chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Upon wakening next day patient experienced redness, warmth, tenderness and swelling. Affected area was below shoulder to above elbow and described as "baseball". Also hard to touch. Started improving by 4th day after injection.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS, FLU4, TDAP, VARZOS
Symptoms: Back pain, Body temperature increased, Headache, SARS-CoV-2 test negative, Tenderness
Clinical narrative: Received call from client on 10/5/2020. Has been having lower back pain with legs painful to touch since 10/01/2020. Verbalized it hurts to shave my legs. Has been taking ibuprofen every 6 hours. Advised to call PCP who ordered cortisone 20 mg tablets daily x10 days and Ibuprofen 600mg every 6 hours. Client also tested for COVID. 10/6/2020 Client now reports severe headaches. 10/07/2020 Client called that she continues with severe headaches. Tested negative for COVID. 10/08/2020 Called client who continues with headaches and developed temp of 100.8 last night. Took Aleve tablets with some relief of headache. Verbalized back and legs have been better since 10/07/2020. 10/13/2020 Spoke to client. Had to visit ER twice 10/13/2020 Spoke to client. Had to visit ER twice due to severe headaches. Had CT of head done which was normal. Given rx for headache. 10/20/2020. Client verbalizes feeling better. Gets occasional headaches and sometimes feels off balance. Taking Ibuprofen for headaches as she did not like rx given last week. RN 11/12/2020 Received call from Client on 11/11/2020. Has been experiencing headaches and skin from axilla to below breasts has felt irritated for past 3 days. States skin is very sensitive to touch. Does not know if it is re-occurrence  of previous symptoms. Was seen by Dr but states headache medication did not help.  RN 11/16/2020 Client in building. Developed scattered vesicles to chest about 3 days ago. States they are itching. Recommended she apply topical cortisone cream and could take Benadryl for relief also. RN
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS, FLU4, TDAP, VARZOS
Symptoms: Back pain, Body temperature increased, Computerised tomogram head normal, Headache, SARS-CoV-2 test negative
Clinical narrative: Received call from client on 10/5/2020. Has been having lower back pain with legs painful to touch since 10/01/2020. Verbalized it hurts to shave my legs. Has been taking ibuprofen every 6 hours. Advised to call PCP who ordered cortisone 20 mg tablets daily x10 days and Ibuprofen 600mg every 6 hours. Client also tested for COVID. 10/6/2020 Client now reports severe headaches. 10/07/2020 Client called that she continues with severe headaches. Tested negative for COVID. 10/08/2020 Called client who continues with headaches and developed temp of 100.8 last night. Took Aleve tablets with some relief of headache. Verbalized back and legs have been better since 10/07/2020. 10/13/2020 Spoke to client. Had to visit ER twice 10/13/2020 Spoke to client. Had to visit ER twice due to severe headaches. Had CT of head done which was normal. Given rx for headache. 10/20/2020. Client verbalizes feeling better. Gets occasional headaches and sometimes feels off balance. Taking Ibuprofen for headaches as she did not like rx given last week. RN 11/12/2020 Received call from Client on 11/11/2020. Has been experiencing headaches and skin from axilla to below breasts has felt irritated for past 3 days. States skin is very sensitive to touch. Does not know if it is re-occurrence  of previous symptoms. Was seen by Dr but states headache medication did not help.  RN 11/16/2020 Client in building. Developed scattered vesicles to chest about 3 days ago. States they are itching. Recommended she apply topical cortisone cream and could take Benadryl for relief also. RN
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS, FLU4, TDAP, VARZOS
Symptoms: Tenderness
Clinical narrative: Received call from client on 10/5/2020. Has been having lower back pain with legs painful to touch since 10/01/2020. Verbalized it hurts to shave my legs. Has been taking ibuprofen every 6 hours. Advised to call PCP who ordered cortisone 20 mg tablets daily x10 days and Ibuprofen 600mg every 6 hours. Client also tested for COVID. 10/6/2020 Client now reports severe headaches. 10/07/2020 Client called that she continues with severe headaches. Tested negative for COVID. 10/08/2020 Called client who continues with headaches and developed temp of 100.8 last night. Took Aleve tablets with some relief of headache. Verbalized back and legs have been better since 10/07/2020. 10/13/2020 Spoke to client. Had to visit ER twice 10/13/2020 Spoke to client. Had to visit ER twice due to severe headaches. Had CT of head done which was normal. Given rx for headache. 10/20/2020. Client verbalizes feeling better. Gets occasional headaches and sometimes feels off balance. Taking Ibuprofen for headaches as she did not like rx given last week. RN 11/12/2020 Received call from Client on 11/11/2020. Has been experiencing headaches and skin from axilla to below breasts has felt irritated for past 3 days. States skin is very sensitive to touch. Does not know if it is re-occurrence  of previous symptoms. Was seen by Dr but states headache medication did not help.  RN 11/16/2020 Client in building. Developed scattered vesicles to chest about 3 days ago. States they are itching. Recommended she apply topical cortisone cream and could take Benadryl for relief also. RN
Age: 53.0
Sex: F
