chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient came in the next morning, 5/30/2018, complaining about his experience following the flu shot.  Complaints included lightheadedness and near syncopal episode starting roughly a half hour after the immunization and lasting 3 to 4 hours later. Patient also complained of severe flu-like symptoms with several episodes diarrhea through the evening and vomiting once in the morning during breakfast.  Complaints also included arm pain at the injection site. All protocols were followed during the immunization process. Patient also received a testosterone injection from a nurse at 10:05AM  before going to the pharmacy for the SHINGRIX vaccine.
Age: 10.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Less than 23 hours after receiving the shots, my granddaughter had a raised red and very itchy rash going across her entire chest. The following day, the rash appeared across her entire back and since then, it has popped up at different location on her entire body including her buttocks, neck, arm, face, etc. The rashes are extremely itchy when they appear and then they disappear and reappear in a different location on her body.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site rash, Pyrexia
Clinical narrative: Feverish, rash on injection site, joint ache, chills.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash
Clinical narrative: Pt developed rash within 24 hours to same location as injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vaccination site swelling
Clinical narrative: Mother notified us over phone about reaction to the vaccine, patient's leg was swollen where vaccine was administered. Told mom to come into clinic for Dr. to exam. BENADRYL, MOTRIN and ice pack for treatment, will follow up on next day.
Age: 19.0
Sex: M
Vaccine: TYP, YF
Symptoms: Arthralgia, Fatigue, Granulocyte percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: Bilateral Hand arthralgias, Headache, Fatigue pressure behind eyes.
Age: 19.0
Sex: M
Vaccine: TYP, YF
Symptoms: Headache, Lymphocyte percentage increased, Monocyte percentage increased, Ocular discomfort, Platelet count decreased
Clinical narrative: Bilateral Hand arthralgias, Headache, Fatigue pressure behind eyes.
Age: 19.0
Sex: M
Vaccine: TYP, YF
Symptoms: Red blood cell count normal, Red cell distribution width normal, White blood cell count decreased
Clinical narrative: Bilateral Hand arthralgias, Headache, Fatigue pressure behind eyes.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 31 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In December 2013, the patient was vaccinated with the first dose of RECOMBIVAX HB, then, in September 2017, the patient received the second dose of RECOMBIVAX HB, and in October 2017, the patient received the third dose of RECOMBIVAX HB(dose, route, lot number and expiration date were not reported) all for prophylaxis. No adverse effects reported.
Sex: M
Vaccine: DTAP, RVX
Symptoms: Paralysis
Clinical narrative: Initial unsolicited information received from a physician and consumer (mother) via phone call on 15-May-2018. This case involves a two-month-old male patient who was vaccinated once with a 0.5 mL dose of a DAPTACEL (batch number: C5102BA, expiry date not reported) intramuscularly in thigh and a dose of ROTAVIRUS VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on 10-Apr-2018. The patient's past medical history and concomitant medication was not provided. On an unknown date, post vaccination, the patient developed palsy (paralysis). The patient was evaluated by his physician on 29-Apr-2018. Relevant lab investigations and corrective treatment were not reported. The outcome of the event was reported as Unknown. Upon internal review the case was considered as serious because of important medical event. The physician assessed that the cause of the event was the DTAP vaccine. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 24-05-2018: This case involves a two-month-old male patient who developed paralysis while he got vaccinated with diphtheria-15/tetanus/5 AC pertussis vaccine. This case cannot be assess due to lack of information. Moreover, information regarding relevant medical history, concurrent conditions, concomitant medications and family history will aid in comprehensive assessment of this case.
