chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Crying, Listless, Unresponsive to stimuli
Clinical narrative: After receiving her shots, my daughter cried, and then became listless. I placed her in her car seat, and was told to wait in the lobby for a few minutes. Once in the lobby, I took her out of her seat and tried to nurse her. At this time, she was completely unresponsive. She was breathing fine, but would not wake up or nurse or make any noise. I returned to the front desk and asked for assistance. Two nurses came to the door and took my daughter and I back to the exam room. They took her out of her car seat, and looked her over. They asked if she cried very hard after her shots, which she had, and that it was normal for them to be "sleepy" after their shots. This was not "sleepy", however, this was near catatonic.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Nervousness, Syncope
Clinical narrative: adverse event patient was nervous, fainted, laid patient down on bed check BP patient is better
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site reaction, Malaise, Rash macular
Clinical narrative: 24 hours after injection pt reported fatigue, soreness, blotchy areas at/near site of injection, also malaise, after 48 hours she feels a lot better, still a little fatigue and splotches are still visible on are
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of VARIVAX on 2/4/2020; This spontaneous report has been received from a pharmacy technician referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 04-FEB-2020, the patient was received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S019461, expiration date: 24-JUN-2021; frequency, route and dose details were unknown) for prophylaxis (product storage error). The sterile diluent used for reconstitution was properly stored.      The vaccine was stored between -14 degrees Celsius to -10 degrees Celsius for 2 hours 30 minutes and between -9 degrees Celsius to 8 degrees Celsius for 5 hours 40 minutes. There were no previous temperature excursions. The digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: severe itching at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe itching at injection site after receiving Shingrix
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: feeling tired today; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix. On 4th February 2020, 1 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The day before reporting, the patient received the 1st dose and felt tired on the reporting date. The patient asked how long might the side effects last.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Muscle twitching
Clinical narrative: We both feel like we have the flu; I have muscle twitching; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and muscle twitching. On an unknown date, the outcome of the influenza-like symptoms and muscle twitching were unknown.   It was unknown if the reporter considered the influenza-like symptoms and muscle twitching to be related to Shingrix.  Additional details were provided as follows: The patient felt like she had the flu and muscle twitching after receiving Shingrix. This case has been linked with case US2020AMR020739,reported by same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: We both feel like we have the flu; I have muscle twitching; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and muscle twitching. On an unknown date, the outcome of the influenza-like symptoms and muscle twitching were unknown.   It was unknown if the reporter considered the influenza-like symptoms and muscle twitching to be related to Shingrix.  Additional details were provided as follows: The patient felt like she had the flu and muscle twitching after receiving Shingrix. This case has been linked with case US2020AMR020739,reported by same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Muscle twitching
Clinical narrative: We both feel like we have the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was patients wife. The age at the vaccination was not reported. The patient felt like he had the flu after rceiving Shingrix. This case has been linked with case US2020AMR020727,reported by same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: We both feel like we have the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was patients wife. The age at the vaccination was not reported. The patient felt like he had the flu after rceiving Shingrix. This case has been linked with case US2020AMR020727,reported by same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: got a rash on my leg / spread to my upper legs and upper body; I use CeraVe with itch relief lotion which helps me get through the day and night; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included atorvastatin calcium (Statin (Atorvastatin Calcium)) for blood cholesterol increased.   The patient's past medical history included chickenpox (in 80s) and shingles (in 80s got shingles on forehead). Previously administered products included Pravastatin Sodium (received Pravastatin Sodium approximately 13 years before reporting date).   On an unknown date, the patient received the 1st dose of Shingrix and Statin (Atorvastatin Calcium) at an unknown dose and frequency. On an unknown date, less than a year after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced rash and pruritus. The patient was treated with cetirizine hydrochloride (Zyrtec) and emollients and protectives (Cerave). On an unknown date, the outcome of the rash and pruritus were unknown.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient got rash on leg after vaccination so did not get the second shot. The rash spread to upper legs and upper body. The patient was using CeraVe with itch relief lotion which help to get through the day and night. The patient stated that the dermatologist felt the rash was from a statin. The patient asked for the treatment of events.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Incomplete course of vaccination, Lethargy, Pain
Clinical narrative: fever; Chills; Body aches; extreme lethargy; exhaustion; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills, general body pain, lethargy, exhaustion and incomplete course of vaccination. On an unknown date, the outcome of the fever, chills, general body pain, lethargy and exhaustion were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, chills, general body pain, lethargy and exhaustion to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had the 1st dose in mid of April 2019. The patient experienced fever, chills, body aches and extreme lethargy and exhaustion after 1st vaccination. The patient was curious because the side effects were pretty bad and meant 36 hours of down time. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient asked If missed the 2 to 6 months window for my 2nd dose of Shingrix, do I have to get the 1st dose again and then get the 2nd dose within 2-6 months after that.