chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Influenza, Mobility decreased, Neurological symptom, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, between 1 and 3 months after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, Guillain Barre syndrome (serious criteria GSK medically significant), tingling of extremity and neurological symptom. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, Guillain Barre syndrome, tingling of extremity and neurological symptom were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza, Guillain Barre syndrome, tingling of extremity and neurological symptom to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. In October approximately 20 years before the date of reporting, the patient stated that she received a flu vaccine (unknown manufacturer). In December, between 1 and 3 months after receiving the flu vaccine (unknown manufacturer), the patient developed the flu. The patient stated that shortly after the flu resolved, she started having neurological symptoms such as tingling in her arm and trouble moving her fingers on the computer. These symptoms started in January of the following year (3 months after receiving the flu vaccine). The patient stated that she saw a neurologist and the neurologist informed her that she might have a mild case of Guillain Barre Syndrome. The neurological symptoms and Guillain Barre Syndrome resolved 3 to 4 months later. The patient stated that she no longer got the flu vaccine. The patient had denied permission to contact their physician. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, between 1 and 3 months after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, Guillain Barre syndrome (serious criteria GSK medically significant), tingling of extremity and neurological symptom. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, Guillain Barre syndrome, tingling of extremity and neurological symptom were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza, Guillain Barre syndrome, tingling of extremity and neurological symptom to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. In October approximately 20 years before the date of reporting, the patient stated that she received a flu vaccine (unknown manufacturer). In December, between 1 and 3 months after receiving the flu vaccine (unknown manufacturer), the patient developed the flu. The patient stated that shortly after the flu resolved, she started having neurological symptoms such as tingling in her arm and trouble moving her fingers on the computer. These symptoms started in January of the following year (3 months after receiving the flu vaccine). The patient stated that she saw a neurologist and the neurologist informed her that she might have a mild case of Guillain Barre Syndrome. The neurological symptoms and Guillain Barre Syndrome resolved 3 to 4 months later. The patient stated that she no longer got the flu vaccine. The patient had denied permission to contact their physician. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received the 2nd dose of Shingrix. On 11th September 2018, 1 days after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown. It was unknown if the reporter considered the pruritus to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix on an unknown arm. The patient reported itching on her chest.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old female patient who received Shingrix (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 12th August 2018, the patient received the 1st dose of Shingrix (subcutaneous). On 12th August 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain and pruritus to be related to Shingrix. Additional details were provided as follows: The healthcare professional stated that the patient was given a dose of Shingrix subcutaneously, which led to Incorrect route of drug administration. Soreness and itching lasted for 1 day. No further details was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On 31st August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. The reporter stated to the representative that she was contacted by a nurse from a nursing home. The only information that was provided was that the patient experienced arm pain. This case has been linked with US2018166437 and US2018166446, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 53-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site lump and injection site warmth. The patient was treated with Tylenol. On an unknown date, the outcome of the injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump and injection site warmth to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported, however it could be 52 or 53 years. The patient received Shingrix on left arm. The reporter noted that the patient had a lump at the injection site the size of a golf ball. The area was warm to the touch. The reporter recommended treating the area with ice and Tylenol. This was all the information that was provided for the report. This case has been linked with US2018166437 and US2018166443, reported by same reporter.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly male patient who received Shingrix for prophylaxis. On 31st July 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient developed a case of shingles. The HCP did not have lot number or expiry date.