chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, 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 erythema in a 67-year-old female patient who received Shingrix for prophylaxis. On 21st August 2018, the patient received the 1st dose of Shingrix (intramuscular). In August 2018, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site lump, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site lump, injection site pain and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site lump, injection site pain and injection site warmth to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left arm. The reporter stated that, she received Shingrix vaccine and noticed the injection site had a red 2 inch circle that had been hot to the touch, felt like a lump and was sore. The symptoms started within 24 hours of receiving vaccine. The symptoms of hot to touch, soreness, and lump had resolved. The patient had provided address detail of there physician. This case has been linked with case US2018165374, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient was 69 to 70 years old at the time of reporting. The caller stated that her friend experienced a red circle at the injection site that resolved in 3 days. This case has been linked with case US2018165372, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injected limb mobility decreased, Musculoskeletal pain, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 64-year-old male patient who received Shingrix for prophylaxis. The patient's past medical history included shoulder operation. Previously administered products included Shingrix (1st dose received on an unknown date, without adverse events). On 10th September 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 10th September 2018, 4 hrs after receiving Shingrix, the patient experienced shoulder pain, nausea, general body pain, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the shoulder pain was recovering/resolving and the outcome of the nausea, general body pain and pain in arm were not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the shoulder pain, nausea, general body pain, injected limb mobility decreased and pain in arm to be related to Shingrix. Additional details were provided as follows: At 11:00, the patient received Shingrix on the left arm. The patient stated that, at 15:00, his whole arm was throbbing and very painful. The patient had a major surgery on his shoulder about 2 years ago with multiple tendon reattachments and 4 screws and this pain from the vaccine was worse than that. The patient also felt nausea and body ache which have not changed. The 1st day, the patient was unable to move his arm at all. The patient was able to move it a little bit at the time of report. The burning pain he had for the first 24 hours had gone away but it was still very painful. The patient asked for help and requested to call back.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 64-year-old male patient who received Shingrix for prophylaxis. The patient's past medical history included shoulder operation. Previously administered products included Shingrix (1st dose received on an unknown date, without adverse events). On 10th September 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 10th September 2018, 4 hrs after receiving Shingrix, the patient experienced shoulder pain, nausea, general body pain, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the shoulder pain was recovering/resolving and the outcome of the nausea, general body pain and pain in arm were not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the shoulder pain, nausea, general body pain, injected limb mobility decreased and pain in arm to be related to Shingrix. Additional details were provided as follows: At 11:00, the patient received Shingrix on the left arm. The patient stated that, at 15:00, his whole arm was throbbing and very painful. The patient had a major surgery on his shoulder about 2 years ago with multiple tendon reattachments and 4 screws and this pain from the vaccine was worse than that. The patient also felt nausea and body ache which have not changed. The 1st day, the patient was unable to move his arm at all. The patient was able to move it a little bit at the time of report. The burning pain he had for the first 24 hours had gone away but it was still very painful. The patient asked for help and requested to call back.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Shingrix (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 26th April 2018, the patient received the 1st dose of Shingrix (intramuscular). In April 2018, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Around 3 days after vaccination, the patient developed shingles. The patient was seen by her doctor and was prescribed unknown treatment.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Colonoscopy, Endoscopy, Malaise, Pain in extremity, Tooth extraction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included colonoscopy (performed on 23rd August 2018), tooth extraction (in June 2018), sickness (in Jul 2018) and endoscopy (on 23rd August 2018). Concurrent medical conditions included pinched nerve, neck pain (she has arthritis in the neck) and upset stomach. On 21st May 2018, the patient received the 1st dose of Shingrix. On 21st May 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at administration was 75 years old. The patient received Shingrix on the left arm. The patient experienced sore arm. The patient planned to receive the 2nd dose of Shingrix on the day of reporting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, 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 pain in a 69-year-old female patient who received Shingrix for prophylaxis. On 8th September 2018 18:00, the patient received the 1st dose of Shingrix (subcutaneous). On 8th September 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In September 2018, the patient experienced injection site pain and injection site erythema. In September 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix. Additional details were reported as follows: The reporter was a patient. The reporter stated that, she was administered a dose of Shingrix vaccine subcutaneously in right arm, which led to inappropriate route of administration. The pharmacist pinched a small area on the back of the arm and that was where the vaccine was administered. The patient experienced redness at the injection site which was 3 inches by 2 inches in area. The patient gave permission to contact her health care provider. No further details were provided. This case was link with case US2018165448 (fiancé's case), reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, 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 69-year-old female patient who received Shingrix (batch number CH2X7, expiry date 25th April 2020) and (batch number D3G59, expiry date unknown) for prophylaxis. On 9th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site rash and pruritus. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the pruritus was not recovered/not resolved. It was unknown if the reporter considered the injection site rash and pruritus to be related to Shingrix. Additional details were provided as follows: The patient received the first dose of Shingrix and beginning an unknown date, the patient experienced a mild rash in the injection site area which lasted a few weeks and was resolved at the time of the report. The patient also experienced itching which remained ongoing at the time of the reporting.
