chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Incorrect route of drug administration, Induration, Pain in extremity
Clinical narrative: Pharmacist administered SHINGRIX vaccine. Mixed the vials; first attempted-he had not pulled the liquid from the vial into the syringe. Second attempt, administered in subcutaneous area on back of left arm. Asked why he wasn't injecting into muscle. He said this goes in subcutaneous. Next day, arm are very sore, hard and red size of tennis ball. Also had chills. Second day, still very red, size of tennis ball and very tender. Was going to go back to Pharmacy and have them look at arm. Later learned CDC says subcutaneous injection is an error. This pharmacist needs training!
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pharmacist administered SHINGRIX vaccine. Mixed the vials; first attempted-he had not pulled the liquid from the vial into the syringe. Second attempt, administered in subcutaneous area on back of left arm. Asked why he wasn't injecting into muscle. He said this goes in subcutaneous. Next day, arm are very sore, hard and red size of tennis ball. Also had chills. Second day, still very red, size of tennis ball and very tender. Was going to go back to Pharmacy and have them look at arm. Later learned CDC says subcutaneous injection is an error. This pharmacist needs training!
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, warm, raised area, 3 inches in diameter.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Culture urine negative, Headache, Neck pain, Oropharyngeal pain
Clinical narrative: Fever 103 degrees F x 3 days, severe headache, chills symptoms started day after vaccine (<24 hours) sore throat. Neck pain persists after 8 days. No contacts became ill.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Red blood cells urine positive, Streptococcus test negative
Clinical narrative: Fever 103 degrees F x 3 days, severe headache, chills symptoms started day after vaccine (<24 hours) sore throat. Neck pain persists after 8 days. No contacts became ill.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site burning in an unspecified number of adult patients who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On an unknown date, the patients received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patients experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter had given over 60 SHINGRIX vaccinations over the past month and over the last week and had noticed that, patients complained of it burning. The reporter was not sure if it was specific to the lot number and expiry date which was a box of 10 vaccines. The patients had been cringing when the vaccine was injected as they said it burns very much. The reporter wanted to know if this was normal and had not had this reaction for the first month and over the past week, but had been getting complaints. The reporter wanted to know if this was heard before and if this was to the specific lot number. The reporter agreed to be followed up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site rash, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 50-year-old female patient who received SHINGRIX (batch number L7F7E ?, expiry date 22nd November 2020). Concomitant products included NUVARING. On 16th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 mg. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness, pain, headache and shivering. On 18th May 2018, the patient experienced injection site rash. The patient was treated with prednisone and BENADRYL. On an unknown date, the outcome of the tiredness, injection site rash, pain, headache and shivering were not recovered/not resolved. It was unknown if the reporter considered the tiredness, injection site rash, pain, headache and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The nurse reported that the patient's rash started at the injection site 2 days after vaccination, went up her arm to her neck and face, and over the opposite shoulder. The nurse reported that the patient was seen at the office on 18th May 2018 and was prescribed Prednisone and BENADRYL. The nurse reported that the patient was seen at the office on 18th May 2018 and was prescribed Prednisone and BENADRYL. The reporter lot number (L7F7E) does not match any GSK lot number and was updated to L7F7E ?.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Pt given PROQUAD subc. in R arm at approx 330. Pt immediately developed a 5x5 cm area of redness, warmth and itching. Pt was given BENADRYL and asked to wait in office for about 20 minutes. No further symptoms developed and itching is beginning to resolve.