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Headache, Movement disorder, Neck pain, Posture abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neck pain in a 17-year-old female patient who received Bexsero (batch number 16B601, expiry date 1st February 2019) for prophylaxis. On 11th September 2018, the patient received the 2nd dose of Bexsero. On 11th September 2018, less than a day after receiving Bexsero, the patient experienced neck pain, movement disorder, skin warm, back pain and headache. On an unknown date, the outcome of the neck pain, movement disorder, skin warm, back pain and headache were not recovered/not resolved. It was unknown if the reporter considered the neck pain, movement disorder, skin warm, back pain and headache to be related to Bexsero. Additional information was received as follows: The healthcare professional reported that at 3:15 pm, the patient received the dose of Bexsero. By the end of the vaccination day the patient experienced a reaction such as headache, neck ache, backache, warm to touch and difficulty to keeping head up. The healthcare professional would like to know if these were common reactions. The reporter's call was transferred to MES for guidelines.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neck pain in a 17-year-old female patient who received Bexsero (batch number 16B601, expiry date 1st February 2019) for prophylaxis. On 11th September 2018, the patient received the 2nd dose of Bexsero. On 11th September 2018, less than a day after receiving Bexsero, the patient experienced neck pain, movement disorder, skin warm, back pain and headache. On an unknown date, the outcome of the neck pain, movement disorder, skin warm, back pain and headache were not recovered/not resolved. It was unknown if the reporter considered the neck pain, movement disorder, skin warm, back pain and headache to be related to Bexsero. Additional information was received as follows: The healthcare professional reported that at 3:15 pm, the patient received the dose of Bexsero. By the end of the vaccination day the patient experienced a reaction such as headache, neck ache, backache, warm to touch and difficulty to keeping head up. The healthcare professional would like to know if these were common reactions. The reporter's call was transferred to MES for guidelines.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site pain, Injection site swelling, Injection site urticaria, Wrong product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received BOOSTRIX (batch number X9YP3, expiry date 2nd October 2020) for prophylaxis. On 12th September 2018, the patient received BOOSTRIX (intradermal). On 12th September 2018, several hours after receiving BOOSTRIX, the patient experienced injection site pain, injection site swelling, injection site wheal, wrong vaccine administered and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site wheal were not recovered/not resolved and the outcome of the wrong vaccine administered and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site wheal to be related to BOOSTRIX. Additional details were provided as follows: The health care professional reported patient was administered a dose of BOOSTRIX Intradermally, which led to inappropriate route of vaccination. The patient was supposed to receive the TB test instead of BOOSTRIX, which led to wrong vaccine administered. The patient developed a welt on the forearm that was swollen and hurting several hours later on that same day. The health care professional recommended the patient apply ice to the affected area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Influenza like illness, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 62-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2018, 1 days after receiving Shingrix, the patient experienced pounding in head, influenza-like symptoms, fever, injection site pain, nausea, general body pain, dizziness and unwell. On an unknown date, the outcome of the pounding in head, influenza-like symptoms, fever, nausea and general body pain were recovered/resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the dizziness and unwell were unknown. It was unknown if the reporter considered the pounding in head, influenza-like symptoms, fever, injection site pain, nausea, general body pain, dizziness and unwell to be related to Shingrix. Additional details were reported as follows: The patient woke up dizzy, and was very ill on Tuesday and Wednesday. She reported that it felt like a train was going through her head, and that her head was pounding and the headache was severe. She also reported that she basically had flu-like symptoms, which included nausea, body aches, and a high fever. She was bedridden on Tuesday and Wednesday of that week, but stated that she was back to normal, but her arm at the injection site was still sore. The reporter suggested that she follow up with her healthcare professional. The patient had denied permission to contact their physician. This case has been linked with US2018167339, reported by same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 62-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2018, 1 days after receiving Shingrix, the patient experienced pounding in head, influenza-like symptoms, fever, injection site pain, nausea, general body pain, dizziness and unwell. On an unknown date, the outcome of the pounding in head, influenza-like symptoms, fever, nausea and general body pain were recovered/resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the dizziness and unwell were unknown. It was unknown if the reporter considered the pounding in head, influenza-like symptoms, fever, injection site pain, nausea, general body pain, dizziness and unwell to be related to Shingrix. Additional details were reported as follows: The patient woke up dizzy, and was very ill on Tuesday and Wednesday. She reported that it felt like a train was going through her head, and that her head was pounding and the headache was severe. She