chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Bursitis, Condition aggravated, Herpes zoster, Injection site pain
Clinical narrative: first dose / around 08/2018  / had some injection site pain./ arm pain; was not well for maybe less than a day; first dose / around 08/2018 / later / got the second dose / does not remember when / (02/2021) she felt she was getting shingles; Nerve pain; (02/2021) she felt she was getting shingles; left trochanter bundle pain / increased during the night/ nerve pain; Could not sleep; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox, shingles (in May 2018) and nerve pain (right trochanteric occurred in May 2018).   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2021, more than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain femoral, insomnia and nerve pain. On an unknown date, the patient experienced injection site pain and unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and nerve pain were unknown and the outcome of the shingles, injection site pain, unwell, pain femoral and insomnia were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site pain, unwell, pain femoral, insomnia and nerve pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient who was a retired physical therapist. Around August 2018, the patient received the first dose of Shingrix vaccine in her left arm and she had some injection site pain (refer linked case US2021060549). Then later the patient received the second dose of the Shingrix vaccine, she does not remember when, in her left arm and had some injection site pain and she stated she was not well for maybe less than a day.  About a month back (February 2021) she felt she was getting shingles, but she did not have a rash, but had left trochanter bundle pain, which increased during the night and thus could not sleep. This lasted for about 5 nights. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. The patient does not saw a Health care professional (HCP). The reporter did not have Shingrix lot no. The reporter did not want to provide pharmacy information. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021060549:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Malaise, Neuralgia, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: first dose / around 08/2018  / had some injection site pain./ arm pain; was not well for maybe less than a day; first dose / around 08/2018 / later / got the second dose / does not remember when / (02/2021) she felt she was getting shingles; Nerve pain; (02/2021) she felt she was getting shingles; left trochanter bundle pain / increased during the night/ nerve pain; Could not sleep; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox, shingles (in May 2018) and nerve pain (right trochanteric occurred in May 2018).   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2021, more than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain femoral, insomnia and nerve pain. On an unknown date, the patient experienced injection site pain and unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and nerve pain were unknown and the outcome of the shingles, injection site pain, unwell, pain femoral and insomnia were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site pain, unwell, pain femoral, insomnia and nerve pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient who was a retired physical therapist. Around August 2018, the patient received the first dose of Shingrix vaccine in her left arm and she had some injection site pain (refer linked case US2021060549). Then later the patient received the second dose of the Shingrix vaccine, she does not remember when, in her left arm and had some injection site pain and she stated she was not well for maybe less than a day.  About a month back (February 2021) she felt she was getting shingles, but she did not have a rash, but had left trochanter bundle pain, which increased during the night and thus could not sleep. This lasted for about 5 nights. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. The patient does not saw a Health care professional (HCP). The reporter did not have Shingrix lot no. The reporter did not want to provide pharmacy information. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021060549:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles twice after getting the shot; got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient got the shot and he got shingles twice after getting the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Night sweats, Pain
Clinical narrative: Red mark at injection site /  2 inches long and 1 inch wide; Got chills; Body ache / Pain; Fever / had a temperature of 101.9 / 98.7 / 101.6 /  have not resolved; Extreme Fatigue /  have not resolved; Night sweats; 2 COVID tests in 2 different locations / waiting for the results; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   The patient's past medical history included covid-19.   On 10th January 2021 16:30, the patient received the 1st dose of Shingrix. On 10th January 2021, 2 hrs after receiving Shingrix, the patient experienced chills. On 11th January 2021, the patient experienced injection site erythema. In January 2021, the patient experienced general body pain, fever, fatigue, night sweat and suspected covid-19. On an unknown date, the outcome of the injection site erythema, chills, general body pain, fever, fatigue, night sweat and suspected covid-19 were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, chills, general body pain, fever, fatigue, night sweat and suspected covid-19 to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient had Covid 19 on 17th March 2020 until 20th 2020.  7 months after Covid, the patient still had antibodies for Coronavirus.  2 hours later after receiving Shingrix, the patient got chills. On the 2nd day, he had a red mark at the injection site that had a size of 2 inches long and 1 inch wide.  The patient also experienced body ache, pain, fever, fatigue, night sweats.  On the 4th day after the injection, at night, the patient's body temperature was 101.9-degree Celsius.  On 15th January 2021, the patient's body temperature was 98.7-degree Celsius in the morning and 101.6-degree Celsius in the evening.  The patient had extreme fatigue and fever symptoms that had not resolved. The reporter consented to follow up. The reporter provided consent to follow up but refused to provide healthcare professional information. The patient had done a 2 COVID tests in 2 different locations and was waiting for the results.