chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 64-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date 8th February 2019) for prophylaxis. On 24th August 2018 15:30, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced malaise, influenza-like symptoms, injection site erythema, headache, injection site warmth and injection site tenderness. In August 2018, the outcome of the malaise, influenza-like symptoms and headache were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tenderness were recovering/resolving. It was unknown if the reporter considered the malaise, influenza-like symptoms, injection site erythema, headache, injection site warmth and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient developed malaise, headaches, flu like symptoms and an injection site reaction described as a big red splotch approximately 5 to 6 inches in diameter that was warm and painful to the touch. This case is linked with US2018155165, reported by same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 64-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date 8th February 2019) for prophylaxis. On 24th August 2018 15:30, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced malaise, influenza-like symptoms, injection site erythema, headache, injection site warmth and injection site tenderness. In August 2018, the outcome of the malaise, influenza-like symptoms and headache were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tenderness were recovering/resolving. It was unknown if the reporter considered the malaise, influenza-like symptoms, injection site erythema, headache, injection site warmth and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient developed malaise, headaches, flu like symptoms and an injection site reaction described as a big red splotch approximately 5 to 6 inches in diameter that was warm and painful to the touch. This case is linked with US2018155165, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a male patient who received SHINGRIX for prophylaxis. On 24th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced malaise, influenza-like symptoms and headache. In August 2018, the outcome of the malaise, influenza-like symptoms and headache were recovered/resolved. It was unknown if the reporter considered the malaise, influenza-like symptoms and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case is linked with US2018155164, reported by same reporter.
Sex: U
Vaccine: MENB
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced influenza-like symptoms, headache, fatigue, respiratory tract congestion, fever and weakness. On an unknown date, the outcome of the influenza-like symptoms, headache, fatigue, respiratory tract congestion, fever and weakness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, fatigue, respiratory tract congestion, fever and weakness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that on the same day of vaccination patient experienced flu like symptoms, high fever of 101 degrees F, weakness, fatigue, congested and headache. The patient completely recovered within 1 to 2 business days. The patient had only completed one dose of the BEXSERO. The patient was put on Intravenous medication. No further details were provided. Lab Comments: Lab test was done on an unspecified date.
Sex: U
Vaccine: MENB
Symptoms: Respiratory tract congestion
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced influenza-like symptoms, headache, fatigue, respiratory tract congestion, fever and weakness. On an unknown date, the outcome of the influenza-like symptoms, headache, fatigue, respiratory tract congestion, fever and weakness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, fatigue, respiratory tract congestion, fever and weakness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that on the same day of vaccination patient experienced flu like symptoms, high fever of 101 degrees F, weakness, fatigue, congested and headache. The patient completely recovered within 1 to 2 business days. The patient had only completed one dose of the BEXSERO. The patient was put on Intravenous medication. No further details were provided. Lab Comments: Lab test was done on an unspecified date.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash and red blotches. On an unknown date, the outcome of the injection site rash and red blotches were recovering/resolving. It was unknown if the reporter considered the injection site rash and red blotches to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a red, blotchy area around the injection site. The rash was slowly lessening. On 25th August 2018, the patient came back with rash, it was not sure when exactly the rash started. This case has been linked with US2018155213, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Borrelia test negative, Laboratory test normal, Skin mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin mass in a 73-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 7th July 2018, the patient received SHINGRIX. On 7th July 2018, less than a day after receiving SHINGRIX, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was unknown. It was unknown if the reporter considered the skin mass to be related to SHINGRIX. Additional details were reported as follows: The patient reported that a bump on her arm, about 3 inches from the needle puncture site on the left arm, appeared a few days after a SHINGRIX injection. She thought it was a tick bite, and she went to an urgent care. The physician said that it did not appear to be from the SHINGRIX injection. The bump was removed, and the patient tested negative for any tick borne diseases, including Lyme disease. The reporter was asking if she can get the 2nd shot. If its ok for her to take the 2nd shot. The reporter said a 3 of her friends had also experienced the same thing. This is one out of 4 linked cases reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Skin mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin mass in a 73-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 7th July 2018, the patient received SHINGRIX. On 7th July 2018, less than a day after receiving SHINGRIX, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was unknown. It was unknown if the reporter considered the skin mass to be related to SHINGRIX. Additional details were reported as follows: The patient reported that a bump on her arm, about 3 inches from the needle puncture