chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Muscle spasms, Pain in extremity
Clinical narrative: painful muscle spasms; prevent from walking; knee pain; chills; back pain moved down into groin and then into thigh; back pain moved down into groin and then into thigh; back pain moved down into groin and then into thigh; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2019, the patient received Shingrix (intramuscular). On 20th July 2019, less than a day after receiving Shingrix, the patient experienced chills, back pain, pain in thigh and groin pain. On an unknown date, the patient experienced muscle spasm, unable to walk and knee pain. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the back pain, pain in thigh, groin pain, muscle spasm and unable to walk were not recovered/not resolved and the outcome of the knee pain was unknown.   It was unknown if the reporter considered the chills, back pain, pain in thigh, groin pain, muscle spasm, unable to walk and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's husband. The reporter reported that, when the patient came back to home, experinced chills and back pain. The chills resolved after 24 hours, but the back pain moved down into his groin and then into his thigh. The patient had painful muscle spasms, that prevent him from working.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Injection site erythema, Injection site streaking, Rash
Clinical narrative: Cellulitis; redness surrounding the injection site; streaking red, resembling a thick red line up the arm; Rash; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis.   On 16th August 2019, the patient received Bexsero. In August 2019, less than a day after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site erythema, injection site streaking and rash. The patient was treated with Antibiotics (Brand Names Not Known). On an unknown date, the outcome of the cellulitis, injection site erythema, injection site streaking and rash were recovering/resolving.   It was unknown if the reporter considered the cellulitis, injection site erythema, injection site streaking and rash to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero on right arm and experienced redness, rash, cellulitis, and streaking following dose of Bexsero. The reporter described the redness as surrounding the injection site, streaking as red, resembling a thick red line up the arm. All events began less than 24 hours after dose administration, no exact time frame provided. The patient was prescribed antibiotics to treat the events. As of 18th August 2019, the events were beginning to resolve. The reporter consented for follow up. This case has been linked with case US2019151259 (for same reporter).
Sex: M
Vaccine: VARZOS
Symptoms: Hypertension, Impaired work ability, Migraine, Peripheral swelling, Skin discolouration
Clinical narrative: High Blood Pressure; Migraine headache; Arm Swelling; Orange area on arm; Missed 3 months work; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received Shingrix. On an unknown date, 35 days after receiving Shingrix, the patient experienced blood pressure high (serious criteria hospitalization), migraine headache, swelling arm, skin discoloration and inability to work. On an unknown date, the outcome of the blood pressure high was recovered/resolved and the outcome of the migraine headache, swelling arm, skin discoloration and inability to work were unknown.   It was unknown if the reporter considered the blood pressure high, migraine headache, swelling arm, skin discoloration and inability to work to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced migraine headache, arm swelling and orange area on the arm after receiving Shingrix. The patient reported that, about 5 weeks later, he admitted in the hospital for 3 days due to blood pressure of 210/110, and because of that, he missed 3 months of work. The patient requested reimbursement for his bills and wanted to involve his attorney. The patient reported that, provided information as per content that reimbursement for vaccines was not available as per our guidelines. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Allergic respiratory disease, Lower respiratory tract infection viral, Lung infection
Clinical narrative: possible viral lung infection; everyone is assuming it's viral; an irritant from the rugs; This case was reported by a consumer via call center representative and described the occurrence of lung infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, 61 days after receiving Shingrix, the patient experienced lung infection (serious criteria GSK medically significant), lower respiratory tract infection viral (serious criteria GSK medically significant) and allergic respiratory disease. The patient was treated with prednisone. On an unknown date, the outcome of the lung infection, lower respiratory tract infection viral and allergic respiratory disease were unknown.   It was unknown if the reporter considered the lung infection, lower respiratory tract infection viral and allergic respiratory disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two months after receiving Shingrix, the patient developed a lung issue was assumed it as viral. The patient would also see an allergist since it might be an irritant from the rugs in her apartment being pulled up. Till the time of reporting, the patient had not missed the 6 month window and was on Prednisone treatment. The reporter did not consent to follow-up. The healthcare professional (HCP) information was not obtained.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Headache, Hypersomnia, Injection site discolouration
