chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure systolic increased, Erythema, Insomnia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: This spontaneous report as received from a 63-year old female patient with pain in knees, asthma and right hip arthritis. The patient did not have any drug allergies/reactions. On 26-SEP-2018 the patient was vaccinated with PNEUMOVAX 23 (lot and expiry date not reported) subcutaneously for prophylaxis. Concomitant therapies included Etodolac, amlodipine, metformin, aspirin, PREMARIN, losartan, Irbesartan and vitamins (unspecified). It was reported that she experienced severe swelling, red, hot, arm pain" after receiving PNEUMOVAX 23. She had been in pain since she got the shot and nothing was helping her, TYLENOL did nothing. She couldn't cook and it was hard for her to get out of bed, she couldn't sleep and couldn't raise her arm overhead. On unspecified dates, she did visit her physician on an unspecified date and that "he couldn't even touch her arm it was so much pain and her blood pressure was 170 systolic when they checked it and it was never that high. Her physician did refer her to an orthopedic physician for evaluation. She reported that in addition that she was taking etodolac for arthritis and had been taking diclofenac which did no good on unspecified dates. Outcome of all the events was not recovered. Causality assessment was not reported for the events. Upon internal review, the event pain in arm which made her hard to get out of bed and affected her sleep was considered to be serious due to disability.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: This spontaneous report as received from a 63-year old female patient with pain in knees, asthma and right hip arthritis. The patient did not have any drug allergies/reactions. On 26-SEP-2018 the patient was vaccinated with PNEUMOVAX 23 (lot and expiry date not reported) subcutaneously for prophylaxis. Concomitant therapies included Etodolac, amlodipine, metformin, aspirin, PREMARIN, losartan, Irbesartan and vitamins (unspecified). It was reported that she experienced severe swelling, red, hot, arm pain" after receiving PNEUMOVAX 23. She had been in pain since she got the shot and nothing was helping her, TYLENOL did nothing. She couldn't cook and it was hard for her to get out of bed, she couldn't sleep and couldn't raise her arm overhead. On unspecified dates, she did visit her physician on an unspecified date and that "he couldn't even touch her arm it was so much pain and her blood pressure was 170 systolic when they checked it and it was never that high. Her physician did refer her to an orthopedic physician for evaluation. She reported that in addition that she was taking etodolac for arthritis and had been taking diclofenac which did no good on unspecified dates. Outcome of all the events was not recovered. Causality assessment was not reported for the events. Upon internal review, the event pain in arm which made her hard to get out of bed and affected her sleep was considered to be serious due to disability.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received FLUARIX TETRA for prophylaxis. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to FLUARIX TETRA. Additional information was reported as follows: The age at vaccination was not reported. The batch number and expiry date for FLUARIX was not reported. After vaccination with FLUARIX, the physician herself experienced redness at the injection site, which was a nickel-to quarter size in diameter. The patient had used shoot blocker to administer the vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX (batch number 3S354, expiry date unknown) for prophylaxis. On 14th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, headache, nausea, chills and injection site pain. On an unknown date, the outcome of the fever, headache, nausea and chills were recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the fever, headache, nausea, chills and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the right deltoid. The patient experienced fever of 104 degree F, slight soreness at injection site, headache, nausea and chills which lasted for 3 days. The nurse did not agree to follow up. For tolerance to 2nd dose refer case US2018GSK207930.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site pain in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report however; patients were 65 years and older. The pharmacist reported that, the patients experienced increased pain at injection site with SHINGRIX vaccine - multiple complaints.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 80-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were reported as follows: This case was reported by the other healthcare professional for himself. The age at vaccination was not reported, however it could be 79 or 80 years. The only side effect the patient had was a sore arm for a couple of days. The patient did not feel any other side effects. The patient did feel it could be attributed to the vaccine. The reporter did not agree to follow-up. The vaccination date, lot number and date of birth of patient were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a other health professional via sales rep and described occurrence of feeling bad in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist for the practice. The age at the vaccination was not reported. The patient felt like they were hit by a truck for 2 days. The reporter agreed to receive follow up from GlaxoSmithKline. This case was linked with the cases US2018GSK205481 and US2018GSK205480, reported by the same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling bad in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX. On 13th November 2018, 1 days after receiving SHINGRIX, the patient experienced feeling bad, fever, headache and chills. The patient was treated with TYLENOL. On an unknown date, the outcome of the feeling bad, fever, headache and chills were unknown. It was unknown if the reporter considered the feeling bad, fever, headache and chills to be related to SHINGRIX. Additional details were reported as follows: The patient felt terrible the day after SHINGRIX shot. The patient was able to sleep after taking TYLENOL.
