chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Foetal death, Foetal heart rate abnormal, Pain, Pyrexia
Clinical narrative: Pt G3P2 at 28.5 weeks with EDD of 12/22/17. Went to OB office on 10/3/17 for routine OB apt at 28.4 weeks. Pt was feeling well, feeling fetal movement, pt's fingerstick blood sugar was 138, Tdap was given per routine office policy. Later that evening, pt began to feel achy and had a low-grade fever of 99 degrees. Pt called MD at approx. 0230 on 10/4/17 to report possible spontaneous rupture of membranes. MD told her it was most likely not her water and to note if it kept coming out. Pt came to triage at hospital at approximately 0830 after feeling certain her water had broken and starting to be in some pain. AmniSure was positive and foul smell noted. Pt was 3cm at this time with no fetal heart tones found. Pt delivered fetal demise 10/4/17 at 1043 am. Baby weighed 1480g, or 3lbs. 4oz.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient was given flu injection on 9/21 and it started hurting hours later. Patient was seen for another visit on 10/2 because she was still having pain in her left shoulder/arm and had limited movement in her arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Pain, Swelling
Clinical narrative: Patient had swelling the size of a baseball, pain and discomfort.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: The patient is an RN and she called me Saturday am after the vaccine. She said she thought she was having an allergic reaction. She said it was swollen and somewhat red. It itched just slightly. She also mentioned a rash on her legs. I recommended to do an ice pack and also an antihistamine for the weekend. I also asked her to mark the edges with a ball point pen to be able to monitor for it increasing in size. I told her to seek treatment if it got worse in spite of recommendations. I checked on her on 10/2/17 and she reported that the whelp was about same size  but not as pronounced. I sent her a message today to follow up but I have not received a response yet.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: The patient is an RN and she called me Saturday am after the vaccine. She said she thought she was having an allergic reaction. She said it was swollen and somewhat red. It itched just slightly. She also mentioned a rash on her legs. I recommended to do an ice pack and also an antihistamine for the weekend. I also asked her to mark the edges with a ball point pen to be able to monitor for it increasing in size. I told her to seek treatment if it got worse in spite of recommendations. I checked on her on 10/2/17 and she reported that the whelp was about same size  but not as pronounced. I sent her a message today to follow up but I have not received a response yet.
Age: 25.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood test, Dizziness, Immediate post-injection reaction, Pruritus
Clinical narrative: Immediately after administration of the flu vaccine, the patient started complaining of itching. She was given a BENADRYL tablet immediately following vaccination. After about 5 minutes, the patient was complaining of feeling lightheaded. She was told to take a seat and was given an EPIPEN to administer if she started having difficulty. Patient continued to decline and pharmacist called 911 and administered EPIPEN to patient. EMS arrived within a few minutes and took patient to hospital where she was given further treatment.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia, Somnolence
Clinical narrative: Fever to 101.4 off and on for 2 days following vaccine administration. Baby also slept more for next 2 days. Baby was more fussy than usual for 2 days following vaccine administration.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypersomnia, Irritability, Pyrexia
Clinical narrative: Fever to 101.4 off and on for 2 days following vaccine administration. Baby also slept more for next 2 days. Baby was more fussy than usual for 2 days following vaccine administration.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: My left armpit became swollen and tender.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain
Clinical narrative: Patient called today and stated that she aches all over her body and hasn't been able to sleep since 9/28. She specifically says aches, not pain. She had received the Fluzone HD last year as well and now remembers that this happened to her last year as well.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, warmth, swelling, pain. Advised to take NSAIDS, anti histamines and apply cool compresses.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Patient called today (10/04/2017) complaining of a severe sore arm with pain referring to her shoulder on the back and of Flu like symptoms which she described as being Fluishy.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Malaise, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I developed a sore throat within 2 hours of receiving the vaccine. I was sick the next day with a sore throat and cold symptoms (sneezing, fatigue, runny nose, sore throat). Advil didn't help with my sore throat. I'm still sick the second day with the same symptoms.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Sneezing