Age: 40.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Dizziness, Feeling hot, Nausea, Pallor
Clinical narrative: Patient became pale and stated that they felt dizzy and nauseous approximately 1 minute after injection. Stated their face felt warm. Patient was instructed to recline with feet elevated until dizziness subsided. This took about 7-8 minutes.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Dyspnoea, Flushing, Oral pruritus, Urticaria
Clinical narrative: Patient complained to mother that his mouth was itching. He then started to wheeze with SOB then became flushed and had one hive on chest. He tolerated BENADRYL, albuterol neb, and ORAPRED well with resolution of his symptoms. I have added varicella to his allergy list. Recommend another dose of BENADRYL in 4-6 hours then as needed. Recommend a second dose of ORAPRED tomorrow but not beyond that.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Patient complained to mother that his mouth was itching. He then started to wheeze with SOB then became flushed and had one hive on chest. He tolerated BENADRYL, albuterol neb, and ORAPRED well with resolution of his symptoms. I have added varicella to his allergy list. Recommend another dose of BENADRYL in 4-6 hours then as needed. Recommend a second dose of ORAPRED tomorrow but not beyond that.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Syncope
Clinical narrative: Pt fainted within 12 minutes of receiving vaccines.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Fever 100.5 degrees, lack of appetite.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased, Insomnia, Psychomotor hyperactivity, Pyrexia
Clinical narrative: Patient reports that after receiving her first SHINGRIX shot, she experienced hyperactivity, increase in heart rate, and insomnia. She also experienced fever and chills.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Pain and swelling at the injection site on upper left arm. Red blistery rash on upper left arm at and below the injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Pain and swelling at the injection site on upper left arm. Red blistery rash on upper left arm at and below the injection site.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying, Dyskinesia, Tremor
Clinical narrative: The night that he received the vaccine, he started having shaking fits. He would cry uncontrollably and his arms would suddenly flail and shake violently, which has never happened before.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient returned to the store to report pain, swelling and redness extending in a large area around the injection site. Inflamed area approx 5x5 inches. Pt reported treating with ibuprofen 200mg two Q 6 h. with pain persisting. Returned to store approx 23 hours after initial injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Rash, Rash erythematous
Clinical narrative: Developed a red bumpy rash across my chest along with muscle aches and exhaustion.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt presented about 30 minutes after injection with a red non-itchy rash on her stomach and side.  Noticed it while trying on a shirt in the store - had been working all day and couldn't say when it actually began. Denied exposure to anything new or different. Pt didn't show any other progressing symptoms of anaphylaxis and refused benadryl. Called pt about 2 hrs later to follow up. Pt said rash was resolving without the use of benadryl, and denied any progressing symptoms of anaphylaxis.  Called pt again today for 2nd follow up; had to leave a message. Pt has not yet returned our call, but did say last night she would call us if anything got worse.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Vaccine was given subcutaneous instead of intramuscularly.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acidosis, Acute kidney injury, Anion gap, Atrial fibrillation, Blood creatine phosphokinase increased
Clinical narrative: Patient was seen in the office a few weeks ago and was feeling well. Apparently, he received recent SHINGRIX vaccine and immediately started feeling worse after. Patient presented to hospital on 5/26 with fevers, malaise and myalgias. Serum creatinine was 4 on admission. Patient was started on broad spectrum antibiotics and developed worsening acidosis. He was eventually intubated for respiratory failure. He developed atrial fibrillation with rapid ventricular rate and was started on vasopressors for hypotension. Transferred to Regional hospital for acute renal failure and septic shock.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatinine increased, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Carbon dioxide decreased
Clinical narrative: Patient was seen in the office a few weeks ago and was feeling well. Apparently, he received recent SHINGRIX vaccine and immediately started feeling worse after. Patient presented to hospital on 5/26 with fevers, malaise and myalgias. Serum creatinine was 4 on admission. Patient was started on broad spectrum antibiotics and developed worsening acidosis. He was eventually intubated for respiratory failure. He developed atrial fibrillation with rapid ventricular rate and was started on vasopressors for hypotension. Transferred to Regional hospital for acute renal failure and septic shock.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Hypotension, Immediate post-injection reaction, Malaise, Myalgia
