chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: had syncope episode; This spontaneous report was received from a medical assistant via a company representative and refers to an 11-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# 1614897, expiration date 20-SEP-2021, intramuscularly (exact dose and site of administration were not reported) for prophylaxis. On the same day, the patient had a syncope episode. The patient was already lying down and was given crackers and water. The outcome of syncope was reported as recovered/resolved on the same day after receiving the treatment. The patient sought medical attention. It was unknown whether the patient had any laboratory tests performed. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, syncope was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash, Rash macular
Clinical narrative: post herpetic neuralgia following chronic pain after the shingles outbreak; erythematous macular rash noted over her right face with burning pain/ diagnosed with shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 20-MAY-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date in 2016 (reported as within two weeks after vaccination), she suffered from an erythematous macular rash noted over her right face with burning pain. The patient was ultimately diagnosed with shingles and later diagnosed with post herpetic neuralgia following chronic pain after the shingles outbreak. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient suffered severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The events were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Trigeminal neuralgia
Clinical narrative: postherpetic neuralgia; trigeminal neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered severe sudden pain on the right side of his forehead and right temple region. The patient presented to his medical provided and was diagnosed with postherpetic neuralgia and trigeminal neuralgia. Despite receiving treatment, the patient continued suffering from postherpetic neuralgia and trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient symptoms resulted in physical limitation not present prior to zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's conditions. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, included medical expenses; loss of accumulation; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of postherpetic neuralgia and trigeminal neuralgia were considered to be disabling.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Extra dose administered, Oral administration complication, Regurgitation
Clinical narrative: patient regurgitated one dose of ROTATEQ; second dose of ROTATEQ due to the regurgitated dose being viewed as an incomplete dose; This spontaneous report was received from a registered nurse via company representative, referring to a 4 month old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, for routine vaccination (strength, dose, frequency, lot# and expiration date were not reported).   On an unknown date, the patient regurgitated one dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (infantile spitting up). It was reported that the patient did not seek medical attention and was unknown if diagnostic laboratories were performed.  On an unknown date (reported as "one week after initial dose"), the patient received a second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) due to the regurgitated dose (extra dos administered), which was viewed as an incomplete dose.   At the time of reporting, the outcome of infantile spitting up was reported as resolved on an unknown date. The causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improper storage conditions during shipping; This spontaneous report was received from a nurse refers to a 67 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 16-SEP-2019, the product was received and stored appropriately in the refrigerator. On 17-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection of lot # S012246 with expiry date 10-FEB-2021 (strength, dose, frequency, route of administration, date unspecified) for prophylaxis, which was deemed by the wholesaler to have been shipped outside of appropriate shipping temperature conditions (product storage error). The office was notified on 18-SEP-2019 about the improper temperature conditions during shipping. No adverse effects reported (no adverse event). There was no previous temperature excursion reported. Digital data logger was not involved. The outcome of the event was unknown.  This is one of two reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 25-JUN-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005979: US-009507513-1909USA008230: US-009507513-1909USA008228: US-009507513-1909USA008229:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 30-MAY-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA008227: US-009507513-1909USA005979: US-009507513-1909USA008230: US-009507513-1909USA008229:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 24-MAY-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005979: US-009507513-1909USA008228: US-009507513-1909USA008230: US-009507513-1909USA008227:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unspecified age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 15-MAY-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided US-009507513-). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA008229: US-009507513-1909USA008228: US-009507513-1909USA005979: US-009507513-1909USA008227:
Sex: M
Vaccine: HPV9, MENB
Symptoms: Migraine
Clinical narrative: extreme migraine; This spontaneous report was received from a medical assistant via company representative referred to a 17-year-old male patient.  The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for Human Papilloma Virus (HPV) infection prevention (prophylaxis) (dose, route, lot # and expiry date were not reported). The patient was also concurrently vaccinated with meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) for prophylaxis (dose, route, lot # and expiry date were not reported). On an unknown date, after the administration of suspect products, the patient's mother contacted the facility to inform that, the patient was experiencing extreme migraines (sought medical attention). The outcome of the event was not reported. The reporter did not provide any causality assessment. The product quality complaint was not involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events; Expired vaccine used; This spontaneous report was received from a pharmacist refers to a patient of unknown demographics.The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 19-SEP-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dosage information, route of administration and anatomical locations were unknown) of lot # N034512 with an expiry date of 13-SEP-2019 for prophylaxis (expired product administered). No adverse events reported. The outcome of expired product administered was unknown. No product quality complaint (PQC) reported.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Dysgeusia, Nausea, Paraesthesia oral