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Coordination abnormal, Feeling abnormal, Irritability, Personality change
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of lack of coordination in a male patient who received FLULAVAL QUADRIVALENT (batch number 972F3, expiry date 13th June 2019) for prophylaxis. Concomitant products included ZOLOFT. On 6th September 2018, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 7th September 2018, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced lack of coordination, personality change, feeling abnormal, anxiety and irritability. On an unknown date, the outcome of the lack of coordination, personality change, feeling abnormal, anxiety and irritability were not recovered/not resolved. It was unknown if the reporter considered the lack of coordination, personality change, feeling abnormal, anxiety and irritability to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The patient developed lack of focus, anxiety, crankiness, out of sorts feeling, and a personality shift the day after receiving the vaccine. The patient was not feeling better. Both health care professional and coworker were taking ZOLOFT and health care professional was concerned about potential drug interaction between ZOLOFT and the FLULAVAL. This was one of the 3 cases reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 73-year-old female patient who received Shingrix (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 2nd July 2018, the patient received Shingrix (intramuscular). On 5th July 2018, 3 days after receiving Shingrix, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was not recovered/not resolved. It was unknown if the reporter considered the leg pain to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in right arm. The healthcare professional confirmed lot number as C523T, but they were initially unsure due to handwritten information being unclear.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, 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 pain in a 72-year-old male patient who received Shingrix for prophylaxis. On 8th September 2018 18:30, the patient received the 1st dose of Shingrix (subcutaneous). On 8th September 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In September 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix. Additional details were reported as follows: The reporter reported this case for her fiancé. The pharmacist pinched a small area on the back of the arm and that where the vaccine administered. The patient experienced redness at the injection site, which was 3 inches by 2 inches in area. The reporter stated that, the patient was administered a dose of Shingrix vaccine subcutaneously in left arm, which led to inappropriate route of administration. The patient gave permission to contact her health care provider. No further details were provided. This case was link with case US2018165440, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a patient who received Bexsero for prophylaxis. On an unknown date, the patient received Bexsero (intramuscular) .5 ml. On an unknown date, immediately after receiving Bexsero, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Bexsero. Additional details were reported as follows: The age at vaccination was not applicable. During the conversation, the physician reported that in general, she had seeing hurting at the injection site when giving Bexsero to the patients. The reporter did not provide specific details of the patients. This case was link with case US2018165454, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 64-year-old female patient who received Shingrix (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 24th April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced blister and vesicular rash. On an unknown date, the outcome of the blister and vesicular rash were recovered/resolved. It was unknown if the reporter considered the blister and vesicular rash to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on the left arm. In 2018, the patient developed blisters on the neck area. As per the pharmacist it looked like the patient developed shingles like symptoms. A definitive diagnosis of shingles was not made. The patient had completely recovered from the blisters. No further data was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a adult female patient who received Shingrix (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. The healthcare professional (HCP) stated that the patient had grade 3 chills and shivering for 3 hours following  a dose of Shingrix. No further information was provided by HCP.