Clinical narrative: I developed a sore throat within 2 hours of receiving the vaccine. I was sick the next day with a sore throat and cold symptoms (sneezing, fatigue, runny nose, sore throat). Advil didn't help with my sore throat. I'm still sick the second day with the same symptoms.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Red rash warm to touch from bottom of deltoid to mid tricep covering most of bicep. advised patient to take benadryl and use benadryl cream as well as an ice pack, patient said nothing else was wrong and if anything else occurred she would report back.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 26-MAY-2016 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and 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 22-JUL-2016, the patient was treated by a Nurse Practitioner at a Family Medicine Practice for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles, with cellulitis due to zoster infections. The patient has been prescribed valacyclovir and cephalexin for management of his painful shingles and subsequent dermal infections. 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. Upon internal review cellulitis was considered to be a medically significant event.   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Skin infection
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 26-MAY-2016 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and 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 22-JUL-2016, the patient was treated by a Nurse Practitioner at a Family Medicine Practice for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles, with cellulitis due to zoster infections. The patient has been prescribed valacyclovir and cephalexin for management of his painful shingles and subsequent dermal infections. 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. Upon internal review cellulitis was considered to be a medically significant event.   Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Cough
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co. Inc. (Manufacturer ref. number 00589602), by a contactable consumer (patient). This female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, a couple days later administration of  vaccine, the patient developed cough which lasted about a year. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Onset of body aches, chills, nausea, and fatigue at 6:00 pm on the date of vaccination 10/3/17. Symptoms lasted for approximately 5 hours.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site rash, Irritability, Pyrexia
Clinical narrative: Fever 101 yesterday and rash. CC: Patient presents for rash. HPI: He developed a rash where he got a shot. He had 101 temp yesterday and got some MOTRIN last night, no fever today. A bit cranky, walking fine. ROS: CV: Denies chest pain. Resp: Denies cough and SOB. GI: Denies diarrhea, nausea and vomiting.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Red around site/fever/chills cephalexin given.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Red/warm area of injection 7 x 8 cm. provider treating as cellulitis with Keflex.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received flu vaccine in am by dinner time in the evening the area was red, raised and warm. By the morning the area had gotten a little bigger and by Monday morning the area continued to be red, raised and warm. Person went to local Urgent Care they gave her a steroid and told her to come back if it continued to get any bigger. It started to decrease in size that evening.
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Facial pain, Musculoskeletal pain, Nausea, Vomiting
Clinical narrative: A few hours after getting the shot I had become nauseous and my face had hurt in my cheeks and temples. I had also gotten shoulder pain. I got very light headed and laid down. When I had woken back up a half an hour to an hour after, I threw up. I laid down again, but this time was probably for a few hours. When I had woken up my face wasn't as sore but I still felt nauseous, and I had thrown up bile.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cardiac monitoring, Heart rate increased
Clinical narrative: HAD INCREASE IN HEART RATE/BLOOD PRESSURE BEGINNING 5-10 MINUTES AFTER RECEIVING THE VACCINE.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Approximately 1 hour after receiving injection the patience arm swelled, started running fever of 102 and nausea/vomiting occurred. Patient seeked treatment. received medication. Patient states that as of 10/4/2017 her arm is still swollen.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Fall, Syncope
