chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 69-year-old patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, tiredness and upset stomach. On an unknown date, the outcome of the muscle pain, tiredness and upset stomach were unknown. It was unknown if the reporter considered the muscle pain, tiredness and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine a few days before the day of reporting on Monday. The patient was asking if upset stomach could be a side effect of SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, feeling bad, pain and influenza-like symptoms. On an unknown date, the outcome of the fever, feeling bad, pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, feeling bad, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, but it was taken as an adult, as per vaccine indication. The patient experience adverse event after receiving 2 doses of SHINGRIX vaccine. Till the time of reporting, the reporter decline to report and would update safety via correspondence. No additional details were provided. This case was 1 of 3 cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, fever, influenza-like symptoms and feeling bad. On an unknown date, the outcome of the pain, fever, influenza-like symptoms and feeling bad were unknown. It was unknown if the reporter considered the pain, fever, influenza-like symptoms and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The physician reported patients that received SHINGRIX experienced symptoms after. The patient experienced adverse event after receiving 2 doses of SHINGRIX vaccine. The reporter was reluctant to provide data on 3 patients. The follow up would be requested, if safety contacted the reporter. Till the time of reporting no other information was provided. This case was 1 of 3 cases, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX intramuscularly and experienced swelling and redness and pain around the injection site about 3 inches in diameter. The reporter was aware of injection site pain from patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 67-year-old male patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included hip replacement (right hip). On 27th March 2019, the patient received SHINGRIX (intramuscular). On 28th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was not recovered/not resolved. It was unknown if the reporter considered the pain in hip to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The pharmacy did not provide lot number. The patient experienced right hip pain, 24 hours after receiving SHINGRIX in left arm. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium decreased, Diarrhoea, Electrolyte depletion, Fall, Food allergy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included irritable bowel syndrome. On 28th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fall (serious criteria hospitalization), head injury (serious criteria hospitalization), premature ventricular contractions (serious criteria hospitalization), potassium decreased (serious criteria hospitalization) and electrolyte depletion. On 28th March 2019, the patient experienced diarrhea (serious criteria hospitalization). The patient was treated with potassium nos (Potassium Supplement). On 29th March 2019, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the fall, head injury, premature ventricular contractions, potassium decreased and electrolyte depletion were unknown. It was unknown if the reporter considered the diarrhea, fall, head injury, premature ventricular contractions, potassium decreased and electrolyte depletion to be related to SHINGRIX. Additional details were provided as follows: The patient experienced diarrhea the evening she received her first dose of SHINGRIX. The patient had severe diarrhea and continued into the night but ended by 6am the next morning. The patient fell in the bathroom, and hit her head probably due to loss of electrolytes from the diarrhea. She went to the emergency room and was kept overnight in the hospital for low potassium and because she had premature ventricular contractions (PVC's) on her heart rhythm. She was treated with potassium supplements. The patient had a follow up appointment with her primary physician on Friday. It was reported that she had a wheat challenge with a slice of bread on the day before date of reporting. She tried to determine if the diarrhea was from the vaccine or the bread. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Head injury, Ventricular extrasystoles
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included irritable bowel syndrome. On 28th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fall (serious criteria hospitalization), head injury (serious criteria hospitalization), premature ventricular contractions (serious criteria hospitalization), potassium decreased (serious criteria hospitalization) and electrolyte depletion. On 28th March 2019, the patient experienced diarrhea (serious criteria hospitalization). The patient was treated with potassium nos (Potassium Supplement). On 29th March 2019, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the fall, head injury, premature ventricular contractions, potassium decreased and electrolyte depletion were unknown. It was unknown if the reporter considered the diarrhea, fall, head injury, premature ventricular contractions, potassium decreased and electrolyte depletion to be related to SHINGRIX. Additional details were provided as follows: The patient experienced diarrhea the evening she received her first dose of SHINGRIX. The patient had severe diarrhea and continued into the night but ended by 6am the next morning. The patient fell in the bathroom, and hit her head probably due to loss of electrolytes from the diarrhea. She went to the emergency room and was kept overnight in the hospital for low potassium and because she had premature ventricular contractions (PVC's) on her heart rhythm. She was treated with potassium supplements. The patient had a follow up appointment with her primary physician on Friday. It was reported that she had a wheat challenge with a slice of bread on the day before date of reporting. She tried to determine if the diarrhea was from the vaccine or the bread. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, headache, ringing in ears, nausea, difficulty sleeping, shingles and blister. The patient was treated with acyclovir. On an unknown date, the outcome of the injection site pain, ringing in ears, nausea, difficulty sleeping, shingles and blister were not recovered/not resolved and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, ringing in ears, nausea, difficulty sleeping, shingles and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was a Retired Nurse. The batch number was updated from 2YN45 to 2YN4S as per sales data sheet. The patient received SHINGRIX vaccine and it was painful during administration. That night she had difficulty falling asleep. Later in the night she developed a sore arm at the injection site, headache, nausea, and ringing in her ears. The ringing in her ears went away and returned in the morning. At the time of this report, her arm was still sore and she feels nauseous. The patient stated that she has developed a small patch of blisters above her left buttock area that appears to be a shingles outbreak. At the time of this report, the patient was taking acyclovir prophylactically and will see her physician next week. At the time of this report, the patient was concerned because she was taking acyclovir for herpes suppression and just read information that this medication could reduce the effectiveness of the SHINGRIX vaccine. The patient stated, the headache had resolved, other reported events remain. The patient gave consent to contact the safety physician and provided contact details for the same.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Tinnitus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, headache, ringing in ears, nausea, difficulty sleeping, shingles and blister. The patient was treated with acyclovir. On an unknown date, the outcome of the injection site pain, ringing in ears, nausea, difficulty sleeping, shingles and blister were not recovered/not resolved and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, ringing in ears, nausea, difficulty sleeping, shingles and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was a Retired Nurse. The batch number was updated from 2YN45 to 2YN4S as per sales data sheet. The patient received SHINGRIX vaccine and it was painful during administration. That night she had difficulty falling asleep. Later in the night she developed a sore arm at the injection site, headache, nausea, and ringing in her ears. The ringing in her ears went away and returned in the morning. At the time of this report, her arm was still sore and she feels nauseous. The patient stated that she has developed a small patch of blisters above her left buttock area that appears to be a shingles outbreak. At the time of this report, the patient was taking acyclovir prophylactically and will see her physician next week. At the time of this report, the patient was concerned because she was taking acyclovir for herpes suppression and just read information that this medication could reduce the effectiveness of the SHINGRIX vaccine. The patient stated, the headache had resolved, other reported events remain. The patient gave consent to contact the safety physician and provided contact details for the same.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site macule
Clinical narrative: Pt's rt deltoid - "palm sized indurated eyrthematous macule, moderate severity"
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nodule, Peripheral swelling
Clinical narrative: Patient's arm became red and swollen with a knot the size of an egg within 2-4 hours. Within 6 hours the knot was the size of a softball and entire upper arm was red and swollen.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Pain, Pain in extremity, Pyrexia
Clinical narrative: Stomach cramping. Body aches, very sore arm, low grade fever
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 40-year-old female patient. It was reported that the patient had no allergies and drug reactions. No information regarding the patient's pertinent medical history and concomitant medication was provided. On 07-MAR-2019, the patient was vaccinated with GARDASIL 9 intramuscular, lot # N032284, expiration date 22-SEP-2020, for human papilloma virus (HPV) prevention (exact dose was not provided). On 08-MAR-2019 (reported: starting day after injection), the patient experienced injection site pain "on and off". On 13-MAR-2019 (reported as 6 days after injection), the patient sought medical attention by contacting pharmacy due to the fact, that she still experienced injection site pain. It was reported that no bruising at the site and no fever were recognized. No treatment was given and no intervention to prevent serious criteria was performed. The outcome of the injection site pain was reported as not recovered. The relatedness between the injection site pain and the GARDASIL 9 was not provided.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; No adverse effects were reported; This spontaneous report was received from a physician concerning to herself a patient of unknown age. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported.     On an unknown date (reported as on an unspecified date quite a few years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route of administration, anatomical site of vaccination were not reported; lot number and expiration date were unknown). Then, on an unknown date (reported as less than a year later), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (inappropriate schedule of product administration). No adverse effects were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Flushing, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX. On 28th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th March 2019, the patient experienced headache, general body pain, chilliness, facial flushing, influenza-like symptoms and fatigue. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, general body pain, injection site pain, facial flushing, influenza-like symptoms and fatigue were not recovered/not resolved and the outcome of the chilliness was unknown. It was unknown if the reporter considered the headache, general body pain, chilliness, injection site pain, facial flushing, influenza-like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine the day before reporting date and experienced minor side effects. The patient reported additional details regarding adverse events those were body aches started this morning, headaches, face flushing around eyes and around cheeks, flu Symptoms, fatigue started in the morning of reporting day and pain at injection site started on the day before reporting date. The patient also reported that she was taking TYLENOL to ease her symptoms. The patient asked do I need to be concerned about being around grandchildren and her pregnant daughter. The reporter was told this was not a live virus but what to make sure the patient not exposing them to anything.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX. On 28th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th March 2019, the patient experienced headache, general body pain, chilliness, facial flushing, influenza-like symptoms and fatigue. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, general body pain, injection site pain, facial flushing, influenza-like symptoms and fatigue were not recovered/not resolved and the outcome of the chilliness was unknown. It was unknown if the reporter considered the headache, general body pain, chilliness, injection site pain, facial flushing, influenza-like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine the day before reporting date and experienced minor side effects. The patient reported additional details regarding adverse events those were body aches started this morning, headaches, face flushing around eyes and around cheeks, flu Symptoms, fatigue started in the morning of reporting day and pain at injection site started on the day before reporting date. The patient also reported that she was taking TYLENOL to ease her symptoms. The patient asked do I need to be concerned about being around grandchildren and her pregnant daughter. The reporter was told this was not a live virus but what to make sure the patient not exposing them to anything.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypertension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 26th February 2019, 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 blood pressure high. On an unknown date, the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the blood pressure high to be related to SHINGRIX. Additional information was provided as follows: The patient reported this case for himself. The reporter indicated that he had experienced high blood pressure since receiving SHINGRIX vaccine on the morning of 26th February 2019. The same day he received the vaccine, he had his yearly physical and his blood pressure was 118/74. In the morning of reporting day, blood pressure was 150/92. The reporter said it had been elevated at other times since having the vaccine, too. The patient had a new blood pressure monitor and did not feel that there was any wrong with it. The reporter consented to follow up. This case linked with US2019057155, reported by same reporter for his wife.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Blood thyroid stimulating hormone, Brain natriuretic peptide, Headache, Metabolic function test
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 26th February 2019, 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 blood pressure high. On an unknown date, the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the blood pressure high to be related to SHINGRIX. Additional information was provided as follows: The patient reported this case for himself. The reporter indicated that he had experienced high blood pressure since receiving SHINGRIX vaccine on the morning of 26th February 2019. The same day he received the vaccine, he had his yearly physical and his blood pressure was 118/74. In the morning of reporting day, blood pressure was 150/92. The reporter said it had been elevated at other times since having the vaccine, too. The patient had a new blood pressure monitor and did not feel that there was any wrong with it. The reporter consented to follow up. This case linked with US2019057155, reported by same reporter for his wife.
Age: 75.0
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 75-year-old male patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced injection site pain after receiving a dose of SHINGRIX. There was consent to follow up.
Sex: F
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 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 pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced minor pain after receiving a dose of SHINGRIX. The reporter declined to provide any additional information.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: REDNESS APPEARED AT VACCINATION SITE ON 4/4/19. PT REPORTED TO ER AND WAS ADMINSITERED IV ABX AS PRECAUTION AGAINST CELLULITIS.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient had shoulder surgery in right arm a few months ago, requested that we give the vaccine in his right shoulder, where his surgery had been. Developed pain in the deltoid and surgery following the vaccine and went to the ER 2 days later, where he received a steroid shot.
Age: 1.33
Sex: M
Vaccine: MMRV
Symptoms: Aggression, Autism spectrum disorder, Decreased eye contact, Eating disorder, Gene mutation identification test positive
Clinical narrative: loss of over 75+ words and phrases. loss of some motor skills. loss of eye contact. stopped responding to his name. extremely aggressive. doesnt like to be touched or hugged. bops his head on couch, carseat. stopped eating all his normal foods.
