chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Pain in extremity, Sensitive skin
Clinical narrative: Beginning the evening of vaccination, I began to feel pain in the general area (right shoulder) of administration.  The following morning, there was significant pain beginning at the administration site, extending down and around my arm and into my arm pit.  This pain was strong enough that it was sensitive to touch.  Even applying deodorant was painful.  This pain has decreased significantly, but can still be felt with palpation in my armpit.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Dyspnoea, Dysstasia, Fatigue, Sensation of foreign body
Clinical narrative: 1:30 PM patient c/o aggitation; between 1:30 and 3:00 PM patient reported extreem fatigue, unable to stand, swelling of eyes and face, feeling of a lump in her throat and difficulty breathing.  Family called 911 and patient was transported via ambulance to local hospital ER.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: 1:30 PM patient c/o aggitation; between 1:30 and 3:00 PM patient reported extreem fatigue, unable to stand, swelling of eyes and face, feeling of a lump in her throat and difficulty breathing.  Family called 911 and patient was transported via ambulance to local hospital ER.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Arm got red hot and hard at injection site, decreased in size by Monday 10/07/19
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Pain
Clinical narrative: Received vaccine Mon am and c/o pain that day. Tues night when putting him to bed mom noticed bumps all over left thigh from knee to groin area. Pea-sized and very itchy. No breathing issues or swelling. Gave Benadryl and less pronounced this am.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Limb discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: I received my flu vaccine on 10/10/19. It was given to me by one of the medical assistants in the Employee Health Department. As the MA began to inject the vaccine, I felt an enormous amount of pain in the area where the needle had entered, and this was something I had never experienced prior when receiving any vaccine. After the injection was completed, I noted that the injection site seemed as if it was extremely high in my arm. I am a registered nurse, so I recognized right away that the injection was given very close to my shoulder joint. I immediately notified one of our NPs in the department who also said it looked like it was given too high. It is now almost one week later. My shoulder discomfort has continued. I have pain in the area of the right biceps, my arm feels heavy, and pain increases when I lift my arm. I am planning to see an orthopedic PA for evaluation if this problem persists.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS FOR TWO DAYS AFTER INJECTIONS. FEVER AND ACHING
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Mammogram abnormal, Oedema peripheral
Clinical narrative: injection site red and hot to touch, arm pit and lymph nodes swelled  redness lasted approximately 1 week, swelling subsided in 3 weeks
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Choking sensation, Dyspnoea, Eye irritation, Oropharyngeal pain
Clinical narrative: Patient reports she received her flu vaccine about 10: 00 am on 10/15/19, and then following she began to feel a choking feeling, constricted from inside with shortness of breath" She returned to the site of vaccine clinic to have further evaluation prior to driving home.  Patient was transported down to the ER to have further evaluation. Patient reports she was evaluated and sent home with warnings. States she took 1 Benadryl last night and Tylenol OTC. Reports she did take need to take Tylenol again this morning because her eyes are burning. Reports she generally has aches and fever for about 48 hrs following a flu vaccine. Reports a sore throat today that is new. Denies shortness of breath today, and is at work.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac failure congestive, Intensive care, Lethargy, Malaise, Pleural effusion
Clinical narrative: Lethagy, malaise, fluid on lungs, CHF, ICU = 6 days, heart floor 3 days Rehab Center admit day = 10/7/19, outcome remains to be seen, potential date to be released is 11/7/19
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: female patient received 1 injection of MMR II / 2 days after the injection, patient was confirmed to be pregnant; This spontaneous prospective pregnancy report as received from an office manager via a company representative refers to a female patient in her mid 30's (exact age not provided). The patient's medical history included pregnancy. No information regarding the patient's concomitant medications, drug reactions and allergies was provided.     On an unknown date in September 2019 (reported as two weeks ago), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 1 dose, subcutaneously (exact dose, lot number and expiration date were not provided) that was reconstituted with sterile diluent, for prophylaxis. On an unknown date in 2019, 2 days after the vaccination, the patient was confirmed to be pregnant by an urinary test. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not reported. The pregnancy outcome was pending. The fetal outcome was unknown.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Feeling abnormal, Headache, Herpes zoster, Hyperaesthesia
