chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Body aches; Terrible headache; Pain started in her back; Pain / shin, legs and calves; Like deep sore muscle pain; 1st dose 9/21/2020 - 2nd dose 11/03/2020; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 33TL7, expiry date 30th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 4th November 2020, the patient experienced general body pain, headache, back pain, pain of lower extremities and muscle pain. On an unknown date, the outcome of the general body pain and headache were not recovered/not resolved and the outcome of the back pain, pain of lower extremities, muscle pain and drug dose administration interval too short were unknown.   The reporter considered the general body pain to be related to Shingrix. It was unknown if the reporter considered the headache, back pain, pain of lower extremities and muscle pain to be related to Shingrix.  Additional details were provided as follows: On 23rd September 2020, the patient received 1st dose of Shingrix. On 3rd November 2020, the patient received 2nd dose of Shingrix in the left deltoid, which led to shortening of vaccination schedule. The patient had body aches and a terrible headache. One day after the vaccination the pain started in her back, shin, legs and calves like deep sore muscle pain. It's worse when she first wakes up in the morning and she suffered periodically during the day. She likens it to a cold without symptoms such as runny nose. The patient stated it did seem to be getting better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Urticaria
Clinical narrative: Arm soreness; Arm redness; Headaches; Hives cover her entire body; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th October 2020, 4 days after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced pain in arm, erythema of extremities and headache. The patient was treated with prednisone. On an unknown date, the outcome of the pain in arm, erythema of extremities and headache were unknown and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, headache and hives to be related to Shingrix.  Additional details were provided as follows: Less than 2 months after vaccination, the patient experienced arm Soreness and redness and headaches.  Hives covered her entire body and were stil present at the time of reporting. The patient had been to the emergency room, and had been treated with Prednisone twice. She was waiting for a call back from her dermatologist.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Swelling at injection site; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced swelling and redness at injection site. The customer did not provide lot or expiration date information or report in which arm the vaccine was injected. The reporter did not consent to follow up. This case has been linked with US2020226624, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226624:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Swelling at injection site; Redness at injection site; Nausea; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, nausea and upset stomach. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved and the outcome of the nausea and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, nausea and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's spouse reported that a patient received the 1st dose of Shingrix vaccine 2 weeks ago and patient experienced swelling and redness at the injection site. The patient also had nausea and upset stomach. Reporter stated that the nausea and upset stomach symptoms had not resolved 2 weeks after the vaccine.  The reporter did not consent to follow up. This case has been linked to US2020226620 case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226620:Same reporter
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Rash all over the body that comes and goes; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 86-year-old  This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10th December 2021) for prophylaxis.   On 3rd August 2020, the patient received the 2nd dose of Shingrix. On 3rd August 2020, less than a day after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: After receiving the Shingrix the patient experienced rash all over her body that comes and goes. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness that intensifies when he lies down; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingrix. In October 2020, 3 days after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were received as follows: The patient reported, four weeks ago of reporting date, the patient received Shingrix. He experienced dizziness that intensifies when he lies down, three days after receiving Shingrix. He stated that he recovered. The patient did not consent to follow-up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Computerised tomogram normal, Dizziness, Injection site pain, Laboratory test normal
Clinical narrative: Muscle soreness at the injection site; Extreme equilibrium issues / Dizziness / Any movement would cause him to feel dizzy; Extreme equilibrium issues / Dizziness / Any movement would cause him to feel dizzy; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th October 2020, 3 days after receiving Shingrix, the patient experienced dizziness and equilibrium trouble. On an unknown date, the patient experienced injection site muscle pain. On 16th November 2020, the outcome of the dizziness and equilibrium trouble were recovered/resolved. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the dizziness, equilibrium trouble and injection site muscle pain to be related to Shingrix.  Additional details were received as follows: The patient received the vaccine in the upper right arm. The patient reported that, he experienced extreme equilibrium issues, dizziness and muscle soreness at the injection site after receiving Shingrix vaccine. He experienced the equilibrium problems and dizziness for four weeks and it recently went away and the soreness was still there, but not as bad as it was. He also reported the area was not red nor was it infected. He stated that, any movement would cause him to feel dizzy. He visited the emergency room and had tests done, including a CAT scan (computerized tomogram) but they were not able to find anything. He was not admitted into the hospital because they did not find anything that warranted the admission. He had also visited a therapist and was tested for vertigo but he did not have it. He sometimes walked with a walker and or cane, but he as able to walk freely without any problems. His doctor is aware of these adverse events. The patient consented to follow up with his doctor and provided the contact information.