Vaccine: DTAP, FLU4, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The patient reports having significant pain in her right arm and shoulder which started the day after she received these vaccines. She reports that since 10/21 she has had difficulty lifting objects with this arm, and difficulty using this arm in daily tasks such as dressing herself. If she rolls onto this arm in her sleep, the pain is enough to wake her up. The pain and decreased mobility do not seem to have improved over time.
Age: 53.0
Sex: F
Vaccine: DTAP, FLU4, TDAP
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: The patient reports having significant pain in her right arm and shoulder which started the day after she received these vaccines. She reports that since 10/21 she has had difficulty lifting objects with this arm, and difficulty using this arm in daily tasks such as dressing herself. If she rolls onto this arm in her sleep, the pain is enough to wake her up. The pain and decreased mobility do not seem to have improved over time.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Headache, Lethargy, Memory impairment, Nausea
Clinical narrative: Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; This spontaneous report was received from a consumer and referred to a 11-year-old white male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions or medical history provided. Concomitant therapies included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL XR).  On 21-OCT-2019, at 9:30, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) needle and syringe (not further specified), in the right arm  for prophylaxis (exact dose, lot #, expiration date, route of administration were not reported).  On 21-OCT-2019 at 20:00, the patient experienced extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever. This had happened several times in two days(comes and goes). No labs or tests had been performed yet. The outcome of the events was reported as not recovered/not resolved.  The causality assessment between the events and suspect therapy was not provided.  Follow-up information has been received from an unspecified person from the physician's office on 09-NOV-2020. The reporter stated that the office received a "VAERS form" from Merck but that she could not fill it out without the patient's name and date of birth. The reporter provided MARRS# 2010USA009715 and the case was reviewed. The patient's name and date of birth were anonymized in this case and could not be provided to assist with follow up. The reporter was unable to provide any follow up information and was thanked for her time. 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.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever; This spontaneous report was received from a consumer and referred to a 11-year-old white male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions or medical history provided. Concomitant therapies included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL XR).  On 21-OCT-2019, at 9:30, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) needle and syringe (not further specified), in the right arm  for prophylaxis (exact dose, lot #, expiration date, route of administration were not reported).  On 21-OCT-2019 at 20:00, the patient experienced extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever. This had happened several times in two days(comes and goes). No labs or tests had been performed yet. The outcome of the events was reported as not recovered/not resolved.  The causality assessment between the events and suspect therapy was not provided.  Follow-up information has been received from an unspecified person from the physician's office on 09-NOV-2020. The reporter stated that the office received a "VAERS form" from Merck but that she could not fill it out without the patient's name and date of birth. The reporter provided MARRS# 2010USA009715 and the case was reviewed. The patient's name and date of birth were anonymized in this case and could not be provided to assist with follow up. The reporter was unable to provide any follow up information and was thanked for her time. 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.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: a patient received a dose of PEDVAX HIB after it was stored outside of the recommended storage range; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history, and drug reactions or allergies.  On 30-OCT-2020, the patient received a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S036822 was confirmed to be valid, expiration date: 02-APR-2022) 1 dose for prophylaxis (strength, dose number, route of site of administration were not reported) after it was stored outside of the recommended storage range (product storage error). The outcome of product storage error was unknown. The vaccine was stored at a temperature of 8.6 Celsius degrees with a timeframe of 9 hours and 10 minutes. There was no previous temperature excursion. Digital data logger was involved.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a 1-year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.    On 02-NOV-2020, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported; 0.5 milliliter, lot # S035125, expiration date was reported as 04-NOV-2022, but upon internal review, it was established as 04-NOV-2021) for prophylaxis (product storage error). The vaccines were exposed to the following temperature excursions: -13.9 degrees Celsius to 14.7 degree Celsius; -14 degree Celsius to -10 degree Celsius, with an average of -13.9 degree Celsius for 30 minutes. -14 degree Celsius to -10 degree Celsius, with an average of -14.2 degree Celsius for 15 minutes; -14 degree Celsius to -10°C, with an average of -14.7 degree Celsius for 20 minutes and -14 degree Celsius to -10 degree Celsius, with an average of -14.6 degree Celsius for 5 minutes. Information regarding previous temperature excursions was not provided. The call was due to digital data logger.  The outcome of the event was unknown.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Biopsy skin abnormal, Chills, Headache, Injection site induration, Injection site necrosis
