chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Leaked on the patient's arm; Leaked onto the patient's arm; Medication leaked out of the prefilled syringe at the location between syringe hub/luer lock and syringe needle; The patient did not receive a full dose of GARDASIL 9; This spontaneous report was received from a nurse, concerning a 30 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 11-SEP-2020, the medical assistant was administering the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S010729 with expiration date of 01-DEC-2021, intramuscular for prophylaxis (dose, frequency and anatomical location were not provided) to the patient, and the medication leaked out of the pre filled syringe at the location between syringe hub/Luer lock and syringe needle, and leaked onto the patient's arm. There was no exposure to the medical assistant that was administering the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient did not receive a full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Product would not be obtained because it was biohazard.    The syringe needle was attached to the syringe tip before the leaking occurred and was able to be attached securely to the syringe. The defect was noticed while the plunger was being pushed forward and while giving the injection. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; 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: M
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: The patient did not experience any additional adverse experience as a result; multiple droplets were not administered; medication was leaking from the site where the syringe and needle meet at the lure lock.; This spontaneous report was received from a healthcare worker referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 11-SEP-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 milliliter, lot # S023475 with expiration date 26-MAR-2022; frequency and route were not reported) for prophylaxis. When administration, the patient's dad noticed that medication was leaking from the site where the syringe and needle meet at the lure lock. The reporter stated enough of the medicine leaked out as the father noticed it, but she felt like it was around 3 drops (incorrect dose administered and syringe issue). The reporter confirmed the product was a prefilled syringe that she attached a needle to. The patient did not experience any additional adverse experience as a result. Product syringe disposed of in the sharps container and not available for return. 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; manufactureraddress: manufacturercity: manufacturerstate:  manufacturercountry: devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; 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: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effects reported; Patient received her first dose of GARDASIL 9 in February 2020 - Second ose of GARDASIL 9 on 13-SEP-2020; This spontaneous report was received from a pharmacist, refers to a 24 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      In February 2020, 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) (strength, route of administration, dose, lot # and expiration date were not provided) for prophylaxis.  The pharmacist reported that, on 13-SEP-2020, the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, dose, lot # and expiration date were not provided) for prophylaxis. No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired Varivax administered; Information has been received from a pharmacist concerning to a 12 month old patient (gender not reported). On 11-SEP-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. R013568, exp. date 13-MAY-2020), 0.5 milliliter (route not reported) for prophylaxis. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Herpes simplex, Incomplete course of vaccination
Clinical narrative: The patient also missed her 2nd dose in the series; She is taking Acyclovir for HSV2; This spontaneous report has received from a pharmacist over by Agent, concerning to 21-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown by reporter.  On 25-MAR-2020, the patient was vaccinated with the first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On 07-AUG-2020, the patient experienced herpes simplex II (HSV2) and was treated with acyclovir. Furthermore, on an unknown date, the patient missed the second dose in the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   The outcome of herpes simplex was reported as resolving. The causal relationship between the adverse event and therapy was not assessed.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 78 years-old female patient (pt). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On 23-JUN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) ) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. In or about 2014, the pt experienced shingles, including any and all of it sequelae. 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 severe and permeant personal injuries including but not limited to shingles, as well as other severe and permanent health consequences; substantial pain and suffering, and emotional distress, as well as to incurred substantial economic damages and loss, significant expenses for medical care and treatment, and will continue to incur such expenses in the future. Plaintiff has lost past earnings and has suffered a loss of earning capacity. The outcome of the event was not reported. The event was considered related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Death
Clinical narrative: cardiovascular event; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 60 year old female patient (pt). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On 17-NOV-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) ) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On 04-DEC-2014, the pt experienced an unspecified cardiovascular event (cardiovascular disorder) which resulted in her untimely passing on the same date, it was not reported if an autopsy was performed. 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 severe and permeant personal injuries including but not limited to a cardiovascular event, as well as other severe and permanent health consequences; substantial pain and suffering, and emotional distress, as well as to incurred in substantial economic damages and loss and significant expenses for medical care and treatment, has lost past earnings and has suffered a loss of earning capacity. The pt's spouse filed for loss of consortium.. The event was considered related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: cardiovascular event
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered to a consumer; This spontaneous report was received from a nurse and refers to a 4-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-SEP-2020, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously, lot # S005249, expiration date 20-FEB-2021 (strength and dose were not reported) for prophylaxis.  On an unknown dates, the dose of the vaccine was exposed to temperature excursion at 54.32 Fahrenheit (F)  for 7 hours and 14 minutes. There was no previous temperature excursion reported. The call was due to digital data logger.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered; This spontaneous report was received from a pharmacist, concerning a 14-years-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not reported.   On 04-SEP-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 05-JAN-2022, that was improperly stored (product storage error) as prophylaxis (dose #, anatomical location and route of administration were not reported). There was no product quality complain involved.  It was unknown if there was previous temperature excursion. Temperature was reported as "stated in the refrigerator". A data logger was not used.  "Lot number [T00341] is an invalid lot number for [varicella virus vaccine live (Oka/Merck)]."