Clinical narrative: Lousy feeling; Lethargic; Sore arm; Sensitive scalp; Sharp tingling; Raised blisters / Scalp blisters; Shingles; Jaw pain; Head pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 23rd September 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, 9 days after receiving Shingrix, the patient experienced jaw pain and headache. On 8th October 2019, the patient experienced shingles, increased skin sensitivity, tingling and scalp blister. On an unknown date, the patient experienced feeling bad, lethargy and pain in arm. On an unknown date, the outcome of the shingles, feeling bad, lethargy, pain in arm, jaw pain, headache, increased skin sensitivity, tingling and scalp blister were unknown.   It was unknown if the reporter considered the shingles, feeling bad, lethargy, pain in arm, jaw pain, headache, increased skin sensitivity, tingling and scalp blister to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine in left arm. The patient had shingles before. Less than 3 weeks after vaccination, the patient had feeling lousy the first few days, reporting lethargic, and sore arm.  The patient doing better but then he began to experienced head and jaw pain last wednesday from day of reporting.  His scalp was sensitive and he had a sharp tingling with raised blisters on day of reporting on his head. 15 days after vaccination, the patient was diagnosed with shingles at the immediate care facility. The emergency room visit was required. The reporter consent to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Lousy feeling; Lethargic; Sore arm; Sensitive scalp; Sharp tingling; Raised blisters / Scalp blisters; Shingles; Jaw pain; Head pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 23rd September 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, 9 days after receiving Shingrix, the patient experienced jaw pain and headache. On 8th October 2019, the patient experienced shingles, increased skin sensitivity, tingling and scalp blister. On an unknown date, the patient experienced feeling bad, lethargy and pain in arm. On an unknown date, the outcome of the shingles, feeling bad, lethargy, pain in arm, jaw pain, headache, increased skin sensitivity, tingling and scalp blister were unknown.   It was unknown if the reporter considered the shingles, feeling bad, lethargy, pain in arm, jaw pain, headache, increased skin sensitivity, tingling and scalp blister to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine in left arm. The patient had shingles before. Less than 3 weeks after vaccination, the patient had feeling lousy the first few days, reporting lethargic, and sore arm.  The patient doing better but then he began to experienced head and jaw pain last wednesday from day of reporting.  His scalp was sensitive and he had a sharp tingling with raised blisters on day of reporting on his head. 15 days after vaccination, the patient was diagnosed with shingles at the immediate care facility. The emergency room visit was required. The reporter consent to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash papular, Skin lesion
Clinical narrative: red papules; Itchy papules; blister; lesions; This case was reported by a nurse via call center representative and described the occurrence of papular rash in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythropapular rash, itchy skin, blister and skin lesion. On an unknown date, the outcome of the erythropapular rash, itchy skin, blister and skin lesion were unknown.   It was unknown if the reporter considered the erythropapular rash, itchy skin, blister and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. This case has been linked with US2019183533, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse event in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced side effects. The patient asked how long would the side effects typically last. This case was identified as duplicate of US2019AMR185012. The case US2019AMR185012 was deleted and all the future correspondence was added in the present case which stands as case of record for this patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Missed dose; This case was reported by a consumer via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.   Follow up information received from consumer on 2nd October 2019: The reporter authorized to contact physician.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Hypoaesthesia, Laboratory test abnormal, Limb discomfort, Magnetic resonance imaging normal
Clinical narrative: Nerve damage in her spine and both legs; Legs feel Heavy; Right shoulder was black and blue after receiving the injection; Had trouble walking / cannot walk without assistance; Leg felt numb; Leg was Weak; Slight temperature; Did not feel good; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included aortic aneurysm (Aortic aneurysm that required surgery on aortic valve two years ago from this December, 2019). Concurrent medical conditions included osteoarthritis.   On 29th August 2019, the patient received the 2nd dose of Shingrix. On 24th September 2019, 26 days after receiving Shingrix, the patient experienced lower extremities weakness of and numbness in leg. On an unknown date, the patient experienced slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. On an unknown date, the outcome of the lower extremities weakness of, nerve damage and heaviness in leg were not recovered/not resolved and the outcome of the slight temperature and feeling unwell were recovered/resolved and the outcome of the skin discoloration, numbness in leg and walking difficulty were unknown.   