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a adult male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient experienced chills. No details were provided by healthcare professional.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received Shingrix (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema, fatigue and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the injection site erythema, fatigue and injection site pain to be related to Shingrix. Additional details were reported as follows: This case was previously reported to the physician. Approximately 2 to 3 weeks before the dater of reporting, the patient received a dose of Shingrix in left arm. The patient experienced redness and pain at the injection site, which resolved. However, at the time of reporting, the patient was still experiencing fatigue. This case was transferred to medial information. The reporter was unable to provide additional information.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 69-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Paracetamol (hives and rash), morphine (nausea), erythromycin (hives and rash), sulfa (hives and rash) and prednisone (hives and rash). On 9th May 2018, the patient received the 1st dose of Shingrix. On 10th May 2018, 1 days after receiving Shingrix, the patient experienced injection site rash and injection site itching. The patient was treated with Benadryl. On an unknown date, the outcome of the injection site rash and injection site itching were recovering/resolving. It was unknown if the reporter considered the injection site rash and injection site itching to be related to Shingrix. Additional details were provided as follows: The reporter was not sure if this was related to the product or not, but reported she had a constant itching and rash area of her right upper arm that began one day after vaccination on 10th May 2018. She stated it had improved but not resolved. She was using Benadryl cream at night. Reporter did not have paperwork on the vaccination dose, site or route of the product, but noted she believed it was in the fatty part toward the back of her right upper arm. She had notified her physician of the events.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Shingrix (batch number DD43M, expiry date March 2019) for prophylaxis. On 8th September 2018, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 8th September 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 9th September 2018, the patient experienced injection site erythema. On 11th September 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. Additional details were reported as follows: The healthcare professional stated the patient was inadvertently administered Shingrix vaccine subcutaneously instead of the indicated intramuscular, which led to incorrect route of vaccine administration. A red injection site reaction developed the day after vaccination. This case has been linked with US2018165485, reported by same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Shingrix (batch number DD43M, expiry date March 2019) for prophylaxis. On 8th September 2018, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 8th September 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 9th September 2018, the patient experienced injection site erythema. On 11th September 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema to be related to Shingrix. Additional details were reported as follows: The healthcare professional stated the patient was inadvertently administered Shingrix vaccine subcutaneously instead of the indicated intramuscular, which led to incorrect route of vaccine administration. A red injection site reaction developed the day after vaccination. This case has been linked with US2018165484, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Myalgia, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2018, 1 days after receiving Shingrix, the patient experienced fever, feeling unwell and pain in arm. On 13th September 2018, the patient experienced localized erythema and itchy skin. In September 2018, the patient experienced muscle soreness. The patient was treated with Tylenol. On an unknown date, the outcome of the fever, feeling unwell and pain in arm were not recovered/not resolved and the outcome of the localized erythema and itchy skin were recovering/resolving and the outcome of the muscle soreness was unknown. It was unknown if the reporter considered the fever, feeling unwell, pain in arm, localized erythema, itchy skin and muscle soreness to be related to Shingrix. Additional details were provided as follows: At 17:35 hours in the evening, the patient received Shingrix on left arm. The patient experienced fever (the patient's body temperature was recorded as 100.2 degree F). The patient stated that her normal body temperature was 97.6 degree F. On 11th Septmber 2018, 1 days after vaccination, the patient woke up in the mroning and said her arm was very sore. On 13th September 2018, in the morning after shower, 3 days after vaccination, the patient noticed a red patch of skin about 2 to 3 inches below the injection site. It was a little itchy as well. It was shrinking and the redness was fading at the time of reporting. In September 2018, less than a week after receiving Shingrix, the patient experienced some muscle soreness which was ongoing at the time of reporting. The patient had been received Tylenol. The patient had denied permission to contact their physician. The patient wanted to know, if the vaccine was the cause of this patch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2018, 