site on the left arm, appeared a few days after a SHINGRIX injection. She thought it was a tick bite, and she went to an urgent care. The physician said that it did not appear to be from the SHINGRIX injection. The bump was removed, and the patient tested negative for any tick borne diseases, including Lyme disease. The reporter was asking if she can get the 2nd shot. If its ok for her to take the 2nd shot. The reporter said a 3 of her friends had also experienced the same thing. This is one out of 4 linked cases reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Skin mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin mass in a 73-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 7th July 2018, the patient received SHINGRIX. On 7th July 2018, less than a day after receiving SHINGRIX, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was unknown. It was unknown if the reporter considered the skin mass to be related to SHINGRIX. Additional details were reported as follows: The patient reported that a bump on her arm, about 3 inches from the needle puncture site on the left arm, appeared a few days after a SHINGRIX injection. She thought it was a tick bite, and she went to an urgent care. The physician said that it did not appear to be from the SHINGRIX injection. The bump was removed, and the patient tested negative for any tick borne diseases, including Lyme disease. The reporter was asking if she can get the 2nd shot. If its ok for her to take the 2nd shot. The reporter said a 3 of her friends had also experienced the same thing. This is one out of 4 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Borrelia test negative, Laboratory test normal, Skin mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin mass in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was unknown. It was unknown if the reporter considered the skin mass to be related to SHINGRIX. Additional details were reported as follows: The patient's demographic details were not available. The patient's age group was taken based on the product indication as no other patient details were provided. The patient had a bump on her arm, about 3 inches from the needle puncture site on the unknown arm. This is 1 out of 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Skin mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin mass in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was unknown. It was unknown if the reporter considered the skin mass to be related to SHINGRIX. Additional details were reported as follows: The patient's demographic details were not available. The patient's age group was taken based on the product indication as no other patient details were provided. The patient had a bump on her arm, about 3 inches from the needle puncture site on the unknown arm. This is 1 out of 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Skin mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin mass in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was unknown. It was unknown if the reporter considered the skin mass to be related to SHINGRIX. Additional details were reported as follows: The patient's demographic details were not available. The patient's age group was taken based on the product indication as no other patient details were provided. The patient had a bump on her arm, about 3 inches from the needle puncture site on the unknown arm. This is 1 out of 4 cases reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M abnormal, Herpes zoster, Product administered at inappropriate site, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hip replacement (on 8th May 2018). Previously administered products included ZOSTAVAX (a few years ago). Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE), cortisone (non-proprietary) (Cortisone Cream) and valaciclovir hydrochloride (Valtrex).  On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced rash. On 19th July 2018, the patient experienced vaccine administered at inappropriate site. On 15th August 2018, the patient experienced shingles. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she received a pneumonia vaccine a couple of weeks prior to the SHINGRIX vaccine. The patient received SHINGRIX vaccine in the afternoon on right gluteus medius. The patient received the vaccination right next to an incision she had from a hip replacement surgery in her gluteus maximus, which led to vaccine administered at inappropriate site. The patient claimed that she first got a rash early in July 2018. On 15th August 2018, 27 day after vaccination, the patient went back in the office and she was diagnosed with shingles (also it was stated that, the patient was diagnosed with shingles a few weeks later). The shingles was presenting itself on the right side of her body which was the same side that she received the vaccination on. The patient described the shingles as a mild case. The patient had an IGG and IGM test done at her dermatology office and the IGG results came back through the roof at 4000 but her IGM test came back mildly out of the normal range. The patient took Valtrex for one week and her shingles had not resolved but it helped. They gave her cortisone cream with did not work and the second week of August they gave her a higher dose of cortisone cream which also did not work.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Disorientation, Hypotension, Muscle rigidity, Syncope
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of low blood pressure in a 16-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and MENACTRA for prophylaxis. On 24th August 2018, the patient received BEXSERO, Hepatitis A vaccine and MENACTRA. On 24th August 2018, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced low blood pressure, disorientation, fainting and rigidity. On 24th August 2018, the outcome of the low blood pressure, disorientation, fainting and rigidity were recovered/resolved. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: This case was reported by a medical assistant. The patient received BEXSERO, MENACTRA and Hepatitis A vaccine on the same day on an empty stomach. The patient almost fainted and had to lie down but recovered completely within 15 minutes. No call back or follow up had been initiated by the patient since then. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to MENACTRA as well. This case was linked with case US2018155237, reported by the same reporter.