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Red mark at injection site /  2 inches long and 1 inch wide; Got chills; Body ache / Pain; Fever / had a temperature of 101.9 / 98.7 / 101.6 /  have not resolved; Extreme Fatigue /  have not resolved; Night sweats; 2 COVID tests in 2 different locations / waiting for the results; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   The patient's past medical history included covid-19.   On 10th January 2021 16:30, the patient received the 1st dose of Shingrix. On 10th January 2021, 2 hrs after receiving Shingrix, the patient experienced chills. On 11th January 2021, the patient experienced injection site erythema. In January 2021, the patient experienced general body pain, fever, fatigue, night sweat and suspected covid-19. On an unknown date, the outcome of the injection site erythema, chills, general body pain, fever, fatigue, night sweat and suspected covid-19 were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, chills, general body pain, fever, fatigue, night sweat and suspected covid-19 to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient had Covid 19 on 17th March 2020 until 20th 2020.  7 months after Covid, the patient still had antibodies for Coronavirus.  2 hours later after receiving Shingrix, the patient got chills. On the 2nd day, he had a red mark at the injection site that had a size of 2 inches long and 1 inch wide.  The patient also experienced body ache, pain, fever, fatigue, night sweats.  On the 4th day after the injection, at night, the patient's body temperature was 101.9-degree Celsius.  On 15th January 2021, the patient's body temperature was 98.7-degree Celsius in the morning and 101.6-degree Celsius in the evening.  The patient had extreme fatigue and fever symptoms that had not resolved. The reporter consented to follow up. The reporter provided consent to follow up but refused to provide healthcare professional information. The patient had done a 2 COVID tests in 2 different locations and was waiting for the results.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia, Inappropriate schedule of product administration, Paraesthesia oral, Vision blurred
Clinical narrative: Inappropriate schedule of vaccine; experienced blurred vision; Metallic taste in mouth; Tingling of tongue; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, several minutes after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced blurred vision, taste metallic, tingling tongue and incomplete course of vaccination. On an unknown date, the outcome of the blurred vision, taste metallic and tingling tongue were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the blurred vision, taste metallic and tingling tongue to be related to Shingrix.  Additional details were provided as follows: The reporter reported for herself. The patient received 1st dose of Shingrix in left deltoid couple of years ago and within a few minutes of receiving the vaccine, experienced blurred vision, a metallic taste in her mouth and tingling in her tongue. The symptoms lasted about an hour and then resolved. Till the time of reporting, the patient did not receive dose 2 of Shingrix, which led to incomplete course of vaccination. The patient thought her HCP or pharmacist already reported this event. No further information was available. The reporter did not consent to followup.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pruritus
Clinical narrative: fever blisters after the administration of Shingrix / developed fever blisters several days after the second dose administration; itchy but not painful; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number J75L9, expiry date 10th October 2022) for prophylaxis.   On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 5th January 2021, 3 days after receiving Shingrix, the patient experienced fever blister and pruritus. On an unknown date, the outcome of the fever blister and pruritus were unknown.   It was unknown if the reporter considered the fever blister and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 64 or 65 years. The patient received 2nd dose of Shingrix, 20 days prior to date of reporting. The patient developed fever blisters, which were itchy but not painful, several days after the 2nd dose administration. According to healthcare professional the patient had no shingles. The reporter did not want to share personal information for patient. The reporter consented to follow up
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Itching at injection site; swelling at injection site; headache; upset stomach; malaise; fever; at injection site / which radiated to the elbow and the shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on an unknown date, refer case US2021AMR016528).   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 2 hrs after receiving Shingrix, the patient experienced injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities. On an unknown date, the outcome of the injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced swelling at injection site, redness at injection site which radiated to the elbow and the shoulder, itching at injection site, fever, malaise, upset stomach, and headache. The patient stated that the events occurred just over a year ago and had since resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016528:1st dose, same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pyrexia
Clinical narrative: Itching at injection site; swelling at injection site; headache; upset stomach; malaise; fever; at injection site / which radiated to the elbow and the shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on an unknown date, refer case US2021AMR016528).   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 2 hrs after receiving Shingrix, the patient experienced injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities. On an unknown date, the outcome of the injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced swelling at injection site, redness at injection site which radiated to the elbow and the shoulder, itching at injection site, fever, malaise, upset stomach, and headache. The patient stated that the events occurred just over a year ago and had since resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016528:1st dose, same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Rash, Swelling
