chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a 62-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. On 28th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain and fever. On 30th January 2019, the patient experienced pericarditis (serious criteria GSK medically significant) and chest pain. On an unknown date, the outcome of the pericarditis and chest pain were not recovered/not resolved and the outcome of the pain and fever were recovered/resolved. It was unknown if the reporter considered the pericarditis, pain, fever and chest pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. On the same day of vaccination in later evening, the patient developed a fever and aches. By Wednesday the patient was starting to feel better. On 30th January 2019, Wednesday night, 2 days after receiving SHINGRIX, the patient developed chest pains. On 31st January 2019 next morning, the patient went to see his doctor and they took him to the hospital.  The patient under went a heart catheterization and there were no major blockages or problems. The patient also got a electrocardiogram and heart sonogram and he was diagnosed with pericarditis.  The patient was still undergoing treatment for the condition and still gets some chest pains from time to time.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pericarditis, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a 62-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. On 28th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain and fever. On 30th January 2019, the patient experienced pericarditis (serious criteria GSK medically significant) and chest pain. On an unknown date, the outcome of the pericarditis and chest pain were not recovered/not resolved and the outcome of the pain and fever were recovered/resolved. It was unknown if the reporter considered the pericarditis, pain, fever and chest pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. On the same day of vaccination in later evening, the patient developed a fever and aches. By Wednesday the patient was starting to feel better. On 30th January 2019, Wednesday night, 2 days after receiving SHINGRIX, the patient developed chest pains. On 31st January 2019 next morning, the patient went to see his doctor and they took him to the hospital.  The patient under went a heart catheterization and there were no major blockages or problems. The patient also got a electrocardiogram and heart sonogram and he was diagnosed with pericarditis.  The patient was still undergoing treatment for the condition and still gets some chest pains from time to time.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 64-year-old male patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th February 2019, several hours after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), erythema and tenderness. On an unknown date, the outcome of the cellulitis, erythema and tenderness were recovering/resolving. It was unknown if the reporter considered the cellulitis, erythema and tenderness to be related to SHINGRIX. Additional details were provided as follows: The pharmacy intern reported that, the patient received Shingrix in right arm and a few hours later he experienced redness, tenderness and appearance of cellulits below the injection site but above the elbow. The events were improving but not resolved. It was believed that the patient had not notified his physician.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 64-year-old male patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th February 2019, several hours after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), erythema and tenderness. On an unknown date, the outcome of the cellulitis, erythema and tenderness were recovering/resolving. It was unknown if the reporter considered the cellulitis, erythema and tenderness to be related to SHINGRIX. Additional details were provided as follows: The pharmacy intern reported that, the patient received Shingrix in right arm and a few hours later he experienced redness, tenderness and appearance of cellulits below the injection site but above the elbow. The events were improving but not resolved. It was believed that the patient had not notified his physician.
Sex: U
Vaccine: PPV
Symptoms: Anaphylactic shock, Therapeutic product cross-reactivity
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, historical drugs, previous drug allergies/reactions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strenght, lot #, expiration date, dose, route and anatomical location were not reported) for prophylaxis. On an unknown date (reported as: "a long time ago"), after administration of the vaccine, the patient experienced anaphylactic shock that lasted for an unspecified amount of time. The outcome of the event anaphylactic shock was unknown. The reporter did not provide causality assessment between the event and PNEUMOVAX 23. Upon internal review, the event anaphylactic shock was determined to be medically significant. This is a non-valid case due to lack of patient identifiers. Follow-up information has been received from a health care professional, via Pfizer, on 11-FEB-2019. The patient was 48-year-old at the time of the event. It was reported that the patient had an anaphylactic reaction or a cross reaction (therapeutic product cross-reactivity) with PNEUMOVAX 23. The outcome of the events and the causal relationship between the events and PNEUMOVAX 23 were not reported. Upon internal review, the event therapeutic product cross-reactivity was determined to be medically significant. Upon receipt of follow-up information, it was determined that this case is now valid because patient's identifiers were provided. Upon internal clarification, it has been determined that the correct initial receipt date of the case is 11-FEB-2019, and not 13-FEB-2019 as initiallyreported. This is a new safety report with case # US-009507513-1902USA008473 has been created to reflect the correct initial receipt date. "US-009507513-1902USA008473" will be nullified. The correct WWID " US-PFIZERINC-US18011639" is referenced within this safety report and will be kept as the master case file.