chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Throat irritation, Throat tightness
Clinical narrative: Employee notified this nurse of suspected reaction at 6:58 pm by text. She reported scratchy throat, cough and tight feeling in her throat. She reports having a reaction 10 years ago to a flu shot but not since; she has had one every year. This nurse directed her to take benadryl and if symptoms persist or  worsen to go to ER. Symptoms improved upon administration of Benadryl but returned at 11:19 pm and she went to the ER. She was released at 2am.
Age: 10.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has swelling,pain and redness on upper right arm. Redness and swelling extend from shoulder to elbow area, extended entire circumference of the arm. Pt was evaluated by provider and was started on antibiotics.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Differential white blood cell count, Full blood count, Mobility decreased, Pain, Rash erythematous
Clinical narrative: Pain, distal from shot red rash warm to touch, and per pt she isn't able to lift arm.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Pain, distal from shot red rash warm to touch, and per pt she isn't able to lift arm.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Malaise, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Local induration and arm swelling x4d; fever and malaise x5d; arm itching (ongoing) Advised tylenol, oral antihistamine.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient claimed sore, swollen, red arm at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Shot given 10:30 am on Saturday. By evening, had intense pain, with redness, swelling and hot to touch all over the deltoid muscle. Fever, body aches and muscle pains persisted through the night. Felt tired, weak and lightheaded the next morning along with headache and body aches. By Monday morning, most of these symptoms were gone, except the arm was still red and somewhat sore. Then it got itchy. This continued through Tuesday and finally subsided Wednesday after at least 96 hours since the shot was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Shot given 10:30 am on Saturday. By evening, had intense pain, with redness, swelling and hot to touch all over the deltoid muscle. Fever, body aches and muscle pains persisted through the night. Felt tired, weak and lightheaded the next morning along with headache and body aches. By Monday morning, most of these symptoms were gone, except the arm was still red and somewhat sore. Then it got itchy. This continued through Tuesday and finally subsided Wednesday after at least 96 hours since the shot was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Shot given 10:30 am on Saturday. By evening, had intense pain, with redness, swelling and hot to touch all over the deltoid muscle. Fever, body aches and muscle pains persisted through the night. Felt tired, weak and lightheaded the next morning along with headache and body aches. By Monday morning, most of these symptoms were gone, except the arm was still red and somewhat sore. Then it got itchy. This continued through Tuesday and finally subsided Wednesday after at least 96 hours since the shot was given.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Patient was given vaccine at 9 am on 9/21. At 4:30 pm that same day, he developed diffuse urticaria throughout body. Responded to Benadryl, however hives persisted. Treated Benadryl and Zyrtec. Urticaria resolved on 9/25. Patient has no known egg or other allergy. Has had flu vaccine in the past without reaction.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Fatigue, Influenza like illness, Periorbital swelling
Clinical narrative: Client in to OHC today for MD f/u physical. Client reports "I felt like I was having the flu". Client reports feeling "tired" and "fatigued", low back pain, and periorbital swelling; left greater than the right. Client reported low back pain, and fatigue were resolved Saturday morning.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure fluctuation, Dizziness, Fall
Clinical narrative: DIZZY, FELL ON HER HEAD, CALLED 911, PT WAS RESPONSIVE AFTER SHE FELL, CHECKED PULSE WAS OK, PARAMEDIC CHECKED VITAL BLOOD PRESSURE WAS CHANGING WITH POSTURE, MAY BE DEHYDRATED, PT WENT HOME OK AFTER 20 MIN CALLED AND FOLLLOWED UP AFTER 1 HOURS SHE WAS DOING OK.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot, Flushing, Headache, Heart rate increased
Clinical narrative: Patient called and reported that she woke up at 3am the morning after the vaccine. Stated her face was flushed, pounding headache and she was burning up. She felt ill and reports her heart was beat 120 bpm. Patient states that she washed her face and went back to bed without checking or recording her temperature. She called the clinic the next morning to report the incident. She reported that the symptoms had resolved other than feeling malaise, mild headache and fatigue.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Patient called and reported that she woke up at 3am the morning after the vaccine. Stated her face was flushed, pounding headache and she was burning up. She felt ill and reports her heart was beat 120 bpm. Patient states that she washed her face and went back to bed without checking or recording her temperature. She called the clinic the next morning to report the incident. She reported that the symptoms had resolved other than feeling malaise, mild headache and fatigue.