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram normal, Full blood count normal, Pyrexia, Ultrasound pelvis normal, Urinary tract infection
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 3 days after receiving dTpa vaccine, the patient experienced fever and white blood cell increased. The patient was treated with Acetaminophen. On an unknown date, the outcome of the fever and white blood cell increased were unknown. The reporter considered the fever and white blood cell increased to possibly related to Dtpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was received via form. The reported did not state if this was BOOSTRIX and was unaware if this was previously reported to GSK. As per reporter, the patient who was reluctant to receive the Tdap vaccine (dTpa vaccine, Reduced antigen) during her recent pregnancy. Her reasoning was that in her last pregnancy (two years before the date of reporting), the patient received dTpa vaccine 5 hours post partum. Three days later, the patient presented to the emergency room with a fever (body temperature 104 degree F). The patient was given a 1000 ml fluid bolus and 1000 mg of acetaminophen and her fever resolved in the emergency room and she was discharged within 5 hours. The patient had multiple tests within the emergency room including electrocardiogram (EKG), pelvic ultrasound (U/S) and blood panel was normal except abnormal test with slight increased in white blood cell count. An urine analysis that they did not treat a possible urinary tract infection because the patient was asymptomatic and was not treated for possible urinary tract infection, it was not considered as an event. No clarification was obtained for the same. The patient was discharged without prescription medication ordered. No further complications. It was told that the patient that the possible cause of this spike in fever was because of the dTpa vaccine.
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis abnormal, White blood cell count increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 3 days after receiving dTpa vaccine, the patient experienced fever and white blood cell increased. The patient was treated with Acetaminophen. On an unknown date, the outcome of the fever and white blood cell increased were unknown. The reporter considered the fever and white blood cell increased to possibly related to Dtpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was received via form. The reported did not state if this was BOOSTRIX and was unaware if this was previously reported to GSK. As per reporter, the patient who was reluctant to receive the Tdap vaccine (dTpa vaccine, Reduced antigen) during her recent pregnancy. Her reasoning was that in her last pregnancy (two years before the date of reporting), the patient received dTpa vaccine 5 hours post partum. Three days later, the patient presented to the emergency room with a fever (body temperature 104 degree F). The patient was given a 1000 ml fluid bolus and 1000 mg of acetaminophen and her fever resolved in the emergency room and she was discharged within 5 hours. The patient had multiple tests within the emergency room including electrocardiogram (EKG), pelvic ultrasound (U/S) and blood panel was normal except abnormal test with slight increased in white blood cell count. An urine analysis that they did not treat a possible urinary tract infection because the patient was asymptomatic and was not treated for possible urinary tract infection, it was not considered as an event. No clarification was obtained for the same. The patient was discharged without prescription medication ordered. No further complications. It was told that the patient that the possible cause of this spike in fever was because of the dTpa vaccine.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Chest pain, Pain
Clinical narrative: Throbbing, tender, sharp pain persisted after initial 2 days she expected; aggravated by up and across chest, felt in shoulder joint. Throbs lying on Rt side as can't lie on left. No redness, swelling, numbness, tingling.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash macular, Tenderness
Clinical narrative: Light pink splotchy rather than red itchy, tender to touch - gave BENADRYL/IBU.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Dtap-IPV was given RT, itchy, pink, splotchy warm to touch no fever BENADRYL/IBU.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Angular cheilitis, Asthenia, Pain, Pyrexia, Toothache
Clinical narrative: Patient received SHINGRIX 0.5 ml IM on left deltoid last 5/11/18 at 3:30 pm and around 4 pm pt feels weak (at home) that last for a day. And next day he developed sores with burning pain on the corners of his mouth and his teeth is painful and this next day symptoms last for 10 days. And patient also feels feverish on 2nd day but last for a day. Pt didn't go to ER or see his PCP.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased
Clinical narrative: Patient was seen for WCC on 5-17-2018 vaccines administered. Returned to clinic on 5-18-2018 triaged had a temp of 101.4 assessed by an FNP reassurance given along with the 24 hour triage line. Family traveled he was given IV fluids and subsequently transferred to an ED, received one dose of ceftriaxone 50mg/kg then transferred to another ED for a higher level of care. An LP was performed which showed findings consistent with meningitis WBC 62, RBC 75, Protein greater than 600, Glucose less than 2, culture positive fror gram-positive cocci in pairs. Given one dose of Vanco and transferred to PICU where he stayed for 2 days he passed away 05-22-2018 at 1842.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Gram stain positive, Intensive care, Meningitis