It was unknown if the reporter considered the lower extremities weakness of, slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration, numbness in leg and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Less tha 2 months after vaccination with dos eof Shingrix, The patient had slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. The reporter styated that, the patient had trouble walking so used walker to help to move around because, the patient thought might be the leg had gone to sleep. However, this has continued since then and both legs were involved. The patient could not walk without assistance. The patient notified to physiscian and ordered test for the patient. The patient had MRI with normal result and other tests which indicated that, the nerve damage in the patient's spine and both legs. The patient experienced slight fever and not felt good after vaccination for 1 day. The patient stated that, the right shoulder was black and blue after receiving the vaccination. The reporter stated that, the patient got lightheaded when gets up but had this before getting the vaccine. The reporter did not consent to follow up.      Lab Comments: On an unknown date lab test performed
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Muscular weakness, Nerve injury, Pyrexia, Skin discolouration
Clinical narrative: Nerve damage in her spine and both legs; Legs feel Heavy; Right shoulder was black and blue after receiving the injection; Had trouble walking / cannot walk without assistance; Leg felt numb; Leg was Weak; Slight temperature; Did not feel good; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included aortic aneurysm (Aortic aneurysm that required surgery on aortic valve two years ago from this December, 2019). Concurrent medical conditions included osteoarthritis.   On 29th August 2019, the patient received the 2nd dose of Shingrix. On 24th September 2019, 26 days after receiving Shingrix, the patient experienced lower extremities weakness of and numbness in leg. On an unknown date, the patient experienced slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. On an unknown date, the outcome of the lower extremities weakness of, nerve damage and heaviness in leg were not recovered/not resolved and the outcome of the slight temperature and feeling unwell were recovered/resolved and the outcome of the skin discoloration, numbness in leg and walking difficulty were unknown.   It was unknown if the reporter considered the lower extremities weakness of, slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration, numbness in leg and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Less tha 2 months after vaccination with dos eof Shingrix, The patient had slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. The reporter styated that, the patient had trouble walking so used walker to help to move around because, the patient thought might be the leg had gone to sleep. However, this has continued since then and both legs were involved. The patient could not walk without assistance. The patient notified to physiscian and ordered test for the patient. The patient had MRI with normal result and other tests which indicated that, the nerve damage in the patient's spine and both legs. The patient experienced slight fever and not felt good after vaccination for 1 day. The patient stated that, the right shoulder was black and blue after receiving the vaccination. The reporter stated that, the patient got lightheaded when gets up but had this before getting the vaccine. The reporter did not consent to follow up.      Lab Comments: On an unknown date lab test performed
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Nerve damage in her spine and both legs; Legs feel Heavy; Right shoulder was black and blue after receiving the injection; Had trouble walking / cannot walk without assistance; Leg felt numb; Leg was Weak; Slight temperature; Did not feel good; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included aortic aneurysm (Aortic aneurysm that required surgery on aortic valve two years ago from this December, 2019). Concurrent medical conditions included osteoarthritis.   On 29th August 2019, the patient received the 2nd dose of Shingrix. On 24th September 2019, 26 days after receiving Shingrix, the patient experienced lower extremities weakness of and numbness in leg. On an unknown date, the patient experienced slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. On an unknown date, the outcome of the lower extremities weakness of, nerve damage and heaviness in leg were not recovered/not resolved and the outcome of the slight temperature and feeling unwell were recovered/resolved and the outcome of the skin discoloration, numbness in leg and walking difficulty were unknown.   It was unknown if the reporter considered the lower extremities weakness of, slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration, numbness in leg and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Less tha 2 months after vaccination with dos eof Shingrix, The patient had slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. The reporter styated that, the patient had trouble walking so used walker to help to move around because, the patient thought might be the leg had gone to sleep. However, this has continued since then and both legs were involved. The patient could not walk without assistance. The patient notified to physiscian and ordered test for the patient. The patient had MRI with normal result and other tests which indicated that, the nerve damage in the patient's spine and both legs. The patient experienced slight fever and not felt good after vaccination for 1 day. The patient stated that, the right shoulder was black and blue after receiving the vaccination. The reporter stated that, the patient got lightheaded when gets up but had this before getting the vaccine. The reporter did not consent to follow up.      Lab Comments: On an unknown date lab test performed
