chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received SHINGRIX. On 6th February 2019, 2 days 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 details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced sore on the arm around the injection sight.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 1st February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced burning sensation, erythema and pruritus. On an unknown date, the outcome of the burning sensation, erythema and pruritus were recovering/resolving. It was unknown if the reporter considered the burning sensation, erythema and pruritus to be related to SHINGRIX. Additional details were reported as follows: The patient experienced the listed side effects after dose of SHINGRIX. The patient symptoms were just starting to resolve as of today.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site hypoaesthesia, Injection site pain, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 31st January 2019, the patient received SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, injection site pain, injection site numbness and nerve pain. On an unknown date, the outcome of the headache, injection site pain and nerve pain were recovered/resolved and the outcome of the injection site numbness was unknown. It was unknown if the reporter considered the headache, injection site pain, injection site numbness and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness and pain at injection site arm, nerve pain, headache with resolution in 1 day. The patient also experienced numbness in vaccination arm. The call was transferred to Risk Compliance.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Wrong technique in product usage process
Clinical narrative: Information has been received from a physician via other company (2018173776), referring to a 75 year old male patient with asthma and chronic obstructive pulmonary disease (COPD). Information about medical history and concomitant therapy was unknown. On unknown dates (reported as before the age of 65), the patient was vaccinated with PNEUMOVAX 23 (2-3 vaccinations; dose, strength, route, lot# and expiration date were unknown) and he also received a booster of PNEUMOVAX 23 (dose, strength, route, lot# and expiration date were unknown) after 70 for prophylaxis. On an unknown date, the patient did not fully respond to the vaccine (no therapeutic response), and he received PREVNAR 13 within 5 months of PNEUMOVAX 23 (wrong technique in product usage process, reported as medical information potential adverse event (AE)). Titers still came back low after PREVNAR 13 (antibody test negative). The outcome of no therapeutic response and antibody test negative was unknown. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: FLUX, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid serious case received from a physician. This case involves a patient of unknown age who had passed out, while he/she received vaccines TRUMENBA, INFLUENZA VACCINE (Flu shot) and MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unspecified date of Nov-2017, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unspecified date of Nov-2017, the patient received a dose of suspect INFLUENZA VACCINE (Flu shot) (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unspecified date of Nov-2017, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unspecified date of Nov-2017, following the vaccination the patient experienced passed out (loss of consciousness). This event was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was passed out. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for passed out. List of documents held by sender: none.; Sender's Comments: This case concerns a patient of unknown age who presented with loss of consciousness after vaccination with MENACTRA, TRUMENBA and INFLUENZA VACCINE. The time to onset, patient's condition at time of vaccination and lab tests to rule out alternate etiologies are not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 27.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Gave rabies # 2 in left deltoid. Minimal bleeding from site after injection. Left arm developed large area of swelling after vaccine (slightly smaller than golf ball) which was hard to palpation. Applied ice.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Hypoaesthesia
Clinical narrative: Headache, dizziness and numbness in right hand-Seen if the emergency department.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Uncontrollable shivering, fever, nausea, dizziness, stomach cramping.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Exposure during pregnancy, Foetal death, Ultrasound antenatal screen normal
Clinical narrative: 21 year old healthy female G2P1001, one prior full term healthy vaginal delivery, presented to initial obstetric visit on 01/10/2019 at 12weeks1day gestation. Last menstrual period of 10/17/2018 provided an estimated due date of 07/24/2019. Ultrasound evaluation during physical exam revealed a single intrauterine pregnancy measuring 11weeks6days, consistent with dating by her period, confirming a due date of 07/24/2019. Patient was counseled by me (the physician) on risks and benefits of the flu vaccine. Patient received the flu vaccine by the nurse practitioner, as routine in the office. Patient's routine blood work returned all normal the following week. Patient returned for a routine scheduled follow up prenatal visit on 02/14/2019, at 17weeks1d. On exam, by my partner, she was diagnosed with a fetal demise, which measured 13weeks5days. She is being scheduled to have a dilation and curettage for early next week.