chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. The patients' concomitant medications included sterile diluent (MERCK) (lot # and expiration date were not provided). The patients' medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. On an unspecified date, unspecified number of patients were vaccinated with improperly stored doses of PROQUAD, M-M-R II, PNEUMOVAX 23, PEDVAXHIB, ROTATEQ and VARIVAX, all for prophylaxis (dose number, route, anatomical location, lot # and expiration date were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between 47°F to 77°F (49.1) (°F degree Fahrenheit) during 1 hour and 20 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers were provided. Follow up information received on 13-JUN-2018: This spontaneous report was received from a nurse regarding a 12 months old patient of unknown gender. On 01-MAR-2018, patient was vaccinated with improperly stored doses of VARIVAX, lot # N017395 (dose number, route, anatomical location and expiration date were not provided). This is one of two reports received from the same reporter (1803USA002638).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Gastrointestinal disorder, Influenza like illness, Musculoskeletal chest pain, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. Concomitant products included doxazosin. On 4th June 2018, the patient received SHINGRIX .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the general body pain was unknown and the outcome of the influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm were not recovered/not resolved. The reporter considered the general body pain, influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received HIGH BLOOD PRESSURE MEDICATION as concomitant drug. The patient received Shingrix vaccine on left arm on 4th June 2018 at 14: 58. The pharmacist reported that the patient experienced side effects after receiving the SHINGRIX vaccine. The patient had body aches, loss of energy, flu like symptoms, an achy arm, rib pain, nausea with gastrointestinal symptoms. The pharmacist advised the patient to take regular Tylenol and she would follow-up with the patient on the day of reporting. The pharmacist spoke with the patient on the day of reporting and the patient was feeling better.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. Concomitant products included doxazosin. On 4th June 2018, the patient received SHINGRIX .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the general body pain was unknown and the outcome of the influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm were not recovered/not resolved. The reporter considered the general body pain, influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received HIGH BLOOD PRESSURE MEDICATION as concomitant drug. The patient received Shingrix vaccine on left arm on 4th June 2018 at 14: 58. The pharmacist reported that the patient experienced side effects after receiving the SHINGRIX vaccine. The patient had body aches, loss of energy, flu like symptoms, an achy arm, rib pain, nausea with gastrointestinal symptoms. The pharmacist advised the patient to take regular Tylenol and she would follow-up with the patient on the day of reporting. The pharmacist spoke with the patient on the day of reporting and the patient was feeling better.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. Concomitant products included doxazosin and antihypertensives nos (High Blood Pressure Medication (Nos)). On 4th June 2018, the patient received SHINGRIX .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, nausea, chills and loss of energy. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the general body pain was unknown and the outcome of the nausea, chills and loss of energy were not recovered/not resolved. The reporter considered the general body pain, nausea, chills and loss of energy to be related to SHINGRIX. Additional details were provided as follows: The patient took HIGH BLOOD PRESSURE MEDICATION as concomitant drug. The patient received Shingrix vaccine on left arm on 4th June 2018 at 14: 58. The pharmacist reported that the patient experienced side effects after receiving the SHINGRIX vaccine. The patient had body aches, loss of energy, nausea with chills. The pharmacist advised the patient to take regular Tylenol and she would follow-up with the patient on the day of reporting. The pharmacist spoke with the patient on the day of reporting and the patient was feeling better.  The patient took Motrin on the last night instead of Tylenol.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 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 week after receiving SHINGRIX the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was not recovered/not resolved. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A patient received SHINGRIX and developed a zoster rash on the back of the neck within 1 to 2 days after vaccination. The caller did not have specific information at the time was calling of behalf of the physician she works with who was inquiring as to whether GlaxoSmithKline offers a test to see if the herpes zoster episode was caused by the vaccine.  The patient had not yet initiated treatment.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included olmesartan medoxomil (Benicar) and levothyroxine + liothyronine (Armour Thyroid). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 15th May 2018, the patient experienced fatigue, pain in arm, swelling arm, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved and the outcome of the pain in arm, swelling arm, erythema of extremities and itchy upper limbs were recovering/resolving. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. The reporter considered the fatigue, pain in arm, erythema of extremities and itchy upper limbs to be probably related to SHINGRIX. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional information was reported as follows: At 17:00, the patient received the SHINGRIX in the left deltoid. The patient had stinging at the injection site initially after vaccination. She experienced fatigue and slept all the next day, after vaccination. The patient's arm was very sore and she had swelling, itching and redness that ran down and around her arm. The condition got worse and she still had a little redness and itching 2 weeks later, after the vaccination. She had planned not to get vaccinated with the 2nd dose of SHINGRIX. This case was linked to case US2018101638 (husband case), reported by the same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included olmesartan medoxomil (Benicar) and levothyroxine + liothyronine (Armour Thyroid). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 15th May 2018, the patient experienced fatigue, pain in arm, swelling arm, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved and the outcome of the pain in arm, swelling arm, erythema of extremities and itchy upper limbs were recovering/resolving. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. The reporter considered the fatigue, pain in arm, erythema of extremities and itchy upper limbs to be probably related to SHINGRIX. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional information was reported as follows: At 17:00, the patient received the SHINGRIX in the left deltoid. The patient had stinging at the injection site initially after vaccination. She experienced fatigue and slept all the next day, after vaccination. The patient's arm was very sore and she had swelling, itching and redness that ran down and around her arm. The condition got worse and she still had a little redness and itching 2 weeks later, after the vaccination. She had planned not to get vaccinated with the 2nd dose of SHINGRIX. This case was linked to case US2018101638 (husband case), reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included nebivolol hydrochloride (Bystolic), rosuvastatin calcium (Crestor), warfarin sodium (Warfarin), lisinopril and torasemide (Torsemide). On 14th May 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, immediately after receiving SHINGRIX the patient experienced headache. On 15th May 2018, the patient experienced fatigue, stiff neck, sleeplessness, wry neck, neck pain, fever and night sweats. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the headache, stiff neck, sleeplessness, wry neck, neck pain, fever and night sweats were recovering/resolving. The reporter considered the fatigue and headache to be probably related to SHINGRIX. The reporter considered the stiff neck, sleeplessness, wry neck, neck pain, fever and night sweats to be possibly related to SHINGRIX. Additional information was reported as follows: At 17:00 the patient was vaccinated with SHINGRIX at left deltoid. This case was reported by the patient's spouse. He experienced fatigue and slept all the next day, after vaccination.  He developed a headache immediately and was unable to turn his head. He could not sleep at night for over a week, after vaccination. The wry neck symptom started on the left side of his neck and moved to the right side. He still had sore neck at the time of reporting. The patient did not had any plan of receiving the 2nd dose of SHINGRIX. This case was linked to case US2018101637 (wife case), reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia, Torticollis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included nebivolol hydrochloride (Bystolic), rosuvastatin calcium (Crestor), warfarin sodium (Warfarin), lisinopril and torasemide (Torsemide). On 14th May 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, immediately after receiving SHINGRIX the patient experienced headache. On 15th May 2018, the patient experienced fatigue, stiff neck, sleeplessness, wry neck, neck pain, fever and night sweats. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the headache, stiff neck, sleeplessness, wry neck, neck pain, fever and night sweats were recovering/resolving. The reporter considered the fatigue and headache to be probably related to SHINGRIX. The reporter considered the stiff neck, sleeplessness, wry neck, neck pain, fever and night sweats to be possibly related to SHINGRIX. Additional information was reported as follows: At 17:00 the patient was vaccinated with SHINGRIX at left deltoid. This case was reported by the patient's spouse. He experienced fatigue and slept all the next day, after vaccination.  He developed a headache immediately and was unable to turn his head. He could not sleep at night for over a week, after vaccination. The wry neck symptom started on the left side of his neck and moved to the right side. He still had sore neck at the time of reporting. The patient did not had any plan of receiving the 2nd dose of SHINGRIX. This case was linked to case US2018101637 (wife case), reported by the same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of neck swelling in a 53-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In May 2018, the patient experienced neck swelling and general body pain. On an unknown date, the outcome of the neck swelling, general body pain and injection site pain were recovered/resolved. The reporter considered the neck swelling, general body pain and injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received the first dose of SHINGRIX and experienced swelling of the neck which led to body pains. The patient experienced a lot of pain when receiving the vaccine as well. As per health care professional, she acted like the vaccine really hurt her. The reaction started within 24 hours and lasted a few days. It was resolved at the point of reporting. She went to see her doctor who prescribed her antihistamines.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, nausea and erythema. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, nausea and erythema were recovered/resolved. The reporter considered the pain in arm, influenza-like symptoms, nausea and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 69 years or 70 years. Twenty four hours after vaccination, the patient experienced flu-like symptoms and nausea which lasted about 24 hours. Arm pain and redness were lasted 7 days. The pharmacist did not have vaccine lot or expiry information readily available at the time of the call. The pharmacist did not feel like any medications or medical history contributed to this.