also reported that she basically had flu-like symptoms, which included nausea, body aches, and a high fever. She was bedridden on Tuesday and Wednesday of that week, but stated that she was back to normal, but her arm at the injection site was still sore. The reporter suggested that she follow up with her healthcare professional. The patient had denied permission to contact their physician. This case has been linked with US2018167339, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abnormal sensation of limbs in a 58-year-old male patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced abnormal sensation of limbs. On an unknown date, the outcome of the abnormal sensation of limbs was recovered/resolved. It was unknown if the reporter considered the abnormal sensation of limbs to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The reporter was a patient, who received Shingrix 2 months ago in left arm. The patient noted arm sensitivity for 2 days and planned plans to get the second dose. The reporter declined to provide patient's demographics and follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Body tinea, Tinea infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tinea in a 82-year-old female patient who received Shingrix for prophylaxis. On 13th August 2018, the patient received the 1st dose of Shingrix. In September 2018, between 2 and 3 weeks after receiving Shingrix, the patient experienced tinea. On an unknown date, the outcome of the tinea was unknown. It was unknown if the reporter considered the tinea to be related to Shingrix. Additional details were received as follows: This case was previously reported to the physician. The age at vaccination was not reported. The reporter was a patient. The patient experienced ringworm infection on her body that developed a week ago and was seen by her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Shingrix for prophylaxis. On 4th April 2018, the patient received the 1st dose of Shingrix. On 4th April 2018, less than a day after receiving Shingrix, the patient experienced injection site erythema, general body pain, fever, injection site swelling, injection site warmth and rash. On an unknown date, the outcome of the injection site erythema, general body pain, fever, injection site swelling and injection site warmth were recovered/resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the injection site erythema, general body pain, fever, injection site swelling, injection site warmth and rash to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. On the day of vaccination, at night, the patient started to experience all the symptoms. The injection site became red, swollen and hot to touch with a rash that went down half of her arm. The patient had a fever and body aches. The redness lasted over a week. The swelling and hotness lasted 8 to 10 days and the body aches lasted for 5 days. The patient denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Shingrix for prophylaxis. On 4th April 2018, the patient received the 1st dose of Shingrix. On 4th April 2018, less than a day after receiving Shingrix, the patient experienced injection site erythema, general body pain, fever, injection site swelling, injection site warmth and rash. On an unknown date, the outcome of the injection site erythema, general body pain, fever, injection site swelling and injection site warmth were recovered/resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the injection site erythema, general body pain, fever, injection site swelling, injection site warmth and rash to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. On the day of vaccination, at night, the patient started to experience all the symptoms. The injection site became red, swollen and hot to touch with a rash that went down half of her arm. The patient had a fever and body aches. The redness lasted over a week. The swelling and hotness lasted 8 to 10 days and the body aches lasted for 5 days. The patient denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date without a knot at injection site). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to Shingrix. Additional details were received as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The reporting healthcare professional (HCP) administered the Shingrix to the patient. The patient developed a knot at the injection site. The reporter stated that, the patient did not experience a knot at injection site after the 1st dose of Shingrix. Hence, the HCP asked if it was his technique that caused his wife to get a knot at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The patient developed a knot at the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year 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: This case was reported by the patient. The age at vaccination was not reported. The patient experienced soreness at the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On 13th September 2018, the patient received the 1st dose of Shingrix. On 13th September 2018, 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 unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were received as follows: This case was previously not reported to anyone. The age at vaccination was not reported. On the date of reporting, the patient received a dose of Shingrix and experienced arm pain. The patient hung up the call before providing any demographics or other information.