chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored doses of GARDASIL 9 has been administered to the patient on 5/26/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 26-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621931, expiration date 26-JAN-2022; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was 30.2 Fahrenheit degree for 1 hour. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. 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: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored doses of GARDASIL 9 have been administered to the patient on 5/21/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 21-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621931, expiration date 26-JAN-2022; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was 30.2 Fahrenheit degree for 1 hour. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. 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: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 14-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 13-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 23-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 06-DEC-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 18-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 02-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 15-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch, covered full thigh from knee to hip. Around 6"-7".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4x2 inch warm and erythematous  induration on anterior upper thigh (where Kinrix was administered)
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Received a dose of GARDASIL 9 on 22-5-20 after previously receiving 2 doses of GARDASIL  on unspecified dates "about 2 to 3 years ago"; Received a dose of GARDASIL 9 on 22-5-20 after previously receiving 2 doses of GARDASIL  on unspecified dates "about 2 to 3 years ago"; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant therapies were not reported. On an unknown date in 2017 (reported as 2 or 3 years ago), the patient was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and then on an unspecified date, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (routes, anatomical positions, lot numbers and expiration dates were not reported) as prophylaxis. On 22-MAY-2020, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, anatomical position, lot number and expiration date were not reported) as prophylaxis (interchange of vaccine products and inappropriate schedule of product administration). The outcome of the events was unknown. Causality assessment for the event of interchange of vaccine products was not reported. No additional information was provided. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided.   On 22-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, anatomical location and route were not reported) of (lot # 1621931, expiry date: 26-JAN-2022) for prophylaxis. It was reported that the vaccine was exposed to a temperature of 30.2 Fahrenheit for a time frame of 1 hour. There was no previous temperature excursion reported. Data logger was involved. No adverse effects were reported. No additional information provided. No product quality complaint (PQC) was associated with this report. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electroencephalogram normal, Muscle spasms
Clinical narrative: After my sons appointment we came home and he took a nap. After he woke up, I was holding him and we noticed he started having spasms. They progressed over the weekend so we took him in to the hospital.
Age: 51.0
Sex: F
Vaccine: MENB
Symptoms: Administration site cellulitis, Chills, Fatigue, Headache, Pain
Clinical narrative: fever, chills for 3 days, headache, fatigue, body aches. Cellulitis to administration site requiring MD visit and treatment with antibiotic.
Age: 51.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: fever, chills for 3 days, headache, fatigue, body aches. Cellulitis to administration site requiring MD visit and treatment with antibiotic.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood thyroid stimulating hormone, Dizziness, Electrocardiogram, Full blood count, Hypertension
Clinical narrative: Influenza Vaccine administration (Flucelvax) -05/06/2020 at 3:00 pm. Date adverse event started at May 8, 2020 (palpitation, dizziness) with evaluation for Dr., MD treatment with Metroprolol  (dx Sinus tachycardia and High Blood Pressure).  Evaluation by Cardiologist with treatment Metoprolol Succinate ER 25mg daily.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Lipids, Metabolic function test, Palpitations, Sinus tachycardia, Urine analysis
Clinical narrative: Influenza Vaccine administration (Flucelvax) -05/06/2020 at 3:00 pm. Date adverse event started at May 8, 2020 (palpitation, dizziness) with evaluation for Dr., MD treatment with Metroprolol  (dx Sinus tachycardia and High Blood Pressure).  Evaluation by Cardiologist with treatment Metoprolol Succinate ER 25mg daily.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No addittional adverse event; Inappropriate administration schedule; This spontaneous report as received from a physician refers to a 45-year-old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis. Approximately on an unknown date in 2020, the patient was getting his third dose and was late due to COVID-19. It was confirmed that the patient did not have COVID-19. No additional adverse event were reported (inappropriate schedule of product administration).
Sex: M
Vaccine: RV5
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction to the second dose; This spontaneous report was received from a patient's mother and refers to a male patient of an unknown age. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On an unknown date, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, frequency, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was vaccinated with a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, frequency, lot # and expiration date were not provided) for prophylaxis.  On an unknown date, the patient had an allergic reaction to the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  The outcome of the event was unknown.  Causality assessment between the event and the suspect therapy was reported as related.
Sex: U
Vaccine: HEPAB, TDAP
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a other health professional via sales rep and described the occurrence of allergic reaction in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose and Twinrix at an unknown dose. On an unknown date, unknown after receiving Boostrix and Twinrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Boostrix and Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced allergic reaction and the patient was transferred to Medical Information department for further assistance.