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Patient had body aches, chills, vomiting, feeling faint, feeling tired and a headache. These symptoms set on in the evening of the day she got the shot. It happened with both her first and second doses. It was worse with the second dose.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Patient had body aches, chills, vomiting, feeling faint, feeling tired and a headache. These symptoms set on in the evening of the day she got the shot. It happened with both her first and second doses. It was worse with the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-NOV-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. On 5th February 2019 01:00, 16 hrs after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 4th February 2019 at 9:00 AM, the patient received a dose of SHINGRIX on an unknown arm. Next morning, the patient experienced arm was sore red and swell. The patient wanted to know, if anything that the patient could did to make the patient's arm felt better and get the swelling down.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, 1 days after receiving SHINGRIX, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient got her 2nd shot of the SHINGRIX, a day before the date of reporting. In the morning of the date of reporting, the patient woke up with a fever of 102-degree F. The reporter wanted to know if that was normal and that 102-degree F was not a bit high. The reporter was provided with the link for the package insert or prescribing information (PI) for the product. The reporter saw that fever was one of the side effects and was just wondering if 102-degree F was pretty high. The reporter did give the patient some TYLENOL, in the morning. The reporter asked should the patient go to see the physician and the reporter was referred to health care provider as primary resource for the patient care. The reporter would check with health care provider and would read the PI information also.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For tolerance of 2nd dose of SHINGRIX, refer case: US2019GSK027744. This case was one of the 6 cases reported by the same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received SHINGRIX (batch number 9277N, expiry date 27th June 2021) for prophylaxis. On 3rd February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 3rd February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. The patient was treated with CLARITIN. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported a patient had severe redness at the injection site following SHINGRIX. Within hours of the injection the redness was the size of a quarter. The redness had been growing by the hour since and was now 3 by 5 inch. The patient took some CLARITIN the day before reporting, but the redness was still growing.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Blepharospasm, Dizziness, Loss of consciousness
Clinical narrative: 5 minutes after immunizations were given, client was walking out of clinic and started to get light headed. Client assisted to cot by RN and client's siblings. After client got to the cot he passed out with a loss of consciousness for 2 minutes. Client started to twitch his eyes after his father started to say his name. Client woke up while laying down and started to talk to us. Client was given water and graham crackers. His color started to come back slowly and said he was starting to feel better. Client continued to lay down and rest for 10 minutes. I then had him sit up on the cot to make sure he felt fine. Client continued to drink water while sitting. After 5 minutes of sitting up, client stated that he felt okay to leave. Client left with father and siblings.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Patient complaint of nerve pain from above injection site to side of head.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Swelling
Clinical narrative: Right Upper Shoulder pain. Swelling of Right Upper Shoulder. MRI scan conducted. Scanned revealed a rotator cuff tear. Had physical therepy and cortisol shot to help relieve pain and discomfort.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Right Upper Shoulder pain. Swelling of Right Upper Shoulder. MRI scan conducted. Scanned revealed a rotator cuff tear. Had physical therepy and cortisol shot to help relieve pain and discomfort.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscular weakness, Pyrexia
Clinical narrative: Onset of headache which became severe within 5 hours - onset of low-grade fever after 6 hours; onset of muscle weakness and tiredness/exhaustion which lasted FOUR DAYS!
Age: 0.92
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Mother called HU at 10:00am to report adverse reaction after immunizations on 02/12/2019. AR appeared 02/13/2019 at 08:00am with red, raised rash on arms, legs, back, and buttocks.........(not on face or torso) with no fever but rash warm to touch. Looking at immunizations given the only thing new given to patient was the flu vaccine. Told mother to report and take patient to primary MD, Dr., outpatient medical or urgent care for assessment. Patient states will get grandmother to take patient to urgent care due to no insurance. Mother stated grandmother was going to get some BENADRYL. I reinforced mother to get an assessment done via medical provider and she stated she is. Mother states patient is not itching or in any distress. Reinforced to call HU nurse with results.
