chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative described the occurrence of extensive swelling of vaccinated limb in a 82-year-old female patient who received SHINGRIX. Concurrent medical conditions included increased tendency to bruise. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site discoloration. On 26th April 2018, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site tenderness were recovered/resolved and the outcome of the injection site discoloration and injection site erythema were unchanged. The reporter considered the extensive swelling of vaccinated limb, injection site tenderness, injection site discoloration and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. Almost immediately after receiving the SHINGRIX vaccine on the morning of 25th April 2018, the injection site of the patient became black and blue, approximately the size of a quarter. The next morning, 1 day, after receiving SHINGRIX, the patient was awakened by pain, swelling, redness, and swelling in her left arm from the injection site to about the length of hand below the injection site. The swelling, tenderness and pain resolved with two weeks of receiving the vaccination, however, the redness, and black and blue area was unchanged. The reporter gave permission for her physician to be contacted and provided details. It was referred to the patient's healthcare professional but was unable to obtain additional information.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative described the occurrence of extensive swelling of vaccinated limb in a 82-year-old female patient who received SHINGRIX. Concurrent medical conditions included increased tendency to bruise. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site discoloration. On 26th April 2018, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site tenderness were recovered/resolved and the outcome of the injection site discoloration and injection site erythema were unchanged. The reporter considered the extensive swelling of vaccinated limb, injection site tenderness, injection site discoloration and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. Almost immediately after receiving the SHINGRIX vaccine on the morning of 25th April 2018, the injection site of the patient became black and blue, approximately the size of a quarter. The next morning, 1 day, after receiving SHINGRIX, the patient was awakened by pain, swelling, redness, and swelling in her left arm from the injection site to about the length of hand below the injection site. The swelling, tenderness and pain resolved with two weeks of receiving the vaccination, however, the redness, and black and blue area was unchanged. The reporter gave permission for her physician to be contacted and provided details. It was referred to the patient's healthcare professional but was unable to obtain additional information.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness at injection site for more than 3 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Hives, swelling, itchy, getting worse.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: Very tired day after vaccination.. Went to sleep 3 times during that day. Better the following day and fine by the next.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Eyelid oedema, Fatigue, Headache, Influenza like illness
Clinical narrative: Patient said that she felt like she had a bad case of the flu. Aching joints, low grade fever, under eye redness and puffiness, slight nausea, fatigue and headache. Recommended treatment was BENADRYL, increase hydration, and MOTRIN to treat symptoms. Patient was told that duration was 1 to 3 days after the shot when symptoms may subside. We called 5/28/18 at 10:30 AM to check on patient and she is reported that she is doing fine with no signs/symptoms that she presented with on 5/27/18.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Ocular hyperaemia, Pyrexia
Clinical narrative: Patient said that she felt like she had a bad case of the flu. Aching joints, low grade fever, under eye redness and puffiness, slight nausea, fatigue and headache. Recommended treatment was BENADRYL, increase hydration, and MOTRIN to treat symptoms. Patient was told that duration was 1 to 3 days after the shot when symptoms may subside. We called 5/28/18 at 10:30 AM to check on patient and she is reported that she is doing fine with no signs/symptoms that she presented with on 5/27/18.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Arthralgia, Erythema, Eye swelling, Head discomfort
Clinical narrative: Patient said that she felt like she had a bad case of the flu. Aching joints, low grade fever, under eye redness and puffiness, slight nausea, fatigue and headache. Recommended treatment was BENADRYL, increase hydration, and MOTRIN to treat symptoms. Patient was told that duration was 1 to 3 days after the shot when symptoms may subside. We called 5/28/18 at 10:30 AM to check on patient and she is reported that she is doing fine with no signs/symptoms that she presented with on 5/27/18.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Patient said that she felt like she had a bad case of the flu. Aching joints, low grade fever, under eye redness and puffiness, slight nausea, fatigue and headache. Recommended treatment was BENADRYL, increase hydration, and MOTRIN to treat symptoms. Patient was told that duration was 1 to 3 days after the shot when symptoms may subside. We called 5/28/18 at 10:30 AM to check on patient and she is reported that she is doing fine with no signs/symptoms that she presented with on 5/27/18.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Post injection 2.5'' circle of redness and mild warmth. It continued for 6 days post-injection.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Crying, Cyanosis, Hypersomnia, Livedo reticularis, Peripheral coldness
Clinical narrative: Patchy rash that began localized over liver and lymph nodes, worsened with each subsequent dose of pneumococcal vaccine. Began to have mottling of legs and cold blue hands and feet. Baby came home and slept for 20 hours almost every day that week, just would lay on the floor and cry.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patchy rash that began localized over liver and lymph nodes, worsened with each subsequent dose of pneumococcal vaccine. Began to have mottling of legs and cold blue hands and feet. Baby came home and slept for 20 hours almost every day that week, just would lay on the floor and cry.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection Site Reaction (Swelling and Redness at Site),  Reported to the Pharmacy 2 days post vaccine administration. No hives or breathing issues.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin ulcer, Swelling face
Clinical narrative: Patient recieved a SHINGRIX vaccination on 5/22/2018 and called 5/28/2018 to notify us that she had an adverse rnx. She said that she had swelling on bridge of nose and underneath her left eye.  The swelling on nose did ended up turning to open sore and scabbed over. These are the same spots that she has had shingles in the past (aprox. 13 years ago).
