chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Fall, Nuclear magnetic resonance imaging, Renal disorder
Clinical narrative: This spontaneous report was received from a consumer and refers to a 11-year-old female patient. The patient's concurrent conditions included attention deficit/hyperactivity disorder (ADHD). The patient did not have any drug reactions or allergies. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 injection dose 1 (dosage, frequency, route of administration, lot validation and expiration date were not provided) for prophylaxis. Subsequently, she received the second dose of GARDASIL 9 on an unspecified date. Concomitant therapies included ADHD medicine (unspecified). The mother reported that at some point after receiving her first dose of GARDASIL 9, her daughter "started to experience issues of falling down (date and time not specified)". The mother reported that her daughter sought medical attention and was diagnosed with epilepsy on 18-SEP-2016. The mother also reported that her daughter was subsequently been put on 6 different unspecified epilepsy medications that have made the condition worse. The mother also reported that her daughter had also developed blood pressure issues as well as kidney issues. The patient received treatment for the events. On an unspecified date, electroencephalogram, magnetic resonance imaging, capillary agglutination test scan, 3 rounds of blood work were performed (results not provided). The outcome of epilepsy, renal disorder, blood pressure fluctuation and fall was reported as not resolved at the time of the report. The action taken was not applicable. The causality between the events and the suspect vaccine was not provided. Upon internal review, epilepsy and epilepsy aggravation were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician for herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees F) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA006189.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1808USA006189:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA006189.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA006189.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient's friend reported this case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced flu like symptoms that lasted a day or two. For tolerance of 2nd dose of SHINGRIX, refer case US2018GSK150388 for same patient. This reporter had not yet received the vaccine. The reporter denied permission to contact their physician. The reporter declined to provide any additional information and said she would tell her friends to call the global response center (GRC). The reporter declined follow up contact. This case has been linked to US2018GSK150389 and US2018GSK150390, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (without issues). On 8th August 2018 13:30, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, diarrhea, headache, fever and chills. On an unknown date, the outcome of the general body pain, diarrhea, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the general body pain, diarrhea, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient had no issues with the first dose of SHINGRIX and so was a little surprised when she had issues with the second dose. The patient was administered SHINGRIX in the right deltoid. The patient noted the body aches were all over. All started within 12 hours of the vaccination and had resolved. The patient had not reported the events to her physician. The patient's health care professional was not asked, since events were not reported to him.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included keratosis. On 9th May 2018, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced injection site pain, general body pain, injection site erythema and rash. On an unknown date, the outcome of the injection site pain, general body pain, injection site erythema and rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, injection site erythema and rash to be related to Shingles vaccine. Additional details were provided as follows: The patient received 1st dose of Shingles vaccine in left arm. The patient had redness, soreness at the injection, general aches, rash. She also had a prior condition of benign keratosis with spots all over her body. For tolerance after 2nd dose, refer case US2018GSK149529.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number M77B4, expiry date unknown) for prophylaxis. On 4th August 2018, the patient received the 1st dose of SHINGRIX. On 4th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site warmth and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The health care professional did not have expiration date of SHINGRIX because her computer system automatically input it as 1 year from vaccination date. The health care professional reported that the patient received SHINGRIX and presented to the pharmacy on 10th August 2018, with worsening redness at the injection site. Redness was described as warm and itchy and being roughly 5cm in diameter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Asthenia, Chills, Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2018GSK150451). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than an hour after receiving SHINGRIX, the patient experienced malaise, chills, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance. In August 2018, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the malaise, chills, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the malaise, chills, pain in arm, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: In the afternoon, the patient received SHINGRIX in the left deltoid. Within an hour or so after vaccination, the patient started to overall not feel well (described as malaise). By 10 pm that night (several hours after vaccination), the patient felt like she had been run over by a truck and by midnight, she started to experience high fever, chills, and weakness and slept off and on and had weird dreams. This lasted for 4 hours. By the morning of 8th August 2018, fever and chills were gone but the patient still had weakness. At the time of reporting, the patient felt better. Less than a week after vaccination, the patient experienced pain in the injected arm that was still sore at the time of reporting.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2018GSK150451). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than an hour after receiving SHINGRIX, the patient experienced malaise, chills, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance. In August 2018, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the malaise, chills, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the malaise, chills, pain in arm, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: In the afternoon, the patient received SHINGRIX in the left deltoid. Within an hour or so after vaccination, the patient started to overall not feel well (described as malaise). By 10 pm that night (several hours after vaccination), the patient felt like she had been run over by a truck and by midnight, she started to experience high fever, chills, and weakness and slept off and on and had weird dreams. This lasted for 4 hours. By the morning of 8th August 2018, fever and chills were gone but the patient still had weakness. At the time of reporting, the patient felt better. Less than a week after vaccination, the patient experienced pain in the injected arm that was still sore at the time of reporting.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 75-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, tiredness and pain. On an unknown date, the outcome of the feeling unwell, tiredness and pain were recovered/resolved. It was unknown if the reporter considered the feeling unwell, tiredness and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient had SHINGRIX into left deltoid. The reporter stated that, (probably by) nightfall the patient started generally not feeling well, had achiness, and was tired for a couple of days after the vaccine. The reporter gave permission to contact their physician.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 67-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced muscle soreness and pain in arm. On an unknown date, the outcome of the muscle soreness and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the muscle soreness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist relaying information regarding adverse event on behalf of the patient. The patient received 1st dose of SHINGRIX at the pharmacy. The patient came on the date of reporting and stated that his left arm still hurts since receiving the first vaccination. The patient was hesitant to receive next dose as the muscle soreness was still present. No further information was provided as patient was unavailable. The patient was not available to provide permission to contact the physician.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Herpes zoster, Influenza like illness, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, headache, influenza-like symptoms and weakness. On 9th July 2018, the patient experienced neck pain. The patient was treated with VALTREX. In May 2018, the outcome of the weakness was recovered/resolved. On an unknown date, the outcome of the shingles, neck pain, headache and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the shingles, neck pain, headache, influenza-like symptoms and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on right arm and she experienced weakness, flu like symptoms and headache which lasted for 2 to 3 days. On 14th June 2018 the patient broke with Shingles on the stomach and headache. She visited her doctor on 15th June 2018, and her doctor prescribed VALTREX to be taken three times a day for a week. She then completely recovered. On 9th July 2018, she experienced sore neck, shooting pain in head and neck, headache and flu like symptoms. On 4th August 2018, vaccination she broke out with Shingles bump on inside of her thighs. On 6th August, 2018 she broke out with Shingles on her knees. She had an appointment scheduled with her doctor on 8th August 2018 but she was not able to make it. She spoke with her doctor on the phone and she was referred to an infectious disease doctor. The patient had denied permission to contact their physician. The patient was referred to her health care provider.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This prospective pregnancy case was reported by a physician via sales rep and described the occurrence of vaccine exposure during pregnancy in a 16-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. Co-suspect products included MENVEO (batch number A17024, expiry date 31st March 2019) for prophylaxis. On 6th August 2018, the patient received BEXSERO and MENVEO. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, unknown after receiving BEXSERO and MENVEO, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The patient received BEXSERO and MENVEO after a positive pregnancy test. There were no reported issues or adverse events. The physician asked about pregnancy registry for BEXSERO. No other information was provided.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neuropathy peripheral in a 60-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. The patient's past medical history included neuropathy (idiopathic Neuropathy). On 5th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced neuropathy peripheral (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy peripheral was unknown. It was unknown if the reporter considered the neuropathy peripheral to be related to SHINGRIX. Additional details were provided as follows: The patient had not an occurrence of idiopathic Neuropathy for many years. The patient received SHINGRIX and the next day the patient presented with symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced cellulitis (serious criteria GSK medically significant) and local reaction. On an unknown date, the outcome of the cellulitis and local reaction were unknown. It was unknown if the reporter considered the cellulitis and local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine the age group was captured as adult. The pharmacist stated that he noticed that the patients who received SHINGRIX often get localized reactions on their arms but closer to the elbow (refer case US2018GSK150513). The reporter had also noticed that one patient did get cellulitis (concerned in this case). The pharmacist did not have specific patient and vaccine information and he made a general comment on what he had been noticing. This case has been linked to the US2018GSK150513, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown. It was unknown if the reporter considered the fever and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 100.6 degree F. Lab Comments: Lab test performed on an unknown date.