chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, headache and tiredness. On an unknown date, the outcome of the shivering, headache and tiredness were unknown. It was unknown if the reporter considered the shivering, headache and tiredness to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient declined to answer any questions or provide her address or phone number. The patient did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain in extremity, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling, influenza-like symptoms and fatigue. On an unknown date, the outcome of the pain in arm, swelling, influenza-like symptoms and fatigue were unknown. It was unknown if the reporter considered the pain in arm, swelling, influenza-like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced severe arm pain, swelling, flu-like symptoms and fatigue within 24 hours of vaccination. The reporter had consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 81-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 4th June 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced incomplete course of vaccination. On 6th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left arm and experienced fever. The patient reported that she missed her 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The patient planned to continue follow-up with her pharmacy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included sinus infection. On 4th February 2019, the patient received SHINGRIX. On 5th February 2019, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported a low grade temperature of 99.9 degrees Fahrenheit the morning after a SHINGRIX injection. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of constipation in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 17th January 2019, the patient received SHINGRIX (intramuscular) .5 ml. In January 2019, 2 days after receiving SHINGRIX, the patient experienced constipation. On an unknown date, the outcome of the constipation was recovered/resolved. It was unknown if the reporter considered the constipation to be related to SHINGRIX. Additional details were provided as follows: The patient had constipation 2 to 3 days after the injection. It took at least 10 days for the constipation to clear up. The reporter provided the consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several hours after receiving SHINGRIX, the patient experienced chills, sweating, nausea, fatigue and feeling bad. On an unknown date, the outcome of the chills, sweating, nausea, fatigue and feeling bad were recovered/resolved. It was unknown if the reporter considered the chills, sweating, nausea, fatigue and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 2.5 months ago around 3 pm in the right deltoid and developed the listed side effects later that night and they lasted about 36 hours.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The Shingles were relatively mild. The patient was given Valtrex within 72 hrs and the Shingles resolved completely. The patient was asking when should she receive her 2nd dose of the SHINGRIX vaccine. This call was coming through the queue and the reporter did not provide all adverse event information.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 5th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The patient received SHINGRIX vaccine on left arm and was 5 days past her six month period. The patient experienced soreness at the injection site after receiving SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Uveitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of uveitis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced uveitis (serious criteria GSK medically significant). On an unknown date, the outcome of the uveitis was unknown. The reporter considered the uveitis to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was recently diagnosed with uveitis and was concerned the uveitis might have been caused by having the 1st dose of SHINGRIX. At the time of reporting, the patient was due for her 2nd dose of SHINGRIX. The patient disconnected before providing additional information.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Condition aggravated, Herpes zoster, Herpes zoster infection neurological, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory infection in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (3 cases). Previously administered products included ZOSTAVAX vaccine. Concurrent medical conditions included blood sugar increased. On 15th September 2018, the patient received the 1st dose of SHINGRIX. On 15th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated. In January 2019, the patient experienced respiratory infection (serious criteria hospitalization and GSK medically significant), wheezing (serious criteria hospitalization), herpes zoster infection neurological (serious criteria hospitalization and GSK medically significant) and pain (serious criteria hospitalization). On an unknown date, the outcome of the respiratory infection, wheezing, herpes zoster infection neurological, pain, influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated were recovered/resolved. It was unknown if the reporter considered the respiratory infection, wheezing, herpes zoster infection neurological, pain, influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated to be related to SHINGRIX. Additional details were received as follows: On the same day of vaccination, the patient's whole body felt like having the flu. The patient had redness at the injection site, lump the size of a hardball at the injection site. The patient also had high blood sugar levels (in the 300's), despite taking her medications to control it. All the symptoms lasted 3 weeks. In January 2019, the patient had a respiratory infection with wheezing. She also started to have shingles again, despite having the first dose of shingles. She has had cases of shingles where it involved one nerve branch involved however, this time she had 3 nerve branches involved. She had a total of five weeks of pain from the shingles. The patient said that she ended up going to the emergency room (ER) and the hospital to get assistance. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pain, Respiratory tract infection, Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory infection in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (3 cases). Previously administered products included ZOSTAVAX vaccine. Concurrent medical conditions included blood sugar increased. On 15th September 2018, the patient received the 1st dose of SHINGRIX. On 15th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated. In January 2019, the patient experienced respiratory infection (serious criteria hospitalization and GSK medically significant), wheezing (serious criteria hospitalization), herpes zoster infection neurological (serious criteria hospitalization and GSK medically significant) and pain (serious criteria hospitalization). On an unknown date, the outcome of the respiratory infection, wheezing, herpes zoster infection neurological, pain, influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated were recovered/resolved. It was unknown if the reporter considered the respiratory infection, wheezing, herpes zoster infection neurological, pain, influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated to be related to SHINGRIX. Additional details were received as follows: On the same day of vaccination, the patient's whole body felt like having the flu. The patient had redness at the injection site, lump the size of a hardball at the injection site. The patient also had high blood sugar levels (in the 300's), despite taking her medications to control it. All the symptoms lasted 3 weeks. In January 2019, the patient had a respiratory infection with wheezing. She also started to have shingles again, despite having the first dose of shingles. She has had cases of shingles where it involved one nerve branch involved however, this time she had 3 nerve branches involved. She had a total of five weeks of pain from the shingles. The patient said that she ended up going to the emergency room (ER) and the hospital to get assistance. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Herpes zoster, Hypersensitivity, Injection site vesicles
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting SHINGRIX, the patient would get partial cases of shingles which would go away before blisters were fully formed). On an unknown date, the patient received the 1st dose of SHINGRIX. In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, allergic reaction, erythema, skin rough and injection site vesicles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, skin rough and injection site vesicles were unknown and the outcome of the shingles was recovering/resolving and the outcome of the allergic reaction and erythema were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and skin rough to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the allergic reaction, erythema and injection site vesicles to be related to SHINGRIX. Additional details were provided as follows: The patient had an allergic reaction to the SHINGRIX. The 2nd dose wadded up under her skin and she got a huge red circle that stayed forever, at least 2 weeks. In the last week from the date of reporting, the patient developed a full blown case of Shingles and had to be treated with Valtrex. The shingles was mostly resolved at the time of reporting, but she did still have a little roughness. The reporter consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting SHINGRIX, the patient would get partial cases of shingles which would go away before blisters were fully formed). On an unknown date, the patient received the 1st dose of SHINGRIX. In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, allergic reaction, erythema, skin rough and injection site vesicles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, skin rough and injection site vesicles were unknown and the outcome of the shingles was recovering/resolving and the outcome of the allergic reaction and erythema were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and skin rough to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the allergic reaction, erythema and injection site vesicles to be related to SHINGRIX. Additional details were provided as follows: The patient had an allergic reaction to the SHINGRIX. The 2nd dose wadded up under her skin and she got a huge red circle that stayed forever, at least 2 weeks. In the last week from the date of reporting, the patient developed a full blown case of Shingles and had to be treated with Valtrex. The shingles was mostly resolved at the time of reporting, but she did still have a little roughness. The reporter consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event was unknown.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Lung neoplasm malignant
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of lung cancer in a 59-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lung cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the lung cancer was unknown. It was unknown if the reporter considered the lung cancer to be related to SHINGRIX. Additional information was reported as follows: The patient received 1st dose of SHINGRIX on the left deltoid. The patient made the pharmacist aware of a lung cancer diagnosis after receiving the 1st dose of SHINGRIX and at time of 2nd dose administration of SHINGRIX. The patient began chemotherapy in November 2018 and completed therapy at the end of January. At the time of reporting, the reporter did not have batch number, expiry date and additional details. The pharmacist did not have more in depth details.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a 64-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. On 5th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm were unknown. The reporter considered the erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced 2 spots that appeared below the injection site that were red, discolored, swollen and warm to touch. The patient had arm soreness. The patient was seen by her physician today and was prescribed antibiotics. Emergency room visit was required. The patient's physician recommended the patient not to receive the 2nd dose of SHINGRIX due to the reaction, as he believed it was related to the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Skin discolouration, Skin swelling, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a 64-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. On 5th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm were unknown. The reporter considered the erythromacular rash, skin discoloration, skin warm, skin swelling and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced 2 spots that appeared below the injection site that were red, discolored, swollen and warm to touch. The patient had arm soreness. The patient was seen by her physician today and was prescribed antibiotics. Emergency room visit was required. The patient's physician recommended the patient not to receive the 2nd dose of SHINGRIX due to the reaction, as he believed it was related to the vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Malaise, Myalgia
