chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient were each administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to two unspecified patients of unknown ages and unknown genders. Information of concurrent condition, medical history and concomitant therapy were not provided.    On 24-OCT-2018, patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot#R017635 with expiration date 20-JUN-2020 (strength, dose and route were not reported) for prophylaxis and sterile diluent (STERILE DILUENT). The varicella virus vaccine live (oka/merck)(VARIVAX) vaccines experienced temperature excursion and were stored at 6 to 14 Fahrenheit degrees (9.1 Fahrenheit degrees ) for 50 minutes (Product storage error). There was no previous temperature excursion. No adverse events were reported in any patients. A data logger was involved. The outcome of the event was not reported.  Follow-up information was received from the reporting nurse on 05-JUN-2019.  The nurse reported the patient's demographics and were updated in the case.  It was also reported that on 24-OCT-2018, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (strength, dose, frequency, route of administration, anatomical site of injection, lot # and expiration date were not reported), for prophylaxis.  There was no information regarding storage of this vaccine.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA002233: US-009507513-1810USA011328:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: nausea; Sick; This case was reported by a consumer and described the occurrence of nausea in a 63-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 a day after receiving Shingrix, the patient experienced nausea and sickness. On an unknown date, the outcome of the nausea and sickness were not recovered/not resolved.   It was unknown if the reporter considered the nausea and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine 2 months before the reporting date and experienced nauseous every day. The patient was sick ever since the vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got really sick from it; This case was reported by a consumer via other manufacturer and described the occurrence of sickness 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, unknown 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 details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter stated that he did not know if he should get Shingrix, just about everyone he knew who got the vaccine, got sick from it on unspecified dates. No patient specifics provided, no dates of administration known. The primary reporter was the consumer, report filed after call ended therefore no demographics were known for the any patients or healthcare professionals. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Inappropriate dose of vaccine administered; wrong solution used in drug reconstitution; This case was reported by a pharmacist via patient support programs and described the occurrence of inappropriate dose of vaccine administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist constituted another solution with the Shingrix vaccine while she administered on the patient, which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. That solution was not a part of the Shingrix vaccine package. No further information was received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin burning sensation
Clinical narrative: shingles; pain; burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a year after receiving Shingrix, the patient experienced shingles, pain and burning sensation skin. On an unknown date, the outcome of the shingles and burning sensation skin were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the shingles, pain and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had an issue for six weeks till the reporting time, with burning and pain.  The patient's doctor said that the patient might had shingles with no rash. The patient wanted to know when the patient would receive second shot. The pain was a little better at the time of reporting, with no rash.  The physician said it could be shingles with no rash. So when was safe to have second shingles vaccine. The patient read that the rash should be gone in order to have the vaccine.
Age: 74.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Drug dose administration interval too long; shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2018, the patient received the 1st dose of Shingrix. In March 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2018, 100 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. In March 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were provided as follows: The patient had out break of shingles post 1st vaccination. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient did not have out break of shingles post 2nd dose. The reporter agreed for follow up contact.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2018, the patient received the 1st dose of Shingrix. On 14th September 2018, the patient received the 2nd dose of Shingrix. On 20th May 2019, 325 days after receiving Shingrix and 248 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient experienced shingles outbreak. This case was a suspected vaccination failure since the details regarding confirmatory lab test for shingles were unknown.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Swelling
