chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In June 2018, several days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported via webform. The age at vaccination was not reported. The age group was not provided, but was captured adult as per vaccine indication. The reporter stated that, they had a patient with a confirmed case (documented case) of shingles several days after SHINGRIX administration (in the buttocks, not injection site) back in June 2018. The case has resolved and the patient was requesting her second dose of SHINGRIX. The reporter was asking, did the GlaxoSmithKline (GSK) have a recommendation on such a scenario. The reporter had seen in the studies, most patients did receive the second dose but she wanted to confirm. This case was already reported to VAERS. No additional information was provided. This case has been linked to the US2018GSK153079, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Rash macular, Rash vesicular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lymph node pain in a 60-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 2nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd August 2018, 1 days after receiving SHINGRIX, the patient experienced enlargement of lymph nodes and chickenpox. On 4th August 2018, the patient experienced lymph node pain. On 8th August 2018, the patient experienced blister. In August 2018, the patient experienced fatigue and red blotches. In August 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the lymph node pain and enlargement of lymph nodes were recovering/resolving and the outcome of the red blotches was unknown and the outcome of the chickenpox and blister were recovered/resolved. It was unknown if the reporter considered the lymph node pain, enlargement of lymph nodes, fatigue, red blotches, chickenpox and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the medical assistant. The patient received SHINGRIX on left deltoid. The day after receiving SHINGRIX in evening the patient experienced swelling in the lymph nodes. She had swollen lymph nodes on her left collarbone (same side as the injection site) and axilla at the same time. It was also painful. At the time of this report, the swelling (swollen lymph nodes) was present but the size of a pea, it was the size of a blueberry. The patient also experienced fatigue, unsure when it started but it had since resolved. The patient applied heat to the swollen lymph nodes on her left collarbone and then developed red blotch area over the lymph nodes. The patient also developed a pox spot with blisters on the right thigh but it cleared after 2 to 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lymph node pain in a 60-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 2nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd August 2018, 1 days after receiving SHINGRIX, the patient experienced enlargement of lymph nodes and chickenpox. On 4th August 2018, the patient experienced lymph node pain. On 8th August 2018, the patient experienced blister. In August 2018, the patient experienced fatigue and red blotches. In August 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the lymph node pain and enlargement of lymph nodes were recovering/resolving and the outcome of the red blotches was unknown and the outcome of the chickenpox and blister were recovered/resolved. It was unknown if the reporter considered the lymph node pain, enlargement of lymph nodes, fatigue, red blotches, chickenpox and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the medical assistant. The patient received SHINGRIX on left deltoid. The day after receiving SHINGRIX in evening the patient experienced swelling in the lymph nodes. She had swollen lymph nodes on her left collarbone (same side as the injection site) and axilla at the same time. It was also painful. At the time of this report, the swelling (swollen lymph nodes) was present but the size of a pea, it was the size of a blueberry. The patient also experienced fatigue, unsure when it started but it had since resolved. The patient applied heat to the swollen lymph nodes on her left collarbone and then developed red blotch area over the lymph nodes. The patient also developed a pox spot with blisters on the right thigh but it cleared after 2 to 3 days.
Sex: U
Vaccine: FLUX, FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a adult patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine. Additional details were reported as follows: The health care professional (HCP) reported that the patient had a history of an allergic reaction with a flu shot. The reporter didn't have any additional information to add to the report as he was inquiring on behalf of a friend. HCP was initially inquiring if any components of SHINGRIX vaccine would cause any reactions that flu vaccine would cause. No further information was available regarding the event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old female patient who received Shingrix (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 11th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced fever, headache and chills. On an unknown date, the outcome of the fever, headache and chills were unknown. The reporter considered the fever, headache and chills to be possibly related to Shingrix. Additional details were reported as follows: The health care professional was unsure if the events had resolved. The question that came in was could the patient receive their prescription for Famciclovir after receiving the Shingrix. No additional information was provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash macular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received and experienced pain in Apr 2018, refer linked case US2018GSK151852). On 4th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th August 2018, 2 days after receiving SHINGRIX, the patient experienced pruritus and rash. On 10th August 2018, the patient experienced erythromacular rash. On 11th August 2018, the patient experienced shooting pain. In August 2018, the patient experienced pain in arm. The patient was treated with hydrocortisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm and pruritus were recovered/resolved and the outcome of the shooting pain was recovering/resolving and the outcome of the erythromacular rash and rash were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shooting