chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included balance difficulty (Balance issues due to age and arthritis.) and arthritis.  In September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell and pain in arm. On an unknown date, the outcome of the feeling unwell and pain in arm were recovered/resolved. It was unknown if the reporter considered the feeling unwell and pain in arm to be related to SHINGRIX. Additional details were received as follows: Six months before the date of reporting, the patient received SHINGRIX in the left arm. The patient's arm hurt for two days and he had to stay in bed because he did not feel well. All symptoms resolved within two days. The reporter could remember very little regarding the first dose of the SHINGRIX vaccination. For tolerance to 2nd dose of SHINGRIX, refer case US2019029648.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site discomfort (1st dose received on an unknown date, refer case US2019029586). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, diarrhea, stomach cramps and chills. On an unknown date, the outcome of the injection site pain, diarrhea, stomach cramps and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, diarrhea, stomach cramps and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain at the injection site that took a little longer to resolve, diarrhea, stomach pain and cramps and chills lasted for about 7 days. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm and tenderness. On 14th February 2019, the patient experienced headache, chills, fever, erythema, pain and swelling. The patient was treated with ADVIL and Cold Compress. On an unknown date, the outcome of the headache, pain, pain in arm and tenderness were unknown and the outcome of the chills and fever were recovered/resolved and the outcome of the erythema and swelling were not recovered/not resolved. It was unknown if the reporter considered the headache, chills, fever, erythema, pain, swelling, pain in arm and tenderness to be related to SHINGRIX. Addition details were received as follows: At 10:30 am, the patient received SHINGRIX in the left arm. On the day of vaccination, she experienced achy arm and tenderness to touch. On the next day after vaccination, the patient experienced headache, chills, fever, redness, soreness and swelling. On the day of reporting, the redness and swelling was worse and it was present around the outside of the upper arm covering an area of 6 inches by 6 inches. The patient was taking ADVIL and applying cold compress to the area. The patient was not able to tolerate the cold compress and could not sleep on the side of the arm. The chills and fever lasted for about 1 day. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm and tenderness. On 14th February 2019, the patient experienced headache, chills, fever, erythema, pain and swelling. The patient was treated with ADVIL and Cold Compress. On an unknown date, the outcome of the headache, pain, pain in arm and tenderness were unknown and the outcome of the chills and fever were recovered/resolved and the outcome of the erythema and swelling were not recovered/not resolved. It was unknown if the reporter considered the headache, chills, fever, erythema, pain, swelling, pain in arm and tenderness to be related to SHINGRIX. Addition details were received as follows: At 10:30 am, the patient received SHINGRIX in the left arm. On the day of vaccination, she experienced achy arm and tenderness to touch. On the next day after vaccination, the patient experienced headache, chills, fever, redness, soreness and swelling. On the day of reporting, the redness and swelling was worse and it was present around the outside of the upper arm covering an area of 6 inches by 6 inches. The patient was taking ADVIL and applying cold compress to the area. The patient was not able to tolerate the cold compress and could not sleep on the side of the arm. The chills and fever lasted for about 1 day. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 14th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2019, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache and tiredness. On an unknown date, the outcome of the muscle pain, headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient planned to follow up with his physician on an unknown date. The reporter gave consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoglycaemia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hypoglycemic reaction in a 66-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. In February 2019, the patient received SHINGRIX (intramuscular) .5 ml. In February 2019, 1 day after receiving Shingrix, the patient experienced hypoglycemic reaction. On an unknown date, the outcome of the hypoglycemic reaction was recovered/resolved. It was unknown if the reporter considered the hypoglycemic reaction to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that patient called to provide additional timeline details. The patient reported that she received SHINGRIX on a friday afternoon and then developed the hypoglycemic reaction saturday evening.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old male patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 3rd December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown. It was unknown if the reporter considered the shingles and pain to be related to SHINGRIX. Additional details were reported as follows: One week before the date of reporting, the patient was diagnosed with Shingles. This was further described as, no rash, just painful. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received TWINRIX (batch number unknown, expiry date 30th September 2018) for prophylaxis. On 14th February 2019, the patient received TWINRIX. On 14th February 2019, unknown after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The age at vaccination was not reported. On 14th February 2019, the patient received TWINRIX which was already expired on 30th September 2018. The pharmacist did not have additional information available at the time of this call, as he was not in-office. The vaccine administration facility was the same as primary reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Sciatica