Clinical narrative: Patient was seen for WCC on 5-17-2018 vaccines administered. Returned to clinic on 5-18-2018 triaged had a temp of 101.4 assessed by an FNP reassurance given along with the 24 hour triage line. Family traveled he was given IV fluids and subsequently transferred to an ED, received one dose of ceftriaxone 50mg/kg then transferred to another ED for a higher level of care. An LP was performed which showed findings consistent with meningitis WBC 62, RBC 75, Protein greater than 600, Glucose less than 2, culture positive fror gram-positive cocci in pairs. Given one dose of Vanco and transferred to PICU where he stayed for 2 days he passed away 05-22-2018 at 1842.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Red, swelling with firmness and warm to touch. Measures approx. 9cmX10cm. No treatment at this time.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swollen tongue, Urticaria
Clinical narrative: 24 hours after injection she had hives in head and back of neck. (5-24-18). 5-25-18 - she developed rash on stomach and arms. 5-26-18 - Her tongue swelled and rash on legs. 5-26-18 - She went to Urgent Care and was treated. 5-29-18 - She notified office of reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm and erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced big red swollen arm after vaccination. The patient might not want to receive 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site lump and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump and injection site itching to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a manufacturer. The age at vaccination was not reported. The healthcare professional (HCP) states patient had injection site redness, swelling, rounded, and itching. The HCP was contacted on the reporting date, and was asked if second dose site reactions were to be expected and had any recommendations on vaccine timing available.
Sex: U
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in an unspecified number of patients who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional reported that the patients have experienced pain after receiving BEXSERO. No additional patient or product information was provided.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Exercise tolerance decreased, Fatigue, Injection site pain, Lethargy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received SHINGRIX. The patient's past medical history included back arthritis and glaucoma. On 17th May 2018, the patient received SHINGRIX (intramuscular). On 17th may 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, appetite absent, lethargy and exercise tolerance decreased. On 18th May 2018, the patient experienced fever and neck pain. On an unknown date, the outcome of the tiredness, lethargy and exercise tolerance decreased were unchanged and the outcome of the appetite absent was unknown and the outcome of the fever and neck pain were recovering/resolving. It was unknown if the reporter considered the tiredness and appetite absent to be related to SHINGRIX. The reporter considered the fever, neck pain, lethargy and exercise tolerance decreased to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced some pain at the injection site. The patient also experienced exercise intolerance. This was defined as cycling being more difficult and requiring more energy. The patient also reported he was not as hungry after injection. One day after vaccination, the patient experienced slight fever of 100.4 degree F and neck pain.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received SHINGRIX. The patient's past medical history included back arthritis and glaucoma. On 17th May 2018, the patient received SHINGRIX (intramuscular). On 17th may 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, appetite absent, lethargy and exercise tolerance decreased. On 18th May 2018, the patient experienced fever and neck pain. On an unknown date, the outcome of the tiredness, lethargy and exercise tolerance decreased were unchanged and the outcome of the appetite absent was unknown and the outcome of the fever and neck pain were recovering/resolving. It was unknown if the reporter considered the tiredness and appetite absent to be related to SHINGRIX. The reporter considered the fever, neck pain, lethargy and exercise tolerance decreased to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced some pain at the injection site. The patient also experienced exercise intolerance. This was defined as cycling being more difficult and requiring more energy. The patient also reported he was not as hungry after injection. One day after vaccination, the patient experienced slight fever of 100.4 degree F and neck pain.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling 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 facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, they have one store with a patient who reported facial swelling within 24 hours after receiving SHINGRIX vaccine. The reporter wanted to know if there was any literature on facial swelling. This case was linked with US2018GSK093923, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 14th May 2018, the patient received the 2nd dose of SHINGRIX. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills and nausea. In May 2018, the patient experienced neck pain and neck mass. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills, nausea and neck pain were. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills, nausea, neck pain and neck mass to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On or around 15th March 2018, the patient received 1st dose of SHINGRIX. After receiving 2nd dose of SHINGRIX, the patient developed symptoms upon awakening on 15th May 2018. The symptoms included fever, generalized body aches, chills, nausea and redness, swelling with increased temperature to the injection site which extended over an approximately 4 inch oval area. The patient also had soreness in the neck and felt a lump or ball (about the size of a dime). The symptoms were gradually resolved and today (on the day of reporting) only has the lump in her neck. The patient asked for to contact if need any further information and would be happy to speak to someone regarding her symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck mass, Neck pain, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 14th May 2018, the patient received the 2nd dose of SHINGRIX. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills and nausea. In May 2018, the patient experienced neck pain and neck mass. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills, nausea and neck pain were. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills, nausea, neck pain and neck mass to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On or around 15th March 2018, the patient received 1st dose of SHINGRIX. After receiving 2nd dose of SHINGRIX, the patient developed symptoms upon awakening on 15th May 2018. The symptoms included fever, generalized body aches, chills, nausea and redness, swelling with increased temperature to the injection site which extended over an approximately 4 inch oval area. The patient also had soreness in the neck and felt a lump or ball (about the size of a dime). The symptoms were gradually resolved and today (on the day of reporting) only has the lump in her neck. The patient asked for to contact if need any further information and would be happy to speak to someone regarding her symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On 21st May 2018 12:00, the patient received SHINGRIX. On 21st May 2018 21:00, 9 hrs after receiving SHINGRIX, the patient experienced fever, nausea and muscle pain. On an unknown date, the outcome of the fever, nausea and muscle pain were unknown. It was unknown if the reporter considered the fever, nausea and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient started to experience the above symptoms about 9 to 10 pm last night. His fever was 100 degrees F. The patient wanted to know how long to expect the symptoms to last after taking the vaccine
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site bruising in a adult female patient who received dTap vaccine. In January 2017, the patient received dTap vaccine. On an unknown date, unknown after receiving dTap vaccine, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was recovered/resolved. It was unknown if the reporter considered the injection site bruising to be related to dTap vaccine. Additional information was reported as follows: This case was reported by the patient's daughter. The reporter expressed how passionate she was about protecting her children from vaccine preventable diseases. She reported that, she made her mother get a Tdap vaccine in the left deltoid at her obstetrics and gynaecology in January 2017. After receiving BOOSTRIX, her mother had bruising at the injection site which lasted for about 2 1/2 weeks. No medical attention was sought and the patient recovered fine. It was unclear if the Tdap vaccine was BOOSTRIX or not, as the reporter only stated that it was Tdap and could not specify the brand name. The reporter did not agree to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Feeling cold, Feeling hot, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain (experienced after 1st dose, refer case US2018GSK094619). In 17th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain. On an unknown date, the outcome of the headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain were not recovered/not resolved. The reporter considered the headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain to be probably related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not provided. In the vaccination night at 2 am, the patient began shivering and could not get warm. The patient would get hot then cold. He also had a headache, body and stomach aches and felt sore all over. The patient declined to provided contact information or additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain (experienced after 1st dose, refer case US2018GSK094619). In 17th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain. On an unknown date, the outcome of the headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain were not recovered/not resolved. The reporter considered the headache, feeling of warmth, general body pain, shivering, feeling cold and stomach pain to be probably related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not provided. In the vaccination night at 2 am, the patient began shivering and could not get warm. The patient would get hot then cold. He also had a headache, body and stomach aches and felt sore all over. The patient declined to provided contact information or additional details.