chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Myalgia, Pruritus, Reaction to previous exposure to any vaccine
Clinical narrative: itch on her chest/body wide including her scalp, legs, feet, and back/itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included covid-19. Previously administered products included flu shot with an associated reaction of myalgia (flu shots over the years without any kind of reaction other than muscle soreness- refer case id-US2020AMR187003).   On 13th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular) .5 ml. On 13th September 2020, less than a day after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced pruritus. The patient was treated with hydrocortisone. On an unknown date, the outcome of the pruritus was recovering/resolving.   The reporter considered the pruritus to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had had many flu shots over the years without any kind of reaction other than muscle soreness.  She began to itch on her chest near her left shoulder. Then it went body wide including her scalp, legs, feet, and back.  There was no rash and she has been using hydrocortisone to help with the itch. She says it is better today but it hasn't resolved completely. She doesn't know if this would have anything to do with the itching, but both she and her husband suffered with Covid 19 this year. The patient was very pleasant, walked through the questions that she had, took my information, and she was very, very pleasant, very professional, the patient felt like she was a really good person to have on the phone.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR187003:same patient
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Systemic hives 2 hours after. 50 mg benadryl taken.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Fatigue, Headache, Pain, SARS-CoV-2 test negative
Clinical narrative: Received Flu vaccine required by job, given by job (hospital). Within 24 hours, had body aches.  within 48 hours had wheezing, crushing trachea pressure, short of breath.  Within  72 hours, extreme exhaustion and headache.  Headache continues and some exhaustion on day 5 post injection.  Symptoms improving. Never had a fever.  Got tested for Covid 19, nasal swab on Day 4 post injection.  Results negative.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Received Flu vaccine required by job, given by job (hospital). Within 24 hours, had body aches.  within 48 hours had wheezing, crushing trachea pressure, short of breath.  Within  72 hours, extreme exhaustion and headache.  Headache continues and some exhaustion on day 5 post injection.  Symptoms improving. Never had a fever.  Got tested for Covid 19, nasal swab on Day 4 post injection.  Results negative.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Metamorphopsia, Visual impairment
Clinical narrative: EXTREME Less than 2 hours after the injection my eyes starting  started bothering me.   All of a sudden , both eyes were extremely bad. My vision was frightening.   I saw a vertical dark (black but  could see through) filter, moving across my vision horizontally. My vision was a wave (dimensional) moving horizontal with a dark (see thru black filter) moving across it.  I could still see, but totally distorted.  Never in my life have I had anything like this.  I am not sure exactly how long  this lasted, maybe 15 - 20 minutes.  I sat down and covered my eyes and did not move for over 1.5 hours.   I did not call an ambulance,  because at that point  I knew it was a reaction. If it did not stop I would of called an ambulance.  Yesterday (Monday) I  went back to and told the pharmacist about my reaction.  This reaction was horrible.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Angioedema, Cellulitis, Injection site reaction, Skin warm
Clinical narrative: Skin Reaction: potential cellulitis or angioedema in right arm near site of injection for Kinrix (DTAP-IPV).  Patient denies respiratory symptoms or fever.  Site of reaction warm to touch compared to other parts of the skin. Patient referred to PCM for further evaluation with post referral to emergency room for observation.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No additional AE reported; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; administered Pneumovax 23 syringe the needle was faulty and medication leaked out; This spontaneous report was received from a pharmacist, concerning a 69-years-old male patient. The patient's concurrent conditions, concomitant medications, historical conditions and drug allergies or reactions were not reported.   On 16-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot number S024808 with expiration date reported and validated as 02-JUN-2021 (strength, dose, route of administration, and anatomical site of injection were not reported) as prophylaxis.   It was stated that during the administration the needle was faulty (syringe issue) and some medication leaked out (product leakage/incorrect dose administrated/poor quality device used). Additionally, it was reported that the needle was attached to the syringe tip before leaking occurred and the syringe was disposed by the pharmacist. No additional adverse event reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Reaction to preservatives
Clinical narrative: rapid heart rate; being allergic to monosodium L-glutamate; This spontaneous report was received from a consumer, referring to a female patient of unknown age. The patient's pertinent medical history and concomitant medication were unknown. Drug reaction/allergy included monosodium L-glutamate.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.  The patient reported that zoster vaccine live (ZOSTAVAX) contained the ingredient monosodium L-glutamate that gave her (also reported as them) a rapid heart rate. She also reported being allergic to monosodium L-glutamate. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No aditional adverse effect reported; patient recieved expired PROQUAD; This spontaneous report has been received from a licensed practical nurse concerning to a patient of an unknown age and gender. Information concerning patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 22-SEP-2020, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHa) (PROQUAD) (lot # S008574, expiration date 16-SEP-2020) (dosage regimen and route of administration were not reported) as prophylaxis. No additional adverse effect was reported.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Allergy test negative, Urticaria