Clinical narrative: Patient was seen in the office a few weeks ago and was feeling well. Apparently, he received recent SHINGRIX vaccine and immediately started feeling worse after. Patient presented to hospital on 5/26 with fevers, malaise and myalgias. Serum creatinine was 4 on admission. Patient was started on broad spectrum antibiotics and developed worsening acidosis. He was eventually intubated for respiratory failure. He developed atrial fibrillation with rapid ventricular rate and was started on vasopressors for hypotension. Transferred to Regional hospital for acute renal failure and septic shock.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Procalcitonin increased, Pyrexia, Respiratory failure, Seizure, Septic shock
Clinical narrative: Patient was seen in the office a few weeks ago and was feeling well. Apparently, he received recent SHINGRIX vaccine and immediately started feeling worse after. Patient presented to hospital on 5/26 with fevers, malaise and myalgias. Serum creatinine was 4 on admission. Patient was started on broad spectrum antibiotics and developed worsening acidosis. He was eventually intubated for respiratory failure. He developed atrial fibrillation with rapid ventricular rate and was started on vasopressors for hypotension. Transferred to Regional hospital for acute renal failure and septic shock.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Troponin increased, Viral test, White blood cell count increased
Clinical narrative: Patient was seen in the office a few weeks ago and was feeling well. Apparently, he received recent SHINGRIX vaccine and immediately started feeling worse after. Patient presented to hospital on 5/26 with fevers, malaise and myalgias. Serum creatinine was 4 on admission. Patient was started on broad spectrum antibiotics and developed worsening acidosis. He was eventually intubated for respiratory failure. He developed atrial fibrillation with rapid ventricular rate and was started on vasopressors for hypotension. Transferred to Regional hospital for acute renal failure and septic shock.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Death, Influenza like illness, Pyrexia
Clinical narrative: Patient was seen in the office a few weeks ago and was feeling well. Apparently, he received recent SHINGRIX vaccine and immediately started feeling worse after. Patient presented to hospital on 5/26 with fevers, malaise and myalgias. Serum creatinine was 4 on admission. Patient was started on broad spectrum antibiotics and developed worsening acidosis. He was eventually intubated for respiratory failure. He developed atrial fibrillation with rapid ventricular rate and was started on vasopressors for hypotension. Transferred to Regional hospital for acute renal failure and septic shock.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PT GOT VACCINATED ON 5/28/2018 AND CAME ON 5/30/2018 AND HER BOTH HANDS ARE SWOLLEN AND REDNESS, WE RECOMMENDED HER TO GO TO DR AND SHE CAME WITH RX FOR ANTIBIOTICS AND STEROIDS.
Age: 65.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: According to patient he was hospitalized for Polymyalgia Rheumatica which he determined was caused by the SHINGRIX injection; however, he also received a Hep A vaccine. The physician treating him suggested he speak with his pharmacist and report it as an adverse reaction. I have no direct knowledge to determine claims made by patient. Patient is now taking steroids for his condition.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Five days later I still have marked swelling and sharp pain when the injection site is touched. I became ill with flu-like symptoms that lasted three and a half days. I was exhausted and out of it. I feel better now, but my arm is still quite painful. I can't imagine wanting to take the second dose. I have no thought it was administered improperly, I just wonder if  the side effects are normal and worth the vaccination. I've never had an adverse reaction to any medication or vaccination previously.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Five days later I still have marked swelling and sharp pain when the injection site is touched. I became ill with flu-like symptoms that lasted three and a half days. I was exhausted and out of it. I feel better now, but my arm is still quite painful. I can't imagine wanting to take the second dose. I have no thought it was administered improperly, I just wonder if  the side effects are normal and worth the vaccination. I've never had an adverse reaction to any medication or vaccination previously.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Pt says he felt dizzy, had a slight fever, headache, nausea, no appetite starting the day after the shot was administered. His arm was also sore. The effects lasted for about 4 days. He says that the same happened with the 1st SHINGRIX vaccination on 03/17/2018, but the effects only lasted about 2 days. This time it took him longer to recover. He did not report the side effects after the first shot at the time.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt says he felt dizzy, had a slight fever, headache, nausea, no appetite starting the day after the shot was administered. His arm was also sore. The effects lasted for about 4 days. He says that the same happened with the 1st SHINGRIX vaccination on 03/17/2018, but the effects only lasted about 2 days. This time it took him longer to recover. He did not report the side effects after the first shot at the time.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: PAIN IN ARM 2 TO 3 INCHES BELOW SITE OF INJECTION - LOW GRADE FEVER FOR 24 HOURS - SHINGLES RASH ON BACK 4 DAYS LATER ITCHY AND PAINFUL (STARTED TO SUBSIDE AFTER A COUPLE OF DAYS).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Gastrooesophageal reflux disease, Injection site rash, Middle insomnia