Sex: U
Vaccine: VARZOS
Symptoms: Gait inability, Nerve injury, Sciatic nerve injury, Sciatica, Walking aid user
Clinical narrative: Sciatic nerve inflammation/; Unable to walk; Permanent nerve damage; Weakness in that nerve; This case was reported by a consumer and described the occurrence of neuritis sciatic in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced neuritis sciatic, unable to walk, nerve damage and sciatic nerve injury. On an unknown date, the outcome of the neuritis sciatic, unable to walk, nerve damage and sciatic nerve injury were not recovered/not resolved.   It was unknown if the reporter considered the neuritis sciatic, unable to walk, nerve damage and sciatic nerve injury to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in late 2019 and experienced very severe side effect. The patient had severe inflammation in sciatic nerve and not able to walk for two months and then required cane. The patient could walk but not normally and had permanent nerve damage and still going to address weakness in that nerve. The patient would send itemized list via registered mail to corporate office. The reporter reported that if no reply was forthcoming and would engaged an attorney to assist in this matter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site pain, Malaise, Pain
Clinical narrative: Suspected vaccination failure; developed an outbreak of Shingles; body aches; Fatigue; Malaise; High Fever; Injection site pain; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, general body pain, fatigue, malaise, fever and injection site pain. On an unknown date, the outcome of the vaccination failure, shingles, general body pain, fatigue, malaise, fever and injection site pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the general body pain, fatigue, malaise, fever and injection site pain to be related to Shingrix.  Additional information was received as follows: The patient's age at vaccination was not reported. The patient received 2 doses of Shingrix and after receiving the 2nd dose they developed body aches, fatigue, malaise, injection site pain (3 days post injection) and then developed an outbreak of Shingles with a high fever. The reporter did not consented to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed an outbreak of Shingles; body aches; Fatigue; Malaise; High Fever; Injection site pain; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, general body pain, fatigue, malaise, fever and injection site pain. On an unknown date, the outcome of the vaccination failure, shingles, general body pain, fatigue, malaise, fever and injection site pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the general body pain, fatigue, malaise, fever and injection site pain to be related to Shingrix.  Additional information was received as follows: The patient's age at vaccination was not reported. The patient received 2 doses of Shingrix and after receiving the 2nd dose they developed body aches, fatigue, malaise, injection site pain (3 days post injection) and then developed an outbreak of Shingles with a high fever. The reporter did not consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain, Papule, Pustule
Clinical narrative: 69 year old male seen today with c/o or L upper arm and shoulder pain. Denies injury but noted worse symptoms after golfing 3 days post injection. Did have a Shingrix shot May 26th in L arm. C/O pain with movement.  L shoulder area with papules and 2 pustules. Mild erythema with swelling.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 69 year old male seen today with c/o or L upper arm and shoulder pain. Denies injury but noted worse symptoms after golfing 3 days post injection. Did have a Shingrix shot May 26th in L arm. C/O pain with movement.  L shoulder area with papules and 2 pustules. Mild erythema with swelling.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: I asked mom before HPV shot was given if patient ate breakfast and if he ever passed out before from an immunization. Mom reports that he did eat breakfast, and that he never passed out before. Patient was given shot in his left upper deltoid. I asked patient right after administration how he was feeling, he reported he was feeling good. I advised mom and patient that he needed to stay in the room for 15 minutes after he got that shot due to it making people not feel good, mom verbalized understanding. Left the door open just in case, and told patient if he started to not feel well that he could lay back in on the table, he verbalized understanding. 15 minutes later, patient walked out with his mom, to go to checkout, asked how patient was feeling and he said good. About 5 minutes afterwards patient was standing at check out and passed out. Employee was made aware, she came to check on patient.  Apple juice was given to patient. An ambulance was called, but was cancelled once doctors finished assessing patient. Patient was then taken to a room after he started coming to it and a 2nd set of vitals were taken. Patient states that he started feeling dizzy when he was standing out checkout and then passed out.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Pt reports waking up around midnight with a headache, shivers and fever. Received immunization around 5 hours prior. Per Dr, pt to use Tylenol for 24 hours, if not resolved he would need to be seen.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Eye pain
Clinical narrative: For both the 1st and the 2nd injections, starting there day after the injection and lastng 3 days:  fever of 100, chills, headache, foggy thinking, eye pain, total body muscle aches, extreme fatigue, weakness,  dizziness, total body skin pain, poor appetite
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain of skin, Pyrexia
Clinical narrative: For both the 1st and the 2nd injections, starting there day after the injection and lastng 3 days:  fever of 100, chills, headache, foggy thinking, eye pain, total body muscle aches, extreme fatigue, weakness,  dizziness, total body skin pain, poor appetite
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Thinking abnormal
Clinical narrative: For both the 1st and the 2nd injections, starting there day after the injection and lastng 3 days:  fever of 100, chills, headache, foggy thinking, eye pain, total body muscle aches, extreme fatigue, weakness,  dizziness, total body skin pain, poor appetite
Sex: M