Clinical narrative: bumps spread from her right breast to her right armpit; Rash; Chills; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 48 hrs after receiving Shingrix, the patient experienced rash, chills and local swelling. On an unknown date, the outcome of the rash and chills were recovered/resolved and the outcome of the local swelling was unknown.   It was unknown if the reporter considered the rash, chills and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after receiving the second Shingrix vaccine approximately two years ago in right arm. The patient had Chills on the day after receiving the vaccination. The chills had resolved by the next day. The patient noticed a rash or bumps on her breast approximately forty eight hours after the vaccination. The bumps spread from her right breast to her right armpit. The Rash lasted approximately ten days. The Rash reappeared approximately four days later and lasted five days. The third time the rash appeared, it lasted approximately three days.  The patient  had the rash three separate times exactly fourteen days apart. Each episode was less severe than the previous one. The patient consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash all over her body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th May 2022) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient suffered of rash all over her body after Shingrix first dose. The pharmacist was looking for common adverse reactions after Shingrix. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Decreased immune responsiveness, Herpes zoster, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Feels that her immune system was made weak; suspected vaccination failure; Diagnosed with shingles on January 15, 2021; tested positive for the COVID virus; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 16th June 2019, the patient received the 2nd dose of Shingrix. On 30th December 2020, not applicable after receiving Shingrix and 563 days after receiving Shingrix, the patient experienced covid-19 virus test positive. On 15th January 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced decreased immune responsiveness. On an unknown date, the outcome of the vaccination failure, shingles, decreased immune responsiveness and covid-19 virus test positive were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The reporter considered the decreased immune responsiveness to be related to Shingrix. It was unknown if the reporter considered the covid-19 virus test positive to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose of Shingrix. The caller reported that she completed the Shingrix series in approximately 1.5 years ago. The patient experienced shingles and felt that her immune system was made weak by the vaccine. On 30th December 2020, the caller reported being tested positive for the COVID virus. The patient reported that got the virus because of taking the vaccine which resulted in getting the shingles. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection was unknown. The reporter consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Coronavirus infection
Clinical narrative: had Covid diagnosis then treated with antibodies; This case was reported by a pharmacist via call center representative and described the occurrence of corona virus infection in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced corona virus infection. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the corona virus infection was unknown.   It was unknown if the reporter considered the corona virus infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Covid diagnosis and then treated with antibodies. The patient was due for the second dose The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Tachycardia 170 bpm for 2 days post 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of tachycardia 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 tachycardia. On an unknown date, the outcome of the tachycardia was unknown.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced tachycardia 170 bpm for 2 days. No additional information was provided. The reporter did not consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, 8 hrs after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's wife. The patient experienced extreme fatigue which reporter described as negative symptoms.   The reporter stated that the fatigue started 8 hours after the vaccination in the patient's right arm and resolved after 12 hours. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2021AMR039223.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021044017:same reporter US-GLAXOSMITHKLINE-US2021AMR039223:same reporter,same patient, same vaccine, different dose (1st dose)
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site / pain; Injection site itchiness / not resolved; Injection site warmth; Headache; Body ache; Fever; Chills; Swollen face / not resolved; Hives / not resolved; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site itching, injection site warmth, headache, general body pain, fever, chills, facial swelling and hives. The patient was treated with benadryl (nos) (Benadryl). In February 2021, the outcome of the injection site pain, injection site warmth, headache, general body pain, fever and chills were recovered/resolved and the outcome of the injection site itching was not recovered/not resolved. On an unknown date, the outcome of the facial swelling and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site warmth, headache, general body pain, fever, chills, facial swelling and hives to be related to Shingrix.  Additional information were provided as follows: The patient received 1st dose of shingrix and experienced headache,body ache, fever,chills, injection site warmth and pain for 2.5 days now those have resolved.  The patient also experienced swollen face ,hives and injection site itchiness,which were not resolved till the time of reporting. The patient had taken benadryl for the treatment of headache, body ache, fever, chills, injection site warmth and pain. The batch number was unknown. The reporter did not consented to follow up. This case was linked with case US2021038381 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021038381:Same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling face, Urticaria