Age: 17.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Disorientation, Hypotension, Muscle rigidity, Syncope
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of low blood pressure in a 17-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and MENACTRA for prophylaxis. On 14th August 2018, the patient received BEXSERO, Hepatitis A vaccine and MENACTRA. On 14th August 2018, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced low blood pressure, disorientation, fainting and rigidity. On 14th August 2018, the outcome of the low blood pressure, disorientation, fainting and rigidity were recovered/resolved. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: This case was reported by a medical assistant. The patient received BEXSERO, MENACTRA and Hepatitis A vaccine on the same day. The patient almost fainted and had to lie down but recovered completely within 15 minutes. No call back or follow up had been initiated by the patient since then. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to MENACTRA as well. This case was linked with case US2018155236, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Loss of personal independence in daily activities, Malaise, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 2 days after receiving SHINGRIX, the patient experienced muscle pain, lethargy, malaise, activities of daily living impaired and pain upon movement. On an unknown date, the outcome of the muscle pain, lethargy, malaise, activities of daily living impaired and pain upon movement were recovered/resolved. It was unknown if the reporter considered the muscle pain, lethargy, malaise, activities of daily living impaired and pain upon movement to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extraordinary muscle aches and pain as well as lethargy and malaise after getting SHINGRIX about 3 months ago from the date of reporting, she lost a week of her life because it was too painful for her to move due to muscle aches all over her body. After a week the patient woke up and the symptoms had resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she might have had a shingles episode after receiving SHINGRIX. The reporter ended call before more information could be obtained.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 20th August 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, general body pain and fever. On an unknown date, the outcome of the extensive swelling of vaccinated limb, general body pain and fever were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient had experienced a swollen left arm approximately double the normal size of her arm, fever, and body aches. The reporter was unable to provide additional information other than the patient stated that they would not receive the second dose of the SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Cellulitis, Immediate post-injection reaction, Pain, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included pneumonia vaccine (the patient received in the past). On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st July 2018, immediately after receiving SHINGRIX, the patient experienced pain. On 4th July 2018, the patient experienced cellulitis (serious criteria GSK medically significant) and erythematous rash. On an unknown date, the outcome of the cellulitis, pain and erythematous rash were recovered/resolved. It was unknown if the reporter considered the cellulitis, pain and erythematous rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. In afternoon, the patient received SHINGRIX in left arm. Immediately, the patient experienced soreness which subsided by Wednesday of that week. Three to four days after, the patient did not experience itching or hurting but experienced rash, which spread on the side of arm and it was red. The patient took blood work and blood levels found to be fine. The reporter thought that, rash could be cellulitis. The patient took an antibiotic for 10 days and the rash resolved. The rash remained for one week and all side effects resolved at the time of reporting. The patient has denied permission to contact their physician. The Pain, Red Rash and Possible Cellulitis were reported below the injection site on the side of her arm.
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Malaise, Nasal congestion
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of body temperature increased in a female patient who received FLUARIX QUADRIVALENT 2017-2018 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a day after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced body temperature increased, general malaise and nasal congestion. On an unknown date, the outcome of the body temperature increased, general malaise and nasal congestion were unknown.  The reporter considered the body temperature increased, general malaise and nasal congestion to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of prefilled FLUARIX QUADRIVALENT 2017-2018 season. In the evening after flu shot, the patient experienced elevated temperature, general malaise and the patient felt congested. The patient felt the event was related to the product. The reporter was agreed for providing follow up information. The second event occurred in the same department. This case has been linked with US2018GSK155553, reported by the same reporter. Lab Comments: On an unknown date, the patient's body temperature was found to be elevated.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of dizziness in a female patient who received FLUARIX QUADRIVALENT (2017-2018 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. The reporter considered the dizziness to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of prefilled FLUARIX QUADRIVALENT 2017-2018 season. The patient felt dizzy and that was impactful to her. The patient felt the event was related to the product. This case has been linked with US2018GSK155551, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Headache, Sinus disorder, Stomatitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 2 doses on an unknown date). On an unknown date, the patient received the 3rd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced headache, sinus disorder, sores mouth and extra dose administered. On an unknown date, the outcome of the headache, sinus disorder, sores mouth and extra dose administered were unknown. It was unknown if the reporter considered the headache, sinus disorder and sores mouth to be related to SHINGRIX. Additional details were provided