chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Got fever of 101.3 and vomited x 1 a few hours after vaccine. The next morning Doing better.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: SkinRash & HIVES
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Cold sweat, Confusional state, Disorientation, Dizziness, Mydriasis
Clinical narrative: Pt received vaccine and was in line at the register, cashier noticed he looked as if he was going to pass out and had him sit in a chair. Customer service came over to find me to let me know what I was going on, I grabbed the emergency kit, told tech to call 911(4:13) and found the pt Pt was in a chair, his eyes were dilated, he did not know where he was and he was cold and clammy. I then said we needed to move pt to the ground and elevate his feet. Pt started to become more alert and less confused. Pts blood pressure was 113/86 and pulse was 85  EMS arrived around 4:30  Pt was able to walk out of the store with them  EMS took his vitals BP 126/66, O2 99%, 94 pulse and 16 RR. Pt went home with parents and when I checked with his mother on 9/20 she said he was doing fine
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Nasopharyngitis
Clinical narrative: Pt received vaccine and was in line at the register, cashier noticed he looked as if he was going to pass out and had him sit in a chair. Customer service came over to find me to let me know what I was going on, I grabbed the emergency kit, told tech to call 911(4:13) and found the pt Pt was in a chair, his eyes were dilated, he did not know where he was and he was cold and clammy. I then said we needed to move pt to the ground and elevate his feet. Pt started to become more alert and less confused. Pts blood pressure was 113/86 and pulse was 85  EMS arrived around 4:30  Pt was able to walk out of the store with them  EMS took his vitals BP 126/66, O2 99%, 94 pulse and 16 RR. Pt went home with parents and when I checked with his mother on 9/20 she said he was doing fine
Age: 71.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Erythema, Infection, Swelling
Clinical narrative: Swell, redress, + didn't improve  Doctor prescribe Antibiotics to treat infection and patient see improvement since. Doctor visit date on 9/20/2020
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site discomfort
Clinical narrative: Arthralgia & mild erythema, discomfort around injection site
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: & left arm warm to the touch, tender, swollen with hard lump, erythema
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Burning sensation, Injection site bruising, Mobility decreased, Product administered at inappropriate site
Clinical narrative: she received her shingrix vaccine 9/14/2020. At the time of administration, she complained of a burning sensation. Then later that day and for several days afterwards, she could not move her arm. Pain was unrelieved by OTC tylenol. She could move her arm after several days, but general pain still was there even as of today. She developed a large bruise at the injection site. I believe the vaccine was administered too high up on the deltoid. The injection should be in the deltoid, 2-3 fingers below the acromion process. The bruise was 2 fingers at the acromonion. So it was not below the finger space required. She showed pharmacy the bruise on 9/22/20, which was 8 days post injection.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Got the shot at a community clinic on 9/13 and on 9/15 spiked a fever of 101.8 and was very lethargic with limited appetite
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site rash, Injection site swelling
Clinical narrative: Developed flat non-blanching petechiae to bilateral Lower extremities after receiving first set of vaccines on 9/3/20. Seen on 9/7/20 @ ER. Rash still present. Today (9/23/20) Rash is still present. Patient is carried by mom to the ED. Chief complaint is a rash on bilateral lower extremities below the knee after receiving her first set of vaccinations on 9 3 , yesterday. Mom reports at the time of the vaccination she had significant redness and swelling of her legs but that has since subsided and she noticed the rash this morning. Baby is breast-feeding well normal wet diapers. Denies fever, baby is nontoxic and well-appearing. C-section delivery for meconium, no other complications, no NICU stay went home after 2 days.
Age: 67.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dry skin, Injection site erythema, Injection site swelling, Paraesthesia, Scar
Clinical narrative: Pt. developed redness & swelling at injection site, after the injection. Since then a rough patch(scarring) has developed with associated tingling sensation.