Clinical narrative: He has tested the patient for allergic reaction to the flu shot and she is negative; hives; This spontaneous report was received from a physician referring to a 12 year old female patient with allergy to shrimp/shellfish. The patient's pertinent medical history and concomitant medications were unknown by reporter.      On 13-NOV-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) by intramuscular route for prophylaxis (indication also reported as "HPV for age hpv and flu vaccine") and received a flu shot (influenza virus vaccine (unspecified)). The immunizations were given at a different providers office. later, on this same vaccination date, patient developed hives and took diphenhydramine (BENADRYL); patient had no other sign and symptoms. One day after, on 14-NOV-2019, she recovered from this condition. Physician requested information to advise of patient should take the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or was there a way to refine of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the cause of the hives. Physician had tested the patient for allergic reaction to the flu shot and she was negative (allergy test negative). He did not know a way to test for allergic reaction to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No product was retrieved as the immunization was given almost a year ago.  At reporting time, the outcome of allergy test negative was unknown. The causality assessment was not reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Fridge was high at 46.13 no alarm, someone open frudge that caused alarm to go off; This spontaneous report was received from a Nurse referring to a 19 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, and anatomical location were unknown) first dose with lot # R030456 and expiration date reported as July 2021, but upon internal validation established a 23-JUL-2021, via intramuscular route for prophylaxis.   There was a digital data logger involved, it was reported that the fridge was high at 46.13 °F degrees Fahrenheit  with no alarm, it seemed that someone opened the fridge and caused the alarm to go off. Additionally, it took 3 days to the Nurse to report the excursion, it was reported that the minimum temperature was 37.23 °F degrees Fahrenheit  and the maximum temperature was 47.65  °F degrees Fahrenheit  with an undefined duration in with alarm report, and the minimum temperature was 36.46 °F degrees Fahrenheit and the maximum temperature was 43.30  °F degrees Fahrenheit  with an undefined duration with the no alarm report . combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA002514: US-009507513-2009USA009583: US-009507513-2009USA009587:
Age: 22.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: Fridge was high at 46.13 no alarm, someone open frudge that caused alarm to go off; This spontaneous report was received from a Nurse referring to a 22 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 01-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, dose number, frequency, and anatomical location were unknown) with lot # R030456 and expiration date reported as July 2021, but upon internal validation established a 23-JUL-2021, via intramuscular route for prophylaxis.   There was a digital data logger involved, it was reported that the fridge was high at 46.13 °F degrees Fahrenheit  with no alarm, it seemed that someone opened the fridge and caused the alarm to go off. Additionally, it took 3 days to the Nurse to report the excursion, it was reported that the minimum temperature was 37.23 °F degrees Fahrenheit  and the maximum temperature was 47.65 °F degrees Fahrenheit with an undefined duration in the alarm report, and the minimum temperature was 36.46 °F degrees Fahrenheit and the maximum temperature was 43.30 °F degrees Fahrenheit  with an undefined duration in the no alarm report . combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA009568: US-009507513-2009USA009587: US-009507513-2009USA002514:
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Fridge was high at 46.13 no alarm, someone open frudge that caused alarm to go off; This spontaneous report was received from a Nurse referring to a 26 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, and anatomical location were unknown) first dose with lot # R030456 and expiration date reported as July 2021, but upon internal validation established a 23-JUL-2021, via intramuscular route for prophylaxis.   There was a digital data logger involved, it was reported that the fridge was high at 46.13 °F degrees Fahrenheit  with no alarm, it seemed that someone opened the fridge and caused the alarm to go off. Additionally, it took 3 days to the Nurse to report the excursion, it was reported that the minimum temperature was 37.23 °F degrees Fahrenheit  and the maximum temperature was 47.65  °F degrees Fahrenheit  with an undefined duration in with alarm report, and the minimum temperature was 36.46 °F degrees Fahrenheit and the maximum temperature was 43.30  °F degrees Fahrenheit  with an undefined duration with the no alarm report . combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA009583: US-009507513-2009USA009568: US-009507513-2009USA002514:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient was inadvertently administered a dose of MMR II which expired on 6/2/2018; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.  On 23-SEP-2020, the patient was inadvertently a dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II) (strength and route of administration not reported; lot # M027637 and expiration date 02-JUN-2018) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 10-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the 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. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and the patient (pt) on 24-SEP-2020, referring to a pt of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster related conditions by a health care provider (HCP). On an unspecified date, the pt suffered and subsequently treated by a nurse practitioner for the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt 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. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and the patient (pt) on 24-SEP-2020, referring to a pt of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-OCT-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster related conditions by a pharmacist. On an unspecified date, the pt suffered and subsequently treated by a physician for the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt 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. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: very sleepy; This case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced sleepiness. On an unknown date, the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the sleepiness 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 it was selected as adult as per the vaccine indication. The patient received Shingrix and feel sleepiness.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint pain; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain and muscle pain. On an unknown date, the outcome of the joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself/herself.  The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient enquired what could be taken to alleviate muscle and joint pain due to shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headaches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The reporter asked how long do headaches from the Shingrix vaccine last.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: headaches / can headaches last this long after the shot?; fever; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix. In September 2020, immediately after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient received the first dose and every day since then the patient experienced headache, some fever.  The patient had no fever the past 3 days but still headaches on the day of reporting. The reporter asked could headaches last this long after the shot.