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; Chills; Body aches; extreme lethargy; exhaustion; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills, general body pain, lethargy, exhaustion and incomplete course of vaccination. On an unknown date, the outcome of the fever, chills, general body pain, lethargy and exhaustion were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, chills, general body pain, lethargy and exhaustion to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had the 1st dose in mid of April 2019. The patient experienced fever, chills, body aches and extreme lethargy and exhaustion after 1st vaccination. The patient was curious because the side effects were pretty bad and meant 36 hours of down time. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient asked If missed the 2 to 6 months window for my 2nd dose of Shingrix, do I have to get the 1st dose again and then get the 2nd dose within 2-6 months after that.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Do I apply ice or heat to keep the sweeling down; This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose in October 2019 and experienced pain, refer case US2020AMR021474).   On 5th February 2020, the patient received the 2nd dose of Shingrix. On 5th February 2020, less than a day after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced swelling after vaccination. The patient asked to apply ice or heat to keep the swelling down.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I received in October of '19 still hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain after vaccination. For tolerance to 2nd dose, refer case US2020AMR021465.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Pyrexia
Clinical narrative: It's been long time ago for the first dose / But It should be 2 years from now; 2 after short feels like got flu; had fever (body temperature was 38°C),; This case was reported by a consumer via sales rep and described the occurrence of influenza like illness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 22nd May 2018, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza like illness and fever. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza like illness and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza like illness and fever to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The age at vaccination was not reported. Next day and day 2 after short feels like got flu, had fever (body temperature was 38 degree C), day3 and day 4 getting better and day 5 back to normal. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination.      Lab Comments: on an unknown date body temperature was recorded
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old 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 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 age at vaccination was not reported. The patient experienced injection site redness after receiving the Shingrix. The patient wanted to know how long could the redness at the injection site last.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Body aches; Headache; Fever 100; Painful injection site; This case was reported by a consumer via call center representative and described the occurrence of general body pain 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 general body pain, headache, fever and injection site pain. On an unknown date, the outcome of the general body pain, headache, fever and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, headache, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, after vaccination with Shingrix, experienced Body aches, headache, fever 100, painful injection site. The patient asked about how long side effects from shingrix to last.      Lab Comments: lab test performed on an unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles like rash on my arm vaccine was administered; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult 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 week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient received Shingrix on an unknown arm. The patient stated that, after vaccination experienced shingles like rash on arm  the vaccine administered. Rash was within a week after receiving the dose. At the time of reporting, the patient was due for 2nd dose of Shingrix and asked information to receive for 2nd immunization
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: soreness in the arm; redness in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix at about 11 am and still experiencing reddness and soreness in the arm 4 days after vaccination. The patient asked if it was normal.
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Electrocardiogram abnormal, Syncope
Clinical narrative: Syncope episode; This case was reported by a nurse via sales rep and described the occurrence of syncope in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   On 4th February 2020, the patient received the 1st dose of Shingrix and MMR vaccine. On 5th February 2020, 1 days after receiving Shingrix and MMR vaccine, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Shingrix and MMR vaccine.  Additional details were provided as follows: The age at vaccination was not reported, however he could be 52 or 53 years old at a time of vaccination. The patient received Shingrix on left deltoid and MMR vaccine on right deltoid. The patient had a syncope episode at the gym. The patient was seen in the emergency room (ER) and an EKG was done that showed some abnormalities.  The patient was sent home same day and an EKG was repeated in doctor's office the next day. The EKG had same findings. The patient was referred to cardiologist. According to the nurse reporting the incidence, no other side effects were reported. The reporter consented for follow up.      Lab Comments: On the day of syncope, the patient had Electrocardiogram (EKG), had some abnormal findings and was referred to cardiologist
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: hurt so much; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter asked  regarding why does it hurt so much. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Dermatoma rash along the nerve path; This case was reported by a nurse via call center representative and described the occurrence of rash in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   On 14th January 2020, the patient received Shingrix. In January 2020, 1 week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The patient experienced dermatoma rash along the nerve path after vaccination. The reporter asked how to proceed with 2nd dose and any information on the type of reaction lasting so long. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Rash at injection site; Lump at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash and injection site lump. On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site rash and injection site lump to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 59 or 60 years old. The patient received Shingrix 2 weeks before the date of reporting. The rash was appeared to be clearing up at the time of reporting. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Balance disorder, Chills, Erythema, Feeling abnormal