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT IS EXPERIENCING TINGLING IN LEFT ARM STARTING DAY AFTER VACCINATION WAS GIVEN. SHE ALSO EXPERIENCES ARM SORENESS NEAR THE INJECTION SITE IF SHE PRESSES ON HER DELTOID MUSCLE WHERE THE VACCINATION WAS GIVEN. SHE IS SEEING AN ORTHOPEDIC DOCTOR THAT IS A FRIEND OF THE FAMILY AND HE IS MONITORING HER PROGRESS. PATIENT STATES THAT THE TINGLING IS NOT CONSTANT BUT COMES AND GOES. HER ARM ALSO FEELS SORE WHEN SHE LIFTS IT. PATIENT WILL KEEP PHARMACY UPDATED OF OUTCOME.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site pain, Musculoskeletal pain
Clinical narrative: PATIENT IS EXPERIENCING TINGLING IN LEFT ARM STARTING DAY AFTER VACCINATION WAS GIVEN. SHE ALSO EXPERIENCES ARM SORENESS NEAR THE INJECTION SITE IF SHE PRESSES ON HER DELTOID MUSCLE WHERE THE VACCINATION WAS GIVEN. SHE IS SEEING AN ORTHOPEDIC DOCTOR THAT IS A FRIEND OF THE FAMILY AND HE IS MONITORING HER PROGRESS. PATIENT STATES THAT THE TINGLING IS NOT CONSTANT BUT COMES AND GOES. HER ARM ALSO FEELS SORE WHEN SHE LIFTS IT. PATIENT WILL KEEP PHARMACY UPDATED OF OUTCOME.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Nerve injury, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT IS EXPERIENCING TINGLING IN LEFT ARM STARTING DAY AFTER VACCINATION WAS GIVEN. SHE ALSO EXPERIENCES ARM SORENESS NEAR THE INJECTION SITE IF SHE PRESSES ON HER DELTOID MUSCLE WHERE THE VACCINATION WAS GIVEN. SHE IS SEEING AN ORTHOPEDIC DOCTOR THAT IS A FRIEND OF THE FAMILY AND HE IS MONITORING HER PROGRESS. PATIENT STATES THAT THE TINGLING IS NOT CONSTANT BUT COMES AND GOES. HER ARM ALSO FEELS SORE WHEN SHE LIFTS IT. PATIENT WILL KEEP PHARMACY UPDATED OF OUTCOME.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Neuritis, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT IS EXPERIENCING TINGLING IN LEFT ARM STARTING DAY AFTER VACCINATION WAS GIVEN. SHE ALSO EXPERIENCES ARM SORENESS NEAR THE INJECTION SITE IF SHE PRESSES ON HER DELTOID MUSCLE WHERE THE VACCINATION WAS GIVEN. SHE IS SEEING AN ORTHOPEDIC DOCTOR THAT IS A FRIEND OF THE FAMILY AND HE IS MONITORING HER PROGRESS. PATIENT STATES THAT THE TINGLING IS NOT CONSTANT BUT COMES AND GOES. HER ARM ALSO FEELS SORE WHEN SHE LIFTS IT. PATIENT WILL KEEP PHARMACY UPDATED OF OUTCOME.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site reaction, Nerve injury, Paraesthesia
Clinical narrative: PATIENT IS EXPERIENCING TINGLING IN LEFT ARM STARTING DAY AFTER VACCINATION WAS GIVEN. SHE ALSO EXPERIENCES ARM SORENESS NEAR THE INJECTION SITE IF SHE PRESSES ON HER DELTOID MUSCLE WHERE THE VACCINATION WAS GIVEN. SHE IS SEEING AN ORTHOPEDIC DOCTOR THAT IS A FRIEND OF THE FAMILY AND HE IS MONITORING HER PROGRESS. PATIENT STATES THAT THE TINGLING IS NOT CONSTANT BUT COMES AND GOES. HER ARM ALSO FEELS SORE WHEN SHE LIFTS IT. PATIENT WILL KEEP PHARMACY UPDATED OF OUTCOME.