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Glossodynia, Stomatitis, Tongue discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ALTACE with an associated reaction of hypersensitivity (similar side effect on her tongue years ago). On 1st February 2019, the patient received the 1st dose of SHINGRIX 50 ug. On 3rd February 2019, 2 days after receiving SHINGRIX, the patient experienced swollen tongue, mouth ulcer and burning tongue. The patient was treated with Valacyclovir and prednisolone. On an unknown date, the outcome of the swollen tongue and burning tongue were not recovered/not resolved and the outcome of the mouth ulcer was recovered/resolved. The reporter considered the swollen tongue, mouth ulcer and burning tongue to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced a similar side effect on her tongue years ago when she tried ALTACE. Physicians at that time believed she developed an allergic reaction to ALTACE. The patient stated that the roof of mouth developed ulcers and tongue was swollen with a burning sensation. As neither issue improved over the next few days, on 7th February 2019, the patient went on to a physician who was associated with the ear nose and throat group. The physician prescribed Prednisolone as a mouth wash and Valacyclovir 1 gm tablets. The patient took both three times a day for a week. The patient had recovered from the ulcers, but was still experiencing the swollen and burning tongue. As it appeared SHINGRIX might be the cause or at least a contributing factor of the patient's ongoing problem. The patient would very much appreciate it if called.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mouth ulceration, Swollen tongue, Tongue discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ALTACE with an associated reaction of hypersensitivity (similar side effect on her tongue years ago). On 1st February 2019, the patient received the 1st dose of SHINGRIX 50 ug. On 3rd February 2019, 2 days after receiving SHINGRIX, the patient experienced swollen tongue, mouth ulcer and burning tongue. The patient was treated with Valacyclovir and prednisolone. On an unknown date, the outcome of the swollen tongue and burning tongue were not recovered/not resolved and the outcome of the mouth ulcer was recovered/resolved. The reporter considered the swollen tongue, mouth ulcer and burning tongue to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced a similar side effect on her tongue years ago when she tried ALTACE. Physicians at that time believed she developed an allergic reaction to ALTACE. The patient stated that the roof of mouth developed ulcers and tongue was swollen with a burning sensation. As neither issue improved over the next few days, on 7th February 2019, the patient went on to a physician who was associated with the ear nose and throat group. The physician prescribed Prednisolone as a mouth wash and Valacyclovir 1 gm tablets. The patient took both three times a day for a week. The patient had recovered from the ulcers, but was still experiencing the swollen and burning tongue. As it appeared SHINGRIX might be the cause or at least a contributing factor of the patient's ongoing problem. The patient would very much appreciate it if called.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose decreased, Dizziness, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: For 2 days, my left shoulder was mildly painful and very sensitive to touch. On the 3rd day, the pain was negligible. On the 4th day, I was standing at the reception desk and began to feel light headed. I am susceptible to low blood sugar and asked the receptionist for some hard candy. I used the candy and a glass of orange juice, and it took 30 minutes for me to feel well enough to complete the reservation change. I went to my room and felt completely drained of energy. I saw no improvement until the 7th day. I was able to drive home from the conference that I had paid to attend and which I missed entirely because I lacked the stamina to attend and fight the crowds.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Muscle aches, headache, Very sore arm where shot was given, Tired and weak. Generally feel bad all over. I hope it goes away soon.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches, headache, Very sore arm where shot was given, Tired and weak. Generally feel bad all over. I hope it goes away soon.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Erythema, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial pain, swelling, redness....especially in the left arm. The pain and swelling involved the entire upper arm to the elbow and shoulder area. Then the stiffness started in both shoulder joints...and pain. Nighttime pain waking up to not being able to move arms...as if locked to the sides of the body. Upon rising and with slow movement am able to get both arms somewhat mobile. Each and every day inflammation continues in the arms, shoulders and neck area. The inoculation area in both arms remains very noticeable. I have felt awful since receiving these inoculations.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Joint stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Initial pain, swelling, redness....especially in the left arm. The pain and swelling involved the entire upper arm to the elbow and shoulder area. Then the stiffness started in both shoulder joints...and pain. Nighttime pain waking up to not being able to move arms...as if locked to the sides of the body. Upon rising and with slow movement am able to get both arms somewhat mobile. Each and every day inflammation continues in the arms, shoulders and neck area. The inoculation area in both arms remains very noticeable. I have felt awful since receiving these inoculations.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an office manager referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history and drug/allergies reactions was not provided. On 22-JAN-2019, the patient received an expired dose of ROTATEQ (lot # N011651, expiration date 02-DEC-2018; frequency was not provided) orally for prophylaxis (expired product administered). No adverse effects were reported.