pain, erythromacular rash, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: On 10:05 AM, the patient received 2nd dose of SHINGRIX on right arm. Less than a day after receiving SHINGRIX, the patient experienced pain in her injection arm, which less than the first dose and resolved after a couple of nights for both injections. On Monday, after the injection, the patient experienced itchy spots which turned into a rash. On Friday of next week from the date of reporting, 6 days after receiving receiving SHINGRIX, the patient looked in the mirror and noticed a rash and red spots on her torso. The patient bought hydrocortisone cream and took Benadryl. On Saturday, 7 days after receiving, SHINGRIX the patient experienced periodic shooting pain on her torso which she described as feeling like shingles. The shooting pain was less on the day of reporting and the itchiness had resolved but the rash was still unresolved. The patient was going to meet her health care professional for an evaluation.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: This case was reported by a other health professional 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, several hours after receiving SHINGRIX, the patient experienced injection site pain and nausea. The patient was treated with analgesic, nos (Narcotic Analgesic). On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the nausea was unknown. It was unknown if the reporter considered the injection site pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One doctor noted a case where the patient received the SHINGRIX in the morning at hospital and came into the office that afternoon complaining of pain so severe that it was making him nauseous and required narcotic pain medications. Three days later at follow up, the pain had not subsided. The purpose of the phone call was to determine if we have treatment recommendations for adverse events. The call center representative asked the caller if she had adverse events she wanted to report and began reading the above from an email chain from her physicians. This case has been linked with case US2018GSK152781, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult 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 pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The adverse events were lasted for at least a week. The patient had denied permission to contact their physician. No further details were provided. For tolerance to 2nd dose, refer case US2018GSK153648, for same patient.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, 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 77-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 13th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and shivering. The patient was treated with ibuprofen and fenoprofen. On an unknown date, the outcome of the injection site pain and shivering were unknown.  It was unknown if the reporter considered the injection site pain and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in right arm. The patient rated pain as 9 from a scale of 1-10 and 10 being the worst. No further details were provided.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 71-year-old male patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 12th August 2018, 6 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The physician reported that one of her patients came in with an itchy rash all over his body.  The physician was not sure if this was related to the vaccine. However, there was nothing new in diet or medication.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis, Immediate post-injection reaction, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of felt faint in a 12-year-old male patient who received BOOSTRIX for prophylaxis. On 13th August 2018, the patient received BOOSTRIX .5 ml. On 13th August 2018, immediately after receiving BOOSTRIX, the patient experienced felt faint, sweating, hearing impaired and wrong injection technique. On 13th August 2018, the outcome of the felt faint, sweating and hearing impaired were recovered/resolved. On an unknown date, the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the felt faint, sweating and hearing impaired to be related to BOOSTRIX. Additional details were provided as follows: The pharmacist reported that she gave a BOOSTRIX vaccine to the patient the day before reporting in left deltoid. Half way through the injection, she had to pull out the syringe and inject the rest of the dose with another syringe, which led to wrong injection technique. The pharmacist reported that the needle was out of patient's arm during injection and replaced needle head and finishing injection in the same arm less than 1 inch from previous injection. The patient was experiencing feeling faint, sweating and unable to hear immediately following injection for 15 minutes which recovered after few minutes and went home with parent. She said there was no leaking. She just had to switch syringes because the patient shook a little bit as if the needle was too strong.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 91-year-old female patient who received SHINGRIX (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. Concomitant products included SHINGRIX. On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information was reported as follows: On 18th July 2018, the patient received 1st dose of SHINGRIX. The patient received her second dose of SHINGRIX earlier than the recommended interval, which led to shortening of the vaccination schedule. No other side effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporting physician was the patient. The physician mentioned the adverse event as an aside and did not provide further details about lot number and vaccination dates. For tolerance to next dose, refer case US2018GSK153043.