Clinical narrative: PT STATED THAT HE HAD INJECTION SITE RASH FOR 4 DAYS FOLLOWING VACCINE. HE ALSO STATED THAT HE EXPERIENCED SEVERE CHEST PAIN/ACID REFLUX IN HIS CHEST AND BOTH SHOULDERS THE NIGHT THE VACCINE WAS GIVEN THAT AWOKE HIM FROM SLEEP. HE STATED THAT HE THOUGHT HE WAS HAVING A HEART ATTACK SO HE TOOK A 325 MG ASA. HE WENT BACK TO SLEEP AND AWOKE THE NEXT MORNING WITH NO SYMPTOMS. HE STATES THAT HE THOUGHT HE EXPEREINCED SEVERE ACID REFLUX AND WANTED IT REPORTED.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood glucose decreased, Dizziness, Fall, Loss of consciousness
Clinical narrative: PATIENT WAS ADMINISTERED ADACEL AND SHINGRIX IMMUNIZATIONS INTRAMUSCULARLY ON LEFT AND RIGHT ARMS RESPECTIVELY. SHE SAID SHE FELT LIGHT HEADED AND WANTED TO DRINK SOME WATER. AS SOON AS I WENT TO GET THE WATER, SHE LOST CONSCIOUSNESS AND FELL WITH HER FACE DOWN. WHEN I GOT BACK TO HER IN A FEW MINUTES SHE REGAINED CONSCIOUSNESS AFTER INHALING AMMONIA. SHE SAT AT OUR FACILITY FOR 15 MINUTES AND ATE CRACKERS AND HAD SPRITE AND LEFT AFTER THAT. SHE CALLED US BACK IN AN HOUR TO TELL US THAT SHE HAD NOT EATEN ANYTHING SINCE MORNING AND HER SUGAR PROBABLY WENT LOW. SHE SAID SHE WAS PERFECTLY FINE AND THANKED US FOR TAKING CARE OF HER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: The patient presented back to the pharmacy on 5/30/18 reporting a significant reaction she had incurred from the SHINGRIX vaccine. Her left deltoid had significant bruising at the injection site (dark purple and blue) about the size of golf ball (circumference). She also had pictures of redness and swelling that she had experienced on 5/27 and 5/28 on the lower half of her humerus as well as at the injection site. She reported significant pain in her left arm to the extent that she could not use it or move it without significant discomfort. The patient said she self-treated with ice and over the counter allegra (dose and quantity unknown). Today, 5/30/18, the bruising is still very apparent, however the redness and swelling seem to have subsided and the paient said shes more comfortable now.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: The patient states the evening on the day (5/28) of receiving the SHINGRIX vaccine her left arm became very sore, swollen and hot to touch. She says the next day, 5/29, she could not move her arm and stayed laid down that day taking Ibuprofen 200mg in the morning and (2) 500mg Tylenol that evening. She reported the situation to the pharmacy on 5/30 at 9:30am saying that she could now move her arm over her head but said she had a painless red rash under both breasts and on the left side of her neck. I spoke to her later at 2:30pm in which she stated she felt better and the rash was clearing up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Fatigue, Feeling abnormal
Clinical narrative: First night I experienced bad nausea. The next day I developed extreme tiredness, weakness, muscle aches, headache, shivering, fever (101 degrees), and swelling and redness on my arm. The red spot on my arm is about 4 inches by 2 inches and is hot to the touch. I am now at 54 hours post-vaccine and still feel lousy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: First night I experienced bad nausea. The next day I developed extreme tiredness, weakness, muscle aches, headache, shivering, fever (101 degrees), and swelling and redness on my arm. The red spot on my arm is about 4 inches by 2 inches and is hot to the touch. I am now at 54 hours post-vaccine and still feel lousy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: First night I experienced bad nausea. The next day I developed extreme tiredness, weakness, muscle aches, headache, shivering, fever (101 degrees), and swelling and redness on my arm. The red spot on my arm is about 4 inches by 2 inches and is hot to the touch. I am now at 54 hours post-vaccine and still feel lousy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Exercise tolerance decreased, Pyrexia
Clinical narrative: Fever 102 for about 10 hours. I slept most of the day. My wife finally made me take 2 acetaminophen and the fever is gone and I was able to eat a small amount of food around 7 pm. Even room temperature water upset my stomach. I wore a tee shirt, a wool shirt, and a light parka to go to a meeting this morning. When we got home I slept with all my clothes on under a heavy blanket. I'm starting to feel better now. I had a similar reaction to the first dose on 3/16/2018, which I didn't report. I am a healthy, active person who rides my bicycle 30-50 miles at least 3 times a week. In March I tried to ride through the symptoms, but I had to quit after 22 miles. That's unusual for me.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: The patient's husband presented to the pharmacy with a prescription for Clindamycin. The patient's husband stated at the counsel window that the antibiotic was prescribed by the patient's doctor to treat a swollen arm due to the shingrix vaccine the patient received 6 days ago.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles attack 13 days post vaccination (first ever). Now 17 days old.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelling 3.5 x 1.5 x  1/4 " red itchy. Has not improved in the last 24 hours. Counseled to do cetirizine 10 mg daily and apply hydrocortisone 1% cream a couple times a day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported a raised bump on left arm a half inch- 1 inch from injection site. Patient reported this happened 4 days after the vaccination and the bump was about 2-3 inches wide. Patient states they went to the ER and received KEFLEX and ibuprofen but states it does not hurt. Patient states it was itching mildly.