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (For tolerance to the 1st dose refer case US2018GSK107320). On 4th June 2018, the patient received the 2nd dose of Shingrix. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, pain in arm, vomiting, swelling arm, general body pain and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, pain in arm, vomiting, swelling arm, general body pain and nausea were recovered/resolved. The reporter considered the fever, pain in arm, vomiting, swelling arm, general body pain and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches, swelling in arm, and pain in arm. These symptoms resolved in 24 hours. The patient experienced the same symptoms after dose 1 but they were more severe with dose 2.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (For tolerance to the 1st dose refer case US2018GSK107320). On 4th June 2018, the patient received the 2nd dose of Shingrix. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, pain in arm, vomiting, swelling arm, general body pain and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, pain in arm, vomiting, swelling arm, general body pain and nausea were recovered/resolved. The reporter considered the fever, pain in arm, vomiting, swelling arm, general body pain and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches, swelling in arm, and pain in arm. These symptoms resolved in 24 hours. The patient experienced the same symptoms after dose 1 but they were more severe with dose 2.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were unknown. It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to SHINGIRX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional did not had any patient or vaccine details at the time of reporting. The healthcare professional reported that several patients complained of arm redness, sore arm, and swollen arm after receiving the SHINGRIX vaccine. The healthcare professional did not had any additional information on the adverse events.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Shingrix (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 14th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2018, 1 day after receiving Shingrix, the patient experienced shingles and sickness. In May 2018, the outcome of the shingles and sickness were recovered/resolved. The reporter considered the shingles and sickness to be probably related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. The health care professional reported that the patient experienced shingles on her arm. It occurred further down, not at the injection site. The patient also felt sick. The adverse events were resolved in 1 week. This case has been linked with US2018102494, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain, X-ray normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly 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 a month after receiving Shingrix, the patient experienced injection site pain and touch sensitivity increased. On an unknown date, the outcome of the injection site pain and touch sensitivity increased were not recovered/not resolved. The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the touch sensitivity increased to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid over a month ago in 2018 but did not recall the exact date. The patient was still experiencing extreme pain at the injection site when touched. The whole arm, especially the shoulder area was sensitive. The patient visited her physician 2 days ago because of the pain. The patient did an X-ray which came back normal. The patient stated the pharmacy had previously reported the adverse event which told her someone would call her.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received Shingrix (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain (After receiving 1st dose, see case US2018GSK106770). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever, muscle ache, headache, chills and joint pain. On an unknown date, the outcome of the fever, muscle ache, headache, chills and joint pain were recovered/resolved. The reporter considered the fever, muscle ache, headache, chills and joint pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient began to experience fever, chills, muscle ache, headache and joint pain, which resolved by the 4th day after the vaccine.  The patient did not require any intervention, hospitalization, emergency room or physician visit, and the symptoms were not considered life threatening or disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a elderly female patient who received Shingrix (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced fatigue, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the fatigue, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the fatigue to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient received only the liquid adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Few days later, the patient experienced fatigue. The health care professional had limited information about when the patient developed the fatigue and said that he could fill out more information if follow up paperwork was sent to him. The health care professional also reported that his pharmacy manager might had already reported the maladministration earlier today but he was unsure.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult male patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and tenderness at injection site continuing now to 7 days post vaccination. The date of onset unknown. The severity was unknown and it was unknown whether the patient had used pain relievers or sought medical treatment.