chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Mononucleosis heterophile test positive, Nausea, Oropharyngeal pain, Pain
Clinical narrative: About 2-3 hrs afterward, pt started having body aches, sore throat, chills, fatigue, nausea and joint pain.
Age: 1.5
Sex: M
Vaccine: FLUX, MMR
Symptoms: Aphthous ulcer, Pyrexia
Clinical narrative: Fever lasting about 24 hours 102.5° highest. Given acetaminophen which brought fever down. At the same time developed a large canker sore on the inside of the lip.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: Itching all over, scalp, face, arms, legs, that lasted for several days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen, painful, erythematous arm for 3-4 weeks with ongoing localized pain, normal function.
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an adult dose of influenza vaccine instead of pediatric dose. No side effects.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Muscle fatigue, Myalgia
Clinical narrative: Pt reports last evening after the shot experiencing a fever of 101 degrees. She says she was shaking so bad from chills that she had difficulty breathing. She also reports having a headache and muscle pain in neck, arm, and back. This am fever was gone but headache and muscular fatigue still present.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Pt reports last evening after the shot experiencing a fever of 101 degrees. She says she was shaking so bad from chills that she had difficulty breathing. She also reports having a headache and muscle pain in neck, arm, and back. This am fever was gone but headache and muscular fatigue still present.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Lymphadenopathy, Pain, Parotid gland enlargement, Parotitis
Clinical narrative: Flu Shot administered on 10/3/18 at approximately 4:30pm. On 10/4/18 at 5:30am first adverse reaction event occurred. After having a bottle of milk, Patient began screaming in pain for approximately 30 minutes until he could be calmed. TYLENOL was provided at this time to help him with the pain. Throughout the day Patient's nanny and father noticed slight swelling in of the left side of his face and neck. By 8pm swelling of the left face and neck was extremely significant. At the swelling location it was red and hot. At that time Patient was brought by his parents to Hospital's ER. Patient was treated by MD. Dr. ordered an ultrasound of Patient's left face/neck. The ultrasound showed swelling of the left Parotid Gland as well as surrounding lymph nodes. Dr. prescribed TYLENOL, MOTRIN, and AUGMENTIN for the diagnosis of Parotitis. 3ml of AUGMENTIN to be taken twice a day for 10 days. On 10/5/18 Patient's swelling increased on his left side of face/neck. 10/5/18 Patient was seen by Dr. (primary pediatrician office), no new medications or directions prescribed. 10/6/18 swelling subsided.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Screaming, Skin warm, Swelling, Swelling face, Ultrasound scan abnormal
Clinical narrative: Flu Shot administered on 10/3/18 at approximately 4:30pm. On 10/4/18 at 5:30am first adverse reaction event occurred. After having a bottle of milk, Patient began screaming in pain for approximately 30 minutes until he could be calmed. TYLENOL was provided at this time to help him with the pain. Throughout the day Patient's nanny and father noticed slight swelling in of the left side of his face and neck. By 8pm swelling of the left face and neck was extremely significant. At the swelling location it was red and hot. At that time Patient was brought by his parents to Hospital's ER. Patient was treated by MD. Dr. ordered an ultrasound of Patient's left face/neck. The ultrasound showed swelling of the left Parotid Gland as well as surrounding lymph nodes. Dr. prescribed TYLENOL, MOTRIN, and AUGMENTIN for the diagnosis of Parotitis. 3ml of AUGMENTIN to be taken twice a day for 10 days. On 10/5/18 Patient's swelling increased on his left side of face/neck. 10/5/18 Patient was seen by Dr. (primary pediatrician office), no new medications or directions prescribed. 10/6/18 swelling subsided.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Skin hypopigmentation, Skin indentation, Skin necrosis
Clinical narrative: Necrosis of skin, indentation of muscle, hypopigmentation once healed.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Hypotension, Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: This spontaneous report was received from a field employee regarding her daughter, a 14 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 25-SEP-2018, the patient was vaccinated with a dose of GARDASIL 9, intramuscular for prophylaxis against cervix carcinoma (anatomical site, lot number and expiration date were not reported). On 25-SEP-2018, immediately after injection the patient fainted with some seizure manifestations and she became hypotensive. The unknown nurse was in the same room with the patient and monitored her closely by "laying her down and elevating her legs". Approximately 30 minutes after the events the physician checked the patients vital signs at the mother's request, and they were normal. The patient was recovered after 30 minutes from the onset of the events. Upon internal review the event seizures was considered to be medically significant. The causal relationship between the event and therapy with GARDASIL 9 was not reported.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema