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fear of death, Headache, Limb discomfort, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced sickness, pain in arm, headache, fever, chills and fear of death. On an unknown date, the outcome of the sickness, pain in arm, headache, fever and chills were recovering/resolving and the outcome of the fear of death was unknown. It was unknown if the reporter considered the sickness, pain in arm, headache, fever, chills and fear of death to be related to SHINGRIX. Additional details were provided as follows: The caller was calling on behalf of patient who was a female friend that stays with him. The caller stated that she was taking care of someone. The patient received 1st dose of SHINGRIX in an unknown arm. On the day of vaccination at evening, the patient felt sick, fever, chills and headache along with arm soreness. The patient stated that she was doing better on the day of reporting, but she felt like she was dying last night. It was recommended that she would seek assistance from healthcare professional to report the events and any necessary treatment recommendations. The healthcare professional not asked, as this was consumer reporting on behalf of a consumer friend.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced sickness, pain in arm, headache, fever, chills and fear of death. On an unknown date, the outcome of the sickness, pain in arm, headache, fever and chills were recovering/resolving and the outcome of the fear of death was unknown. It was unknown if the reporter considered the sickness, pain in arm, headache, fever, chills and fear of death to be related to SHINGRIX. Additional details were provided as follows: The caller was calling on behalf of patient who was a female friend that stays with him. The caller stated that she was taking care of someone. The patient received 1st dose of SHINGRIX in an unknown arm. On the day of vaccination at evening, the patient felt sick, fever, chills and headache along with arm soreness. The patient stated that she was doing better on the day of reporting, but she felt like she was dying last night. It was recommended that she would seek assistance from healthcare professional to report the events and any necessary treatment recommendations. The healthcare professional not asked, as this was consumer reporting on behalf of a consumer friend.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: 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 SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. Previously administered products included Zostavax vaccine (age 60 received the Zostavax vaccine). On 31st May 2018, the patient received SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased and muscle pain were unknown.  It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she received the SHINGRIX vaccine on left arm at 3:00 PM. She experienced soreness at the injection site. She claims that she could not comfortably put her arm all the way up without bending and her arm still hurts as it did the first day she received the vaccination. The reporter called because they had a reaction to a, the new shingles shot. They understood that there would be some muscle pain, but it had been a matter of months, and she just wanted to find out if there was anything, any kind of a precedent set. The reporter did an inquiry and she thought the whole issue was proceeding as normal, since there wasn't any side effect issue that could be resolved over the phone. This case has been linked with US2018147956, reported by same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. On 31st May 2018, the patient received SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient's wife reported that the patient received the SHINGRIX vaccine in the afternoon and experienced soreness at the injection site. The event resolved with no problem in a couple of days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced fever, poor sleep, influenza-like symptoms, injection site pain, chills and pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and influenza-like symptoms were recovering/resolving and the outcome of the poor sleep and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the fever, poor sleep, influenza-like symptoms, injection site pain, chills and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced a 101 fever, soreness at the injections site, a few chills during the night, and mild flu like symptoms with an achy feeling. The patient took some Tylenol and the fever and flu like symptoms were resolving. The patient explained that she did not feel like herself after getting the vaccine. The patient could not sleep last night, however, she was able to nap on the day of reporting. She claimed that the side effects started in the middle of the night. The patient had denied permission to contact their physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced fever, poor sleep, influenza-like symptoms, injection site pain, chills and pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and influenza-like symptoms were recovering/resolving and the outcome of the poor sleep and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the fever, poor sleep, influenza-like symptoms, injection site pain, chills and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced a 101 fever, soreness at the injections site, a few chills during the night, and mild flu like symptoms with an achy feeling. The patient took some Tylenol and the fever and flu like symptoms were resolving. The patient explained that she did not feel like herself after getting the vaccine. The patient could not sleep last night, however, she was able to nap on the day of reporting. She claimed that the side effects started in the middle of the night. The patient had denied permission to contact their physician.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 19-year-old female patient who received BEXSERO for prophylaxis. On 10th August 2018, the patient received BEXSERO. On 10th August 2018, less than a day after receiving BEXSERO, the patient experienced pain in arm, fever, general body pain and vaccine administered at inappropriate site. The patient was treated with ALEVE and Muscle Relaxant. On an unknown date, the outcome of the pain in arm, fever and general body pain were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the pain in arm, fever and general body pain to be related to BEXSERO. Additional details were provided as follows: The patient reported that she might have received the BEXSERO injection outside of the deltoid region on the upper arm, which led to vaccine administered at inappropriate site. The patient reported arm soreness, body aches, and fever. The patient was seen by the physician and prescribed ALEVE and a muscle relaxant. Symptoms still remains. The mother of the patient was the reporter, the mother said the medical staff might have injected the bone or a nerve in the arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced fever, malaise and muscle pain. On 30th May 2018, the outcome of the fever, malaise and muscle pain were recovered/resolved. It was unknown if the reporter considered the fever, malaise and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist (Rph). The patient received SHINGRIX in left arm. The events resolved after about 1 day. This case was linked with the case US2018147989, reported by the same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced fever, malaise and muscle pain. On an unknown date, the outcome of the fever, malaise and muscle pain were recovered/resolved. It was unknown if the reporter considered the fever, malaise and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist (Rph). The patient received SHINGRIX in left arm. The events resolved after about 1 day. This case was linked with the case US2018147988, reported by the same reporter. The reported batch number M1532 for SHINGRIX does not exist in sales database and was updated as ML532 as per sales database.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Scab
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 87-year-old female patient who received Shingrix (batch number 9779K, expiry date 11th October 2020) and (batch number NR4Z4, expiry date unknown) for prophylaxis. On 25th May 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In May 2018, less than a day after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the patient experienced scab. On an unknown date, the outcome of the blister, pruritus and scab were recovered/resolved. It was unknown if the reporter considered the blister, pruritus and scab to be related to Shingrix. Additional information was reported as follows: Within a day or two the patient experienced blisters on inside part of her thigh. The blisters were itchy but scabbed over and went away. The reporter was not sure of when the events resolved.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 55-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. The patient's past medical history included breast cancer. On 7th May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 7th May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. In May 2018, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the physician. The patient received a SHINGRIX vaccine underneath her left arm, in the subcutaneous tissue instead of the recommended deltoid region, which led to inappropriate route of vaccine administration and vaccine administration at inappropriate site. The patient stated that, next day after receiving a dose of SHINGRIX, she experienced swelling and soreness in the left arm. The patient reported that the swelling seemed to get worse each day and lasted for approximately 1 week. For tolerance to next dose, refer case US2018GSK153681.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin discolouration, Skin exfoliation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX (batch number TZ9L5, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX(intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced fever, skin discoloration and skin peeling. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the skin discoloration and skin peeling were not recovered/not resolved. It was unknown if the reporter considered the fever, skin discoloration and skin peeling to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to the physician. The pharmacist did not wish to provide patient's demographic details. The age at vaccination was not reported. The patient received SHINGRIX vaccine in an unknown deltoid. The pharmacist reported that, the patient's skin has turned brown and started peeling. The reporter did not have any additional details regarding the event and did not know where on the body the skin was brown or peeling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gastric disorder, 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 67-year-old female patient who received SHINGRIX for prophylaxis. On 8th May 2018, the patient received the 1st dose of SHINGRIX. On 8th May 2018, 11 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills and gastric disorder. On an unknown date, the outcome of the pain in arm, chills and gastric disorder were unknown. It was unknown if the reporter considered the pain in arm, chills and gastric disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at 09:31 hours. The patient reported that about 11 hours later, at 20:31 hours the patient experienced arm soreness and sick to stomach.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 22nd February 2021) for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The patient stated that he received a dose SHINGRIX and experienced soreness at the site on the next day. The soreness resolved after about 2 to 3 days. The healthcare professional information was not asked. This case has been linked with case US2018GSK151213 (same patient), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Impaired work ability, Injection site pain, Malaise, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 2nd dose of SHINGRIX. On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, inability to work, appetite absent, fever and nausea. On an unknown date, the outcome of the injection site pain, inability to work, appetite absent, fever and nausea were unknown. It was unknown if the reporter considered the injection site pain, inability to work, appetite absent, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site pain, nausea, loss of appetite and fever of 101 degrees. The reporter noted that the patient was so ill that she could not go to work.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 2nd dose of SHINGRIX. On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, inability to work, appetite absent, fever and nausea. On an unknown date, the outcome of the injection site pain, inability to work, appetite absent, fever and nausea were unknown. It was unknown if the reporter considered the injection site pain, inability to work, appetite absent, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site pain, nausea, loss of appetite and fever of 101 degrees. The reporter noted that the patient was so ill that she could not go to work.