chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Dermatomyositis, Fatigue, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of systemic lupus erythematosus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant) and dermatomyositis (serious criteria GSK medically significant). On an unknown date, the outcome of the systemic lupus erythematosus and dermatomyositis were unknown. It was unknown if the reporter considered the systemic lupus erythematosus and dermatomyositis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported bad reaction to the SHINGRIX vaccine. The patient had lupus and dermatomyositis, and the patient said that her doctor was not aware SHINGRIX was not tested on patients with autoimmune disease.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash generalised, Systemic lupus erythematosus
Clinical narrative: This case was reported by a consumer and described the occurrence of systemic lupus erythematosus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant) and dermatomyositis (serious criteria GSK medically significant). On an unknown date, the outcome of the systemic lupus erythematosus and dermatomyositis were unknown. It was unknown if the reporter considered the systemic lupus erythematosus and dermatomyositis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported bad reaction to the SHINGRIX vaccine. The patient had lupus and dermatomyositis, and the patient said that her doctor was not aware SHINGRIX was not tested on patients with autoimmune disease.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatomyositis, Systemic lupus erythematosus, Vaccination complication
Clinical narrative: This case was reported by a consumer and described the occurrence of systemic lupus erythematosus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant) and dermatomyositis (serious criteria GSK medically significant). On an unknown date, the outcome of the systemic lupus erythematosus and dermatomyositis were unknown. It was unknown if the reporter considered the systemic lupus erythematosus and dermatomyositis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported bad reaction to the SHINGRIX vaccine. The patient had lupus and dermatomyositis, and the patient said that her doctor was not aware SHINGRIX was not tested on patients with autoimmune disease.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Nuclear magnetic resonance imaging brain, Post herpetic neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles 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 was selected adult as per vaccine indication. The healthcare professional reported that his physician mentioned that the patient who recently received SHINGRIX got Shingles on the side where the injection was administered. This case was considered as suspected vaccination failure as the vaccination schedule and the time to onset for Shingles was not provided at the time of reporting. No further information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Post herpetic neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles 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 was selected adult as per vaccine indication. The healthcare professional reported that his physician mentioned that the patient who recently received SHINGRIX got Shingles on the side where the injection was administered. This case was considered as suspected vaccination failure as the vaccination schedule and the time to onset for Shingles was not provided at the time of reporting. No further information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles 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 was selected adult as per vaccine indication. The healthcare professional reported that his physician mentioned that the patient who recently received SHINGRIX got Shingles on the side where the injection was administered. This case was considered as suspected vaccination failure as the vaccination schedule and the time to onset for Shingles was not provided at the time of reporting. No further information was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 73-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In October 2018, the patient experienced hives and malaise. On an unknown date, the patient experienced pain in arm, skin warm, erythema of extremities and swelling arm. The patient was treated with (NOS) BENADRYL. On an unknown date, the outcome of the hives and malaise were not recovered/not resolved and the outcome of the pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the hives, pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm to be related to SHINGRIX. The reporter considered the malaise to be related to SHINGRIX. Additional details were provided as follows: The reporter was a retired registered nurse who was also the patient in this report. The patient stated that she received the SHINGRIX on left arm approximately 10 days before the reporting date and soon after receiving the vaccine (unsure of exact timeline), she experienced swelling, redness, pain, and heat on her left arm. The patient stated that the space between her shoulder and her elbow was where the symptoms occurred and they resolved after several days in 2018. The patient stated that this area was hot to the touch. In 2018, approximately 10 days after receiving the vaccine, she started getting hives all over her body and started to experience malaise. She had taken BENADRYL twice, and stated that it might have helped but not enough for her to notice. The patient stated that she also experienced some injection site pain. She stated that as soon as the liquid went into her arm, she knew something was not right and stated that the fluid seemed very "active". She further stated that it felt like she received a live virus. The patient had denied permission to contact their physician. This case has been linked with case US2018179264, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 73-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In October 2018, the patient experienced hives and malaise. On an unknown date, the patient experienced pain in arm, skin warm, erythema of extremities and swelling arm. The patient was treated with (NOS) BENADRYL. On an unknown date, the outcome of the hives and malaise were not recovered/not resolved and the outcome of the pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the hives, pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm to be related to SHINGRIX. The reporter considered the malaise to be related to SHINGRIX. Additional details were provided as follows: The reporter was a retired