Age: 67.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Sensory disturbance
Clinical narrative: Pt. developed redness & swelling at injection site, after the injection. Since then a rough patch(scarring) has developed with associated tingling sensation.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Contusion, Erythema
Clinical narrative: 9/20 date of vaccine administration, arm was very red. Next day it looked like it was bruising but spreading to most of upper arm
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: patient was administered doses of Pentacel and Fluzone Quadrivalent before finding out the products were not viable/ No AE; Initial information received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant).  This case is linked to case 2020SA245000 (same reporter).  This case involves a six month-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] before finding out the products were not viable (poor quality product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination and CEFTRIAXONE SODIUM (VERTEX) for an unknown indication.  On 01-Sep-2020, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ146AAA and expiry date 14-Feb-2021) via intramuscular route in the left thigh and also received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number an expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination respectively.  It was an actual medication error due to poor quality vaccine administered (latency: on same day).  Case details: Medical assistant called to report that two doses of Pentacel and Fluzone Quadrivalent were administered before administered before finding out the products were not viable.  At the time of report, no adverse event symptoms 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 on lot number for suspect Fluzone Quadrivalent.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Pain of skin, X-ray
Clinical narrative: diagnosis of shingles; skin sensitivity; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th August 2020, 1 days after receiving Shingrix, the patient experienced shingles, sensitive skin and muscle pain. On an unknown date, the outcome of the shingles, sensitive skin and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, sensitive skin and muscle pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on right arm The patient did not have lot number or expiration date information. The patient developed muscle pain and skin sensitivity the day after receiving the vaccine and these were still ongoing. The patient has been to several doctors and the consensus was a diagnosis of shingles even though he does not have a rash. The reporter consented to follow up. The reporter consented to follow up with Health Care Professional (HCP).
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Myalgia, Sensitive skin
Clinical narrative: diagnosis of shingles; skin sensitivity; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th August 2020, 1 days after receiving Shingrix, the patient experienced shingles, sensitive skin and muscle pain. On an unknown date, the outcome of the shingles, sensitive skin and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, sensitive skin and muscle pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on right arm The patient did not have lot number or expiration date information. The patient developed muscle pain and skin sensitivity the day after receiving the vaccine and these were still ongoing. The patient has been to several doctors and the consensus was a diagnosis of shingles even though he does not have a rash. The reporter consented to follow up. The reporter consented to follow up with Health Care Professional (HCP).
Age: 53.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Throat irritation
Clinical narrative: Stomach pain, swallowing of throat
Age: 50.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: 11:30PM 09-21 : headache, pain at injection site  4 hours after Vaccination  Ibuprophen 400mg 9:00 AM 09-22 : continued headache, Mild nausea 10:30 AM Fever(100.9), chills, muscle ache, headache, rersting heart rate 85bbp,Unable to proceed with daily activities  2:00 PM symptoms continue; ibuprofen 800mg 7:00PM Symptoms begin to lessen muscle aches gone 10:00PM Fever gone 400MG ibuprofen  02:00AM 09-23 Headache gone
Age: 50.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: 11:30PM 09-21 : headache, pain at injection site  4 hours after Vaccination  Ibuprophen 400mg 9:00 AM 09-22 : continued headache, Mild nausea 10:30 AM Fever(100.9), chills, muscle ache, headache, rersting heart rate 85bbp,Unable to proceed with daily activities  2:00 PM symptoms continue; ibuprofen 800mg 7:00PM Symptoms begin to lessen muscle aches gone 10:00PM Fever gone 400MG ibuprofen  02:00AM 09-23 Headache gone
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Pain of skin, Skin erosion, Skin exfoliation
Clinical narrative: Bruise formed same day on 17 skin started peeling about 4 inches long raw and painful on 20th skin started to try to form on22nd it became raw again and bruise is forming around it peeling again went to doctor on 21 she said she has never seen anything like it she said measure it and come back if worse thinking about going to hospital no other symptoms or fevers