Age: 38.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 38 years old female patient. The patient had no pertinent medical history or drug reactions. Concomitant therapies included sterile diluent, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and FLUZONE. On 27-DEC-2018 (reported as 3 weeks ago), the patient was vaccinated with M-M-R II (lot# N032751, expiration date 20-NOV-2019, subcutaneously for prophylaxis; dose and frequency were not provided) and VARIVAX (lot# R018138, expiration date 25-JUN-2020, subcutaneously for prophylaxis; dose and frequency were not provided). On 17-JAN-2019 (reported as 3 weeks after vaccination), the patient returned to office to take a pregnancy test and the patient was 4 weeks pregnant. The last menstrual period (LMP) was calculated as 20-DEC-2018 (17-JAN-2019 subtracting 4 weeks) and estimated date of delivery (EDD) was calculated as 26-SEP-2019. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse effects were reported. There was no treatment given for the event.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Product preparation issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date May 2019) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The reporter asked if 1st dose of SHINGRIX was given subcutaneously (which could lead to incorrect route of vaccine administration), could the patient still receive the 2nd dose. Follow up information received from pharmacist on 7th February 2019: The reporter's contact details were updated. The patient's demographic details were updated. The age of patient was reported as 79 years and 3 months old. The batch number and expiry date of SHINGRIX was updated. On 18th December 2018, the patient received 1st dose of SHINGRIX subcutaneously instead of intramuscular. The SHINGRIX was not premixed, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Less than a year after receiving SHINGRIX, the patient experienced redness at left elbow not at injection site. At the time of reporting, the patient was fine with no harm at all. The VAERS details were updated. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, nausea, fatigue and injection site pain post vaccination. All the symptoms listed, required the patient to take 2 days of sick leave from work. The patient fully recovered after 3 to 4 days with no prolonged symptoms. This case has been linked to case US2019GSK023610, US2019GSK023612, US2019GSK023611 and US2019GSK023600, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter had reported the case of behalf of his/her mother-in-law and four of her coworkers. The age at vaccination was not reported. The patient experienced fever, nausea, fatigue and injection site pain following their vaccination. All the symptoms listed, required the patient to take 2 days of sick leave from work. The patient full recovery after 3 to 4 days with no prolonged symptoms. This case has been linked to case US2019GSK023610, US2019GSK023609, US2019GSK023612 and US2019GSK023600, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day 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 details were provided as follows: The patient asked that, was there more than one type of SHINGRIX vaccine. The patient received 1st dose of SHINGRIX was viscous, seems like the needle was in her arm awhile, it was a bit painful. On 7th February 2019, the patient received 2nd dose of SHINGRIX was a quick shot and not painful. Batch number of 2nd dose of SHINGRIX was 455KD. Both doses given in the deltoid muscle region of the same upper arm.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 50 years or 51 years. The patient's wife reported that her husband received the 1st dose of SHINGRIX last year and approximately 1 year later, received the 2nd dose. The patient experienced soreness at the injection site after first dose which subsided after 2 to 3 days. For tolerability of the second dose of SHINGRIX, refer case US2019023105.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX. 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 recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The batch number, expiration date, injection site or other details were not reported at the time of initial report. Till the time of reporting, the patient was experiencing injection site pain. At the time of reporting, the patient told the pharmacist that he just started to feel better.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling cold, Feeling hot, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 30th January 2019, the patient received the 1st dose of SHINGRIX. On 30th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain, muscle pain, feeling cold, feeling hot, weakness and tiredness. On an unknown date, the outcome of the pain, muscle pain, feeling cold, feeling hot, weakness and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain, muscle pain, feeling cold, feeling hot, weakness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing achiness, minor muscle pain, weakness, tiredness and feeling cold and hot. The patient had these symptoms for the last 7 days. The reporter gave consent to follow up. The patient did not have physician (MD) information at the time of the call.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 30th January 2019, the patient received the 1st dose of SHINGRIX. On 30th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain, muscle pain, feeling cold, feeling hot, weakness and tiredness. On an unknown date, the outcome of the pain, muscle pain, feeling cold, feeling hot, weakness and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain, muscle pain, feeling cold, feeling hot, weakness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing achiness, minor muscle pain, weakness, tiredness and feeling cold and hot. The patient had these symptoms for the last 7 days. The reporter gave consent to follow up. The patient did not have physician (MD) information at the time of the call.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Injection site pain, Neck pain, Toothache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 27th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 27th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 28th January 2019, the patient experienced neck pain, ear pain and toothache. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the neck pain, ear pain and toothache were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, neck pain, ear pain and toothache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. One day after receiving vaccination, the patient experienced pain in neck, ear and teeth on her left side, the same side where the patient received SHINGRIX. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood test normal, Computerised tomogram normal, Hepatomegaly, Laboratory test normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In January 2019, the patient received the 2nd dose of SHINGRIX. On 23rd January 2019, less than a month after receiving SHINGRIX, the patient experienced abdominal pain, spleen enlarged and liver enlargement. On an unknown date, the outcome of the abdominal pain and liver enlargement were not recovered/not resolved and the outcome of the spleen enlarged was unknown. It was unknown if the reporter considered the abdominal pain, spleen enlarged and liver enlargement to be related to SHINGRIX. Additional details were received as follows: The patient received 1st dose of SHINGRIX in November 2018. About 2 weeks ago from the reporting date, the patient received 2nd dose of SHINGRIX. The patient was experiencing abdominal pain. The patient's sonogram results were an enlarged liver, and an enlarged spleen which was twice its normal sized. The symptoms began about 2 weeks ago from the reporting date. The patient had computed tomography (CT) scans, blood tests, and other labs and there was nothing remarkable. Consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Spleen scan normal, Splenomegaly, Ultrasound liver abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In January 2019, the patient received the 2nd dose of SHINGRIX. On 23rd January 2019, less than a month after receiving SHINGRIX, the patient experienced abdominal pain, spleen enlarged and liver enlargement. On an unknown date, the outcome of the abdominal pain and liver enlargement were not recovered/not resolved and the outcome of the spleen enlarged was unknown. It was unknown if the reporter considered the abdominal pain, spleen enlarged and liver enlargement to be related to SHINGRIX. Additional details were received as follows: The patient received 1st dose of SHINGRIX in November 2018. About 2 weeks ago from the reporting date, the patient received 2nd dose of SHINGRIX. The patient was experiencing abdominal pain. The patient's sonogram results were an enlarged liver, and an enlarged spleen which was twice its normal sized. The symptoms began about 2 weeks ago from the reporting date. The patient had computed tomography (CT) scans, blood tests, and other labs and there was nothing remarkable. Consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerability of the first dose of SHINGRIX, refer case US2019GSK027933). On 6th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported that her husband received the 1st dose of SHINGRIX last year and approximately 1 year later, received the 2nd dose. The reporter stated that the patient was not able to get the 2nd dose within 6 months due to the shortage. The patient experienced soreness at the injection site. The soreness from the 2nd dose had not subsided till the time of reporting. There was some by the pharmacist thinking that the patient would have to start the series again since it was too long since he had the first shot but later it was cleared and they confirmed that it was not necessary.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Immunisation, Product preparation issue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 14th November 2018, the patient received SHINGRIX. On 12th November 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 14th November 2018, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the fever and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 12th November 2018, the patient only received the liquid component of the SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient came back to the physician's office on 14th November 2018 where he received the full dose of the SHINGRIX. Less than a day after receiving SHINGRIX, the patient experienced fever and shivering starting at approximately 7 or 8 pm and lasted for 12 hours after receiving the vaccine. The reporter consented to follow up. The reporter gave permission to contact his physician.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown. It was unknown if the reporter considered the arm discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient reported that she had issues with her arm after SHINGRIX vaccine. The information was provided via chat, which was transferred to GlaxoSmithKline representative prior to being able to document.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of herpes zoster in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 7 days after receiving SHINGRIX, the patient experienced herpes zoster and rash. On an unknown date, the patient experienced shooting pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On an unknown date, the outcome of the herpes zoster, rash and shooting pain were unknown. It was unknown if the reporter considered the herpes zoster, rash and shooting pain to be related to SHINGRIX. Additional details were provided as follows: The patient never had an episode of herpes zoster or chicken pox. About 1 week after receiving SHINGRIX, the patient had an outbreak of herpes zoster rash on the right abdomen, back and flank. The patient went out of town when she experienced the rash. She contacted her doctor via phone and was advised to get evaluated. The patient would come back 2 weeks later to see her doctor. Her doctor diagnosed her with mild case of herpes zoster, along with shooting pain. The doctor also noticed the presence of new lesions along the same dermatome. He prescribed the patient gabapentin and valtrex.