chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Pain
Clinical narrative: Lost shoulder mobility, chills, throbbing.  Mobility is improving slightly today
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: visual disturbances
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: large red, swollen rash covering the majority of left deltoid muscle, told patient to take benadryl and let us know if it gets better or worse
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Angiogram, Computerised tomogram head normal, Facial paralysis, Headache, Magnetic resonance imaging brain normal
Clinical narrative: 9/25 Patient presents to ED complaining of left sided throbbing headache 9/28 Patient presents to ED with facial droop 10/4 Patients primary care doctor diagnosis Bell's Palsy
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom reported Patient's injection site became swollen and red. She also noted that it was "hot to the touch". Patient did not show any signs of trouble breathing or itch or any other adverse reaction. I advised mom to place an ice pack on the site and to take Patient to the ER if he shows signs of troubled breathing. Mom said she will watch him. I called mom on 10/3 to see how Patient was doing but mom did not pick up the phone. I asked the mom to call back.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Had slight localized reaction (redness, no itching) at injection site.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea
Clinical narrative: Pt reports he had an extreme headache, severe chills, pain at injection site & nausea.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Patient reported hives/rash about 30 minutes after administration of the immunization. We referred patient to urgent care where an injectable steroid was administered which resolved the reaction. No further action was necessary per patient.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Syncope, hit head (5-10 min. after injections) Dizzy x 30 min after syncope
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the pregnant patient was administered one dose of GARDASIL 9; No adverse effects; This spontaneous report was received from a physician referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 11-SEP-2019, this pregnant patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # and expiration date were not reported) via intramuscular route for prophylaxis (maternal exposure during pregnancy). Information about the last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; a patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 06-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S009759, expiration date 27-SEP-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine experienced the temperature excursion of 15 to 46 degrees Fahrenheit (17.6 degrees) for 56 hours and 40 minutes. Administered dose of vaccine experienced previous temperature excursion of 6 to 14 degrees Fahrenheit (6.2 degrees) for 10 minutes. The digital data logger was not involved in recording the temperature excursion details. There was no adverse effects reported.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray, Diarrhoea, Dizziness, Electrocardiogram, Headache
Clinical narrative: intermittent headaches; diarrhea; dizzy; This spontaneous report was received from a registered nurse and refers to a 60-year-old female patient. The patient's pertinent medical histories included Cushing's. The patient was allergic to levofloxacin (LEVAQUIN) and codeine. The patient had no concomitant therapies.  On 27-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S020157 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 30-JUN-2021 (exact dose, dose number, route and site of administration were not reported) for immunization.  On 27-SEP-2019, reported as in 30 seconds after vaccine administration, the patient became dizzy. On 28-SEP-2019, reported as on the next day, the patient developed diarrhea and intermittent headaches. On an unknown date in 2019, the patient had basic lab work, electrocardiogram (EKG) and chest x-ray, the results were not provided. The patient sought medical attention, the patient had emergency room visit and office visit. The treatment was not given. On 29-SEP-2019, the patient recovered from diarrhea, it was reported that diarrhea lasted for one day. The dizziness and headaches had decreased at the reporting time. The causality assessment was not provided.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test
Clinical narrative: intermittent headaches; diarrhea; dizzy; This spontaneous report was received from a registered nurse and refers to a 60-year-old female patient. The patient's pertinent medical histories included Cushing's. The patient was allergic to levofloxacin (LEVAQUIN) and codeine. The patient had no concomitant therapies.  On 27-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S020157 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 30-JUN-2021 (exact dose, dose number, route and site of administration were not reported) for immunization.  On 27-SEP-2019, reported as in 30 seconds after vaccine administration, the patient became dizzy. On 28-SEP-2019, reported as on the next day, the patient developed diarrhea and intermittent headaches. On an unknown date in 2019, the patient had basic lab work, electrocardiogram (EKG) and chest x-ray, the results were not provided. The patient sought medical attention, the patient had emergency room visit and office visit. The treatment was not given. On 29-SEP-2019, the patient recovered from diarrhea, it was reported that diarrhea lasted for one day. The dizziness and headaches had decreased at the reporting time. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Bone pain, Magnetic resonance imaging abnormal, Myalgia