Clinical narrative: WED. UPPER LEFT ARM SWELLED, BECAME HARD, RED, VERY PAINFUL. COULD NOT SLEEP. RED GRADUALLY WENT DOWN TO ELBOW. THURSDAY- SLIGHT IMPROVEMENT - CALLED PHARMACY. I ALREADY TOOK ANTIHISTAMIN & TYLENOL. HE SIAD - ICE PACK. - I AM THE THIRD ONE TO CALL WHO HAD BAD REACTION TO PNEUMONIA SHOT. SUNDAY - 4TH DAY - STILL SOME RED & YELLOW TO TOP ELBOW Sunday - Aug. 25. Woke up with slight headache, ocular crystals. Bicep - left arm - sore but not painful. Skin looking much better. Only a little yellow & slight red left. Wednesday night - when I got up to go to bathroom - I was dizzy. Thurs., Fri, & Sat. - I was sleepy & slept a lot. Sunday- up @ 7:30AM. took nap at 11AM & when I awoke, the crystals - ocular-were gone. Slight headaches. Still some exhaustion left. Why exhaustion? I thought it would be done in a couple of days & was surprised That it took so long. Thinking back, I think I should have had my family doctor check it. Pharmacist said I am Third one to get this reaction. Aug. 26, 19. - Monday. only slightly lt, red, no swelling, only slightly headachy - lt. tinney sounds in head - off & on. Arm seems pain free. I am very tired. Going now to store to fax this.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: WED. UPPER LEFT ARM SWELLED, BECAME HARD, RED, VERY PAINFUL. COULD NOT SLEEP. RED GRADUALLY WENT DOWN TO ELBOW. THURSDAY- SLIGHT IMPROVEMENT - CALLED PHARMACY. I ALREADY TOOK ANTIHISTAMIN & TYLENOL. HE SIAD - ICE PACK. - I AM THE THIRD ONE TO CALL WHO HAD BAD REACTION TO PNEUMONIA SHOT. SUNDAY - 4TH DAY - STILL SOME RED & YELLOW TO TOP ELBOW Sunday - Aug. 25. Woke up with slight headache, ocular crystals. Bicep - left arm - sore but not painful. Skin looking much better. Only a little yellow & slight red left. Wednesday night - when I got up to go to bathroom - I was dizzy. Thurs., Fri, & Sat. - I was sleepy & slept a lot. Sunday- up @ 7:30AM. took nap at 11AM & when I awoke, the crystals - ocular-were gone. Slight headaches. Still some exhaustion left. Why exhaustion? I thought it would be done in a couple of days & was surprised That it took so long. Thinking back, I think I should have had my family doctor check it. Pharmacist said I am Third one to get this reaction. Aug. 26, 19. - Monday. only slightly lt, red, no swelling, only slightly headachy - lt. tinney sounds in head - off & on. Arm seems pain free. I am very tired. Going now to store to fax this.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Myalgia, Tinnitus, Visual impairment
Clinical narrative: WED. UPPER LEFT ARM SWELLED, BECAME HARD, RED, VERY PAINFUL. COULD NOT SLEEP. RED GRADUALLY WENT DOWN TO ELBOW. THURSDAY- SLIGHT IMPROVEMENT - CALLED PHARMACY. I ALREADY TOOK ANTIHISTAMIN & TYLENOL. HE SIAD - ICE PACK. - I AM THE THIRD ONE TO CALL WHO HAD BAD REACTION TO PNEUMONIA SHOT. SUNDAY - 4TH DAY - STILL SOME RED & YELLOW TO TOP ELBOW Sunday - Aug. 25. Woke up with slight headache, ocular crystals. Bicep - left arm - sore but not painful. Skin looking much better. Only a little yellow & slight red left. Wednesday night - when I got up to go to bathroom - I was dizzy. Thurs., Fri, & Sat. - I was sleepy & slept a lot. Sunday- up @ 7:30AM. took nap at 11AM & when I awoke, the crystals - ocular-were gone. Slight headaches. Still some exhaustion left. Why exhaustion? I thought it would be done in a couple of days & was surprised That it took so long. Thinking back, I think I should have had my family doctor check it. Pharmacist said I am Third one to get this reaction. Aug. 26, 19. - Monday. only slightly lt, red, no swelling, only slightly headachy - lt. tinney sounds in head - off & on. Arm seems pain free. I am very tired. Going now to store to fax this.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Flu-like symptoms during the day; uncontrollable shivering most of the night; fever up 100 degrees; malaise and lack of energy on the second day.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Two days after vaccine employee reported to ED for treatment of red, swollen and firm injection site
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient developed a rash on her torso that spread to her lower extremities 1 day after vaccine administration. I recommended to guardian that if her symptoms worsened she would have to seek medical attention for the child.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient had raised red area about the size of a baseball , still present 5 days after injection.  Presented with pain and swelling
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Individual donated plasma and then received the Twinrix vaccination.  She became pale, diaphoretic and lost consciousness for approximately 3-5 seconds.  She recovered almost immediately.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient describing myalgias starting one day after receiving the Shingrix vaccine at clinic. No other flu symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Myalgia
Clinical narrative: bad flu like symptoms, muscle and joint pain, intense fatigue
Sex: U
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: blurred vision; This case was reported by a consumer and described the occurrence of blurred vision in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was unknown.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. On 15th August 2019, in the night, the patient received a dose of Shingrix and the next day in the morning had some blurred vision.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site; headache; MUSCLE ACHES; diarrhea; FATIGUE; SHIVERING; body aches; slept; could not move; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased. On an unknown date, the outcome of the injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported that all the symptoms presented the same day as the vaccination.  The pain was at the injection site and lasted a day or two. The diarrhea lasted about 12 hours.  All other symptoms lasted about 24 hours.  She said she could not move due to the body aches and slept for 24 hours. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain, Somnolence