Vaccine: HPV9, HPV9, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects; the patient was administered the first dose on or around 12/24/19 (Patient age: 35 years old); This spontaneous report was received from a pharmacist referring to a 35-year-old male patient. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date in approximately December 2019 (also reported "on or around 24-DEC-2019"), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot# and expiry date not reported) via unknown route as prophylaxis (product administered to patient of inappropriate age). On 16-MAR-2020, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # R025725, expiry date 25-MAY-2021 (strength and dose were not reported). No additional adverse effects reported. 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: R025725; expirationdate: 25-MAY-2021; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 21-MAY-2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, for prophylaxis (lot number 1660704 which has been verified to be valid, expiration date reported and validated as 20-MAR-2021) (dose and vaccination scheme frequency were not reported).   The administered dose of the vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes, as recorded by a data logger. There was no previous temperature excursion.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Eyelid injury, Fall, Head injury, Loss of consciousness, Skin laceration
Clinical narrative: Then about 10 minutes later, the patient fainted for about 7 seconds.; He sat in a chair and fainted again for about 5 seconds.; Laceration to the back of the head and the right lower eyelid; Laceration to the back of the head and the right lower eyelid; When he fainted, he hit the back of his head on the floor and the front of his head on the countertop.; This spontaneous report was received from a health care worker referring to an 18-year-old male patient.   The patient did not have any medical history, concurrent conditions, drug allergies/reactions and was not taking any concomitant medications.  On 28-MAY-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection via intramuscular route (lot # R036913, expiration date: 23-SEP-2021, strength and anatomical location were not reported) to prevent human papilloma virus (HPV).   On the same day, about 10 minutes after the administration of vaccine, the patient fainted for about 7 seconds (syncope). When he fainted, he hit the back of his head on the floor and the front of his head on the countertop (fall). As a result, the patient now had a laceration to the back of the head and the right lower eyelid (eyelid injury and skin laceration). The patient regained consciousness and he sat in a chair and fainted again for about 5 seconds (syncope). Then, the patient was taken to the hospital and it was unknown if the patient was admitted to the hospital. There was no treatment given for adverse events. No lab diagnostic test performed, and the present status of the patient was unknown by the reporter. The patient sought medical attention and seen by a physician. No product quality complaints (PQC) were involved. The outcome of event syncope (first episode) was recovering. The outcome of the events syncope (second episode), skin laceration, fall and eyelid injury was unknown. The causality assessment was not provided.  Upon internal review, the event syncope was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Then about 10 minutes later, the patient fainted for about 7 seconds.; He sat in a chair and fainted again for about 5 seconds.; Laceration to the back of the head and the right lower eyelid; Laceration to the back of the head and the right lower eyelid; When he fainted, he hit the back of his head on the floor and the front of his head on the countertop.; This spontaneous report was received from a health care worker referring to an 18-year-old male patient.   The patient did not have any medical history, concurrent conditions, drug allergies/reactions and was not taking any concomitant medications.  On 28-MAY-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection via intramuscular route (lot # R036913, expiration date: 23-SEP-2021, strength and anatomical location were not reported) to prevent human papilloma virus (HPV).   On the same day, about 10 minutes after the administration of vaccine, the patient fainted for about 7 seconds (syncope). When he fainted, he hit the back of his head on the floor and the front of his head on the countertop (fall). As a result, the patient now had a laceration to the back of the head and the right lower eyelid (eyelid injury and skin laceration). The patient regained consciousness and he sat in a chair and fainted again for about 5 seconds (syncope). Then, the patient was taken to the hospital and it was unknown if the patient was admitted to the hospital. There was no treatment given for adverse events. No lab diagnostic test performed, and the present status of the patient was unknown by the reporter. The patient sought medical attention and seen by a physician. No product quality complaints (PQC) were involved. The outcome of event syncope (first episode) was recovering. The outcome of the events syncope (second episode), skin laceration, fall and eyelid injury was unknown. The causality assessment was not provided.  Upon internal review, the event syncope was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Fall, Haemorrhage, Head injury, Loss of consciousness, Pallor
Clinical narrative: Then about 10 minutes later, the patient fainted for about 7 seconds.; He sat in a chair and fainted again for about 5 seconds.; Laceration to the back of the head and the right lower eyelid; Laceration to the back of the head and the right lower eyelid; When he fainted, he hit the back of his head on the floor and the front of his head on the countertop.; This spontaneous report was received from a health care worker referring to an 18-year-old male patient.   The patient did not have any medical history, concurrent conditions, drug allergies/reactions and was not taking any concomitant medications.  On 28-MAY-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection via intramuscular route (lot # R036913, expiration date: 23-SEP-2021, strength and anatomical location were not reported) to prevent human papilloma virus (HPV).   On the same day, about 10 minutes after the administration of vaccine, the patient fainted for about 7 seconds (syncope). When he fainted, he hit the back of his head on the floor and the front of his head on the countertop (fall). As a result, the patient now had a laceration to the back of the head and the right lower eyelid (eyelid injury and skin laceration). The patient regained consciousness and he sat in a chair and fainted again for about 5 seconds (syncope). Then, the patient was taken to the hospital and it was unknown if the patient was admitted to the hospital. There was no treatment given for adverse events. No lab diagnostic test performed, and the present status of the patient was unknown by the reporter. The patient sought medical attention and seen by a physician. No product quality complaints (PQC) were involved. The outcome of event syncope (first episode) was recovering. The outcome of the events syncope (second episode), skin laceration, fall and eyelid injury was unknown. The causality assessment was not provided.  Upon internal review, the event syncope was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Skin laceration, Visual impairment