Clinical narrative: nausea; tingling on lips; bad taste in mouth; This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 51-year-old male patient who received HAB (Twinrix adult) (batch number 9355D, expiry date 14th March 2022) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Twinrix adult. On 27th August 2019, 1 hr after receiving Twinrix adult, the patient experienced nausea, tingling lips and dysgeusia. On an unknown date, the outcome of the nausea, tingling lips and dysgeusia were recovered/resolved.   It was unknown if the reporter considered the nausea, tingling lips and dysgeusia to be related to Twinrix adult.  Additional case details were reported as follows: The patient experienced nausea, tingling in lips, and bad taste in mouth. The events were resolved. The reporter consented to follow up. This is 2 of the 3 linked cases reported by the same reporter.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Lightheadedness; Sweating on palm of hands; Face felt numb; This case was reported by a other health professional via call center representative and described the occurrence of light headedness in a 47-year-old male patient who received HAB (Twinrix adult) (batch number 9355D, expiry date 14th March 2022) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Twinrix adult. On 27th August 2019, 1 hr after receiving Twinrix adult, the patient experienced light headedness, sweating increased palms and numbness facial. On an unknown date, the outcome of the light headedness, sweating increased palms and numbness facial were recovered/resolved.   It was unknown if the reporter considered the light headedness, sweating increased palms and numbness facial to be related to Twinrix adult.  Additional case details were reported as follows: The patient experienced lightheadedness, sweating on palm of hands, and face felt numb.  The events began about 1 hour after injection. The events were resolved. The reporter consented to follow up. This is 3 of the 3 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle swelling
Clinical narrative: Swelling in the bicep; This case was reported by a pharmacist via call center representative and described the occurrence of muscle swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle swelling. On an unknown date, the outcome of the muscle swelling was unknown.   It was unknown if the reporter considered the muscle swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was selected as per the vaccine indication. The reporter stated that the patient experienced swelling in the bicep. The doses were given within the past 2 months from the time of reporting and the swelling started within day after the vaccination. The reporter did not have any further information about the patient. This case has been linked with case US2019167103, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Headache; Chills; Achy; Slept all morning; Little nausea; This case was reported by a consumer and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and had no problem).   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, chills, pain, daytime sleepiness and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, chills, pain, daytime sleepiness and nausea were unknown.   It was unknown if the reporter considered the fever, headache, chills, pain, daytime sleepiness and nausea to be related to Shingrix.  Additional information received were as follows: A day before the reporting date, the patient received Shingrix and started experiencing symptoms that night. The patient experienced fever, headache, chills, achy, and a little nausea. On the reporting date, the patient did not went to work. The patient slept all morning for 4 hours and started to feel a little better compared to the morning on the reporting date. The patient had been taking Tylenol every 4 to 6 hours and thought that had helped. The patient had not reported these events to her doctor. The patient asked that how long would the side effects of the shingles shot last.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Fever; Headache; Chills; Achy; Slept all morning; Little nausea; This case was reported by a consumer and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and had no problem).   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, chills, pain, daytime sleepiness and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, chills, pain, daytime sleepiness and nausea were unknown.   It was unknown if the reporter considered the fever, headache, chills, pain, daytime sleepiness and nausea to be related to Shingrix.  Additional information received were as follows: A day before the reporting date, the patient received Shingrix and started experiencing symptoms that night. The patient experienced fever, headache, chills, achy, and a little nausea. On the reporting date, the patient did not went to work. The patient slept all morning for 4 hours and started to feel a little better compared to the morning on the reporting date. The patient had been taking Tylenol every 4 to 6 hours and thought that had helped. The patient had not reported these events to her doctor. The patient asked that how long would the side effects of the shingles shot last.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Severe pain; Swelling at the site; Bruising; Shoulder pain; Not back to normal activities; Extreme fatigue; No strength; dizziness; Foggy head; Couldn't sleep; diarrhea; freezing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019 01:00, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced diarrhea, feeling cold, fatigue, weakness, dizziness, foggy feeling in head and sleeplessness. On 5th September 2019 05:00, the patient experienced pain in arm, injection site swelling, injection site bruising, shoulder pain and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site bruising, shoulder pain, sleeplessness and activities of daily living impaired were unknown and the outcome of the diarrhea, fatigue and weakness were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved and the outcome of the dizziness and foggy feeling in head were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site swelling, injection site bruising, diarrhea, feeling cold, fatigue, weakness, shoulder pain, dizziness, foggy feeling in head, sleeplessness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had severe pain and swelling at the site with bruising. She noted these began about 5pm and her vaccine received on at 1pm. She noted these also extended up into her shoulder area.  She does believe the vaccine was given in the muscle but noted she was only 4 feet 11 inches and 95 pounds.     