Clinical narrative: Next day after flu vaccine, noticed redness below injection site, no fever or other symptoms noted, ice pack applied to arm resolved within 2 days.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity, X-ray normal
Clinical narrative: The patient reported pain/stiffness in his arm the morning after the flu shot was given. He said he could not lift his arm. A doctor (unnamed) told him at the Orthopedic that they could not see any damage on XRAY, but gave him a steroid shot in the shoulder.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Peripheral swelling, Skin tightness
Clinical narrative: Patient woke up with myalgia at the back of her neck, mild swelling and tightness of her fingers. She was treated with NSAIDs and BENADRYL which decreased her symptoms.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Redness and swelling to right arm, subjective fever reported by patient - began the day after vaccines were given.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Generalized red rash over arms, torso & legs began day after injection.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Periarthritis
Clinical narrative: When patient was called to set up 2nd dose he said he was reluctant as he had been having trouble with his left shoulder ever since receiving the first dose. On exam it is similar to an impingement injury. Patient was seen by ortho physician and diagnoses with frozen shoulder. Recommended physical therapy so he was lined up for that. Just started so don't have an update.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient developed a bruise from injection site to elbow. Patient's daughter called me to today to inform me about this reaction. She informed me at that time that the patient is on warfarin. Her INR was just checked last week and it was 2.4. I instructed the daughter to have a MD look at the patient's arm to make sure bleeding has stopped. I told her that the bruise should start to clear up on its own but may take some time.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Swelling within 15 minutes of injection, progressing to dark bruising in distinct rectangular pattern on arm below injection site and above the elbow over next 2 days. Patient did not complain of pain initially.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Continued deltoid soreness.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: Dr stated patient Had a "Vasovagal Syncope Episode" Patient was Pale, and clammy. Patient stated he couldn't see for roughly 15 minutes. Dr had me bring patient by wheelchair to exam room, had him lay on stretcher & propped his feet up. After about 20 minutes. Patient stated he felt better, then Dr  discharged him. Parent drove him home.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Coccydynia, Herpes zoster
Clinical narrative: Pt developed Shingles after the second dosage. Symptoms started 9/4/18 as tail bone pain. This pain is the same pain as when she had Shingles in the past. She saw physician on 10/8/18 and the diagnosis was confirmed. Pt was started on Gabapentin 300 mg, Acyclovir 400mg and Hydrocortisone rectal suppositories.
Age: 17.0
Sex: F
Vaccine: FLU4, IPV, MMR
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Patient began to have chest pain and SOB half hour after administration.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Rash papular, Skin warm
Clinical narrative: PATIENT CAME IN TODAY WITH A HOT, RED, SLIGHTLY RAISED CIRCULAR RASH ON THE INSIDE FRONT OF HER RIGHT ARM (ABOUT 16 SQUARE INCHES IN SIZE). SHE SAID SHE HAD BEEN FEELING NAUSEOUS ALSO. I MARKED THE EDGES OF THE RASH WITH AN INK PEN SO SHE COULD KEEP TRACK OF IT AND ADVISED HER TO TAKE BENADRYL 50 MG BY MOUTH EVERY FOUR HOURS AND TO FOLLOW UP WITH HER FAMILY DR. I TOLD HER TO GO TO THE ER IF IT GOT ANY WORSE.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV, TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: PATIENT CAME IN TODAY C/O RIGHT ARM PAIN AND REDNESS. PNEUMOVAX 23 WAS GIVEN ON THAT ARM. I TOLD PATIENT THAT I HAVE SEEN, THOUGH RARE, THIS REACTION BEFORE WITH PNEUMOVAX. SHE MAY TAKE SOME TYLENOL IF NECESSARY. RECOMMENDED PATIENT TO SEEK MEDICAL HELP IF SHE FEELS SYMPTOMS WORSENING. THERE WAS NO REPORT OF DIFFICULTY BREATHING, OR ANYTHING LIFE THREATENING (SWOLLEN THROAT, LIPS, ETC.).