Clinical narrative: Severe muscle aches; Severe bone aches; Very strong reaction; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery (previous failed surgery).   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 muscle pain, bone pain and back pain. The patient was treated with prednisone (Prednisone Dose Pack). On an unknown date, the outcome of the muscle pain, bone pain and back pain were recovered/resolved.   It was unknown if the reporter considered the muscle pain, bone pain and back pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On 22nd September 2019, the patient just completed a 12 day Prednisone dose pack  and it just so happened that the patient's pharmacy called and said they had second dose of the vaccine available for the patient until 28th September 2019. The patient asked would it be better to put this off as the recent prednisone may make it so the patient did had an effective response to the vaccine. The patient asked that if so then how long should the patient wait. The prednisone was because of terrible back pain and the Magnetic resonance imaging showed so much that it was time the patient had to have surgery to do a fusion from a previous failed surgery.  The patient asked in regards to this would it be best to hold off until after surgery. The patient experienced very strong reaction the first time with 10 days of severe muscle and bone aches.
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Pyrexia
Clinical narrative: Sky High Fevers; Was actually allergic to the tetanus in this combo vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   Concurrent medical conditions included tetanus immunization.   On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced fever and allergy. On an unknown date, the outcome of the fever and allergy were unknown.   It was unknown if the reporter considered the fever and allergy to be related to DTPa vaccine.  Additional information received were as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The reporter reported that their son also ran sky high fevers with DPT. Years later the reporter found out that he was actually allergic to the tetanus in this combo vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 13th June 2019, 1 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hives after the shot and that they still have not cleared up.  The reporter wanted to know how many people have called in to report side effects. The reporter advised them that he may have his physician call GlaxoSmithKline MI department.  The reporter stated he wanted to speak to a manager. No additional information was provided concerning this event. The reporter did not consent to follow-up. No physician information was provided. This case has been linked with US2019175400 having same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise, Pain
Clinical narrative: Inappropriate Schedule of Vaccine; Body aches; Significant Malaise; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on November 2018, refer case US2019175365).   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In September 2019, the patient experienced general body pain and malaise. On an unknown date, the outcome of the general body pain and malaise were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix approximately two weeks ago from the date of reporting, which led to lengthening of vaccination schedule. After vaccination with dose of Shingrix, the patient experienced symptoms but were milder. The symptoms were resolved within 2 days. The sales representative indicated that, the reporter provided this information to her during a Congress she was attending and was unable to provide any additional details. This case is one of 5 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue 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 asked how long the fatigue typically last after receiving the second dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Pyrexia, Rash
Clinical narrative: Slight pain at the injection site; Headache; Mild fever; Extreme tenderness of arm starting about 2" below the injection site and extending about 4" toward the elbow; Rash; This case was reported by a consumer and described the occurrence of injection site pain in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included methotrexate and infliximab (Remicade).   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 injection site pain, headache, fever, tenderness and rash. On an unknown date, the outcome of the injection site pain, headache, fever, tenderness and rash were unknown.   It was unknown if the reporter considered the injection site pain, headache, fever, tenderness and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 77 or 76 years old at time of vaccination. The patient had a few symptoms or reaction some of which are listed as possible reactions and a couple of which do not see noted. The patient stated that the ones that are apparently common are very slight pain at the injection site, headache and mild fever 100.8. The unexpected reactions include extreme tenderness of my arm starting about 2 inch below the injection site and extending about 4 inch toward the elbow with a rash appearing in this. The tendered was sufficient than the patient cannot lay on that side. The patient just wanted to check this out as do not know anyone else who has experienced these symptoms and have not seen them listed anywhere.      Lab Comments: On unknown date, body temperature was 100.8
