chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-SEP-2014, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 18-DEC-2014, she was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and prednisone for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-JAN-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 21-MAY-2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site cyst, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Concurrent medical conditions included rotator cuff tear and arthritis. Concomitant products included Pravastatin, VALIUM, JANUVIA, LYRICA and NEXIUM. On 26th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site cyst and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site cyst were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the injection site pain, injection site warmth, injection site erythema and injection site cyst to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left arm. The patient received Multivitamin concomitantly. The patient experienced pain, redness and heat at the injection site. The center became mushy inside, like a cyst. Her arm became so sore that she could hardly do anything. The symptoms continued for several weeks, but the pain, heat and mushiness eventually resolved. At the reporting time, the patient had a red area about the size of a small pancake on her arm around the injection site. It was not quite as red as before, but still very distinctive. The contact details of the physician was provided. Follow up information received from physician on 14th June 2018: The 70 to 80 percentage of people experienced mild reaction. Sender's Comments: US2018087748: Previous VAERS submission in paper format.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Concurrent medical conditions included rotator cuff tear and arthritis. Concomitant products included Pravastatin, VALIUM, JANUVIA, LYRICA and NEXIUM. On 26th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site cyst and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site cyst were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the injection site pain, injection site warmth, injection site erythema and injection site cyst to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left arm. The patient received Multivitamin concomitantly. The patient experienced pain, redness and heat at the injection site. The center became mushy inside, like a cyst. Her arm became so sore that she could hardly do anything. The symptoms continued for several weeks, but the pain, heat and mushiness eventually resolved. At the reporting time, the patient had a red area about the size of a small pancake on her arm around the injection site. It was not quite as red as before, but still very distinctive. The contact details of the physician was provided. Follow up information received from physician on 14th June 2018: The 70 to 80 percentage of people experienced mild reaction. Sender's Comments: US2018087748: Previous VAERS submission in paper format.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. On 4th June 2018 14:37, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever and fatigue. On 5th June 2018 15:00, the patient experienced nausea and headache. In June 2018, the patient experienced pain in arm. In June 2018, the patient experienced shivering. The patient was treated with TYLENOL. On 5th June 2018 20:00, the outcome of the headache was recovered/resolved. On 6th June 2018, the outcome of the fever, nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the shivering and pain in arm were recovered/resolved. The reporter considered the shivering, fever, nausea, headache, pain in arm and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient woke up at 1:00 am the next morning shivering (latency 10 hours and 23 minutes) and barely able to get out of bed. She did take some TYLENOL and the shivering subsided after 20 minutes and was gone when she woke up that morning. She had fever on and off during the day on 5th June 2018 but only measured her temperature later in the day when it registered 100 degrees F. She felt it was higher earlier in the day. She had a bit of nausea and developed a headache around 3:00 pm on 5th June 2018 that lasted about 5 hours (latency 1 day and 23 minutes). She said she thought her arm may have hurt (latency less than a week) but it was so secondary to all other events she could not remember. She went to sleep that night and when she awoke of June 6, all symptoms were resolved. The patient usually had a strong reaction to medication as she was only 110 pounds. The patient did say her doctor was unaware she received the vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. On 4th June 2018 14:37, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever and fatigue. On 5th June 2018 15:00, the patient experienced nausea and headache. In June 2018, the patient experienced pain in arm. In June 2018, the patient experienced shivering. The patient was treated with TYLENOL. On 5th June 2018 20:00, the outcome of the headache was recovered/resolved. On 6th June 2018, the outcome of the fever, nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the shivering and pain in arm were recovered/resolved. The reporter considered the shivering, fever, nausea, headache, pain in arm and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient woke up at 1:00 am the next morning shivering (latency 10 hours and 23 minutes) and barely able to get out of bed. She did take some TYLENOL and the shivering subsided after 20 minutes and was gone when she woke up that morning. She had fever on and off during the day on 5th June 2018 but only measured her temperature later in the day when it registered 100 degrees F. She felt it was higher earlier in the day. She had a bit of nausea and developed a headache around 3:00 pm on 5th June 2018 that lasted about 5 hours (latency 1 day and 23 minutes). She said she thought her arm may have hurt (latency less than a week) but it was so secondary to all other events she could not remember. She went to sleep that night and when she awoke of June 6, all symptoms were resolved. The patient usually had a strong reaction to medication as she was only 110 pounds. The patient did say her doctor was unaware she received the vaccine.