Clinical narrative: Pain at injection site; headache; MUSCLE ACHES; diarrhea; FATIGUE; SHIVERING; body aches; slept; could not move; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased. On an unknown date, the outcome of the injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported that all the symptoms presented the same day as the vaccination.  The pain was at the injection site and lasted a day or two. The diarrhea lasted about 12 hours.  All other symptoms lasted about 24 hours.  She said she could not move due to the body aches and slept for 24 hours. The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Rash
Clinical narrative: rash on her back and stomach; body aches; headache; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 14th August 2019, the patient experienced general body pain and headache. On 15th August 2019, the patient experienced rash. On 15th August 2019, the outcome of the general body pain and headache were recovered/resolved. On 16th August 2019, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, general body pain, headache and rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient reported that her rash was on her back and stomach. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Chest discomfort, Cough, Pyrexia, Secretion discharge, Throat tightness
Clinical narrative: - Tight Chest - Tight Throat - Lots of mucous/coughing - Fever (101.3) at 9:00 PM Treatment (Benadryl, Solumedrol) @ 6:00 PM Possible immune system reaction to flu vaccine?
Sex: M
Vaccine: UNK
Symptoms: Drug interaction, Feeling hot, Flushing, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Flushed face; Feeling warmer than normal; Tingling at injection site; Numbness at injection site; Drug interaction; This case was reported by a physician via call center representative and described the occurrence of facial flushing in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included triamcinolone acetonide (Kenalog) for an unknown indication.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, the patient started Kenalog at an unknown dose and frequency. On 23rd July 2019, 20 days after receiving Shingrix, the patient experienced drug interaction. On an unknown date, the patient experienced facial flushing, feeling of warmth, injection site tingling and injection site numbness. On an unknown date, the outcome of the facial flushing, feeling of warmth, injection site tingling, injection site numbness and drug interaction were unknown.   It was unknown if the reporter considered the facial flushing, feeling of warmth, injection site tingling and injection site numbness to be related to Shingrix.  Additional information received were as follows: The reporter asked for any information on drug interactions with Shingrix and Kenalog Shot. The reporter stated that, the patient received Shingrix 1st dose on 23rd July 2019 and Kenalog on 12th August 2019.  The reporter stated that the patient experienced experience flushed face, feeling warmer than normal, tingling and numbness at injection site when he received the kenalog shot, which led to a drug interaction. The reporter declined to provide patient details. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Lethargy, Myalgia, Pyrexia
Clinical narrative: Muscle Pain, Difficulty Walking, Lethargy (over 10 day period), Fever
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Night sweats, Pain, Pyrexia
Clinical narrative: Fevers, chills, night sweats, soreness.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction; red, swollen, ring around injection site, hot to the touch, painful
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Tendonitis
Clinical narrative: 13 days post vaccine employee reported right shoulder pain, he states it started  a few days post vaccine. At time of reporting he was seen in the clinic no swelling or erythema  painful arm, some pain with  range of motion. No history of allergies or previous shoulder injury, new job required pushing and pulling as he is a transporter in the hospital. He was advised to use ice and Over the counter Ibuprofen as directed. He returned for a second visit 8/8/19 with continued complaints of right shoulder pain with no visible signs of swelling or erythema. No neurovascular symptoms noted.  Due to continued complaints of shoulder pain he was referred to Occupational Health for further evaluation and treatment. His diagnosis at this time is right shoulder tendonitis possible associated with the vaccine, although new job required pushing, pulling and transporting of patients
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site reaction, Joint stiffness, Pruritus, Rash vesicular
Clinical narrative: CHICKENPOX LIKE RASH ON THE SITE OF THE INJECTION, EXTREME PRURITUS, FATIGUE , STIFFNESS IN LEFT HIP JOINT
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Left upper arm there is a rough,fine papular rash without erythema or edema. Almost eczematous appearing.  About 3 inches by 1/2 inch
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported; administered a dose of PROQUAD and a dose of VARIVAX on 07-MAR-2017; This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-MAR-2017, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: rHA) (PROQUAD) lot # M035689, expiration date not reported, but upon internal validation established as 06-FEB-2018 and varicella virus vaccine live (oka/merck)(VARIVAX) lot # M028549, expiration date not reported, but upon internal validation established as 07-JUN-2018 (route of administration was not reported), when the patient was between 12 and 14 months old. Concomitant therapies included sterile diluent. On 31-JUN-2019, at age 3 years old, patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) R018933, expiration date 02-JUL-2020. No adverse effect were reported.