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complains of arm soreness, swelling, and redness around the site of injection. Patient states most of the swelling happened two days after the injection. She states no fever, extreme fatigue, hives or other non localized adverse effects. Patient has been instructed to ice the area and take some anti-inflammatories and to call the doctor if the symptoms get worse.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's arm was red and swollen which began about 24 hrs after vaccination. Patient did not have reaction after first dose.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever-101.8, nausea and  vomiting, severe headache.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Red area about 3 inches below the administered site. Bruising of the bicep muscle on the inside of the arm near the red area.
Age: 1.67
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, mild swelling with blisters on left arm where vaccine was given 1 week ago.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Peripheral swelling
Clinical narrative: Swelling of upper arm larger than a dollar bill, shivering, bone aches over whole body lasted three day, swelling lasted a week.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, weakness, tiredness.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Ultrasound scan abnormal
Clinical narrative: Chronic shoulder pain, still unresolved 5 months after the injection. Was referred to neurologist who stated this is not nerve pathology but may be SIRVA (shoulder injury related to vaccine administration).
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe right shoulder pain - almost unusable arm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling around the injection site, pain at injection site, redness around injection site, and itching at injection site. Lasted about 5 days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 53-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th May 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 17th May 2018, the patient experienced injection site cellulitis (serious criteria other: Serious as per reporter). The patient was treated with Cephalexin and prednisone. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) received report of this adverse event from a co-worker at her retail pharmacy, did not directly speak to the patient. The HCP reports that the physician (MD) diagnosed left arm cellulitis and documented that the SHINGRIX was administered midway in the upper left arm, not the deltoid, which led to vaccine administered at inappropriate site. Three days after vaccination the patient was diagnosed with cellulitis at the injection site on the left arm. The patient reported to the retail pharmacy that they went to the doctor, were diagnosed with cellulitis, and prescribed antibiotics (Cephalexin) and prednisone to treat. The HCP stated disagreement with this documentation and thought the cellulitis spread lower.