Clinical narrative: Myalgias, arthralgias, chills, general malaise all beginning around 2015.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient reports swollen erythematous rash at site of reaction.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect dose administered
Clinical narrative: Gave patient adult Hep A instead of pediatric Hep A dose. Patient was 17 & 11 months of age.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 04-JAN-2019, the patient was administered 1 dose of improperly stored VARIVAX (three lot numbers and expiration date (lot# R019235 with expiration date 04-JUL-2020, lot # R018932 with expiration date 02-JUL-2020 and lot # R013565 with expiration date 13-MAY-2020) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) for prophylaxis. Three lots of VARIVAX were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1902USA004204: US-009507513-1902USA004203: US-009507513-1902USA004205.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse as well as the clinical manager referring to a 44 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided. On 24-JAN-2019 the patient was vaccinated with M-M-R II (0.5 ml, lot number: M045390, batch#: 7002151400, expiration date: 14-NOV-2018, therapy type: rHA (recombinant Human albumin); strength was not provided) subcutaneously for prophylaxis (expired product administered) because the titre shows 0 immunity. The vaccine was reconstituted by unspecified sterile diluent. No adverse events were observed and the patient's doctor was contacted. The nurse reported there is no record of the patient previously receiving M-M-R II.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 05-FEB-2019, the patient was vaccinated with a dose of improperly stored VARIVAX, lot # N034551, expiration date: 05-DEC-2019 for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 21.7 degrees Fahrenheit for 3 hours 45 minutes and previous temperature excursion of 12.9 degrees Fahrenheit for 30 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA004129; US-009507513-1902USA004130; US-009507513-1902USA004131.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 05-FEB-2019, the patient was vaccinated with a dose of improperly stored PROQUAD lot # R017803, expiration date: 21-OCT-2019 (reported as 19-DEC-2019) for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 21.7 degrees Fahrenheit for 3 hours 45 minutes and previous temperature excursion of 12.9 degrees Fahrenheit for 30 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA004129: US-009507513-1902USA003115: US-009507513-1902USA004131.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 04-JAN-2019, the patient was administered 1 dose of improperly stored VARIVAX (three lot numbers and expiration dates (lot# R019235 with expiration date 04-JUL-2020, lot # R018932 with expiration date 02-JUL-2020 and lot # R013565 with expiration date 13-MAY-2020) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) (product storage error) for prophylaxis. Three lots of VARIVAX were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1901USA007256; US-009507513-1902USA004204; US-009507513-1902USA004205.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 07-JAN-2019, the patient was administered 1 dose of improperly stored PROQUAD (therapy type: recombinant Human albumin (rHA), two lot numbers and expiration dates (lot # R011214 with expiration date 15-OCT-2019; lot # R008203 with expiration date 16-SEP-2019) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) for prophylaxis. Two lots of PROQUAD were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1902USA004203: US-009507513-1901USA007256: US-009507513-1902USA004205.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 07-JAN-2019, the patient was administered 1 dose of improperly stored PROQUAD (therapy type: recombinant Human albumin (rHA), two lot numbers and expiration dates (lot # R011214 with expiration date 15-OCT-2019; lot # R008203 with expiration date 16-SEP-2019) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) (product storage error) for prophylaxis. Two lots of PROQUAD were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1902USA004203; US-009507513-1902USA004204; US-009507513-1901USA007256.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a female patient of age 10 years, height 54 in, weight 31 kg. No medical history was reported. No concomitant products were reported. The patient started treatment with FLUMIST QUADRIVALENT (batch number(s) Unknown), nasal, on 06-OCT-2018 for flu prevention. The report described a medication error for FLUMIST QUADRIVALENT. On 15-JAN-2019, the patient experienced diagnosed with influenza type A (preferred term: Influenza). Treatment with FLUMIST QUADRIVALENT was not changed. At the time of reporting, diagnosed with influenza type A was ongoing. Company physician assessed diagnosed with influenza type A to be non-serious. The event was considered non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Blood urine present
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of blood in urine in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced blood in urine. On an unknown date, the outcome of the blood in urine was unknown.  It was unknown if the reporter considered the blood in urine to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The physician did not provide any further information and said he would agree to follow-up from GSK.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Inflammation, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flare up of arthritis in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 9th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced flare up of arthritis, inflammation localized and pain. On an unknown date, the outcome of the flare up of arthritis, inflammation localized and pain were recovered/resolved. It was unknown if the reporter considered the flare up of arthritis, inflammation localized and pain to be related to SHINGRIX. Additional details were provided as follows: The patient asked what was the longest amount of time that could be elapsed before receiving the second dose of SHINGRIX. It was less than 6 months the patient had received the 1st dose of SHINGRIX. Currently at the time of reporting, the patient received a new immunosuppressant drug series and had a strong reaction with the 1st dose of SHINGRIX, so the doctor had asked the patient hold off until after the next infusion therapy, that is till March. The patient experienced inflammation flare up in the wrist and hands, aches and pains for 3 days. The patient asked if there was any problem in receiving the 2nd dose of SHINGRIX in early March without receiving the repeated series.