registered nurse who was also the patient in this report. The patient stated that she received the SHINGRIX on left arm approximately 10 days before the reporting date and soon after receiving the vaccine (unsure of exact timeline), she experienced swelling, redness, pain, and heat on her left arm. The patient stated that the space between her shoulder and her elbow was where the symptoms occurred and they resolved after several days in 2018. The patient stated that this area was hot to the touch. In 2018, approximately 10 days after receiving the vaccine, she started getting hives all over her body and started to experience malaise. She had taken BENADRYL twice, and stated that it might have helped but not enough for her to notice. The patient stated that she also experienced some injection site pain. She stated that as soon as the liquid went into her arm, she knew something was not right and stated that the fluid seemed very "active". She further stated that it felt like she received a live virus. The patient had denied permission to contact their physician. This case has been linked with case US2018179264, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Malaise, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 73-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In October 2018, the patient experienced hives and malaise. On an unknown date, the patient experienced pain in arm, skin warm, erythema of extremities and swelling arm. The patient was treated with (NOS) BENADRYL. On an unknown date, the outcome of the hives and malaise were not recovered/not resolved and the outcome of the pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the hives, pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm to be related to SHINGRIX. The reporter considered the malaise to be related to SHINGRIX. Additional details were provided as follows: The reporter was a retired registered nurse who was also the patient in this report. The patient stated that she received the SHINGRIX on left arm approximately 10 days before the reporting date and soon after receiving the vaccine (unsure of exact timeline), she experienced swelling, redness, pain, and heat on her left arm. The patient stated that the space between her shoulder and her elbow was where the symptoms occurred and they resolved after several days in 2018. The patient stated that this area was hot to the touch. In 2018, approximately 10 days after receiving the vaccine, she started getting hives all over her body and started to experience malaise. She had taken BENADRYL twice, and stated that it might have helped but not enough for her to notice. The patient stated that she also experienced some injection site pain. She stated that as soon as the liquid went into her arm, she knew something was not right and stated that the fluid seemed very "active". She further stated that it felt like she received a live virus. The patient had denied permission to contact their physician. This case has been linked with case US2018179264, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Skin warm, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 73-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In October 2018, the patient experienced hives and malaise. On an unknown date, the patient experienced pain in arm, skin warm, erythema of extremities and swelling arm. The patient was treated with (NOS) BENADRYL. On an unknown date, the outcome of the hives and malaise were not recovered/not resolved and the outcome of the pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the hives, pain in arm, injection site pain, skin warm, erythema of extremities and swelling arm to be related to SHINGRIX. The reporter considered the malaise to be related to SHINGRIX. Additional details were provided as follows: The reporter was a retired registered nurse who was also the patient in this report. The patient stated that she received the SHINGRIX on left arm approximately 10 days before the reporting date and soon after receiving the vaccine (unsure of exact timeline), she experienced swelling, redness, pain, and heat on her left arm. The patient stated that the space between her shoulder and her elbow was where the symptoms occurred and they resolved after several days in 2018. The patient stated that this area was hot to the touch. In 2018, approximately 10 days after receiving the vaccine, she started getting hives all over her body and started to experience malaise. She had taken BENADRYL twice, and stated that it might have helped but not enough for her to notice. The patient stated that she also experienced some injection site pain. She stated that as soon as the liquid went into her arm, she knew something was not right and stated that the fluid seemed very "active". She further stated that it felt like she received a live virus. The patient had denied permission to contact their physician. This case has been linked with case US2018179264, reported by the same reporter.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Swelling at injection sight and whole arm. Hand tingling. Followed up with patient on 10/6/18, he said he went to see his doctor, doctor did no treatment and suggested to wait the symptoms out.  Patient stated he was feeling better, less tingling and swelling.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Paraesthesia, Peripheral swelling
Clinical narrative: Swelling at injection sight and whole arm. Hand tingling. Followed up with patient on 10/6/18, he said he went to see his doctor, doctor did no treatment and suggested to wait the symptoms out.  Patient stated he was feeling better, less tingling and swelling.
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, feeling cold, feeling unwell and fever. On an unknown date, the outcome of the shivering, feeling cold, feeling unwell and fever were recovering/resolving. It was unknown if the reporter considered the shivering, feeling cold, feeling unwell and fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received SHINGRIX shot the day before the time of reporting. At that time, the pharmacist suggested that the patient also get the flu shot. On the day vaccination, in the night, the patient did not feel well at all. The patient was freezing and shivering. The patient did not check, but the he stated that he had a fever. The patient asked that was this par for the course, or should he be concerned. On the day of reporting the patient still did not feel great, but better than last night. The patient agreed to be contacted his physician for follow up and provided contact details of physician.