Sex: U
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Slight pain at the injection site; Headache; Mild fever; Extreme tenderness of arm starting about 2" below the injection site and extending about 4" toward the elbow; Rash; This case was reported by a consumer and described the occurrence of injection site pain in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included methotrexate and infliximab (Remicade).   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 injection site pain, headache, fever, tenderness and rash. On an unknown date, the outcome of the injection site pain, headache, fever, tenderness and rash were unknown.   It was unknown if the reporter considered the injection site pain, headache, fever, tenderness and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 77 or 76 years old at time of vaccination. The patient had a few symptoms or reaction some of which are listed as possible reactions and a couple of which do not see noted. The patient stated that the ones that are apparently common are very slight pain at the injection site, headache and mild fever 100.8. The unexpected reactions include extreme tenderness of my arm starting about 2 inch below the injection site and extending about 4 inch toward the elbow with a rash appearing in this. The tendered was sufficient than the patient cannot lay on that side. The patient just wanted to check this out as do not know anyone else who has experienced these symptoms and have not seen them listed anywhere.      Lab Comments: On unknown date, body temperature was 100.8
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side Effects; This case was reported by a consumer via sales rep and described the occurrence of adverse drug reaction 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, less than 2 years after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction 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 was selected as per the vaccine indication. The patient experienced side effects after receiving vaccine. The patient asked for how many days the side effects occur.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Muscle aches; Shivering; Pain at the injection site; Tired; Diarrhea; Headaches; muscle fatigue; aching; This case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, 2 days after receiving Shingrix, the patient experienced muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain were unknown.   It was unknown if the reporter considered the muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st shingrix vaccine 2 days ago, and pretty much had all of the side effects. The patient had severe muscle aches, shivering and pain at the injection site, headache muscle ache so severe. The patient was putting ice pack everywhere. On 26th September 2019, the patient feel tired and had diarrhea all day. Th patient bother getting the second vaccine 2 months. The patient stated that am young, very healthy, exercise regularly and take no medications for any underlying issues. The patient had no choice but to be in bed. The muscle fatigue and aching was pretty intense and patient took Motrin and Tylenol around the clock so would had any benefits at all in just having this vaccine or must had both.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Muscle fatigue, Myalgia, Pain
Clinical narrative: Muscle aches; Shivering; Pain at the injection site; Tired; Diarrhea; Headaches; muscle fatigue; aching; This case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, 2 days after receiving Shingrix, the patient experienced muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain were unknown.   It was unknown if the reporter considered the muscle pain, shivering, injection site pain, tiredness, diarrhea, headache, muscle fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st shingrix vaccine 2 days ago, and pretty much had all of the side effects. The patient had severe muscle aches, shivering and pain at the injection site, headache muscle ache so severe. The patient was putting ice pack everywhere. On 26th September 2019, the patient feel tired and had diarrhea all day. Th patient bother getting the second vaccine 2 months. The patient stated that am young, very healthy, exercise regularly and take no medications for any underlying issues. The patient had no choice but to be in bed. The muscle fatigue and aching was pretty intense and patient took Motrin and Tylenol around the clock so would had any benefits at all in just having this vaccine or must had both.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Rash that looks like chicken pox / Vesicular rash; This case was reported by a physician via sales rep and described the occurrence of varicella-like rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, 1 days after receiving Shingrix, the patient experienced varicella-like rash. Shingrix was discontinued. On an unknown date, the outcome of the varicella-like rash was unknown.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 61 or 60 years old at time of vaccination. The physician reported the patient developed vesicular rash one day after first dose of Shingrix. The dermatologist at practice biopsied site and believes it could be chicken pox. The adverse event was reported on 26th September 2019 at 12:17pm. Upon speaking with physician morning, physician stated that they would not be administering the second dose of the Shingrix series. The reporter was agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included handicap.