Clinical narrative: Patient experienced syncope and began to fall to floor. Spouse noted that patient had experienced symptoms 6 months previously without exposure to vaccine. Patient was medically evaluated at that time and physician could not determine cause.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Markedly swollen, pink, warm arm day after vaccine given. Ibuprofen, Benadryl.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Small hematoma at injection site; physician encouraged to elevate and ice his arm.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysarthria, Loss of consciousness, Pyrexia
Clinical narrative: Patient was dizzy, spiked a fever of 101.8, slurring words, and "passed out" on mom. Mom was directed to take the patient to the Emergency Room immediately.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema multiforme, Gait disturbance, Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling at injection site the next AM following injection. Child refused to walk x 2 days. Rash developed serpiginous border by 5 days post vaccination concerning for E.Multiforme type reaction.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt complains of swelling and pain in the arm beyond what she expected.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersomnia, Romberg test positive, Somnolence, Tremor
Clinical narrative: Patient fell asleep at 2:30pm and was difficult to wake up at 9am the following day. Awake after chiropractor visit. Patient appeared somnolent at noon when patient seen in office. Positive Romberg noted on exam and mild tremor when hands fully extended. Tremor noted at neurology appointment 9/16/17, but Romberg test not mentioned. Patient walked out of office with a pedialyte popsicle.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthropathy, Cellulitis
Clinical narrative: Patient was seen at physician's office and was diagnosed with cellulitis and arthropathy.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Burning sensation, Erythema, Inflammation, Local reaction, Pain in extremity
Clinical narrative: Patient received influenza on the right arm, and PREVNAR on the left arm on 10/2/17. Patient reports following adverse reactions on 10/4/17 at the pharmacy. Patient reports that on 10/3/17 her RIGHT ARM started hurting during the day time and started burning in the middle of the night. On 10/4/17, patient reports she saw redness, inflammation, and swelling. Patient reports local reaction only and denies any systemic reactions. Patient came to the pharmacy on 10/4/17 and reported these adverse reactions.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Swelling
Clinical narrative: Patient received influenza on the right arm, and PREVNAR on the left arm on 10/2/17. Patient reports following adverse reactions on 10/4/17 at the pharmacy. Patient reports that on 10/3/17 her RIGHT ARM started hurting during the day time and started burning in the middle of the night. On 10/4/17, patient reports she saw redness, inflammation, and swelling. Patient reports local reaction only and denies any systemic reactions. Patient came to the pharmacy on 10/4/17 and reported these adverse reactions.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Pain, X-ray
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Patient still has a sore arm 2 weeks later.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Flushing, Haemorrhage, Injection site swelling
Clinical narrative: Patient was bleeding and had a ~2cm diameter raised bump at injection site. Patient felt flushed and hot. Patient was requested to stay seated under observation for about 15-30 minutes. 50mg of diphenhydramine liquid was administered orally. Patient refused any other treatment reported to be fine an hour later.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Ecchymosis, Injection site pain, Subcutaneous haematoma
Clinical narrative: On 10/3/17 patient called us here at her PCP office to report reaction to flu vaccine she had received at pharmacy. (Pt remembered the vaccine date as 9/25/17 but pharmacy confirmed she had it done on 9/19/17.) Pt reported that 4 days after the vaccine she developed soreness in the arm where she had the vaccine. At the time of her call 10/3/17 pt reported that she had just that day noticed that her arm had a new, very large bruise from deltoid down to the elbow and it appeared to be spreading. Pt takes LOVENOX injections daily so was quite concerned. Pt was advised to have provider evaluate at local urgent care (which she did). Urgent care provider documented the following: "The patient has a large hematoma subcutaneous in her right shoulder in the deltoid muscle area. The patient has ecchymoses inferior to this consistent with blood running downstream in her arm. She does not have any underlying erythema. Nothing at this time to suggest infection." Provider advised pt: "We have found a definite hematoma in your right arm. Given the size, I would guess that this will take 6 weeks to completely reabsorbed. However, it should slowly get smaller over the next 2 weeks.  If you are not allergic to TYLENOL, you may take up to 500 mg every 4 hours as needed for pain. I would recommend 20 minutes of heat off and on. Do not sleep on a heating pad. I would purchase a thermometer. If you have a temperature of 99.5 or higher, I would return for reevaluation to consider infection.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Cold sweat, Pallor, Posture abnormal, Staring, Unresponsive to stimuli