1 days after receiving Shingrix, the patient experienced fever, feeling unwell and pain in arm. On 13th September 2018, the patient experienced localized erythema and itchy skin. In September 2018, the patient experienced muscle soreness. The patient was treated with Tylenol. On an unknown date, the outcome of the fever, feeling unwell and pain in arm were not recovered/not resolved and the outcome of the localized erythema and itchy skin were recovering/resolving and the outcome of the muscle soreness was unknown. It was unknown if the reporter considered the fever, feeling unwell, pain in arm, localized erythema, itchy skin and muscle soreness to be related to Shingrix. Additional details were provided as follows: At 17:35 hours in the evening, the patient received Shingrix on left arm. The patient experienced fever (the patient's body temperature was recorded as 100.2 degree F). The patient stated that her normal body temperature was 97.6 degree F. On 11th Septmber 2018, 1 days after vaccination, the patient woke up in the mroning and said her arm was very sore. On 13th September 2018, in the morning after shower, 3 days after vaccination, the patient noticed a red patch of skin about 2 to 3 inches below the injection site. It was a little itchy as well. It was shrinking and the redness was fading at the time of reporting. In September 2018, less than a week after receiving Shingrix, the patient experienced some muscle soreness which was ongoing at the time of reporting. The patient had been received Tylenol. The patient had denied permission to contact their physician. The patient wanted to know, if the vaccine was the cause of this patch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swollen thumb in a 55-year-old female patient who received Shingrix for prophylaxis. On 6th September 2018, the patient received the 1st dose of Shingrix .5 ml. On 9th September 2018, 3 days after receiving Shingrix, the patient experienced swollen thumb, pain in thumb, injection site pain and injection site swelling. On an unknown date, the outcome of the swollen thumb, pain in thumb, injection site pain and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the swollen thumb, pain in thumb, injection site pain and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right deltoid. The patient's soreness was little around the injection site and but mostly at the base of her right thumb. The patient said that it felt swollen more than it looks swollen (not specified if around the injection site or thumb).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a female patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix (intramuscular). In July 2018, immediately after receiving Shingrix, the patient experienced light headedness, tiredness and pain in arm. On an unknown date, the outcome of the light headedness, tiredness and pain in arm were recovered/resolved. It was unknown if the reporter considered the light headedness, tiredness and pain in arm to be related to Shingrix. Additional information was reported as follows: The batch number for Shingrix was not reported. In July 2018 at 12:00, exactly two months before the date of reporting, the patient was vaccinated with the 1st dose of Shingrix. Less than a day after vaccination with Shingrix, the patient experienced pain in arm. One day after vaccination with Shingrix, the patient felt extremely tired and it lasted for a week to a week and a half before resolving. The patient experienced extreme arm soreness, which lasted for a week. The patient's husband experienced the same symptoms, in the same time frame.  This case was linked to case US2018165509 (husband case), reported by the same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a male patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix. In July 2018, immediately after receiving Shingrix, the patient experienced light headedness, tiredness and pain in arm. On an unknown date, the outcome of the light headedness, tiredness and pain in arm were recovered/resolved. It was unknown if the reporter considered the light headedness, tiredness and pain in arm to be related to Shingrix. Additional information was reported as follows: The case was reported by patient's wife. The batch number for Shingrix was not reported. In July 2018 at 12: 00, exactly two months before the date of reporting, the patient was vaccinated with the 1st dose of Shingrix. Less than a day after vaccination with Shingrix, the patient experienced arm soreness. 1 day after vaccination with Shingrix, the patient felt extremely tired and it lasted for a week to a week and a half before resolving. The patient experienced extreme arm soreness, which lasted for a week. This case was linked to case US2018165505 (wife's case) reported by the same reporter and with case US2018GSK171293 (dose 2) reported by the same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) in own words reported that the Shingrix was given in arm. The reporter was requested by another patient for getting the vaccine in the gluteal region. The reporter was asking was there any reason why it could not be given in the gluteal region. The patient's deltoid region was extremely sore and therefore several patients were wanting to avoid the sore arm. The reporter would relay that on when the issue arises. The HCP disconnected chat right after that so unable to get any follow up questions to HCP.