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: White urticarial and redness and swelling surrounding injection site 10 minutes after administration.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: 72 hours of recurrent chills and fever accompanied by persistent headache and debilitating fatigue.
Age: 44.0
Sex: M
Vaccine: ANTH, MNQ, SMALL, TYP
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram abnormal, Myocarditis, Pericarditis
Clinical narrative: Pt presented to Medical Center on 10/6/18 with continuous nonradiating, nonexertional substernal chest pain x 12 hours. S/P smallpox, anthrax, typhoid vaccine on 9/25/18. ECG with some suspicion for pericarditis and had elevated troponin. CXR normal. He received nitroglycerin (which did not alleviate pain which was discontinued). He was also given aspirin, hep drip, PLAVIX, and atorvastatin. Due to elevated trop, pt was transferred to another Medical Center that day. 3 day hospital course was uneventful. Initial bump in trops which started to trend downward.  Dx with myocarditis, started on colchicine and MOTRIN with improvement of symptoms. Discharged on 10/8/18.
Age: 44.0
Sex: M
Vaccine: ANTH, MNQ, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: Pt presented to Medical Center on 10/6/18 with continuous nonradiating, nonexertional substernal chest pain x 12 hours. S/P smallpox, anthrax, typhoid vaccine on 9/25/18. ECG with some suspicion for pericarditis and had elevated troponin. CXR normal. He received nitroglycerin (which did not alleviate pain which was discontinued). He was also given aspirin, hep drip, PLAVIX, and atorvastatin. Due to elevated trop, pt was transferred to another Medical Center that day. 3 day hospital course was uneventful. Initial bump in trops which started to trend downward.  Dx with myocarditis, started on colchicine and MOTRIN with improvement of symptoms. Discharged on 10/8/18.
Age: 45.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Injection site rash
Clinical narrative: Complaints of rash to injection site of the PNEUMOVAX injection, went to urgent care 09/30/2018, given Cephalexin 500mg QID and started it 10/01/2018, did not improve, went to the ER 10/02/2018, given IV Clindamycin 600mg and discharged with Clindamycin 300m gq 6 hours for 10 days. Evaluated at PCP office on 10/08/2018, reports symptoms improving but not gone and will finish Clindamycin course.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Rash, Vaccination complication, Vomiting
Clinical narrative: Vomiting, diarrhea, and rash. The vomiting lasted for 2 days. Diarrhea lasted for 14 days. The rash lasted for 3 1/2 weeks. Took him in to the doctor and was told that he had a reaction to the vaccination and that it was being documented in his list of allergies/sensitivities.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Back pain, Chest pain, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt states that the shot, when given, hurt more than usual shots for immunizations than he had previously received. And as time went on that day, his arm became more and more sore. Later during the same day, he reports he was unable to move the affected arm like usual. He was unable to lift his arm, and that it ached him all the way to his wrist. He reported the matter to me on Thurs morning Oct 4. I encouraged him to seek further medical attention unless he started improving soon or if the matter got worse. I believe there was an issue of anxiety that may have added to his response. The patient later was unable to rest, and reported a shooting pain across his back and or chest, and after he spoke with a nurse at insurance company (?), they recommended to him that he go to the local Emerg. Room, which he did. Rxs from E.R. were filled on Oct 7 for prednisone, PERCOCET, cetirizine and PHENERGAN. Today is Oct 9 and he reports that use of his arm is back to about 70% and he is improving. I can't ascertain if the E.R. doctor felt this would be considered an allergic rxn or not. There seemed to be no outward visible change to his arm or injection site.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Restlessness