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Muscular weakness, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness and itchy rash. In June 2018, the patient experienced injection site pain, lower extremities weakness of and dizziness. On 7th June 2018, the outcome of the itchy rash was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the lower extremities weakness of, dizziness and tiredness were unknown. It was unknown if the reporter considered the injection site pain, lower extremities weakness of, dizziness, tiredness and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient receive SHINGRIX in left arm. Less than a week after receiving SHINGRIX, the patient experienced injection site pain which had since resolved. The patient later developed progressive leg weakness, dizziness. The healthcare professional reported that, the patient felt tired and developed an itchy rash on their right forearm, wrist and hand area. Initially spoke to office secretary, who then passed the phone to the physician. The physician did not want to share further information. The office secretary stated that, the vaccine was administered at another facility.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness and itchy rash. In June 2018, the patient experienced injection site pain, lower extremities weakness of and dizziness. On 7th June 2018, the outcome of the itchy rash was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the lower extremities weakness of, dizziness and tiredness were unknown. It was unknown if the reporter considered the injection site pain, lower extremities weakness of, dizziness, tiredness and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient receive SHINGRIX in left arm. Less than a week after receiving SHINGRIX, the patient experienced injection site pain which had since resolved. The patient later developed progressive leg weakness, dizziness. The healthcare professional reported that, the patient felt tired and developed an itchy rash on their right forearm, wrist and hand area. Initially spoke to office secretary, who then passed the phone to the physician. The physician did not want to share further information. The office secretary stated that, the vaccine was administered at another facility.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: The reporter was the patient's friend. The age at vaccination was not reported. The patient after vaccination with SHINGRIX experienced a very bad reaction. The caller wished to remain anonymous and declined to provide specifics regarding the patient. The reporter did take down the GlaxoSmithKline response center phone number, to give to the patient, so that she could call and provide the details for the events she experienced. The patient has denied permission to contact their physician.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Extensive swelling of vaccinated limb, Lymphoedema, Pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 75-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 20th May 2019) for prophylaxis. The patient's past medical history included mastectomy (one on left breast 30 years ago and one on right breast 12 years ago), breast cancer (previous diagnosis on both sides) and breast implant user (one silicone and one saline breast implant). Previously administered products included PREVENAR (received previously) and flu shot (in fall 2017). Concurrent medical conditions included hypertension. Concomitant products included Calcitonin Nasal Spray, hydrochlorothiazide, nifedipine, raloxifene, TOPROL, trospium and PLAQUENIL. On 6th May 2018, the patient received the 1st dose of SHINGRIX. On 6th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 9th May 2018, the patient experienced extensive swelling of vaccinated limb. In May 2018, the patient experienced lymphedema. On an unknown date, the outcome of the extensive swelling of vaccinated limb was not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the lymphedema was unknown. The reporter considered the extensive swelling of vaccinated limb, pain and lymphedema to be probably related to SHINGRIX. Additional details were reported as follows: At 10:00 AM, the patient received SHINGRIX in left arm. On Wednesday or Thursday, the patient developed what she believed was lymphedema. Her arm was swollen from her shoulder to her wrist. She claimed that she put on a long sleeve top and it felt tight on her arm and then she noticed that her left arm was 1.5 times larger than her right arm. She was referred to a physical therapist for treatment. She also reported that the first day she felt achy during the day and it hurt to roll over at night but by the next afternoon, everything was fine. She had a CAT scan done after she experienced swelling and it showed no abnormalities and her silicone and saline implants were in place and fine. She had the CAT scan to rule out a cancer recurrence.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis A antibody positive, Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a adult female patient who received TWINRIX (batch number AHABB251AA, expiry date 30th May 2014) for prophylaxis. Co-suspect products included TWINRIX (batch number AHABB251AA, expiry date 30th May 2014) for prophylaxis, TWINRIX (batch number AHABB251AA, expiry date 30th May 2014) for prophylaxis and HEPATITIS B VACCINE for prophylaxis. On 13th November 2012, the patient received the 1st dose of TWINRIX. On 14th December 2012, the patient received the 2nd dose of TWINRIX. On 14th May 2013, the patient received the 3rd dose of TWINRIX. In February 2014, the patient received HEPATITIS B VACCINE. In June 2018, unknown after receiving TWINRIX, TWINRIX and TWINRIX, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the outcome of the therapy non-responder, hepatitis b antibody negative, therapy non-responder and hepatitis b antibody negative were unknown. It was unknown if the reporter considered the therapy non-responder, hepatitis b antibody