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, feeling cold, feeling unwell and fever. On an unknown date, the outcome of the shivering, feeling cold, feeling unwell and fever were recovering/resolving. It was unknown if the reporter considered the shivering, feeling cold, feeling unwell and fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received SHINGRIX shot the day before the time of reporting. At that time, the pharmacist suggested that the patient also get the flu shot. On the day vaccination, in the night, the patient did not feel well at all. The patient was freezing and shivering. The patient did not check, but the he stated that he had a fever. The patient asked that was this par for the course, or should he be concerned. On the day of reporting the patient still did not feel great, but better than last night. The patient agreed to be contacted his physician for follow up and provided contact details of physician.
Age: 78.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Product preparation issue
Clinical narrative: We only injected the patient with adjuvant suspension component.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Injection site pain, Pain
Clinical narrative: Alot of pain. Had shivers at night with bad headache. Site is painful even today. There is redness and swelling 1-2 inches.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Alot of pain. Had shivers at night with bad headache. Site is painful even today. There is redness and swelling 1-2 inches.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysphagia, Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: Flu like symptoms for 4 days, 102 fever, chills, body aches, sore throat unable to swallow. Diagnosed with strep throat in the medical aid unit on 10/3. Symptoms started within hours of taking flu shot. Influenza Quadrivalent Lot: FCVMDV252228.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngitis streptococcal, Pyrexia
Clinical narrative: Flu like symptoms for 4 days, 102 fever, chills, body aches, sore throat unable to swallow. Diagnosed with strep throat in the medical aid unit on 10/3. Symptoms started within hours of taking flu shot. Influenza Quadrivalent Lot: FCVMDV252228.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Headache, Vertigo
Clinical narrative: FEELING SWIMMY, VERIGO, HEADACHE.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided. On 13-SEP-2018, the patient was administered an improperly stored dose of RECOMBIVAX HB (1 dosage form (DF), lot# R004185, expiration date 06-NOV-2020; strength, frequency and route were not reported), and ROTATEQ (lot# R002516, expiration date 13-SEP-2019; strength, frequency and route were not reported) for prophylaxis. It was also reported that on that day, VAQTA (1DF; strength, frequency, lot#, expiration date and route were not reported), and GARDASIL 9 (1DF; strength, frequency, lot#, expiration date and route were not reported) were also administered for prophylaxis. The vaccines were exposed to the temperature excursion of 32 Fahrenheit (F) degree to 35 F degree (34 F degree) for 1 hour and 47 minutes. No adverse event was reported. The vaccine was noted OK for use. It was a temperature excursion fridge temperature was noted at 34 degrees. There was no previous temperature excursion. No data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from a medical assistant referring to about 12 infants of unknown age and gender. The patients' had taken their bottle. The patient's, medical history and concomitant therapies were not reported. On an unknown date in 2017 (reported as over the last year), the patients were vaccinated with ROTATEQ (dose, frequency lot number and expiration date were not reported) orally for prophylaxis. On an unknown date in 2017 (reported as over the last year), the patients' would vomit up the entire contents of the ROTATEQ. The outcome of the event was not provided. The causality for the event was not reported.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Information has been received from the patient's son referring to an elderly female patient of above age 65 years old. The patient's concomitant medication and drug reactions/allergies were not reported. The patient's pertinent medical history included completing chemotherapy for breast cancer in March 2017. In April 2017, a month after completing chemotherapy for breast cancer, the patient was vaccinated with PNEUMOVAX 23 (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. No specifics or symptoms were provided. The patient did not seek medical attention.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist concerning an unknown age female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-SEP-2018, the patient received a dose of improperly stored VARIVAX (0.5 ml, once, lot # N027627, expiration date 04-OCT-2019) subcutaneously for prophylaxis (incorrect product storage). Sterile diluent used for reconstitution of VARIVAX was properly stored. The vaccine was exposed to temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degree for 18 hours. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concomitant medications and drug reactions/allergies was not provided. On 07-SEP-2018, the patient was inadvertently administered improperly stored PROQUAD (lot # R002934, expired date 29-JUL-2019) for prophylaxis, which was reconstituted with properly stored sterile diluent (MERCK). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 46 minutes. Data logger was involved. The vaccine was previously exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 28 hours and 24 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 35 hours and 21 minutes.  No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA004377.