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Blister, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: papules; blister; lesions; Itchy papule; This case was reported by a nurse via call center representative and described the occurrence of papular rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. In August 2019, 3 days after receiving Shingrix, the patient experienced papular rash, blister, skin lesion and itchy rash. The patient was treated with steroid shot (nos) and prednisone. On an unknown date, the outcome of the papular rash, blister, skin lesion and itchy rash were recovered/resolved.   The reporter considered the papular rash, blister, skin lesion and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and it was unknown if it was administered IM or in what arm because it was administered by another provider.  Three to four days later that, the patient had red, itchy papules that started behind the knees and spread to other body areas. The patient noticed single large blister between fingers but was unsure when this developed. On 4th September 2019, the patient received a steroid IM injection that provided short term benefit. On 13th September 2019, the patient began oral prednisone for 14 days. The nurse stated the prednisone has helped with symptoms and lesions are smaller but patient does continue to develop new lesions, hundreds of them (on trunk, extremities, and a few on the face). On 20th September2019, the patient's provider (dermatologist) thought they were probably an adverse reaction to Shingrix. A skin biopsy was obtained on 20th September2019, the day of the visit, and the HCP decreased to prednisone to 20mg/day to saw if that helped diminish symptoms. The pathology was obtained and determined reaction was due to medication. The nurse called patient and patient stated that the lesions were doing much better. The lesions had stopped coming. The patient felt that, it was now resolved.  The reporter consented to follow up. This case has been linked with US2019AMR184058, reported by same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Vaccination complication
Clinical narrative: papules; blister; lesions; Itchy papule; This case was reported by a nurse via call center representative and described the occurrence of papular rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. In August 2019, 3 days after receiving Shingrix, the patient experienced papular rash, blister, skin lesion and itchy rash. The patient was treated with steroid shot (nos) and prednisone. On an unknown date, the outcome of the papular rash, blister, skin lesion and itchy rash were recovered/resolved.   The reporter considered the papular rash, blister, skin lesion and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and it was unknown if it was administered IM or in what arm because it was administered by another provider.  Three to four days later that, the patient had red, itchy papules that started behind the knees and spread to other body areas. The patient noticed single large blister between fingers but was unsure when this developed. On 4th September 2019, the patient received a steroid IM injection that provided short term benefit. On 13th September 2019, the patient began oral prednisone for 14 days. The nurse stated the prednisone has helped with symptoms and lesions are smaller but patient does continue to develop new lesions, hundreds of them (on trunk, extremities, and a few on the face). On 20th September2019, the patient's provider (dermatologist) thought they were probably an adverse reaction to Shingrix. A skin biopsy was obtained on 20th September2019, the day of the visit, and the HCP decreased to prednisone to 20mg/day to saw if that helped diminish symptoms. The pathology was obtained and determined reaction was due to medication. The nurse called patient and patient stated that the lesions were doing much better. The lesions had stopped coming. The patient felt that, it was now resolved.  The reporter consented to follow up. This case has been linked with US2019AMR184058, reported by same reporter.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Pain, Vomiting
Clinical narrative: Pain (left wrist to finger) / Achiness; Vomiting; Weakness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). On 10th October 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain, vomiting and weakness. On an unknown date, the outcome of the pain, vomiting and weakness were not recovered/not resolved.   It was unknown if the reporter considered the pain, vomiting and weakness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received vaccines on left arm. The patient experienced pain (left wrist to finger), vomiting, achiness and weakness. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. The outcome reported for all AES in the structured field of XML is "recovering" instead of "not resolved" (outcome uploaded in system).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site rash, Middle insomnia, Pain