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, nausea, fatigue and injection site pain post vaccination. All the symptoms listed, required the patient to take 2 days of sick leave from work. The patient full recovery after 3 to 4 days with no prolonged symptoms. This is 1 of the 6 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The symptoms were milder post vaccination and did not come on so fast. For tolerability of the second dose of SHINGRIX, refer case US2019021233. The reporter did not provide the consent to follow up. The reporter was tried to be contacted but they got answering machine and therefore were unable to obtain any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The symptoms were milder post vaccination and did not come on so fast. For tolerability of the second dose of SHINGRIX, refer case US2019021233. The reporter did not provide the consent to follow up. The reporter was tried to be contacted but they got answering machine and therefore were unable to obtain any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (first dose received in November, 2018. For tolerability of the first dose of SHINGRIX, refer case US2019GSK027086). On 4th February 2019, the patient received the 2nd dose of SHINGRIX. On 4th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 5th February 2019, the patient experienced headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms. The patient was treated with TYLENOL and ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In the evening after vaccination, the patient experienced pain, soreness, and redness in her arm. On the day of reporting (5th February 2019), she woke up and felt like she had the flu. Her arms and legs were achy, she had a headache, she felt like she had a mild fever and had mild nausea. The reporter did not provide the consent to follow up. The reporter was tried to be contacted but they got answering machine and therefore were unable to obtain any additional details. For tolerability of the first dose of SHINGRIX, refer case US2019GSK027086.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (first dose received in November, 2018. For tolerability of the first dose of SHINGRIX, refer case US2019GSK027086). On 4th February 2019, the patient received the 2nd dose of SHINGRIX. On 4th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 5th February 2019, the patient experienced headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms. The patient was treated with TYLENOL and ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In the evening after vaccination, the patient experienced pain, soreness, and redness in her arm. On the day of reporting (5th February 2019), she woke up and felt like she had the flu. Her arms and legs were achy, she had a headache, she felt like she had a mild fever and had mild nausea. The reporter did not provide the consent to follow up. The reporter was tried to be contacted but they got answering machine and therefore were unable to obtain any additional details. For tolerability of the first dose of SHINGRIX, refer case US2019GSK027086.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fibromyalgia worsened in a 75-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received on 1st June 2018 and did not report any issues). Concurrent medical conditions included fibromyalgia. Concomitant products included tramadol. On 12th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fibromyalgia worsened, feeling queasy and pain. On an unknown date, the outcome of the fibromyalgia worsened, feeling queasy and pain were not recovered/not resolved. It was unknown if the reporter considered the fibromyalgia worsened, feeling queasy and pain to be related to SHINGRIX. Additional details were provided as follows: The patient told that the 2nd SHINGRIX vaccination aggravated her fibromyalgia. The patient still had the events at the time of reporting. It was stated that, the patient takes Tramadol for her fibromyalgia, and the pharmacist thought she might had had to take more Tramadol after her 2nd SHINGRIX vaccination. The pharmacist did not had lot number, expiration date, injection site, or other details at the time of initial report.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Discomfort, Feeling abnormal, Peripheral swelling, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash, swelling arm, contusion, feels awful and discomfort. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the swelling arm, contusion, feels awful and discomfort were unknown. It was unknown if the reporter considered the rash, swelling arm, contusion, feels awful and discomfort 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 a few months before the date of reporting, unknown how long ago on an unknown arm. The batch number and expiry date was unknown. The patient experienced rash for 4 to 5 days, whole arm was swollen, bruise on arm, feeling really awful, bad and uncomfortable after receiving SHINGRIX. SHINGRIX was not administered at the pharmacy from which the pharmacist was calling. It is unknown which arm SHINGRIX was administered and the arm which was affected by rash, swelling and bruise.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of painful rash in an adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced painful rash and rash vesicular. On an unknown date, the outcome of the painful rash and rash vesicular were unknown. It was unknown if the reporter considered the painful rash and rash vesicular to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received 1st dose). On 5th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient reported had received the 2nd dose of SHINGRIX 5 days past his six month period and experienced soreness at the injection site on his left arm. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever blister in a 65-year-old female patient who received SHINGRIX (batch number B57NG, expiry date 16th April 2021) and (batch number EY93J, expiry date 13th April 2021) for prophylaxis. The patient's past medical history included dental operation (at the same time of the vaccination). On 30th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown. It was unknown if the reporter considered the fever blister to be related to SHINGRIX. Additional details were reported as follows: The patient has never had fever blisters before. The patient experienced the listed side effects after dose of SHINGRIX.