Age: 1.33
Sex: M
Vaccine: MMRV
Symptoms: Regressive behaviour, Unresponsive to stimuli
Clinical narrative: loss of over 75+ words and phrases. loss of some motor skills. loss of eye contact. stopped responding to his name. extremely aggressive. doesnt like to be touched or hugged. bops his head on couch, carseat. stopped eating all his normal foods.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site warmth, Mass, Pruritus
Clinical narrative: Patient with complaints of redness and lump starting two days after vaccine. Now seven days out and lump and redness persist, and now having itchiness and site is warm to the touch.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Lethargy, Myalgia
Clinical narrative: Severe pain at injection sight after 4 hours (compare to being slugged in shoulder by boxer) with pain decreasing over the next 48 hours; Within 12-16 hours after injection, muscle pain in both  arms and legs, total body weakness, lethargy and shivering. Recovery took about 36-48 hours. Similar adverse event after first injection in January, 2019. This was perhaps the most painful, uncomfortable vaccine I have ever received. Patients need to be advised by medical provider of these possible reactions to the vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site joint pain, Nuclear magnetic resonance imaging
Clinical narrative: From the time of the patient's injection he continued to experience pain for 2 months after no localized to the site of injection but to the joint L shoulder. Imaging completed showed findings of inflammation/synovitis and patient received a steroid injection to the subacromial bursa.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood creatine phosphokinase, Blood culture, Blood lactic acid, Blood magnesium
Clinical narrative: Patient received SHINGRIX vaccine date she reported of  3/20/2019 and 3/28/2019 started to experience myalgias and arthralgias and severe pain in all her joints of the body and muscles to the extent that she was unable to turn herself and her husband had to lift her and which point she went to urgent care with a fever of 102 and they told her to report to the Emergency department at which time she was admitted, treated with IV toradol, experienced improvement and was dc home on ibuprofen with Prilosec and instructed not to take the booster dose. She was admitted in the hospital x 4 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Full blood count, Incomplete course of vaccination, Lipase
Clinical narrative: Patient received SHINGRIX vaccine date she reported of  3/20/2019 and 3/28/2019 started to experience myalgias and arthralgias and severe pain in all her joints of the body and muscles to the extent that she was unable to turn herself and her husband had to lift her and which point she went to urgent care with a fever of 102 and they told her to report to the Emergency department at which time she was admitted, treated with IV toradol, experienced improvement and was dc home on ibuprofen with Prilosec and instructed not to take the booster dose. She was admitted in the hospital x 4 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Mobility decreased, Myalgia, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Patient received SHINGRIX vaccine date she reported of  3/20/2019 and 3/28/2019 started to experience myalgias and arthralgias and severe pain in all her joints of the body and muscles to the extent that she was unable to turn herself and her husband had to lift her and which point she went to urgent care with a fever of 102 and they told her to report to the Emergency department at which time she was admitted, treated with IV toradol, experienced improvement and was dc home on ibuprofen with Prilosec and instructed not to take the booster dose. She was admitted in the hospital x 4 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory viral panel, Urine analysis
Clinical narrative: Patient received SHINGRIX vaccine date she reported of  3/20/2019 and 3/28/2019 started to experience myalgias and arthralgias and severe pain in all her joints of the body and muscles to the extent that she was unable to turn herself and her husband had to lift her and which point she went to urgent care with a fever of 102 and they told her to report to the Emergency department at which time she was admitted, treated with IV toradol, experienced improvement and was dc home on ibuprofen with Prilosec and instructed not to take the booster dose. She was admitted in the hospital x 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Nasopharyngitis
Clinical narrative: Patient states that her vaccinated arm became incredibly painful and swollen shortly after administration. On Saturday, she developed cold-like symptoms and sneezing...these symptoms have since resolved. She currently is still experiencing warmth around the injection site, soreness, and red welts. She has been taking Ibuprofen regularly since the start of symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Sneezing, Urticaria
