chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Musculoskeletal pain
Clinical narrative: Drug dose administration interval too long; Soreness at injection site; Shoulder soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal pain (received 1st dose in March 2019, refer case US2020032232).   On 19th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and shoulder soreness. On 19th February 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and shoulder soreness were recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain and shoulder soreness to be related to Shingrix.  Additional case details were reported as follows: The patient received the 2nd dose and experienced soreness at the injection site and soreness in her right shoulder. On 19th February 2020, the patient received the 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The patient was prescribed methotrexate and she wants to know if she can take it Informed patient that immunosuppressive therapies may reduce the effectiveness of Shingrix, referred patient to her healthcare professional. The patient consented to follow up.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: mild pain injection site; severe pain in her left knee when walking / right knee; severe pain in her left knee when walking / right knee/ severe pain/felt it was a reaction to the vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October 2019, for tolerance refer case US2020034267).   On 2nd December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 2 days after receiving Shingrix, the patient experienced injection site pain, knee pain and pain upon movement. The patient was treated with ibuprofen (Advil), naproxen (Aleve), paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the knee pain and pain upon movement were recovered/resolved.   It was unknown if the reporter considered the injection site pain, knee pain and pain upon movement to be related to Shingrix.  Additional details were received as follows: The patient reported for herself. The patient reported that, she was very active, plays tennis and does aerobics, she walks and jogs every day and was very healthy. She was not on any medications. The patient received Shingrix injection in left arm and experienced mild pain at the injection site.  Ten days later, she experienced a sudden onset of severe pain in her left knee when walking but had no pain when she stood still. She reported, there was no swelling or pain to touch to the knee. After this, 24 hours later she experienced the same sudden onset of severe pain in her right knee. She stated that, icing the sites or taking Advil, Aleve or Tylenol did not help with the pain.  Three days later, the pain in her left knee resolved and five days later the pain in her right knee resolved.  In the last week of reporting, she saw her primary doctor and orthopedic doctor and nothing was found but they felt it was a reaction to the vaccine.  A few days ago of the reporting date, her both knees simultaneously developed the severe pain which lasted three days and then it resolved, no swelling was noted. The patient consented to follow up and also provided her physician's contact details.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: currently believe that I have shingles, and have just had the first injection of singrex; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week 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 applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles. The reporter asked would that mitigate the shingles rashes and what other effects might arise from this situation.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Hyperacusis, Hyperhidrosis
Clinical narrative: thought I had flu together with shingrix reaction; woke up in the middle of the night with chills; massive HEADACHE; sweats; sensitivity to light; sensitivity to noise; terrible body ache / body's ache from head to toe; Felt as bad as a bad/ felt like hit by truck; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1sy dose on an unknown date, refer case US2020AMR035745).   On 23rd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient woke up in the middle of the night of vaccination day with chills, then sweats, massive headache, sensitivity to light and noise and terrible body ache. The patient felt as bad as a bad case of the flu.  The patient was in the bed most of the day sick. The patient thought the patient had flu together with Shingrix reaction. On the day of reporting, the patient did not feel well for a second day with headache and body ache. The patient stated the patient's reactions were Grade 3+++ and the patient do not miss work often for illness and was in bed terribly sick. The patient stated that the vaccine made the patient extremely ill for 2 days. The patient still had chills and headache and body's ache from head to toe. The patient felt like the patient was hit by a truck.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Photophobia
Clinical narrative: thought I had flu together with shingrix reaction; woke up in the middle of the night with chills; massive HEADACHE; sweats; sensitivity to light; sensitivity to noise; terrible body ache / body's ache from head to toe; Felt as bad as a bad/ felt like hit by truck; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1sy dose on an unknown date, refer case US2020AMR035745).   On 23rd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, headache, sweating, photophobia, sound sensitivity increased, general body pain and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient woke up in the middle of the night of vaccination day with chills, then sweats, massive headache, sensitivity to light and noise and terrible body ache. The patient felt as bad as a bad case of the flu.  The patient was in the bed most of the day sick. The patient thought the patient had flu together with Shingrix reaction. On the day of reporting, the patient did not feel well for a second day with headache and body ache. The patient stated the patient's reactions were Grade 3+++ and the patient do not miss work often for illness and was in bed terribly sick. The patient stated that the vaccine made the patient extremely ill for 2 days. The patient still had chills and headache and body's ache from head to toe. The patient felt like the patient was hit by a truck.
