcome of the events (skin warm and erythema) was unknown. The reporter assessed the case as non-serious.
Age: 62.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Burning sensation, Rash vesicular
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 711799), concerns a 62-year-old, adult, male patient. The patient's relevant medical history and allergies were not reported. However, it was also reported that the patient's concomitant medications included potassium, allopurinol, Glipizide, ELIQUIS, VASCEPA, rosuvastatin, digoxin, torsemide, metolazone, carvedilol, TRADJENTA for an unknown indication. On 05-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 195210A, and expiry date: not reported) and non-company suspect product ZOSTAVAX (dose: 1 [as reported], route of administration: subcutaneous, anatomical location: right arm, batch number: M0370016 and expiry date: not reported). On 08-Sep-2017, 3 days after vaccination, the patient experienced shingles like rash on his left rib cage, which was burning. The lab investigations were not reported. At the time of the report, the patient had not recovered from the events (burning sensation and rash vesicular). The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Blood test normal, Chest pain, Electrocardiogram normal
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712159), concerns a 62-year-old, adult female patient. The patient's current conditions included, high blood pressure, reflux disorder (reported as medical history) and was allergic to latex. Concomitant medications included, Vit B6, dextroamphetamine, NEXIUM, SYMBICORT, furosemide, modafinil, carvedilol, lisinopril, spironolactone, isoniazid. Current illness at the time of vaccination was unknown. On 09-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml (reported as first dose), route of administration: intramuscular, anatomical location: right arm, batch number: 195222, expiry date: not reported). The patient was also administered BOOSTRIX (dose: 1 DF (reported as first dose), route of administration: intramuscular, anatomical location: right arm, batch number: ZN937, expiry date: not reported). On the same day, after vaccination, the patient began to experience chest pain. Subsequently the patient was taken to the emergency room (urgent care). The patient was admitted in the hospital for observation. It was reported that chest pain lasted for 1 hour. The patient underwent electrocardiogram (EKG) and blood tests (results were negative). Approximately at 10 pm the patient was discharged, as the patient felt better (recovered). The reporter assessed this case as non-serious. Update 22-Jul-2018: Case correction was performed 11-Jun-2018: The causality of the event 'chest pain' was corrected from unassessable to not related. The case comment was amended accordingly.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712189), concerns a 35-year-old, adult, female patient. The patient medical history and the concomitant medications were not reported. On 08-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], route of administration: intramuscular, batch number: 195221, anatomical location and expiry date: not reported). On 09-Sep-2017 [Saturday as reported], 1 day after vaccination, the patient experienced swelling of lymph node in right groin. On 10-Sep-2017, at approximately 03:00 PM, it was still swollen and was tender to touch. The lab investigations were not reported. At the time of the report, the patient had not recovered from the events (swollen lymph nodes and lymph node tenderness). The reporter assessed the case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint noise, Nuclear magnetic resonance imaging normal, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712897), concerns a 28-year-old, adult female patient. It was reported that, the patient worked out in the gym and lifted weights. On 03-Oct-2016, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number, expiry date: not reported). It was reported that the injection was injected to high in the arm. On the same day (03-Oct-2016), during vaccine administration, the patient felt pain as soon as the needle entered in her arm. The patient was sent to an ortho surgeon who stated injection was given in her bursa. A year later patient had clicking in her left shoulder joint. Magnetic resonance imaging (MRI) was done twice with no tears noted. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712989), concerns a 63-year-old, adult, female patient The subject had no relevant medical history and no known allergies. The patient had no current illnesses. The patient's concomitant medications included CELEXA, fish oil and Amphetamine salts for an unknown indication. On 27-Oct-2016, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 185325A and expiry date: not reported). On the same day, after vaccination, the patient experienced pain in right am, which was characterized by extreme muscle pain when lifting or reaching. It was reported that, pain was reported as '6' according to the pain scale. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update 22-Jun-2018: Non-significant case correction was performed with IRD 11-Jun-2018: The narrative statement was amended from "pain was reported as '6' according to the scale" to "pain was reported as '6' according to the pain scale".