Age: 75.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Began getting errythemia and induration of the left deltoid on 10/1/2018. It continued to spread. When seen in the office it covered just posterior of the left shoulder to proximal of the left elbow. It was hot to the touch and the client said it was spreading. She had not tried anything for relief. Referred to Urgent Care.
Age: 94.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Patient had fever and chills the night of the vaccine which persisted for 3 days and disrupted patient's quality of life - was not able to do daily functions.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Rash papular
Clinical narrative: Patient came into the pharmacy yesterday 10/2/18 to discuss her reaction to the arm. Pharmacist on site suggested a treatment for her with BENADRYL. Spoke to both mom and patient today and verified just local reaction of bumps and it started the following morning 9/29 when the patient woke up. Patient mentioned it spread but has stopped as of yesterday.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Inflammation, Injection site pain, Joint range of motion decreased
Clinical narrative: SYMPTOMS -injection site seemed to be quite higher on the arm than in the past -injection site very painful -severe pain deep in tissue and shoulder area -some numbness -limited range of motion -the normal pain experienced in the 24 hours follows the procedure has persisted for two weeks  I am currently under the care of my primary physician for possible Bursitis.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Large local reaction 8.5 x 10cm.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: On 9/26/18-Developed 3-quarter sized red-purplish, warm, hot to touch the area where flu vaccine was given. The patient's red area spread  6-8 inch in length and hard, warm, red to touch. Health care provider recommended Zyrtec 2 x Q daily, benadryl at HS, and cold compresses.  Physician recommended flu Mist for next seasons.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: My son was given 0.5 ml instead of 0.25 ml of the flu vaccine so double the dose for his age-not sure which vaccine it was so in item 17 I was guessing based on the info from my son's medical chart available. When the doctor's office notified me via a message from a nurse, I attempted to call back and was unable to reach them. I went to the office directly and spoke with nursing staff and then Dr. who said he didn't understand why I was upset since "this wasn't chemotherapy just a flu shot" and that "this kind of thing doesn't happen often but it does happen so it is unfortunate it happened to us". This is the not the first concerning thing that has happened with regard to the care of my children in this practice and I believe it should be investigated. Upon calling poison control I was told to watch for a reaction for the next 24 hours, so far my son seems fine but 24 hours will pass at 6:30pm tonight.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patients stated that they have carpel tunnel and that the symptoms feel very similar to that. 5 minutes after the injection the patient felt throbbing pain in waves starting in the right arm at the base of the thumb with lighter radiating pain the forearm to the elbow. No pain in shoulder. 60 minutes after the vaccination patient reports pain has lessened but still ongoing.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Patient recieved Flu shot on 09/27/18. The next day he began to feel tingeling sensations in his arms and legs. He is unsure if it is related to the vaccine but takes no other medication and has no other diagnoses. He came in to the pharmacy approximately a week and a half later still complaining of the symptoms.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported her arm got really swollen and red, symptoms started the evening after she received the shot, and progressively got worse. Patient came back to pharmacy next day to seek help, RPH Evan suggested benadryl cream, which patient used and her arm got better after a day.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse and refers to a 9 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) for varicella prevention (dose, frequency, route of administration, lot #, and expiration date were not reported). The reporter heard from a coworker that the patient had developed shingles "even though they were 'up-to-date' on all of their childhood vaccines". The reporter was unsure if the child definitively received any Merck-manufactured vaccine(s). At the reporting time, the outcome of shingles (Herpes zoster) was unknown. The causality assessment between Herpes zoster and the suspect vaccines was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 21-SEP-2018, the patient was vaccinated with PROQUAD, subcutaneously for prophylaxis (lot#, expiration date, dose, strength and frequency were unknown). On the same date, the patient was vaccinated with Oka/Merck VARIVAX subcutaneously for prophylaxis (lot#, expiration date, dose, strength and frequency were unknown). On 21-SEP-2018, the event was considered to be an inappropriate schedule of drug administration, no adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unknown date, the patients was vaccinated with improperly stored doses of M-M-R II lot # N023150 with expiration date 24-AUG-2019 (strength, anatomical location or route of administration were not provided) for prophylaxis; which was previously reconstituted with a properly stored sterile diluent (MERCK). The storage temperature of the vaccine was reported as 47.3 degrees Fahrenheit (°F) for a time frame of 45 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger. This case is a non valid case due to no patient identifier.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Paraesthesia oral, Throat irritation, Vomiting