as follows: The patient was a healthcare professional. The age at vaccination was not reported. In 2018, the patient received the 3rd dose of SHINGRIX at her physician's office. Since then the patient experienced increased sinus issues, headaches and mouth sores. The physician erroneously gave her 3 doses of the SHINGRIX vaccine about 3 weeks ago, which led to extra dose administered. The reporter enquired whether the events would be related to the 3rd dose. It was an accidental medication error with adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Neuralgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nerve 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, less than a year after receiving SHINGRIX, the patient experienced nerve pain and burning sensation. The patient was treated with non-drug therapy (Heat Therapy) and analgesic, nos. On an unknown date, the outcome of the nerve pain and burning sensation were unknown. It was unknown if the reporter considered the nerve pain and burning sensation 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 captured adult as per vaccine indication. The reporter asked if there were any side effects with nerve pain without a rash lasted for approximately 3 months. The patient also had a strong burning sensation. The patient got relieved with heat and mild pain medication.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, Herpes virus test, Laboratory test, Pyrexia, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Bell's palsy in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant), fever and rash. On an unknown date, the outcome of the Bell's palsy was unknown and the outcome of the fever and rash were recovering/resolving. It was unknown if the reporter considered the Bell's palsy, fever and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient spiked with a high fever and presented Bell's Palsy on injection side of the body. The patient also had a small rash on head. The patient was tested for Zoster and test was showed to be negative. The patient was treated with antibiotics. Lab Comments: The patient did laboratory test on an unknown date.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Viral test negative
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Bell's palsy in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant), fever and rash. On an unknown date, the outcome of the Bell's palsy was unknown and the outcome of the fever and rash were recovering/resolving. It was unknown if the reporter considered the Bell's palsy, fever and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient spiked with a high fever and presented Bell's Palsy on injection side of the body. The patient also had a small rash on head. The patient was tested for Zoster and test was showed to be negative. The patient was treated with antibiotics. Lab Comments: The patient did laboratory test on an unknown date.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Facial paralysis, Headache, Hypoacusis, Nausea
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Bell's palsy in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant), fever and rash. On an unknown date, the outcome of the Bell's palsy was unknown and the outcome of the fever and rash were recovering/resolving. It was unknown if the reporter considered the Bell's palsy, fever and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient spiked with a high fever and presented Bell's Palsy on injection side of the body. The patient also had a small rash on head. The patient was tested for Zoster and test was showed to be negative. The patient was treated with antibiotics. Lab Comments: The patient did laboratory test on an unknown date.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Speech disorder
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Bell's palsy in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant), fever and rash. On an unknown date, the outcome of the Bell's palsy was unknown and the outcome of the fever and rash were recovering/resolving. It was unknown if the reporter considered the Bell's palsy, fever and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient spiked with a high fever and presented Bell's Palsy on injection side of the body. The patient also had a small rash on head. The patient was tested for Zoster and test was showed to be negative. The patient was treated with antibiotics. Lab Comments: The patient did laboratory test on an unknown date.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case is linked to case 2018SA237938, 2018SA237937, 2018SA237939. This case involves a [19 years] female patient who was vaccinated with a 0.5 ml dose of vaccine FLUZONE QUADRIVALENT. (Batch number: UI982AC, expiration date: 30-Jun-2018, site of administration left arm and route was not reported) on 20-Aug-2018. It was an actual medication error due to incorrect product storage as FLUZONE QUADRIVALENT given to 4 patients after shipment of vaccine shipped on Saturday and not received until the following Tuesday/improper storage these doses cannot be counted as valid. It was unknown if any adverse event was reported. 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: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case is linked to case 2018SA237938, 2018SA237767, 2018SA237939. This case involves a 14 years old female patient who received 0.5 ml FLUZONE QUADRIVALENT (lot detail UI982AC, expiry date 30 June 2019) in left arm on 20 August 2018. This is actual medication error case due to Incorrect product storage as FLUZONE QUADRIVALENT given to 4 patients after shipment of vaccine shipped on Saturday and not received until the following Tuesday/improper storage these doses cannot be counted as valid. It was not reported if the patient experienced 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. Documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician via phone. This case is linked to case 2018SA237937, 2018SA237767, 2018SA237939. This case involves a 15 years old male patient who received 0.5 ml FLUZONE QUADRIVALENT (lot detail UI982AC, expiry date 30 June 2019) in left arm on 20 August 2018. This is actual medication error case due to Incorrect product storage as FLUZONE QUADRIVELANT given to patient after shipment of vaccine shipped on Saturday and not received until the following Tuesday. It was not reported if the patient experienced 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. Documents held by sender: none.