Clinical narrative: Injection site / pain; Injection site itchiness / not resolved; Injection site warmth; Headache; Body ache; Fever; Chills; Swollen face / not resolved; Hives / not resolved; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site itching, injection site warmth, headache, general body pain, fever, chills, facial swelling and hives. The patient was treated with benadryl (nos) (Benadryl). In February 2021, the outcome of the injection site pain, injection site warmth, headache, general body pain, fever and chills were recovered/resolved and the outcome of the injection site itching was not recovered/not resolved. On an unknown date, the outcome of the facial swelling and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site warmth, headache, general body pain, fever, chills, facial swelling and hives to be related to Shingrix.  Additional information were provided as follows: The patient received 1st dose of shingrix and experienced headache,body ache, fever,chills, injection site warmth and pain for 2.5 days now those have resolved.  The patient also experienced swollen face ,hives and injection site itchiness,which were not resolved till the time of reporting. The patient had taken benadryl for the treatment of headache, body ache, fever, chills, injection site warmth and pain. The batch number was unknown. The reporter did not consented to follow up. This case was linked with case US2021038381 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021038381:Same reporter
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Burning sensation, Erythema, Pain
Clinical narrative: blister pumps / upper part of the body, chest, both shoulders / upper part of the back / on the scalp / thin, raised / elongated shape blister; They are red / Red blister; are painful; fever; When brushing my hair / blistera / "busted and have a clear liquid not blood"; burning from the shoulders up / body was on fire from the button of my shoulders up; This case was reported by a consumer via call center representative and described the occurrence of blister in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced blister, erythema, pain, fever, blister rupture and burning sensation. On an unknown date, the outcome of the blister, erythema, pain, fever, blister rupture and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain, fever, blister rupture and burning sensation to be related to Shingrix.  Additional information were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced blister pumps on the upper part of the body, chest, both shoulders and the upper part of the back.  The patient reported that, it has been 10 days to 2 weeks they are mainly on the scalp, red thin, raised, and they are an elongated shape blister,instead of round.  The reporter informed that they are painful and when scratched it was busted,while brushing his hair, it had clear liquid not blood. The patient reported fever and burning from the shoulders up described it as It was like my body was on fire from the button of my shoulders up. The patient stated that he was supposed to get his 2nd dose at the beginning or mid of February 2021. The batch and lot number were unknown. Till the time of reporting , there was nothing from the male breast down and symptoms have not resolved and it was getting worse. The reporter consented to follow up via email.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: blister pumps / upper part of the body, chest, both shoulders / upper part of the back / on the scalp / thin, raised / elongated shape blister; They are red / Red blister; are painful; fever; When brushing my hair / blistera / "busted and have a clear liquid not blood"; burning from the shoulders up / body was on fire from the button of my shoulders up; This case was reported by a consumer via call center representative and described the occurrence of blister in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced blister, erythema, pain, fever, blister rupture and burning sensation. On an unknown date, the outcome of the blister, erythema, pain, fever, blister rupture and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema, pain, fever, blister rupture and burning sensation to be related to Shingrix.  Additional information were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced blister pumps on the upper part of the body, chest, both shoulders and the upper part of the back.  The patient reported that, it has been 10 days to 2 weeks they are mainly on the scalp, red thin, raised, and they are an elongated shape blister,instead of round.  The reporter informed that they are painful and when scratched it was busted,while brushing his hair, it had clear liquid not blood. The patient reported fever and burning from the shoulders up described it as It was like my body was on fire from the button of my shoulders up. The patient stated that he was supposed to get his 2nd dose at the beginning or mid of February 2021. The batch and lot number were unknown. Till the time of reporting , there was nothing from the male breast down and symptoms have not resolved and it was getting worse. The reporter consented to follow up via email.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itching; developed a rash / on the torso, back shoulders and lower abdomen; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received many years before reporting). Concomitant products included hmg coa reductase inhibitors (nos) (Statins).   On 30th November 2020, the patient received the 1st dose of Shingrix. In January 2021, between 2 and 4 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient himself. The patient developed a rash 2 to 3 weeks after the vaccine in the areas where others get the shingles rash. The patient inquired that could it be Shingles or a statin rash. The patient reported that the rash was located on the torso, back shoulders and lower abdomen. Patient reported itching. Patient stated the rash had improved but he still had it. Lot and expiration date not available. Patient did not have HCP phone number. The reporter consented to follow up. Note: Discrepancy in product start date, reported as 30th December 2020 in structure field, however reported as 30th November 2020 in narrative.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Two inch skin discoloration, on each side of her body; This case was reported by a consumer via call center representative and described the occurrence of skin discoloration in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was recovered/resolved.   It was unknown if the reporter considered the skin discoloration to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient reported adverse reactions after 1st dose of Shingrix vaccine was given as a two inch skin discoloration, on each side of her body starting below the underarms and ending just below the panty line. The patient stated that the discoloration started a couple days after receiving Shingrix vaccine and completely disappearing about 2 months after Shingrix vaccine was given. The reporter did not give permission to contact her healthcare professional. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2021AMR047261.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR047261:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Tremor