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 88-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had more than once). Concomitant products included Valacyclovir. In January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site discomfort and injection site pain. On an unknown date, the patient experienced shingles and weakness. On an unknown date, the outcome of the injection site erythema, injection site discomfort, shingles, weakness and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site discomfort, shingles, weakness and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient took valacyclovir to prevent shingles symptoms. The patient describes that he stopped taking the medication for three days prior to receiving the SHINGRIX vaccine. Approximately a little over a week ago from the date of reporting, the patient received SHINGRIX on left arm. The patient could not lay on his left arm. The patient experienced pain which resolved within two days and soon after the redness resolved. A few days after these symptoms resolved the patient began to have a shingles eruption on his backside and he felt weak.  These symptoms resolved after a few days. The reporter was difficult to follow and did not always answer the questions provided. Unable to obtain additional information. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site inflammation, Loss of personal independence in daily activities, Muscular weakness, Neuropathy peripheral
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neuropathy peripheral in a male patient who received SHINGRIX (batch number 9NJ59, expiry date unknown) for prophylaxis. Concomitant products included SHINGRIX. On 19th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced neuropathy peripheral (serious criteria GSK medically significant), weakness of arms, injected limb mobility decreased and injection site inflammation. On an unknown date, the outcome of the neuropathy peripheral, weakness of arms, injected limb mobility decreased and injection site inflammation were not recovered/not resolved. It was unknown if the reporter considered the neuropathy peripheral, weakness of arms, injected limb mobility decreased and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The reporting physician was the concerned patient. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX in the left deltoid. The patient provided lot number for each dose but did not have expiration dates to provide. The physician reported that the symptoms of weak arm came on gradually within a week or two where he had difficulty reaching up to a top shelf and then on 13th December 2018, he noted during a fitness class that he could not lift appropriate weight with his left arm. The patient reported that the neurologist had diagnosed him with axillary neuropathy secondary to inflammation from the injection site and that the issue had not resolved. The patient consented to follow up and requested any correspondence be directed to him since he was a physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Last evening complained of shivering, nausea, vomiting and diarrhea last night.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: Shivers, fever, flu-like feeling, migraine, body-ache, severe left arm soreness and redness  within hours after vaccine, sustained 24 hours after vaccine, severe tiredness, 3rd day eyes did not focus, persistent headache and left arm soreness.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pain, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: Shivers, fever, flu-like feeling, migraine, body-ache, severe left arm soreness and redness  within hours after vaccine, sustained 24 hours after vaccine, severe tiredness, 3rd day eyes did not focus, persistent headache and left arm soreness.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Flu shot caused purple welt which I still have a month later.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivering for approximately 5 hours.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: None. Patient was supposed to receive Men B but instead received MCV4.
Age: 56.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Patient given HPV vaccine when provider asked MA to "add HPV". Confusion arose as the patient was having her pnuemo vaccine that day but had also had a pap and the provider had really meant to add HPV to the pap as opposed to the vaccine. Provider aware of issue and patient contacted by provider so the situation could be explained and patient assessed. No adverse reactions noted.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came into the pharmacy a few days after injection showing an area of cellulitis-like skin below but not near the injection site (but on the same arm). He said a few hours after the injection he noticed it starting to appear, with redness and heat from the area and the area also being sensitive to the touch. His wife is a nurse and she said that she thought it looked like cellulitis. He came into the pharmacy a few days later and showed us the site and we agreed that it looked like cellulitis. It has since gone down in redness and heat but is still tender to the touch.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient came into the pharmacy a few days after injection showing an area of cellulitis-like skin below but not near the injection site (but on the same arm). He said a few hours after the injection he noticed it starting to appear, with redness and heat from the area and the area also being sensitive to the touch. His wife is a nurse and she said that she thought it looked like cellulitis. He came into the pharmacy a few days later and showed us the site and we agreed that it looked like cellulitis. It has since gone down in redness and heat but is still tender to the touch.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The patient had a terrible reaction to the SHINGRIX vaccine. The patient also told me she had contacted an attorney and would be joining the class action law suit. The patient asked were you aware of this. The reporter did not have any additional information. This was a potential legal case. This case has been linked to case US2019GSK027998, reported by same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 58-year-old female patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site wheal, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site wheal, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site wheal, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced welts, swelling and hot to touch at the injection site. No further details were provided. This case has been linked to the case US2019021287, reported by the same reporter.