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills, nausea, fatigue and headache. On an unknown date, the outcome of the fever, chills, nausea, fatigue and headache were unknown. It was unknown if the reporter considered the fever, chills, nausea, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician's assistant. The age at vaccination was not reported. The patient received SHINGRIX on Thursday. The patient experienced fever of 100.9 associated with chills, nausea, fatigue and headache within the first 24 hours after administration. This caused him to miss work the following day. The reporter agree to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and general malaise. On an unknown date, the outcome of the injection site pain and general malaise were unknown. It was unknown if the reporter considered the injection site pain and general malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not reporter agree to follow up. The patient experienced moderate pain at injection site, general malaise for 2 days.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 28th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 29th May 2018, the patient experienced general body pain, malaise and headache. On 30th May 2018, the outcome of the general body pain, malaise and headache were recovered/resolved. On 1st June 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, malaise and headache to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in his arm and reported his arm was sore but not so severe that he could not do activities. It was sore but if someone hit him in the arm it would have really hurt. On 29th May 2018, 1 day after receiving vaccination, the patient also stated he experienced body aches, malaise, headache and would have wanted to stay home but he had to work.  The body aches, malaise and headache all resolved by 30th May 2018.
Sex: M
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 male patient who received SHINGRIX for prophylaxis. On 22nd May 2018, the patient received SHINGRIX On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was the spouse of the patient. The age at the vaccination was not reported. The patient had redness at the injection site described as the site's being really red. The reporter declined to answer any specific questions on behalf of her spouse. The reporter said her spouse might call GlaxoSmithKline in the future with further details. The reporter was called back to know who had administered the vaccine to her regarding her report, and she noted that her husband's health care professional was already aware of the symptom. This case was linked to the case US2018100625 and US2018GSK101153, reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Malaise, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 77-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a year after receiving SHINGRIX, the patient experienced feeling unwell, walking difficulty and muscle pain. On an unknown date, the outcome of the feeling unwell, walking difficulty and muscle pain were unknown. It was unknown if the reporter considered the feeling unwell, walking difficulty and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was a friend of the patient from her walking group. The patient told her that she had the first dose of the SHINGRIX vaccine sometime in late April 2018. The patient did not walk on the last Tuesday because she was not feeling up to it. On 5th Jun 2018, the patient returned to walk with the group. The reporter noticed that the patient was walking only a little distance, so she told the patient that she was concerned because of that reason and because the patient had not felt up to walking with the group. The patient told her that she has been having funny pains which felt muscular. The reporter said the patient might call GlaxoSmithKline in the future with further details. The reporter's friend was already scheduled for the second dose of the series and was beginning to wonder if the symptoms could be due to the first SHINGRIX dose and was now concerned about receiving the second dose in the series. No further information was provided. This case has been linked with US2018100625 and US2018GSK101152 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult 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 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 SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter was a pharmacy manager/director for a national health plan. The reporter indicated anecdotally' that he had heard increased occurrence of or more significant injection site reactions (pain, soreness) with SHINGRIX. The reporter also stated that the chief concerned wasn't of impact to patients from a reaction but would this be something that would prevent a patient from receiving the second dose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a adult female patient who received Shingrix for prophylaxis. 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 cellulitis (serious criteria GSK medically significant), pain, tenderness, erythema, feeling hot and swelling. On an unknown date, the outcome of the cellulitis, pain, tenderness, erythema, feeling hot and swelling were unknown. It was unknown if the reporter considered the cellulitis, pain, tenderness, erythema, feeling hot and swelling to be related to Shingrix. Additional information was reported as follows: The age at vaccination can be 56 or 57 years. The patient experienced pain, tenderness to touch  which as diagnosed as cellulitis of approximately 3 into 5 inches size with redness, hot to touch and raised in the area of cellulitis.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a adult female patient who received Shingrix for prophylaxis. 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 cellulitis (serious criteria GSK medically significant), pain, tenderness, erythema, feeling hot and swelling. On an unknown date, the outcome of the cellulitis, pain, tenderness, erythema, feeling hot and swelling were unknown. It was unknown if the reporter considered the cellulitis, pain, tenderness, erythema, feeling hot and swelling to be related to Shingrix. Additional information was reported as follows: The age at vaccination can be 56 or 57 years. The patient experienced pain, tenderness to touch  which as diagnosed as cellulitis of approximately 3 into 5 inches size with redness, hot to touch and raised in the area of cellulitis.