Clinical narrative: The doctor determined that patient had "skin necrosis"; Injection site became sensitive and a thin film developed on the skin; Injection site swelling; Injection site was hard; consumer started having headaches and body chills; consumer started having headaches and body chills; This spontaneous report was received from a 60 year old, former smoker female patient reporting on herself. The patient's concurrent conditions included allergy to sulfamethoxazole, trimethoprim (BACTRIM), the patient developed rash due to "antibiotics ointment". The patient's pertinent medial history was not reported.  On 31-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029542, expiration date reported as 06-OCT-2021, but upon internal validation established as 10-JUN-2021 (dose and route were not reported)  for prophylaxis. Concomitant therapies included potassium citrate, atorvastatin, thyroid (ARMOUR THYROID TABLETS), hydrochlorothiazide and "Duprofidon".     On 01-SEP-2020, the patient started having headaches and body chills (chills). The patient took ibuprofen (ADVIL). The next day on 02-SEP-2020, the injection site was hard (injection site induration) and swollen (injection site swelling). The patient contact with her doctor who prescribed her "PREDNOSONE" for 5 days. The swelling went down, but then on 07-SEP-2020 the skin at the injection site became sensitive (injection site hyperaesthesia) and a thin film developed on the skin. The patient stated that her doctor prescribed an unspecified antibiotic and did a biopsy of the skin. The doctor determined that she had "skin necrosis" (injection site necrosis) and then sent the patient to a surgeon who on 11-SEP-2020 removed the skin.  At the time of the report, the patient was recovering from the events. The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  "Skin necrosis" and then sent the patient to a surgeon who on 11-SEP-2020 removed the skin was considered to be medically significant by the reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Sensitive skin, Skin disorder, Skin operation
Clinical narrative: The doctor determined that patient had "skin necrosis"; Injection site became sensitive and a thin film developed on the skin; Injection site swelling; Injection site was hard; consumer started having headaches and body chills; consumer started having headaches and body chills; This spontaneous report was received from a 60 year old, former smoker female patient reporting on herself. The patient's concurrent conditions included allergy to sulfamethoxazole, trimethoprim (BACTRIM), the patient developed rash due to "antibiotics ointment". The patient's pertinent medial history was not reported.  On 31-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029542, expiration date reported as 06-OCT-2021, but upon internal validation established as 10-JUN-2021 (dose and route were not reported)  for prophylaxis. Concomitant therapies included potassium citrate, atorvastatin, thyroid (ARMOUR THYROID TABLETS), hydrochlorothiazide and "Duprofidon".     On 01-SEP-2020, the patient started having headaches and body chills (chills). The patient took ibuprofen (ADVIL). The next day on 02-SEP-2020, the injection site was hard (injection site induration) and swollen (injection site swelling). The patient contact with her doctor who prescribed her "PREDNOSONE" for 5 days. The swelling went down, but then on 07-SEP-2020 the skin at the injection site became sensitive (injection site hyperaesthesia) and a thin film developed on the skin. The patient stated that her doctor prescribed an unspecified antibiotic and did a biopsy of the skin. The doctor determined that she had "skin necrosis" (injection site necrosis) and then sent the patient to a surgeon who on 11-SEP-2020 removed the skin.  At the time of the report, the patient was recovering from the events. The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  "Skin necrosis" and then sent the patient to a surgeon who on 11-SEP-2020 removed the skin was considered to be medically significant by the reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient over 45 years of age may have received Gardasil 9; patient over 45 years of age may have received Gardasil 9; no additional adverse events reported; This spontaneous report was received from a pharmacist, via companny representative, referring to a male patient whose age was reported as over 45 years-old. The patient's medical history, drug reactions/allergies, and concomitant therapies were not reported. His concurrent conditions included genital warts.  The pharmacist reported that the patient may have recieved hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, on an unknown date (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error) (strength, dose, frequency, route of administration, lot number and expiration date were not provided). No additional adverse events were reported.      The outcome of the events was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired VAQTA administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 10-NOV-2020, the patient was accidently vaccinated with expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 milliliter, lot # S032055 was confirmed to be valid, expiration date 09-NOV-2020 (route and site of administration were not provided), for prophylaxis. The product was supported per post expiry memo for 3 months post expiration date. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: FLUN3