Sex: U
Vaccine: HPV9
Symptoms: Accidental exposure to product
Clinical narrative: inadvertently administered a dose of GARDASIL 9 to  60 years old patient; This spontaneous report as received from nurse refers to a 60-year-old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 14-SEP-2020, the patient was inadvertently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).
Age: 70.0
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: G9 administered to 70 year old pt by accident; This spontaneous report was received from a physician referring to a 70 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 14-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis by mistake (product administered to patient of inappropriate age).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; break out on my arm; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th August 2020, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced shingles and eruption of limbs. On an unknown date, the outcome of the shingles and eruption of limbs were unknown.   It was unknown if the reporter considered the shingles and eruption of limbs to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles. The patient had a break out on his/her arm. This case was linked with case US2020AMR183114, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR183114:copy for second patient
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Lymph node pain, Pain
Clinical narrative: Complete exhaustion; Total body pain in all my glands and joints; Total body pain in all my glands and joints; Extreme chills; Shaking; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, tremor, exhaustion, general body pain and joint pain. On an unknown date, the outcome of the chills, tremor, exhaustion, general body pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the chills, tremor, exhaustion, general body pain and joint pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had extreme chills and shaking lasting 3-4 hours, complete exhaustion, total body pain in all my glands and joints. The insurance would not reimburse for a doctor's visit. For tolerances of 2nd dose, refer case US2020AMR184227, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR184227:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Complete exhaustion; Total body pain in all my glands and joints; Total body pain in all my glands and joints; Extreme chills; Shaking; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, tremor, exhaustion, general body pain and joint pain. On an unknown date, the outcome of the chills, tremor, exhaustion, general body pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the chills, tremor, exhaustion, general body pain and joint pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had extreme chills and shaking lasting 3-4 hours, complete exhaustion, total body pain in all my glands and joints. The insurance would not reimburse for a doctor's visit. For tolerances of 2nd dose, refer case US2020AMR184227, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR184227:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of chills (received 1st dose on unknown date, refer case US2020AMR184222).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had pain at injection site maybe due to inexperience pharmacist who administered. The insurance would not reimburse for a doctor's visit. Event lasted for 20 hours.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR184222:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Clavicle fracture, Death, Face injury, Fall
Clinical narrative: death certificate / cause of death / vaccine injury; passed out; shingles / it spread / 85% covered and on morphine / all over her body; constant pain / couldnt have clothes on at all / increasing pain / pain killed her; fell; breaking her arm; breaking / collsr bone; huge gash on her face; coukd barely move; was bed ridden; This case was reported by a consumer via interactive digital media and described the occurrence of injury in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced injury (serious criteria death), passed out (serious criteria GSK medically significant), shingles, pain, fall, arm fracture, fractured collar bone, face injury, mobility decreased and bedridden. The patient was treated with morphine. On an unknown date, the outcome of the injury was fatal and the outcome of the passed out, shingles, fall, arm fracture, fractured collar bone, face injury, mobility decreased and bedridden were unknown and the outcome of the pain was not recovered/not resolved. The reported cause of death was injury.   The reporter considered the injury to be related to Shingles vaccine. It was unknown if the reporter considered the passed out, shingles, pain, fall, arm fracture, fractured collar bone, face injury, mobility decreased and bedridden to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's neighbor. The patient's doctor suggested to prevent shingles, but the patient got it. 3 weeks after receiving Shingle vaccine, the patient had shingles. The patient's doctor told her, it would last a week or 2weeks Instead of getting better, the shingles were spread. Within a month after receiving Shingles vaccine, the patient was 50 percent covered with shingles and in constant pain. Another month and the patient were 85 percent covered and she was on Morphine. After 3 months, the patient was in so much pain, she passed out and she fall, and her arm and collar bone were broken and making a huge gash on her face. After 6 months, the patient could barely move. After 9 months, the patient was bed ridden. After 13 months, shingles was all over her body and she couldn't have clothes on at all. After 22 months of constant and increasing pain, then the pain killed her. The patient's death certificate said cause of death was vaccine injury. It was reported that, the patient died a horrible suffering death due to a shingles vaccine. The patient's doctor no longer advised or given the shingles vaccine. He also no longer given other vaccines because after he researched every vaccine, he had given anyone and said what he learned shocked him, and he did not trust vaccines anymore. The reporter had 3 kids in family and had severe adverse reactions to vaccines. The reporter's one of grandsons was hospitalized for vaccine poisoning.; Reported Cause(s) of Death: Vaccine injury