Clinical narrative: sore arm; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, see case US2019AMR097029).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm and swelling. On an unknown date, the outcome of the pain in arm and swelling were unknown.   It was unknown if the reporter considered the pain in arm and swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that she has experienced adverse events sore arm, swelling with Bexsero that seemed to be higher incidence after 1st dose than 2nd dose.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: redness at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on 28th February 2019, refer case US2019098228).   On 28th May 2019, the patient received the 2nd dose of Shingrix. On 28th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site swelling was recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow-up with her physician. The reporter consented to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site discolored; Injection site pain/ Injection site tenderness; Injection site redness; Injection site warmth; Injection site itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, 5 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site itching. On an unknown date, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site itching and injection site discoloration were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site itching and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The symptoms continued to get worse over the next few days until the red area was about 6 inches in diameter. The pain was tenderness to the touch. The site was still a little tender, discolored and a little itchy, but the symptoms are getting better daily till the time of reporting. The reporter did not consented to follow-up
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 5 raised bumps around the injection site; injection site Itchy; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 28th May 2019, 4 days after receiving Shingrix, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received their Shingrix intramuscularly, on left arm. At the day of reporting the patient developed 5 raised bumps around the injection site that were slightly itchy. The reporter declined to provide any patient identifiers.  Lot number/expiry date unknown.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: International normalised ratio increased
Clinical narrative: High INR; This case was reported by a consumer via call center representative and described the occurrence of international normalized ratio increased in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 4 days after receiving Shingrix, the patient experienced international normalized ratio increased. On an unknown date, the outcome of the international normalized ratio increased was unknown.   It was unknown if the reporter considered the international normalized ratio increased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient stated that, after vaccination with Shingrix, her international normalized ratio bloodwork for coagulation was increased. About 4 days later of vaccination international normalized ratio was 3.1, on 6th May 2019, INR was 2.9, on 13th May 2019, INR was 3.4,and on 20 May 2019, INR was 3.3. On the day of reporting the INR was 2.0. The patient had to decrease dose of Warfarin on 2 different doses. The patient consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash (unknown area; not at injection site); This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   Concurrent medical conditions included yeast infection (in an unknown area).   On 27th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th March 2019, 1 days after receiving Shingrix, the patient experienced rash. The action taken with Shingrix was unknown. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the left arm. The patient expereinced rash on an unknown area (not at injection site).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sores; This case was reported by a consumer via call center representative and described the occurrence of cold sore mouth in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th March 2019, 2 days after receiving Shingrix, the patient experienced cold sore mouth. On an unknown date, the outcome of the cold sore mouth was recovered/resolved.   It was unknown if the reporter considered the cold sore mouth to be related to Shingrix.  Additional case details were provided as follows: The  patient reported that she developed cold sores all over her mouth 2 days after getting the dose of Shingrix. The patient ended up with 8 cold sores. It took 3 weeks for them to resolve completely. The patient consented to follow up and provided contact details of the physician related to her.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever; Aching; Generally feeling bad; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix. In May 2019, 1 day after receiving Shingrix, the patient experienced fever, pain and feeling bad. On an unknown date, the outcome of the fever, pain and feeling bad were unknown.   It was unknown if the reporter considered the fever, pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced fever, aching, and generally feeling bad after receiving Shingrix. The health care professional noted that the events began the next morning after the vaccine was given.  The fever was described as low grade.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow-up with her physician. The reporter consented to follow-up. For tolerance dose refer case US2019GSK102052. There is a discrepancy with respect to the outcome of the event Injection site erythema. In the core the outcome is reported as Not Recovered/Not Resolved, however in provided source document it is recovering/resolving. The outcome of these events retains as per the structural field.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Food allergy, Generalised erythema, Pruritus generalised, Skin warm