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 71-year-old female patient who received Shingrix for prophylaxis. On 26th July 2018, the patient received Shingrix. On 26th July 2018, 1 hr after receiving Shingrix, the patient experienced heart rate increased. The patient was treated with Benadry). On an unknown date, the outcome of the heart rate increased was recovered/resolved. It was unknown if the reporter considered the heart rate increased to be related to Shingrix. Additional details were provided as follows: The patient experienced a rapid heart rate. She defined this as 120 to 130 bpm. Twenty four hours later, it was still present. She contacted her pharmacist. The pharmacist advised to take a Benadryl, which the patient did. The patient reported that the Benadryl worked and her heart rate returned to normal. The patient had denied permission to contact their physician.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 61-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain and influenza-like symptoms. On an unknown date, the outcome of the pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain and influenza-like symptoms to be related to Shingrix. Additional information was received as follows: This case was not previously reported to anyone. The reporter described that he received the first dose of Shingrix (right arm) in May or June of 2018. The reporter stated that he had symptoms to include achiness, pain and flu-like symptoms that resolved within 4 days. The reporter gave permission for his physician (cardiologist) to be contacted. The reporter was not able to provide full address of the physician. For tolerance to next dose, refer case US2018GSK168383.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received Bexsero for prophylaxis. On 12th September 2018 10:00, the patient received the 1st dose of Bexsero (intramuscular). On 12th September 2018, less than a day after receiving Bexsero, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. It was unknown if the reporter considered the injection site pain to be related to Bexsero. Additional details were provided as follows: The case was reported by the patient's mother. The reporter stated that her daughter received a dose of Bexsero and was experiencing soreness at injection site. The patient's mother had denied permission to contact their physician. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Shingrix for prophylaxis. On 5th June 2018, the patient received the 1st dose of Shingrix. On 5th June 2018, couple of hours after receiving Shingrix, the patient experienced injection site pain. On 9th June 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported, but it could be 76 or 77 years. The patient experienced soreness at the injection site within a few hours and persisted for 3 to 4 days. The event was resolved without sequelae. The patient denied permission to contact their physician. The patient declined to provide any contact information for follow-up including date of birth. The patient did not have lot number or expiry date of the vaccine. This case was one of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Shingrix for prophylaxis. On 5th June 2018, the patient received the 1st dose of Shingrix. On 5th June 2018, couple of hours after receiving Shingrix, the patient experienced injection site pain. On 9th June 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced soreness at the injection site within a few hours and persisted for 3 to 4 days. The event was resolved without sequelae. The patient denied permission to contact their physician. The reporter declined to provide any contact information for follow-up including patient identifiers. The reporter did not have lot number or expiry date of the vaccine. This case was one of the 2 cases, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Shingrix (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of Shingrix. On 20th July 2018, 38 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The healthcare professional reported that after receipt of 1st dose of Shingrix a patient developed shingles the following month.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Premature delivery, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of premature delivery in a 27-year-old female patient who received BOOSTRIX for prophylaxis. On 5th October 2017, the patient received BOOSTRIX (intramuscular). The patient's last menstrual period was on 20th August 2017 and estimated date of delivery was 11th May 2018. The patient received BOOSTRIX at week 6 of the pregnancy and during the first trimester of pregnancy. On 8th February 2018, 126 days after receiving BOOSTRIX, the patient experienced premature delivery (serious criteria hospitalization). On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the premature delivery and vaccine exposure during pregnancy were unknown. The pregnancy ended in a stillbirth at greater than 22 weeks gestation with no apparent congenital anomaly present. On 8th February 2018 after 24 weeks and 4 days, the patient gave birth to a [gender] neonate via unknown delivery. It was unknown if the reporter considered the premature delivery to be related to BOOSTRIX. See case US2018GSK168756 for details regarding the baby case. Additional details were provided as follows: This case was reported by the patient for herself. The patient received BOOSTRIX while she was pregnant at 6 weeks and 4 days of gestation. On 5th February 2018, she was hospitalized (reason unspecified) and her baby was still alive. On 6th February 2018, the baby's heart had stopped beating. On 8th February 2018, 126 days after receiving BOOSTRIX, the baby was delivered prematurely at 24 weeks and 4 days of gestation. The contact details of the physician were provided.