negative, therapy non-responder and hepatitis b antibody negative to be related to TWINRIX, TWINRIX and TWINRIX. Additional details were provided as follows: This case was reported by the office manager. The healthcare professional reported that after vaccination with 3 doses of TWINRIX, they tested the levels and the patient was positive for Hepatitis A titers but was borderline for Hepatitis B titers. Thus leading the patient to be a therapy non-responder. So they gave a booster dose of the Merck brand Hepatitis B in February 2014 and they re-drew the levels in June of the reporting year and the patient was still borderline for Hepatitis B titers. Thus, again leading the patient to be therapy non-responder. It was unclear if the reported batch number AHABB251AA for TWINRIX corresponded 1st, 2nd or 3rd dose of the vaccine or it belongs to all doses of vaccine. Lab Comments: On unknown date, the patient underwent hepatitis A antibody and hepatitis B antibody test.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 55-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concomitant products included Atorvastatin and hydrochlorothiazide. On 10th June 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, injection site erythema, feelings of weakness, tiredness and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, feelings of weakness, tiredness and chills were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site rash, injection site pain, injection site erythema, feelings of weakness, tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. At the time of the injection (immediately), the patient commented that the injection itself was painful. The patient returned to the pharmacy on the date of reporting, and was feeling under the weather with complaints of being tired, having chills and feeling limp like a noodle (feelings of weakness). There was a large rash that was very red at the injection site. It was about 3 inches long and 2.5 inches wide and was painful to the touch. The patient stated that, it felt like a burn.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 55-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concomitant products included Atorvastatin and hydrochlorothiazide. On 10th June 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, injection site erythema, feelings of weakness, tiredness and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, feelings of weakness, tiredness and chills were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site rash, injection site pain, injection site erythema, feelings of weakness, tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. At the time of the injection (immediately), the patient commented that the injection itself was painful. The patient returned to the pharmacy on the date of reporting, and was feeling under the weather with complaints of being tired, having chills and feeling limp like a noodle (feelings of weakness). There was a large rash that was very red at the injection site. It was about 3 inches long and 2.5 inches wide and was painful to the touch. The patient stated that, it felt like a burn.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Vitamins. On 10th May 2018, the patient received the 1st dose of SHINGRIX. On 11th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. The reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: The reporter was the patient herself. The reporter reported that, two weeks after the vaccination the events improved but till the time of reporting, the outline of the circle where it was swollen was still visible. This case was linked to case US2018105432, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX. On 11th May 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness and feeling unwell. On 12th May 2018, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the feeling unwell was recovered/resolved. The reporter considered the tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient's spouse (wife). The patient took vitamins as a concomitant medication. The reporter stated that after vaccination the patient experienced tiredness for two days. The patient felt exhausted and didn't feel well and spent two days on the couch and then the event resolved. This case was linked to case US2018105431, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 75-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. On 31st May 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced erythema, blister and pain. On 8th June 2018, the outcome of the blister and pain were recovered/resolved. On an unknown date, the outcome of the erythema was recovered/resolved. The reporter considered the erythema to be almost certainly related to SHINGRIX. The reporter considered the blister and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. The day after the injection, the area about 5 to 7 inches below the injection site became red and sore. As the redness started to improve, the soreness also started to resolve. A blister about the size of a nickel developed within the redness. It took about 7 to 8 days for all symptoms to resolve. The registered pharmacist was transferred to MI on whether or not patient should receive 2nd dose based on her reaction to the first dose.