Clinical narrative: chills; joint pain; feel hot; feel hungry; nausea; foggy feeling; off balanced leaning to right; redness on face; This case was reported by a nurse via call center representative and described the occurrence of red face in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included disorder equilibrium.   On 4th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th February 2020, less than a day after receiving Shingrix, the patient experienced red face. On 5th February 2020, the patient experienced chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder. On an unknown date, the outcome of the red face, chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder were not recovered/not resolved.   It was unknown if the reporter considered the red face, chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient planned to follow up with his physician on an unknown date. The outcome of all the events were reported as not recovered/resolved in the database however in source document, it was mentioned as recovering/resolving. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Hunger, Nausea
Clinical narrative: chills; joint pain; feel hot; feel hungry; nausea; foggy feeling; off balanced leaning to right; redness on face; This case was reported by a nurse via call center representative and described the occurrence of red face in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included disorder equilibrium.   On 4th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th February 2020, less than a day after receiving Shingrix, the patient experienced red face. On 5th February 2020, the patient experienced chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder. On an unknown date, the outcome of the red face, chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder were not recovered/not resolved.   It was unknown if the reporter considered the red face, chills, joint pain, feeling hot, hunger, nausea, foggy feeling in head and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient planned to follow up with his physician on an unknown date. The outcome of all the events were reported as not recovered/resolved in the database however in source document, it was mentioned as recovering/resolving. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: flu-like symptoms; muscle ache; headache; shivering; tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 1st February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, headache, shivering and tiredness. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the influenza-like symptoms, muscle pain, headache, shivering and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, headache, shivering and tiredness to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix in the left arm. The reporter stated that by 2nd February 2020 after vaccination, the patient experienced flu-like symptoms which includes muscle ache, tiredness, headache and shivering who has been going on. The opatient received Tylenol and Advil as a treatment mediaction. No additional information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced shingles a couple of days after receiving the dose of Shingrix. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in the injection arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   On 28th January 2020, the patient received the 2nd dose of Shingrix. On 28th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient experienced pain in the injection arm after receiving the dose of Shingrix, that increased and continued until the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Malaise, Pyrexia
Clinical narrative: has a fever; and cannot move her arm where she received the injection; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female 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 fever, injected limb mobility decreased and feeling unwell. On an unknown date, the outcome of the fever, injected limb mobility decreased and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, injected limb mobility decreased and feeling unwell to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient had a fever and cannot move her arm where she received the vaccination.   The patient did not felt well. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: experienced hives on both of her legs; This case was reported by a nurse via call center representative and described the occurrence of hives in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 5G479, expiry date 23rd January 2021) for prophylaxis.   On 5th January 2020, the patient received the 1st dose of Shingrix. In January 2020, 30 hrs after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient experienced hives on both of her legs The reporter consented to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Feeling cold, Injection site pain, Myalgia
Clinical narrative: fever; chills /get so chilly; colder last night; it burned like hell when the needle was removed from his arm; pain in his left deltoid muscle when he moves; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of injection site pain (received a flu shot every year and would experience pain in his arm for 24 hours at the injection site but described the pain and experience as negligible and infrequent) and Vaccination with an associated reaction of feeling cold (in the army the patient would receive 5-6 vaccinations in one day and would get so chilly that he had to take a shower and the chills resolved). Concurrent medical conditions included drug allergy (from 55 years ago).   On 5th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, coldness and injection site burning. In February 2020, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain, coldness and injection site burning were unknown and the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fever, chills, coldness and injection site burning to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in his left deltoid muscle when he moved.   The patient also had a fever and chills that have resolved and he was colder on the day of vaccination than he usually was.   The patient reported that for years he has been hot in the morning and cold at night.   He also reported that upon receiving the injection, it burned like hell when the needle was removed from his arm but the burning sensation has resolved.   The reporter consented to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; chills /get so chilly; colder last night; it burned like hell when the needle was removed from his arm; pain in his left deltoid muscle when he moves; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of injection site pain (received a flu shot every year and would experience pain in his arm for 24 hours at the injection site but described the pain and experience as negligible and infrequent) and Vaccination with an associated reaction of feeling cold (in the army the patient would receive 5-6 vaccinations in one day and would get so chilly that he had to take a shower and the chills resolved). Concurrent medical conditions included drug allergy (from 55 years ago).   On 5th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, coldness and injection site burning. In February 2020, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain, coldness and injection site burning were unknown and the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fever, chills, coldness and injection site burning to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in his left deltoid muscle when he moved.   The patient also had a fever and chills that have resolved and he was colder on the day of vaccination than he usually was.   The patient reported that for years he has been hot in the morning and cold at night.   He also reported that upon receiving the injection, it burned like hell when the needle was removed from his arm but the burning sensation has resolved.   The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Dizziness, Fatigue