Age: 70.0
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 70-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, 15 days after receiving SHINGRIX, the patient experienced shingles (serious criteria other: as per reporter). The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The healthcare professional (HCP) stated that the patient was diagnosed with shingles on 18th May 2018. The HCP stated that the patient presented to the retail pharmacy to have prescriptions filled for PO (per os) and topical antivirals after seeking medical treatment on 18th May 2018. The HCP was unsure when exactly the patient's symptoms were started. The HCP was willing to provide further details regarding this adverse event after she speaks with patient again later on the reporting day. The HCP was opened to be contacted from the safety department for further details. The HCP stated that she/he had no idea when asked about clinical opinion on causality.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mobility decreased
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of mobility decreased in a female patient who received SHINGRIX. 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 mobility decreased and feeling abnormal. On an unknown date, the outcome of the mobility decreased and feeling abnormal were recovered/resolved. It was unknown if the reporter considered the mobility decreased abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After injection of SHINGRIX, the patient reported she could not move her arms. The reporter said she was almost in a coma like state. The patient went to bed, and mobility returned in the next morning.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Pericarditis
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pericarditis in a 58-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant) and chest pain. On an unknown date, the outcome of the pericarditis and chest pain were unknown. It was unknown if the reporter considered the pericarditis and chest pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the medical assistant (MA). The patient did not have a history of heart trouble. The age at vaccination was not reported. In 2018, the patient received the SHINGRIX vaccine and experienced chest pain and went to the emergency room (ER). The treating physician did not see anything and released the patient. The patient went back to the ER later the same day and was seen by another physician, who diagnosed him with pericarditis and was 100 percent certain that it was caused by the SHINGRIX vaccine. The vaccination responsible physician did not believe that the event was caused by the SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastrointestinal disturbance in a adult female patient who received SHINGRIX. 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 gastrointestinal disturbance. On an unknown date, the outcome of the gastrointestinal disturbance was unknown. It was unknown if the reporter considered the gastrointestinal disturbance to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The patient experienced gastrointestinal side effects after receiving first dose of SHINGRIX. The caller declined to provided further details or identifiers without getting permission from patient involved. Limited report was filed. This case was 1 of the 3 linked cases, reported by the same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old male patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were unknown. It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was approximately 65 years old. The caller was a field based account manager who was doing an in-service on SHINGRIX. The patient received the SHINGRIX sometime in the previous week before the date of reporting. The events were reported to the physician the day after the shot was administered. The reporter had limited information. No additional details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX. 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 event. On an unknown date, the outcome of the adverse event was unknown. The reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter while reporting her own adverse event, mentioned she had a friend who also had a reaction to the SHINGRIX vaccine. No further detail was provided. This case has been linked with case US2018086788, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 61-year-old female patient who received SHINGRIX. Concomitant products included amlodipine, folic acid and methotrexate. On 9th May 2018 01:00, the patient received the 1st dose of SHINGRIX. On 9th May 2018, less than an hour after receiving SHINGRIX, the patient experienced skin warm and erythema. On 10th May 2018, the patient experienced swelling of limb. On an unknown date, the outcome of the skin warm and erythema were recovered/resolved and the outcome of the swelling of limb was unknown. The reporter considered the skin warm, erythema and swelling of limb to be related to SHINGRIX. Additional information was received as follows: After receiving SHINGRIX, within one hour after receiving the vaccination, the patient experienced swollen, red and hot in the right hand. The patient took BENADRYL but the events did not resolve. By the next day, swelling appeared on the left hand down to the elbow and then all the way down both legs to her toes. The patient's toes was looked like little sausages. The swollen areas felt hot but it was not painful. By next day it was better. It took a couple days for the right hand to go down. A day before the date of reporting her right arm started to swell in the muscle between her wrist and her elbow. On the day of reporting, it was returning to normal. The patient was seen by a physician assistance (PA) and was told that the patient had a systemic reaction. The patient called her physician but could not get in so she went to the clinic. The patient would be seen by her physician for follow up.