Clinical narrative: Shingles; Caller reports waking up in the middle of the night in a lot of pain; Having residual burning; Itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2019, 1 days after receiving Shingrix, the patient experienced shingles, pain, burning sensation and pruritus. On 20th September 2019, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the pain, burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, burning sensation and pruritus to be related to Shingrix.  Additional details were provided as follows The patient received 1st dose Shingrix in her right arm. Early the next morning, the patient was preparing for travel for vacation and noticing two areas on her chest where she broke out initially thinking they were insect bites.  The breakouts spread, and the patient reported later that evening and into the next day she was breaking out all over her chest.  On 3rd September 2019, she called a pharmacy near her vacation spot due to breakout spreading to her back extending over to her arm above the injection site.  The patient was waking up in the middle of the night in a lot of pain.  She went to an urgent care clinic and she was diagnosed with shingles.  The patient reported the breakout resolved approximately 20th November 2019, but still having residual burning, itching, but no severe pain. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Shingles; Caller reports waking up in the middle of the night in a lot of pain; Having residual burning; Itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2019, 1 days after receiving Shingrix, the patient experienced shingles, pain, burning sensation and pruritus. On 20th September 2019, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the pain, burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, burning sensation and pruritus to be related to Shingrix.  Additional details were provided as follows The patient received 1st dose Shingrix in her right arm. Early the next morning, the patient was preparing for travel for vacation and noticing two areas on her chest where she broke out initially thinking they were insect bites.  The breakouts spread, and the patient reported later that evening and into the next day she was breaking out all over her chest.  On 3rd September 2019, she called a pharmacy near her vacation spot due to breakout spreading to her back extending over to her arm above the injection site.  The patient was waking up in the middle of the night in a lot of pain.  She went to an urgent care clinic and she was diagnosed with shingles.  The patient reported the breakout resolved approximately 20th November 2019, but still having residual burning, itching, but no severe pain. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Elevated blood glucose; This case was reported by a pharmacist via call center representative and described the occurrence of blood glucose increased in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced blood glucose increased. On an unknown date, the outcome of the blood glucose increased was unknown.   It was unknown if the reporter considered the blood glucose increased to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on Tuesday this week, the day before reporting date. The patient's blood glucose was elevated out of his normal range. The contact stepped away from chat, no further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: The sickest she has ever been; This case was reported by a other health professional via call center representative and described the occurrence of sickness in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) 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 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 Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The medical assistant reported that the patient was the sickest she had ever been following dose one of Shingrix. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: Shingles; PAIN IN THE HIP AREA; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2019, 32 days after receiving Shingrix, the patient experienced shingles and pain in hip. On an unknown date, the outcome of the shingles and pain in hip were unknown.   It was unknown if the reporter considered the shingles and pain in hip to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's sister. The patient experienced pain in the hip area and developed what appeared to be a shingles outbreak on her hip area. The caller reported that the patient would be going to see physician on the reporting date to be evaluated. The reason the reporter called was her sister received the Shingrix vaccine 31 days ago from the reporting date and on the reporting date she developed shingles. The patient seemed too much of a coincidence.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash vesicular, Spinal pain
Clinical narrative: Shingles; PAIN IN THE HIP AREA; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2019, 32 days after receiving Shingrix, the patient experienced shingles and pain in hip. On an unknown date, the outcome of the shingles and pain in hip were unknown.   It was unknown if the reporter considered the shingles and pain in hip to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's sister. The patient experienced pain in the hip area and developed what appeared to be a shingles outbreak on her hip area. The caller reported that the patient would be going to see physician on the reporting date to be evaluated. The reason the reporter called was her sister received the Shingrix vaccine 31 days ago from the reporting date and on the reporting date she developed shingles. The patient seemed too much of a coincidence.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Tiredness; Nausea; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2018, the patient received the 1st dose of Shingrix. On 2nd July 2018, 1 days after receiving Shingrix, the patient experienced tiredness, nausea and dizziness. On an unknown date, the outcome of the tiredness, nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the tiredness, nausea and dizziness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient experienced tiredness, nausea and dizziness after each vaccination and the symptoms lasted for a day. The outcome reported for all AES in the structured field of XML is "recovered/resolved with sequel" instead of "recovered/resolved" (outcome uploaded). For tolerance of 2nd dose of Shingrix, refer case US2019AMR186591.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Analgesic drug level therapeutic, Biopsy bone marrow normal, Biopsy liver abnormal, Blood culture negative, Blood triglycerides increased