Sex: M
Vaccine: HPVX
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache recurrent in a 17-year-old male patient who received HPV 16-18 (Human papilloma type 16 + 18 vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Human papilloma type 16 + 18 vaccine. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine, the patient experienced headache recurrent and drug use in unapproved population. On an unknown date, the outcome of the headache recurrent and drug use in unapproved population were unknown. It was unknown if the reporter considered the headache recurrent to be related to Human papilloma type 16 + 18 vaccine. Additional details were provided as follows: This case was reported by the patient's mother who herself was a nurse. The age at vaccination was not reported. The male patient received unspecified Human Papillomaviru Virus (HPV) vaccine, which led to drug use in unapproved population. In 2015, the patient experienced recurring headaches. The reporter did not take the patient back for the second one for 2 years. This case has been linked to the US2018GSK204638, reported for the different dose of the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: This case was reported by a consumer and described the occurrence of vesicular rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced vesicular rash, itchy rash and pain. On an unknown date, the outcome of the vesicular rash, itchy rash and pain were not recovered/not resolved. It was unknown if the reporter considered the vesicular rash, itchy rash and pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that approximately 14 days after she was given the injection of the vaccine she developed a shingles-type rash from the middle of her abdomen to the middle of her back. It itches and was painful. The patient reported that it seems to be no relief in sight. The patient wanted to know would this happen with her second injection to be given on 22nd December 2018.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 22nd August 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 shingles and tingling. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles and tingling were unknown. It was unknown if the reporter considered the shingles and tingling to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX on the left arm. The patient was recently diagnosed with shingles. The patient had no lesions or itching. She only reported tingling under her right rib. The patient visited emergency room. The pharmacist did not know when the tingling had begun, but thought it to be within the past few days before the reporting date, as the patient saw her doctor and received a prescription of Valacyclovir on the date of reporting.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a 64-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 5th November 2018, the patient received the 2nd dose of SHINGRIX. On 5th November 2018, less than a year after receiving SHINGRIX, the patient experienced unwell and tremor limb. On an unknown date, the outcome of the unwell was recovered/resolved and the outcome of the tremor limb was not recovered/not resolved. It was unknown if the reporter considered the unwell and tremor limb to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional stated, the patient that got his 2nd SHINGRIX and was feeling really lousy. All symptoms were normal except his arm was continuing to shake. Just wanted to see if this was something heard of. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly female patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX , the patient experienced headache, fever, nausea, muscle pain, injection site swelling and injection site erythema. On 7th November 2018, the outcome of the headache, fever, nausea and muscle pain were recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the headache, fever, nausea, muscle pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient planned to continue follow-up with her physician on an unknown date. The reporter had consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly female patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX , the patient experienced headache, fever, nausea, muscle pain, injection site swelling and injection site erythema. On 7th November 2018, the outcome of the headache, fever, nausea and muscle pain were recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the headache, fever, nausea, muscle pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient planned to continue follow-up with her physician on an unknown date. The reporter had consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in spring 2018). On 9th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 10th November 2018, the patient experienced influenza-like symptoms, fever, cough, chills, fatigue and headache. In November 2018, the patient experienced diaphoresis. On an unknown date, the outcome of the influenza-like symptoms, fever, cough, diaphoresis, chills, fatigue and headache were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. The reporter considered the influenza-like symptoms, fever, cough, diaphoresis, chills and fatigue to be related to SHINGRIX. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient's left arm was sore from the vaccine. On Saturday morning the patient woke up with flu like symptoms, fever, coughing, chills, fatigue and headache. The patient stated that the fever got up to 100 degree F. On the same day Saturday night, in the middle of the night the patient experienced a major episode of diaphoresis and her sheets were soaked with sweat. The patient stated that she had another episode of diaphoresis on the day of reporting approximately 30 minutes before she called GlaxoSmithKline. The patient had consented to follow up. The patient gave contact details of the physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in spring 2018). On 9th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 10th November 2018, the patient experienced influenza-like symptoms, fever, cough, chills, fatigue and headache. In November 2018, the patient experienced diaphoresis. On an unknown date, the outcome of the influenza-like symptoms, fever, cough, diaphoresis, chills, fatigue and headache were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. The reporter considered the influenza-like symptoms, fever, cough, diaphoresis, chills and fatigue to be related to SHINGRIX. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient's left arm was sore from the vaccine. On Saturday morning the patient woke up with flu like symptoms, fever, coughing, chills, fatigue and headache. The patient stated that the fever got up to 100 degree F. On the same day Saturday night, in the middle of the night the patient experienced a major episode of diaphoresis and her sheets were soaked with sweat. The patient stated that she had another episode of diaphoresis on the day of reporting approximately 30 minutes before she called GlaxoSmithKline. The patient had consented to follow up. The patient gave contact details of the physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin laceration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 62-year-old female patient who received SHINGRIX (batch number 5S34K, expiry date 13th March 2021) for prophylaxis. Concomitant products included POLYSPORIN. On 26th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th October 2018, less than a month after receiving SHINGRIX, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash and red rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient claimed that she cut herself on her elbow after the shot and then she got a rash soon after down her arm that had been itchy with red sports and it was spreading. The registered pharmacist claimed that the rash was on her forearm and above her elbow area. The batch number of SHINGRIX diluent was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a adult 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The age at the vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter had a question regarding SHINGRIX vaccine reaction (unspecified) and pre medication recommendations for the 2nd dose to prevent the similar reaction. The reporter did not consent to follow-up. No further details were provided. The healthcare professional abandoned the chat.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the tiredness and pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: On a Friday in September 2018, the patient received flu vaccine (name unknown) in the right arm. The patient experienced a very sore arm for about a week after receiving the flu vaccine. The patient was also tired for the entire weekend. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tenderness in a 63-year-old female patient who received SHINGRIX (batch number 3Z53C, expiry date unknown) for prophylaxis. Concomitant products included cetirizine hydrochloride (Zyrtec). On 23rd October 2018, the patient received the 1st dose of SHINGRIX. On 24th October 2018, 1 days after receiving SHINGRIX and an unknown time after starting Zantac, the patient experienced tenderness and itchy rash. The patient was treated with ranitidine hydrochloride (Zantac) and prednisone. On an unknown date, the outcome of the tenderness was unknown and the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the tenderness and itchy rash to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on an unknown arm. The patient experienced rash and itching in the vaccinated arm and some tenderness.  The itching spread to the left low back and to the right arm. The patient was advised to increase her daily Zyrtec dose to twice a day and to take Zantac over the counter (OTC) daily until symptoms resolve. The patient did go to urgent care for symptoms. The patient was also given 5 days of oral prednisone by urgent care but till the reporting time, the rash was very itchy after starting prednisone.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, less than a week after receiving SHINGRIX, the patient experienced shoulder pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient came back to the pharmacy and complained of soreness in his shoulder and could not sleep on it. The reporter stated that, the sore shoulder was on the same arm in which he received the SHINGRIX, however, the reporter was not sure which arm. The reporter stated that, the patient took Ibuprofen for the pain. The reporter did not had lot number at the time of the reporting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Diarrhoea, Influenza like illness, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, several hours after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness. On an unknown date, the outcome of the influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient developed flu like symptoms (joint pain, diarrhea, aches, shakes, and weakness) several hours after receiving the SHINGRIX. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, several hours after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness. On an unknown date, the outcome of the influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient developed flu like symptoms (joint pain, diarrhea, aches, shakes, and weakness) several hours after receiving the SHINGRIX. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 70-year-old female 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 general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional information received as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient had a bad reaction when she received the SHINGRIX vaccine. She was achy all over her body for about a week. The time frame for the 2nd shot was unknown. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, stomach discomfort and headache. On an unknown date, the outcome of the influenza-like symptoms, stomach discomfort and headache were unknown. It was unknown if the reporter considered the influenza-like symptoms, stomach discomfort and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms, stomach discomfort and headache after SHINGRIX.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Peripheral swelling, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, extremities hot feeling of and local swelling. On an unknown date, the outcome of the swelling arm, erythema of extremities, extremities hot feeling of and local swelling were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, extremities hot feeling of and local swelling to be related to SHINGRIX. Additional details were reported as follows: The vaccine was administered in the first week of August. The patient reported swelling, redness and hot to touch the area below the injection site. The swelling also presented in the arm pit area of that same arm. The swelling lasted 2 months. The reporter gave consent to follow up. The patient declined to provide her phone number.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pharyngeal oedema, Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 73-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 21st February 2021) for prophylaxis. On 6th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced allergic reaction, swollen tongue and throat swelling. On an unknown date, the outcome of the allergic reaction, swollen tongue and throat swelling were unknown. It was unknown if the reporter considered the allergic reaction, swollen tongue and throat swelling to be related to SHINGRIX. Additional details were provided as follows: Pharmacist reported a call was made to a patient about getting her second SHINGRIX vaccine. The patient informed the pharmacist at that time that she had an allergic reaction of swollen tongue and throat with the vaccination. The patient was believed to have notified her physician. The patient noted she awoke the next morning with the swollen tongue and throat. The reporter was consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 14th November 2018, the patient received SHINGRIX. On 14th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was a physician. The patient received the SHINGRIX on an unknown arm. After the dose the patient noticed she was developing tenderness at the injection site. The patient looked at her arm and saw that the band aid and soreness were over the deltoid tendon instead of the muscle. The patient thought the vaccine was injected into the tendon, which led to vaccine administered on an inappropriate site. The pain at the time of reporting was still over the tendon, but also posterior to the deltoid.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction and sickness. On an unknown date, the outcome of the adverse reaction was unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the adverse reaction and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient who received SHINGRIX about 3 months ago before the date of reporting. The patient experienced a terrible reaction and was sick for 3 days. The patient hung up before any demographics or further details could be obtained.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Herpes simplex test positive, Immunology test, Induration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of herpes simplex antibody positive in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2018GSK214221). In September 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced herpes simplex antibody positive. On an unknown date, the patient experienced fever, chills, induration, swelling, erythema and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the herpes simplex antibody positive, fever, chills, induration, swelling and erythema were unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the herpes simplex antibody positive, fever, chills, induration, swelling, erythema and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse for herself. The patient had a worse reaction after the 2nd dose of SHINGRIX than 1st dose. The patient had fever, chills, large induration, swelling, redness diameter of about 4 inches. The patient experienced a false positive Elisa IGg HSV2 result following SHINGRIX. In 2015, the patient was tested negative and in October 2018, resulted positive. The patient did not have a partner for 5 years. As the patient was tested every 2 years due to her job. She forgot she had received vaccine, or she would have waited to test her yearly tests exposure risk. The patient thought this might had given a false positive test result. She called the lab and they said they use Elisa. The gynecologist referred the patient to ID to question this. He did not have the answer. The 2nd dose was worse in every aspect. The fever lasted longer. The pain was occurring till the reporting time. Lot and expiration date was not available. Lab Comments: In October 2018, the patient resulted Elisa IGg HSV2 false positive.