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from the pharmacy student and refers to a 72-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included LUMIGAN, levothyroxine, liothyronine, COSOPT, fluticasone propionate, azelastine hydrochloride, cephalexin, phenazopyridine, ciprofloxacin, ondansetron, CHERATUSSIN AC, permethrin, meclizine, methylprednisolone, meloxicam, ketoconazole, amoxicillin, polyethylene glycol 3350 and ANUCORT. On 26-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the left arm (lot # R022232, expiration date: 16-APR-2020) for prophylaxis. On 27-SEP-2018, the patient called the pharmacy to report that the injection site was painful and warm to the touch and that the pain radiated from the injection site down her entire left arm and into her left hand. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 79 year old female patient regarding herself. Information on medical history was not provided. The patient had no drug allergies. The patient current condition included high blood pressure.Concomitant therapies included Lisinopril (manufacturer unknown). The patient stated that previously approximately in 2017 ("about a year ago") she had received a dose of PREVNAR 13. On 25-SEP-2018, the patient received an unspecified influenza virus vaccine inactivated (unspecified) (reported as "flu shot") in the morning at a pharmacy (full demographics not provided) and then returned to the same pharmacy in the evening around 17:00 to get a dose of PNEUMOVAX 23(dosing details, lot# and expiry date unknown by reporter) via intramuscular route for prevention of pneumococcal disease. It was reported that the same evening after receiving the PNEUMOVAX 23 vaccine she started to experienced "extreme heat and redness in the right arm (the site of the PNEUMOVAX 23 injection) which got worse at night and started spreading" and by approximately 27-SEP-2018 (reported as Thursday) at 11:00, it was so swollen that she could not move it and was applying ice bags and taking ibuprofen(manufacturer unknown) and went to the physician. The patient sought medical attention. The physician diagnosed cellulitis and prescribed cephalexin(manufacturer unknown) 500mg twice a day and sent the patient for an ultrasound to rule out a blood clot which was completed on 27-SEP-2018 and revealed no clot present. The physician instructed the patient to keep applying ice and to keep her arm elevated above her shoulder. The outcome of cellulitis was reported as recovering (reported as "on the following days it started to get better" but "it was not quite completely resolved").  Causality assessment for the event was not reported. No product quality complaint(PQC) was involved. Upon internal review, the event cellulitis was determined to be medically significant.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Ultrasound scan normal
Clinical narrative: This spontaneous report was received from a 79 year old female patient regarding herself. Information on medical history was not provided. The patient had no drug allergies. The patient current condition included high blood pressure.Concomitant therapies included Lisinopril (manufacturer unknown). The patient stated that previously approximately in 2017 ("about a year ago") she had received a dose of PREVNAR 13. On 25-SEP-2018, the patient received an unspecified influenza virus vaccine inactivated (unspecified) (reported as "flu shot") in the morning at a pharmacy (full demographics not provided) and then returned to the same pharmacy in the evening around 17:00 to get a dose of PNEUMOVAX 23(dosing details, lot# and expiry date unknown by reporter) via intramuscular route for prevention of pneumococcal disease. It was reported that the same evening after receiving the PNEUMOVAX 23 vaccine she started to experienced "extreme heat and redness in the right arm (the site of the PNEUMOVAX 23 injection) which got worse at night and started spreading" and by approximately 27-SEP-2018 (reported as Thursday) at 11:00, it was so swollen that she could not move it and was applying ice bags and taking ibuprofen(manufacturer unknown) and went to the physician. The patient sought medical attention. The physician diagnosed cellulitis and prescribed cephalexin(manufacturer unknown) 500mg twice a day and sent the patient for an ultrasound to rule out a blood clot which was completed on 27-SEP-2018 and revealed no clot present. The physician instructed the patient to keep applying ice and to keep her arm elevated above her shoulder. The outcome of cellulitis was reported as recovering (reported as "on the following days it started to get better" but "it was not quite completely resolved").  Causality assessment for the event was not reported. No product quality complaint(PQC) was involved. Upon internal review, the event cellulitis was determined to be medically significant.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blindness transient, Blood pressure decreased, Mydriasis, Nuclear magnetic resonance imaging, Pallor