Clinical narrative: itching; redness; hot to touch; peanut allergy; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received Shingrix (intramuscular). On 28th May 2019, 12 days after receiving Shingrix, the patient experienced generalized pruritus, generalized erythema, feeling hot and peanut allergy. On 28th May 2019, the outcome of the generalized pruritus, generalized erythema and feeling hot were recovered/resolved. On an unknown date, the outcome of the peanut allergy was unknown.   It was unknown if the reporter considered the generalized pruritus, generalized erythema, feeling hot and peanut allergy to be related to Shingrix.  Additional case details were provided as follows: The patient's neck and chest started to itch and became really, really red.  Also, the outside of both elbows became red like tomatoes and hot to the touch. The patient thought that, this might be an allergic reaction to some peanuts she ate but she had never had a peanut allergy before.  The patient was wondering if Shingrix could cause someone to develop a peanut allergy. These reactions stayed that way for about 45 min.  The patient did not consent to follow-up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Injection site pain, Malaise, Neck pain, Pain in extremity
Clinical narrative: neck,arms, bone pain; arm pain; pain in bone; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced neck pain, pain in arm, bone pain and feeling unwell. On 16th May 2019, the outcome of the neck pain, pain in arm, bone pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the neck pain, pain in arm, bone pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The reporter stated that, her husband also had a Shingrix injection in left deltoid and the patient reported feeling the fluid go into his arm during the injection and that the day following the injection, he reported that his neck, arms, and bones were hurt and that he did not feel 100%. These events did not stop the patient from doing things. The day after that, the patient felt better. The reporter did not consent to follow-up. A call back was done to the consumer to obtain physician's information but no one answered.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Muscle aches; Feeling of fainting; Stomach upset; nausea; Headache; Flu Like Symptoms; Sweats; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, 16 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, sweating, chills, muscle pain, felt faint, upset stomach, nausea and headache. In May 2019, the outcome of the influenza-like symptoms, sweating, chills, felt faint, upset stomach, nausea and headache were recovered/resolved. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, sweating, chills, muscle pain, felt faint, upset stomach, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who was a pharmacist.  The patient received Shingrix in the left arm. He stated that about 16 hours after receiving the vaccine he experienced flu like symptoms, sweats, chills, muscle aches, felt like fainting, stomach upset, nausea and headache. It was intense for the next 6 hours. He recovered from everything 24 hours later except the muscle ache which he was still experiencing. The reporter did not consent to follow-up. No further details were provided.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Nausea
Clinical narrative: Muscle aches; Feeling of fainting; Stomach upset; nausea; Headache; Flu Like Symptoms; Sweats; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, 16 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, sweating, chills, muscle pain, felt faint, upset stomach, nausea and headache. In May 2019, the outcome of the influenza-like symptoms, sweating, chills, felt faint, upset stomach, nausea and headache were recovered/resolved. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, sweating, chills, muscle pain, felt faint, upset stomach, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who was a pharmacist.  The patient received Shingrix in the left arm. He stated that about 16 hours after receiving the vaccine he experienced flu like symptoms, sweats, chills, muscle aches, felt like fainting, stomach upset, nausea and headache. It was intense for the next 6 hours. He recovered from everything 24 hours later except the muscle ache which he was still experiencing. The reporter did not consent to follow-up. No further details were provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Eosinophil count increased, Eosinophilia, Inflammation, Injection site pain, Malaise