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than 2 years after receiving Shingles vaccine, 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 Shingles vaccine.  Additional information was reported as follows: This case was reported by the reporter's friend wife. The age at vaccination was not reported. After vaccination, the patient instantly got shingles. The reporter told that, the shingles was cured very quickly with hydrogen peroxide. The reporter's husband had shingles for maybe a week. With hydrogen peroxide compresses and hydrogen peroxide bath, it was gone in a week. The results were seen within the first treatment and did not need a shingles shot which was full of dangerous poisons. Getting the shingles shot did not guarantee that the patient won't get shingles infected causes shingles in many cases.  She could very well get shingles again also, it was no guarantee getting a vaccine did not guarantee to anything. Well the reporter took that back and pretty well guaranteed of having bad results from the poisons and various viruses and bacteria that have now had put into the bloodstream. The patient could not put something in their body that was never meant to be there and expect to secure anything because it won't because it could not. The patient body would fight to get rid of it.  This vaccination agenda was insanity on steroids. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Dermatitis, Fatigue
Clinical narrative: Generalized Bodily Muscle Pain; Injection Site Redness; Pain at the injection site; Feeling Tired; Feeling Weak; Felt sick; acute dermatitis; Persistent rash developed on her back and shoulder that is red and bumpy; Shivers; Terrible Headache / headache was on and off stemming from her neck into her head; Stomach Pain; Persistent rash developed on her back and shoulder that is red and bumpy; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a day after receiving Shingrix, the patient experienced shivers, headache, stomach pain, erythropapular rash, dermatitis and red rash. On 16th August 2019, the patient experienced muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness and feeling unwell. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the shivers, headache, stomach pain, muscle pain, injection site erythema, tiredness and feelings of weakness were recovered/resolved and the outcome of the injection site pain was unknown and the outcome of the erythropapular rash, dermatitis and red rash were not recovered/not resolved and the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the shivers, headache, stomach pain, muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness, erythropapular rash, feeling unwell, dermatitis and red rash to be related to Shingrix.  Additional details were provided as follows: The patient receiving 2nd dose Shignrix in her left arm in the late afternoon and the next morning waking up with shivers followed by quick onset of a terrible headache and then stomach pains.  The patient also experienced generalized bodily muscle pain, redness and pain at the injection site, and feeling weak and tired.  The patient still felt sick but not as sick as the previous day and the patient had taken ibuprofen.  The patient reported that headache was on and off stemming from her neck into her head for a couple of weeks and taking ibuprofen for relief. Approximately 1 to 2 weeks after vaccination, the patient  reported a persistent rash developed on her back and shoulder that was red and bumpy and appears similar to acute dermatitis.  The patient was taking a 15-day course of prednisone, but reported that she still having rash as it had not completely subsided or cleared. The reporter consented to follow up. There was discrepancy in the onset date of the event tired and weak it was reported as 15th August 2019 and time to onset was given as 1 day, hence onset date was taken as 16th August 2019.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Malaise, Myalgia
Clinical narrative: Generalized Bodily Muscle Pain; Injection Site Redness; Pain at the injection site; Feeling Tired; Feeling Weak; Felt sick; acute dermatitis; Persistent rash developed on her back and shoulder that is red and bumpy; Shivers; Terrible Headache / headache was on and off stemming from her neck into her head; Stomach Pain; Persistent rash developed on her back and shoulder that is red and bumpy; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a day after receiving Shingrix, the patient experienced shivers, headache, stomach pain, erythropapular rash, dermatitis and red rash. On 16th August 2019, the patient experienced muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness and feeling unwell. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the shivers, headache, stomach pain, muscle pain, injection site erythema, tiredness and feelings of weakness were recovered/resolved and the outcome of the injection site pain was unknown and the outcome of the erythropapular rash, dermatitis and red rash were not recovered/not resolved and the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the shivers, headache, stomach pain, muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness, erythropapular rash, feeling unwell, dermatitis and red rash to be related to Shingrix.  Additional details were provided as follows: The patient receiving 2nd dose Shignrix in her left arm in the late afternoon and the next morning waking up with shivers followed by quick onset of a terrible headache and then stomach pains.  The patient also experienced generalized bodily muscle pain, redness and pain at the injection site, and feeling weak and tired.  