Sex: U
Vaccine: DTAP, DTAPIPV, DTAPIPVHIB, HIBV, IPV, MNQ, TD, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 25 Adult patients (age and gender not reported), who experienced due to temp excursion product was not acceptable for use/calling about stability for two separate coolers/lowest temp was -2.2 degrees C for 45 min and a 2nd temp excursion lowest temp was -1.9 degrees C for 1 hour/lowest temp was -1 degree C for, while he/she received vaccines ADACEL, MENACTRA, IPOL, ACT-HIB, QUADRACEL, PENTACEL, DAPTACEL and TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot C5432AB. On an unknown date he/she also received a dose of the same vaccine lot C5463AA. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5948AB. On an unknown date he/she also received a dose of the same vaccine lot U5986AA. On an unknown date he/she also received a dose of the same vaccine lot U5848AA. On an unknown date he/she also received a dose of the same vaccine lot U6015AA. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5850AA. On an unknown date he/she also received a dose of the same vaccine lot C5546BA. It was a case of actual medication error due to incorrect product storage because for stability and due to temp excursion product was not acceptable for use. It was unknown if any adverse event was 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 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 the sender: None.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA. It was a case of actual medication error due to Product storage error. First cooler contained DAPTACEL, PENTACEL, QUADRACEL, ACT HIB, IPOL (opened), MENACTRA and ADACEL. Lowest temp was -2.2 degrees C for 45 min and a 2nd temp excursion lowest temp was -1.9 degrees C for 1 hour. Second cooler contained DAPTACEL, PENTACEL, QUADRACEL, IPOL (opened), MENACTRA, TENIVAC and ADACEL. Lowest temp was -1 degree C for 30 min and a 2nd excursion lowest temp was -4.1 degrees C for 1 hour and 30 min. It was unknown whether patient experienced any adverse event. 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.
Sex: U
Vaccine: DTAP, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case was linked with the case 2018SA242242 (Siblings/ Same reporter). This case involves a patient (gender and age unknown) who was vaccinated with a 0.5 ml dose of DAPTACEL (lot C5202BA and expiry date: 16-May-2019) via intramuscular route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient's concomitant medications included PREVENAR 13. It was a case of actual medication error due to Inappropriate schedule of vaccine administered because DAPTACEL given too early. It was unknown if any adverse reaction was 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 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 the sender: None.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medication administration error. Nurse misunderstood the verbal order the provider had given.  Nurses station was short staffed, loud and busy, nurse was on the phone with another pt when the provider gave the order. Nurse was unable to log into the EHR. Vaccination given was what she heard. Provider, medical Director, and mother notified as soon as it was realized. No s/s of reactions. Outcome: Verbal orders are no longer taken and vaccines are not given without verifying in EHR.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Mild fever at night along shivering. Okay by morning.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm from elbow up to mid arm (right below shoulder) is swollen, painful to touch, and warm to the touch. The patient has been taking acetaminophen for the pain, as she is unable to take NSAIDS. Patient is going to try to ice area, but the area is painful to touch. Her primary physician was contacted and the patient was informed to go into the MD office today. The patient was informed of this, and is going in to see her doctor this evening. We will follow up with the patient in the morning.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Patient mother took him to Pediatrician due to redness on Right upper arm. Dr. diagnosed as cellulitis prescribed BACTRIM 4tsp x10days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain on injection, then recurred 2 hours later, very painful 9/5/18. On 9/6/18 painful only to touch. Chills began 9/5/18 at 1:30 am, lasted couple of hours, Muscle aches and headache 9/5/18, starting around 7:AM, lasting until approx. 10:pm. Ibuprofen taken throughout the day with no relief. Warm soaking bath and ALEVE taken approx. 7:00pm, symptoms gone 9/6/18, Red rash, 5x6cm, appeared around injection site 9/6/18, was not there 9/5/18, Induration 1cm noted 9/6/18.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Myalgia
Clinical narrative: Pain on injection, then recurred 2 hours later, very painful 9/5/18. On 9/6/18 painful only to touch. Chills began 9/5/18 at 1:30 am, lasted couple of hours, Muscle aches and headache 9/5/18, starting around 7:AM, lasting until approx. 10:pm. Ibuprofen taken throughout the day with no relief. Warm soaking bath and ALEVE taken approx. 7:00pm, symptoms gone 9/6/18, Red rash, 5x6cm, appeared around injection site 9/6/18, was not there 9/5/18, Induration 1cm noted 9/6/18.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise, Pyrexia, Vomiting
Clinical narrative: Patient's daughter called on 9/6/18 to report that mother felt very sick the night of vaccine administration (9/5/2018). She reported headache, chills, fever, vomiting. Patient took dose of TYLENOL at time of fever and again at 3am when she started to feel better. Reported no redness or swelling at injection site. Spoke to patient around 12:30pm on 9/6/2018 and is feeling a little better. Pharmacist did ask patient at the time of vaccination if they had vaccine in the past and if they had any reaction to it. Patient stated they had it in the past with no reaction. However, when daughter called to report the reaction on 9/6/18 and the pharmacist asked again if they had any similar reaction in the past that is when the patient stated that they had a similar reaction but not as strong as this year. Pharmacist asked why the patient did not tell her at the time when asked but she did not think it was a concern. Pharmacist offered to call primary doctor to inform but daughter told Pharmacist that she would contact primary doctor.