Age: 57.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: muscle aches throughout my body and hip and ankle joints; Injection site was also painful; severe headache; stuffy nose; mild fever; tinnitus; chills; Daily living activity impaired; This case was reported by a consumer and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date unknown) and (batch number 4Z432, expiry date unknown) for prophylaxis.   On 25th February 2020 09:30, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In February 2020, less than a day after receiving Shingrix, the patient experienced activities of daily living impaired. On 25th February 2020, the patient experienced fever, tinnitus and chills. On 25th February 2020 12:00, the patient experienced headache and nasal stuffiness. On 25th February 2020 18:00, the patient experienced muscle pain and injection site pain. The patient was treated with ibuprofen and atorvastatin. On 26th February 2020, the outcome of the headache, fever and chills were recovered/resolved and the outcome of the muscle pain and injection site pain were not recovered/not resolved. On an unknown date, the outcome of the nasal stuffiness was not recovered/not resolved and the outcome of the tinnitus was recovering/resolving and the outcome of the activities of daily living impaired was unknown.   The reporter considered the headache, nasal stuffiness, muscle pain, injection site pain, fever, tinnitus, chills and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received the intramuscular injection of the vaccine on 25th February 2020 at 9:30am. By 12pm, the patient had severe a headache and stuffy nose. By 6pm, the patient had muscle aches throughout the body and hip and ankle joints. The Injection site was also painful (but not swollen), the night following the injection the symptoms persisted and patient had mild fever and tinnitus. The symptoms were severe enough to prevent him from going to work on next day of vaccination. On 26th February 2020 morning, headache resolved. The muscle aches, injection site pain, plus chills & mild fever persist. Tinnitus has reduced in intensity but not resolved as of this time. Symptoms were managed using Ibuprofen 400 to 600mg, q 6 to 8 hours. The patient was not taking any other medication except for Atorvastatin 10mg daily. The reporter consented to follow up.
Age: 57.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Nasal congestion, Pyrexia, Tinnitus
Clinical narrative: muscle aches throughout my body and hip and ankle joints; Injection site was also painful; severe headache; stuffy nose; mild fever; tinnitus; chills; Daily living activity impaired; This case was reported by a consumer and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date unknown) and (batch number 4Z432, expiry date unknown) for prophylaxis.   On 25th February 2020 09:30, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In February 2020, less than a day after receiving Shingrix, the patient experienced activities of daily living impaired. On 25th February 2020, the patient experienced fever, tinnitus and chills. On 25th February 2020 12:00, the patient experienced headache and nasal stuffiness. On 25th February 2020 18:00, the patient experienced muscle pain and injection site pain. The patient was treated with ibuprofen and atorvastatin. On 26th February 2020, the outcome of the headache, fever and chills were recovered/resolved and the outcome of the muscle pain and injection site pain were not recovered/not resolved. On an unknown date, the outcome of the nasal stuffiness was not recovered/not resolved and the outcome of the tinnitus was recovering/resolving and the outcome of the activities of daily living impaired was unknown.   The reporter considered the headache, nasal stuffiness, muscle pain, injection site pain, fever, tinnitus, chills and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received the intramuscular injection of the vaccine on 25th February 2020 at 9:30am. By 12pm, the patient had severe a headache and stuffy nose. By 6pm, the patient had muscle aches throughout the body and hip and ankle joints. The Injection site was also painful (but not swollen), the night following the injection the symptoms persisted and patient had mild fever and tinnitus. The symptoms were severe enough to prevent him from going to work on next day of vaccination. On 26th February 2020 morning, headache resolved. The muscle aches, injection site pain, plus chills & mild fever persist. Tinnitus has reduced in intensity but not resolved as of this time. Symptoms were managed using Ibuprofen 400 to 600mg, q 6 to 8 hours. The patient was not taking any other medication except for Atorvastatin 10mg daily. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Headache; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache and muscle pain. On an unknown date, the outcome of the headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and muscle pain 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 an adult as per vaccine indication.  The patient received Shingrix vaccine and had headache and muscle pain. The reporter inquired how long did headache and muscle pain lasted after receiving vaccine for shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental underdose, Erythema, Musculoskeletal pain, Swelling