Clinical narrative: About 5mins after receiving vaccine, team member starting vomiting. Continued vomiting and 7min after vaccine states her lips are tingling and throat scratchy. She was in ER triage by 1127.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient came today in pharmacy to report a reaction, the injection site was red and the redness at the injection site was spreading for up to the left inside area of the left arm (about the size of a palm) and it was warm to touch and patient was suggested to apply cold compress.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the dose for 6-35 months instead of the dose for 3 years and older. No adverse reactions or symptoms have been reported.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: About 24-36 hours after vaccination, the patient began to experience fatigue and malaise, along with chills. By the next day, she experienced low grade fever, scratchy throat, myalgia, arthralgia of hips and lower back, and tinnitus. All of these symptoms began to diminish after about 5-6 days, and most have now fully resolved at day 10 post vaccination, when she presented to our Clinic.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Throat irritation, Tinnitus
Clinical narrative: About 24-36 hours after vaccination, the patient began to experience fatigue and malaise, along with chills. By the next day, she experienced low grade fever, scratchy throat, myalgia, arthralgia of hips and lower back, and tinnitus. All of these symptoms began to diminish after about 5-6 days, and most have now fully resolved at day 10 post vaccination, when she presented to our Clinic.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised
Clinical narrative: Rash covering entire body.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: "Light rash, size of a tennis ball" at SHINGRIX injection site. Appeared 2 hours after vaccination received. Resolved in 24 hours. Experienced arm soreness lasting 2 days. Denies itching, swelling, warmth, fever or joint pain.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Full blood count, Metabolic function test, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, epigastric pain, low grade fever.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound abdomen, Vomiting
Clinical narrative: Nausea, vomiting, epigastric pain, low grade fever.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Nausea, vomiting, epigastric pain, low grade fever.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, epigastric pain, low grade fever.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: I received an influenza vaccine around 11:30AM. At approximaly 1:30AM that night I woke up with severe chills and body and joint aches. After about 30 minutes of shivering in bed, I fell back asleep and woke approximately and hour later sweating heavily and still had joint and body aches. I also had a headache at this time. I was in and out of sleep for the next 3 hours (approximately) as these symptoms continued. Upon waking for the day, I felt fatigued (could also be due to poor sleep), and the headache remained for approximately 24-hours.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Poor quality sleep
Clinical narrative: I received an influenza vaccine around 11:30AM. At approximaly 1:30AM that night I woke up with severe chills and body and joint aches. After about 30 minutes of shivering in bed, I fell back asleep and woke approximately and hour later sweating heavily and still had joint and body aches. I also had a headache at this time. I was in and out of sleep for the next 3 hours (approximately) as these symptoms continued. Upon waking for the day, I felt fatigued (could also be due to poor sleep), and the headache remained for approximately 24-hours.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: Notified by HR Specialist of the clinic that patient had a reaction to her shots via email.  "Our Director of Compensation and Benefits had a reaction to her shots. She then went to her doctor who said the pneumonia and flu shot should never be given at the same time. She wants to make sure at the future clinics these 2 shots are not given together. Do you have any clinical data on this?" No further information was reported after inquiry.  Provided HR Specialist with information and data requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache, body aches, tiredness, lack of energy, fever.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Presyncope
Clinical narrative: Post flu injection, patient reported feeling light headed and faint. Nurse asked client to lie on the floor.  Ice pack was applied to back of neck. Vitals were monitored. Approximately 15 minutes later patient was alert and oriented. No dizziness. No diaphoresis.