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error; no adverse event; This spontaneous report was received from a medical assistant referring to a 12 month old male patient. The patient's medical history included Penicillin allergy. No information was provided regarding the concurrent conditions, drug reactions or concomitant medication.   On 08-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, oka/merck)(VARIVAX) lot # number S005084 in right leg and hepatitis a vaccine, inactivated (VAQTA) lot # S005725 for prophylaxis (dose was not provided). No adverse symptoms were reported.   The vaccine was exposed to a temperature excursion with a total time and lowest temperature below 6°F to 14°F For 11 hours. There was no previous temperature.
Age: 0.92
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported; Was administered a dose of VARIVAX and PROQUAD at the same visit; The patient was administered the first dose of PROQUAD too early; This spontaneous report was received from a medical assistant concerning a currently 12 year old patient. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.  On 05-NOV-2007, the patient was administered the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis too early (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). Since measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was administered too early it did not count on immunization records and the patient needed a dose of varicella and measles, mumps, and rubella (M-M-R II); instead, on 15-AUG-2019, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) lot # S008577 with expiration date of 16-SEP-2020, for prophylaxis and with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R017638 with expiration date of 20-JUN-2020) for prophylaxis (dose, frequency, route of administration and anatomical location were not reported for none of both vaccines). Both, measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) were reconstituted with sterile diluent(STERILE DILUENT) lot # N023666 with expiration date of 05-FEB-2020.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received one dose of improperly stored MMR II; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 12-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), albumin status: rHA, lot # R031681, expiration date 01-NOV-2020 (dose and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent, lot # reported as N029636, expiration date reported as 29-MAR-2020. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 47 degrees Fahrenheit (48 degrees Fahrenheit) for 7 hours. There were no previous excursions reported. The data logger was involved.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Pain / Aches; Shivering; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering, fever and fatigue. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the shivering, fever and fatigue were unknown.   It was unknown if the reporter considered the pain, shivering, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms the day he received the injection. The reporter refused to answer any additional questions. The reporter denied permission to follow up. In the XML document outcome of event pain was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system. Also in XML document age group was mentioned as infant, but as per Shingrix indication age group was captured as adult.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: Pain / Aches; Shivering; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering, fever and fatigue. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the shivering, fever and fatigue were unknown.   It was unknown if the reporter considered the pain, shivering, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms the day he received the injection. The reporter refused to answer any additional questions. The reporter denied permission to follow up. In the XML document outcome of event pain was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system. Also in XML document age group was mentioned as infant, but as per Shingrix indication age group was captured as adult.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site movement impairment
Clinical narrative: Pain / Aches; Shivering; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering, fever and fatigue. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the shivering, fever and fatigue were unknown.   It was unknown if the reporter considered the pain, shivering, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms the day he received the injection. The reporter refused to answer any additional questions. The reporter denied permission to follow up. In the XML document outcome of event pain was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system. Also in XML document age group was mentioned as infant, but as per Shingrix indication age group was captured as adult.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Pain / Aches; Shivering; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering, fever and fatigue. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the shivering, fever and fatigue were unknown.   It was unknown if the reporter considered the pain, shivering, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms the day he received the injection. The reporter refused to answer any additional questions. The reporter denied permission to follow up. In the XML document outcome of event pain was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system. Also in XML document age group was mentioned as infant, but as per Shingrix indication age group was captured as adult.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain / Aches; Shivering; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering, fever and fatigue. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the shivering, fever and fatigue were unknown.   It was unknown if the reporter considered the pain, shivering, fever and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms the day he received the injection. The reporter refused to answer any additional questions. The reporter denied permission to follow up. In the XML document outcome of event pain was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system. Also in XML document age group was mentioned as infant, but as per Shingrix indication age group was captured as adult.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: low grade fever; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced low grade fever, muscle pain and weakness. On an unknown date, the outcome of the low grade fever, muscle pain and weakness were unknown.   It was unknown if the reporter considered the low grade fever, muscle pain and weakness to be related to Shingrix.  Additional details were provided as follows: The patient experienced low grade fever, muscle ache and weakness. The patient did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: low grade fever; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced low grade fever, muscle pain and weakness. On an unknown date, the outcome of the low grade fever, muscle pain and weakness were unknown.   It was unknown if the reporter considered the low grade fever, muscle pain and weakness to be related to Shingrix.  Additional details were provided as follows: The patient experienced low grade fever, muscle ache and weakness. The patient did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site movement impairment
Clinical narrative: low grade fever; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced low grade fever, muscle pain and weakness. On an unknown date, the outcome of the low grade fever, muscle pain and weakness were unknown.   It was unknown if the reporter considered the low grade fever, muscle pain and weakness to be related to Shingrix.  Additional details were provided as follows: The patient experienced low grade fever, muscle ache and weakness. The patient did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: low grade fever; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced low grade fever, muscle pain and weakness. On an unknown date, the outcome of the low grade fever, muscle pain and weakness were unknown.   It was unknown if the reporter considered the low grade fever, muscle pain and weakness to be related to Shingrix.  Additional details were provided as follows: The patient experienced low grade fever, muscle ache and weakness. The patient did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: low grade fever; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced low grade fever, muscle pain and weakness. On an unknown date, the outcome of the low grade fever, muscle pain and weakness were unknown.   It was unknown if the reporter considered the low grade fever, muscle pain and weakness to be related to Shingrix.  Additional details were provided as follows: The patient experienced low grade fever, muscle ache and weakness. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anal incontinence, Condition aggravated, Diarrhoea, Extra dose administered, Functional gastrointestinal disorder
Clinical narrative: Vaccination failure; Shingles; Loss of Bowel Function; Diarrhea; Off label use; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diarrhea, intestinal functional disorder and shingles (internal shingles affected her intestines).   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, intestinal functional disorder, diarrhea and drug prescribing error. On an unknown date, the outcome of the vaccination failure, shingles, intestinal functional disorder, diarrhea and drug prescribing error were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the intestinal functional disorder and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st and 2nd dose of Shingrix. The age at vaccination was not applicable for 3rd dose of Shingrix. The patient who has gotten two doses of Shingrix, and had a prescription for a third dose, which led to drug prescribing error.  The patient had complications from shingles where it has invaded her internal organs, and she was getting periodic symptoms even after her two standard doses of Shingrix. The patient's internal shingles affected her intestines, and she has experienced urgent diarrhea both during her initial outbreak (before the vaccine doses) and again now (approximately 7 months after her 2nd dose). In both cases she completely lost control of her bowels. The reporter consented for follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Product prescribing error, Vaccination failure
Clinical narrative: Vaccination failure; Shingles; Loss of Bowel Function; Diarrhea; Off label use; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diarrhea, intestinal functional disorder and shingles (internal shingles affected her intestines).   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, intestinal functional disorder, diarrhea and drug prescribing error. On an unknown date, the outcome of the vaccination failure, shingles, intestinal functional disorder, diarrhea and drug prescribing error were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the intestinal functional disorder and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st and 2nd dose of Shingrix. The age at vaccination was not applicable for 3rd dose of Shingrix. The patient who has gotten two doses of Shingrix, and had a prescription for a third dose, which led to drug prescribing error.  