Clinical narrative: weak; blood pressure was 81/65 (hypotensive); pulse rate 120; fatigued; nasal congestion; chills; temperature 100.3; mild nausea; headache; felt awful; felt like passing out; This case was reported by a physician via call center representative and described the occurrence of weakness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 1 days after receiving Shingrix, the patient experienced weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the weakness and headache were not recovered/not resolved and the outcome of the hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, feels awful and felt faint were recovering/resolving.   It was unknown if the reporter considered the weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix in the left deltoid. On 5th Nevember 2019 at 11:30am, the patient received vaccine and on 6th November 2019, the patient reported that felt awful and felt like passing out, weak, blood pressure was 81 and 65 (hypotensive), pulse rate 120, fatigued, chills, temperature 100.3, mild nausea, headache, nasal congestion, extremely weak. The patient had blood pressure 81 and 65, body temperature was 100.3 and pulse rate 120. The patient received Tylenol as a treatment medication. In about 6 hours after vaccination, the patient felt better with some weakness and headache. No additional information provided. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Heart rate increased, Hypotension, Nasal congestion
Clinical narrative: weak; blood pressure was 81/65 (hypotensive); pulse rate 120; fatigued; nasal congestion; chills; temperature 100.3; mild nausea; headache; felt awful; felt like passing out; This case was reported by a physician via call center representative and described the occurrence of weakness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 1 days after receiving Shingrix, the patient experienced weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the weakness and headache were not recovered/not resolved and the outcome of the hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, feels awful and felt faint were recovering/resolving.   It was unknown if the reporter considered the weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix in the left deltoid. On 5th Nevember 2019 at 11:30am, the patient received vaccine and on 6th November 2019, the patient reported that felt awful and felt like passing out, weak, blood pressure was 81 and 65 (hypotensive), pulse rate 120, fatigued, chills, temperature 100.3, mild nausea, headache, nasal congestion, extremely weak. The patient had blood pressure 81 and 65, body temperature was 100.3 and pulse rate 120. The patient received Tylenol as a treatment medication. In about 6 hours after vaccination, the patient felt better with some weakness and headache. No additional information provided. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: weak; blood pressure was 81/65 (hypotensive); pulse rate 120; fatigued; nasal congestion; chills; temperature 100.3; mild nausea; headache; felt awful; felt like passing out; This case was reported by a physician via call center representative and described the occurrence of weakness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 1 days after receiving Shingrix, the patient experienced weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the weakness and headache were not recovered/not resolved and the outcome of the hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, feels awful and felt faint were recovering/resolving.   It was unknown if the reporter considered the weakness, hypotension, pulse increased, fatigue, nasal congestion, chills, body temperature increased, nausea, headache, feels awful and felt faint to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix in the left deltoid. On 5th Nevember 2019 at 11:30am, the patient received vaccine and on 6th November 2019, the patient reported that felt awful and felt like passing out, weak, blood pressure was 81 and 65 (hypotensive), pulse rate 120, fatigued, chills, temperature 100.3, mild nausea, headache, nasal congestion, extremely weak. The patient had blood pressure 81 and 65, body temperature was 100.3 and pulse rate 120. The patient received Tylenol as a treatment medication. In about 6 hours after vaccination, the patient felt better with some weakness and headache. No additional information provided. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was resolved with sequelae.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine about 2 and half months ago from reporting date and developed muscle pain about 12 hours after that dose. The muscle pain lasted for a day and a half  and then resolved. The reporter did not consent to follow up. This case was 1 of 3 cases reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Myalgia
Clinical narrative: immediate injection site pain; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 3rd February 2020, immediately after receiving Shingrix, the patient experienced injection site pain and muscle pain. On 4th February 2020, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose 2 and had immediate injection site pain that was still ongoing at the time of reporting.  The patient developed muscle pain with in a few hours of the second dose and that was resolved. The reporter did not consent to follow-up. This is 1 of 3 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose 1 of Shingrix and developed diarrhea that lasted for three months.  The reporter stated that it had resolved at the time of reporting. The reporter did not consent to follow-up. This is 1 of 3 case reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema
Clinical narrative: chills; fatigue; The injection was also red; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced chills, fatigue and injection site erythema. On an unknown date, the outcome of the chills, fatigue and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the chills, fatigue and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient had the 1st dose on either 15th October 2019 or 16th October 2019. The patient experienced chills and fatigue for a few days and the injection site was also red for a few days. The reporter did not consent to follow up.