Clinical narrative: Started to feel cold; Shaking uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunoglobulin g decreased. Concomitant products included immunoglobulin human normal (Gammagard).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling cold and tremor. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the feeling cold and tremor were recovered/resolved.   It was unknown if the reporter considered the feeling cold and tremor to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however could be 76 or 77 years old. The patient had an IgG deficiency and received an infusion of Gammaguard every six to eight weeks. The patient received the second dose of the Shingrix vaccine and she believed it was the next day that she had her Gammaguard infusion. Approximately 1.5 hours into the infusion she started to feel cold and stopped the infusion to go to the restroom. When the patient returned to continue the infusion, she started shaking uncontrollably and was given steroids and other medications (she did not know what they were) to stop the shaking.  She was told it was a reaction to the infusion but she said that she had received the infusion for five years and never had a reaction. The shaking ultimately stopped and she was able to complete the infusion.  When asked if she thought it was shivering she replied that it was not and it was uncontrollable shaking. The reporter gave permission for her physician to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Injection site warmth, Pain
Clinical narrative: Whole body ached; Had a headache all day; Injection site was hot to touch; Bull's eye rash; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th February 2021, less than a day after receiving Shingrix, the patient experienced injection site warmth and injection site rash. On 17th February 2021, the patient experienced general body pain and headache. On an unknown date, the outcome of the injection site warmth, injection site rash, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site rash, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first shot of Shingrix on (16th February)Tuesday morning and on the same day evening he started to have a bulls eye rash near the injection site and the injection site was hot to touch. On the night of 17th February 2021(Wednesday), his whole body ached and he had a headache all day on Wednesday. He did not have any difficulty in breathing. The reporter did not consent to follow-up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash
Clinical narrative: post-herpetic neuralgia, intermittently; pain; rash; This case was reported by a nurse via call center representative and described the occurrence of post herpetic neuralgia in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th September 2020).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced post herpetic neuralgia, pain and rash. On an unknown date, the outcome of the post herpetic neuralgia and pain were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the post herpetic neuralgia, pain and rash to be related to Shingrix.  Additional details were provided as follows: The Nurse practitioner reported that the patient received Shingrix and about 1 week later experienced a rash and pain like Post-herpetic Neuralgia, intermittently. The reporter consented to follow up.  The reporter had no vaccine data because the vaccine was administered at other facility in the US and mentioned that the last time that spoke with patient and had the active condition.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Itching; Redness / primarily on her left arm / had a red patch on her right cheek.; Redness / at the injection site; Swelling, / at the injection site; Burning at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site burning. On an unknown date, the patient experienced pruritus and erythema. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site burning, pruritus and erythema were recovered/resolved.   The reporter considered the injection site erythema, injection site swelling, injection site burning, pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The patient had the first Shingrix vaccine in December, 2020 in her left arm. By that evening, she had swelling, redness ,and burning at the injection site. The Swelling and Burning lasted over one week. The patient also reported itching and redness which lasted for two and one half to three weeks. The redness was primarily on her left arm, but she also had a red patch on her right cheek. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Reaction around her small pox vaccine site / redness; Reaction around her small pox vaccine site / swelling; Reaction around her small pox vaccine site /raised, Inflamed skin; Reaction around her small pox vaccine site / and discolored skin / (not resolved); Reaction around her small pox vaccine site / tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th December 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site inflammation, injection site discoloration and injection site tenderness. On 22nd December 2020, the outcome of the injection site erythema, injection site swelling, injection site inflammation and injection site tenderness were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site inflammation, injection site discoloration and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received 1st dose of Shingrix vaccine and by the evening of 10th December 2020, she began to had a reaction around her small pox vaccine site which included redness, swelling, inflamed skin, raised and discolored skin and tenderness. All of these symptoms lasted about 2 weeks and then resolved except for skin discoloration which still not resolved. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: slight pain in her left shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had episode of Chickenpox.).   On 25th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that she received first dose of Shingrix on 25th-December-2020 on her left arm and developed slight pain in her left shoulder, it lasted for 2days. The reporter had episode of Chickenpox. The reporter did not consent to follow up. This case has been linked to case US2021AMR053770  (had same patient for 2nd dose).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053271:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR053770:same patient, same reporter , 2nd dose US-GLAXOSMITHKLINE-US2021AMR053866:same reporter (husband´s case)