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivers in a 64-year-old male patient who received SHINGRIX (batch number DA34Z, expiry date 30th April 2019). On an unknown date, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced shivers, injection site pain, lightheadedness, upset stomach and headache. The patient was treated with Aspirin. On an unknown date, the outcome of the shivers, lightheadedness, upset stomach and headache were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. The reporter considered the shivers, lightheadedness, upset stomach and headache to be related to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient received first dose of SHINGRIX last night of the date of reporting. The patient was experiencing shivers, upset stomach, headache and lightheadedness. He has taken 2 aspirin to treat his events. The reporter could not provide full demographics for the pharmacy that administered the vaccine. The patient denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pain in extremity, Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 2nd April 2018 09:30, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and erythematous rash. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm and erythematous rash were recovered/resolved. The reporter considered the pain in arm and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient developed arm pain within 24 hours after injection which lasted for 5 to 6 days then resolved. The patient took TYLENOL for the pain. The health care professional stated that it was quite intense pain and was mildly debilitating. The patient also developed a delayed pink rash that came on 4 to 5 days after she was administered SHINGRIX and lasted for 4 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included lymphoma. Concomitant products included valsartan and IMBRUVICA. In January 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were recovered/resolved. The reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was previously reported to a physician. The patient received SHINGRIX on left arm in her oncologist's office. The reporter reported that 24 hours after injection she developed pain, redness and swelling at the injection site that she categorized as severe. The reporter reported that on day two it was warm to the touch and that all events were resolved after about 3 to 4 days. The reporter was unable to provide full demographics of oncologist.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site scab, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received HAVRIX 1440 adult. Concomitant products included Aspirin, Calcium Unknown and vitamin D. On 23rd April 2018, the patient received HAVRIX 1440 adult (intramuscular). In April 2018, less than a week after receiving HAVRIX 1440 adult, the patient experienced injection site erythema, injection site swelling and injection site scab. On 17th May 2018, the patient experienced injection site itching and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching and injection site lump were not recovered/not resolved and the outcome of the injection site scab was recovered/resolved. The reporter considered the injection site erythema, injection site swelling, injection site scab, injection site itching and injection site lump to be related to HAVRIX 1440 adult. Additional details were provided as follows: The patient's concomitant medication included Insulin as well. The patient experienced redness, swelling and scabbing at the injection site within the first week after the vaccination. It presented within that week and resolved within that week. The scabbing was described as 2 or 3 long marks like little claw marks. On the day before reporting, 24 days after vaccination, she noticed a quarter size areas at the injection site that was red, slightly swollen and itchy. There was also a lump at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Colonoscopy, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020). Concurrent medical conditions included Propofol. On 15th may 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: On 14th May 2018, the patient had a colonoscopy for which the patient was sedated with Propofol. At 20:35, the patient received SHINGRIX in the left deltoid. The patient experienced redness at the injection site, which was first noted in the morning of 17th May 2018. The area had continued to spread and the red area did not itch. The patient returned to the pharmacy on the day of reporting. At time of reporting, no other medical attention had been sought or recommended. The pharmacist read a hand written record and reported the lot number (AS9LM) for SHINGRIX vaccine which did not exist and was updated to AS9CM, according to the sales database.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 63-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concurrent medical conditions included hypercholesterolemia. Concomitant products included BOOSTRIX. On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site itching, injection site erythema and injection site hives. On an unknown date, the outcome of the injection site itching, injection site erythema and injection site hives were recovered/resolved. The reporter considered the injection site itching, injection site erythema and injection site hives to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced an itchy red area and hives around the injection site on the left arm and hives also developed in this location. It took 2 to 3 weeks to resolve. The patient applied anti-itch cream to the area. Time to onset was not documented in the patient's chart. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence shingles in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced 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 was given the vaccine and within 4 days developed an outbreak of shingles. Sender's comments: This had been reported by the facility to the CDC. The reporter was calling GSK on behalf of a nurse for more information and did not have many details to provide. She was transferred to medical information team.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: The parent called the clinic about 3:45 to report the patient had fever, headache, and abdominal pain with diarrhea, and body ache. The parent was advised to report to the urgent care for evaluation and follow up care.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Weight bearing difficulty