Clinical narrative: He held arms out locked limbs head to the side blanked stare & on responsive. Pale clammy skin he was immediately carried back into the building (never left the property) started coming to & his vitals were checked & blood sugar checked.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood glucose normal, Cold sweat, Feeling abnormal, Loss of consciousness, Muscle rigidity
Clinical narrative: He held arms out locked limbs head to the side blanked stare & on responsive. Pale clammy skin he was immediately carried back into the building (never left the property) started coming to & his vitals were checked & blood sugar checked.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pallor, Seizure
Clinical narrative: He held arms out locked limbs head to the side blanked stare & on responsive. Pale clammy skin he was immediately carried back into the building (never left the property) started coming to & his vitals were checked & blood sugar checked.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: I was part of off site-health care event. I went over consent form with patient, he signed release of li-ability form, and I confirmed no medical conditions or allergies. After I gave patient a flu shot, he put his head down on the table in front of him. For the second it looked like he was just relaxing. I tapped his shoulder couple of times asking him if he was ok, but I haven't received any answer. I just then realized that pt had fainted. I got help from lady who was together with me in the room as part of the health care event. We gently put patient from the chair to the ground protecting his head at all the time. We then elevated his legs. At that moment I saw that patients was responsive again. I asked him if he wanted me to call 911. He said no. His face was really pale. I asked the lady to go and call nurses  who also were present at the event. In the same time I checked patient BP. His BP was normal 119/72 but HR was 44. Two nurses stepped in the room, one of them was with the patient till recovery. Nurses put ice packs behind patient's neck and on upper chest, just below the neck. Patient  started feel better but he was still weak. We transferred patient to adjustable chair that nurses use for blood donations. They gave patient apple juice ( he had 2) and bag of pretzels. I checked his BP again This time 128/78 and HR 56. Patient was recovered and after 20 minutes of observation and he stood up.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Arthralgia, Body temperature increased, Eye pain, Fatigue
Clinical narrative: 9/30 Elevated temperature (99), muscle pain, joint pain, increased joint crepitus, fatigue. 10/1 Fever (100), increased muscle pain, extreme stabbing pains in abdomen (both front and back) near bottom of rib cage, muscle spasms, eye pain. 10/2 normal temperature, continued but decreased stabbing pains in abdomen, muscle spasms. 10/3 continued but decreased stabbing pains in abdomen, no other muscle spasms detected.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Joint crepitation, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: 9/30 Elevated temperature (99), muscle pain, joint pain, increased joint crepitus, fatigue. 10/1 Fever (100), increased muscle pain, extreme stabbing pains in abdomen (both front and back) near bottom of rib cage, muscle spasms, eye pain. 10/2 normal temperature, continued but decreased stabbing pains in abdomen, muscle spasms. 10/3 continued but decreased stabbing pains in abdomen, no other muscle spasms detected.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT REPORTED AND SHOWED REDNESS, SWELLING, AND PAIN AT SITE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash, Rash erythematous
Clinical narrative: 2 weeks after the shot, the site of the shot was raised, bumpy and pink 3 inches in diameter. He also had small red bumps on his back, chest, shoulders, and penis.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Excessive soreness in arm lasting for 2+ weeks.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Bone pain, Paraesthesia, Pyrexia