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness at the injection site; Extreme equilibrium issues / Dizziness / Any movement would cause him to feel dizzy; Extreme equilibrium issues / Dizziness / Any movement would cause him to feel dizzy; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th October 2020, 3 days after receiving Shingrix, the patient experienced dizziness and equilibrium trouble. On an unknown date, the patient experienced injection site muscle pain. On 16th November 2020, the outcome of the dizziness and equilibrium trouble were recovered/resolved. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the dizziness, equilibrium trouble and injection site muscle pain to be related to Shingrix.  Additional details were received as follows: The patient received the vaccine in the upper right arm. The patient reported that, he experienced extreme equilibrium issues, dizziness and muscle soreness at the injection site after receiving Shingrix vaccine. He experienced the equilibrium problems and dizziness for four weeks and it recently went away and the soreness was still there, but not as bad as it was. He also reported the area was not red nor was it infected. He stated that, any movement would cause him to feel dizzy. He visited the emergency room and had tests done, including a CAT scan (computerized tomogram) but they were not able to find anything. He was not admitted into the hospital because they did not find anything that warranted the admission. He had also visited a therapist and was tested for vertigo but he did not have it. He sometimes walked with a walker and or cane, but he as able to walk freely without any problems. His doctor is aware of these adverse events. The patient consented to follow up with his doctor and provided the contact information.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles episode after first dose administration.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at event onset was not reported but it colud be 77 or 78 years. The patient received Shingrix and developed episode of Shingles. The reporter did not consent to follow up. No expiration date nor lot number were provided.
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Mobility decreased, Pain in extremity
Clinical narrative: arm was so sore; arm was so sore and she could hardly move it; the first dose two years ago / never received the second dose; 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 Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, Influenza vaccine, PNEUMONIA SHOT and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Influenza vaccine and not applicable after receiving Shingrix, the patient experienced pain in arm, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix and Influenza vaccine.  Additional information was provided as follows: The patient reported that no one told her she needed two doses of the Shingrix vaccine. She received the first dose two years before reporting and never received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. On the same day of receiving Shingrix, she also received the second dose of the pneumonia vaccine and a flu vaccine. She claimed that after getting her Shingrix vaccine, her arm was so sore and she could hardly move it. The side effects lasted a couple of weeks. They gave her the shot in her left arm in the back of her arm. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to pneumonia shot. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mouth ulceration, Oral disorder, Oral mucosal blistering, Oral pain
Clinical narrative: soreness in her mouth /  mouth is still tender; blisters/lesions/ulcers in her mouth on the tongue and along the gums; ulcers in her mouth on the tongue and along the gums; lesions in her mouth on the tongue and along the gums; body aches; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of oral pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose 3 months ago,refer case US2020AMR228248).   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 14th November 2020, 1 days after receiving Shingrix, the patient experienced general body pain, chills and fever. On 16th November 2020, the patient experienced oral pain, blistering of mouth, mouth ulcer and oral lesion. On an unknown date, the outcome of the oral pain was not recovered/not resolved and the outcome of the general body pain, chills, fever and blistering of mouth were recovered/resolved and the outcome of the mouth ulcer and oral lesion were unknown.   It was unknown if the reporter considered the oral pain, general body pain, chills, fever, blistering of mouth, mouth ulcer and oral lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix around 6 pm and experienced fever, chills, and body aches which lessened and had gone away.  The patient noticed soreness in her mouth and says that there are small blisters, lesions and ulcers in her mouth on the tongue and along the gums.  The patient was wondering if this could be a reaction to Shingrix.  This had not yet resolved and mouth was still tender and she only eat soft food. The caller did not want to provide the contact information for the pharmacy and did not want to answer any further questions.  The caller did not want to provide her personal address and provided limited information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR228248:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: soreness in her mouth /  mouth is still tender; blisters/lesions/ulcers in her mouth on the tongue and along the gums; ulcers in her mouth on the tongue and along the gums; lesions in her mouth on the tongue and along the gums; body aches; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of oral pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose 3 months ago,refer case US2020AMR228248).   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 14th November 2020, 1 days after receiving Shingrix, the patient experienced general body pain, chills and fever. On 16th November 2020, the patient experienced oral pain, blistering of mouth, mouth ulcer and oral lesion. On an unknown date, the outcome of the oral pain was not recovered/not resolved and the outcome of the general body pain, chills, fever and blistering of mouth were recovered/resolved and the outcome of the mouth ulcer and oral lesion were unknown.   It was unknown if the reporter considered the oral pain, general body pain, chills, fever, blistering of mouth, mouth ulcer and oral lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix around 6 pm and experienced fever, chills, and body aches which lessened and had gone away.  The patient noticed soreness in her mouth and says that there are small blisters, lesions and ulcers in her mouth on the tongue and along the gums.  The patient was wondering if this could be a reaction to Shingrix.  This had not yet resolved and mouth was still tender and she only eat soft food. The caller did not want to provide the contact information for the pharmacy and did not want to answer any further questions.  The caller did not want to provide her personal address and provided limited information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR228248:same patient