The patient still felt sick but not as sick as the previous day and the patient had taken ibuprofen.  The patient reported that headache was on and off stemming from her neck into her head for a couple of weeks and taking ibuprofen for relief. Approximately 1 to 2 weeks after vaccination, the patient  reported a persistent rash developed on her back and shoulder that was red and bumpy and appears similar to acute dermatitis.  The patient was taking a 15-day course of prednisone, but reported that she still having rash as it had not completely subsided or cleared. The reporter consented to follow up. There was discrepancy in the onset date of the event tired and weak it was reported as 15th August 2019 and time to onset was given as 1 day, hence onset date was taken as 16th August 2019.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Generalized Bodily Muscle Pain; Injection Site Redness; Pain at the injection site; Feeling Tired; Feeling Weak; Felt sick; acute dermatitis; Persistent rash developed on her back and shoulder that is red and bumpy; Shivers; Terrible Headache / headache was on and off stemming from her neck into her head; Stomach Pain; Persistent rash developed on her back and shoulder that is red and bumpy; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a day after receiving Shingrix, the patient experienced shivers, headache, stomach pain, erythropapular rash, dermatitis and red rash. On 16th August 2019, the patient experienced muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness and feeling unwell. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the shivers, headache, stomach pain, muscle pain, injection site erythema, tiredness and feelings of weakness were recovered/resolved and the outcome of the injection site pain was unknown and the outcome of the erythropapular rash, dermatitis and red rash were not recovered/not resolved and the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the shivers, headache, stomach pain, muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness, erythropapular rash, feeling unwell, dermatitis and red rash to be related to Shingrix.  Additional details were provided as follows: The patient receiving 2nd dose Shignrix in her left arm in the late afternoon and the next morning waking up with shivers followed by quick onset of a terrible headache and then stomach pains.  The patient also experienced generalized bodily muscle pain, redness and pain at the injection site, and feeling weak and tired.  The patient still felt sick but not as sick as the previous day and the patient had taken ibuprofen.  The patient reported that headache was on and off stemming from her neck into her head for a couple of weeks and taking ibuprofen for relief. Approximately 1 to 2 weeks after vaccination, the patient  reported a persistent rash developed on her back and shoulder that was red and bumpy and appears similar to acute dermatitis.  The patient was taking a 15-day course of prednisone, but reported that she still having rash as it had not completely subsided or cleared. The reporter consented to follow up. There was discrepancy in the onset date of the event tired and weak it was reported as 15th August 2019 and time to onset was given as 1 day, hence onset date was taken as 16th August 2019.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on trunk; This case was reported by a nurse via call center representative and described the occurrence of rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bedridden and dementia.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 case details were reported as follows: The immunocompromised female patient with history of dementia received the first dose of Shingrix about 6 months ago, and afterwards she experienced a rash on her trunk.  The reporter described the rash as "white and pink bumps, could not say whether there was a head, and she had no other symptoms or pain, and it did not spread."  The nurse practitioner treated the rash with Valtrex, but stated it could have just been a heat rash. The reporter stated she could not provide further information. The reporter did not consented to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose decreased
Clinical narrative: decreased blood glucose levels; This case was reported by a consumer via call center representative and described the occurrence of blood glucose decreased in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included insulin nos (Insulin).   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced blood glucose decreased. On an unknown date, the outcome of the blood glucose decreased was not recovered/not resolved.   It was unknown if the reporter considered the blood glucose decreased to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's wife. The patient received Shingrix on left arm. Since receiving the vaccine, the patient's blood glucose levels had been lower than normal. The caller stated that the patient had not needed his normal doses of insulin since receiving the vaccine.  The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Local reaction, Pruritus, Urticaria