Clinical narrative: Feritine was found to be more than 40000 mcg/l/Extreme hyperferritinemia; Hypertriglyceridemia to 2285 mg/dl; Hepatocellular injury with deranged liver function tests; This is a literature case initially retrieved on 07-Oct-2019, concerning a 65-year-old, male patient.   A 65-year-old man presented to clinic with daily nausea, vomiting and diarrhea in the setting of 15 lbs weight loss, ferritin level more than 1000 mcg/L, cytopenias and mild liver function test (LFT) abnormalities. There was no lymphadenopathy on exam. Hemochromatosis DNA testing was negative. Magnetic Resonance Imaging of brain, Computed Tomography of chest, abdomen, pelvis, and upper and lower endoscopies were non-contributory. The patient had an unknown illness causing non-specific constitutional symptoms and derangement of acute phase reactants (APRs).  During this work-up, seasonal influenza trivalent adjuvant vaccine was given [influenza virus vaccine polyvalent; dose, batch number, route of administration, anatomical location and expiry date: not reported] for an unknown indication.  Less than 24 hours later, a routine ferritin was found to be more than 40,000 mcg/L, along with deranged LFTs and hypertriglyceridemia to 2285 mg/dL without cytopenia. Due to concern for rapidly escalating unknown illness, patient was admitted to hospital for monitoring and expedited work up. Tests including, but not limited to, blood culture, hepatitis panel, human immunodeficiency virus, acetaminophen level, stool culture, C. difficile polymerase chain reaction (PCR) as well as soluble CD25 returned negative. Liver biopsy showed hepatocellular injury but no hemophagocytosis. Bone marrow biopsy was also without hemophagocytosis and otherwise normocellular.   Hyperferritinemia and abnormal LFTs remained persistent for 3 to 4 days before spontaneous downtrend without antibiotics or immunosuppressive therapy (recovered).   The outcome for the event of 'hypertriglyceridaemia' was not provided.  The reporter's comment is as follows: Laboratory, imaging and pathology work up was non-contributory, and there was a close temporal relationship between vaccine administration and onset of hyperferritinemia', while the causality assessment for the other two events was not reported.; Sender's Comments: The patient experienced hyperferritinaemia, hypertriglyceridaemia and hepatocellular injury 24 h after vaccination with the suspect product seasonal influenza trivalent adjuvant vaccine. Chronology is suggestive. Medical history of unknown illness may have contributed to development of the events. No concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Clostridium test negative, Computerised tomogram abdomen normal, Computerised tomogram normal, Computerised tomogram pelvis, Computerised tomogram thorax normal
Clinical narrative: Feritine was found to be more than 40000 mcg/l/Extreme hyperferritinemia; Hypertriglyceridemia to 2285 mg/dl; Hepatocellular injury with deranged liver function tests; This is a literature case initially retrieved on 07-Oct-2019, concerning a 65-year-old, male patient.   A 65-year-old man presented to clinic with daily nausea, vomiting and diarrhea in the setting of 15 lbs weight loss, ferritin level more than 1000 mcg/L, cytopenias and mild liver function test (LFT) abnormalities. There was no lymphadenopathy on exam. Hemochromatosis DNA testing was negative. Magnetic Resonance Imaging of brain, Computed Tomography of chest, abdomen, pelvis, and upper and lower endoscopies were non-contributory. The patient had an unknown illness causing non-specific constitutional symptoms and derangement of acute phase reactants (APRs).  During this work-up, seasonal influenza trivalent adjuvant vaccine was given [influenza virus vaccine polyvalent; dose, batch number, route of administration, anatomical location and expiry date: not reported] for an unknown indication.  Less than 24 hours later, a routine ferritin was found to be more than 40,000 mcg/L, along with deranged LFTs and hypertriglyceridemia to 2285 mg/dL without cytopenia. Due to concern for rapidly escalating unknown illness, patient was admitted to hospital for monitoring and expedited work up. Tests including, but not limited to, blood culture, hepatitis panel, human immunodeficiency virus, acetaminophen level, stool culture, C. difficile polymerase chain reaction (PCR) as well as soluble CD25 returned negative. Liver biopsy showed hepatocellular injury but no hemophagocytosis. Bone marrow biopsy was also without hemophagocytosis and otherwise normocellular.   Hyperferritinemia and abnormal LFTs remained persistent for 3 to 4 days before spontaneous downtrend without antibiotics or immunosuppressive therapy (recovered).   The outcome for the event of 'hypertriglyceridaemia' was not provided.  The reporter's comment is as follows: Laboratory, imaging and pathology work up was non-contributory, and there was a close temporal relationship between vaccine administration and onset of hyperferritinemia', while the causality assessment for the other two events was not reported.; Sender's Comments: The patient experienced hyperferritinaemia, hypertriglyceridaemia and hepatocellular injury 24 h after vaccination with the suspect product seasonal influenza trivalent adjuvant vaccine. Chronology is suggestive. Medical history of unknown illness may have contributed to development of the events. No concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Culture stool negative, Endoscopy normal, HIV test negative, Hepatitis viral test negative, Hepatocellular injury