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal discomfort, Abdominal distension, Diarrhoea, Headache, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 20-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019). The patient's past medical history included thigh abscess. Concomitant products included BACTRIM, ZYRTEC and LEXAPRO. On 10th May 2018, the patient received BEXSERO (intramuscular). On 10th May 2018, less than a day after receiving BEXSERO, the patient experienced nausea, vomiting, headache and diarrhea. On 17th May 2018, the patient experienced bloating and abdominal discomfort. On an unknown date, the outcome of the nausea, vomiting and headache were recovering/resolving and the outcome of the bloating, abdominal discomfort and diarrhea were unknown. It was unknown if the reporter considered the nausea, bloating, abdominal discomfort, vomiting, headache and diarrhea to be related to BEXSERO. Additional information was received as follows: This case was previously reported to a doctor. The patient was immunized during a well check visit. During that visit and prior to the vaccination, the patient presented with an intermittent abscess on the thigh. In the morning, the patient received BEXSERO on right arm. Around noon, the patient called the office to report nausea, vomiting, diarrhea, and headache. About 1 week after receiving BEXSERO, the patient experienced bloating and abdominal discomfort. As a precaution, BACTRIM would be discontinued on the reporting day.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 20-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019). The patient's past medical history included thigh abscess. Concomitant products included BACTRIM, ZYRTEC and LEXAPRO. On 10th May 2018, the patient received BEXSERO (intramuscular). On 10th May 2018, less than a day after receiving BEXSERO, the patient experienced nausea, vomiting, headache and diarrhea. On 17th May 2018, the patient experienced bloating and abdominal discomfort. On an unknown date, the outcome of the nausea, vomiting and headache were recovering/resolving and the outcome of the bloating, abdominal discomfort and diarrhea were unknown. It was unknown if the reporter considered the nausea, bloating, abdominal discomfort, vomiting, headache and diarrhea to be related to BEXSERO. Additional information was received as follows: This case was previously reported to a doctor. The patient was immunized during a well check visit. During that visit and prior to the vaccination, the patient presented with an intermittent abscess on the thigh. In the morning, the patient received BEXSERO on right arm. Around noon, the patient called the office to report nausea, vomiting, diarrhea, and headache. About 1 week after receiving BEXSERO, the patient experienced bloating and abdominal discomfort. As a precaution, BACTRIM would be discontinued on the reporting day.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included hip replacement. On 16th May 2018 10:00, the patient received the 1st dose of SHINGRIX. On 16th May 2018, several hours after receiving SHINGRIX, the patient experienced pain, fever, pain in hip, chills and muscle pain. On an unknown date, the outcome of the pain, fever, chills and muscle pain were recovered/resolved and the outcome of the pain in hip was not recovered/not resolved. The reporter considered the pain, fever, chills and muscle pain to be related to SHINGRIX. The reporter considered the pain in hip to be possibly related to SHINGRIX. Additional details were provided as follows: Concomitant products included gout medications, statins and vitamins. All symptoms were presented the evening on the day the patient was received SHINGRIX but they intensified the next day. All the symptoms were begun to resolve the following day except the hip pain which was still present, at the time of reporting. The other symptoms were almost gone by the 4th day and completely resolved by the 5th day. The patient had denied permission to contact their physician and he was not sure if the hip pain was due to the shot or a 6 hour hike he took the day of the vaccination. The patient also had a fall which he described as a bouncing fall on that hike. That same hip had also been replaced.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 59-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood pressure high. Concomitant products included LIPITOR. 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 discoloration, injection site swelling, injection site erythema and injection site warmth. In May 2018, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the injection site discoloration, injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the pain in arm and shoulder pain were unknown. The reporter considered the injection site discoloration, injection site swelling, injection site erythema, injection site warmth, pain in arm and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient reported events to his pharmacist prior to contacting GlaxoSmithKline. On the 9th May 2018, at 9:45, the patient received SHINGRIX in the right arm. The patient did not have lot number or expiration date of the suspect. The patient received Blood pressure medicine and strength of LIPITOR was 40mg. The patient noted that the pain noted approximately 18 hours after SHINGRIX injection. The patient described pain as soreness and pain in his right shoulder and right arm. The patient noted area around injection was discolored and it was described as discolored as redness with some black and blue. The patient noted area around injection was hot and swollen and it was described swollen as swelling of at least 3 inches. The patient noted that the skin puncture from SHINGRIX injection appears as black dot. The pain, discoloration, heat, swelling and black dot had not improved or worsened since it began. The patient denied hospitalization for treatment of any of the events described. The patient could not recall the name of pharmacist that administered the vaccine. No additional information was provided.