Clinical narrative: Eosinophilia in blood, accompanied by sporadic mild-to-moderate myalgia of skeletal muscles (e.g.,  aches, pain, tenderness, stiffness).  Dose 1 of SHINGRIX was administered on 02/01/2019, followed by Dose 2 on 04/30/2019.  Both doses caused substantial injection site myalgia for about 3 days as well as general malaise, which are typical adverse events from SHINGRIX.  However, over months after Dose 1, sporadic pain, etc. in muscles or possibly tendons, particularly in the abdomen, back and right hand was experienced.  [See Continuation Page Below]  Although the myalgia was initially attributed to dancing and yard work activity, which may have been contributing causes, their slow resolution was considered unusual,by the patient, suggesting continuing inflammation instead of healing.  The adverse symptoms continued after Dose 2.  A blood test on 05/23/2019 (i.e. 23 days after Dose 2) showed 725 eosinophils / uL, indicative of Eosinophilia.  No doubt the Eosinophilia began well before the 05/23/2019 blood test, likely after Dose 1.   Eosinophilia is well known to potentially promote inflammation, thus causing or exacerbating observed symptoms.  The patient has no prior history of Eosinophilia; a test on 05/15/2018 measured 270 eosinophils  / uL.  As of 06/05/2019, the adverse muscular symptomology appears to be gradually resolving.  A quick literature search did not find previous disclosure of SHINGRIX causing Eosinophilia, but found that Quillaja saponin component QH-A (which includes SHINGRIX's adjuvant) both alone and in combination with a viral antigen markedly increases expression of the cytokine interleukin 5 (IL-5), which is well known to promote the production of eosinophils.  As a probably not relevant side note:  The patient was determined to be homozygous with the CCR5 delta 32 mutation.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Eosinophilia in blood, accompanied by sporadic mild-to-moderate myalgia of skeletal muscles (e.g.,  aches, pain, tenderness, stiffness).  Dose 1 of SHINGRIX was administered on 02/01/2019, followed by Dose 2 on 04/30/2019.  Both doses caused substantial injection site myalgia for about 3 days as well as general malaise, which are typical adverse events from SHINGRIX.  However, over months after Dose 1, sporadic pain, etc. in muscles or possibly tendons, particularly in the abdomen, back and right hand was experienced.  [See Continuation Page Below]  Although the myalgia was initially attributed to dancing and yard work activity, which may have been contributing causes, their slow resolution was considered unusual,by the patient, suggesting continuing inflammation instead of healing.  The adverse symptoms continued after Dose 2.  A blood test on 05/23/2019 (i.e. 23 days after Dose 2) showed 725 eosinophils / uL, indicative of Eosinophilia.  No doubt the Eosinophilia began well before the 05/23/2019 blood test, likely after Dose 1.   Eosinophilia is well known to potentially promote inflammation, thus causing or exacerbating observed symptoms.  The patient has no prior history of Eosinophilia; a test on 05/15/2018 measured 270 eosinophils  / uL.  As of 06/05/2019, the adverse muscular symptomology appears to be gradually resolving.  A quick literature search did not find previous disclosure of SHINGRIX causing Eosinophilia, but found that Quillaja saponin component QH-A (which includes SHINGRIX's adjuvant) both alone and in combination with a viral antigen markedly increases expression of the cytokine interleukin 5 (IL-5), which is well known to promote the production of eosinophils.  As a probably not relevant side note:  The patient was determined to be homozygous with the CCR5 delta 32 mutation.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Pruritus generalised, Rash, Rash erythematous
Clinical narrative: Three hours after receiving vaccines patient complained of itchy , redness at vaccine site.  In the morning complained of red rash on face and whole body itching.  Called us we advised to see doctor or go to urgent care. Patient had no insurance . Advised to see his school nurse on arrival at school.  Seen by school nurse and given Benadryl.  Called patient in afternoon and patient reported feeling better, rash gone and no itching. He just feels drowsy.  Explained continued Benadryl use as needed and to go to urgent care if problem persists.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Somnolence
Clinical narrative: Three hours after receiving vaccines patient complained of itchy , redness at vaccine site.  In the morning complained of red rash on face and whole body itching.  Called us we advised to see doctor or go to urgent care. Patient had no insurance . Advised to see his school nurse on arrival at school.  Seen by school nurse and given Benadryl.  Called patient in afternoon and patient reported feeling better, rash gone and no itching. He just feels drowsy.  Explained continued Benadryl use as needed and to go to urgent care if problem persists.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: 101.7 temp. Nausea. Flu-like symptoms. Arm pain. Headache.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Alopecia, Alopecia areata, Autoimmune disorder, Blood test normal, Inflammation
Clinical narrative: 5 (possibly sooner) months after my vaccines, I noticed my hair falling out in patches. After going to the dermatologist, I was diagnosed with Alopecia Areata, and autoimmune disease on May 30th 2019.  I have never ever noticed my hair falling out before, and highly believe the HPV vaccine kickstarted the autoimmune disease.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Laboratory test normal
Clinical narrative: 5 (possibly sooner) months after my vaccines, I noticed my hair falling out in patches. After going to the dermatologist, I was diagnosed with Alopecia Areata, and autoimmune disease on May 30th 2019.  I have never ever noticed my hair falling out before, and highly believe the HPV vaccine kickstarted the autoimmune disease.