Sex: F
Vaccine: VARZOS
Symptoms: Upper limb fracture
Clinical narrative: death certificate / cause of death / vaccine injury; passed out; shingles / it spread / 85% covered and on morphine / all over her body; constant pain / couldnt have clothes on at all / increasing pain / pain killed her; fell; breaking her arm; breaking / collsr bone; huge gash on her face; coukd barely move; was bed ridden; This case was reported by a consumer via interactive digital media and described the occurrence of injury in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced injury (serious criteria death), passed out (serious criteria GSK medically significant), shingles, pain, fall, arm fracture, fractured collar bone, face injury, mobility decreased and bedridden. The patient was treated with morphine. On an unknown date, the outcome of the injury was fatal and the outcome of the passed out, shingles, fall, arm fracture, fractured collar bone, face injury, mobility decreased and bedridden were unknown and the outcome of the pain was not recovered/not resolved. The reported cause of death was injury.   The reporter considered the injury to be related to Shingles vaccine. It was unknown if the reporter considered the passed out, shingles, pain, fall, arm fracture, fractured collar bone, face injury, mobility decreased and bedridden to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's neighbor. The patient's doctor suggested to prevent shingles, but the patient got it. 3 weeks after receiving Shingle vaccine, the patient had shingles. The patient's doctor told her, it would last a week or 2weeks Instead of getting better, the shingles were spread. Within a month after receiving Shingles vaccine, the patient was 50 percent covered with shingles and in constant pain. Another month and the patient were 85 percent covered and she was on Morphine. After 3 months, the patient was in so much pain, she passed out and she fall, and her arm and collar bone were broken and making a huge gash on her face. After 6 months, the patient could barely move. After 9 months, the patient was bed ridden. After 13 months, shingles was all over her body and she couldn't have clothes on at all. After 22 months of constant and increasing pain, then the pain killed her. The patient's death certificate said cause of death was vaccine injury. It was reported that, the patient died a horrible suffering death due to a shingles vaccine. The patient's doctor no longer advised or given the shingles vaccine. He also no longer given other vaccines because after he researched every vaccine, he had given anyone and said what he learned shocked him, and he did not trust vaccines anymore. The reporter had 3 kids in family and had severe adverse reactions to vaccines. The reporter's one of grandsons was hospitalized for vaccine poisoning.; Reported Cause(s) of Death: Vaccine injury
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: received dose 1 of Shingrix in June 2019, dose 2 in December 2019. He states he was diagnosed with shingles on August 1, 2020 / your vaccine, which didn't work in my case/ vaccination failure; shingles / having shingles; received 2nd dose after 1 month 24 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphoma (non Hodgkin lymphoma).   On 21st October 2019, the patient received the 1st dose of Shingrix. On 15th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 1st August 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride). On 5th August 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient received 2 doses of Shingrix and diagnosed with shingles on 1st August 2020. The patient started valcyclovir Hcl treatment and symptoms resolved on 5th August 2020. The date of the second vaccine was unknown, but the consumer thought it was 15th December 2019. The patient stated that vaccine did not work in his case. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortning of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash
Clinical narrative: rash; the patient was in contact with plants and developed dermatitis to contact; This case was reported by a physician via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced rash and contact dermatitis. On an unknown date, the outcome of the rash and contact dermatitis were unknown.   It was unknown if the reporter considered the rash and contact dermatitis 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 it was selected as an adult as per vaccine indication. The physician reported that the patient received Shingrix on Saturday, 5th September 2020 and experienced dermatitis and rash. The physician related the adverse event as the patient was in contact with plants and developed dermatitis to contact, which led to contact dermatitis No further information provided. The reporter has consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Flushing, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: allergic reaction; throat swelling; raspy voice; flushed face; itching; fever; redness and splotchy areas on her chest; redness and swelling at injection site; swelling at injection site; redness at injection site; Based on information received on 11-Sep-2020, the report previously considered as non-valid becames valid: [events added for validity].  Initial information received on 17-Sep-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-hcp and additional information received on same date.  