Clinical narrative: Patients wife describes his symptoms as a high fever of at least 101 degrees farenheit with tingling in his extremeties. He also stated his bones hurt and his fever was much worse standing up. This lasted 2 days after the vaccine but the patient is recovered now. Patient did contact his MD and was told to go to emergency if fever increased but the patient did not end up needed to seek additional care.
Age: 49.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient called and complained of severe muscle pain in his left shoulder and that he could not use his left arm at all, he said that he had to use his right arm to move his left arm. He also stated that the immunization given into his left arm muscle was injected near the shoulder and may have hit bone or a nerve.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/itching about 2 hours after injection.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity, Paraesthesia
Clinical narrative: As I inserted the needle, I felt some resistance; so I pulled back very slightly on the needle and the patient moved (twitched) more than once. She stated that her hand/fingers were tingling. She said it was better after the immunization was completed. I called her later in the evening to see how she was feeling. She called me the next day and stated that the arm was a little sore around the nerves, but better.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Patient presented to the pharmacy a couple days later with swelling, itchiness, redness, and warm to the touch. Said she had taken benadryl and it has gotten better. The rash was about 8 inches. Patient is doing better, told her to continue with what she was doing.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Patient began experiencing injection site reaction and a headache hour after immunization. Site reaction did not subside and is warm to touch and spread down towards elbow and started itching  (Wed,  3 days later). Patient was advised to use cold compress, use hydrocortisone for itching and acetaminophen for headache if it persists.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Vomiting
Clinical narrative: Patient's wife called pharmacy at 8pm reporting that the patient had chills and was vomitting.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Injection site pruritus, Pulmonary function test
Clinical narrative: Complaints of itching at the injection site. No visible hives. Complaints of chest tightness and feeling SOB. No visible signs of respiratory distress observed.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Altered state of consciousness, Blood pressure decreased, Headache, Nausea, Oral pain
Clinical narrative: PT BECAME VERY PALE, SAID HER HEAD AND MOUTH WERE HURTING, SHE LOOKED AS IF SHE WAS GOING TO PASS OUT. ALSO SAID SHE FELT LIKE SHE MIGHT VOMIT. I TOOK PT'S BLOOD PRESSURE AND IT HAD DROPPED TO APPROX 80/40. OVER THE NEXT 5 MINUTES SHE DID NOT IMPROVE AT ALL AND I HAD TROUBLE GETTING HER TO TALK TO ME AND DESCRIBE HER SYMPTOMS, SO I CALLED FOR AMBULANCE TO COME EVALUATE HER AND TREAT IF NECESSARY. THEY ARRIVED AND TRANSPORTED HER TO THE LOCAL HOSPITAL FACILITY.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pallor
Clinical narrative: PT BECAME VERY PALE, SAID HER HEAD AND MOUTH WERE HURTING, SHE LOOKED AS IF SHE WAS GOING TO PASS OUT. ALSO SAID SHE FELT LIKE SHE MIGHT VOMIT. I TOOK PT'S BLOOD PRESSURE AND IT HAD DROPPED TO APPROX 80/40. OVER THE NEXT 5 MINUTES SHE DID NOT IMPROVE AT ALL AND I HAD TROUBLE GETTING HER TO TALK TO ME AND DESCRIBE HER SYMPTOMS, SO I CALLED FOR AMBULANCE TO COME EVALUATE HER AND TREAT IF NECESSARY. THEY ARRIVED AND TRANSPORTED HER TO THE LOCAL HOSPITAL FACILITY.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: PATIENT CAME TO PHARMACY TWO DAYS POST VACCINATION FROM 10/2/17- DELTOID AND SURROUNDING AREA WAS SWOLLEN AND WARM MORE USUAL.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The immunizations were given in her Right arm on 9/29/2017 (the FLUZONE top right and PNEUMOVAX bottom right arm). The patient woke up the morning of 9/30/2017 and states her arm was swollen to twice its size from her shoulder to her elbow. Her arm was red and hot to the touch. Then shortly after she experienced fever/ chills and started vomiting. Patient states these symptoms lasted for 5 days. I spoke with her today and she is doing good.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: The immunizations were given in her Right arm on 9/29/2017 (the FLUZONE top right and PNEUMOVAX bottom right arm). The patient woke up the morning of 9/30/2017 and states her arm was swollen to twice its size from her shoulder to her elbow. Her arm was red and hot to the touch. Then shortly after she experienced fever/ chills and started vomiting. Patient states these symptoms lasted for 5 days. I spoke with her today and she is doing good.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Flu and DTaP both given. Muscle pain in left arm that never went away. Some tingling starting to happen now (10/17).