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712996), concerns a 53-year-old adult female patient. The patient had no medical history and known drug allergies [NKDA]. The patient's concomitant medications included LEXAPRO and Multivitamin for unknown indication. On 27-Oct-2016, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as unk), route of administration: intramuscular anatomical location: left arm, batch number: 185325A and expiry date: not reported]. On the same day (27-Oct-2016), after vaccination, the patient experienced pain in the left arm characterized upon use and at rest. It was reported that, the subject had decreased shoulder mobility and the patent radiated to the left outer chest wall. The patient was on activator to adjust shoulder and arm, besides making the arm to rest often. Laboratory tests were not performed. The chiropractor felt that the events were occurred due to the vaccination. On an unspecified date, the patient had an office visit for the events. The patient had not yet recovered from the events (injected limb mobility decreased, pain in extremity and musculoskeletal pain).
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Skin infection
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713091), concerns a 51-year-old adult female patient. The patient's current condition included allergy to PERCOCET. The patient's concomitant medications were not reported. On 14-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as unk), route of administration: intramuscular, anatomical location: right arm, batch number: 195217 and expiry date: not reported]. On 15-Sep-2017, 1 day after vaccination in the morning, the patient experienced a large red rash around the injection site, which was warm to touch. On 16-Sep-2017, the patient returned to pharmacy to report the events. The pharmacist recommended to outline the rash with marker and take BENADRYL. The patient was suggested to visit the emergency room or urgent care if rash continued to spread. On the same day (16-Sep-2017) in the evening, the patient was evaluated at the emergency room due to spreading rash. The patient was diagnosed with unspecified skin infection. It was reported that, the patient was prescribed with cephalexin (500 mg four times daily for 7 days). At the time of report, the outcome of the events was unknown.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713136), concerns a 40-year-old, adult, female patient. The patient was allergic to MACROBID and penicillin. On 13-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195128 and expiry date: not reported). On the same day after vaccination, the patient experienced swelling, redness, soreness and pain on the left arm, which was warm to touch. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update on 22-Jul-2018: Non-significant case correction was performed with IRD 11-Jun-2018: The sentence in the case comment was corrected from 'the causality of the events is assessed as related due to temporal relationship' to 'the causality of the events is assessed as related due to plausible temporal relationship between vaccination to event onset'.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Erythema, Malaise, Pyrexia, Tenderness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713344), concerns a 61-year-old adult female patient. The patient's medical history and current illness was not reported. The patient had no known allergies. On 15-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 195216 and expiry date: not reported). On the same day, the patient was also administered with non-company suspect drugs PNEUMOVAX (dose: 1 DF, route of administration: intramuscular, anatomical location: right arm, batch number: N019983 and expiry date: not reported) and ZOSTAVAX (dose: 1 DF, route of administration: subcutaneous, anatomical location: right arm, batch number: M041182 and expiry date: not reported. On 16-Sep-2017, one day after vaccination, the patient experienced tenderness and redness in the arm, fever of about 101 and was not feeling well. The patient was advised to take ibuprofen or acetaminophen for fever and suggested to monitory the injection site. The patient had recovered from the events (feeling unwell, tenderness, redness and fever). The reporter assessed this case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713482), concerns a 63-year-old, adult, female patient. The patient's current condition included asthma. The patient was allergic to erythromycin. On 01-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported) and was administered with co-suspect PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: M037669, dose, anatomical location: not reported). On the same day after vaccination, the patient experienced shortness of breath, redness, swelling and pain at the injection site. The patient was treated with Ibuprofen. Pharmacist recommended BENADRYL, however patient was on the way to physician's office. At the time of this report, the outcome of all the events was unknown. The reporter assessed this case as non-serious.