Symptoms: Feeling abnormal
Clinical narrative: THEY GAVE US THE NOSE ONE IN SCHOOL ITS A LIVE VACCINE AND MAKES YOU FEEL LIKE CRAP; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: NASK    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced they gave us the nose one in school its a live vaccine and makes you feel like crap (preferred term: Feeling abnormal).     The outcome of the event was unknown.    The event was considered non-serious.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Pain in extremity
Clinical narrative: arm soreness is also more than he had with the flu shot / sore arm lasting 1 -1.5 days; The cotton patch had 10 drops of blood, more than he saw after his flu shot in the same (left) arm 1 month ago; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm and injection site hemorrhage. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and injection site hemorrhage were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site hemorrhage to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu shot 1 month ago and experienced the effects as sore arm lasting 1 to 1.5 days. The patient was successfully treated with Tylenol. The reporter did not consent to follow up. This case has been linked with case US2020225610, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225610:same patient
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Increasing pain / in the left upper arm; Limited range of motion in the left upper arm; given FluLaval in the bursa instead of the muscle; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 37-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.  On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received FluLaval Tetra 2020-2021 season in the bursa instead of the muscle, which led to vaccine administered at inappropriate site. The reporter did not have patient or vaccine information at the time of call.   Follow up information received from other health professional on 12th November 2020: The patient received FluLaval Tetra 2020-2021 season intramuscularly in left deltoid. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. The patient experienced pain in arm and joint range of motion decreased. The VAERS details were updated.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: very sick with fever; chills; was very tired; very sick; could not get her 2nd dose on time due to Shingrix vaccine being on back order; the COVID-19 pandemic the reason she could not get her 2nd dose on time; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 3N7F2, expiry date 25th March 2020) for prophylaxis.   On 17th September 2018, the patient received the 1st dose of Shingrix. On 4th August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills, tiredness, sickness, product supply issue and social problem. On an unknown date, the outcome of the fever, chills, tiredness and sickness were recovered/resolved and the outcome of the product supply issue and social problem were unknown.   It was unknown if the reporter considered the fever, chills, tiredness and sickness to be related to Shingrix.  Additional details were provided as follows: The patient got her 1st Shingrix dose in her left arm.  The patient reported she got very sick with fever, chills and was very tired. The symptoms last one day or so. The patient got her 2nd vaccine dose in her left arm. The patient reported she had no reaction at all.  The patient stated that she could not get her 2nd dose on time due to Shingrix vaccine being on back order, which led to product supply issue.  The patient stated that after this it was the COVID-19 pandemic the reason she could not get the dose, which led to social problem. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10 cm round red circle around the injection site; small bump at the injection site; bump at the injection site and it is slightly warm to the touch.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The patient experienced 10 cm round red circle around the injection site, a small bump at the injection site and it was slightly warm to the touch. The reporter consented to follow up. This case is linked with case US2020222259, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222259:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: minor flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 69-year-old male 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 flu like symptoms. On an unknown date, the outcome of the flu like symptoms was recovered/resolved.   The reporter considered the flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's sister. After receiving Shingrix, the patient experienced minor flu-like symptoms. No further details were collected. Reporter provided limited information. This case was linked with case US2020223077, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223077:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: severe flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 68-year-old female 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 flu-like symptoms. On an unknown date, the outcome of the flu-like symptoms was recovered/resolved.   The reporter considered the flu-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's sister in law. After receiving Shingrix, the patient experienced severe flu-like symptoms. No further details were collected. Reporter provided limited information. This case was linked with case US2020223073, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223073:same reporter