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: rash / it was / swollen; rash / it was raised /rash / measured / 5"x9" appeared below the injection site; rash / it was / hot to the touch; feeling achy; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced general body pain. On 28th October 2020, the patient experienced extensive swelling of vaccinated limb, red rash and localized feeling of warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, general body pain, red rash and localized feeling of warmth were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, general body pain, red rash and localized feeling of warmth to be related to Shingrix.   Additional details were provided as follows: The reporting nurse was the concerned patient. The patient received the 1st dose of Shingrix in right deltoid and experienced feeling achy, swelling, hot to touch and red rash which was resloved. On day seven following the vaccine, a rash that measured approximately 5inchx9inch appeared below the injection site, It was raised, swollen, red and hot to the touch. The reporter did not conented to follow up. No further information was available.  Note As per the case description the patient experienced ony aching but theadverse event reported muscle pain with no supporting information,so the event was coded as pain as per narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: vaccine gave her the shingles / in her Back and arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The reporter was patient spouse. The patient experienced shingles in back and arm. The reporter stated that the vaccine gave the patient shingle.   The patient did not have symptoms of shingle before. The reporter stated that the patien's shingle was treated. The information regarding consent to follow up was not reported. Call got disconnected. The reporter was called back twice but unsuccessfully. A voice mail was left with GSK phone. No additional information could be provided or collected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: blisters on back, arms and legs; rash; This case was reported by a nurse via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 24DP5, expiry date 8th April 2022) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. In September 2020, 1 week after receiving Shingrix, the patient experienced blister and rash. On an unknown date, the outcome of the blister and rash were not recovered/not resolved.   It was unknown if the reporter considered the blister and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced rash and blisters. The patient experienced rash and blisters on back ,arms and legs. The patient reported they would come and go. The patent was not recovered. The reporter consented to follow up. No further information was available.
Age: 64.0
Sex: F
Vaccine: FLUR3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: fever of 102.0 degrees F; redness at injection site; swelling at injection site; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix and FLUBLOK (intramuscular). On 24th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 25th September 2020, the patient experienced injection site erythema and injection site swelling. On 26th September 2020, the patient experienced fever. On an unknown date, the outcome of the pain in arm, injection site erythema, injection site swelling and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, injection site swelling and fever to be related to Shingrix.  Additional details were provided as follows: The patient's body temperature was 102.0 degrees F. The patient reported arm soreness, redness at injection site, swelling at injection site. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Insomnia, Neuralgia, Pain
Clinical narrative: has had nerve pain radiating the neck to the finger on the right arm; has had difficulty sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2020, immediately after receiving Shingrix, the patient experienced nerve pain and difficulty sleeping. On an unknown date, the outcome of the nerve pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. Since the vaccination, the patient had nerve pain radiating from the neck to the finger on the right arm and difficulty sleeping due to the nerve pain. Till the time of reporting nerve pain and difficulty sleeping was ongoing. No further details were provided. The reporter did not consent to follow up. This case has been linked to US2020228544, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228544:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: have experienced pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in unspecfied number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist reported that a lot of patients had experienced pain after receiving the Shingrix vaccine.  The reporter did not consented to follow up, No further information was available. This case was linked with case US2020228543 reported by same reporter. .; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228543:Same Reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: having arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number ZX27E, expiry date 16th September 2022) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix a month before that date of reporting. The patient still had arm pain at the time of reporting. No further details were reported. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza, Influenza like illness
Clinical narrative: felt a little off for 2 days; felt like she was getting the flu; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling abnormal and influenza-like symptoms. On an unknown date, the outcome of the feeling abnormal and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the feeling abnormal and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and  experienced getting the flu and felt a little off which was resolved in 2 days. The reporter did not consented to folow up. No further information was available. This case was linked with case US2020AMR229116 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229116:same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Feeling abnormal, Injection site rash, Pyrexia, Rash vesicular