Clinical narrative: Information has been received from a nurse via field employee, referring to a 17 year old male patient. The patient had multiple allergies to unspecified medication. Information of concomitant therapy and medical history was not provided. On 19-SEP-2018, the patient was vaccinated with a dose of MENACTRA, and then the second dose of GARDASIL 9 (dose unknown; lot # R002344 and expiration date 16-NOV-2020) intramuscularly for prophylaxis around 04:10pm.  In the 30 minutes after the dose of GARDASIL 9 was administered, the patient was fine. About 30 minutes later after the vaccination, the patient then turned gray (pallor), stated he couldn't see (blindness transient), his eyes became dilated (mydriasis) and his blood pressure dropped (blood pressure decreased).  The reporter worried he might have a seizure and called an ambulance who took the patient to the emergency room in a hospital, where he was admitted and had a magnetic resonance imaging (MRI) performed.  Results of the MRI were not known. In the following evening, the patient felt better and was discharged from the facility. The outcome of the events was reported as recovered. The causality between the events and GARDASIL 9 was not reported. Upon internal review, Blindness transient was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 53 year old female patient of an unknown race. The patient's concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that, on an unspecified date, the patient received a dose of ZOSTAVAX vial 19400 PFU subcutaneously (frequency, lot number and expiration date not reported) for prophylaxis. The physician reported that on an unspecified date, after the administration of ZOSTAVAX, the patient experienced a four to five inch area of significant redness and swelling on her arm. It was unknown if the subject sought for medical attention, if lab tests were performed or if she received treatment for the events. At the reporting time, the outcome of the events erythema and swelling arm was unknown. The causal relationship between the events and ZOSTAVAX was unknown.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning an elderly (in early 70's) female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 01-OCT-2017, the patient was vaccinated with PREVNAR 13 (dose, strength, frequency, route of administration, lot #, expiration date and indication were not provided). On 01-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, lot # reported as R018741, per intramuscular route (strength and expiration date were not provided) for prophylaxis. On an unspecified date in 2018, the patient went back and her arm was heavy swollen around the deltoid muscle and was slightly warm. The patient was recommended to take BENADRYL as treatment. It was unknown if laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The causality assessment between the heavy swollen and slightly warm with the suspect vaccines was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash generalised
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about September 2016, the patient was inoculated with ZOSTAVAX at a medical center for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient broke out with a rash on her arm that then spread throughout her entire body. In or about November 2016, she presented to her primary care physician who referred her to a Dermatologist. In or about December 2016, the patient was diagnosed with shingles by the Dermatologist. She was evaluated and diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, 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 were unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram, Cyanosis, Electrocardiogram, Eye movement disorder
Clinical narrative: This spontaneous report was received from a 23-year-old female patient (medical assistant), who was reporting on herself via a company representative. The patient's concurrent conditions and medical history were not reported. Her concomitant therapy included an unspecified vaccine. On 29-AUG-2018, the patient was vaccinated with a single dose of GARDASIL 9, intramuscularly for prevention on Human papillomavirus (HPV) (lot # N03595; expiration date 09-OCT-2020). On 27-SEP-2018, the patient experienced the event of seizure, which lasted 5 minutes. It was reported that her eyes rolled back, her lips turned blue, she had trouble speaking, and she was shaking. The patient sought medical attention. She was taken to an unspecified emergency room but was not admitted to the hospital. An unspecified treatment was given to the patient. Computerized tomography (CT) scan, electrocardiography (EKG) and an unspecified blood work were done, however, the results were not provided. Outcome of the event was not reported. Causality between the event of seizure and GARDASIL 9 was not provided. The event of seizure was determined to be life threatening by the reporter due to its duration and, upon internal review, it was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Speech disorder, Tremor
Clinical narrative: This spontaneous report was received from a 23-year-old female patient (medical assistant), who was reporting on herself via a company representative. The patient's concurrent conditions and medical history were not reported. Her concomitant therapy included an unspecified vaccine. On 29-AUG-2018, the patient was vaccinated with a single dose of GARDASIL 9, intramuscularly for prevention on Human papillomavirus (HPV) (lot # N03595; expiration date 09-OCT-2020). On 27-SEP-2018, the patient experienced the event of seizure, which lasted 5 minutes. It was reported that her eyes rolled back, her lips turned blue, she had trouble speaking, and she was shaking. The patient sought medical attention. She was taken to an unspecified emergency room but was not admitted to the hospital. An unspecified treatment was given to the patient. Computerized tomography (CT) scan, electrocardiography (EKG) and an unspecified blood work were done, however, the results were not provided. Outcome of the event was not reported. Causality between the event of seizure and GARDASIL 9 was not provided. The event of seizure was determined to be life threatening by the reporter due to its duration and, upon internal review, it was considered to be medically significant.