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sciatica in a 59-year-old male patient who received SHINGRIX (batch number 455KD, expiry date 31st May 2021) for prophylaxis. On 8th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, 5 days after receiving SHINGRIX, the patient experienced sciatica. The patient was treated with prednisone (Prednisone Dose Pack). On an unknown date, the outcome of the sciatica was unknown. It was unknown if the reporter considered the sciatica to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient was started on Prednisone dose pack for sciatica 5 days after receiving his 2nd dose of SHINGRIX. The pharmacist said that the patient did not feel the event was related to SHINGRIX vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of psoriasis flare-up in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included psoriasis (psoriasis only on her elbow and has not been treated for it in the past). In August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 61 days after receiving SHINGRIX, the patient experienced psoriasis flare-up. On an unknown date, the outcome of the psoriasis flare-up was unknown. It was unknown if the reporter considered the psoriasis flare-up to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient who experienced flare up of psoriasis on her foot about 2 months after 2nd dose and that it has moved to all over her body. The caller stated she received doses from the pharmacy but could not remember which one or the phone number. The reporter did not consent to follow-up. The reporter declined to follow up with Medical Doctor.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. On 25th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, fatigue, shivering, sweating, fever, gastrointestinal disorder and pain in arm. On 26th January 2019, the outcome of the injection site pain, headache, fatigue, shivering, sweating, fever and gastrointestinal disorder were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved.  It was unknown if the reporter considered the injection site pain, headache, fatigue, shivering, sweating, fever, gastrointestinal disorder and pain in arm to be related to SHINGRIX. Additional details were provided as follows: In the evening, the patient experienced pain at injection site, headache, fatigue, shivering, sweating, fever, GI problems which went away the next day. The patient stated that she had pain on the arm that did not get vaccine. The patient confirmed that she would not get more than one vaccine. The reporter did not consent to follow-up. This case has been linked with case US2019028262 (patient's husband), reported by same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. On 25th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, fatigue, shivering, sweating, fever, gastrointestinal disorder and pain in arm. On 26th January 2019, the outcome of the injection site pain, headache, fatigue, shivering, sweating, fever and gastrointestinal disorder were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved.  It was unknown if the reporter considered the injection site pain, headache, fatigue, shivering, sweating, fever, gastrointestinal disorder and pain in arm to be related to SHINGRIX. Additional details were provided as follows: In the evening, the patient experienced pain at injection site, headache, fatigue, shivering, sweating, fever, GI problems which went away the next day. The patient stated that she had pain on the arm that did not get vaccine. The patient confirmed that she would not get more than one vaccine. The reporter did not consent to follow-up. This case has been linked with case US2019028262 (patient's husband), reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient experienced soreness in forearm. The reporter declined providing details of the patient. The reporter did not consent to follow-up. This case has been linked with case US2019028258 (patient's wife), reported by same reporter.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was not recovered/not resolved. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient received SHINGRIX and Flu vaccine at a different pharmacy and sometime after receiving the SHINGRIX and Flu vaccine, the patient developed Guillain Barre Syndrome. The reporter did not have any additional details at the time of the reporting. The healthcare professional was transferred to MI Vaccines for more information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 62-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 discomfort. On an unknown date, the outcome of the injection site discomfort was recovered/resolved. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced discomfort at the injection site that went away quickly. The reporter did not consent to follow-up. For tolerance to the 2nd of SHINGRIX refer case US2019GSK033744, reported by same reporter.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included drug hypersensitivity. Previously administered products included shingles vaccine with an associated reaction of herpes zoster (previous vaccination had years before the time of reporting). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. The patient was treated with Ice Pack. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: Approximately 6 months before the time of reporting, the patient received 2nd dose of SHINGRIX on an unknown arm. After vaccination, the patient experienced a sore arm with swelling at the injection site. The patient also experienced redness, which occurred at the very upper part of her arm. The patient put some ice on the area and the issues were resolved in a couple of days. The patient also claims that, when the patient as a young child and received a diphtheria shot and she felt like she was going to faint. The next time the physician divided the vaccine into two portions and her issue resolved. No additional details were available. The reporter did not consent to follow-up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included heart attack (in 2006). Concurrent medical conditions included cardiac pacemaker insertion (in the left side of chest) and implantable defibrillator insertion (in the left side of chest). Concomitant products included ramipril, atorvastatin calcium (Atorvastatin), acetylsalicylic acid (Ecotrin), clopidogrel bisulphate (Plavix), carvedilol, spironolactone and alfuzosin. On 15th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 12 hrs after receiving SHINGRIX, the patient experienced shivering and muscle pain. On 16th February 2019, the patient experienced fever, tiredness and headache. The patient was treated with paracetamol (Tylenol). In February 2019, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the shivering, fever, tiredness and headache were recovered/resolved. It was unknown if the reporter considered the shivering, muscle pain, fever, tiredness and headache to be related to SHINGRIX. Additional details were received as follows: This case was reported by the patient's wife. At 1:00 pm, the patient received SHINGRIX in the left arm. On 16th February 2019, Saturday, at 1:00 am, the patient woke with shivering. It lasted a couple of hours and then it resolved. The shivering presented again for 3 to 4 hours later and lasted for 30 minutes. In the morning of Saturday, 16th February 2019, several hours after vaccination, the patient experienced muscle aches all over which lasted for 12 to 16 hours. One day after vaccination, the patient experienced headache and fever. On early Saturday evening, the patient experienced headache. It resolved but came back 5 to 6 hours later. The patient had slight fever of 100 degrees F and it was present most of the day on Saturday. The patient was very tired on Saturday afternoon and slept for a few hours. On Sunday, 17th February 2019, the patient was fine. The reporter did not consent to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Mental impairment, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 months ago from reporting date, refer case US2019GSK033538). Concurrent medical conditions included balance difficulty (Balance issues due to age and arthritis.). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th February 2019, less than a day after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), influenza-like symptoms, pain in arm, general body pain and queasy. On 18th February 2019, the patient experienced papular rash. Rechallenge with SHINGRIX was positive. On 16th February 2019, the outcome of the difficulty thinking, influenza-like symptoms, general body pain and queasy were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the papular rash was unknown. It was unknown if the reporter considered the difficulty thinking, influenza-like symptoms, pain in arm, general body pain, queasy and papular rash to be related to SHINGRIX. Additional details were received as follows: In the morning, the patient received SHINGRIX in left arm. Around 2:00 pm, his arm began to hurt. The patient developed flu like symptoms, including body aches and pains, queasiness, and he could not think. The patient was afraid he would fall in the hall because he already had balance issues due to his age and arthritis prior to receiving the SHINGRIX vaccine.   In the next morning, he felt fine. There was still some soreness in his left arm where he had the dose.   On the day of reporting, in the morning, 3 days after vaccination, the patient noted a cluster of 5 to 6 bumps under his right breast, some were more prominent. They did no not hurt or itch. The patient did not consent to follow-up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash papular, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 months ago from reporting date, refer case US2019GSK033538). Concurrent medical conditions included balance difficulty (Balance issues due to age and arthritis.). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th February 2019, less than a day after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), influenza-like symptoms, pain in arm, general body pain and queasy. On 18th February 2019, the patient experienced papular rash. Rechallenge with SHINGRIX was positive. On 16th February 2019, the outcome of the difficulty thinking, influenza-like symptoms, general body pain and queasy were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the papular rash was unknown. It was unknown if the reporter considered the difficulty thinking, influenza-like symptoms, pain in arm, general body pain, queasy and papular rash to be related to SHINGRIX. Additional details were received as follows: In the morning, the patient received SHINGRIX in left arm. Around 2:00 pm, his arm began to hurt. The patient developed flu like symptoms, including body aches and pains, queasiness, and he could not think. The patient was afraid he would fall in the hall because he already had balance issues due to his age and arthritis prior to receiving the SHINGRIX vaccine.   In the next morning, he felt fine. There was still some soreness in his left arm where he had the dose.   On the day of reporting, in the morning, 3 days after vaccination, the patient noted a cluster of 5 to 6 bumps under his right breast, some were more prominent. They did no not hurt or itch. The patient did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received SHINGRIX. On 15th February 2019, 4 days after receiving SHINGRIX, the patient experienced swelling arm, erythema and skin warm. On an unknown date, the outcome of the swelling arm, erythema and skin warm were unknown. It was unknown if the reporter considered the swelling arm, erythema and skin warm to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient said that her arm was extremely swollen and it covered the majority of the upper arm. The area was hot to touch. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a 84-year-old female patient who received Flu vaccine for prophylaxis. Concurrent medical conditions included shellfish allergy. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was recovered/resolved. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Flu vaccine. Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. At the time of reporting, the patient was 84 years old. Several years before the time of reporting, the patient received a dose of Flu vaccine. The patient was hospitalized and received blood treatment. It took the patient about a year to recover. No further details were provided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concomitant products included valaciclovir (Valacyclovir). On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th November 2018, the patient received the 2nd dose of SHINGRIX. On 15th February 2019, 196 days after receiving SHINGRIX and 99 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient had a history of shingles and took valcyclovir.  The batch number and expiry date was not available. The patient reported that she developed another case of shingles and was very upset as the vaccine did not work.  The patient was requesting reimbursement as well. The reporter granted permission to contact her physician.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Feeling abnormal, Hypoaesthesia, Myelitis transverse, Sensory loss
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antibody test, Blood folate normal, Blood glucose normal, Blood test, Blood test normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: C-reactive protein normal, CSF pressure normal, CSF test normal, Cauda equina syndrome, Diarrhoea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Glycosylated haemoglobin normal, Hypoaesthesia, Lethargy, Lumbar puncture
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Nuclear magnetic resonance imaging thoracic abnormal, Peripheral sensory neuropathy
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan with contrast, Small fibre neuropathy, Vitamin B12 normal, X-ray normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Central nervous system lesion, Lumbar puncture normal, Nuclear magnetic resonance imaging spinal, Sensory disturbance
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria GSK medically significant), diarrhea, feels awful, sleepiness, numbness in feet and sensory loss. On an unknown date, the outcome of the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss were unknown. It was unknown if the reporter considered the myelitis transverse, diarrhea, feels awful, sleepiness, numbness in feet and sensory loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired Doctor of Medicine (MD). The age at vaccination was not reported. The day after the shot, the patient felt terrible and slept all day. A few days later, he had severe diarrhea. A week later after vaccination, he had numbness in his feet. The patient was diagnosed with transverse myelitis of the spinal cord at the T3 T4 level. The patient described it as sensory loss. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Bursitis
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. An elderly female patient of an unspecified age received PREVNAR 13, lot number and expiration date were not reported, via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date in 2016/2017 the patient experienced bursitis in elbow/experienced bursitis-like reaction in elbow/arm. The outcome of the event was unknown. Information on the lot number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Pallor
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient started to receive TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  The patient had not eaten all day, felt light headed and lost color when she received her vaccines. She lay down and had a cracker for 5 minutes.  The outcome of the event was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced pain on an unspecified date. The outcome of the event was unknown. No follow up attempts are possible; information on the batch number cannot be obtained.
Age: 1.25
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked to 2019SA024754 (same reporter). This case involves a 15 months old patient (one of the twins) who received an expired fourth single dose of 0.5 ml of vaccine DAPTACEL (lot C5102AA and expiry date 04-Dec-2018) via unknown route in the right thigh on 22-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE. It was a case of actual medication error due to expired vaccine used. 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. Follow-up information received on 20-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. No new information was received. List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 56 years old female patient who received vaccine DAPTACEL instead of Tdap and reported that gave a DTaP shot to a 56 year old patient that was supposed to be given TDaP. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Feb-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5202AA and expiry date: 16-May-2019) (dose in series was not reported) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. 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 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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who was vaccinated with 0.5 ml first single dose of PENTACEL (batch number: C5262AB and expiration date: 03-Jun-2019) via intramuscular route in the right thigh on 12-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient received PREVNAR 13 and ROTATEQ on the same day of vaccination (12-Feb-2019). It was also a case of actual medication error due to inappropriate reconstitution technique because the liquid wasn't mixed with the powder, missed the ACTHIB from the PENTACEL box, the DTaP-IPV liquid component was administered separately it would count as a valid DTaP and IPV dose, the Hib lyophilized component administered separately will count as a valid dose only if it was reconstituted with proper diluent 0.4 percent NaCl solution. It was unknown if the patient had any adverse effects. 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.