Clinical narrative: shoulder pain; swelling; REDNESS; Pt. jerked away and incomplete dose was injected.; This case was reported by a other health professional via sales rep and described the occurrence of shoulder pain in a 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 shoulder pain, swelling, erythema and accidental underdose. On an unknown date, the outcome of the shoulder pain, swelling, erythema and accidental underdose were unknown.   It was unknown if the reporter considered the shoulder pain, swelling and erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient jerked away and incomplete dose was injected, which led to accidental underdose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise
Clinical narrative: had a rash at the injection site; felt ill for a day; This case was reported by a consumer and described the occurrence of malaise in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise and injection site rash. On an unknown date, the outcome of the malaise and injection site rash were recovered/resolved.   It was unknown if the reporter considered the malaise and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt ill for a day and had a rash at the injection site. This case has been linked to US2020AMR042562 and US2020AMR042566, reported by the same reporter. This case has been linked to the case US2020AMR042562, reported for the same patient (2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise
Clinical narrative: rash at the injection site; felt ill for a day; This case was reported by a consumer and described the occurrence of injection site rash in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (1st dose, refer case US2020AMR042554).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site rash and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt ill for a day and had a rash at the injection site. This case has been linked to US2020AMR042554 and US2020AMR042566, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt ill for a day; This case was reported by a consumer and described the occurrence of feeling unwell in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt ill for a day. For tolerance of 2nd dose of Shingrix, refer case US2020AMR042566. This case has been linked to US2020AMR042554 and US2020AMR042562, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt ill for a day; This case was reported by a consumer and described the occurrence of feeling unwell in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose, refer case US2020AMR042565).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt ill for a day. This case has been linked to US2020AMR042554 and US2020AMR042562, reported by the same reporter.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Balance disorder, Blepharospasm, Fatigue, Feeling abnormal
Clinical narrative: left eye spasm; developed a rash; it is itchy; an increased in her heart rate; headache; extremely tired; a fever of 100.6,; sore arm; sweating; upset stomach; feeling off; her balance is off; This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in October 2019 and experienced events, refer case US2020028114).   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder. On 18th February 2020, the patient experienced itchy rash, red rash and heart rate increased. On 19th February 2020, the patient experienced blepharospasm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash, red rash and blepharospasm were not recovered/not resolved and the outcome of the heart rate increased, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder were recovered/resolved.   It was unknown if the reporter considered the itchy rash, red rash, heart rate increased, blepharospasm, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient developed a rash as one bump below the injection site as a red streak and it is itchy after vaccination. The patient also experienced a left eye spasm. The other side effects she reported included a headache, extremely tired, sore arm, sweating, a fever of 100.6, upset stomach, feeling off, and her balance was off. The patient also experienced increased in heart rate after vaccination. The patient consented to follow up.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: left eye spasm; developed a rash; it is itchy; an increased in her heart rate; headache; extremely tired; a fever of 100.6,; sore arm; sweating; upset stomach; feeling off; her balance is off; This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in October 2019 and experienced events, refer case US2020028114).   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder. On 18th February 2020, the patient experienced itchy rash, red rash and heart rate increased. On 19th February 2020, the patient experienced blepharospasm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash, red rash and blepharospasm were not recovered/not resolved and the outcome of the heart rate increased, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder were recovered/resolved.   It was unknown if the reporter considered the itchy rash, red rash, heart rate increased, blepharospasm, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient developed a rash as one bump below the injection site as a red streak and it is itchy after vaccination. The patient also experienced a left eye spasm. The other side effects she reported included a headache, extremely tired, sore arm, sweating, a fever of 100.6, upset stomach, feeling off, and her balance was off. The patient also experienced increased in heart rate after vaccination. The patient consented to follow up.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: left eye spasm; developed a rash; it is itchy; an increased in her heart rate; headache; extremely tired; a fever of 100.6,; sore arm; sweating; upset stomach; feeling off; her balance is off; This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in October 2019 and experienced events, refer case US2020028114).   