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle tightness, Myalgia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (to Neomycin and Erythromycin). In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced pain in arm, muscle tightness, muscle pain and tendon pain. On an unknown date, the outcome of the pain in arm and muscle tightness were not recovered/not resolved and the outcome of the muscle pain and tendon pain were unknown. It was unknown if the reporter considered the pain in arm, muscle tightness, muscle pain and tendon pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received the SHINGRIX vaccine on left arm at approximately 3:00 PM and his left arm throbbed for one week and then it went into a phase where his muscles were tight and hurt. He seemed to believe that it was his tendons because if he stretched it would slightly subside, however, if he rolled over at night during sleep, it would wake him up. The pain had progressed to his forearm area and his arm hurting was still unresolved till the day of reporting.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendon pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (to Neomycin and Erythromycin). In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced pain in arm, muscle tightness, muscle pain and tendon pain. On an unknown date, the outcome of the pain in arm and muscle tightness were not recovered/not resolved and the outcome of the muscle pain and tendon pain were unknown. It was unknown if the reporter considered the pain in arm, muscle tightness, muscle pain and tendon pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received the SHINGRIX vaccine on left arm at approximately 3:00 PM and his left arm throbbed for one week and then it went into a phase where his muscles were tight and hurt. He seemed to believe that it was his tendons because if he stretched it would slightly subside, however, if he rolled over at night during sleep, it would wake him up. The pain had progressed to his forearm area and his arm hurting was still unresolved till the day of reporting.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Monoplegia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of paralysis in a 82-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. On 14th August 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain. In August 2018, the patient experienced paralysis (serious criteria GSK medically significant) and injected limb mobility decreased. On an unknown date, the outcome of the paralysis and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the paralysis, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient developed severe pain at injection site after receiving initial dose of SHINGRIX. It was reported that the pain began "about 2 hours after" receiving the injection however pain had subsided, but the patient was unable to move arm due to a feeling of paralysis in her shoulder at the time of reporting. No further information was reported regarding the event.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Musculoskeletal pain, Pain in extremity, Paralysis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of paralysis in a 82-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. On 14th August 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain. In August 2018, the patient experienced paralysis (serious criteria GSK medically significant) and injected limb mobility decreased. On an unknown date, the outcome of the paralysis and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the paralysis, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient developed severe pain at injection site after receiving initial dose of SHINGRIX. It was reported that the pain began "about 2 hours after" receiving the injection however pain had subsided, but the patient was unable to move arm due to a feeling of paralysis in her shoulder at the time of reporting. No further information was reported regarding the event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at the injection site from her upper arm to her elbow. The redness resolved in three weeks after the injection. The patient reported that she already followed-up with her physician. Partial information was provided. The patient was getting frustrated with the questions from this report and did not want to answer any other questions. Towards the end of the call, the patient reported that she had siblings (unknown number) that also experienced redness. The patient had denied permission to contact their physician. This case has been linked with the case US2018GSK153537, reported for her siblings. Clarification raised to confirm which vaccine the siblings received.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Insomnia, Muscle tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle tension in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 11th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 mg. On 12th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle tension, back pain and difficulty sleeping. The patient was treated with cyclobenzaprine. On an unknown date, the outcome of the muscle tension, back pain and difficulty sleeping were not recovered/not resolved. It was unknown if the reporter considered the muscle tension, back pain and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient had muscle tension on back and right arm along with soreness (pain) on back. The patient reported that he followed-up with his physician and was prescribed cyclobenzaprine. The patient provided contact detail of his physician.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperhidrosis, Incorrect route of drug administration, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 54-year-old female patient who received Shingrix (batch number ML532, expiry date unknown) for prophylaxis. On 13th August 2018, the patient received Shingrix (subcutaneous). On 13th August 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In August 2018, the patient experienced erythema of extremities, sweating, swelling arm and fever. On an unknown date, the outcome of the erythema of extremities, sweating, swelling arm and fever were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the erythema of extremities, sweating, swelling arm and fever to be related to Shingrix. Additional details were provided as follows: The pharmacist reported that he administered Shingrix subcutaneously to a patient, which led to inappropriate route of vaccination. The patient's arm was red and swollen and it seemed to be spreading at the time of reporting.