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthralgia in a 82-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included prostatic specific antigen. Concomitant products included ORENCIA and methotrexate. On 10th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced arthralgia, myalgia and malaise. The patient was treated with MEDROL Injection. On an unknown date, the outcome of the arthralgia, myalgia and malaise were unknown. It was unknown if the reporter considered the arthralgia, myalgia and malaise to be related to SHINGRIX. Additional details reported as follows: The patient experienced severe adverse events following administration of SHINGRIX in the week of 10th August 2018. After vaccination the patient developed severe myalgia, arthralgia, malaise. The patient was treated with DEPO MEDROL injection but not sure if it had helped the symptoms as this all just happened within that week. This case has been linked with US2018GSK145212, reported by same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included giant cell arteritis. Concomitant products included prednisone. On 10th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced myalgia, arthralgia and malaise. The patient was treated with MEDROL Injection. On an unknown date, the outcome of the myalgia, arthralgia and malaise were unknown. It was unknown if the reporter considered the myalgia, arthralgia and malaise to be related to SHINGRIX. Additional details reported as follows: The patient experienced severe events following administration of SHINGRIX in the week of 10th August 2018. The patient developed severe myalgia, arthralgia and malaise following administration of SHINGRIX in that week. The patient was treated with intramuscular DEPO MEDROL injection but not sure of outcome till the time of reporting since this just happened in the week of reporting. This case has been linked with US2018GSK145191, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced redness and swelling that lasted over two weeks. It was resolved on it owns.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO for prophylaxis. On 9th August 2018, the patient received BEXSERO. In August 2018, less than a week after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details reported as follows: This case was reported by the patient's mother. The patient experienced sore arm after the vaccine used before the day of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer
Clinical narrative: This case was reported by a consumer and described the occurrence of aphthous stomatitis in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the aphthous stomatitis was recovering/resolving. It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no history of canker sores. In 2018, about 7 weeks before the reporting date, the patient received first SHINGRIX shot. About 6 weeks before the reporting date, the patient experienced numerous canker sores. The patient and his dentist could not determine any other possible causes for the sores. The sores were still present but healing slowly. The patient wanted to report this possible side effect, and find out if there had been any other similar reports before he schedule his second shot.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Erythema, Hyperkeratosis, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received Shingles vaccine for prophylaxis. The patient's past medical history included keratosis. Previously administered products included Shingles vaccine (1st dose, refer case US2018145443). In July 2018, the patient received the 2nd dose of Shingles vaccine. In July 2018, 1 day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the patient experienced injection site pain, general body pain, injection site erythema and rash. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, injection site pain, general body pain, injection site erythema and rash were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, general body pain, injection site erythema and rash to be related to Shingles vaccine. Additional details were provided as follows: The 2nd dose was administered sometime in the 2nd week of July. The next day after that dose, she had a fever of 100.4 that lasted 2 days. She also had redness and soreness at the injection and general aches that lasted 3 to 4 days. A rash also presented around the same time. The rash presented in the folds of her skin under her breast area, in the groan area, armpits and lower part of her right leg. She also had a prior condition of benign keratosis with spots all over her body. Those spots became very red especially on her back and abdomen areas. She said that she might have had all the same symptoms (with the exception of the fever) after the 1st dose but they were much less severe after dose 1.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received Shingles vaccine for prophylaxis. The patient's past medical history included keratosis. Previously administered products included Shingles vaccine (1st dose, refer case US2018145443). In July 2018, the patient received the 2nd dose of Shingles vaccine. In July 2018, 1 day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the patient experienced injection site pain, general body pain, injection site erythema and rash. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, injection site pain, general body pain, injection site erythema and rash were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, general body pain, injection site erythema and rash to be related to Shingles vaccine. Additional details were provided as follows: The 2nd dose was administered sometime in the 2nd week of July. The next day after that dose, she had a fever of 100.4 that lasted 2 days. She also had redness and soreness at the injection and general aches that lasted 3 to 4 days. A rash also presented around the same time. The rash presented in the folds of her skin under her breast area, in the groan area, armpits and lower part of her right leg. She also had a prior condition of benign keratosis with spots all over her body. Those spots became very red especially on her back and abdomen areas. She said that she might have had all the same symptoms (with the exception of the fever) after the 1st dose but they were much less severe after dose 1.