Clinical narrative: Feritine was found to be more than 40000 mcg/l/Extreme hyperferritinemia; Hypertriglyceridemia to 2285 mg/dl; Hepatocellular injury with deranged liver function tests; This is a literature case initially retrieved on 07-Oct-2019, concerning a 65-year-old, male patient.   A 65-year-old man presented to clinic with daily nausea, vomiting and diarrhea in the setting of 15 lbs weight loss, ferritin level more than 1000 mcg/L, cytopenias and mild liver function test (LFT) abnormalities. There was no lymphadenopathy on exam. Hemochromatosis DNA testing was negative. Magnetic Resonance Imaging of brain, Computed Tomography of chest, abdomen, pelvis, and upper and lower endoscopies were non-contributory. The patient had an unknown illness causing non-specific constitutional symptoms and derangement of acute phase reactants (APRs).  During this work-up, seasonal influenza trivalent adjuvant vaccine was given [influenza virus vaccine polyvalent; dose, batch number, route of administration, anatomical location and expiry date: not reported] for an unknown indication.  Less than 24 hours later, a routine ferritin was found to be more than 40,000 mcg/L, along with deranged LFTs and hypertriglyceridemia to 2285 mg/dL without cytopenia. Due to concern for rapidly escalating unknown illness, patient was admitted to hospital for monitoring and expedited work up. Tests including, but not limited to, blood culture, hepatitis panel, human immunodeficiency virus, acetaminophen level, stool culture, C. difficile polymerase chain reaction (PCR) as well as soluble CD25 returned negative. Liver biopsy showed hepatocellular injury but no hemophagocytosis. Bone marrow biopsy was also without hemophagocytosis and otherwise normocellular.   Hyperferritinemia and abnormal LFTs remained persistent for 3 to 4 days before spontaneous downtrend without antibiotics or immunosuppressive therapy (recovered).   The outcome for the event of 'hypertriglyceridaemia' was not provided.  The reporter's comment is as follows: Laboratory, imaging and pathology work up was non-contributory, and there was a close temporal relationship between vaccine administration and onset of hyperferritinemia', while the causality assessment for the other two events was not reported.; Sender's Comments: The patient experienced hyperferritinaemia, hypertriglyceridaemia and hepatocellular injury 24 h after vaccination with the suspect product seasonal influenza trivalent adjuvant vaccine. Chronology is suggestive. Medical history of unknown illness may have contributed to development of the events. No concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Hyperferritinaemia, Hypertriglyceridaemia, Laboratory test normal, Liver function test abnormal, Magnetic resonance imaging brain normal
Clinical narrative: Feritine was found to be more than 40000 mcg/l/Extreme hyperferritinemia; Hypertriglyceridemia to 2285 mg/dl; Hepatocellular injury with deranged liver function tests; This is a literature case initially retrieved on 07-Oct-2019, concerning a 65-year-old, male patient.   A 65-year-old man presented to clinic with daily nausea, vomiting and diarrhea in the setting of 15 lbs weight loss, ferritin level more than 1000 mcg/L, cytopenias and mild liver function test (LFT) abnormalities. There was no lymphadenopathy on exam. Hemochromatosis DNA testing was negative. Magnetic Resonance Imaging of brain, Computed Tomography of chest, abdomen, pelvis, and upper and lower endoscopies were non-contributory. The patient had an unknown illness causing non-specific constitutional symptoms and derangement of acute phase reactants (APRs).  During this work-up, seasonal influenza trivalent adjuvant vaccine was given [influenza virus vaccine polyvalent; dose, batch number, route of administration, anatomical location and expiry date: not reported] for an unknown indication.  Less than 24 hours later, a routine ferritin was found to be more than 40,000 mcg/L, along with deranged LFTs and hypertriglyceridemia to 2285 mg/dL without cytopenia. Due to concern for rapidly escalating unknown illness, patient was admitted to hospital for monitoring and expedited work up. Tests including, but not limited to, blood culture, hepatitis panel, human immunodeficiency virus, acetaminophen level, stool culture, C. difficile polymerase chain reaction (PCR) as well as soluble CD25 returned negative. Liver biopsy showed hepatocellular injury but no hemophagocytosis. Bone marrow biopsy was also without hemophagocytosis and otherwise normocellular.   Hyperferritinemia and abnormal LFTs remained persistent for 3 to 4 days before spontaneous downtrend without antibiotics or immunosuppressive therapy (recovered).   The outcome for the event of 'hypertriglyceridaemia' was not provided.  The reporter's comment is as follows: Laboratory, imaging and pathology work up was non-contributory, and there was a close temporal relationship between vaccine administration and onset of hyperferritinemia', while the causality assessment for the other two events was not reported.; Sender's Comments: The patient experienced hyperferritinaemia, hypertriglyceridaemia and hepatocellular injury 24 h after vaccination with the suspect product seasonal influenza trivalent adjuvant vaccine. Chronology is suggestive. Medical history of unknown illness may have contributed to development of the events. No concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.