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: blacked out intermittently without loss of consciousness; Dizziness/felt verylightheaded; This case was reported by a nurse via sales rep and described the occurrence of blackout in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero .5 ml. On an unknown date, unknown after receiving Bexsero, the patient experienced blackout (serious criteria GSK medically significant) and light headedness. On an unknown date, the outcome of the blackout and light headedness were unknown.   It was unknown if the reporter considered the blackout and light headedness to be related to Bexsero.  Additional details were as follows: The age at vaccination was not reported.  After receiving 1st dose of Bexsero, the patient experienced dizziness, felt very lightheaded and blacked out intermittently without loss of consciousness. The HCP said patient denied any fainting or syncopal episodes. The MSL called HCP back and left message since HCP was with patients. The reporter consented to follow up. This case has been linked with US2020AMR182434 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR182434:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: lymph node on the right side of her neck swelled; This case was reported by a nurse via call center representative and described the occurrence of enlargement of lymph nodes in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2020, the patient received the 1st dose of Shingrix. On 4th September 2020, 8 hrs after receiving Shingrix, the patient experienced enlargement of lymph nodes. The patient was treated with BENADRYL (NOS) (BENADRYL). On an unknown date, the outcome of the enlargement of lymph nodes was recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were reported as follows: The case was reported by the nurse who reported for herself. The patient received the 1st dose of Shingrix and experienced  swelling of lymph node after 8 hours of vaccination which is recovered till the time of of reporting. The patient has taken benadryl for treatment of enlargement of lymph nodes which is resolved after 2 hours. The reporter did not consented to follow up. No further information was available.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: big round circle around the injection site. It was puffed up and red; big round circle around the injection site. It was puffed up and red; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z5N5G, expiry date 30th June 2021) for prophylaxis.   On 17th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 17th September 2020, less than a day after receiving Fluarix Quadrivalent 2020-2021 season, 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 Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination not reported. The patient received Fluarix Quadrivalent 2020-2021 season and experienced a big round circle around the injection site,It was puffed up and red,which is recovered. The reporter consented to follow up. The reporter did not provided any other information. This case was linked with case id US2020189720 and US2020189733 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189720:same reporter US-GLAXOSMITHKLINE-US2020189733:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Inappropriate schedule of product administration, Oral herpes, Sunburn
Clinical narrative: Bell's Palsy; Fever Blister; lips became sunburnt; first injection of Shingrix in September 2019/second injection of Shingrix in April, 2020; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling face (received 1st dose in September 2019 and experienced swelling of her lymph nodes in her neck, swelling in face and right arm was sore). Concurrent medical conditions included fever blister.   In April 2020, the patient received the 2nd dose of Shingrix (intramuscular). In April 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2020, the patient experienced fever blister and sunburn. In September 2020, the patient experienced bell's palsy (serious criteria GSK medically significant). The patient was treated with ibuprofen. On an unknown date, the outcome of the bell's palsy, fever blister, sunburn and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the bell's palsy, fever blister and sunburn to be related to Shingrix.  Additional details were provided as follows:  The patient received 2nd dose of shingrix and at the end of July, lips became sunburnt, 3  fever blisters and bell's palsy this week. The patient received 2nd dose of shingrix, more than the recommended interval, which led to lenghetening of vaccination schedule. The patient received ibuprofen prophylactically and did not experienced symptoms. The patient received 1st dose of shingrix in September 2019 and experienced swelling of her lymph nodes in her neck, swelling in face and right arm was sore and was treated with ibuprofen and symptoms disappeared next day. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR191361:same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site warmth
Clinical narrative: red hot circle in the injection area; red hot circle in the injection area; administered first dose of Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 21st September 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported the physician administered 1sr dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient had a red hot circle in the injection area after the vaccination, which was not recovered till the time of reporting. The reporter did not consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: Dtap series were given at 6 months, 2 and 3rd in three years of age and fourth dose after he turned 4 years old (4 months apart of third dose) /No AE; Initial information was received on 10-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 4-year-old male patient who received four doses of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (inappropriate schedule of product administration).  Medical history, past medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  The patient received, first, second and third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at the age of 6 month, 3 year and later but still at 3 year respectively via an unknown route at an unknown administration site for prophylactic vaccination.  