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of Proquad; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 02-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: rHA, lot # T003835, expiration date: 01-AUG-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 7 hours in the temperature 0 degrees Celsius. There was no previous temperature excursion. Digital Data Logger was not involved.  The outcome of medication error was unknown.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-AUG-2020, the patient was vaccinated subcutaneously with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: rha, lot # T001187, expiration date: 11-JUL-2020 (dose was not reported) for prophylaxis (reported as "well check"). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 1 hour and 15 minutes in the temperature between -9 degrees Celsius (C) and 8 degrees Celsius (6.1C) and for an unknown time frame in the temperature from -9 degrees Celsius and 8 degrees Celsius (-6.1C) (multiple excursions). There was no previous temperature excursion. Digital Data Logger was involved.  The outcome of product storage error was unknown.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 18-AUG-2020, the patient was vaccinated subcutaneously with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: rHA, lot # T005406, expiration date: 12-AUG-2021(dose was not reported) for prophylaxis (reported as "well check"). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 116 hours in the temperature between -14 degrees Celsius (C) and -10 degrees Celsius and for 13 hours in the temperature between -9 degrees Celsius and 8 degrees Celsius (-6.1C) (multiple excursions). There was no previous temperature excursion. Digital Data Logger was involved.  The outcome of product storage error was unknown.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis, Polymerase chain reaction, Pyrexia
Clinical narrative: gastroenteritis; This spontaneous report has been received from a physician referring to a 2-month-old male patient. Information about the patient's pertinent medical history was unknown; the patient had no  drug allergy or reactions.   The patient swapped multiple times prior for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 24-JUL-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose (1st of 3), lot# 1684137, expiration date was reported as May 30 in an unknown year (upon internal validation established as 30-MAY-2021) orally (strength and frequency were not reported) for prevention of rotavirus gastroenteritis. Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not available for retrieval. On the same day, the patient was also vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and diphtheria toxoid (+) Hib conj vaccine (tet toxoid) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (MRC-5) (+) tetanus toxoid (PENTACEL) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.   On the same date, the patient started to have a slight fever that night. No exact fever information was provided. Vomiting started on 26-JUL-2020 and lasted until 28-JUL-2020. Diarrhea started on 29-JUL-2020. The patient was hospitalized on 30-JUL-2020 for dehydration. The polymerase chain reaction (PCR) and stool samples was tested, but the results were not provided. The patient was administered with intravenous (IV) fluids as treatment for dehydration. On 01-AUG-2020, 2 days later in hospital, the patient was diagnosed the same day with gastroenteritis. On an unspecified date in 2020, the patient was recovered from gastroenteritis. The physician believed he was released on 04-AUG-2020 fully recovered. The causality between gastroenteritis and the suspect therapies was not reported.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Stool analysis, Vomiting
Clinical narrative: gastroenteritis; This spontaneous report has been received from a physician referring to a 2-month-old male patient. Information about the patient's pertinent medical history was unknown; the patient had no  drug allergy or reactions.   The patient swapped multiple times prior for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 24-JUL-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose (1st of 3), lot# 1684137, expiration date was reported as May 30 in an unknown year (upon internal validation established as 30-MAY-2021) orally (strength and frequency were not reported) for prevention of rotavirus gastroenteritis. Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not available for retrieval. On the same day, the patient was also vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and diphtheria toxoid (+) Hib conj vaccine (tet toxoid) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (MRC-5) (+) tetanus toxoid (PENTACEL) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.   On the same date, the patient started to have a slight fever that night. No exact fever information was provided. Vomiting started on 26-JUL-2020 and lasted until 28-JUL-2020. Diarrhea started on 29-JUL-2020. The patient was hospitalized on 30-JUL-2020 for dehydration. The polymerase chain reaction (PCR) and stool samples was tested, but the results were not provided. The patient was administered with intravenous (IV) fluids as treatment for dehydration. On 01-AUG-2020, 2 days later in hospital, the patient was diagnosed the same day with gastroenteritis. On an unspecified date in 2020, the patient was recovered from gastroenteritis. The physician believed he was released on 04-AUG-2020 fully recovered. The causality between gastroenteritis and the suspect therapies was not reported.