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain in arm, vomiting, swelling arm, general body pain and nausea. On an unknown date, the outcome of the fever, pain in arm, vomiting, swelling arm, general body pain and nausea were recovered/resolved. It was unknown if the reporter considered the fever, pain in arm, vomiting, swelling arm, general body pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches, swelling in arm and pain in arm. For tolerance to the 2nd dose refer case US2018101674, reported for the same patient with same adverse events.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain in arm, vomiting, swelling arm, general body pain and nausea. On an unknown date, the outcome of the fever, pain in arm, vomiting, swelling arm, general body pain and nausea were recovered/resolved. It was unknown if the reporter considered the fever, pain in arm, vomiting, swelling arm, general body pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches, swelling in arm and pain in arm. For tolerance to the 2nd dose refer case US2018101674, reported for the same patient with same adverse events.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Tuesday - small dot where needle went in, no swelling no redness to left thigh. Wednesday - 0900 - no redness, swelling. Went swimming and after mom noticed a nickel size spot at 0930. 1830 - 6 cm by 6 cm of red spot then mom called nurse advice line and informed to go to ER. 1900 - mom took pt. to ER. In ER - vitals done and MD stated no concern, and reaction localized.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: When received the injection at 1:45 pm on a Friday, was extremely painful, subsided a little bit for a couple hours then around 4:30pm arm was so sore could not lift to side at all, and to lift forward had to use other arm for support. At 9 pm that night developed bad headache, body aches, joint pain, nausea, with chills and sweats throughout the night, these symptoms continued all the next day and on through Saturday evening, and around 4 am Sunday morning symptoms started subsiding and was able to sleep from around 4 am to 9 am Sunday and when awakened at that time, symptoms had notably subsided and by mid-day Sunday felt pretty good and could resume normal activities, with exception of very sore muscle at injection site. Pain in the muscle at injection site (left upper arm) resolved completely by 6th/7th day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: When received the injection at 1:45 pm on a Friday, was extremely painful, subsided a little bit for a couple hours then around 4:30pm arm was so sore could not lift to side at all, and to lift forward had to use other arm for support. At 9 pm that night developed bad headache, body aches, joint pain, nausea, with chills and sweats throughout the night, these symptoms continued all the next day and on through Saturday evening, and around 4 am Sunday morning symptoms started subsiding and was able to sleep from around 4 am to 9 am Sunday and when awakened at that time, symptoms had notably subsided and by mid-day Sunday felt pretty good and could resume normal activities, with exception of very sore muscle at injection site. Pain in the muscle at injection site (left upper arm) resolved completely by 6th/7th day.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: redness, swelling, warm to touch.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Throat irritation, Vision blurred
Clinical narrative: Patient experienced itching after receiving vaccine, about 10-15 minutes. She was given a ZYRTEC 10 mg. After, she started to scratch her throat and stated that her throat was itchy. 911 was called. They arrived less than five minutes later and checked her vitals, which were within normal range. They asked if she wanted to be transported to the hospital, she declined. She was not having difficulty breathing and her itching had decreased. After 20+ minutes later she was not expereincing any worsening of the itching and said that it was not itching as much and she had no difficulty breathing. Patient did mention blurry vision that had started with the itching, but that was not getting better, but was not worsening.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Application site odour, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received the vaccine around 11:40 am in the morning and by the evening she said her arm started to hurt/swell/warm to touch. She came back to the pharmacy today with a large area of redness, swelling and warm to touch. The size is bigger than the size of my palm. Pt did not peel the bandaid off since the day of the shot, I removed it to check the injection site underneath. There was no oozing but there was a stinky smell to the area. We have contacted the pt's doctor and they will have a nurse follow up with the patient.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin reaction, Tenderness
Clinical narrative: Arm became swollen and red, painful when touched, the following morning, swelling about four inches diameter, improving slowly over time.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Peripheral swelling, Tenderness
Clinical narrative: Bicep swollen three times normal. Painful to touch. Day #2 swelling went from the bicep to the elbow area and remained swollen all day. Day #3 still some swelling in elbow area. Both areas are painful to touch.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Electromyogram normal, Hypoaesthesia, Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: Dull pain for 2 months to right shoulder, at approximately 2 months pain became intermittent with numbness/tingling from right upper shoulder that radiates to fingers. Severe pain at night, about 3-4 nights per week. Pain is increasing over time. 06/15/18 seen PCP, was given steroid shot, currently doing physical therapy, 3 times a week. EMG performed with normal results on 05/31/18. (Burning with vaccine injection.)