Age: 1.25
Sex: M
Vaccine: DTAPIPV, HIBV
Symptoms: Wrong product administered
Clinical narrative: Provider ordered DTaP (DAPTACEL) and HIB (ACTHIB) vaccines for the 15 month physical exam. Medical assistant accidently administered QUADRACEL (DTaP and Polio) along with the HIB vaccine.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Employee received vaccine at work yesterday. This afternoon, her arm was painful and she noticed a red raised area at the insertion site measuring 1.5 inches in diameter. Warm to touch. Employee is currently afebrile. Recommended she take TYLENOL or ADVIL for discomfort and apply warm moist compresses. Instructed to go to walk-in clinic for evaluation if worsens.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Pain, Rash
Clinical narrative: Patient reported reoccurrence of shingles symptoms including headache, pain, rash and fatigue. Symptoms begin the morning after the vaccine was administered and resolved within 3 days.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Pt developed rash on chest and legs 9 hours after receiving vaccine. Mother also noted fever tmax 99.8 today. Diagnosed with allergic urticaria today 10/3/18. Prescribed Benadryl and instructed to follow up with primary care doctor in 2 days. Appt scheduled in clinic for 10/5/18.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Myalgia, Tendonitis
Clinical narrative: Bursitis, muscle pain, tendonitis for 2 weeks following vaccination per patient.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 2 weeks post flu immunization, patient reported pain from shoulder to wrist on left arm. He said the pain began soon after the immunization was administered but he thought it would go away. 2 weeks later the pain has not subsided. This writer explained that it is hard to say if the flu shot caused this pain in his arm but understood why he would think the pain is related to the administration of his flu shot. Suggested he consult with his primary healthcare provider.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Injection site pain, Mobility decreased
Clinical narrative: Tiredness and fatigue appeared first. Then nausea, dizziness, fainting, excessive sweating, and anxiety began within a few minutes. The whole event was over in about 20 minutes. Pain at the injection site also got worse around this time, and stayed for several hours after. Patient could not easily lift arm above their head.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Syncope
Clinical narrative: Tiredness and fatigue appeared first. Then nausea, dizziness, fainting, excessive sweating, and anxiety began within a few minutes. The whole event was over in about 20 minutes. Pain at the injection site also got worse around this time, and stayed for several hours after. Patient could not easily lift arm above their head.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysgeusia, Dysphonia, Malaise
Clinical narrative: Within 30 minutes, patient complained of a metallic taste in her mouth, dizziness, throat hoarseness and a general feeling of being unwell.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in 10/3/2018 to complain of redness, swelling and warmness around the injection site on the LEFT arm which the PNEUMOVAX was given; had fatigue, body chills, aches, pt took tylenol to relieve symptoms at night, states that she has started feeling better since; still has some redness; FLUZONE HIGH-DOSE given in Right arm, soreness in both arms.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt came in 10/3/2018 to complain of redness, swelling and warmness around the injection site on the LEFT arm which the PNEUMOVAX was given; had fatigue, body chills, aches, pt took tylenol to relieve symptoms at night, states that she has started feeling better since; still has some redness; FLUZONE HIGH-DOSE given in Right arm, soreness in both arms.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Chills, Decreased appetite, Nausea
Clinical narrative: Patient reported to pharmacy with symptoms of fever, chills, back pain, nausea, not eating, chest pain.  symptoms started friday after receiving FLUARIX QUAD immunization.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient reported to pharmacy with symptoms of fever, chills, back pain, nausea, not eating, chest pain.  symptoms started friday after receiving FLUARIX QUAD immunization.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Immediate post-injection reaction, Injection site discolouration, Injection site pain, Malaise
Clinical narrative: Immediately feeling ill. Pain to the site that increased over the next week. Pain persisted for several weeks. Febrile T max unknown, Fatigued for several days. Spent several days in bed.  Hyper pigmentation at the injection site began after several days and she still has it.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Immediately feeling ill. Pain to the site that increased over the next week. Pain persisted for several weeks. Febrile T max unknown, Fatigued for several days. Spent several days in bed.  Hyper pigmentation at the injection site began after several days and she still has it.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site pain, Injection site swelling, Joint stiffness, Malaise