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia, Swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of herpes simplex antibody positive in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2018GSK214221). In September 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced herpes simplex antibody positive. On an unknown date, the patient experienced fever, chills, induration, swelling, erythema and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the herpes simplex antibody positive, fever, chills, induration, swelling and erythema were unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the herpes simplex antibody positive, fever, chills, induration, swelling, erythema and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse for herself. The patient had a worse reaction after the 2nd dose of SHINGRIX than 1st dose. The patient had fever, chills, large induration, swelling, redness diameter of about 4 inches. The patient experienced a false positive Elisa IGg HSV2 result following SHINGRIX. In 2015, the patient was tested negative and in October 2018, resulted positive. The patient did not have a partner for 5 years. As the patient was tested every 2 years due to her job. She forgot she had received vaccine, or she would have waited to test her yearly tests exposure risk. The patient thought this might had given a false positive test result. She called the lab and they said they use Elisa. The gynecologist referred the patient to ID to question this. He did not have the answer. The 2nd dose was worse in every aspect. The fever lasted longer. The pain was occurring till the reporting time. Lot and expiration date was not available. Lab Comments: In October 2018, the patient resulted Elisa IGg HSV2 false positive.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nerve conduction studies
Clinical narrative: The patient said that she experiences excessive shoulder pain. She has undergone nerve conduction tests and is still able to use full range of motion.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, YF
Symptoms: Blindness, Blood culture positive, Blood glucose increased, CSF glucose increased, CSF protein normal
Clinical narrative: The patient is a 34 yo male with a history of GBS and more recently diagnosed with scleroderma. He reports the GBS onset as Nov 05 2003 during training. He reports he was nearing his final tests and awoke SOB, unable to swallow, couldn't see and describes being obtunded. He was flown to a hospital and put on 'life support.' He reports he was diagnosed with GBS Miller Fisher variant. He does not recall any prior infectious symptoms such as fever, chills, cough, rhinorrhea, sore throat, nausea, vomiting or diarrhea. Review of records provides scant but consistent support for his report of events. On 05 NOV 2003, there is a radiology report for CXR for ETT placement, lab reports for sputum, blood cultures; CBC and CSF are also recorded verifying the reported date and supporting an aggressive evaluation for infection and neurologic symptoms. There is a 02 Jan 2004 consult for rehab services which was closed as he was still on a ventilator. The listed diagnosis is GBS- Miller Fisher variant. There is vaccine records for Yellow Fever vaccine (YF-VAX), inactivated polio vaccine (IPV) and Hepatitis A/hepatitis B (TWINRIX) #2 on 27 OCT 2003 and his event was 9 days later. He also received measles/mumps/rubella (MMR) (1229M) and TWINRIX #1 (HAB265A6)  61 days prior to his event. He was ultimately discharged.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, YF
Symptoms: CSF white blood cell count increased, Cardiac imaging procedure normal, Chest X-ray normal, Depressed level of consciousness, Dysphagia
Clinical narrative: The patient is a 34 yo male with a history of GBS and more recently diagnosed with scleroderma. He reports the GBS onset as Nov 05 2003 during training. He reports he was nearing his final tests and awoke SOB, unable to swallow, couldn't see and describes being obtunded. He was flown to a hospital and put on 'life support.' He reports he was diagnosed with GBS Miller Fisher variant. He does not recall any prior infectious symptoms such as fever, chills, cough, rhinorrhea, sore throat, nausea, vomiting or diarrhea. Review of records provides scant but consistent support for his report of events. On 05 NOV 2003, there is a radiology report for CXR for ETT placement, lab reports for sputum, blood cultures; CBC and CSF are also recorded verifying the reported date and supporting an aggressive evaluation for infection and neurologic symptoms. There is a 02 Jan 2004 consult for rehab services which was closed as he was still on a ventilator. The listed diagnosis is GBS- Miller Fisher variant. There is vaccine records for Yellow Fever vaccine (YF-VAX), inactivated polio vaccine (IPV) and Hepatitis A/hepatitis B (TWINRIX) #2 on 27 OCT 2003 and his event was 9 days later. He also received measles/mumps/rubella (MMR) (1229M) and TWINRIX #1 (HAB265A6)  61 days prior to his event. He was ultimately discharged.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, YF
Symptoms: Dyspnoea, Endotracheal intubation, Guillain-Barre syndrome, Haematocrit normal, Haemoglobin normal