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS, FLU4, VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Somnolence
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX. On 17th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 18th May 2018, the patient experienced injection site pain, myalgia and sleepiness. In May 2018, the outcome of the myalgia and fatigue were recovered/resolved. On 20th May 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the sleepiness was unknown. The reporter considered the injection site pain, myalgia, fatigue and sleepiness to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced myalgias and fatigue which were not experienced after the first dose of SHINGRIX. She did Pilates later that day with some fatigue and less performance than usual, but on 18th May 2018, 1 day after receiving SHINGRIX, the patient really noted the fatigue and myalgias which she initially attributed to Pilates but realized was secondary to the vaccine especially as she found herself sleepy and falling asleep several times throughout the day. There was also some moderate injection site pain she described as like a flu shot on the 18th which by 20th May 2018 was resolved completely (see case US2018GSK096241). On the day of reporting all symptoms had completely resolved. She did attribute all the aforementioned symptoms to receiving SHINGRIX. This case has been linked with US2018GSK096241, reported by the same reporter for the same patient.
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS, FLU4, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX. On 17th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 18th May 2018, the patient experienced injection site pain, myalgia and sleepiness. In May 2018, the outcome of the myalgia and fatigue were recovered/resolved. On 20th May 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the sleepiness was unknown. The reporter considered the injection site pain, myalgia, fatigue and sleepiness to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced myalgias and fatigue which were not experienced after the first dose of SHINGRIX. She did Pilates later that day with some fatigue and less performance than usual, but on 18th May 2018, 1 day after receiving SHINGRIX, the patient really noted the fatigue and myalgias which she initially attributed to Pilates but realized was secondary to the vaccine especially as she found herself sleepy and falling asleep several times throughout the day. There was also some moderate injection site pain she described as like a flu shot on the 18th which by 20th May 2018 was resolved completely (see case US2018GSK096241). On the day of reporting all symptoms had completely resolved. She did attribute all the aforementioned symptoms to receiving SHINGRIX. This case has been linked with US2018GSK096241, reported by the same reporter for the same patient.
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS, FLU4, VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Somnolence
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 74-year-old female patient who received Influenza vaccine Quadrivalent. Concomitant products included SHINGRIX. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced injection site pain. On 20th May 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The patient experienced moderate injection site pain she described as like a flu shot on the 18th which by 20th May 2018 was resolved completely. This case has been linked with US2018GSK091252, reported by the same reporter for the same patient.