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Erythema, Formication, Joint range of motion decreased, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax (dose received on an unknown date). On 26th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 26th July 2018, less than a day after receiving Shingrix, the patient experienced pain in arm, arthritis of neck, erythema of extremities, neck pain and shoulder pain. On an unknown date, the patient experienced vibratory sense increased, joint range of motion decreased and tingling sensation. On an unknown date, the outcome of the pain in arm, vibratory sense increased, arthritis of neck, joint range of motion decreased and tingling sensation were not recovered/not resolved and the outcome of the erythema of extremities, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the pain in arm, vibratory sense increased, arthritis of neck, joint range of motion decreased, tingling sensation, erythema of extremities, neck pain and shoulder pain to be related to Shingrix. Additional information was received as follows: The patient received Shingrix on the right arm. The patient stated that later that evening of the vaccination day, she experienced the pain and the redness in her right arm and the pain traveled to the right side of her neck and to the right shoulder. The patient stated that she had the tingling sensation in her neck (right side) and in right shoulder that felt like ants were crawling in her neck and shoulder (latency of less than 2 months). The patient stated that she had got the vibration sensation for every 30 minutes in the neck and stated that the vibration sensations started some time later than the same day. The patient stated that she could not turn her neck to the right side. The patient went to visit her physician 1 week before the reporting day and had X-ray. The physician informed to the patient that she had a little arthritis in the neck. The patient stated that she did not have arthritis or pain before she received Shingrix. The patient stated that her physician advised her not to receive the 2nd dose of Shingrix. The patient also reported this to two of the pharmacist at the pharmacy in which she received Shingrix. The contact details of the physician were provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Paraesthesia, Spinal X-ray abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax (dose received on an unknown date). On 26th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 26th July 2018, less than a day after receiving Shingrix, the patient experienced pain in arm, arthritis of neck, erythema of extremities, neck pain and shoulder pain. On an unknown date, the patient experienced vibratory sense increased, joint range of motion decreased and tingling sensation. On an unknown date, the outcome of the pain in arm, vibratory sense increased, arthritis of neck, joint range of motion decreased and tingling sensation were not recovered/not resolved and the outcome of the erythema of extremities, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the pain in arm, vibratory sense increased, arthritis of neck, joint range of motion decreased, tingling sensation, erythema of extremities, neck pain and shoulder pain to be related to Shingrix. Additional information was received as follows: The patient received Shingrix on the right arm. The patient stated that later that evening of the vaccination day, she experienced the pain and the redness in her right arm and the pain traveled to the right side of her neck and to the right shoulder. The patient stated that she had the tingling sensation in her neck (right side) and in right shoulder that felt like ants were crawling in her neck and shoulder (latency of less than 2 months). The patient stated that she had got the vibration sensation for every 30 minutes in the neck and stated that the vibration sensations started some time later than the same day. The patient stated that she could not turn her neck to the right side. The patient went to visit her physician 1 week before the reporting day and had X-ray. The physician informed to the patient that she had a little arthritis in the neck. The patient stated that she did not have arthritis or pain before she received Shingrix. The patient stated that her physician advised her not to receive the 2nd dose of Shingrix. The patient also reported this to two of the pharmacist at the pharmacy in which she received Shingrix. The contact details of the physician were provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vibratory sense increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax (dose received on an unknown date). On 26th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 26th July 2018, less than a day after receiving Shingrix, the patient experienced pain in arm, arthritis of neck, erythema of extremities, neck pain and shoulder pain. On an unknown date, the patient experienced vibratory sense increased, joint range of motion decreased and tingling sensation. On an unknown date, the outcome of the pain in arm, vibratory sense increased, arthritis of neck, joint range of motion decreased and tingling sensation were not recovered/not resolved and the outcome of the erythema of extremities, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the pain in arm, vibratory sense increased, arthritis of neck, joint range of motion decreased, tingling sensation, erythema of extremities, neck pain and shoulder pain to be related to Shingrix. Additional information was received as follows: The patient received Shingrix on the right arm. The patient stated that later that evening of the vaccination day, she experienced the pain and the redness in her right arm and the pain traveled to the right side of her neck and to the right shoulder. The patient stated that she had the tingling sensation in her neck (right side) and in right shoulder that felt like ants were crawling in