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Diarrhoea
Clinical narrative: Two days after receiving flu shot patient reported feeling extremely weak with a loss of appetite. Then had severe diarrhea.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain
Clinical narrative: Headache (x 2 days), full body aches (x 1 day). Resolved on its own with only minimal intervention (OTC NSAID). Onset of symptoms was approx. 30-45 minutes post-injection.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Large, red, slightly painful, raised area at site of injection appeared 2 days after vaccination. Was about 2 inches long and 1 inch wide. Lasted about 2 days and very slowly went away on its own. No medication taken or applied topically.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: PATIENT EXPERIENCED A FEVER THE DAY AFTER RECEIVING THE SHOTS, THEN DEVELOPED A 4 INCH RASH THAT WAS WARM TO THE TOUCH.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Brain scan normal, Chills, Dehydration, Dizziness, Head injury
Clinical narrative: Pt  had chills night of vaccines, then dizzy, lightheaded morning after. Sat on toilet to gather himself but passed out to floor and hit his head. Ambulance took him to hospital for 2 days.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Loss of consciousness
Clinical narrative: Pt  had chills night of vaccines, then dizzy, lightheaded morning after. Sat on toilet to gather himself but passed out to floor and hit his head. Ambulance took him to hospital for 2 days.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted after receiving flu shot. Never lost consciousness. Was able to return to class.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Eye discharge, Eye disorder, Eye swelling
Clinical narrative: Pt complained of SOB/tightness of chest and eye issues roughly 2 hours after vaccine. Took BENADRYL as advised from MD and woke up in AM w/eyes swollen, pus/mucus and redness MD advised patient may have had RXN to the vaccine/previous lots could have had actual live vaccine in it, I informed MD that was not the case w/ the vaccine. Pt was given steroid shot and MD prescribed TAMIFLU BID for 5 days as she was running a fever as well, she could have been reacting/fighting infection. Pt was given BENADRYL, EMERGEN C, and TAMIFLU at pharmacy per MD orders and she was feeling better following shot.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pyrexia
Clinical narrative: Pt complained of SOB/tightness of chest and eye issues roughly 2 hours after vaccine. Took BENADRYL as advised from MD and woke up in AM w/eyes swollen, pus/mucus and redness MD advised patient may have had RXN to the vaccine/previous lots could have had actual live vaccine in it, I informed MD that was not the case w/ the vaccine. Pt was given steroid shot and MD prescribed TAMIFLU BID for 5 days as she was running a fever as well, she could have been reacting/fighting infection. Pt was given BENADRYL, EMERGEN C, and TAMIFLU at pharmacy per MD orders and she was feeling better following shot.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Redness; swelling and pain right outer arm. It got big quick and has grown in size. No previous incidents.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, hot patch to injection site.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Immunisation reaction, Ocular hyperaemia
Clinical narrative: Patient had to go to ER and they told her she was having an immune reaction/response to flu vaccine and will be rechecked in 2 wks. Right eye was very red and painful.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Arm hurt, felt heavy. Hand became swollen.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Paraesthesia, Periarthritis
Clinical narrative: Reported given too high. Pain in shoulder and tingling down arm. Can't raise arm. MD gave antiinflammatory then sent to orthopedic. Inferior acromion adhesive capsulitis.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate affect, Pyrexia, Seizure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of seizure in a 6-year-old male patient who received FLUARIX QUADRIVALENT (batch number B5592, expiry date 20th June 2017). Previously administered products included influenza vaccine  (without any issue). Concurrent medical conditions included autism. On 22nd September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 22nd September 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced seizure (serious criteria GSK medically significant), fever and inappropriate laughter. On 23rd September 2016, the outcome of the fever and inappropriate laughter were recovered/resolved. On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure and inappropriate laughter to be related to FLUARIX QUADRIVALENT. The reporter considered the fever to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in right deltoid. The patient's parents brought the patient back to the doctor office next day because 5 hours after the vaccination the patient developed a fever of 102F and also had inappropriate laughter during the night. The practitioners were concerned that this might be a seizure. The healthcare professional called to see if they had any data for seizures in FLUARIX or FLULAVAL. They have FLULAVAL in stock this season and were curious if he might experience the same adverse events.
Age: 64.0
Sex: F
Vaccine: TDAP, FLU4, TDAP
Symptoms: Anxiety, Chills, Confusional state, Disorientation, Dizziness
Clinical narrative: Patient says she experienced disorientation, confusion, spacing out, chills, shakiness about 1 hour after the injections. She got into an accident. She also reported this event to the CDC.
Age: 64.0
Sex: F
Vaccine: TDAP, FLU4, TDAP
Symptoms: Palpitations, Road traffic accident, Tremor
Clinical narrative: Patient says she experienced disorientation, confusion, spacing out, chills, shakiness about 1 hour after the injections. She got into an accident. She also reported this event to the CDC.
Age: 64.0
Sex: F
Vaccine: TDAP, FLU4, TDAP
Symptoms: Accident, Chills, Confusional state, Disorientation, Feeling abnormal
Clinical narrative: Patient says she experienced disorientation, confusion, spacing out, chills, shakiness about 1 hour after the injections. She got into an accident. She also reported this event to the CDC.