Clinical narrative: Pt states that the shot, when given, hurt more than usual shots for immunizations than he had previously received. And as time went on that day, his arm became more and more sore. Later during the same day, he reports he was unable to move the affected arm like usual. He was unable to lift his arm, and that it ached him all the way to his wrist. He reported the matter to me on Thurs morning Oct 4. I encouraged him to seek further medical attention unless he started improving soon or if the matter got worse. I believe there was an issue of anxiety that may have added to his response. The patient later was unable to rest, and reported a shooting pain across his back and or chest, and after he spoke with a nurse at insurance company (?), they recommended to him that he go to the local Emerg. Room, which he did. Rxs from E.R. were filled on Oct 7 for prednisone, PERCOCET, cetirizine and PHENERGAN. Today is Oct 9 and he reports that use of his arm is back to about 70% and he is improving. I can't ascertain if the E.R. doctor felt this would be considered an allergic rxn or not. There seemed to be no outward visible change to his arm or injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain of skin
Clinical narrative: Skin very tender with red marks all on right side to middle of chest and around to middle of back. Very sore, painful. Was given VALTREX for 2 weeks along with prednisone. Marks started clearing up in 3rd week. Skin was still tender. At least 5 weeks before back to normal.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: REDNESS AND INFLAMMATION OF UPPER ARM AROUND INJECTION SITE. NOTICED THE NEXT DAY AND WAS CLEARING BY THE SECOND DAY.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis contact, Rash papular, Rash vesicular
Clinical narrative: Rash (two papular erythematous patches to L upper arm with small clustered vesicles, smaller patch on back of left hand); couple pearly, flesh colored papules to R upper arm. Asymmetrical vesicular appearance somewhat suspicious for shingles, though would be atypical for age. Discussed contact dermatitis most likely cause. Recommend treating presumptively. Will reach out to dermatology as well.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX injection, lot # N026070 with expiration date on 20-SEP-2019, for prophylaxis (exact dose and route of administration were unknown) reconstituted with properly stored sterile diluent (MRK). The vaccines experienced a temperature excursion at 46 degrees Fahrenheit for 10 minutes. There were no previous temperature excursion. The digital data logger was not involved in recording the temperature excursion details. No adverse events were reported. This case is non-valid due to lack of patients' identifiers. As of 05-OCT-2018, all attempts to obtain follow-up information were unsuccessful.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient's date of birth was unknown. Flu vaccine was given years before the reporting date and was not administered by the reporting facility. The health care professional reported that the patient had a reaction following administration of an unknown flu vaccine, clarified as she got really sick. FLu vaccine was given years ago and not administered by the reporting facility. The health care professional was unsure if this was previously reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 64-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 7th May 2018, the patient received the 1st dose of SHINGRIX. On 7th May 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, general body pain and shivering. On 9th May 2018, the outcome of the fatigue, general body pain and shivering were recovered/resolved. It was unknown if the reporter considered the fatigue, general body pain and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient experienced fatigue, shivering and body aches. No further information was provided by the healthcare professional.