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever / low grade fever; aches; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced fever, pain and fatigue. On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced fever, pain and fatigue which was resolved. The reporter consented to follow up directly with physician. No further information was available. This case was linked with case US2020223956,US2020223951 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223956:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: feel well; Gastrointestinal distress; Fatigue; Headache; spent the whole day in bed; This case was reported by a consumer via call center representative and described the occurrence of distress gastrointestinal in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2020, the patient received the 2nd dose of Shingrix. On 10th November 2020, less than a day after receiving Shingrix, the patient experienced distress gastrointestinal, fatigue, headache and loss of personal independence in daily activities. On 12th November 2020, the patient experienced unwell. On an unknown date, the outcome of the distress gastrointestinal, fatigue and headache were not recovered/not resolved and the outcome of the loss of personal independence in daily activities and unwell were unknown.   It was unknown if the reporter considered the distress gastrointestinal, fatigue, headache, loss of personal independence in daily activities and unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 2nd shot of Shingrix and 6-8 hours after the symptoms presented. The reporter had every symptom except shivering and fever. The patient confirmed gastrointestinal distress, fatigue to the point where she spent the whole day in bed and headache. The patient abruptly ended the call because she did not feel well. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eye swelling, Herpes zoster, Ocular hyperaemia
Clinical narrative: Could be shingles according to the Dr. but they are not sure; Redness / in the eye; Swelling in the eye; Soreness in the eye; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced shingles, eye red, eye swelling and soreness in eyes. On an unknown date, the outcome of the shingles was unknown and the outcome of the eye red, eye swelling and soreness in eyes were not recovered/not resolved.   It was unknown if the reporter considered the shingles, eye red, eye swelling and soreness in eyes to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and after that experienced redness, soreness and swelling in the eye, could be shingles according to the physician but they were not sure. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: little cold which was not too bad; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case is linked to cases 2020SA305222, 2020SA305230, 2020SA305270, 2020SA305371, 2020SA305401, 2020SA305420, 2020SA305444, 2020SA305474, 2020SA305488, 2020SA305527, 2020SA305545, 2020SA305591, 2020SA305629 and 2020SA305651 (same reporter).  This case involves a male patient (age unspecified) who had little cold which was not too bad (nasopharyngitis), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a little cold which was not too bad (nasopharyngitis) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The patient got the cold before flu shot settled in the 2 weeks duration. The patient was feeling much better now though  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was recovering.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via regulatory authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310462, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  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
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310464, 2020SA310557, 2020SA310558, 2020SA310559 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  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
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310464, 2020SA310559 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  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
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310559, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708 and 2020SA277871 (same reporter)  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  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
Sex: F
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: covid-19; Initial information was received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient's friend) via social media.  This case involves female patient (age unspecified) who had corona virus disease (COVID-19) while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date in 2020, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient had a non-serious corona virus disease (COVID-19) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.