Age: 71.0
Sex: F
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 71-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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: The patient received SHINGRIX on an left deltoid. The patient's injected arm was sore for 1 week. No other symptoms reported for the first dose. For tolerance of 2nd dose of SHINGRIX, refer case US2018145478.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local reaction 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 local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured adult as per vaccine indication. The pharmacist stated that he noticed that the patients who received SHINGRIX often get localized reactions on their arms but closer to the elbow. The pharmacist did not have specific patient and vaccine information and he made a general comment on what he had been noticing. This case has been linked to the US2018146919, reported by the same reporter.
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial unsolicited report received from a pharmacist via nurse on 06-Aug-2018. This case involves a female patient (age was not reported) who was vaccinated with a dose of IMOVAX RABIES (Batch number, expiration date, dose, dose in series and route of administration were not reported) in the hip/gluteal region on an unknown date. It was a case of actual medication error due to product administered at inappropriate site as it may affect the immune response and titer levels. It was reported that the doctor only order four total dose for this patient for day 0.3.7 and 14 instead of five. It was not reported whether the patient experienced any adverse events or not. 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: 1.0
Sex: M
Vaccine: DTOX, TDAP
Symptoms: Expired product administered, Extra dose administered, Gait disturbance, Pyrexia, Rash erythematous
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from Consumer. This case involves a 1 years old male patient who did not want to walk, had slight fever, red dots and given a dose of ADACEL that was expired, while he received vaccine ADACEL and DIPHTHERIA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Aug-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in leg and also received DIPHTHERIA VACCINE. The patient developed a non-serious did not want to walk following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA VACCINE. The patient developed a non-serious slight fever same evening following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA VACCINE. The patient developed a non-serious red dots following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA VACCINE. It was also case of actual medication error due to expired vaccine used. (Other relevant tests included No lab test). Final diagnosis was slight fever, given a dose of ADACEL that was expired, red dots and did not want to walk. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for did not want to walk, as Unknown for slight fever, as Unknown for red dots and as Not Applicable for given a dose of ADACEL that was expired. 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.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old patient who received a dose of PENTACEL (Lot number: C5542AA, expiry date: 08-Sep-2019), which was inappropriately reconstituted, intramuscularly in thigh NOS on 08-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that nurse gave PENTACEL as two injections. HIB portion given with sterile Patient. It was not reported if the patient experienced any adverse event or not. 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: 1.5
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old female patient who received ADACEL instead of DAPTACEL, while she received vaccines DAPTACEL and ADACEL. The patient's past medical treatment included DTAP. The patient's past medical history, vaccination(s) and family history were not provided. On 06-Aug-2018, the patient received a fourth 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA, expiry date-13-Jun-2020 via intramuscular route in the right thigh instead of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication due to wrong vaccine administered. (Other relevant tests included No lab test). Final diagnosis was patient was administered ADACEL instead of DAPTACEL. No reportable adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15 years old patient (15 years four months old) who received a dose of MENACTRA (at the age of 11 years) and extra dose of the same vaccine (0.5 mL, lot number: U5839AA) in right deltoid on 10-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if the patient experienced any adverse event or not. 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 and Module VI of the 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: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who experienced redness, swelling and increased skin temperature at site of injection/ nurse states almost looks like cellulitis, while he received vaccine QUADRACEL. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious patient experienced redness, swelling and increased skin temperature at site of injection/ nurse states almost looks like cellulitis but not quite that severe (vaccination site cellulitis) and (vaccination site inflammation) with unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Lab data was not provided. Final diagnosis was redness, swelling and increased skin temperature at site of injection/ nurse states almost looks like cellulitis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown. List of documents held by sender- none.
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA226774, 2018SA226817, 2018SA226818, 2018SA226819 and 2018SA226820 and 2018SA227033 (same reporter). This case involves adult female patient (age not reported) who was vaccinated with a 0.5 ml dose of MENACTRA (Batch number: U5833AA and expiry date: 25-Feb-2019) via intramuscular route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because stability on MENACTRA, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. 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 holders compliance with the requirements set out in Directive and Module VI of the 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.
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2018SA226816, 2018SA226774, 2018SA226818, 2018SA226819, 2018SA226820, 2018SA227033 and 2018SA227019 (same reporter). This case involves adult female patient (age not reported) who was vaccinated with a 0.5 ml dose of MENACTRA (Batch number: U5833AA and expiry date: 25-Feb-2019) via intramuscular route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because stability on MENACTRA, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. 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 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.