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder. On 18th February 2020, the patient experienced itchy rash, red rash and heart rate increased. On 19th February 2020, the patient experienced blepharospasm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash, red rash and blepharospasm were not recovered/not resolved and the outcome of the heart rate increased, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder were recovered/resolved.   It was unknown if the reporter considered the itchy rash, red rash, heart rate increased, blepharospasm, headache, tiredness, fever, pain in arm, sweating, upset stomach, feeling abnormal and balance disorder to be related to Shingrix.  Additional case details were reported as follows: The patient developed a rash as one bump below the injection site as a red streak and it is itchy after vaccination. The patient also experienced a left eye spasm. The other side effects she reported included a headache, extremely tired, sore arm, sweating, a fever of 100.6, upset stomach, feeling off, and her balance was off. The patient also experienced increased in heart rate after vaccination. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: mild case of shingles; This case was reported by a consumer and described the occurrence of shingles in a 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 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   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 received the first dose of Shingrix. Prior to receiving the 2nd dose, the patient developed a mild case of shingles which had almost but not quite resolved. the patient's deadline (6 months) for the 2nd shot is a week away. The patient had a concern that, should they go ahead with the 2nd dose? Patient's primary care Dr. was uncertain. If the patient's didn't get the 2nd dose, do they start over when they shingles was completely resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Musculoskeletal stiffness
Clinical narrative: Stiffness in shoulders and neck area; Some upset stomach problems; This case was reported by a consumer via call center representative and described the occurrence of musculoskeletal stiffness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced musculoskeletal stiffness and upset stomach. On an unknown date, the outcome of the musculoskeletal stiffness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the musculoskeletal stiffness and upset stomach 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 adult as per vaccine indication. The patient had stiffness in shoulders and neck area plus some upset stomach problems.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: Feeling crappy; Flu like symptoms; HEADACHE; FATIGUE; UPSET STOMACH; Injection site reactions; CHILLS; Arm is still red / redness; arm is still red and a little swollen; no appetite; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix. On 15th February 2020, less than a day after receiving Shingrix, the patient experienced headache, fatigue, upset stomach, injection site reaction, chills, erythema of extremities and swelling arm. In February 2020, the patient experienced appetite absent. On 19th February 2020, the patient experienced influenza-like symptoms. On 20th February 2020, the patient experienced feeling bad. On an unknown date, the outcome of the headache, fatigue, upset stomach and chills were recovered/resolved and the outcome of the injection site reaction was not recovered/not resolved and the outcome of the erythema of extremities and swelling arm were recovering/resolving and the outcome of the influenza-like symptoms, appetite absent and feeling bad were unknown.   It was unknown if the reporter considered the headache, fatigue, upset stomach, injection site reaction, chills, erythema of extremities, swelling arm, influenza-like symptoms, appetite absent and feeling bad to be related to Shingrix.  Additional details were provided as follows: At 9:00 am, the patient received the vaccine in left arm.  The patient had headache, fatigue, upset stomach and injection site reactions presented that afternoon. The chills presented that evening. The symptoms resolved by Sunday evening except that the arm was still red and a little swollen. The redness was the size of an orange the first day and on 18th February 2020, the size of a 50 cent piece. The patient said that symptoms were resolving. On 19th and 20th February 2020, 4 days after receiving Shingrix, the patient had flu like symptoms. The patient did not like the side effect of Shingrix. The patient was not going to receive 2nd dose of Shingrix for another 6 months because the patient did not like the way it feels. On day 5, the patient was feeling good for couple of days but again feeling crappy.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Injection site reaction, Peripheral swelling