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingle vaccine (received several years before the reporting date, without adverse events). Concurrent medical conditions included eye dryness. Concomitant products included RESTASIS, Simvastatin, Aspirin and MYRBETRIQ. On 10th June 2018, the patient received the 1st dose of SHINGRIX. On 11th June 2018, 1 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovered/resolved. The reporter considered the hives to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient reported that, around noon on Sunday, she received the SHINGRIX vaccine on left arm. The patient noticed on Monday that she had hives on her arms, bottom and back. The patient called her physician and he told her to take BENADRYL and it cleared up a little bit but came back over night. The night before reporting date, she took BENADRYL again at night and her hives cleared up in morning of reporting day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. The reporter considered the injection site reaction to be probably related to SHINGRIX. Additional details were provided as follows: The patient received her first dose of SHINGRIX in March or April 2018 and experienced a reaction at the injection site. For tolerance to the 2nd dose of SHINGRIX vaccine, refer case US2018GSK111506 reported for the same patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Rash, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to the 1st dose received 2 and half months ago refer case US2018GSK111694). Concomitant products included gabapentin and trazodone. On 22nd May 2018 14:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th June 2018, 20 days after receiving SHINGRIX, the patient experienced rash, redness, itching, blisters, facial swelling and burning skin. The patient was treated with VALTREX. On an unknown date, the outcome of the rash, redness, itching, blisters, facial swelling and burning skin were not recovered/not resolved. It was unknown if the reporter considered the rash, redness, itching, blisters, facial swelling and burning skin to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced a rash and blisters accompanied with redness, burning, itching, and swelling on entire left side of her face going down to her chin. The patient stated that it was covering about 75 percent of the left side of her face. The patient called her doctor on 12th June 2018 and sent her pictures of the rash. The patient was currently taking VALTREX that her doctor called in to the pharmacy on 12th June 2018. The patient stated the rash was still getting worse. No further details were provided.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to the 1st dose received 2 and half months ago refer case US2018GSK111694). Concomitant products included gabapentin and trazodone. On 22nd May 2018 14:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th June 2018, 20 days after receiving SHINGRIX, the patient experienced rash, redness, itching, blisters, facial swelling and burning skin. The patient was treated with VALTREX. On an unknown date, the outcome of the rash, redness, itching, blisters, facial swelling and burning skin were not recovered/not resolved. It was unknown if the reporter considered the rash, redness, itching, blisters, facial swelling and burning skin to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced a rash and blisters accompanied with redness, burning, itching, and swelling on entire left side of her face going down to her chin. The patient stated that it was covering about 75 percent of the left side of her face. The patient called her doctor on 12th June 2018 and sent her pictures of the rash. The patient was currently taking VALTREX that her doctor called in to the pharmacy on 12th June 2018. The patient stated the rash was still getting worse. No further details were provided.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (received several years ago with no side effects). Concomitant products included Atorvastatin and irbesartan. On 10th June 2018, the patient received the 1st dose of SHINGRIX. On 12th June 2018, 2 days after receiving SHINGRIX, the patient experienced hives. On 13th June 2018, the outcome of the hives was recovered/resolved. The reporter considered the hives to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The patient received the SHINGRIX vaccine at around noon. The patient experienced bumps on his arms which the reporter believed are hives. The hives had cleared up on the day of reporting. The reporter stated that, her husband was not home to provide additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Incomplete course of vaccination, Pharyngeal oedema, Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction, swollen tongue and throat swelling. On an unknown date, the outcome of the allergic reaction, swollen tongue and throat swelling were unknown. It was unknown if the reporter considered the allergic reaction, swollen tongue and throat swelling to be related to SHINGRIX. Additional information was reported as follows: The reporter reported that, she had a patient who developed an allergic reaction to SHINGRIX, so instead of getting vaccinated with her 2nd dose of SHINGRIX, the doctor recommended her to receive a ZOSTAVAX shot instead. The patient experienced throat and tongue swollenness. No additional information was reported. The dose of SHINGRIX was not administered at the reporter's pharmacy.
Sex: U
Vaccine: MENB
Symptoms: Headache, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized muscle aches in a patient who received BEXSERO for prophylaxis. On 12th June 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 12th June 2018, less than a day after receiving BEXSERO, the patient experienced generalized muscle aches and headache. On 13th June 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the generalized muscle aches was unchanged. It was unknown if the reporter considered the generalized muscle aches and headache to be related to BEXSERO. Additional information was received as follows: This case was reported by a Medical Assistant. The age at vaccination was not reported. The patient received BEXSERO on the left deltoid. The patient experienced full body muscle aches. The reporter did not have the lot number, expiration date or the patient information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (in 1988). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: This report was received via healthcare professional (HCP) only email forum. The patient noted that, she was not an HCP but that was the only way to contact GlaxoSmithKline. The age at vaccination was not reported. But, it could be 70 or 71 years old. The patient had local reaction described as unpleasant local swelling, soreness, and severe itchiness. The patient further stated that, the redness and swelling at the site was 2.5 inches in diameter and it was worst. The reaction began to develop in the morning of the day after vaccination and grew for at least 8 days. The patient stated that, the events lasted for 2 weeks and she never had shingles. No further information was provided. For tolerance after the 2nd dose of SHINGRIX for this patient, refer case US2018107167.