Clinical narrative: At time of shot "the shoulder got tight during the shot so pt experienced more pain. also after shot that place of the shot ws a bit swollen. Advised pt to put some ice or cool. Take orally some Tylenol. Pt was ok after shot, and left." On 092418 pt came to pharmacy and talked to rph. Discussed symptoms and rph thought the other pharmacist may have hit a nerve. On 100318 came in to discuss further pt had malaise for a week. Is having radiating pain down the shoulder to almost the elbow and across the shoulder to the front. Pt still has a bruise and had swelling. Pt has constant pain. The pain is not getting better but has not gotten worse. Pt applied ice every hour for 15 to 20 minutes for 7 days. Then switched to heat. Pt did not take any otc meds to treat pain.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: At time of shot "the shoulder got tight during the shot so pt experienced more pain. also after shot that place of the shot ws a bit swollen. Advised pt to put some ice or cool. Take orally some Tylenol. Pt was ok after shot, and left." On 092418 pt came to pharmacy and talked to rph. Discussed symptoms and rph thought the other pharmacist may have hit a nerve. On 100318 came in to discuss further pt had malaise for a week. Is having radiating pain down the shoulder to almost the elbow and across the shoulder to the front. Pt still has a bruise and had swelling. Pt has constant pain. The pain is not getting better but has not gotten worse. Pt applied ice every hour for 15 to 20 minutes for 7 days. Then switched to heat. Pt did not take any otc meds to treat pain.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache
Clinical narrative: Very bad Headache everyday ever since I took the flu shot.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Fatigue, Hyperhidrosis, Hypersomnia
Clinical narrative: About eight hours after receiving the influenza vaccination on the left arm, felt very tired and achiness on left arm. Around 2am, sudden onset of dizziness, fast heart racing, and sweating that lasted for several hours. Had multiple episodes of diarrhea for 24 hours. Went to work for a few hours and then went home. Slept for more than 12 hours after returning home. Contacted Employee Health to report the adverse event.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Palpitations
Clinical narrative: About eight hours after receiving the influenza vaccination on the left arm, felt very tired and achiness on left arm. Around 2am, sudden onset of dizziness, fast heart racing, and sweating that lasted for several hours. Had multiple episodes of diarrhea for 24 hours. Went to work for a few hours and then went home. Slept for more than 12 hours after returning home. Contacted Employee Health to report the adverse event.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood cadmium increased, Blood lead increased, Chelation therapy, Dizziness
Clinical narrative: She was given the high dose elders shot along with the high dose pneumonia shot at the same visit.  The next day she became ill, very weak and tired, achy. She went to the emergency room three times within the following two weeks after receiving the shot. She then developed pneumonia and was hospitalized for 17 days. She almost died while in the hospital. After being released, she was dizzy, had brain fog, and suffered extreme  fatigue. We had her a hair tested for metals and she had elevated levels of Aluminum, mercury, lead, and cadmium, all of which were in the two doses of vaccines she received. We did an oral chelation on her for a few weeks and she showed signs of recovery but is still experiencing extreme vertigo and fatigue.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Hair metal test abnormal, Malaise, Pain
Clinical narrative: She was given the high dose elders shot along with the high dose pneumonia shot at the same visit.  The next day she became ill, very weak and tired, achy. She went to the emergency room three times within the following two weeks after receiving the shot. She then developed pneumonia and was hospitalized for 17 days. She almost died while in the hospital. After being released, she was dizzy, had brain fog, and suffered extreme  fatigue. We had her a hair tested for metals and she had elevated levels of Aluminum, mercury, lead, and cadmium, all of which were in the two doses of vaccines she received. We did an oral chelation on her for a few weeks and she showed signs of recovery but is still experiencing extreme vertigo and fatigue.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Vaccination complication, Vertigo
Clinical narrative: She was given the high dose elders shot along with the high dose pneumonia shot at the same visit.  The next day she became ill, very weak and tired, achy. She went to the emergency room three times within the following two weeks after receiving the shot. She then developed pneumonia and was hospitalized for 17 days. She almost died while in the hospital. After being released, she was dizzy, had brain fog, and suffered extreme  fatigue. We had her a hair tested for metals and she had elevated levels of Aluminum, mercury, lead, and cadmium, all of which were in the two doses of vaccines she received. We did an oral chelation on her for a few weeks and she showed signs of recovery but is still experiencing extreme vertigo and fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hypoaesthesia, Lip swelling, Speech disorder, Swelling face
Clinical narrative: Patient reported lip and facial swelling on the left side. Patient also reported headache. Residual speech issue with pronouncing "s". Numbness down but not fully resolved. Did not report until weekend of 9/28/18.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Lip swelling, Paraesthesia oral
Clinical narrative: Patient reported lip and facial swelling on the left side. Patient also reported headache. Residual speech issue with pronouncing "s". Numbness down but not fully resolved. Did not report until weekend of 9/28/18.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia oral, Swelling face