Age: 59.0
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 injection site discoloration in a 59-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood pressure high. Concomitant products included LIPITOR. 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 discoloration, injection site swelling, injection site erythema and injection site warmth. In May 2018, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the injection site discoloration, injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the pain in arm and shoulder pain were unknown. The reporter considered the injection site discoloration, injection site swelling, injection site erythema, injection site warmth, pain in arm and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient reported events to his pharmacist prior to contacting GlaxoSmithKline. On the 9th May 2018, at 9:45, the patient received SHINGRIX in the right arm. The patient did not have lot number or expiration date of the suspect. The patient received Blood pressure medicine and strength of LIPITOR was 40mg. The patient noted that the pain noted approximately 18 hours after SHINGRIX injection. The patient described pain as soreness and pain in his right shoulder and right arm. The patient noted area around injection was discolored and it was described as discolored as redness with some black and blue. The patient noted area around injection was hot and swollen and it was described swollen as swelling of at least 3 inches. The patient noted that the skin puncture from SHINGRIX injection appears as black dot. The pain, discoloration, heat, swelling and black dot had not improved or worsened since it began. The patient denied hospitalization for treatment of any of the events described. The patient could not recall the name of pharmacist that administered the vaccine. No additional information was provided.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 77-year-old male patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th April 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, tiredness, pain in arm, shivering and sleeplessness. On an unknown date, the outcome of the muscle pain, tiredness, pain in arm and shivering were recovered/resolved and the outcome of the sleeplessness was unknown. The reporter considered the muscle pain and shivering to be related to SHINGRIX. It was unknown if the reporter considered the tiredness, pain in arm and sleeplessness to be related to SHINGRIX. Additional information was received as follows: The patient reported that he received a dose of SHINGRIX in the afternoon. On the same evening, the patient experienced tiredness, muscle pain, and shivering. The patient stated that he was not able to sleep because of the shivering. The patient stated that he emailed his physician to let him know about the symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of lip swelling in a female patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, several days after receiving SHINGRIX, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was not recovered/not resolved. It was unknown if the reporter considered the lip swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the last week before date of reporting. The patient experienced swelling of the lip about a few days after getting SHINGRIX. The patient's lip was slightly swollen. The demographic details were not provided for the patient and physician. This case was not reported to FDA. No additional information was available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising of hand in a 81-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, 6 days after receiving SHINGRIX, the patient experienced bruising of hand. On an unknown date, the outcome of the bruising hand was not recovered/not resolved. The reporter considered the bruising of hand to be possibly related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left arm. The healthcare professional reported 2 to 3 days before the reporting date (14th May 2018 or 15th May 2018) that the patient developed a bruise on the back of her hand on the same arm where she received the vaccine. Bruise was smaller at first but got larger and on the reporting date, it was covering almost the entire backside of the hand. The patient had no other symptoms.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Rash, Skin exfoliation, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a 63-year-old male patient who received SHINGRIX (batch number 7FY22, expiry date 25th June 2020). On 12th May 2018 13:17, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced raised rash, skin scaly and injection site warmth. In May 2018, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the raised rash and skin scaly were recovering/resolving. It was unknown if the reporter considered the raised rash, skin scaly and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife to the pharmacist. The age at vaccination was not reported. The patient's wife reported on Tuesday, 15th May 2018 that on Saturday the patient received SHINGRIX vaccine on the left arm. The patient experienced a circular raised rash around the site. It was scaly and warm to the touch. At the reporting time, the area was no longer warm but the rash was still there. The pharmacist's call was transferred to medical information for additional information and for recommendation if the patient should have the 2nd shot.
Age: 0.25
Sex: F
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 3-month-old female patient who received ROTARIX (batch number 9R3ZC, expiry date 18th October 2019). On an unknown date, the patient received ROTARIX 1 ml. On an unknown date, 1 hr after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related ROTARIX. Additional details were provided as follows: The health care professional stated that the patient was 3 month old child vomited curdled breast milk approximately 1 hour after vaccination. The batch number does not exit in sales data sheet and corrected from 9R32C to 9R3ZC.