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS, FLU4, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 74-year-old female patient who received Influenza vaccine Quadrivalent. Concomitant products included SHINGRIX. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced injection site pain. On 20th May 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The patient experienced moderate injection site pain she described as like a flu shot on the 18th which by 20th May 2018 was resolved completely. This case has been linked with US2018GSK091252, reported by the same reporter for the same patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX (batch number BN9L9, expiry date 30th March 2020). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain. On an unknown date, the outcome of the headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain were recovered/resolved. The reporter considered the headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on right deltoid. The batch number reported for SHINGRIX (BN919), did not exist and was updated as BN9L9, as per sales database.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX (batch number BN9L9, expiry date 30th March 2020). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain. On an unknown date, the outcome of the headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain were recovered/resolved. The reporter considered the headache, injection site itching, upset stomach, diarrhea, fatigue and injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on right deltoid. The batch number reported for SHINGRIX (BN919), did not exist and was updated as BN9L9, as per sales database.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old female patient who received SHINGRIX. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 23rd May 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, headache and pain. On an unknown date, the outcome of the nausea, headache and pain were not recovered/not resolved. The reporter considered the nausea, headache and pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on left arm. The patient woke up during the night about 3:00 AM feeling as if she was going to throw up. The patient was achy all over and had a very bad headache. The patient had denied permission to contact their physician.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Pneumonia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Previously administered products included zoster vaccine (received at the age of 55 years without any adverse events) and pneumonia vaccine (received in May 2018). Concomitant products included Metoprolol. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd May 2018, 8 hrs after receiving SHINGRIX, the patient experienced fever, headache, chills and heart rate increased. On 22nd May 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the headache and heart rate increased were recovered/resolved. The reporter considered the fever, headache, chills and heart rate increased to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on right arm. The fever resolved after 2 hours. The chills resolved after 3 hours. The slight fast heart beat did not last long at all.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever. 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: The age at vaccination was not applicable for this report. The healthcare professional (HCP) reported that a few patients had experienced fever, usually within 12 to 14 hours of SHINGRIX administration. The HCP declined to provide any further specifics.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lymphadenopathy, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 55-year-old female patient who received SHINGRIX. On 18th May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced tiredness, pruritus, enlargement of lymph nodes and pain. On an unknown date, the outcome of the tiredness, pruritus, enlargement of lymph nodes and pain were unknown. It was unknown if the reporter considered the tiredness, pruritus, enlargement of lymph nodes and pain to be related to SHINGRIX. Additional details were provided as follows: The consumer reported possible adverse reactions to SHINGRIX on online chat. The patient stated that she was not a health care professional and received SHINGRIX on Friday. The patient suspected that she was having a reactions like tired, achy, enlarged lymph node on my collar bone area and itchy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure, Crohn's disease, adrenal insufficiency and decreased immune responsiveness. Concomitant products included hydrocortisone, methotrexate, triamterene, ENTYVIO, JANUVIA, metoprolol, MYRBETRIQ and PENTASA. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. In April 2018, the patient experienced fever, muscle pain, nausea, chills and fatigue. In April 2018, the outcome of the fever, muscle pain, injection site swelling, nausea, injection site erythema, chills and fatigue were recovered/resolved. The reporter considered the fever, muscle pain, injection site swelling, nausea, injection site erythema, chills and fatigue to be almost certainly related to SHINGRIX. Additional information was received as follows: At 14:00, the patient received SHINGRIX on left arm. On 13th April 2018, at 2 AM, 12 hours after receiving SHINGRIX, the patient experienced a high degree fever, severe chills, muscles aches, fatigue and nausea. On 13th April 2018, the patient's body temperature was recorded as 102 degree F. The fever lasted for about 3 days. The severe chills, muscle ache and nausea lasted for about one day. The fatigue lasted for approximately about a week. The redness and swelling on the injection site, lasted for total of three to four days. The patient gave permission to contact her healthcare physician. The physician's information was same as noted in vaccine facility information. No further details were provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure, Crohn's disease, adrenal insufficiency and decreased immune responsiveness. Concomitant products included hydrocortisone, methotrexate, triamterene, ENTYVIO, JANUVIA, metoprolol, MYRBETRIQ and PENTASA. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. In April 2018, the patient experienced fever, muscle pain, nausea, chills and fatigue. In April 2018, the outcome of the fever, muscle pain, injection site swelling, nausea, injection site erythema, chills and fatigue were recovered/resolved. The reporter considered the fever, muscle pain, injection site swelling, nausea, injection site erythema, chills and fatigue to be almost certainly related to SHINGRIX. Additional information was received as follows: At 14:00, the patient received SHINGRIX on left arm. On 13th April 2018, at 2 AM, 12 hours after receiving SHINGRIX, the patient experienced a high degree fever, severe chills, muscles aches, fatigue and nausea. On 13th April 2018, the patient's body temperature was recorded as 102 degree F. The fever lasted for about 3 days. The severe chills, muscle ache and nausea lasted for about one day. The fatigue lasted for approximately about a week. The redness and swelling on the injection site, lasted for total of three to four days. The patient gave permission to contact her healthcare physician. The physician's information was same as noted in vaccine facility information. No further details were provided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Myalgia