This case involves a 60-year-old female patient who experienced allergic reaction (hypersensitivity) with symptoms throat swelling (pharyngeal swelling), raspy voice (dysphonia), flushed face (flushing), itching (pruritus), redness and splotchy areas on her chest (rash macular) and also fever (pyrexia), redness and swelling at injection site (vaccination site inflammation with vaccination site swelling and vaccination site erythema), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing asthma that was sulfide sensitive.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]); and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]).  On an unknown date (last year), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (single dose) (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity), throat swelling (pharyngeal swelling), raspy voice (dysphonia), flushed face (flushing), itching (pruritus), fever (pyrexia), splotchy areas on her chest (rash macular), redness and swelling at injection site (vaccination site inflammation with vaccination site swelling and vaccination site erythema), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other case details: reporter requested to know if the Flublok contains sulfates, latex, nickle, or gelatin as she had a reaction for Fluzone Quad (single dose) in the past.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of all events was unknown.  There will be no information available on the batch number for this case.  Follow up information was received on 11-Sep-2020, from a consumer.  Case was updated from non-valid to valid. New events added. Concomitant medications were added.
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Pruritus, Pyrexia, Rash, Rash macular
Clinical narrative: allergic reaction; throat swelling; raspy voice; flushed face; itching; fever; redness and splotchy areas on her chest; redness and swelling at injection site; swelling at injection site; redness at injection site; Based on information received on 11-Sep-2020, the report previously considered as non-valid becames valid: [events added for validity].  Initial information received on 17-Sep-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-hcp and additional information received on same date.  This case involves a 60-year-old female patient who experienced allergic reaction (hypersensitivity) with symptoms throat swelling (pharyngeal swelling), raspy voice (dysphonia), flushed face (flushing), itching (pruritus), redness and splotchy areas on her chest (rash macular) and also fever (pyrexia), redness and swelling at injection site (vaccination site inflammation with vaccination site swelling and vaccination site erythema), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing asthma that was sulfide sensitive.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]); and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]).  On an unknown date (last year), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (single dose) (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity), throat swelling (pharyngeal swelling), raspy voice (dysphonia), flushed face (flushing), itching (pruritus), fever (pyrexia), splotchy areas on her chest (rash macular), redness and swelling at injection site (vaccination site inflammation with vaccination site swelling and vaccination site erythema), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other case details: reporter requested to know if the Flublok contains sulfates, latex, nickle, or gelatin as she had a reaction for Fluzone Quad (single dose) in the past.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of all events was unknown.  There will be no information available on the batch number for this case.  Follow up information was received on 11-Sep-2020, from a consumer.  Case was updated from non-valid to valid. New events added. Concomitant medications were added.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site ulcer, Pain in extremity, Product administered at inappropriate site, Wrong product administered
Clinical narrative: experiencing a lot of pain in the left arm; ulcer at the injection site; there was swelling in the area where the injection was given; Patient was supposed to receive a tuberculin skin test intradermally, but instead inadvertently administered with the Adacel single-dose vial intradermally; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a health professional (pharmacy technician). This case involves a 40 years old female patient who had ulcer at the injection site, experiencing a lot of pain in the left arm (pain in extremity), and there was swelling in the area where the injection was given (vaccination site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] intradermally instead of tuberculin skin test.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Patient did not receive any other concomitant vaccines.  On 09-Sep-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5669AA and expiry date 09-Oct-2021) via intradermal route in the left forearm for prophylactic vaccination instead of tuberculin skin test.  On an unknown date, the patient developed a non-serious ulcer at the injection site (vaccination site ulcer), experiencing a lot of pain in the left arm (pain in extremity), and there was swelling in the area where the injection was given (vaccination site swelling) on an unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  This was an actual medication error case due to wrong vaccine administered (latency same day).  Case details: It was reported that a nurse improperly gave the Adacel vaccine and the patient was now having an adverse reaction. Patient was supposed to receive a tuberculin skin test intradermally, but instead the patient was inadvertently administered the Adacel single-dose vial intradermally, in the left forearm and patient was experiencing adverse events.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events and was not applicable for wrong product administered.