Clinical narrative: The patient is a 34 yo male with a history of GBS and more recently diagnosed with scleroderma. He reports the GBS onset as Nov 05 2003 during training. He reports he was nearing his final tests and awoke SOB, unable to swallow, couldn't see and describes being obtunded. He was flown to a hospital and put on 'life support.' He reports he was diagnosed with GBS Miller Fisher variant. He does not recall any prior infectious symptoms such as fever, chills, cough, rhinorrhea, sore throat, nausea, vomiting or diarrhea. Review of records provides scant but consistent support for his report of events. On 05 NOV 2003, there is a radiology report for CXR for ETT placement, lab reports for sputum, blood cultures; CBC and CSF are also recorded verifying the reported date and supporting an aggressive evaluation for infection and neurologic symptoms. There is a 02 Jan 2004 consult for rehab services which was closed as he was still on a ventilator. The listed diagnosis is GBS- Miller Fisher variant. There is vaccine records for Yellow Fever vaccine (YF-VAX), inactivated polio vaccine (IPV) and Hepatitis A/hepatitis B (TWINRIX) #2 on 27 OCT 2003 and his event was 9 days later. He also received measles/mumps/rubella (MMR) (1229M) and TWINRIX #1 (HAB265A6)  61 days prior to his event. He was ultimately discharged.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, YF
Symptoms: Laboratory test normal, Life support, Mechanical ventilation, Miller Fisher syndrome, Neisseria test positive
Clinical narrative: The patient is a 34 yo male with a history of GBS and more recently diagnosed with scleroderma. He reports the GBS onset as Nov 05 2003 during training. He reports he was nearing his final tests and awoke SOB, unable to swallow, couldn't see and describes being obtunded. He was flown to a hospital and put on 'life support.' He reports he was diagnosed with GBS Miller Fisher variant. He does not recall any prior infectious symptoms such as fever, chills, cough, rhinorrhea, sore throat, nausea, vomiting or diarrhea. Review of records provides scant but consistent support for his report of events. On 05 NOV 2003, there is a radiology report for CXR for ETT placement, lab reports for sputum, blood cultures; CBC and CSF are also recorded verifying the reported date and supporting an aggressive evaluation for infection and neurologic symptoms. There is a 02 Jan 2004 consult for rehab services which was closed as he was still on a ventilator. The listed diagnosis is GBS- Miller Fisher variant. There is vaccine records for Yellow Fever vaccine (YF-VAX), inactivated polio vaccine (IPV) and Hepatitis A/hepatitis B (TWINRIX) #2 on 27 OCT 2003 and his event was 9 days later. He also received measles/mumps/rubella (MMR) (1229M) and TWINRIX #1 (HAB265A6)  61 days prior to his event. He was ultimately discharged.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, YF
Symptoms: Neutrophil percentage increased, Spinal X-ray normal
Clinical narrative: The patient is a 34 yo male with a history of GBS and more recently diagnosed with scleroderma. He reports the GBS onset as Nov 05 2003 during training. He reports he was nearing his final tests and awoke SOB, unable to swallow, couldn't see and describes being obtunded. He was flown to a hospital and put on 'life support.' He reports he was diagnosed with GBS Miller Fisher variant. He does not recall any prior infectious symptoms such as fever, chills, cough, rhinorrhea, sore throat, nausea, vomiting or diarrhea. Review of records provides scant but consistent support for his report of events. On 05 NOV 2003, there is a radiology report for CXR for ETT placement, lab reports for sputum, blood cultures; CBC and CSF are also recorded verifying the reported date and supporting an aggressive evaluation for infection and neurologic symptoms. There is a 02 Jan 2004 consult for rehab services which was closed as he was still on a ventilator. The listed diagnosis is GBS- Miller Fisher variant. There is vaccine records for Yellow Fever vaccine (YF-VAX), inactivated polio vaccine (IPV) and Hepatitis A/hepatitis B (TWINRIX) #2 on 27 OCT 2003 and his event was 9 days later. He also received measles/mumps/rubella (MMR) (1229M) and TWINRIX #1 (HAB265A6)  61 days prior to his event. He was ultimately discharged.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Headache, Rash, Throat tightness
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 17-Nov-2018, concerning a 55-year-old, adult female patient. The patient was allergic to FLAGYL, nortriptyline, iron fusion, metformin and sulpha drugs (reported as medical history). On 16-Nov-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, influenza  vaccine,  batch number: YF39908, expiry date: 30-Jun-2019 in deltoid). It was reported that, this was the first influenza vaccine patient ever received. On 16-Nov-2018, the same day, a few hours after vaccination, the patient experienced rash and throat closing up. Additionally, the patient also experienced hoarseness and headache. The patient was treated with EPIPEN, BENADRYL and SOLUMEDROL and then sent to emergency room (ER) but was not admitted. The outcome of the events rash and throat tightness was resolved on an unspecified date in Nov-2018 and the outcome of the events hoarseness and headache was not recovered. The reporter assessed the case as serious (medically significant).
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a newborn patient of unknown gender. There was no information about the patient's concurrent conditions and medical histories provided. On unknown date in November 2018, the patient inadvertently received two doses of RECOMBIVAX HB (doses, routes of administration, lot numbers and expiration dates were not reported) for prophylaxis. No adverse events were reported.