She noted she did report these events to her physician via a message portal but has not been seen by her physician, who noted these did not require follow up.The patient states also on Thursday evening she had diarrhea, that has improved but not resolved. She was freezing but that resolved after 24 hours. She had extreme fatigue and no strength, which has gotten better but not resolved. She noted she had to cancel a vacation. She also had dizziness and what foggy head that continue but have improved.She noted she couldn't sleep due to the pain in her arm and shoulder. She was not back to normal activity but feels she is about 80 percent better.    The patient noted the continued issues are occurring longer than expected and was concerned about the long term effects would be.   The patient was referred to her physician and shared the information from post marketing adverse event reports from the prescribing Information.That document was also being emailed to the consumer. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site bruising, Injection site swelling, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Severe pain; Swelling at the site; Bruising; Shoulder pain; Not back to normal activities; Extreme fatigue; No strength; dizziness; Foggy head; Couldn't sleep; diarrhea; freezing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019 01:00, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced diarrhea, feeling cold, fatigue, weakness, dizziness, foggy feeling in head and sleeplessness. On 5th September 2019 05:00, the patient experienced pain in arm, injection site swelling, injection site bruising, shoulder pain and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site bruising, shoulder pain, sleeplessness and activities of daily living impaired were unknown and the outcome of the diarrhea, fatigue and weakness were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved and the outcome of the dizziness and foggy feeling in head were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site swelling, injection site bruising, diarrhea, feeling cold, fatigue, weakness, shoulder pain, dizziness, foggy feeling in head, sleeplessness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had severe pain and swelling at the site with bruising. She noted these began about 5pm and her vaccine received on at 1pm. She noted these also extended up into her shoulder area.  She does believe the vaccine was given in the muscle but noted she was only 4 feet 11 inches and 95 pounds.     She noted she did report these events to her physician via a message portal but has not been seen by her physician, who noted these did not require follow up.The patient states also on Thursday evening she had diarrhea, that has improved but not resolved. She was freezing but that resolved after 24 hours. She had extreme fatigue and no strength, which has gotten better but not resolved. She noted she had to cancel a vacation. She also had dizziness and what foggy head that continue but have improved.She noted she couldn't sleep due to the pain in her arm and shoulder. She was not back to normal activity but feels she is about 80 percent better.    The patient noted the continued issues are occurring longer than expected and was concerned about the long term effects would be.   The patient was referred to her physician and shared the information from post marketing adverse event reports from the prescribing Information.That document was also being emailed to the consumer. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain; Swelling at the site; Bruising; Shoulder pain; Not back to normal activities; Extreme fatigue; No strength; dizziness; Foggy head; Couldn't sleep; diarrhea; freezing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019 01:00, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced diarrhea, feeling cold, fatigue, weakness, dizziness, foggy feeling in head and sleeplessness. On 5th September 2019 05:00, the patient experienced pain in arm, injection site swelling, injection site bruising, shoulder pain and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site bruising, shoulder pain, sleeplessness and activities of daily living impaired were unknown and the outcome of the diarrhea, fatigue and weakness were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved and the outcome of the dizziness and foggy feeling in head were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site swelling, injection site bruising, diarrhea, feeling cold, fatigue, weakness, shoulder pain, dizziness, foggy feeling in head, sleeplessness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had severe pain and swelling at the site with bruising. She noted these began about 5pm and her vaccine received on at 1pm. She noted these also extended up into her shoulder area.  She does believe the vaccine was given in the muscle but noted she was only 4 feet 11 inches and 95 pounds.     She noted she did report these events to her physician via a message portal but has not been seen by her physician, who noted these did not require follow up.The patient states also on Thursday evening she had diarrhea, that has improved but not resolved. She was freezing but that resolved after 24 hours. She had extreme fatigue and no strength, which has gotten better but not resolved. She noted she had to cancel a vacation. She also had dizziness and what foggy head that continue but have improved.She noted she couldn't sleep due to the pain in her arm and shoulder. She was not back to normal activity but feels she is about 80 percent better.    The patient noted the continued issues are occurring longer than expected and was concerned about the long term effects would be.   The patient was referred to her physician and shared the information from post marketing adverse event reports from the prescribing Information.That document was also being emailed to the consumer. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle swelling
Clinical narrative: Swelling in the bicep; This case was reported by a pharmacist via call center representative and described the occurrence of muscle swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle swelling. On an unknown date, the outcome of the muscle swelling was unknown.   It was unknown if the reporter considered the muscle swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that the patient experienced swelling in the bicep. The doses were given within the past 2 months from the time of reporting and the swelling started within day after the vaccination. The reporter did not have any further information about the patient. This case has been linked with case US2019AMR167772, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash, Injection site warmth