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a female patient of one year old. There were no concomitant medications, drug reactions/allergies or pertinent medical history in regards to the patient. On 21-JAN-2019, the patient received a dose of M-M-R II (rHA) (lot#: R000557, expiration date: 8-JAN-2020; dosage and route not provided) along with sterile diluent for prophylaxis. On 22-JAN-2019, the patient developed hives. The reporter further reported that the patient was noted to have "hives all over" when seen by physician on 23-JAN-2019 and the patient was treated with "Hydroxyzine Hcl Oral", prescribed by the physician. No lab diagnostics were performed. The patient was currently not recovered. The causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot # R003293, expiration date 31-JUL-2019 for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute PROQUAD was properly stored. No adverse effects were reported. The vaccine was exposed to temperature excursion between minus 14 degree Celsius (C) and minus 10 degree C (average minus 12 degree C) for a time frame of 25.5 hours without previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter (MARRS # 1902USA006189). Sender's Comments: US-009507513-1902USA006189.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a nurse referring to a 60 years old female patient who was allergic to codeine. The patient's concomitant therapies included ZYRTEC, estradiol, COLACE and calcium. Concurrent conditions included diabetes mellitus, hypertension and hyperlipidemia. On 11-JAN-2019, the patient received one dose of PNEUMOVAX 23 (lot # R012550 and expiration date 25-JAN-2020) intramuscularly for prophylaxis. On 12-JAN-2019, the patient began experiencing blisters, redness and swelling at the injection site. The patient was treated with metronidazole cream (manufacturer unknown) and triamcinolone cream (manufacturer unknown) for the events. None of lab diagnostic/studies was performed. The patient sought medical attention and had physician visit. On 24-JAN-2019, the patient recovered from blisters, redness and swelling at the injection site. The causality between the events and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication, and drug reactions/allergies was not provided. On 06-FEB-2019, the patient was administered an expired dose of ROTATEQ (lot #: N01645, expiration date: 08-DEC-2018, strength, dose, and route were not reported) for prophylaxis (expired product administrated). No adverse effect was reported.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician and referring to a 2 months old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with 1 dose of VAQTA (lot # reported as R027431 and expiration date 08-SEP-2019; route of administration was not provided) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot #R006218, expiration date 28-AUG-2019 for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute PROQUAD was properly stored. No adverse effects were reported. The vaccine was exposed to temperature excursion between minus 14 degree Celsius (C) and minus 10 degree C (average minus 12 degree C) for a time frame of 25.5 hours without previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter (# 1901USA010583). Sender's Comments: US-009507513-1901USA010583.
Sex: F
Vaccine: HPVX
Symptoms: Muscle disorder, Wheelchair user
Clinical narrative: This spontaneous report was received from a nurse who was a friend of a patient's mother and refers to a female patient of unknown age (reported as "in her teens (years)"). The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an unidentified Merck human papillomavirus (HPV) vaccine (name, dose, route and site of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, reported as within 6 months after receiving the vaccine, the patient developed severe muscle problems. It was reported that as a result of the severe muscle problems the patient was currently confined to a wheelchair. The outcome of the event was unknown. The relatedness between the event and unspecified Merck HPV was not provided by the reporter. Additionally, a physician who examined the patient on an unknown date attributed the severe muscle problems to the unspecified Merck HPV vaccine. The event was considered as disabling.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash vesicular, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 month old male patient. The patient don't referred historical condition, concomitant medications and drug reactions or allergies. On 01-FEB-2019, the patient was vaccinated with VARIVAX for varicella, lot # N027619 and expiration date 04-OCT-2019 (dosage schedule, route, anatomical location were not reported). On 13-FEB-2019 (reported as today), the patient woke up with a chicken pox like rash from head to toe (varicella). No treatment was offered. On the same day. The patient's mother called to seek medical attention. Any laboratory diagnostics or studies was performed. On 18-FEB-2019, the patient recovered from varicella. The causality between varicella VARIVAX was unknown.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Leukaemia
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative referring to a 20 year old male patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9, 0.5 mL dose,  second dose, for prophylaxis (anatomical location, route of administration, lot # and expiration date were not reported). On an unknown date (reported as 6 weeks later), the patient was diagnosed with leukemia. It was unknown if the patient received treatment for the event. The outcome of the event was reported as not recovered. No causality assessment was provided. Upon internal review, leukemia was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 66 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-AUG-2016, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 72 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2016, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). In December 2016, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 75 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-MAY-2014, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On or about 06-MAR-2017, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 64 year old male. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-JUL-2012, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On or about 06-OCT-2015, the patient was treated by a by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-MAR-2017, at 80 years of age, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (strength, dose, route were not reported) lot # R017640, expiration date 20-JUN-2020, for prophylaxis. No adverse effect were reported. Administered dose experienced temperature of excursion of -4.8 degrees Celsius for 13 hours 12 minutes. Previous temperature excursion of -1.5 degrees Celsius for 5 hours 41 minutes. Digital data logger was involved. This is one of 3 reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was experiencing all of the side effects of the vaccine. The patient was asking was there anything she should do or would the side effects wear off soon.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of painful rash in a 55-year-old female 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 painful rash and influenza-like symptoms. On an unknown date, the outcome of the painful rash was unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the painful rash and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient developed painful rash on side of body after administration of SHINGRIX. Rash duration was 2 to 3 days. The patient had mild flu like symptoms for several days.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 1st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st April 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain. On 2nd April 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm. The batch number and expiry date were not available. The patient experienced pain 6 to 8 hours after vaccination and that went away a day later. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait inability, Headache, Neck pain, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shingles. Concomitant products included acyclovir. On 30th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 30th January 2019, less than a day after receiving SHINGRIX, the patient experienced chills. On 31st January 2019, the patient experienced tremor and unable to walk. On an unknown date, the patient experienced headache and neck pain. The patient was treated with lorazepam. On an unknown date, the outcome of the chills, headache, neck pain and unable to walk were unknown and the outcome of the tremor was not recovered/not resolved. It was unknown if the reporter considered the chills, tremor, headache, neck pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX at night, the patient experienced chills when going to sleep. The next morning the patient got up and experienced tremors that progressed to the point where she could not walk and was taken by ambulance to emergency room (ER) around 12:30 PM the next day. The patient was not admitted to hospital and was prescribed Lorazepam and sent home. Less than a month after receiving SHINGRIX, the patient had developed severe headache and neck pain as well related to the tremors. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain 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, several weeks after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had soreness at injection site weeks after SHINGRIX vaccination. The caller could not provide any details about the patient or the vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 13th February 2019 20:30, the patient received the 2nd dose of SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced shivering, tremor and fever. On an unknown date, the outcome of the shivering, tremor and fever were not recovered/not resolved. It was unknown if the reporter considered the shivering, tremor and fever to be related to SHINGRIX. Additional details were provided as follows: In the morning of 14th February 2019, the patient had shivering, shaking and low grade fever. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old male 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 fever and chills. On an unknown date, the outcome of the fever was resolved with sequelae and the outcome of the chills was recovering/resolving. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was a contractor for GlaxoSmithKline and she works in research. The age at vaccination was not reported. The pharmacist told her that he had chills and fever when he had the first dose of SHINGRIX about a year before the date of reporting in 2018. The patient received the 2nd dose of SHINGRIX but reported side effects with the 1st dose. The reporter did not have any additional details on this report. The reporter heard about this at time of reporting. This case has been linked to the case US2019027654, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old 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 fever and chills. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the chills was resolved with sequelae. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was a contractor for GlaxoSmithKline and she works in research. The age at vaccination was not reported. The pharmacist told her that his wife developed the same symptoms after the 1st dose of SHINGRIX about a year before the date of reporting in 2018. The patient received the 2nd dose of SHINGRIX but reported side effects with the 1st dose. The reporter did not have any additional details on this report. The reporter heard about this at time of reporting. This case has been linked to the case US2019027650, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site cellulitis, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 59-year-old female patient who received SHINGRIX (batch number 9277N, expiry date unknown) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site cellulitis, intramuscular formulation administered by other route and wrong injection technique. On an unknown date, the outcome of the injection site cellulitis, intramuscular formulation administered by other route and wrong injection technique were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the reporter's fellow pharmacist. The age at vaccination was reported. The pharmacy administered SHINGRIX to a patient too low in the left arm, which led to wrong injection technique. The pharmacy thought that, the dose was given subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. After vaccination, the patient experienced cellulitis in the left arm, which the pharmacist believed that was related to the injection technique, but could not be sure of causality. The reported batch number (92779) for SHINGRIX did not exist and was updated to 9277N, according to sales datasheet.