Sex: U
Vaccine: VARZOS
Symptoms: Type III immune complex mediated reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of type iii hypersensitivity reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced type iii hypersensitivity reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the type iii hypersensitivity reaction was unknown. It was unknown if the reporter considered the type iii hypersensitivity reaction to be related to SHINGRIX. Additional details were provided as follows: The adverse event was reported via click to chat. The age at the vaccination was not reported. The health care professional asked regarding the data on the effectiveness of a single dose of SHINGRIX. The reporter did not have lot number or expiration date. The reporter could give the patients age and gender but she was concerned about HIPA privacy with initials and date of birth. The reporter was not reporting a severe unexpected adverse reaction. No additional information was provided.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a 82-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Embrel). On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a year after receiving SHINGRIX, the patient experienced tingling (serious criteria hospitalization). On 27th September 2018, the patient experienced tingling lips. On an unknown date, the outcome of the tingling and tingling lips were not recovered/not resolved. It was unknown if the reporter considered the tingling and tingling lips to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she went to the emergency room on 18th September 2018 because she was having tingling in her left arm and left leg. The patient was admitted to the hospital and stayed for three days. All tests were negative and she was discharged. The patient indicated that the reaction was worsening and the tingling involved both arms and her face.  On 27th September 2018, 73 days after receiving vaccination, also, stated that she started experiencing tingling in her lips and nose. The reporter did not know if these symptoms were related to the SHINGRIX. The reporter seemed somewhat confused and phone and had difficulty recalling dates and when symptoms occurred.  The reporter was unable to provide the location where the vaccination was administered on her body.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Dehydration, Headache, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 19th September 2018, the patient received the 2nd dose of SHINGRIX. On 19th September 2018, less than a day after receiving SHINGRIX, the patient experienced nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), dehydration (serious criteria hospitalization), injected limb mobility decreased (serious criteria hospitalization), headache (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the nausea, vomiting, dehydration, injected limb mobility decreased, headache and fever were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, dehydration, injected limb mobility decreased, headache and fever to be related to SHINGRIX. Additional details were provided as follows: On 3rd July 2018 at 4:33 pm, the patient received the 1st dose of SHINGRIX and did not experience side effects. The patient received 2nd dose of SHINGRIX in the left deltoid and she could not lift her left arm that took about a week for this to resolve. Around 11:30 pm, the patient began to feel nauseous. She threw up all night and had a massive headache which involved the temples, eyes, and nose. She had a fever of 100.3. The patient went to the hospital on 20th September 2018 and stayed overnight. The patient was released about 2 pm on Friday 21st September 2018.  The patient was dehydrated from throwing up and the headache while in the hospital and they did a CAT scan to rule out a stroke. All reported events had resolved. The patient had provided contact details of her physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Urine analysis, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 19th September 2018, the patient received the 2nd dose of SHINGRIX. On 19th September 2018, less than a day after receiving SHINGRIX, the patient experienced nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), dehydration (serious criteria hospitalization), injected limb mobility decreased (serious criteria hospitalization), headache (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the nausea, vomiting, dehydration, injected limb mobility decreased, headache and fever were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, dehydration, injected limb mobility decreased, headache and fever to be related to SHINGRIX. Additional details were provided as follows: On 3rd July 2018 at 4:33 pm, the patient received the 1st dose of SHINGRIX and did not experience side effects. The patient received 2nd dose of SHINGRIX in the left deltoid and she could not lift her left arm that took about a week for this to resolve. Around 11:30 pm, the patient began to feel nauseous. She threw up all night and had a massive headache which involved the temples, eyes, and nose. She had a fever of 100.3. The patient went to the hospital on 20th September 2018 and stayed overnight. The patient was released about 2 pm on Friday 21st September 2018.  The patient was dehydrated from throwing up and the headache while in the hospital and they did a CAT scan to rule out a stroke. All reported events had resolved. The patient had provided contact details of her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Confusional state, Depressed level of consciousness, Fall, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fall in a 81-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Flu unspecified (Flu vaccine). On 28th September 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced fall (serious criteria hospitalization), feeling dazed (serious criteria hospitalization), increased blood pressure (serious criteria hospitalization), obtundation (serious criteria hospitalization and GSK medically significant), sleepiness (serious criteria hospitalization), tiredness (serious criteria hospitalization), confusion (serious criteria hospitalization) and memory impairment. On an