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Fatigue, Herpes zoster, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX. On 26th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 days after receiving SHINGRIX, the patient experienced shingles, chills, fever and fatigue. On 7th May 2018, the patient experienced blister. In May 2018, the patient experienced injection site rash and injection site pain. The patient was treated with OTC medicines and Ice Pack (Nos). On an unknown date, the outcome of the shingles, chills, fever, fatigue, injection site rash, injection site pain and blister were unknown. It was unknown if the reporter considered the shingles, chills, fever, fatigue, injection site rash, injection site pain and blister to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she had a healthy immune system as noted in her recent lab work and overall health and lifestyle. The patient received SHINGRIX vaccine on an unknown deltoid during her annual physical. The patient, 2 days later experienced chills, fever and fatigue. About 10 day after that the patient developed a painful rash on my upper arm where the vaccine was given. The patient called her doctor who assured her that it was just a coincidence and that she should treat it with OTC (over the counter) medicines and ice. The patient did that and by the past Monday 11 days post vaccination, the pain was bad and it began to blister. The patient went to the doctor a day before date of reporting and was diagnosed with Shingles. The patient was doubtful that this was a coincidence. The patient thought it was important that this information was to be shared as the vaccine was so newly released.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX. On 26th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 days after receiving SHINGRIX, the patient experienced shingles, chills, fever and fatigue. On 7th May 2018, the patient experienced blister. In May 2018, the patient experienced injection site rash and injection site pain. The patient was treated with OTC medicines and Ice Pack (Nos). On an unknown date, the outcome of the shingles, chills, fever, fatigue, injection site rash, injection site pain and blister were unknown. It was unknown if the reporter considered the shingles, chills, fever, fatigue, injection site rash, injection site pain and blister to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she had a healthy immune system as noted in her recent lab work and overall health and lifestyle. The patient received SHINGRIX vaccine on an unknown deltoid during her annual physical. The patient, 2 days later experienced chills, fever and fatigue. About 10 day after that the patient developed a painful rash on my upper arm where the vaccine was given. The patient called her doctor who assured her that it was just a coincidence and that she should treat it with OTC (over the counter) medicines and ice. The patient did that and by the past Monday 11 days post vaccination, the pain was bad and it began to blister. The patient went to the doctor a day before date of reporting and was diagnosed with Shingles. The patient was doubtful that this was a coincidence. The patient thought it was important that this information was to be shared as the vaccine was so newly released.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 69-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date unknown). Concomitant products included Calcium, LIPITOR, Metformin, ZETIA, Aspirin, ALDACTAZIDE, ALIGN, COZAAR, PRILOSEC and TOPROL. On 8th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, several hours after receiving SHINGRIX, the patient experienced injection site muscle pain, injected limb mobility decreased and swelling. On an unknown date, the outcome of the injection site muscle pain, injected limb mobility decreased and swelling were recovered/resolved. The reporter considered the injection site muscle pain, injected limb mobility decreased and swelling to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse practitioner. The patient's concomitant medication included Multivitamin. The patient received the vaccine at a pharmacy. The patient experienced exaggerated muscle pain in the area of the SHINGRIX injection with the inability to move their arm. In May 2018, injection site muscle pain, injected limb mobility decreased and swelling were resolved.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Amnesia, Asthenia, Chills, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of chills in a 76-year-old male patient who received SHINGRIX. On 16th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, malaise, weakness, foggy feeling in head, forgetfulness, memory loss, fatigue, tremor and influenza-like symptoms. On 17th May 2018, the outcome of the chills, fever, malaise, foggy feeling in head, forgetfulness, memory loss, tremor and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the weakness and fatigue were not recovered/not resolved. The reporter considered the chills, fever, malaise, weakness, foggy feeling in head, forgetfulness, memory loss, fatigue, tremor and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. At 17:00 patient received SHINGRIX on left deltoid. The morning of 17th May 2018, the patient experienced chills, shaking, fever, malaise, memory loss, flu like symptoms, followed by significant brain fog and forgetting the names of common household objects. On the day of reporting, all of the symptoms had resolved except he was weak and felt fatigued. The reporter initially reported the adverse event on the after hours voicemail line. The reporter's husband got on the telephone and gave permission for his physician to be contacted.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Memory impairment, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of chills in a 76-year-old male patient who received SHINGRIX. On 16th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, malaise, weakness, foggy feeling in head, forgetfulness, memory loss, fatigue, tremor and influenza-like symptoms. On 17th May 2018, the outcome of the chills, fever, malaise, foggy feeling in head, forgetfulness, memory loss, tremor and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the weakness and fatigue were not recovered/not resolved. The reporter considered the chills, fever, malaise, weakness, foggy feeling in head, forgetfulness, memory loss, fatigue, tremor and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. At 17:00 patient received SHINGRIX on left deltoid. The morning of 17th May 2018, the patient experienced chills, shaking, fever, malaise, memory loss, flu like symptoms, followed by significant brain fog and forgetting the names of common household objects. On the day of reporting, all of the symptoms had resolved except he was weak and felt fatigued. The reporter initially reported the adverse event on the after hours voicemail line. The reporter's husband got on the telephone and gave permission for his physician to be contacted.