her neck and shoulder (latency of less than 2 months). The patient stated that she had got the vibration sensation for every 30 minutes in the neck and stated that the vibration sensations started some time later than the same day. The patient stated that she could not turn her neck to the right side. The patient went to visit her physician 1 week before the reporting day and had X-ray. The physician informed to the patient that she had a little arthritis in the neck. The patient stated that she did not have arthritis or pain before she received Shingrix. The patient stated that her physician advised her not to receive the 2nd dose of Shingrix. The patient also reported this to two of the pharmacist at the pharmacy in which she received Shingrix. The contact details of the physician were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were received as follows: This case was reported by the patient's sister. The age at vaccination was not reported. The patient received a dose of Shingrix and had a sore arm. The reporter did not want to provide additional details regarding this event.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 80-year-old female patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix (intramuscular). In July 2018, 1 day after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 79 or 80 years. The patient received 1st dose of Shingrix on left deltoid. The next day after receiving Shingrix, the patient experienced intense itching with redness but no hives and no pain on her arm where she received the vaccination. No additional details were available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (in June 2018 at the age of 72) and blood cholesterol increased. On 11th September 2018, the patient received Shingrix (intramuscular). On 11th September 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal were unknown. It was unknown if the reporter considered the influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal to be related to Shingrix. Additional details were provided as follows: The patient was receiving unspecified cholesterol medication as concomitant product. In the evening after receiving Shingrix, the patient experienced flu like symptoms of headache, chills, fever, weakness and feeling out of it. The patient also reported arm soreness, redness and a bulge below the arm and below the injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (in June 2018 at the age of 72) and blood cholesterol increased. On 11th September 2018, the patient received Shingrix (intramuscular). On 11th September 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal were unknown. It was unknown if the reporter considered the influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal to be related to Shingrix. Additional details were provided as follows: The patient was receiving unspecified cholesterol medication as concomitant product. In the evening after receiving Shingrix, the patient experienced flu like symptoms of headache, chills, fever, weakness and feeling out of it. The patient also reported arm soreness, redness and a bulge below the arm and below the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Feeling abnormal, Headache, Hyperacusis, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles and chickenpox (both experienced at the age of 30 year old). On 7th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain, feels awful, neck pain and pain in arm. On 8th September 2018, the patient experienced varicella-like rash. On 12th September 2018, the patient experienced sciatica. In September 2018, the patient experienced fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation. The patient was treated with ibuprofen (Motrin). In September 2018, the outcome of the fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation were recovered/resolved. On an unknown date, the outcome of the pain, feels awful and neck pain were recovered/resolved and the outcome of the sciatica and varicella-like rash were recovering/resolving and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain, feels awful, fever, sciatica, ear pain, sound sensitivity increased, nocturnal headache, abnormal physical sensation, neck pain, pain in arm and varicella-like rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. Around 4:30 pm, the patient received SHINGRIX on the left arm. The patient experienced neck pain more than arm pain. She started to feel achy. The patient babysat her granddaughter and by 10:00 pm, 5 hours 30 minutes after receiving SHINGRIX, at evening, she felt nasty and felt like she was coming down with something.  At 2:00 am, 9 hours 30 minutes after receiving SHINGRIX, she felt a fever and different sensations in her body and she could not lift her head off the pillow. The patient was down all day of vaccination. She took Motrin at 3:00 am which, helped her. On 8th September 2018, 1 day after receiving SHINGRIX, she took two Motrin. Days (less than a week) after receiving SHINGRIX, she experienced pain in her ear that was bothering her with sensitivity to sound and headaches at night for three days. The patient also reported that 1 day after receiving SHINGRIX, the patient experienced rash on her face that looked like pimples or chickenpox. The rash was resolving at the time of reporting and was not as noticeable. The day before reporting day (5 days after receiving SHINGRIX, she experienced sciatic nerve pain in the back of her right leg by her knee which was resolving at the time of reporting. The contact details of the physician were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles and chickenpox (both experienced at the age of 30 year old). On 