Clinical narrative: Patient reported lip and facial swelling on the left side. Patient also reported headache. Residual speech issue with pronouncing "s". Numbness down but not fully resolved. Did not report until weekend of 9/28/18.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Limited arm mobility to shoulder height and can't reach behind her, muscle pain, can pick arm up over her head but can't lift it that high on its own.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 26-SEP-2018, the patient was vaccinated with an unsupported and improperly stored dose of M-M-R II lot # N027780 with expiration date on 08-AUG-2019 (strength, dose and anatomical location were not provided), administered subcutaneously for prophylaxis; which was previously reconstituted with a properly stored sterile diluent (MERCK). The storage temperature of the vaccine was reported as 9 to 25 degrees Celsius (°C) (13.5°C) for a time frame of 3 hours and 4 minutes. There was a previous temperature excursion from 9 to 25°C (14.1°C) for 2 hours 13 minutes; therefore, the cumulative time for the temperature excursions at the same temperature was 5 hours 17 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. This case was previously reported to the physician. The batch number for SHINGRIX was not reported. The case was reported by the patient's husband, who stated that his wife was vaccinated with the 2nd dose of SHINGRIX and experienced fever. Further details were not obtained regarding this from the reporter. This case was linked with case US2018173510 (husband case), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis.  On 14th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the healthcare professional (HCP) for herself. The HCP experienced redness at the injection site following a dose of SHINGRIX. The HCP did not have access to the lot or expiration date.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 15th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm, pain in elbow and shoulder pain. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the pain in elbow and shoulder pain were unknown.  It was unknown if the reporter considered the pain in arm, pain in elbow and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in the left arm. The patient was experiencing constant pain in her left arm. The patient stated that the pain went down to her elbow and was going up into the left shoulder, at the time of reporting. The patient stated that she had been taking Motrin for the pain, however, it was not really helping. The patient disconnected the call before providing any additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, couple of days after receiving SHINGRIX, the patient experienced shingles, rash and pain in arm. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles, rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was a patient who received a SHINGRIX about 4 weeks before the time of reporting. The patient reported that he experienced a sore arm which had resolved. The patient reported that within a couple days after the shot, he developed a shingles outbreak on his chest. The patient reported that he was seen by his doctor and put on 10 day course of Valacyclovir and that the rash resolved. The patient was unable to provide phone number for pharmacy or his physician's office.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional said that the patient experienced an outbreak of shingles after the 1st dose of SHINGRIX. The healthcare professional said that the patient was needing to get her 2nd dose of SHINGRIX and healthcare professional was asking how long after a shingles outbreak could the patient be vaccinated with SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Feeling abnormal, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of disorientation in a female patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, less than a day after receiving SHINGRIX, the patient experienced disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling were unknown. It was unknown if the reporter considered the disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt very odd (lightheaded, disoriented and extreme pain at the injection site for the entire day). The patient's arms were very sore much longer. However, since then, the patient had been itching constantly mostly on stomach but it had moved to her lower extremities at the time of reporting. The patient received Cortisone Cream which did help but the patient was not sure how long this was suppose to last and asked would the side effects be as severe with the second dose. This case has been linked with US2018GSK175246, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of disorientation in a female patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, less than a day after receiving SHINGRIX, the patient experienced disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling were unknown. It was unknown if the reporter considered the disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt very odd (lightheaded, disoriented and extreme pain at the injection site for the entire day). The patient's arms were very sore much longer. However, since then, the patient had been itching constantly mostly on stomach but it had moved to her lower extremities at the time of reporting. The patient received Cortisone Cream which did help but the patient was not sure how long this was suppose to last and asked would the side effects be as severe with the second dose. This case has been linked with