Clinical narrative: Patient states that her vaccinated arm became incredibly painful and swollen shortly after administration. On Saturday, she developed cold-like symptoms and sneezing...these symptoms have since resolved. She currently is still experiencing warmth around the injection site, soreness, and red welts. She has been taking Ibuprofen regularly since the start of symptoms.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Patient reported stiff neck on the side opposite of where she received the injection. The pain was decreased after taking OTC TYLENOL, but the pain has still persisted for 2 days so far. I confirmed no other areas of pain and no chest pain to exclude from any potential signs of myocardial infarction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck mass, Pain
Clinical narrative: Received vaccination sometime after 4p.m. To left arm Saturday, 04/06/2019, next morning around 8:00a.m. Going into,shower noticed painful lump on left side of neck which had not been there before. Researched online and saw that this is a possible rare occurrence so am reporting it.  I took TYLENOL 500mg and one ALEVE both 04/06/19 and 04/07/2019, There are actually two lumps, only painful to touch.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Heart rate increased, Pruritus
Clinical narrative: Shortly after receiving zoster vacc, pt experienced tightness in his chest, itching to back of his head, and elevated pulse (115 bpm)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Influenza like illness, Peripheral swelling
Clinical narrative: LOW GRADE TEMPERATURE, SWOLLEN ARM, FLU LIKE SYMPTOMS.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, weakness, tiredness, headache, upper abdominal discomfort and upper abdominal pain. On an unknown date, the outcome of the pain in arm, general body pain, weakness, tiredness, headache, upper abdominal discomfort and upper abdominal pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, weakness, tiredness, headache, upper abdominal discomfort and upper abdominal pain to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX vaccine on the day before the reporting in the arm and experienced side effect such as whole arm hurts, body aches, tired-weak, headache. The patient wanted to know how long the symptoms would last. The patient requested to send the ingredients to this SHINGRIX shot. The patient gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, weakness, tiredness, headache, upper abdominal discomfort and upper abdominal pain. On an unknown date, the outcome of the pain in arm, general body pain, weakness, tiredness, headache, upper abdominal discomfort and upper abdominal pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, weakness, tiredness, headache, upper abdominal discomfort and upper abdominal pain to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX vaccine on the day before the reporting in the arm and experienced side effect such as whole arm hurts, body aches, tired-weak, headache. The patient wanted to know how long the symptoms would last. The patient requested to send the ingredients to this SHINGRIX shot. The patient gave consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The patient was wondering about how long the adverse event would last. The patient provided details to the reporter. The follow up would be requested.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a medical representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was reluctant to get her second dose of SHINGRIX due to the reaction. The reporter was unable to obtain additional details of the event or demographics of the patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The reporter consented to follow up. This case has been linked to case US2019057191, reported for the dose 2 of the same patient.
Sex: F
Vaccine: MNQ
Symptoms: Cough, Fatigue, Infectious mononucleosis, Lyme disease, Lymphadenitis
Clinical narrative: This case was reported by a physician and described the occurrence of lyme disease in a adolescent female patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. Co-suspect products included tuberculin purified unknown for product used for unknown indication. On 2nd June 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and tuberculin purified (unknown) at an unknown dose and frequency. On 9th June 2009, 7 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced lyme disease (serious criteria GSK medically significant and other: serious per reporter) and mononucleosis infectious (serious criteria other: serious per reporter). On 24th October 2009, the patient experienced sore throat (serious criteria other: serious per reporter), cough (serious criteria other: serious per reporter) and jaw pain (serious criteria other: serious per reporter). On an unknown date, the patient experienced lymphadenitis (serious criteria other: serious per reporter), swollen lymph nodes (serious criteria other: serious per reporter) and fatigue (serious criteria other: serious per reporter). The action taken with tuberculin purified was unknown. On an unknown date, the outcome of the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain were recovered/resolved. It was unknown if the reporter considered the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional detail: The age at vaccination was not reported. It was unknown if the reporter considered the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain to be related to tuberculin purified. Initial information was received from a Physician via regulatory authority on 25th March 2019: Lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain.