7th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain, feels awful, neck pain and pain in arm. On 8th September 2018, the patient experienced varicella-like rash. On 12th September 2018, the patient experienced sciatica. In September 2018, the patient experienced fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation. The patient was treated with ibuprofen (Motrin). In September 2018, the outcome of the fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation were recovered/resolved. On an unknown date, the outcome of the pain, feels awful and neck pain were recovered/resolved and the outcome of the sciatica and varicella-like rash were recovering/resolving and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain, feels awful, fever, sciatica, ear pain, sound sensitivity increased, nocturnal headache, abnormal physical sensation, neck pain, pain in arm and varicella-like rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. Around 4:30 pm, the patient received SHINGRIX on the left arm. The patient experienced neck pain more than arm pain. She started to feel achy. The patient babysat her granddaughter and by 10:00 pm, 5 hours 30 minutes after receiving SHINGRIX, at evening, she felt nasty and felt like she was coming down with something.  At 2:00 am, 9 hours 30 minutes after receiving SHINGRIX, she felt a fever and different sensations in her body and she could not lift her head off the pillow. The patient was down all day of vaccination. She took Motrin at 3:00 am which, helped her. On 8th September 2018, 1 day after receiving SHINGRIX, she took two Motrin. Days (less than a week) after receiving SHINGRIX, she experienced pain in her ear that was bothering her with sensitivity to sound and headaches at night for three days. The patient also reported that 1 day after receiving SHINGRIX, the patient experienced rash on her face that looked like pimples or chickenpox. The rash was resolving at the time of reporting and was not as noticeable. The day before reporting day (5 days after receiving SHINGRIX, she experienced sciatic nerve pain in the back of her right leg by her knee which was resolving at the time of reporting. The contact details of the physician were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Sciatica, Sensory disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles and chickenpox (both experienced at the age of 30 year old). On 7th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain, feels awful, neck pain and pain in arm. On 8th September 2018, the patient experienced varicella-like rash. On 12th September 2018, the patient experienced sciatica. In September 2018, the patient experienced fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation. The patient was treated with ibuprofen (Motrin). In September 2018, the outcome of the fever, ear pain, sound sensitivity increased, nocturnal headache and abnormal physical sensation were recovered/resolved. On an unknown date, the outcome of the pain, feels awful and neck pain were recovered/resolved and the outcome of the sciatica and varicella-like rash were recovering/resolving and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain, feels awful, fever, sciatica, ear pain, sound sensitivity increased, nocturnal headache, abnormal physical sensation, neck pain, pain in arm and varicella-like rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. Around 4:30 pm, the patient received SHINGRIX on the left arm. The patient experienced neck pain more than arm pain. She started to feel achy. The patient babysat her granddaughter and by 10:00 pm, 5 hours 30 minutes after receiving SHINGRIX, at evening, she felt nasty and felt like she was coming down with something.  At 2:00 am, 9 hours 30 minutes after receiving SHINGRIX, she felt a fever and different sensations in her body and she could not lift her head off the pillow. The patient was down all day of vaccination. She took Motrin at 3:00 am which, helped her. On 8th September 2018, 1 day after receiving SHINGRIX, she took two Motrin. Days (less than a week) after receiving SHINGRIX, she experienced pain in her ear that was bothering her with sensitivity to sound and headaches at night for three days. The patient also reported that 1 day after receiving SHINGRIX, the patient experienced rash on her face that looked like pimples or chickenpox. The rash was resolving at the time of reporting and was not as noticeable. The day before reporting day (5 days after receiving SHINGRIX, she experienced sciatic nerve pain in the back of her right leg by her knee which was resolving at the time of reporting. The contact details of the physician were provided.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included sulfur with an associated reaction of mass (sulfur drugs caused bumps between fingers). On 21st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced rash and hives. The patient was treated with fexofenadine hydrochloride (Allegra) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash and hives were unknown. It was unknown if the reporter considered the rash and hives to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received the vaccine on the right arm. The reporter reported that, she was experiencing patches of hives/rash that had been occurring off and on since received SHINGRIX but she could not recall the first date seen. The reporter stated that, they are located on her belly, groin, neck, back of thighs, arm pits and on her lower inner arm below the elbow. She had not notified to her physician. The reporter stated it was becoming more intense and more often. She noted taking Allegra and Benadryl and the issue gets resolved but it returns back.