Age: 77.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Asthenia, Erythema, Injection site nodule, Lethargy, Pain in extremity
Clinical narrative: Sore arm, knot at site, lethargy, high fever (104.4), weakness, red skin (rash) on torso.
Age: 77.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Sore arm, knot at site, lethargy, high fever (104.4), weakness, red skin (rash) on torso.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had redness, pain, and swelling at the site for 1 to 2 days. The redness, swelling, and itching has spread down the patients arm and hand. The affected area has become warm to the touch. Patient also reports insomnia since the redness and swelling has started. The patient was making a paste of Chlorpheniramine tablets and applying to area. On June 15th she took 1 Chlorpheniramine 4mg tablet orally. She was advised to contact her primary care provider and to take BENADRYL.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Insomnia, Peripheral swelling, Pruritus
Clinical narrative: Patient had redness, pain, and swelling at the site for 1 to 2 days. The redness, swelling, and itching has spread down the patients arm and hand. The affected area has become warm to the touch. Patient also reports insomnia since the redness and swelling has started. The patient was making a paste of Chlorpheniramine tablets and applying to area. On June 15th she took 1 Chlorpheniramine 4mg tablet orally. She was advised to contact her primary care provider and to take BENADRYL.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Oxygen saturation decreased, Pyrexia, Tachycardia
Clinical narrative: Awoke about 1:00 a.m. with 101.8 fever (teeth chattering, shivering), bad headache. Took 2 TYLENOL, temperature went back to normal. Also had tachycardia (heart rate in the 120's, took 12mg metoprolol, 50mg flecainide, and heart rate went down to 105 or so and stayed there for about 3 more hours. I used a pulse oximeter to determine heart rate, and oxygen level was also lower than my normal 98% (92-94%) during those 3 hours.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: Localized inflammation, redness and swelling reported with 12 hours of injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: SEMI CIRCULAR; RAISED; RED AREA THAT MEASURED 1 1/2 INCHES WIDE AND 2 INCHES LONG. THE PATIENT WAS ASKED TO COVER THE AREA AND TAKE A PAIN RELIEVER IF COULD NOT TOLERATE THE PAIN.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT DEVELOPED ARTHUS REACTION AT SITE OF INJECTION. PATIENT STATED IT IS TENDER AND WARM TO TOUCH AND SWOLLEN. PATIENT STATED THE SWELLING HAS GROWN LARGER SINCE RECEIVING THE VACCINE. VACCINE ALSO APPEARED TO BE GIVEN SUBCUTANEOUSLY RATHER THAN INTRAMUSCULARLY.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Type III immune complex mediated reaction
Clinical narrative: PATIENT DEVELOPED ARTHUS REACTION AT SITE OF INJECTION. PATIENT STATED IT IS TENDER AND WARM TO TOUCH AND SWOLLEN. PATIENT STATED THE SWELLING HAS GROWN LARGER SINCE RECEIVING THE VACCINE. VACCINE ALSO APPEARED TO BE GIVEN SUBCUTANEOUSLY RATHER THAN INTRAMUSCULARLY.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Full body hives with itching and redness.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Patient reported having severe flu-like symptoms including fever, chills, and headache. He stated he could not get out of bed for a day but the symptoms resolved after that day.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling and hot to touch at injection site.