Clinical narrative: Then about 10 minutes later, the patient fainted for about 7 seconds.; He sat in a chair and fainted again for about 5 seconds.; Laceration to the back of the head and the right lower eyelid; Laceration to the back of the head and the right lower eyelid; When he fainted, he hit the back of his head on the floor and the front of his head on the countertop.; This spontaneous report was received from a health care worker referring to an 18-year-old male patient.   The patient did not have any medical history, concurrent conditions, drug allergies/reactions and was not taking any concomitant medications.  On 28-MAY-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection via intramuscular route (lot # R036913, expiration date: 23-SEP-2021, strength and anatomical location were not reported) to prevent human papilloma virus (HPV).   On the same day, about 10 minutes after the administration of vaccine, the patient fainted for about 7 seconds (syncope). When he fainted, he hit the back of his head on the floor and the front of his head on the countertop (fall). As a result, the patient now had a laceration to the back of the head and the right lower eyelid (eyelid injury and skin laceration). The patient regained consciousness and he sat in a chair and fainted again for about 5 seconds (syncope). Then, the patient was taken to the hospital and it was unknown if the patient was admitted to the hospital. There was no treatment given for adverse events. No lab diagnostic test performed, and the present status of the patient was unknown by the reporter. The patient sought medical attention and seen by a physician. No product quality complaints (PQC) were involved. The outcome of event syncope (first episode) was recovering. The outcome of the events syncope (second episode), skin laceration, fall and eyelid injury was unknown. The causality assessment was not provided.  Upon internal review, the event syncope was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, Chills, Muscle Soreness, Headache, Fatigue
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Hypersensitivity, Pyrexia
Clinical narrative: Redness began in patient's right arm on morning of 5/30/2020.  The redness worsened throughout the day.  Patient was sent to ER where she was febrile to 101.1 degrees F and had 10 X 10 cm area on Right arm.  She was dx with either allergic reaction vs cellulitis.  Patient was placed on Keflex and sent home.  Follow-up appt with PCP on 6/1/20 arm looking better.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered an improperly sotered dose of ROTATEQ on 5/26/2020; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender.   The patient's concurrent conditions, pertinent medical history, drug reactions allergies, and concomitant therapies were not reported.   On 26-MAY-2020, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  lot number 1660704, expiration date 20-MAR-2021, for prophylaxis (dose and route of administration were not reported). There was no additional adverse effect reported. Administered doses of vaccines experienced the temperature excursion of12.1 (°C)  degrees Celsius for 16 hours 11 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered an improperly stored dose of ROTATEQ on 22-MAY-2020; No additional AE information provided; This spontaneous report as received from a register nurse refers to a patient of unknown age and gender.      The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 22-MAY-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660704 with expiration date 20-MAR-2021 (dosage was not reported) for prophylaxis, which was exposed to temperature excursion of 12.1°C for a time frame of 16 hours and 11 minutes, because of data logger. There was no previous temperature excursion. No additional adverse event (AE) information provided.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product prescribing error
Clinical narrative: prescribing Adacel administration 1 year after previous vaccine, no adverse event; Initial information was received on 21-May-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a pregnant female patient who had a been prescribed DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 1 year after previous Tdap vaccine (Product prescribing error). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known and this event occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient previous pregnancy not reported.  The patient had received a dose of Boostrix in past.   On an unknown date, the patient was prescribed a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS 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 Product prescribing error. It was reported that the patient that came in and got tetanus and diphtheria toxoids with acellular pertussis (TDAP) from her primary care doctor a year ago. The patient was going to have a new baby and her obstetrician/gynecologist (OBGYN) wanted a guidance on administering Tdap within a year of receiving the vaccine previously  It was product prescribing error and it was not confirmed if vaccine was administered or not.  Pregnancy outcome was unknown at the time of report.  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: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: adult patient got Daptacel instead of Adacel/no AE; adult patient got Daptacel instead of Adacel/no AE; Initial information received on 27-May-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an adult patient of unknown demographics who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number not reported) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age and wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no Information available on the batch number for this case, currently..