Age: 0.25
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: Patient administered Kinrix in error as it should have been a Hepatitis B vaccine.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Musculoskeletal pain, Pain in extremity
Clinical narrative: Soreness in arm and pain in arm and shoulder for a week. Chills on the first night.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling hot, Headache, Injection site pain
Clinical narrative: Patient reports feeling like body is on fire, chills, and weakness. Terrible headache. No swelling or redness at injection site but does have a little pain. Patient advised to come into office today.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: 7cm x 5cm rash around injection site with arm soreness and soreness around rash
Age: 0.58
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt given an unlicensed dose for his current age
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Swelling at vaccine site which went away after two days.  Yesterday,  I developed rash on my upper arm, vaccination site, which is limited to site, but the rash has spread to another site on my upper left arm
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: Chills and fever, swelling at the area
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: fever chills aches and pains "felt like I was run over by a truck"
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, UNK
Symptoms: Irritability, Rash, Urticaria
Clinical narrative: Vaccines administered around 10.15 am. Mom spent next door and returned at 10.30 am, child had rash and hives to entire front of neck and chin. Rash to cheeks and chest. Child in no visible distress and looked fussy. Benadryl 0.25mg PO given.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: FEVER CHILLS ACHES "FELT LIKE I WAS RUN OVER BY A TRUCK"
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site warmth
Clinical narrative: Pt developed redness (about 3cm diameter) at injection site (left deltoid) 2-3 days after immunization, as well as about half way down the upper arm (about 3 x 6cm area). A week later she woke at 4am with left arm and left posterior shoulder pain and tenderness, prompting an office visit. On examination, the areas involved were faintly erythematous and with increased warmth, and with some superficial capillary prominence, no appreciable fullness to skin to suggest cellulitis. No arm edema, no arterial cords to suggest UE DVT. Suspect delayed intradermal allergic reaction. No facial, oral, or pharyngeal edema, no breathing problems at any point.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: fever chills aches - felt extremely ill
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Cellulitis, Fatigue, Pruritus, Rash
Clinical narrative: Patient reports itchy, rash, swelling, joint pain, tired symptoms. She went to provider and was diagnosed with cellulites from vaccine.  The patient was prescribed clindamycin 300mg 1 tablet every 6 hours for 7 days.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling
Clinical narrative: Patient reports itchy, rash, swelling, joint pain, tired symptoms. She went to provider and was diagnosed with cellulites from vaccine.  The patient was prescribed clindamycin 300mg 1 tablet every 6 hours for 7 days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Alanine aminotransferase normal, Albumin urine absent, Anion gap normal, Aspartate aminotransferase normal, Bacterial test negative
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Basophil count decreased, Basophil percentage decreased, Bilirubin urine, Blood albumin decreased, Blood alkaline phosphatase increased
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood bicarbonate normal, Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Blood glucose increased, Blood lactic acid normal, Blood pH normal, Blood potassium normal
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood sodium normal, Blood urea normal, C-reactive protein increased, CSF culture negative, CSF glucose normal
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF protein normal, CSF red blood cell count positive, CSF white blood cell count negative, Carbon dioxide normal, Differential white blood cell count
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enterovirus test negative, Eosinophil count normal, Eosinophil percentage decreased, Febrile convulsion, Full blood count
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Glomerular filtration rate normal, Glucose urine absent, Gram stain, Granulocyte count decreased, Granulocyte percentage
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematocrit decreased, Haemoglobin normal, Herpes simplex test negative, Lymphocyte count normal, Lymphocyte percentage
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Metabolic function test, Monocyte count increased
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage, Nitrite urine absent, Oxygen saturation decreased
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: PCO2 decreased, PO2 decreased, Platelet count normal, Polymerase chain reaction, Postictal state
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Protein total normal, Protein urine absent, Pyrexia, Red blood cell count normal, Red blood cell nucleated morphology
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Red blood cells urine negative, Red cell distribution width normal, Seizure, Septic screen, Specific gravity urine normal
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cells urine negative, pH urine normal