US2018GSK175246, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Feeling abnormal, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of disorientation in a male patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, less than a day after receiving SHINGRIX, the patient experienced disorientation, light headedness, injection site pain, pain in arm and weird feeling. On an unknown date, the outcome of the disorientation, light headedness, injection site pain, pain in arm and weird feeling were unknown. It was unknown if the reporter considered the disorientation, light headedness, injection site pain, pain in arm and weird feeling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient felt very odd (light headed, disoriented and extreme pain at the injection site for the entire day). The patient's arms were very sore much longer. The reporter asked would the side effects be as severe with the second dose. This case has been linked with US2018GSK175244, reported by the same reporter.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 82 years old female patient who had expired fluzone HD, while she received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for Immunisation. On 28-Sep-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI848AA via intramuscular route in the left deltoid. It was also a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for FLUZONE had expired given to a patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Influenza vaccine administered at school. I do not have any of the info re: lot #, manufacturer, dose number. Appears to have been administered at Right Deltoid.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 101+ fever, severe headache, severe body aches lasting 24 hours.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Gave the shot and soon after it swelled up and became hard. The patient also noted some itching and feeling of warmth. Told her to put on some ice and see how it looks. She waited in the store for 15 to 25 minutes with no other symptoms to note. I told her if anything else happens to see PCP/urgent care or ER.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Disorientation, Pyrexia
Clinical narrative: Pt. came in on 10/01/18 to receive her flu shot. When in the room with the patient the patient expressed her concern about receiving the flu vaccine due to having an adverse reaction to the TDAP vaccination she received on 07/05/18. Patient stated that after receiving the TDAP vaccine in our clinic within the next couple of days an abscess had formed, she was running and fever and was disoriented for two days. Patient states that she used a drying salve to draw the puss from the abscess and has been getting better since the abscess has drained. After receiving this information I has one of our providers Dr. look at the healing abscess and assess if the patient should receive the flu vaccine. Dr. stated that she would be fine to receive the flu vaccine just on the other arm to avoid further irritation to the Right arm.
Age: 70.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Syncope
Clinical narrative: Syncope approximately 10 minutes after injection. Recovered after lying down.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Herpes zoster, Influenza like illness, Injection site pain
Clinical narrative: The injection itself was very painful. The first two days after getting the vaccine, I developed flu like symptoms.......chills, body aches, slight fever. Soreness at the injection site for a week. A few weeks later I developed pus like sores, itching and redness around the left side of my mouth, down the left side of my jaw, neck and in my hairline. It was a weekend when these symptoms developed. Since there was no pain, only itching, I decided to wait until Monday morning to call for appt with my Dr which I got the next day. I was very surprised when she told me I had the shingles. I told her that I had just taken the shingles shot so that I would not get it. She told me to let the pharmacy know that I got the shingles after being given the first dose of the shot. So, I did and they were very surprised as well to see that I had the shingles and told me to report it and to wait closer to the six month before taking the second dosage. Is this common, and is there a chance that I will get it again after taking the second dosage? Should I even take the second dosage? I don't know; you tell me.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal erythema, Oral pruritus, Pain, Pruritus, Pyrexia
Clinical narrative: The injection itself was very painful. The first two days after getting the vaccine, I developed flu like symptoms.......chills, body aches, slight fever. Soreness at the injection site for a week. A few weeks later I developed pus like sores, itching and redness around the left side of my mouth, down the left side of my jaw, neck and in my hairline. It was a weekend when these symptoms developed. Since there was no pain, only itching, I decided to wait until Monday morning to call for appt with my Dr which I got the next day. I was very surprised when she told me I had the shingles. I told her that I had just taken the shingles shot so that I would not get it. She told me to let the pharmacy know that I got the shingles after being given the first dose of the shot. So, I did and they were very surprised as well to see that I had the shingles and told me to report it and to wait closer to the six month before taking the second dosage. Is this common, and is there a chance that I will get it again after taking the second dosage? Should I even take the second dosage? I don't know; you tell me.