unknown date, the outcome of the fall and increased blood pressure were recovered/resolved and the outcome of the feeling dazed, obtundation, sleepiness, tiredness and confusion were not recovered/not resolved and the outcome of the memory impairment was unknown. It was unknown if the reporter considered the fall, feeling dazed, increased blood pressure, obtundation, sleepiness, tiredness, confusion and memory impairment to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported but the patient could be 80 or 81 years old. The patient received the dose of the SHINGRIX in the left deltoid and also received the flu shot simultaneously. The next morning, the patient collapsed on the floor while trying to go to the bathroom. She fell again that morning but was not hurt. The patient was very tired and was also dazed and confused. The reporter did report to the emergency room where her blood pressure was elevated to 210/110 when it usually runs around 120/80. The patient was hospitalized and her blood pressure did not go down to a more normal range until a day before date of reporting, after the doctors were able to adjust her blood pressure medications. The patient remained confused and had difficulty identifying her name and of her husband. She also was obtunded and wanted to sleep. The patient was doing several tests to determine a cause and would also be having a lumbar puncture performed. The patient had denied permission to contact their physician. The reporter was called back in attempts to gather the initials for the patient but the reporter stated that he could not talk at that moment. This case was linked with US2018179237, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Memory impairment, Somnolence, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fall in a 81-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Flu unspecified (Flu vaccine). On 28th September 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced fall (serious criteria hospitalization), feeling dazed (serious criteria hospitalization), increased blood pressure (serious criteria hospitalization), obtundation (serious criteria hospitalization and GSK medically significant), sleepiness (serious criteria hospitalization), tiredness (serious criteria hospitalization), confusion (serious criteria hospitalization) and memory impairment. On an unknown date, the outcome of the fall and increased blood pressure were recovered/resolved and the outcome of the feeling dazed, obtundation, sleepiness, tiredness and confusion were not recovered/not resolved and the outcome of the memory impairment was unknown. It was unknown if the reporter considered the fall, feeling dazed, increased blood pressure, obtundation, sleepiness, tiredness, confusion and memory impairment to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported but the patient could be 80 or 81 years old. The patient received the dose of the SHINGRIX in the left deltoid and also received the flu shot simultaneously. The next morning, the patient collapsed on the floor while trying to go to the bathroom. She fell again that morning but was not hurt. The patient was very tired and was also dazed and confused. The reporter did report to the emergency room where her blood pressure was elevated to 210/110 when it usually runs around 120/80. The patient was hospitalized and her blood pressure did not go down to a more normal range until a day before date of reporting, after the doctors were able to adjust her blood pressure medications. The patient remained confused and had difficulty identifying her name and of her husband. She also was obtunded and wanted to sleep. The patient was doing several tests to determine a cause and would also be having a lumbar puncture performed. The patient had denied permission to contact their physician. The reporter was called back in attempts to gather the initials for the patient but the reporter stated that he could not talk at that moment. This case was linked with US2018179237, reported by the same reporter.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Cataract operation, Condition aggravated, Pemphigoid, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of bullous pemphigoid in a 85-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cataract. On 30th April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, several weeks after receiving SHINGRX, the patient experienced bullous pemphigoid (serious criteria GSK medically significant) and rash. The patient was treated with steroids nos (Steroid Injection). On an unknown date, the outcome of the bullous pemphigoid and rash were not recovered/not resolved. It was unknown if the reporter considered the bullous pemphigoid and rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash a few days after receiving cataract surgery in May 2018 (several weeks after SHINGRIX). The patient saw a dermatologist and was given Steroid injection and rash got significantly better in mid-July 2018.  The patient then had second cataract surgery and rash seemed to get worse following the surgery. In 2018, rash was biopsied and diagnosed as bullous pemphigoid. The rash was bilateral and on torso, arms and legs. The lot number, expiration date, site of administration and route of administration of SHINGRIX were asked but were unknown to the reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Dizziness, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of viral infection in a 18-year-old female patient who received Meningococcal B vaccine for prophylaxis. In August 2018, the patient received Meningococcal B vaccine. In August 2018, less than a day after receiving Meningococcal B vaccine, the patient experienced viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired. On an unknown date, the outcome of the viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired were unknown. It was unknown if the reporter considered the viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired to be related to Meningococcal B vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The patient received meningitis vaccine and the day she received it, she had headaches, neck pain, palpitations and fever. She