Clinical narrative: Rash at the deltoid injection site; Rash feels like bubble underneath the rash; Fever; Cough; Mild hay fever type symptoms; Rash feels weird; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number E9Y5M, expiry date 31st May 2022) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a week after receiving Shingrix, the patient experienced injection site rash, blistery rash, fever, cough, hay fever and weird feeling. The patient was treated with cough cold preparations nos (Cough Medicine (Nos)). On an unknown date, the outcome of the injection site rash, blistery rash, fever, cough, hay fever and weird feeling were not recovered/not resolved.   The reporter considered the injection site rash, blistery rash, fever, cough and hay fever to be related to Shingrix. It was unknown if the reporter considered the weird feeling to be related to Shingrix.  Additional details were provided as follows: The reporter who was a retail pharmacist reported that she had administered Shingrix to the patient at the left deltoid . The patient had a rash on her left arm at the deltoid injection site after the vaccination. The patient indicated that the rash felt weird because it felt like there were bubbles underneath the rash.  The patient had also reported to the pharmacist that she had experienced fever, cough and mild hay-fever type symptoms.  The patient was taking an unspecified cough medicine to treat the cough. These symptoms were mild but they had not resolved till the time of reporting. The pharmacist had called to inquire if a second dose of Shingrix should be given to the patient in 2 to 6 months or not and call was transferred to GSK-medical information. The reporter consented to follow-up. This case has been linked to US2020228575, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228575:same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Seasonal allergy
Clinical narrative: Rash at the deltoid injection site; Rash feels like bubble underneath the rash; Fever; Cough; Mild hay fever type symptoms; Rash feels weird; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number E9Y5M, expiry date 31st May 2022) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a week after receiving Shingrix, the patient experienced injection site rash, blistery rash, fever, cough, hay fever and weird feeling. The patient was treated with cough cold preparations nos (Cough Medicine (Nos)). On an unknown date, the outcome of the injection site rash, blistery rash, fever, cough, hay fever and weird feeling were not recovered/not resolved.   The reporter considered the injection site rash, blistery rash, fever, cough and hay fever to be related to Shingrix. It was unknown if the reporter considered the weird feeling to be related to Shingrix.  Additional details were provided as follows: The reporter who was a retail pharmacist reported that she had administered Shingrix to the patient at the left deltoid . The patient had a rash on her left arm at the deltoid injection site after the vaccination. The patient indicated that the rash felt weird because it felt like there were bubbles underneath the rash.  The patient had also reported to the pharmacist that she had experienced fever, cough and mild hay-fever type symptoms.  The patient was taking an unspecified cough medicine to treat the cough. These symptoms were mild but they had not resolved till the time of reporting. The pharmacist had called to inquire if a second dose of Shingrix should be given to the patient in 2 to 6 months or not and call was transferred to GSK-medical information. The reporter consented to follow-up. This case has been linked to US2020228575, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228575:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: they got a rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that her pharmacy has administered 100's to 1000's of Shingrix shots and out of all those patients "a handful" of them have come back indicating that they got a rash after vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228570:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Fever ranged from 100 to 102.9 degree Fahrenheit/ still had a fever of 100.7 at 2 am in morning of reporting date; Had nausea when her fever was high; Loss of appetite when her fever was high; Chills /chills would also happen when her fever was high; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th November 2020, less than a day after receiving Shingrix, the patient experienced chills. On 14th November 2020 11:00, the patient experienced fever, nausea and appetite lost. The patient was treated with paracetamol (Tylenol). In November 2020, the outcome of the chills and nausea were recovered/resolved. On 18th November 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the appetite lost was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, nausea and appetite lost to be related to Shingrix.  Additional details were provided as follows: The patient had fever on morning of next day after vaccination. The fever had ranged from 100 to 102.9 degree Fahrenheit. The patient did had a fever of 100.7 degree Fahrenheit at 2:00 am on reporting date and took Tylenol and the fever had resolved at the time of reporting. On the same night of vaccination, the patient also had chills and the chills also had happened when her fever was high.  She also had nausea and loss of appetite when her fever was high and did not have an appetite till the time of reporting. Patient did not have lot number or expiration date information to provide.  The reporter consented to follow-up and also gave consent to follow-up with health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu like symptoms / and mild ones; feeling sick / symptoms were so bad / almost goes to an emergency room; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported the paient had sever flu like symptoms for a few days and mild ones for another few days. The patient stated that she woke up in the middle of the night felt sick for a few days and the symptoms were so bad she almost goes to an emergency room.   The reporter was not sure when the patient received the vaccine or when the symptoms started and could not find the details for the adverse event report.      The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Erythema, Headache, Pyrexia