Age: 27.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Foetal exposure during pregnancy, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of premature delivery in a 27-year-old female patient who received BOOSTRIX for prophylaxis. On 5th October 2017, the patient received BOOSTRIX (intramuscular). The patient's last menstrual period was on 20th August 2017 and estimated date of delivery was 11th May 2018. The patient received BOOSTRIX at week 6 of the pregnancy and during the first trimester of pregnancy. On 8th February 2018, 126 days after receiving BOOSTRIX, the patient experienced premature delivery (serious criteria hospitalization). On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the premature delivery and vaccine exposure during pregnancy were unknown. The pregnancy ended in a stillbirth at greater than 22 weeks gestation with no apparent congenital anomaly present. On 8th February 2018 after 24 weeks and 4 days, the patient gave birth to a [gender] neonate via unknown delivery. It was unknown if the reporter considered the premature delivery to be related to BOOSTRIX. See case US2018GSK168756 for details regarding the baby case. Additional details were provided as follows: This case was reported by the patient for herself. The patient received BOOSTRIX while she was pregnant at 6 weeks and 4 days of gestation. On 5th February 2018, she was hospitalized (reason unspecified) and her baby was still alive. On 6th February 2018, the baby's heart had stopped beating. On 8th February 2018, 126 days after receiving BOOSTRIX, the baby was delivered prematurely at 24 weeks and 4 days of gestation. The contact details of the physician were provided.
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Premature delivery, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of stillbirth in a foetus exposed to BOOSTRIX in utero. The mother received the product for prophylaxis. On 5th October 2017, the 27-year-old mother received BOOSTRIX. The mother's last menstrual period was on 20th August 2017 and estimated date of delivery was 11th May 2018. The foetus was exposed to BOOSTRIX at week 6 of gestation and during the first trimester of pregnancy. On an unknown date, at [weeks gestation], the foetus was born via unknown delivery. The foetus was diagnosed with stillbirth (serious criteria death and GSK medically significant). On an unknown date, the foetus experienced fetal exposure during pregnancy. On an unknown date, the outcome of the stillbirth was fatal and the outcome of the fetal exposure during pregnancy was unknown. The foetus died on 6th February 2018. The reported cause of death was stillbirth. It was unknown if the reporter considered the stillbirth to be related to BOOSTRIX. See case US2018166378 for details regarding the mother case. Additional details were provided as follows: This case was reported by the patient for herself. On 5th February 2018, the mother was hospitalized (reason unspecified) and her baby was still alive. On 6th February 2018, 124 days after receiving Boostrix, the baby's heart had stopped beating. On 8th February 2018, the baby was delivered.; Reported Cause(s) of Death: Stillbirth.
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Foetal exposure during pregnancy, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of stillbirth in a foetus exposed to BOOSTRIX in utero. The mother received the product for prophylaxis. On 5th October 2017, the 27-year-old mother received BOOSTRIX. The mother's last menstrual period was on 20th August 2017 and estimated date of delivery was 11th May 2018. The foetus was exposed to BOOSTRIX at week 6 of gestation and during the first trimester of pregnancy. On an unknown date, at [weeks gestation], the foetus was born via unknown delivery. The foetus was diagnosed with stillbirth (serious criteria death and GSK medically significant). On an unknown date, the foetus experienced fetal exposure during pregnancy. On an unknown date, the outcome of the stillbirth was fatal and the outcome of the fetal exposure during pregnancy was unknown. The foetus died on 6th February 2018. The reported cause of death was stillbirth. It was unknown if the reporter considered the stillbirth to be related to BOOSTRIX. See case US2018166378 for details regarding the mother case. Additional details were provided as follows: This case was reported by the patient for herself. On 5th February 2018, the mother was hospitalized (reason unspecified) and her baby was still alive. On 6th February 2018, 124 days after receiving Boostrix, the baby's heart had stopped beating. On 8th February 2018, the baby was delivered.; Reported Cause(s) of Death: Stillbirth.