Clinical narrative: 5/5/18 clinic note: Pt called c/o of waking with fever and body aches. Referred to local ED. 5/5/18 outside facility note: Pt c/o of chills, malaise, general weakness; no fever. Pt was d/c b/c no emergent medical condition. Headache, Myalgia and chills, malaise, weakness.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: 5/5/18 clinic note: Pt called c/o of waking with fever and body aches. Referred to local ED. 5/5/18 outside facility note: Pt c/o of chills, malaise, general weakness; no fever. Pt was d/c b/c no emergent medical condition. Headache, Myalgia and chills, malaise, weakness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Catheterisation cardiac abnormal, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 29th August 2020). On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on left arm. The patient experienced extreme fatigue ever since. The healthcare professional stated that fatigue was so extreme that patient had been woke up in the morning. The patient had checked with her cardiologist and had a catheterization which was clear. The healthcare professional was not sure if it was due to SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult female patient who received SHINGRIX. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX one month ago after recurring Shingles. The patient was told that she will never get them again. The patient experienced Shingles and currently laying in bed and pissed off with the worst case of Shingles ever had. The patient asked whether she should receive the booster dose of SHINGRIX.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza B virus test positive, Malaise, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 54-year-old female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included lung cancer (stage 4). Concomitant products included CLARITIN, SUDAFED and TAGRISSO. In April 2017, the patient received Influenza vaccine Quadrivalent (intramuscular). On 24th April 2018, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza B virus infection. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza B virus infection was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza B virus infection to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The patient had stage 4 lung cancer and is susceptible to illnesses like influenza. On 24th April 2018, the patient was diagnosed with influenza B. She had gone to her doctor's office because she had been sick for the past 5 days from the date of reporting. The case was considered as suspected vaccination failure as the time to onset for the event was not provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 16th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown. The reporter considered the injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: Concomitant therapies or other specific dosing details were unknown. The patient experienced red and itchy area at the injection site about 2 inch by 1 inch in diameter next day after vaccination. The current status of the symptom described as an injection site reaction was unknown. The reporter planned to see the patient at an office visit later today to examine the area. The reporter was transferred to the GlaxoSmithKline medical information team regarding her inquiry of whether or not symptom was typical of injection site reactions reported already within the PI and whether or not this patient should get the 2nd dose in the SHINGRIX series.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). On 16th May 2018, the patient received SHINGRIX. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The adverse event was reported by Medical Information who transferred caller to the GSK response center. The patient reported that after receiving SHINGRIX, she developed Shingles the next day morning. The patient had indicated she would consult with an attorney. No additional information was provided.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Hepatitis B vaccine administered at 1855 to (R) thigh on 5/29/18. Within short period of time (within 30 minute) developed diffuse erythematous urticarial like rash. No cardiorespiratory compromise. Rash dissipated significantly within 1 hour of PO BENADRYL administration.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Crying, Immediate post-injection reaction, Injection site swelling, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 79-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (occurred in 1980s). Concurrent medical conditions included osteoarthritis, fusion lumbar spine and nerve pain (experienced after shingles, got flare of nerve pain in scapular nerve). Concomitant products included LIPITOR, PLAVIX, amlodipine, gabapentin, Lidocaine, Vitamin D3, CELEBRAX, NEXIUM, Estrogen Gel, Lisinopril, Mag Oxide, Metoprolol and tizanidine. In February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling. In May 2018, the patient experienced nerve pain and condition aggravated. On 22nd May 2018, the patient experienced crying. On an unknown date, the outcome of the nerve pain, condition aggravated and crying were unknown and the outcome of the injection site swelling was recovered/resolved. The reporter considered the nerve pain and condition aggravated to be possibly related to SHINGRIX. The reporter considered the injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the crying to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The concomitant product include BIOMED cream. The patient experienced mild flare of the nerve pain which lasted about 2 weeks. Starting about 3 weeks before the reporting date, the patient had almost daily severe flares of nerve pain. The patient started crying because the patient was so bad. The swelling at injection site lasted about 3 days before resolving. The patient had not received the 2nd dose of SHINGRIX, till the time of reporting and was not sure if she should. This case has been linked to the case US2018092509, reported by same reported (wife's case).