Clinical narrative: fever (103 as reported); chills; red arm; headache; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HD) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix and FLUZONE HD. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, chills, erythema of extremities and headache. On an unknown date, the outcome of the fever, chills, erythema of extremities and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills, erythema of extremities and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The patient experienced fever (body temperature 103 degree F), chills, red arm, headache and which lasted for 2 to 3 days. It was unknown if the reporter considered the fever, chills, erythema of extremities and headache to be related to Fluzone HD as well. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: swelling at injection site/pain, redness, swelling, and wheals below the injection site; redness/pain, redness, swelling, and wheals below the injection site; wheals/wheals below the injection site/pain, redness, swelling, and wheals below the injection site; pain at injection site/pain, redness, swelling, and wheals below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site wheal and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site wheal and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site wheal and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine in her left arm and stated that within 24 hours of receiving the vaccine, she had pain, redness, swelling, and wheals below the injection site. The reporter did not provide additional information as she was in a hurry and also did not want to provide DOB. The reporter did not consent to follow-up
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: it itches sometimes/developed a rash / rash/rash is red and it; it itches sometimes/developed a rash / rash/rash is red and it; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in the past 2 episodes of Shingles in her lifetime).   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd September 2020, 1 days after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.  Additional details were reported as follows: The reporter ws the spouse of the patient. The patient received her 1st Shingrix dose in left arm. The reporter stated that the patient developed a rash a day or so after receiving the injection. The rash was red and it itches sometimes.  The rash was located inside of the area of her left elbow. The reporter stated that patient had in the past 2 episodes of Shingles in her lifetime. The patient was scheduled to get her 2nd dose day after reporting day but would consult with her healthcare professional first. The reporter did not consent to follow-up
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Musculoskeletal chest pain, Rash, Swelling
Clinical narrative: Left chest/breast area is swollen; Left chest/breast area is / tender to touch still; Rash in the left arm pit; A golf ball swelling in the right side of his forehead; Severe headache on the left side of his head; Sweating / for 2 hours; Shaking, trembling for 2 hours; This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastrostomy tube insertion. Previously administered products included chemotherapy (finished his chemotherapy for squamous cell carcinoma of his tonsils). Concurrent medical conditions included squamous cell carcinoma (of his tonsils).   On 15th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced headache, sweating, tremor, swelling, chest tenderness, rash and forehead swelling. On an unknown date, the outcome of the headache, swelling, chest tenderness and rash were unknown and the outcome of the sweating and tremor were recovered/resolved and the outcome of the forehead swelling was not recovered/not resolved.   It was unknown if the reporter considered the headache, sweating, tremor, swelling, chest tenderness, rash and forehead swelling to be related to Shingrix.  Additional details were reported as follows: The patient finished chemotherapy for squamous cell carcinoma of his tonsils and for the past two months (before the Shingles vaccine), the patient was put on a G-tube. The patient received Shingrix vaccine in left arm from the healthcare professional office.  The patient reported that 2 weeks after vaccination he  started to have severe headache on the left side of his head, He reported after 2 weeks of receiving the vaccine, he started to experienced sweating, shaking, trembling for 2 hours. The patient reported that the left chest/breast area was swollen and tender to touch still and rash in the left arm pit. The patient also reported a golf ball swelling in the right side of his forehead, which did not resolved. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face, Tremor
Clinical narrative: Left chest/breast area is swollen; Left chest/breast area is / tender to touch still; Rash in the left arm pit; A golf ball swelling in the right side of his forehead; Severe headache on the left side of his head; Sweating / for 2 hours; Shaking, trembling for 2 hours; This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastrostomy tube insertion. Previously administered products included chemotherapy (finished his chemotherapy for squamous cell carcinoma of his tonsils). Concurrent medical conditions included squamous cell carcinoma (of his tonsils).   On 15th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced headache, sweating, tremor, swelling, chest tenderness, rash and forehead swelling. On an unknown date, the outcome of the headache, swelling, chest tenderness and rash were unknown and the outcome of the sweating and tremor were recovered/resolved and the outcome of the forehead swelling was not recovered/not resolved.   It was unknown if the reporter considered the headache, sweating, tremor, swelling, chest tenderness, rash and forehead swelling to be related to Shingrix.  Additional details were reported as follows: The patient finished chemotherapy for squamous cell carcinoma of his tonsils and for the past two months (before the Shingles vaccine), the patient was put on a G-tube. The patient received Shingrix vaccine in left arm from the healthcare professional office.  The patient reported that 2 weeks after vaccination he  started to have severe headache on the left side of his head, He reported after 2 weeks of receiving the vaccine, he started to experienced sweating, shaking, trembling for 2 hours. The patient reported that the left chest/breast area was swollen and tender to touch still and rash in the left arm pit. The patient also reported a golf ball swelling in the right side of his forehead, which did not resolved. The reporter consented to follow up.