Age: 70.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not experience any reactions to GARDASIL-9; Patient was inadvertently given GARDASIL-9 instead of the intended 'flu shot' on 08-SEP-2020; Patient was inadvertently given GARDASIL-9 instead of the intended 'flu shot' on 08-SEP-2020; Patient of 70-year-old was inadvertently given GARDASIL-9; This spontaneous report was received from a physician referring to a 70-year-old female patient. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 08-SEP-2020, the patient was inadvertently given hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S020255  and expiration date reported as 12-SEP-2021, but upon internal validation established as 12-DEC-2021) as prophylaxis (concentration, vaccination scheme frequency, anatomical location and route of administration were not reported), instead of the intended influenza virus vaccine inactivated (unspecified) (reported as Flu Shot) (concentration, vaccination scheme frequency, anatomical location, route of administration, lot number and expiration date were not reported) (interchange of vaccine products, product use issue and wrong product administered). Patient did not experience any reactions to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (no adverse event). 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: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropiate schedule of product administration; This spontaneous report was received from a pharmacist concerning to a female patient of an unknown age .   The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unspecified date between February or March 2020, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot#, expiration date) for prophylaxis.  At the reporting time, the patient got vaccinated with her second dose (inappropriate schedule of product administration).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired VAQTA vaccine was administered; This spontaneous report has been received from a consumer referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 27-AUG-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S021092 (strength, indication, dose, route, frequency, and anatomical location were not provided) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021092; expirationdate: 18-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: she got the 1st dose at 16 years old, she is now 22 and never got the second and third dose; NO additional AE/NO PQC reported.; This spontaneous report was received from a consumer concerning a 22 years old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unspecified date in 2014, 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) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided); the consumer reported that she never got the second and third dose (inappropriate schedule of product administration).     No adverse event reported.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Contusion, Skin discolouration, Tenderness
Clinical narrative: arm bruising, 'a little blue and red'; tenderness in arm; This spontaneous report was received from a pharmacist and the patient referring to a 72 years old patient of unknown gender. Concomitant therapy included warfarin. The patient's pertinent medical history and concurrent condition were not provided.     On 14-SEP-2020 (on Monday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 14-SEP-2020, the patient experienced arm bruising, which was a little blue and red. The patient also reported tenderness in arm. No infection was present as confirmed by the pharmacist. No treatment was given to the patient. The outcome of the events was unknown.    The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: M
Vaccine: HPV9, HPV9, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: another GARD A SIL 9 was given at another pediatric office on 28 FEB 2020/third dose today 17 SEP 2020.; third dose today 17 SEP 2020/another GARD A SIL 9 was given at another pediatric office on 28 FEB 2020; This spontaneous report was received from a medical assistant referring to a 13 years old male patient. The patient's pertinent medical history, concomitant therapy and concurrent condition were not provided.  On 25-OCT-2018 and 19-SEP-2019, the patient was respectively vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 28-FEB-2020, the patient received another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) at another pediatric office (inappropriate schedule of product administration). On 17-SEP-2020, the patient was accidentally vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 time vaccine dose in a 3 dose regiment, lot# 1637642, expiration date 28-MAY-2022; route and strength were not provided) (extra dose administered). The outcome of inappropriate schedule of product administration and extra dose administered was unknown.   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: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Limb mass, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: arm pain and numbness in the arm she felt she was given the immunization; arm pain and numbness in the arm she felt she was given the immunization; left arm mass; This spontaneous report was received from a physician and refers to a female patient of unknown age (reported as between 11 and 13 years old).   Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was unknown by reporter.  On an unknown date, 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) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On 17-AUG-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) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On 31-AUG-2020, the patient experienced arm  pain and numbness (hypoaesthesia ) in the arm she felt she was given the immunization, which the patient reported as her left arm.  On the same date, patient went to physician office and the physician noticed a left arm mass and sent the patient for an ultrasound which showed a small focal convexity in the region of clinical concern involving the superior lateral aspect of the left upper arm. However, the medical record showed that the patient received the vaccine in her right upper arm, and the patient is having these issues in her left upper arm. It was reported that the patient  did not have any issues previously when received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  The outcome of pain in extremity, limb mass and hypoaesthesia was reported as recovered on an unknown date.  The causality between the events  and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was unknown.