Clinical narrative: Feeling crappy; Flu like symptoms; HEADACHE; FATIGUE; UPSET STOMACH; Injection site reactions; CHILLS; Arm is still red / redness; arm is still red and a little swollen; no appetite; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix. On 15th February 2020, less than a day after receiving Shingrix, the patient experienced headache, fatigue, upset stomach, injection site reaction, chills, erythema of extremities and swelling arm. In February 2020, the patient experienced appetite absent. On 19th February 2020, the patient experienced influenza-like symptoms. On 20th February 2020, the patient experienced feeling bad. On an unknown date, the outcome of the headache, fatigue, upset stomach and chills were recovered/resolved and the outcome of the injection site reaction was not recovered/not resolved and the outcome of the erythema of extremities and swelling arm were recovering/resolving and the outcome of the influenza-like symptoms, appetite absent and feeling bad were unknown.   It was unknown if the reporter considered the headache, fatigue, upset stomach, injection site reaction, chills, erythema of extremities, swelling arm, influenza-like symptoms, appetite absent and feeling bad to be related to Shingrix.  Additional details were provided as follows: At 9:00 am, the patient received the vaccine in left arm.  The patient had headache, fatigue, upset stomach and injection site reactions presented that afternoon. The chills presented that evening. The symptoms resolved by Sunday evening except that the arm was still red and a little swollen. The redness was the size of an orange the first day and on 18th February 2020, the size of a 50 cent piece. The patient said that symptoms were resolving. On 19th and 20th February 2020, 4 days after receiving Shingrix, the patient had flu like symptoms. The patient did not like the side effect of Shingrix. The patient was not going to receive 2nd dose of Shingrix for another 6 months because the patient did not like the way it feels. On day 5, the patient was feeling good for couple of days but again feeling crappy.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness, Osteoarthritis, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Two unspecified bones in the shoulder were rubbing together; Weakness of the arm; cannot lift anything; pain and numbness in the entire arm; pain and numbness in the entire arm; Injection was given in the left arm, about 7 inches below the shoulder, and not into the deltoid; This case was reported by a consumer via call center representative and described the occurrence of osteoarthritis in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 15th November 2019, less than a week after receiving Shingrix, the patient experienced osteoarthritis, weakness of arms, weight bearing difficulty, pain in arm, numbness of upper extremities and vaccine administered at inappropriate site. On an unknown date, the outcome of the osteoarthritis, weakness of arms and vaccine administered at inappropriate site were unknown and the outcome of the weight bearing difficulty, pain in arm and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the osteoarthritis, weakness of arms, weight bearing difficulty, pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were received as follows: The case was reported by daughter of the patient. The patient received dose 1 of Shingrix and the injection was given in the left arm, about 7 inches below the shoulder, and not into the deltoid, which led to vaccine administered at inappropriate site.   The patient had experienced weakness of the arm, and could not lift anything. The patient was also experiencing pain and numbness in the entire arm.   The patient was seen by a physician who order X-Rays.  The results showed that two unspecified bones in the shoulder were rubbing together, and the patient was referred to an orthopedist. The reporter consented to follow up.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Weight bearing difficulty, X-ray limb abnormal
Clinical narrative: Two unspecified bones in the shoulder were rubbing together; Weakness of the arm; cannot lift anything; pain and numbness in the entire arm; pain and numbness in the entire arm; Injection was given in the left arm, about 7 inches below the shoulder, and not into the deltoid; This case was reported by a consumer via call center representative and described the occurrence of osteoarthritis in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 15th November 2019, less than a week after receiving Shingrix, the patient experienced osteoarthritis, weakness of arms, weight bearing difficulty, pain in arm, numbness of upper extremities and vaccine administered at inappropriate site. On an unknown date, the outcome of the osteoarthritis, weakness of arms and vaccine administered at inappropriate site were unknown and the outcome of the weight bearing difficulty, pain in arm and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the osteoarthritis, weakness of arms, weight bearing difficulty, pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were received as follows: The case was reported by daughter of the patient. The patient received dose 1 of Shingrix and the injection was given in the left arm, about 7 inches below the shoulder, and not into the deltoid, which led to vaccine administered at inappropriate site.   The patient had experienced weakness of the arm, and could not lift anything. The patient was also experiencing pain and numbness in the entire arm.   The patient was seen by a physician who order X-Rays.  The results showed that two unspecified bones in the shoulder were rubbing together, and the patient was referred to an orthopedist. The reporter consented to follow up.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Mobility decreased, Nausea, Pain