had since been missed the school and experienced continuous headaches and pain in her chest with palpitations as well as dizziness and nausea. Initially the mother of the patient brought her to the doctor's office twice. The first few days, the patient was not feeling well and was informed by medical professionals this might be expected after receiving the vaccine. The mother brought the patient again a week later and explained she still had the same symptoms then medical professionals said she might had a viral infection. After the third recent visit to a medical professional, the doctor said the patient might need to see a cardiologist because it might be a side effect from the vaccine. The reporter did not know if there was anyone, who could have a discussion with. The reporter stated, it seemed to get worse rather than better. The patient was an athlete and she could not compete in figure skating anymore. The patient's mother noted her daughter studying overseas and that she had documentation on the vaccination at home. The patient's mother had been investigating the serious side effects that might be caused by the vaccine and got inconsistent feedback from the medical professionals she had spoken with. The reporter agreed to be contacted for follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Neck pain, Palpitations, Pyrexia, Viral infection
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of viral infection in a 18-year-old female patient who received Meningococcal B vaccine for prophylaxis. In August 2018, the patient received Meningococcal B vaccine. In August 2018, less than a day after receiving Meningococcal B vaccine, the patient experienced viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired. On an unknown date, the outcome of the viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired were unknown. It was unknown if the reporter considered the viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired to be related to Meningococcal B vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The patient received meningitis vaccine and the day she received it, she had headaches, neck pain, palpitations and fever. She had since been missed the school and experienced continuous headaches and pain in her chest with palpitations as well as dizziness and nausea. Initially the mother of the patient brought her to the doctor's office twice. The first few days, the patient was not feeling well and was informed by medical professionals this might be expected after receiving the vaccine. The mother brought the patient again a week later and explained she still had the same symptoms then medical professionals said she might had a viral infection. After the third recent visit to a medical professional, the doctor said the patient might need to see a cardiologist because it might be a side effect from the vaccine. The reporter did not know if there was anyone, who could have a discussion with. The reporter stated, it seemed to get worse rather than better. The patient was an athlete and she could not compete in figure skating anymore. The patient's mother noted her daughter studying overseas and that she had documentation on the vaccination at home. The patient's mother had been investigating the serious side effects that might be caused by the vaccine and got inconsistent feedback from the medical professionals she had spoken with. The reporter agreed to be contacted for follow up.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site erythema in a 76-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling, general body pain and fever. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, general body pain and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, general body pain and fever to be related to SHINGRIX. Additional details were reported as follows: The patient's injection site was red and hot and very swollen, the patient experienced whole body aches and feverish. When should the temperature be of a concern. The patient was asking regarding 2nd dose of SHINGRIX vaccine be as uncomfortable.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, rash, chills and influenza-like symptoms. On an unknown date, the outcome of the fever, rash, chills and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, rash, chills and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. After receiving SHINGRIX, the patient sustained a fever, rash, chills and flu like symptoms. The patient did not seek any medical.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AND ITCHING OF UPPER ARM AROUND INJECTION SITE AND DOWN TO THE ELBOW. NOTICED THE NEXT DAY AND WAS CLEARING BY THE SECOND DAY.
Age: 27.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Erythema, Full blood count, Lymphadenopathy, Metabolic function test, Pain
Clinical narrative: Pt presented with redness and pain x 10 days and streaking, moving medially into the Axilla and lymphadenopathy in the cervical region.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fatigue, Pallor, Seizure
Clinical narrative: Shortly after vaccination (roughly 1 -2 minutes) patient stood and felt dizzy/lightheaded and appeared very pale. She sat down in pharmacy waiting area (accompanied by mother and sister) and began to have a mild seizure. The seizure lasted approximately 30 seconds-1 minute. She waited for roughly 15 minutes while resting and being observed by myself and mother. Pt has known seizure disorder, but has never had a seizure as a result of the flu shot. I provided the patient with a sprite, after about 15 minutes, she felt much better and felt ok to walk out of the store and go home. I called patient roughly 2 hours later and 1 day later as well. Patient reported no further seizure activity. She stated feeling overall tired but was being monitored very closely all weekend by her mother. She reported she would notify her neurologist on Monday.
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms for a few days.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Per patient report via messaging: "my flu shot injection site on my right arm is itchy, red and I'm trying not to scratch it to avoid welting; I assume this is normal?"