Age: 1.5
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: An 18 month old patient received Quadracel, no AE; An 18 month old patient received Quadracel in the left thigh, no AE; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an 18 months old female patient who received 0.5ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C588AA, expiry date: 26-Nov-2021, form: Injection) once via unknown route in the left thigh for prophylactic vaccination on 08-Sep-2020 (product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age and vaccine administered at inappropriate site (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: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: Day 1: 4:30pm received injection, 8:30pm headache and chills began,  extreme chills all night, could not stand up to do dizziness, took 2 Tylenol around 3pm,  Day 2: woke up around 6:00am, fever was 100 again, headache persisted, took 2 more Tylenol,  12:00pm - extreme chills returned to the point where my teeth were chattering uncontrollably, fever persisted, took 2 more Tylenol, 4:30pm took a nap for about 15 minutes, 8:00 fever was 101.4, 8:30 went to bed and slept all night Day 3: Mild headache persisting, 7:00am, fever 99.7, took 2 more Tylenol, 7:40am filing this report  General malaise, aches, and fatigue throughout and still continuing  FYI - my base temperature is usually around 98, rather than the general 98.6.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Day 1: 4:30pm received injection, 8:30pm headache and chills began,  extreme chills all night, could not stand up to do dizziness, took 2 Tylenol around 3pm,  Day 2: woke up around 6:00am, fever was 100 again, headache persisted, took 2 more Tylenol,  12:00pm - extreme chills returned to the point where my teeth were chattering uncontrollably, fever persisted, took 2 more Tylenol, 4:30pm took a nap for about 15 minutes, 8:00 fever was 101.4, 8:30 went to bed and slept all night Day 3: Mild headache persisting, 7:00am, fever 99.7, took 2 more Tylenol, 7:40am filing this report  General malaise, aches, and fatigue throughout and still continuing  FYI - my base temperature is usually around 98, rather than the general 98.6.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills, nausea, headache
Age: 50.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Back pain, Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Mild pain at injection site turned to severe pain at injection site by 10pm night of vaccine (9/22).  When I awoke the next morning (9/23)  I felt very tired, out of sorts and the pain in my right arm had grown significantly worse.  By noon the pain had migrated to back and neck, I was experiencing flu like symptoms (nausea, dizziness, overly tired, body aches throughout the body and had a fever of 102).  I went to bed for the night at 4pm.  Sweats and chills alternated throughout the night.  Awoke 9/24 feeling significantly better.  Fever gone, still dizzy, mild body aches and still moderate pain in right shoulder/arm.
Age: 50.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Influenza like illness, Injection site pain, Nausea, Neck pain, Pain
Clinical narrative: Mild pain at injection site turned to severe pain at injection site by 10pm night of vaccine (9/22).  When I awoke the next morning (9/23)  I felt very tired, out of sorts and the pain in my right arm had grown significantly worse.  By noon the pain had migrated to back and neck, I was experiencing flu like symptoms (nausea, dizziness, overly tired, body aches throughout the body and had a fever of 102).  I went to bed for the night at 4pm.  Sweats and chills alternated throughout the night.  Awoke 9/24 feeling significantly better.  Fever gone, still dizzy, mild body aches and still moderate pain in right shoulder/arm.