Age: 64.0
Sex: F
Vaccine: TDAP, FLU4, TDAP
Symptoms: Tremor
Clinical narrative: Patient says she experienced disorientation, confusion, spacing out, chills, shakiness about 1 hour after the injections. She got into an accident. She also reported this event to the CDC.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable healthcare professional, an office manager, calling on behalf of a contactable physician. A 6-month-old male patient of an unspecified ethnicity, received the third dose of PREVNAR 13, (Lot: S39564 and Expiry: 30Sep2018), via an unspecified route of administration on the Vastus Lateral Right on 27Sep2017 11:00 at a single dose and PENTACEL, (Lot: C5293AA and Expiry: 12Mar2018), via an unspecified route of administration on 27Sep2017 at unknown dose both due for his 6 month (for immunization). The patient had no relevant medical history/conditions, family medical history, concomitant medications, or relevant tests/investigations. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) at the age of a little over 2 months old on 24May2017 and the second dose at the age of 4 months old on 26Jul2017, both intramuscular on Right Vastus Lateral with Lot: R49357 and Expiry Date: 31May2018. The patient also previously received the first dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Lot: C5334AA and Expiry: 04Mar2018) intramuscular on Left Vastus Lateral at the age of 2 months old on 24May2017. The office manager was reporting an adverse event for a patient that received 2 vaccines that were given at once. On 27Sep2017, the patient experienced rash on neck and face that was red and elevated. The outcome of the event was resolved on 27Sep2017 reported as cleared mostly within 1 hour and didn't seem to be itchy, no new foods, no cold, or cough. Seriousness was unknown, and the office manager did not wish to speak on the provider's behalf because he was not there. All she could say was that they sent the child home and the child seemed fine but they wanted her to make sure she reported it on the office's behalf. The event did not require a visit to the ER or hospitalization. Causality for both products was unknown.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable healthcare professional, an office manager, calling on behalf of a contactable physician. A 6-month-old male patient of an unspecified ethnicity, received the third dose of PREVNAR 13, (Lot: S39564 and Expiry: 30Sep2018), via an unspecified route of administration on the Vastus Lateral Right on 27Sep2017 11:00 at a single dose and PENTACEL, (Lot: C5293AA and Expiry: 12Mar2018), via an unspecified route of administration on 27Sep2017 at unknown dose both due for his 6 month (for immunization). The patient had no relevant medical history/conditions, family medical history, concomitant medications, or relevant tests/investigations. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) at the age of a little over 2 months old on 24May2017 and the second dose at the age of 4 months old on 26Jul2017, both intramuscular on Right Vastus Lateral with Lot: R49357 and Expiry Date: 31May2018. The patient also previously received the first dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Lot: C5334AA and Expiry: 04Mar2018) intramuscular on Left Vastus Lateral at the age of 2 months old on 24May2017. The office manager was reporting an adverse event for a patient that received 2 vaccines that were given at once. On 27Sep2017, the patient experienced rash on neck and face that was red and elevated. The outcome of the event was resolved on 27Sep2017 reported as cleared mostly within 1 hour and didn't seem to be itchy, no new foods, no cold, or cough. Seriousness was unknown, and the office manager did not wish to speak on the provider's behalf because he was not there. All she could say was that they sent the child home and the child seemed fine but they wanted her to make sure she reported it on the office's behalf. The event did not require a visit to the ER or hospitalization. Causality for both products was unknown.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Cold sweat, Pallor, Posture abnormal, Staring, Unresponsive to stimuli
Clinical narrative: Seizure vs passing out - location in car after leaving office. Dad states turned to back out of parking spot and his sone was ridgid and in a daze for several seconds. He then brought him back into office. Appearance, pale and clammy - vitals were performed all WNL. Glucose was normal.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Blood glucose normal, Cold sweat, Feeling abnormal, Loss of consciousness, Muscle rigidity
Clinical narrative: Seizure vs passing out - location in car after leaving office. Dad states turned to back out of parking spot and his sone was ridgid and in a daze for several seconds. He then brought him back into office. Appearance, pale and clammy - vitals were performed all WNL. Glucose was normal.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Pallor, Seizure
Clinical narrative: Seizure vs passing out - location in car after leaving office. Dad states turned to back out of parking spot and his sone was ridgid and in a daze for several seconds. He then brought him back into office. Appearance, pale and clammy - vitals were performed all WNL. Glucose was normal.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Contusion, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Swollen, fever, headache, breathing, severe pain/burning sensation. First visit to urgent care, given toradol shot. Systems not changed went to primary dr 9/30, given predisol, fever gone, arm still swollen and bruised, very bad appetite and now experiencing diarrhea and its been almost 15 days after injection. Breathing hurts in upper stomach, right under breast.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Painful respiration, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Swollen, fever, headache, breathing, severe pain/burning sensation. First visit to urgent care, given toradol shot. Systems not changed went to primary dr 9/30, given predisol, fever gone, arm still swollen and bruised, very bad appetite and now experiencing diarrhea and its been almost 15 days after injection. Breathing hurts in upper stomach, right under breast.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pain, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: Fever, achiness, severe congestion, headache, rash.