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Dermatitis contact, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: Morning after vaccination 10/7, sore arm Sunday night, quarter-size bruise, developed into red, hot, swollen rash down the arm to elbow by reporting, saw primary provider at advise of pharmacist when reported 10/9 bactrim bid x7d prescribed after contact dermatitis/skin infection diagnosed, filled at pharmacy of patient's choosing.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin abrasion, Skin infection
Clinical narrative: Morning after vaccination 10/7, sore arm Sunday night, quarter-size bruise, developed into red, hot, swollen rash down the arm to elbow by reporting, saw primary provider at advise of pharmacist when reported 10/9 bactrim bid x7d prescribed after contact dermatitis/skin infection diagnosed, filled at pharmacy of patient's choosing.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain, Sleep disorder
Clinical narrative: Extremely sore upper left arm, which affected my sleep very badly. Generalized aches and pains.  Headache on left side. Fatigue. Lasted for 5 days after the vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Areflexia, Asthenia, CSF protein normal, Chills, Computerised tomogram head abnormal
Clinical narrative: The patient had received the first dose of the SHINGRIX vaccine earlier in the year. He received the second dose on Monday, Oct. 1, 2018, for which he initially developed pain at the injection site. Within 24 hours he was reporting fevers and chills, then, on Friday, Oct. 5, 2018, he noted that he could not get out of bed due to significant weakness. He does have weakness at baseline from a previous episode of severe Guillan-Barre sustained in the early 1980s, for which he was tracheostomized and developed residual lower extremity weakness. The patient normally ambulates with braces and crutches due to Guillan-Barre but this new weakness prevented him from ambulating. He was areflexic in the patellar and calcaneal jerks bilaterally, but this seems to be chronic for him since the 1980s. The patient suffered a gunshot wound in 1982 in the left upper extremity, which caused marked atrophy of that limb. His only good limb is his right arm, for which he can do most of his routine activities with prior to the onset of this weakness. His right upper extremity is now unable to maintain antigravity positioning.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: The patient had received the first dose of the SHINGRIX vaccine earlier in the year. He received the second dose on Monday, Oct. 1, 2018, for which he initially developed pain at the injection site. Within 24 hours he was reporting fevers and chills, then, on Friday, Oct. 5, 2018, he noted that he could not get out of bed due to significant weakness. He does have weakness at baseline from a previous episode of severe Guillan-Barre sustained in the early 1980s, for which he was tracheostomized and developed residual lower extremity weakness. The patient normally ambulates with braces and crutches due to Guillan-Barre but this new weakness prevented him from ambulating. He was areflexic in the patellar and calcaneal jerks bilaterally, but this seems to be chronic for him since the 1980s. The patient suffered a gunshot wound in 1982 in the left upper extremity, which caused marked atrophy of that limb. His only good limb is his right arm, for which he can do most of his routine activities with prior to the onset of this weakness. His right upper extremity is now unable to maintain antigravity positioning.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Deep intramuscular pain, positionally and load dependent, persisting for a week after inoculation. Gradually increasing in severity beginning 3 days after initial injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: Sore arm, fatigue, general not feeling well SINCE vaccine was given. Patient reported on 10/7/18 that she has felt awful since the immunization. She has not reported to or looked for medical care.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Periorbital swelling, Pruritus generalised, Urticaria
Clinical narrative: Periorbital swelling, hives on face and chest, whole body itching.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt came into the pharmacy today stating that her left arm was still sore and had a hard time lifting her arm above shoulder height. She explained signs of shoulder impingement, however also stated that the spot of injection was also sore. The spot of soreness is at an appropriate injection location just above the armpit line.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain
Clinical narrative: Large red area next to where the injection was given. This is the second follow up booster shot, per pt she did not have a reaction to the first shot. Per pt it feels like a bruise. Painful when touched.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Shooting arm pain since time of injection. Was treated twice for this, once at urgent care and once at your doctors office. Was given lidocaine injection at urgent care and kenalog at dr office. No relief from those treatments.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling in arm.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain during injection and not being able to move arm a couple hours after receiving injection. Patient said she did not experience any injection site reaction (redness, swelling, warmness).