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 67-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) and (batch number ZX3YA, expiry date unknown). On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain and weight bearing difficulty. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the weight bearing difficulty was unknown. The reporter considered the injection site muscle pain to be related to SHINGRIX. It was unknown if the reporter considered the weight bearing difficulty to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that, the patient still had muscle soreness where the vaccine was administered in the left arm. The patient told the healthcare professional about this 5 weeks after receiving the vaccine but the healthcare professional did not know when the reaction started. The patient said it was not severe but she did work out with weights and she was unable to lift the weights.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Corneal lesion, Herpes simplex
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of corneal lesion in a 69-year-old female patient who received SHINGRIX. Concomitant products included Vitamin C, DELZICOL, ELIQUIS, fish oil, and Salt Tablets. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced corneal lesion and herpes simplex. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced corneal lesion and herpes simplex. On an unknown date, the outcome of the corneal lesion was not recovered/not resolved and the outcome of the herpes simplex was unknown. The reporter considered the corneal lesion and herpes simplex to be possibly related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient also received Vitamin B as concomitant drug. The age at vaccination was not reported, but could be 68 or 69 years. The patient was seen by her eye physician and was diagnosed with corneal lesions that could be related to herpes simplex infection. The patient did not know which pharmacy where the patient had received the SHINGRIX dose.
Age: 64.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Hyperhidrosis, Pain
Clinical narrative: Fever 102.4 degrees F sweats, chills, body aches, loss of energy, loss of appetite. 72 hours.
Age: 64.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102.4 degrees F sweats, chills, body aches, loss of energy, loss of appetite. 72 hours.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: SHINGRIX was administered on 05-09-18. On 05/13/18 she noticed a rash on the right buttock, (R) leg, and right side of back. On 5/14/18 she saw a dermatologist who diagnosed shingles. Rx: VALTREX one gram TID for 7 days and LYRICA 50 mg TID for 10 days. Drying up on 5/18/18.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 15th May 2018, the patient experienced chills, muscle pain, fever, headache and weakness. On an unknown date, the outcome of the pain in arm, chills, muscle pain, fever, headache and weakness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, chills, muscle pain, fever, headache and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One day after receiving SHINGRIX, the patient experienced chills, muscle aches, fever, headache and weakness. The limited information was provided by the patient. The patient wanted to remain anonymous and has denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 15th May 2018, the patient experienced chills, muscle pain, fever, headache and weakness. On an unknown date, the outcome of the pain in arm, chills, muscle pain, fever, headache and weakness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, chills, muscle pain, fever, headache and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One day after receiving SHINGRIX, the patient experienced chills, muscle aches, fever, headache and weakness. The limited information was provided by the patient. The patient wanted to remain anonymous and has denied permission to contact their physician.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a 83-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 11th May 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On 14th May 2018, the patient experienced rash. The patient was treated with ZYRTEC. In May 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the rash was unknown. The reporter considered the pain and rash to be related to SHINGRIX. Additional information was received as follows: The health care professional (HCP) reported that the patient began to experienced pain on 12th May 2018 or 13th May 2018. The pain lasted for about 3 to 4 days then resolved. The patient also developed a delayed pink rash (no vesicles) that started that on 14th May 2018 or 15th May 2018. The HCP was unsure if it had since resolved. The HCP instructed the patient to take ZYRTEC.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, chills and fever. On an unknown date, the outcome of the pain in arm, general body pain, chills and fever were unknown. It was unknown if the reporter considered the pain in arm, general body pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX injection at a pharmacy and complained of chills, fever, general achiness, and a sore arm. No other details were available for the patient. The reporter did not wish to provide her demographics. She hung up the call when she got her answer despite of asking her  if some questions might be asked. This case is linked to case US2018GSK094752 (husband's case), reported by the same reporter.