Clinical narrative: Felt like had the flu; Rash at injection site; Warmth at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, injection site rash and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, injection site rash and injection site warmth were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site rash and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient felt like he had the flu and developed a rash and warmth at the injection site. The healthcare professional reported via chat and the conversation was dropped before any additional details could be given. The reporter stated follow up not required.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling; This case was reported by a other health professional via call center representative and described the occurrence of swollen tongue in a 35-year-old male patient who received HAB (Twinrix adult) (batch number 9355D, expiry date 14th March 2022) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Twinrix adult. On 27th August 2019, 1 hr after receiving Twinrix adult, the patient experienced swollen tongue. Twinrix adult was continued with no change. On an unknown date, the outcome of the swollen tongue was recovered/resolved.   It was unknown if the reporter considered the swollen tongue to be related to Twinrix adult.  Additional case details were reported as follows: The patient experienced tongue swelling about 1 hour after the injection. The event was resolved. The reporter consented to follow up. This is 1 of the 3 linked cases reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Incorrect route of product administration, Peripheral swelling
Clinical narrative: Inappropriate route of vaccination; Arm bruised; Arm swelled; This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 9th September 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 9th September 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In September 2019, the patient experienced bruising of arm and swelling arm. On an unknown date, the outcome of the bruising of arm and intramuscular formulation administered by other route were unknown and the outcome of the swelling arm was not recovered/not resolved.   It was unknown if the reporter considered the bruising of arm and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm, subcutaneously which led to an incorrect route of product administration. The patient's arm bruised and swelled.  The swelling was going down and the patient felt fine.  At the time of this report, the swelling has not completely resolved. The reporter agreed to recontact but said she was not always at the store.  Patient safety could call if details were needed. The reporter consented to follow up. In the XML document outcome of swelling arm was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Nausea, Tenderness, Vomiting
Clinical narrative: nausea; vomiting; soreness/ sore arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 18th September 2019, the patient experienced nausea and vomiting. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received Shingrix in her left arm. The patient had a sore arm at the injection site. The soreness had mostly resolved on 18th September 2019 but she was experiencing nausea and vomiting which was unresolved. The patient consented to follow up. There was a discrepancy in the reported outcomes of the events tenderness nausea and vomiting. In XML, outcome was mentioned as recovering/resolving and in case narrative, it was reported as not recovered. However outcome of these events is captured as per narrative.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: nausea; vomiting; soreness/ sore arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 18th September 2019, the patient experienced nausea and vomiting. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received Shingrix in her left arm. The patient had a sore arm at the injection site. The soreness had mostly resolved on 18th September 2019 but she was experiencing nausea and vomiting which was unresolved. The patient consented to follow up. There was a discrepancy in the reported outcomes of the events tenderness nausea and vomiting. In XML, outcome was mentioned as recovering/resolving and in case narrative, it was reported as not recovered. However outcome of these events is captured as per narrative.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Neck pain, Pain in extremity, Vomiting
Clinical narrative: nausea; vomiting; soreness/ sore arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 18th September 2019, the patient experienced nausea and vomiting. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received Shingrix in her left arm. The patient had a sore arm at the injection site. The soreness had mostly resolved on 18th September 2019 but she was experiencing nausea and vomiting which was unresolved. The patient consented to follow up. There was a discrepancy in the reported outcomes of the events tenderness nausea and vomiting. In XML, outcome was mentioned as recovering/resolving and in case narrative, it was reported as not recovered. However outcome of these events is captured as per narrative.
Age: 5.0
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Ipol was given yesterday to a patient, but it expired on August 2nd 2019, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old patient who was inadvertently vaccinated with an expired dose of 0.5 mL IPV (VERO) [IPOL] lot N1G511M via intramuscular route in unknown administration site (right dosterm was reported) on an unknown date which was expired in 02-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included- VARICELLA ZOSTER VACCINE (Flu vaccine) and VARICELLA ZOSTER VACCINE (Varicella).  It is an actual medication error case due to expired vaccine used.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given a 5th dose of Pentacel, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old patient of an unknown gender who received a fourth and fifth doses of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number, expiry date, dose, route and site of administration were not reported) on an unknown date.  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 extra dose administered. It was reported that the interval between the 4th and 5th administrations was 12 weeks and 3 days.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9-week-old patient that received a dose of Fluzone Quadrivalent; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 weeks old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that 9-week-old patient that received a dose of Fluzone Quadrivalent (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL).  On 13-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UJ209AA and expiry date: 30-Jun-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: extreme temperature for an unknown cumulative time of exposure; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves an 8 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that extreme temperature for an unknown cumulative time of exposure (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 12-Sep-2019, the patient received one dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UJ237AB and expiry date: 30-Jun-2020 via unknown route in the right arm.  It was a case of actual medication error due to incorrect product storage.  It was unknown 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 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.