chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date in December 2018, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N012134, expiration date 17-APR-2019 (exact dose, frequency and route of administration were not reported) for prophylaxis. The suspect therapy was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 15 to 46 degrees Fahrenheit (also reported as 24.6 degrees Fahrenheit) for 4 hours. Data logger was involved. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a a registered nurse via company representative referring to 3 unspecified adult patients of unknown gender and reported as in their 20's. The patients' concurrent conditions, medical hisory, drug allergies and concomitant therapies were unknown by the reporter. On an unspecified date, the patients were vaccinated with VARIVAX (strength, dose, frequency, lot number and expiration date were not provided) as prophylaxis.      Within the next 24 hours from VARIVAX administration,  the 3 patients experienced cellulitis. Two of them were vaccinated with the same unspecified lot number and the other patient received a different unspecified lot number. The patients sought medical attention and the reporter stated that one of the patients received 2 rounds of unspecified oral antibiotics followed by an unspecified intravenous antibiotic. It was unknown which treatments did the other two patients receive and if laboratory diagnostic or studies were performed. At the reporting time, the patients had recovered from cellulitis. Relatedness between the event of cellulitis and VARIVAX was not provided. Upon internal review the event of cellulitis was found to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-DEC-2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a nursing and rehabilitation center. On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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-MAY-2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a hospital pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 19-SEP-2011, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a healthcare provider at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider at a clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Vaginal mucosal blistering
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaginal mucosal blistering in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included immunocompromised and rheumatoid arthritis (RA). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced vaginal mucosal blistering and shingles. On an unknown date, the outcome of the vaginal mucosal blistering and shingles were not reported. It was unknown if the reporter considered the vaginal mucosal blistering and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced vesicles around vaginal area 1 week of 1st dose. The patient experienced shingles after an unspecified period of time from the 1st dose of SHINGRIX. The reporter agreed to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mastectomy (on left side). On 6th March 2019, the patient received SHINGRIX. In March 2019, several hours after receiving SHINGRIX, the patient experienced sickness, pain in arm, swelling arm and swelling. On an unknown date, the outcome of the sickness, pain in arm, swelling arm and swelling were unknown. It was unknown if the reporter considered the sickness, pain in arm, swelling arm and swelling to be related to SHINGRIX. Additional details were provided as follows: In the afternoon, the patient was received SHINGRIX on an unknown deltoid. The patient woke up sick on 7th March 2019, with an very severe pain in upper arm, it hurt to even move it. The patient asked if she could use heat or ice or Lidocaine patch. The patient arm and chest were swollen too. The patient called her healthcare provider and the healthcare provider advised her to come in if it gets worse. The patient had mastectomy on left side so it was likely lymphedema.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Dermatitis, Inflammation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hair loss and dermatitis. On an unknown date, the outcome of the hair loss and dermatitis were unknown. It was unknown if the reporter considered the hair loss and dermatitis to be related to SHINGRIX. Additional details were provided as follows: The patient had two shingles vaccines two months apart. After 2nd dose, the patient has expressed scalp inflammation and hair loss. The reporter was not seeing scalp inflammation or hair loss listed as an expected side effect based on clinical trial data. The patient had a return appointment with her dermatologist. The patient not totally sure that she received SHINGRIX vaccine or another Shingles vaccine from market. The patient was required to get two and it was ordered by her primary care physician. The patient had to get injections from her pharmacist. The reporter said that it probably was SHINGRIX but perhaps there was a receipt that the patient might have that you can confirm or some other paperwork from the pharmacy nearby. The patient was traveling at the time of reporting. The patient asked that, should be able to get the answer within an hour.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Eczema, Erythema, Herpes zoster, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 1st February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced shingles, erythema, pruritus and eczema. On an unknown date, the outcome of the shingles, erythema, pruritus and eczema were not recovered/not resolved. It was unknown if the reporter considered the shingles, erythema, pruritus and eczema to be related to SHINGRIX. Additional details were reported as follows: After receiving SHINGRIX, few days to a week later the patient had itching, red, eczema looking areas on his face, mostly the left but also on the right. He also had it on both arms and shoulders. The patient states that it looks possibly like shingles but he has never had shingles.  The patient did not receive the previous shingles vaccine on the market, he has had chickenpox but never had shingles. At the time of report, he was getting worse now, but he has not been to a physician about this issue yet. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 2nd March 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 3rd March 2019, 1 days after receiving SHINGRIX, the patient experienced fever and chills. On 4th March 2019, the patient experienced swelling arm. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved.  It was unknown if the reporter considered the fever, chills and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The pharmacist reported the patient had fever and chills and at the time of reporting had swelling or a large circular bump three inches below the injection site. The reporter stated she thought that the fever and chills were started the next day following the injection, but they have resolved. The reporter did not know when they resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, pain in arm, swelling arm, nausea, vomiting and general body pain. On an unknown date, the outcome of the fever, pain in arm, swelling arm, nausea, vomiting and general body pain were unknown. It was unknown if the reporter considered the fever, pain in arm, swelling arm, nausea, vomiting and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, arm swelling and pain, nausea, vomiting, and body aches after receiving SHINGRIX. The health care professional was not at her office and could not provide full patient details or lot number and expiration date of the product.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, pain in arm, swelling arm, nausea, vomiting and general body pain. On an unknown date, the outcome of the fever, pain in arm, swelling arm, nausea, vomiting and general body pain were unknown. It was unknown if the reporter considered the fever, pain in arm, swelling arm, nausea, vomiting and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, arm swelling and pain, nausea, vomiting, and body aches after receiving SHINGRIX. The health care professional was not at her office and could not provide full patient details or lot number and expiration date of the product.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Asthenia, Blood pressure increased, Decreased appetite, Depression
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of bloating in a 53-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 4ZY53, expiry date 30th June 2019) for prophylaxis. The patient's past medical history included chronic leukemia (was stable until 2 weeks after she received the flu vaccine.). Previously administered products included Amoxicilin (received in the past with no problems) and antidepressant (received unnamed antidepressants in the past with no problems). On 16th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In November 2018, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced depression and rash. In February 2019, the patient experienced weakness and sinus infection. On an unknown date, the patient experienced bloating, tissue puffing and anorexia. The patient was treated with amoxicillin trihydrate (Amoxicilline) and azithromycin (Z-Pak). On an unknown date, the outcome of the bloating, tissue puffing, anorexia, depression, rash, weakness and sinus infection were unknown. It was unknown if the reporter considered the bloating, tissue puffing, anorexia, depression, rash, weakness and sinus infection to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: On the date of reporting, the patient notified to her manager that she was going to see a specialist for adverse events that she experienced due to the vaccine. The vaccine was administered at an offsite campus on left deltoid. The reporter called the patient and knew that she was on the way to MD to be evaluated. The patient experienced bloating, puffiness, anorexia and no appetite. In November 2018, she had depression issues. and was prescribed with an unnamed antidepressant, but this time her blood pressure shot up and she developed a rash on her arms. Three weeks before the date of reporting, she had a sinus infection and was prescribed Amoxicillin, She has now been prescribed a ZPAC and she was weak and had abnormal white blood count, but had no itching or abdominal pain. The patient had not received any flu vaccine since 10 to 15 years. This case was reported by a nurse via call center representative and described the occurrence of bloating in a 53-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 4ZY53, expiry date 30th June 2019) for prophylaxis.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Sinusitis, Swelling, White blood cell count abnormal
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of bloating in a 53-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 4ZY53, expiry date 30th June 2019) for prophylaxis. The patient's past medical history included chronic leukemia (was stable until 2 weeks after she received the flu vaccine.). Previously administered products included Amoxicilin (received in the past with no problems) and antidepressant (received unnamed antidepressants in the past with no problems). On 16th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In November 2018, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced depression and rash. In February 2019, the patient experienced weakness and sinus infection. On an unknown date, the patient experienced bloating, tissue puffing and anorexia. The patient was treated with amoxicillin trihydrate (Amoxicilline) and azithromycin (Z-Pak). On an unknown date, the outcome of the bloating, tissue puffing, anorexia, depression, rash, weakness and sinus infection were unknown. It was unknown if the reporter considered the bloating, tissue puffing, anorexia, depression, rash, weakness and sinus infection to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: On the date of reporting, the patient notified to her manager that she was going to see a specialist for adverse events that she experienced due to the vaccine. The vaccine was administered at an offsite campus on left deltoid. The reporter called the patient and knew that she was on the way to MD to be evaluated. The patient experienced bloating, puffiness, anorexia and no appetite. In November 2018, she had depression issues. and was prescribed with an unnamed antidepressant, but this time her blood pressure shot up and she developed a rash on her arms. Three weeks before the date of reporting, she had a sinus infection and was prescribed Amoxicillin, She has now been prescribed a ZPAC and she was weak and had abnormal white blood count, but had no itching or abdominal pain. The patient had not received any flu vaccine since 10 to 15 years. This case was reported by a nurse via call center representative and described the occurrence of bloating in a 53-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 4ZY53, expiry date 30th June 2019) for prophylaxis.