Age: 50.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Mild pain at injection site turned to severe pain at injection site by 10pm night of vaccine (9/22).  When I awoke the next morning (9/23)  I felt very tired, out of sorts and the pain in my right arm had grown significantly worse.  By noon the pain had migrated to back and neck, I was experiencing flu like symptoms (nausea, dizziness, overly tired, body aches throughout the body and had a fever of 102).  I went to bed for the night at 4pm.  Sweats and chills alternated throughout the night.  Awoke 9/24 feeling significantly better.  Fever gone, still dizzy, mild body aches and still moderate pain in right shoulder/arm.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: patient reported swelling at top of sholder and pain , that developed some time after injection was given . pt also received  fluad  quadrivalent  lot 279790 exp 5-25-2021 .  at this time I am unable to confirm which vaccine was given in his right arm
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous report was received from a physician concerning a patient of unknown age. No concurrent condition, medical history or concomitant therapy was reported.      On 02-SEP-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # R024907, expiration date: 30-AUG-2020; dose, frequency and route were not reported) as prophylaxis (expired product administered).         This is one of two reports from the same reporter.
Age: 46.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report as received from a nurse refers to a 46 year old patient (gender was not reported).  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T009744, expiration date 28-JAN-2020, 0.5 milliliter for prophylaxis (route and site of administration were not reported). The vaccine underwent a temperature excursion of 48.39 degrees Fahrenheit for 1 hour and 45 minutes. The digital data logger was involved. There was no previous temperature excursion.  No additional adverse event details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster, Post herpetic neuralgia, Tremor
Clinical narrative: herpes zoster; post herpetic neuralgia; Bell's palsy; tremors; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 12-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered from herpes zoster, post herpetic neuralgia, Bell's palsy and tremors. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster, post herpetic neuralgia, Bell's palsy and tremors was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster, post herpetic neuralgia, Bell's palsy and tremors to be disability.   Upon internal review, Bell's palsy was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: large rash on arm; This case was reported by a nurse via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at he vaccination was not reported. The patient received dose of Shingrix and experienced large rash on arm. No further information was available. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: harsh pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The age at vaccination was not reported. The patient experienced harsh pain and asked what was good for Shingles shot.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Lightheaded and dizziness; Increased heart rate; Difficulty Breathing; . This case was reported by a consumer via call center representative and described the occurrence of dizziness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced dizziness, heart rate increased and difficulty breathing. On an unknown date, the outcome of the dizziness, heart rate increased and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, heart rate increased and difficulty breathing to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was reported. The patient reported that he received 1st dose of Shingrix on the other day. The patient reported difficulty breathing, increased heart rate, lightheaded and dizziness after receiving 1st dose of Shingrix. The reporter did not consented to follow up. No additional information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Pain; arm was sore; arm was sore and uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain, pain in arm and arm discomfort. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain, pain in arm and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the pain, pain in arm and arm discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that after the 1st dose of Shingrix vaccine, pain, arm was sore and uncomfortable. The patient took one Ibuprofen and felt relieved. The reporter did not consent to follow-up. The reporter discontinued the call abruptly so all information was not available. For further tolerance of 2nd dose refer case ID US2020AMR188514.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR188514:same reporter, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Myalgia, Pyrexia
Clinical narrative: high fever; chills; myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills and myalgia. On an unknown date, the outcome of the fever, chills and myalgia were recovered/resolved.   It was unknown if the reporter considered the fever, chills and myalgia to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced high fever, chills and myalgia after the 1st dose of Shingrix. The reporter did not consent to follow up. The case is linked with the case-US2020188955, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188955:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: a low grade fever; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a patient (unknown demographics) who experienced a low grade fever (pyrexia), while received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date (3 weeks ago), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, dosing details and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a low grade fever (pyrexia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, patent had not recovered from pyrexia.  There will be no information available on batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Quadracel vaccine which was expired 10 days ago/ NO AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4-years-old male patient who received 0.5 mL once first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5500CA, expiry date: 16-Aug-2020, strength: standard, via an intramuscular route in the left leg) which was expired ten days ago (expired product used) on 26-Aug-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.