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (in 1988). Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: This report was received via healthcare professional (HCP) only email forum. The patient noted that, she was not an HCP but that was the only way to contact GlaxoSmithKline. The age at vaccination was not reported. But, it could be 70 or 71 years old. The patient received the 2nd dose of SHINGRIX with exactly 2 months apart from the 1st dose. The patient had local reaction described as unpleasant local swelling, soreness, and severe itchiness. The patient further stated that, the redness and swelling at the site was 2.5 inches in diameter and it was worst. The reaction began to develop in the morning of the day after vaccination and grew for at least 8 days. The patient stated that, the events lasted for 2 weeks and she never had shingles. No further information was provided. For tolerance after the 1st dose of SHINGRIX for this patient, refer case US2018107157.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth and red blotches. On an unknown date, the outcome of the injection site pain, injection site warmth and red blotches were unknown. The reporter considered the injection site pain, injection site warmth and red blotches to be probably related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with SHINGRIX a little over a week ago, before the date of reporting. The patient came to the pharmacy before the date of reporting because the injection site was still sore and warm. The patient also experienced red blotches under the injection site. Other information was not available at the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date unknown) for prophylaxis. Concomitant products included B12 Injection. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, injection site swelling and injection site erythema. On 30th March 2018, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching, injection site warmth, injection site pain, injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site itching, injection site warmth, injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received SHINGRIX vaccine on her right arm around 11:37 am. At the time of vaccination she was on maintenance medications and she had a B12 injection on 26th March 2018. The patient experienced swelling and redness at the injection site that was hot with pain. The pain and swelling occurred the day after the vaccination and then the patient had itching two to three days later.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccine with an associated reaction of pyrexia (see link case US2018GSK111713 for the same patient). On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, chills, fever and injection site pain. On 12th June 2018, the patient experienced tiredness. In June 2018, the patient experienced influenza. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the tiredness, injection site pain and influenza were recovering/resolving and the outcome of the chills and fever were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, tiredness, chills, fever, injection site pain and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient received SHINGRIX this past Monday. That evening she had soreness and pink coloring at the injection site. She also noted fever and chills on Monday evening but those had resolved till the time of reporting. Tuesday was the worst day she stated, noting she slept in her car at lunch due to being tired, the redness and soreness were worse. She stated the soreness and redness and warmth of the area were now below the actual injection site, she describes like a streak that is 3 to 4 inches long and about an inch wide. The redness had gotten more red and the soreness was less. She noted she called and reported this to her physician office, but they did not seem to be concerned. She also noted a history of fever, chills and soreness at the injection site with flu vaccine from unknown manufacturer. She noted her last flu vaccine was a couple of years ago when they combined with the swine flu. That was the worst of her reactions and she had not gotten one since. This case has been linked with US2018GSK111713, reported for the same patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccine with an associated reaction of pyrexia (see link case US2018GSK111713 for the same patient). On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, chills, fever and injection site pain. On 12th June 2018, the patient experienced tiredness. In June 2018, the patient experienced influenza. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the tiredness, injection site pain and influenza were recovering/resolving and the outcome of the chills and fever were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, tiredness, chills, fever, injection site pain and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient received SHINGRIX this past Monday. That evening she had soreness and pink coloring at the injection site. She also noted fever and chills on Monday evening but those had resolved till the time of reporting. Tuesday was the worst day she stated, noting she slept in her car at lunch due to being tired, the redness and soreness were worse. She stated the soreness and redness and warmth of the area were now below the actual injection site, she describes like a streak that is 3 to 4 inches long and about an inch wide. The redness had gotten more red and the soreness was less. She noted she called and reported this to her physician office, but they did not seem to be concerned. She also noted a history of fever, chills and soreness at the injection site with flu vaccine from unknown manufacturer. She noted her last flu vaccine was a couple of years ago when they combined with the swine flu. That was the worst of her reactions and she had not gotten one since. This case has been linked with US2018GSK111713, reported for the same patient.