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 61-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, unknown after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient could be 60 or 61 years old. The batch number and expiry date for SHINGRIX was not reported. The patient experienced a local non-allergic reaction (an injection site thing). The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Pain, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 2nd March 2019, the patient received the 1st dose of SHINGRIX. On 3rd March 2019, 1 days after receiving SHINGRIX, the patient experienced pain and erythema. On 5th March 2019, the patient experienced swelling, skin warm and injection site bruising. On an unknown date, the outcome of the pain, erythema, swelling, skin warm and injection site bruising were unknown. It was unknown if the reporter considered the pain, erythema, swelling, skin warm and injection site bruising to be related to SHINGRIX. Additional details were provided as follows. The patient received SHINGRIX in the left deltoid. The next day of vaccination the patient had soreness that was more than expected normal she stated to pharmacist. The patient also had redness below the injection site, so she marked the redness. The area of redness was larger, swollen and hot. The area of redness was about 5.5 inches down from the injection site itself. The reporter stated there was bruising at the site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hyperaesthesia, Papule, Rash papular, Rash vesicular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a elderly female patient who received SHINGRIX (batch number JE45P, expiry date 29th May 2021) for prophylaxis. Concomitant products included SHINGRIX. On 22nd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister. On an unknown date, the outcome of the vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister were recovered/resolved. It was unknown if the reporter considered the vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister to be related to SHINGRIX. Additional details were provided as follows: On 11th December 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX in her left arm. One to two days after receiving the 2nd dose of vaccine, the patient broke out in a vesicular rash in her right antecubital. The rash had persistent burning and hypersensitivity to touch. The blisters became papules then resolved 4 to 5 days later.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a elderly female patient who received SHINGRIX (batch number JE45P, expiry date 29th May 2021) for prophylaxis. Concomitant products included SHINGRIX. On 22nd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister. On an unknown date, the outcome of the vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister were recovered/resolved. It was unknown if the reporter considered the vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister to be related to SHINGRIX. Additional details were provided as follows: On 11th December 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX in her left arm. One to two days after receiving the 2nd dose of vaccine, the patient broke out in a vesicular rash in her right antecubital. The rash had persistent burning and hypersensitivity to touch. The blisters became papules then resolved 4 to 5 days later.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling. On an unknown date, the outcome of the nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling were recovered/resolved. It was unknown if the reporter considered the nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling to be related to SHINGRIX. Additional case details were provided as follows: The next day after vaccination, the patient experienced nausea, fever, tiredness, headache, muscle aches, body aches and felt lightheaded. These symptoms were lasted one day before resolving. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling. On an unknown date, the outcome of the nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling were recovered/resolved. It was unknown if the reporter considered the nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling to be related to SHINGRIX. Additional case details were provided as follows: The next day after vaccination, the patient experienced nausea, fever, tiredness, headache, muscle aches, body aches and felt lightheaded. These symptoms were lasted one day before resolving. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX (batch number T73K2, expiry date unknown) for prophylaxis. On 6th March 2019 18:10, the patient received SHINGRIX. On 6th March 2019 22:00, 3 hrs 50 min after receiving SHINGRIX, the patient experienced fever, chills, nausea and injection site pain. In March 2019, the outcome of the fever, chills, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, chills, nausea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine into the left deltoid. The pharmacist stated that the side effects resolved late the night before the day of reporting.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Autoimmune disorder, C-reactive protein increased, Inflammatory marker increased, Movement disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 83-year-old female patient who received SHINGRIX for prophylaxis.  On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, 7 days after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant), systemic sclerosis sine scleroderma (serious criteria GSK medically significant), sjogren's syndrome (serious criteria GSK medically significant), pain in hand, swelling, stiffness, tingling and movement disorder. On 23rd December 2018, the patient experienced inflammatory marker increased and c-reactive protein increased. In January 2019, the patient experienced antinuclear antibody positive. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, swelling, stiffness, tingling, inflammatory marker increased and c-reactive protein increased were unknown and the outcome of the pain in hand was not recovered/not resolved and the outcome of the movement disorder was recovering/resolving. It was unknown if the reporter considered the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, pain in hand, swelling, stiffness, tingling, movement disorder, inflammatory marker increased and c-reactive protein increased to be related to SHINGRIX. Additional details were provided as follows: A week later after receiving SHINGRIX, the patient woke up with swollen, painful hands, difficult to make a fist and her fingers tingling and stiff. The patient had seen her physician at the office and was also seen at an urgent care on 23rd December 2018 for these issues. At the first visit, blood tests were drawn that showed antinuclear antibody (ANA) negative, elevated inflammatory markers at 56 with a normal at 40 and C-reactive protein of 14.9 and normal at 4.9. Two weeks later, the patient had blood test which showed antinuclear antibody (ANA) positive. The patient had paperwork which showed autoimmune disorder, systemic sclerosis sine scleroderma and Sjogren's syndrome. The patient received Prednisone as a treatment for the pain. The patient was taking physical therapy for her hands. The patient had been referred to a Rheumatologist and that appointment was on 13th March 2019. The blood test for rheumatoid arthritis came back negative. The reporter consented for follow up. Lab Comments: On an unknown date, the patient performed blood test for rheumatoid arthritis.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Peripheral swelling, Rheumatoid factor negative
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 83-year-old female patient who received SHINGRIX for prophylaxis.  On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, 7 days after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant), systemic sclerosis sine scleroderma (serious criteria GSK medically significant), sjogren's syndrome (serious criteria GSK medically significant), pain in hand, swelling, stiffness, tingling and movement disorder. On 23rd December 2018, the patient experienced inflammatory marker increased and c-reactive protein increased. In January 2019, the patient experienced antinuclear antibody positive. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, swelling, stiffness, tingling, inflammatory marker increased and c-reactive protein increased were unknown and the outcome of the pain in hand was not recovered/not resolved and the outcome of the movement disorder was recovering/resolving. It was unknown if the reporter considered the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, pain in hand, swelling, stiffness, tingling, movement disorder, inflammatory marker increased and c-reactive protein increased to be related to SHINGRIX. Additional details were provided as follows: A week later after receiving SHINGRIX, the patient woke up with swollen, painful hands, difficult to make a fist and her fingers tingling and stiff. The patient had seen her physician at the office and was also seen at an urgent care on 23rd December 2018 for these issues. At the first visit, blood tests were drawn that showed antinuclear antibody (ANA) negative, elevated inflammatory markers at 56 with a normal at 40 and C-reactive protein of 14.9 and normal at 4.9. Two weeks later, the patient had blood test which showed antinuclear antibody (ANA) positive. The patient had paperwork which showed autoimmune disorder, systemic sclerosis sine scleroderma and Sjogren's syndrome. The patient received Prednisone as a treatment for the pain. The patient was taking physical therapy for her hands. The patient had been referred to a Rheumatologist and that appointment was on 13th March 2019. The blood test for rheumatoid arthritis came back negative. The reporter consented for follow up. Lab Comments: On an unknown date, the patient performed blood test for rheumatoid arthritis.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Sjogren's syndrome, Systemic scleroderma
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 83-year-old female patient who received SHINGRIX for prophylaxis.  On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, 7 days after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant), systemic sclerosis sine scleroderma (serious criteria GSK medically significant), sjogren's syndrome (serious criteria GSK medically significant), pain in hand, swelling, stiffness, tingling and movement disorder. On 23rd December 2018, the patient experienced inflammatory marker increased and c-reactive protein increased. In January 2019, the patient experienced antinuclear antibody positive. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, swelling, stiffness, tingling, inflammatory marker increased and c-reactive protein increased were unknown and the outcome of the pain in hand was not recovered/not resolved and the outcome of the movement disorder was recovering/resolving. It was unknown if the reporter considered the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, pain in hand, swelling, stiffness, tingling, movement disorder, inflammatory marker increased and c-reactive protein increased to be related to SHINGRIX. Additional details were provided as follows: A week later after receiving SHINGRIX, the patient woke up with swollen, painful hands, difficult to make a fist and her fingers tingling and stiff. The patient had seen her physician at the office and was also seen at an urgent care on 23rd December 2018 for these issues. At the first visit, blood tests were drawn that showed antinuclear antibody (ANA) negative, elevated inflammatory markers at 56 with a normal at 40 and C-reactive protein of 14.9 and normal at 4.9. Two weeks later, the patient had blood test which showed antinuclear antibody (ANA) positive. The patient had paperwork which showed autoimmune disorder, systemic sclerosis sine scleroderma and Sjogren's syndrome. The patient received Prednisone as a treatment for the pain. The patient was taking physical therapy for her hands. The patient had been referred to a Rheumatologist and that appointment was on 13th March 2019. The blood test for rheumatoid arthritis came back negative. The reporter consented for follow up. Lab Comments: On an unknown date, the patient performed blood test for rheumatoid arthritis.