Clinical narrative: Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Pain
Clinical narrative: dizziness, headache, shortness of breath, body aches, increased heart rate within 30 minutes injection. only treatment taken naproxin
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Diarrhoea, Dyspnoea, Injection site swelling, Nausea
Clinical narrative: Diarrhea, Dyspnea, Cough, Shortness of Breath, Nausea and Swelling of right upper arm
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Started running a fever (99-102, varying) 5 days after vaccine.  The fever left and then came back daily for 3 days intermittently.  She was lethargic but still eating and drinking fine. No rash is present. Vomiting on morning of day 3, nearly back to normal on day 4 with a slight fever and will continue to monitor.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: red rash and swelling around injection site; Rash around vaccine site; red rash and swelling around injection site; provider suggested cold compress and OTC benadryl for itching; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old female patient. Concurrent condition included constipation. The patient was not ill at time of vaccination. Concomitant medication included polyethylene glycol 3350 (MIRALAX). There was no information about the patient's medical history.  On 09-APR-2019, the patient was vaccinated with a first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneously in the right thigh for vaccination (lot no. R021101 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD), expiration date not reported, but upon internal validation established as 20-JAN-2020) (formulation and dose  were not reported). Other suspect vaccine received on the same date included diphtheria toxoid, pertussis acellular 1-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV) intramuscularly in the left thigh (formulation, dose and indication were not reported).  On 11-APR-2019, the patient experienced red rash and swelling around injection site, provider suggested cold compress and over the counter (OTC) diphenhydramine (BENADRYL) for itching and to return to clinic for evaluation if no improvement. The patient did not received any prescription drug treatment for the events. On 13-APR-2019, the patient was in office and swelling, rash at injection site resolved. The outcome of red rash and itching and was not reported. The causality assessment  was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002505:
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blood pressure increased, Confusional state, Ear pain, Emotional distress, Insomnia
Clinical narrative: trouble sleeping; feeling irritable; red eyes; ear pain; blood pressure was way up; fever; but she does not think she received the right product; she is really upset and confused; she is really upset and confused; This spontaneous report was received from a 69-year-old female patient, who refers to herself. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On 20-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot# and expiration date were not provided) or with the second dose of zoster rge vaccine (mammalian) (SHINGRIX), 50 micrograms, intramuscularly, (lot# and expiration date were not provided) for prophylaxis.  On 22-MAY-2019 (reported as 2 or 3 days after vaccination), the patient had trouble sleeping, red eyes, ear pain, fever, she was feeling irritable and thought that her blood pressure was way up. Since an unknown date in May 2019, the patient was really upset and confused. The patient stated, that she thought she was dying. She was taking an antibiotic to treat her symptoms. The outcome of trouble sleeping, irritability, red eyes, ear pain, fever and increased blood pressure was unknown. The outcome of feeling upset and confused was reported as not recovered.  The relatedness between the events and the suspect vaccines was not provided.  The reporter considered the events of trouble sleeping, irritability, red eyes, ear pain, fever and increased blood pressure to be life threatening.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Irritability, Ocular hyperaemia, Pyrexia
Clinical narrative: trouble sleeping; feeling irritable; red eyes; ear pain; blood pressure was way up; fever; but she does not think she received the right product; she is really upset and confused; she is really upset and confused; This spontaneous report was received from a 69-year-old female patient, who refers to herself. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On 20-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot# and expiration date were not provided) or with the second dose of zoster rge vaccine (mammalian) (SHINGRIX), 50 micrograms, intramuscularly, (lot# and expiration date were not provided) for prophylaxis.  On 22-MAY-2019 (reported as 2 or 3 days after vaccination), the patient had trouble sleeping, red eyes, ear pain, fever, she was feeling irritable and thought that her blood pressure was way up. Since an unknown date in May 2019, the patient was really upset and confused. The patient stated, that she thought she was dying. She was taking an antibiotic to treat her symptoms. The outcome of trouble sleeping, irritability, red eyes, ear pain, fever and increased blood pressure was unknown. The outcome of feeling upset and confused was reported as not recovered.  The relatedness between the events and the suspect vaccines was not provided.  The reporter considered the events of trouble sleeping, irritability, red eyes, ear pain, fever and increased blood pressure to be life threatening.