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 63 year old female patient. The patient's concurrent conditions included high cholesterol, prediabetes, hypothyroidism, asthma, sulfa allergy, penicillin allergy and allergy to VIACIN. The patient's concomitant therapies included PROZAC, SYNTHROID, simvastatin, DETROL and vitamins (unspecified). Information regarding the patient's medical history was not reported. On 02-OCT-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R009162, expiration date 06-JAN-2020, intramuscular (dose and anatomical location were not provided), for prophylaxis. On the same date, hours after receiving the PNEUMOVAX 23, the patient experienced injection site swelling, hot to touch, fever, chills, pain and redness. It was reported that the patient sought medical attention, however the patient did not receive treatment for the events. No laboratory diagnostic studies were performed. It was reported that the improperly stored PNEUMOVAX 23 vaccine was exposed to a temperature of 32°F up to 35°F, during 10 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. The outcome of injection site erythema, injection site swelling, injection site warmth, pyrexia, chills and injection site pain was reported as not recovered/not resolved. The causality between the events and PNEUMOVAX 23 was not provided.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Product storage error, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 63 year old female patient. The patient's concurrent conditions included high cholesterol, prediabetes, hypothyroidism, asthma, sulfa allergy, penicillin allergy and allergy to VIACIN. The patient's concomitant therapies included PROZAC, SYNTHROID, simvastatin, DETROL and vitamins (unspecified). Information regarding the patient's medical history was not reported. On 02-OCT-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R009162, expiration date 06-JAN-2020, intramuscular (dose and anatomical location were not provided), for prophylaxis. On the same date, hours after receiving the PNEUMOVAX 23, the patient experienced injection site swelling, hot to touch, fever, chills, pain and redness. It was reported that the patient sought medical attention, however the patient did not receive treatment for the events. No laboratory diagnostic studies were performed. It was reported that the improperly stored PNEUMOVAX 23 vaccine was exposed to a temperature of 32°F up to 35°F, during 10 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. The outcome of injection site erythema, injection site swelling, injection site warmth, pyrexia, chills and injection site pain was reported as not recovered/not resolved. The causality between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of general body pain in a adult female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, pain in arm and gastrointestinal disorder. On an unknown date, the outcome of the general body pain, pain in arm and gastrointestinal disorder were unknown. It was unknown if the reporter considered the general body pain, pain in arm and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The reporter was a healthcare worker in a facility for medical coding, work as a certified nursing assistant (CNA) and was a nursing student, who was also the patient. The reporter asked if there was any average time delay before side effects on the second dose, for example 6 hours or 12 hours. The patient had noticeable side effects with the 1st dose. At the time of report, she worked and she needed to plan ahead. The reported called back and mentioned that, she experienced pain (body pain and arm aches), and gastrointestinal (GI) issues.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chronic pain in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (In 2004). Previously administered products included ZOSTAVAX (In 2007). Concurrent medical conditions included fibromyalgia (In 1991, due to trauma to the spine and she was treating her condition with alternative therapies). On 28th July 2018, the patient received the 1st dose of SHINGRIX. On 28th July 2018, less than a day after receiving SHINGRIX, the patient experienced chronic pain and tiredness. On an unknown date, the outcome of the chronic pain and tiredness were unknown. It was unknown if the reporter considered the chronic pain and tiredness to be related to SHINGRIX. Additional details were reported as follows: The night after the patient received the vaccine, she had pain from her head to her toes that was a 10 level. She could not open her eyes due to tiredness and rested all day on Sunday and Monday.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and malaise. On an unknown date, the outcome of the fever and malaise were recovered/resolved. It was unknown if the reporter considered the fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The physician casually reported that, they heard of a patient who experienced more severe symptoms of fever and malaise which lasted for 3 to 4 days. The healthcare professional wondered the occurrence of systemic adverse events and provided general statements of what he had heard in terms of patient experiences but did not had an adverse event to directly report. This case has been linked with US2018GSK181365, reported by the same reporter.
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upper back pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 26th September 2018, the patient received SHINGRIX .5 ml and Influenza vaccine Quadrivalent 2018-2019 season. In September 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced upper back pain. On an unknown date, the outcome of the upper back pain was not recovered/not resolved. It was unknown if the reporter considered the upper back pain to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The reported stated that she was having a lot of pain in her upper back. The pain started after she received the SHINGRIX and flu shot in the right arm 50 mcg the day before reporting. Flu shot received in left arm at the same time. The reporter was unsure of which flu vaccine was received. The reporter given permission to contact physician.