Age: 39.0
Sex: F
Vaccine: FLUR3, HIBV, MENB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old female patient who received vaccine ACT-HIB that was reconstituted without the diluent provided (lot UJ055AA, expiry date 17-Nov-2020) via intramuscular route in the gluteal muscle on 04-Mar-2019 prior to a splenectomy. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BEXSERO; and FLUBLOK 0.5 ml on the same day. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who received an expired dose of ADACEL lot U5593AA, expiry date: 07-Mar-2019 via intramuscular route in the left deltoid on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was MENACTRA. It was an actual medication error due to expired vaccine used. Nurse manager stated that they used an expired ADACEL on a patient and states that it is so tiny so she needed a minute to read it. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a physician's assistant. This case involves a 74 years old male patient who received a 0.5 ml of ADACEL, lot C5577AA via intramuscular route in unknown administration site, on 10-Mar-2019 as prescribed by the physician's assistant. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate age at vaccine administration and product prescribing error. It was reported that the caller had written orders for a patient who was 74 years old to receive a ADACEL vaccination. Received an IM, of 0.5ml ADACEL, in the right arm on 3/10/2019 by, from a multi-dose vial. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DT
Symptoms: Allergy to vaccine, Rash
Clinical narrative: Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer). This case involves patient (with unknown age and gender) who experienced allergy to tetanus and diphtheria toxoids, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus and diphtheria toxoids (allergy to vaccine) with unknown latency following the administration of DIPHTHERIA AND TETANUS TOXOIDS. On an unknown date, the patient developed a non-serious rash with unknown latency following the administration of DIPHTHERIA AND TETANUS TOXOIDS. Lab data was not provided. Final diagnosis was allergy to tetanus and diphtheria toxoids. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus and diphtheria toxoids and as Unknown for rash. Documents held by the sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who received expired dose of vaccine MENACTRA (lot number: U5839AA, expiry date: 05-Mar-2019) (dose, dose in series, route not reported) in left deltoid on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient had any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none. Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who received expired dose of vaccine MENACTRA (lot number: U5839AA, expiry date: 05-Mar-2019) (dose, dose in series, route not reported) in left deltoid on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient had any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 46 years old male patient who was vaccinated with 0.5 ml dose of DAPTACEL (Batch number: C5190AA and expiry date: 11-Apr-2019) via intramuscular route in the right deltoid on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of FLUZONE QUADRIVALENT. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ, VARCEL
Symptoms: Differential white blood cell count, Full blood count, Vomiting
Clinical narrative: Vomiting.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Skin mass
Clinical narrative: Erythematous nodule which now progressed to a 0.5 cm mobile nodule.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Neck pain, Pain in jaw
Clinical narrative: Severe pain and swelling in L shoulder going across neck and up into jaw. Still there after 4 days. Can't lift L arm.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: Severe pain and swelling in L shoulder going across neck and up into jaw. Still there after 4 days. Can't lift L arm.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Bone pain, Dizziness, Dysphonia, Initial insomnia
Clinical narrative: Severe pain and swelling in L shoulder going across neck and up into jaw. Still there after 4 days. Can't lift L arm.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Musculoskeletal pain, Neck pain
Clinical narrative: Severe pain and swelling in L shoulder going across neck and up into jaw. Still there after 4 days. Can't lift L arm.