Clinical narrative: body aches / could not move her body because of the body aches; chills; nausea; could not sleep; could not move body; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included exposure to communicable disease (patient was exposed to tuberculosis).   On 18th February 2020, the patient received Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced general body pain, chills, nausea, difficulty sleeping and mobility decreased. On an unknown date, the outcome of the general body pain was not recovered/not resolved and the outcome of the chills, nausea, difficulty sleeping and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the general body pain, chills, nausea, difficulty sleeping and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. The patient experienced body aches, chills, nausea, could not move her body because of the body aches and for two days, and she could not sleep. On 21st February 2020, the patient feeling much better, but she continued to experience body aches. The patient was exposed to a patient who had tuberculosis and would like to get herself tested for tuberculosis. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: losing more hair; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hair loss.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had noticed that she was losing more hair after receiving the Shingrix vaccine. The reporter was unwilling to provide any additional details.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rhinorrhoea, Sneezing
Clinical narrative: Incomplete course of vaccination; sneezing; running nose; This case was reported by a consumer via call center representative and described the occurrence of sneezing in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 24th February 2020, 410 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sneezing and runny nose. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the sneezing, runny nose and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sneezing and runny nose to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 59 or 60 years. The patient received the first dose of the Shingrix vaccine and now she was due for the second dose of the Shingrix vaccine, but the patient was experiencing sneezing with running nose symptoms.  No additional information provided.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: pain in his left thigh area; Tingling sensation in thigh; This case was reported by a consumer via call center representative and described the occurrence of pain in thigh in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 1st dose of Shingrix. On 31st January 2020, 1 days after receiving Shingrix, the patient experienced pain in thigh and tingling of extremity. On an unknown date, the outcome of the pain in thigh and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the pain in thigh and tingling of extremity to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient started to experienced pain in his left thigh area with some tingling sensation. The patient stated that he had gone for massages and chiropractic manipulations and this pain did not resolved. The patient was stating that the pain get worsen with extended standing. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: redness at the site; redness at the site which was itchy; Low grade fever; had "a possible allergic reaction,"; redness spread further on the arm; The area looked ike a bruise,; warm to touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received the 1st dose of Shingrix. On 18th February 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site itching, low grade fever, allergic reaction, erythema of extremities, injection site bruising and injection site warmth. On 19th February 2020, the outcome of the injection site itching was resolved with sequelae. On an unknown date, the outcome of the injection site erythema, low grade fever, allergic reaction, erythema of extremities, injection site bruising and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, low grade fever, allergic reaction, erythema of extremities, injection site bruising and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and the next day had a possible allergic reaction, further described as redness at the site which was itchy, the area looked like a bruise, it was warm to touch, and she also experienced a low grade fever.  The redness spread further on the arm the patient The itching had resolved.  The reporter would classify the reaction as mild. The follow up consent was granted. .
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: redness at the site; redness at the site which was itchy; Low grade fever; had "a possible allergic reaction,"; redness spread further on the arm; The area looked ike a bruise,; warm to touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received the 1st dose of Shingrix. On 18th February 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site itching, low grade fever, allergic reaction, erythema of extremities, injection site bruising and injection site warmth. On 19th February 2020, the outcome of the injection site itching was resolved with sequelae. On an unknown date, the outcome of the injection site erythema, low grade fever, allergic reaction, erythema of extremities, injection site bruising and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, low grade fever, allergic reaction, erythema of extremities, injection site bruising and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and the next day had a possible allergic reaction, further described as redness at the site which was itchy, the area looked like a bruise, it was warm to touch, and she also experienced a low grade fever.  The redness spread further on the arm the patient The itching had resolved.  The reporter would classify the reaction as mild. The follow up consent was granted. .