The patient had complications from shingles where it has invaded her internal organs, and she was getting periodic symptoms even after her two standard doses of Shingrix. The patient's internal shingles affected her intestines, and she has experienced urgent diarrhea both during her initial outbreak (before the vaccine doses) and again now (approximately 7 months after her 2nd dose). In both cases she completely lost control of her bowels. The reporter consented for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Itching; changed from red to purple at this time; Fever; Lethargy; Red blotches; Back pain; Knee pain; Allergic reaction; Injection site aching; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of red blotches in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th August 2019, 1 days after receiving Shingrix, the patient experienced red blotches (serious criteria clinically significant/intervention required), injection site pain, injection site erythema, allergic reaction, back pain and knee pain. On 17th August 2019, the patient experienced itchy rash (serious criteria clinically significant/intervention required), skin discoloration, fever and lethargy. The patient was treated with paracetamol (Tylenol) and prednisone. On 17th August 2019, the outcome of the lethargy was recovered/resolved. On an unknown date, the outcome of the red blotches, itchy rash and skin discoloration were not recovered/not resolved and the outcome of the injection site pain, injection site erythema and allergic reaction were recovering/resolving and the outcome of the fever, back pain and knee pain were recovered/resolved.   It was unknown if the reporter considered the red blotches, itchy rash, injection site pain, injection site erythema, skin discoloration, allergic reaction, fever, back pain, knee pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and next day woke up in the evening on with red blotches on her thighs are arms. The patient notified her physician at that time. Next day, the red blotches spread to her back and ears and started itching. At that point her physician treated her for an allergic reaction and started her on a prednisone taper. The patient also experienced injection site redness and aching that started on 16th August 2019 in the morning. On 17th August 2019, she had fever that resolved with Tylenol. The patient had back and knee pain that started on 16th August 2019 in the evening that she treated with Tylenol as well. On 17th August 2019, she states she had lethargy that resolved after 4-6 hours. The reporter stated that the blotches remain, but have changed from red to purple at this time. emergency room (ER) visit was required. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia, Rash macular, Rash pruritic, Skin discolouration
Clinical narrative: Itching; changed from red to purple at this time; Fever; Lethargy; Red blotches; Back pain; Knee pain; Allergic reaction; Injection site aching; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of red blotches in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th August 2019, 1 days after receiving Shingrix, the patient experienced red blotches (serious criteria clinically significant/intervention required), injection site pain, injection site erythema, allergic reaction, back pain and knee pain. On 17th August 2019, the patient experienced itchy rash (serious criteria clinically significant/intervention required), skin discoloration, fever and lethargy. The patient was treated with paracetamol (Tylenol) and prednisone. On 17th August 2019, the outcome of the lethargy was recovered/resolved. On an unknown date, the outcome of the red blotches, itchy rash and skin discoloration were not recovered/not resolved and the outcome of the injection site pain, injection site erythema and allergic reaction were recovering/resolving and the outcome of the fever, back pain and knee pain were recovered/resolved.   It was unknown if the reporter considered the red blotches, itchy rash, injection site pain, injection site erythema, skin discoloration, allergic reaction, fever, back pain, knee pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and next day woke up in the evening on with red blotches on her thighs are arms. The patient notified her physician at that time. Next day, the red blotches spread to her back and ears and started itching. At that point her physician treated her for an allergic reaction and started her on a prednisone taper. The patient also experienced injection site redness and aching that started on 16th August 2019 in the morning. On 17th August 2019, she had fever that resolved with Tylenol. The patient had back and knee pain that started on 16th August 2019 in the evening that she treated with Tylenol as well. On 17th August 2019, she states she had lethargy that resolved after 4-6 hours. The reporter stated that the blotches remain, but have changed from red to purple at this time. emergency room (ER) visit was required. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood heavy metal normal, Blood test normal, Borrelia test negative, Full blood count normal, Helicobacter test negative
Clinical narrative: Day after vaccine, had 3 minutes of severe vertigo,  and for several hours felt like I had a virus. Within a few weeks I often felt very ill, as if I had a virus. But symptoms would come and go. By May 2018 I had developed tingling in all extremeties and head, and continued to feel very ill often. After many tests and several doctors (primary care, a new primary care, vascular, neurology (2 different neurologists), provider at Neurology diagnosed me July 17, 2019 after reviewing all MRIs, blood work, et al. His diagnosis is that my symptoms are caused by the Shingrix vaccine, that the nerve damage creating the tingling sensations are not permanent but will take another 18-24 months to clear. I have now gone 85 days without feeling ill as if I have a virus. The tingling is constant, but has reduced since May of 2018.