Age: 1.08
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Developed fever and redness in left thigh on 10/1/17. Pt was evaluated on 10/4/17, afebrile and monitoring redness, no treatment recommended.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Patient received the influenza vaccine at work around 09:30 on 4 October 2017. Patient felt dizzy and had a headache/lightheadedness following the vaccine. That evening around 6PM, the Patient took a bath and following began to feel weak, lightheaded, dizzy, and vision blurred. Patient's heart rate elevated and breathing was rapid and shallow. Patient's hands/arms began to tingle and feel numb. Patient legs and cheeks also began to tingle and hands cramped. The Patient laid on the couch and elevated their feet. The Patient's spouse was able to assist. The Patient began alternate nostril breathing to control breathing and decrease heart rate. Symptoms persisted for about 20 minutes before slowly subsiding. The Patient was able to drink water. Following the event, the Patient was exhausted and developed a migraine. Sleep was also disrupted the night following.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Hypopnoea, Migraine, Muscle spasms, Paraesthesia
Clinical narrative: Patient received the influenza vaccine at work around 09:30 on 4 October 2017. Patient felt dizzy and had a headache/lightheadedness following the vaccine. That evening around 6PM, the Patient took a bath and following began to feel weak, lightheaded, dizzy, and vision blurred. Patient's heart rate elevated and breathing was rapid and shallow. Patient's hands/arms began to tingle and feel numb. Patient legs and cheeks also began to tingle and hands cramped. The Patient laid on the couch and elevated their feet. The Patient's spouse was able to assist. The Patient began alternate nostril breathing to control breathing and decrease heart rate. Symptoms persisted for about 20 minutes before slowly subsiding. The Patient was able to drink water. Following the event, the Patient was exhausted and developed a migraine. Sleep was also disrupted the night following.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Respiratory rate increased, Sleep disorder, Vision blurred
Clinical narrative: Patient received the influenza vaccine at work around 09:30 on 4 October 2017. Patient felt dizzy and had a headache/lightheadedness following the vaccine. That evening around 6PM, the Patient took a bath and following began to feel weak, lightheaded, dizzy, and vision blurred. Patient's heart rate elevated and breathing was rapid and shallow. Patient's hands/arms began to tingle and feel numb. Patient legs and cheeks also began to tingle and hands cramped. The Patient laid on the couch and elevated their feet. The Patient's spouse was able to assist. The Patient began alternate nostril breathing to control breathing and decrease heart rate. Symptoms persisted for about 20 minutes before slowly subsiding. The Patient was able to drink water. Following the event, the Patient was exhausted and developed a migraine. Sleep was also disrupted the night following.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to multiple patients of unknown demographics. There was no information about the patients concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA005524: US-009507513-1709USA005553.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 25-SEP-2017, the patient was the patient was inadvertently administered a dose of VARIVAX lot # L015047 which expired on 29-APR-2017 (dose and route of administration were not reported). No adverse effects was reported. Product quality complaint was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a 65 year old male patient. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. On unknown dates, the patient experienced chronic inflammatory demyelinating polyneuropathy and severe pain. The patient sought medical attention, he spoke with the physician. At the time of reporting, the patient was in severe pain. The outcome of chronic inflammatory demyelinating polyneuropathy was unknown. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of chronic inflammatory demyelinating polyneuropathy was considered to be medically significant.