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered Fluzone Quadrivalent highdose instead of Fluzone Highdose to a 70-year-old patient/No AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 70 year old patient (gender not reported) who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (latency same day).  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.  There will be no information available on the batch number for this case.
Age: 62.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given an expired dose of Tenivac, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 62 year old male patient who was given an expired dose of TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 03-Sep-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6021AA, expiry date: 27-Jul-2020) once via unknown route in the left arm for prophylactic vaccination.  No other medications or vaccinations were given during the visit.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  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: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 year old patient was given 0.7 ml of Fluzone HD Quad, no AE; 2 year old patient was given 0.7 ml of Fluzone HD Quad, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 2 years old female patient who was given 0.7 ml of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ469AA and expiration date: 30-Jun-2021) via unknown route in the left thigh as prophylactic vaccination on an unspecified date (product administered to patient of inappropriate age and overdose).  Medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose (latency same day).  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: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of vaccine, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a four-year-old male patient who was vaccinated with 0.5 mL expired dose (third dose number and frequency once) of DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE (lot C5511AA and expiry date: 30-Aug-2020) via an intramuscular route in the right thigh for prophylactic vaccination on 31-Aug-2020.  The patient's medical history, past medical treatment, family history and concomitant medication were not provided. At the time of the event, the patient had ongoing Tuberculosis. Patient did not have other vaccines.   It was an actual medication error case due to expired vaccine used (latency same day).   At the time of this 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: FLU4, FLUX
Symptoms: Exposure via skin contact, No adverse event, Underdose, Wrong product administered
Clinical narrative: she felt something drip down her arm, no AE; she felt something drip down her arm, no AE; Fluzone Quadrivalent not High Dose because she wasn't aware there is a HD available, no AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 66 years old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE (Fluzone quadrivalent) and during the administration she felt something drip down her arm (exposure via skin contact) (underdose), she also did not have a bump, like she always does after an injection. She also stated that she received Fluzone Quadrivalent and not INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Fluzone High Dose) because she wasn't aware there is a HD (high dose) available (wrong product administered).  The patient's past vaccination included IMMUNOTHERAPY.  At the time of the event, the patient had ongoing Asthma.  Concomitant medications were not reported.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported for both the vaccines) not reported via unknown route in unknown arm as prophylactic vaccination.  It was a case of medication error due to wrong vaccine administered and exposure via skin contact.(latency same day).  It was also a case of vaccine underdose (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.  There will be no information in the batch number for this case.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Patient only received the Hib portion of the Pentacel vaccine reconstituted with a sterile diluent/No AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four months old female patient who on 11-Sep-2020 received 0.5 mL second dose of only hib portion of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217ACA and expiry date 25-Apr-2021) via intramuscular route in the left thigh for prophylactic vaccination which was reconstituted with a sterile diluent (product preparation issue)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique (latency: on same day).  It was unknown whether the patient had any adverse reactions.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired dose of Act-Hib/no AE.; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a 19 month-old female patient who was vaccinated with 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] which was already expired (batch number uj076aa and expiry date 21-Aug-2020) via intramuscular route in unknown administration site on 31-Aug-2020 for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination  It was an actual medication error case due to expired vaccine used (latency: on same day).  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: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Large area of redness and inflammation and swelling left shoulder.  Nausea and vomiting about 24 hours after the vaccination.  Temp 100.5 F with shivering.  Treated with tylenol.  Symptoms from about 48 hours after immunization.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Large area of redness and inflammation and swelling left shoulder.  Nausea and vomiting about 24 hours after the vaccination.  Temp 100.5 F with shivering.  Treated with tylenol.  Symptoms from about 48 hours after immunization.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Feeling cold
Clinical narrative: PT ARRIVED AT CLINIC AT 14:20, WITH C/O FEELING COLD AND WEAK. VITAL SIGNS COMPLETED,  PT STATES WEAKNESS RESOLVED BY TIME SHE LEFT CLINIC. PATIENT EDUCATION  COMPLETED.