Clinical narrative: Reaction was itchy; Hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Fluzone (On 4th September 2019, received Fluzone 0.5 ml high dose 2019-2020, manufactured by Sanofi).   On 22nd September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd September 2019, couple of hours after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the hives and pruritus were recovering/resolving.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Singrix in the left arm. Approximately couple hours after vaccination, the patient had 1 small hive appeared around the area of injection and then spread about 5 inches on arm and continued to spread around arm from the front to the side of arm. The patient woke up the following morning and discovered noticeably more hives and then reports several little hives combined to form one large hive. It was localized reaction to upper arm. The patient reported that, the hives was itchy. The reporter stated that, reaction was slowly going away and that it was not as itchy. The patient stated that, simillar reaction occurred with Fluzone High Dose 2019-202 0.5 mL manufactured by Sanofi that was administered on 4th September 2019. The reporter wanted to compare and contrast ingredients in Shingrix and flu vaccine. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Water blister at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FJ59, expiry date 27th November 2021) for prophylaxis.   On 22nd September 2019, the patient received the 1st dose of Shingrix. On 22nd September 2019, couple of hours after receiving Shingrix, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was not recovered/not resolved.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 70 or 71 years. The reporter stated that, the patient developed a water blister at site of injection a couple hours after vaccination. The event was ongoing.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot injection site; Red injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient developed a hot, red injection site that lasted for 2 weeks. The patient did not consent to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 48.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; Inappropriate Age at Vaccine Administration; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 48-year-old male patient who received Herpes zoster (Shingrix) (batch number LS42K, expiry date 4th December 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and inappropriate age at vaccine administration. On an unknown date, the outcome of the pain in arm and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The reporter stated that, the patient who was 48 years old was given Shingrix, which led to inappropriate age at vaccine administration. The patient experienced sore arm after vaccination. No other details provided. The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Extensive swelling of vaccinated limb, Influenza like illness, Injection site discomfort
Clinical narrative: get redness five inches beyond the injection site with swelling; felt discomfort at the injection site; flu like symptoms; red; tingling; uncomfortable; area hurt / she felt pain during the injection; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 23rd September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination with dose of Shingrix, the patient experienced discomfort at the injection site and flu like symptoms, and on Monday afternoon, the arm was swelling, red and felt tingling and described it as an uncomfortable reaction. The patient stated that, did not experienced pain during injection with 1st dose, but felt pain with 2nd dose of Shingrix and it was uncomfortable. As the area hurt, the patient took Tylenol as an treatment medication. On 25th September 2019, the patient got redness five inches beyond the injection site with swelling and discomfort again. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: get redness five inches beyond the injection site with swelling; felt discomfort at the injection site; flu like symptoms; red; tingling; uncomfortable; area hurt / she felt pain during the injection; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 23rd September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site discomfort, influenza-like symptoms, erythema of extremities, tingling, discomfort and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination with dose of Shingrix, the patient experienced discomfort at the injection site and flu like symptoms, and on Monday afternoon, the arm was swelling, red and felt tingling and described it as an uncomfortable reaction. The patient stated that, did not experienced pain during injection with 1st dose, but felt pain with 2nd dose of Shingrix and it was uncomfortable. As the area hurt, the patient took Tylenol as an treatment medication. On 25th September 2019, the patient got redness five inches beyond the injection site with swelling and discomfort again. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site warmth, Laboratory test normal, Pain in extremity, Pyrexia
Clinical narrative: Fever; sore arm; hot site of injection; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, 1 days after receiving Shingrix, the patient experienced fever, pain in arm, injection site warmth and influenza-like symptoms. The patient was treated with ibuprofen (Advil). On 23rd September 2019, the outcome of the pain in arm, injection site warmth and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the fever was not recovered/not resolved.   The reporter considered the fever, pain in arm, injection site warmth and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. The patient had fever of 103.9 degree F. The patient had Advil as a treatment medication for fever, but it keeps popping up again. The patient stated that, all symptoms were resolved except fever. On the day of reporting, the patient had routine check up, but forgot to have temperature taken. All other test were normal. The patient consented to follow up.      Lab Comments: Unspecified laboratory test were normal.