In 2015, on an unknown date (4 months apart of third dose), the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C4751AA, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate schedule of vaccine administered. Reporter he asked if the 4th dose would be considered valid because the school is concerned and iIf it is not valid, she asked if ADACEL would be ok to use even though the patient is below age 10.  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 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: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the patient was given Pentacel in the left thigh and a other Hib vaccination in the right thigh on the same office visit/ NO AE; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 15-months-old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB VACCINE [HIB VACCINE] on the same visit (extra dose administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccination included a dose of hepatitis A vaccine on 21-Aug-2020 (on same visit).  On 21-Aug-2020, the patient received a dose of 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ214AAA and expiry date: 02-May-2021) in the left thigh and a dose of HIB VACCINE [HIB VACCINE] in the right thigh on the same visit for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  Reporter wanted to know if extra dose administration would hurt the patient and recommendations.  At the time of reporting, 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 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: PENTACEL was given without the powder to a patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional (medical assistant).  This case involves a four-months-old female patient who was vaccinated with a 0.5 mL second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ344AA and expiration date 04-Apr-2021) via an intramuscular route in the left vastus lateralis on 26-Aug-2020 for prophylactic vaccination however only powder portion of pentacel was given to the patient.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with a dose of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  This was an actual medication error case due to active ingredient not added to diluent (latency was same day).  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.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Wrong product administered
Clinical narrative: redness and soreness at the injection site; redness at the injection site; soreness at the injection site; patient received Menactra insted of Tuberculin; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 41 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of TUBERCULIN PPD (TUBERCULIN TEST)(wrong product administered) and experience redness and soreness at the injection site (vaccination site inflammation, vaccination site erythema and vaccination site pain).    Medical history, past medical treatments, past vaccination and family history were not provided.  No other vaccines were administered concomitantly.  On 09-Sep-2020, patient went for TB test and accidently grabbed and administered a 0.1 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6560BA, expiry date: 02-Apr-2021] once via an intradermal route at the right forearm instead of TUBERCULIN PPD for prophylactic vaccination (wrong product administered- same day latency).  On an unknown date, the patient developed a non-serious redness and soreness at the injection site (vaccination site inflammation with symptom of vaccination site erythema and vaccination site pain) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  No laboratory data was provided.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for redness and soreness at the injection site.  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.
Age: 56.0
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient was given back to back Flublok vaccines in different arms, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 56 years old male patient who was given back to back 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number QFAA2017 and expiration date:30-Jun-2021 (same batch numbers of both regimens)) via intramuscular route in different arms that is one in the right deltoid and other in the left deltoid as prophylactic vaccination on 15-Sep-2020 (extra dose administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive concomitant medications.  It was an actual medication error case due to extra dose administered (same day latency).  No adverse event reported at the time of reporting.  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: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 year old male patient was inadvertently administered an expired Quadracel, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four year old male patient who was vaccinated with an expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] inadvertently (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 15-Sep-2020, the patient received a 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (single vial) (lot C5560CA and expiry date: 16-Aug-2020) via an unknown route in the left leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (same day latency).  At the time of report, no adverse reactions was reported.  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: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: dose of PENTACEL was given to a child on a catch up schedule and due to it being a combination vaccine she received a extra polio dose, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 25 months old female patient who was vaccinated with 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ260AAA Expiration date:14-May-2021) on a catch up schedule and due to it being a combination vaccine she received a extra polio dose (PT: extra dose administered) via unknown route in the left vastus lateralis  for prophylactic vaccination on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination on an unspecified date.  It was an actual medication error case due to extra dose administered. The patient has received 4 doses of IPV, 4 doses of DTaP and 3 doses of Hib.    No adverse event reported at the time of reporting.  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.