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis 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 as adult as per vaccine indication. The patient developed cellulitis after receiving SHINGRIX. The reporter was unsure of the dose number. The reporter did not see the patient or reaction. The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: From waking up the next day, until waking up this morning (-2/22/19), have been unable to lift my left arm. Beginning around 10 am on 02/20, I began having chills and aches all over. By time I got home from work, I had and maintained a fever reaching up to just over 102 until about 4 pm on 02/21, when it finally returned to a normal range.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Limb discomfort, Muscular weakness, Pain in extremity, Pneumonia
Clinical narrative: Pt states experienced weakness and pain in right arm. Unable to raise arm overhead. She also developed pneumonia after the shot, for which she was treated as with levofloxacin, not hospitalized. Still feels weakness and discomfort in right arm as of report date. Saw MD for PNA.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Large rash on entire back (both sides), developed 16 hours post-administration. Does not hurt.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Muscular weakness, Pain, Pyrexia, Somnolence
Clinical narrative: Extreme soreness on injection site, fever/weakness in legs. Pain all over body. Cannot walk without assistance. Cannot stay awake.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Walking aid user
Clinical narrative: Extreme soreness on injection site, fever/weakness in legs. Pain all over body. Cannot walk without assistance. Cannot stay awake.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient states that the evening after receiving the vaccine, his entire upper arm became inflamed and painful. The next day the redness grew in size around the injection site. It was also very painful. He presented to pharmacy on 02/20/19 and said that by the second day, the pain had subsided mostly, but he still felt the adverse event needed to be reported. His wife received vaccine at same time with no issue.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: 2/13-rec'd vaccine in left deltoid; 2/16-pain in left side of neck, developed blistery lines there which then crusted over; 2/17-felt ball-like area at injection site which also developed blistery bumps and felt hot; no documented fever; 2/21-redness and itchiness left neck, shoulder and arm; blistery bumps over deltoid.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pruritus, Rash vesicular, Scab
Clinical narrative: 2/13-rec'd vaccine in left deltoid; 2/16-pain in left side of neck, developed blistery lines there which then crusted over; 2/17-felt ball-like area at injection site which also developed blistery bumps and felt hot; no documented fever; 2/21-redness and itchiness left neck, shoulder and arm; blistery bumps over deltoid.
Age: 21.0
Sex: F
Vaccine: FLU4, MENB, PPV
Symptoms: Discomfort, Erythema, Fatigue, Skin warm, Tenderness
Clinical narrative: Patient reported redness to the R) arm with warmth and tenderness as well as fatigue2/20/19.  Sent message to provider with picture on 2/22/19. Provider recommended ice, rest, Tylenol for the discomfort, follow up with clinic if it worsens or a fever develops.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Flu mist given after it expired.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Skin exfoliation
Clinical narrative: The patient experienced swelling of the arm, fever, and peeling of the skin. They began the day after receiving the vaccine and lasted for several weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-FEB-2010, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose on an unknown date). 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 influenza-like symptoms and muscle pain. On an unknown date, the outcome of the influenza-like symptoms and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX 3 months after 1st dose of SHINGRIX and experienced muscle ache and flu like symptoms. The reporter wanted to know how long should side effects last.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Nasal congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose on an unknown date). 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 influenza-like symptoms and muscle pain. On an unknown date, the outcome of the influenza-like symptoms and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX 3 months after 1st dose of SHINGRIX and experienced muscle ache and flu like symptoms. The reporter wanted to know how long should side effects last.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 78-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in November 2018, refer case US2019GSK029754). On 9th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 10th February 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, nasal congestion, chills and feeling miserable. On an unknown date, the outcome of the influenza-like symptoms, nasal congestion, chills and feeling miserable were recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, nasal congestion, chills and feeling miserable to be related to SHINGRIX. Additional details were received as follows: Prior to 12:00 noon, the patient was vaccinated with SHINGRIX vaccine. The patient experienced flu like symptoms, including, nasal congestion, occasional chills and feeling miserable. These symptoms were resolving and the patient could function at the time of reporting. The reporter did not consent to follow up. The reporter was unable to obtain additional information.