Sex: F
Vaccine: MNQ
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in jaw
Clinical narrative: This case was reported by a physician and described the occurrence of lyme disease in a adolescent female patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. Co-suspect products included tuberculin purified unknown for product used for unknown indication. On 2nd June 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and tuberculin purified (unknown) at an unknown dose and frequency. On 9th June 2009, 7 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced lyme disease (serious criteria GSK medically significant and other: serious per reporter) and mononucleosis infectious (serious criteria other: serious per reporter). On 24th October 2009, the patient experienced sore throat (serious criteria other: serious per reporter), cough (serious criteria other: serious per reporter) and jaw pain (serious criteria other: serious per reporter). On an unknown date, the patient experienced lymphadenitis (serious criteria other: serious per reporter), swollen lymph nodes (serious criteria other: serious per reporter) and fatigue (serious criteria other: serious per reporter). The action taken with tuberculin purified was unknown. On an unknown date, the outcome of the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain were recovered/resolved. It was unknown if the reporter considered the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional detail: The age at vaccination was not reported. It was unknown if the reporter considered the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain to be related to tuberculin purified. Initial information was received from a Physician via regulatory authority on 25th March 2019: Lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Axillary pain, Lymphadenopathy, Mass, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional and described the occurrence of axillary pain in a male patient who received Meningococcal ACWY Vaccine (potential MENVEO) for prophylaxis. Co-suspect products included GARDASIL for prophylaxis. On 3rd August 2010, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and GARDASIL (intramuscular). On 4th August 2010, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced axillary pain. In August 2010, the patient experienced swollen lymph nodes. On an unknown date, the patient experienced mass, swelling and tenderness. On 7th August 2010, the outcome of the axillary pain, mass, swelling and tenderness were recovered/resolved. On an unknown date, the outcome of the swollen lymph nodes was unknown. It was unknown if the reporter considered the axillary pain, mass, swelling, swollen lymph nodes and tenderness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details: Age at vaccination was not reported. It was unknown if the reporter considered the axillary pain, mass, swelling, swollen lymph nodes and tenderness to be related to GARDASIL. Initial information was received from other health professional via regulatory authority on 25th March 2019. Axillary pain, mass, swelling, swollen lymph nodes and tenderness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, 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 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (previously had a ZOSTAVAX vaccination) and Infusion. On 23rd February 2019, the patient received SHINGRIX. On 24th February 2019, 1 days after receiving SHINGRIX, the patient experienced arm discomfort, headache, shivering and mobility decreased. On 5th March 2019, the patient experienced injection site pain, injection site warmth, injection site induration, injection site erythema and injection site rash. On an unknown date, the patient experienced pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site induration, injection site erythema, injection site rash, arm discomfort, headache, shivering and pain were recovered/resolved and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site induration, injection site erythema, injection site rash, arm discomfort, headache, shivering, pain and mobility decreased to be related to SHINGRIX. Additional information was provided as follows: The patient had an Magnetic resonances imaging and infusion the next day after the vaccination. The patient experienced discomfort in her left arm after receiving SHINGRIX. Ten days later she had redness and a rash at the injection site. The area was hot to the touch and felt hard. She was having recurring trouble raising her arm and it has lasted 4 to 5 days. While exercising her arm the patient felt better, but later in the day, the pain returned. She was applying a cold compress to the area and took TYLENOL yesterday and the pain resolved. Lab Comments: The patient had an MRI and IV the next day after the vaccination
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Limb discomfort, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (previously had a ZOSTAVAX vaccination) and Infusion. On 23rd February 2019, the patient received SHINGRIX. On 24th February 2019, 1 days after receiving SHINGRIX, the patient experienced arm discomfort, headache, shivering and mobility decreased. On 5th March 2019, the patient experienced injection site pain, injection site warmth, injection site induration, injection site erythema and injection site rash. On an unknown date, the patient experienced pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site induration, injection site erythema, injection site rash, arm discomfort, headache, shivering and pain were recovered/resolved and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site induration, injection site erythema, injection site rash, arm discomfort, headache, shivering, pain and mobility decreased to be related to SHINGRIX. Additional information was provided as follows: The patient had an Magnetic resonances imaging and infusion the next day after the vaccination. The patient experienced discomfort in her left arm after receiving SHINGRIX. Ten days later she had redness and a rash at the injection site. The area was hot to the touch and felt hard. She was having recurring trouble raising her arm and it has lasted 4 to 5 days. While exercising her arm the patient felt better, but later in the day, the pain returned. She was applying a cold compress to the area and took TYLENOL yesterday and the pain resolved. Lab Comments: The patient had an MRI and IV the next day after the vaccination