chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Herpes zoster, Injection site erythema
Clinical narrative: Received second Shingrix vaccine (7/16/2020). Pain, redness, swelling at injection sight the following day and for about a week afterwards. I was also running a fever, had a headache and chills for a day. Three weeks later, around 8/7/20120, broke out with shingles Currently still have shingles along with being tired and achy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Received second Shingrix vaccine (7/16/2020). Pain, redness, swelling at injection sight the following day and for about a week afterwards. I was also running a fever, had a headache and chills for a day. Three weeks later, around 8/7/20120, broke out with shingles Currently still have shingles along with being tired and achy.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: After being administered the first dose of Shingrix, I experienced the following side effects: soreness/pain at the site of the injection; fever which rose to 103.4 degrees; body aches/muscle aches. Fever and body/muscle aches disappeared overnight; soreness/pain at the injection site gradually faded. I am a 64yo male with no underlying health conditions.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: BP 128/88; dizziness; This spontaneous report as received from a other health professional refers to a 37 year old female patient with drug hypersensitivity, food allergy and asthma.    On 03-JUL-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2, intramuscular in the left arm for prophylaxis.    Concomitant therapies included albuterol sulfate (manufacturer unknown), docusate sodium(COLACE), escitalopram oxalate(LEXAPRO), fluticasone propionate(FLOVENT), fluticasone propionate(FLONASE), ibuprofen(IBUPROFEN), loratadine(CLARITIN), pantoprazole(PANTOPRAZOLE) and sodium fluoride(COLGATE PREVIDENT).   On 03-JUL-2019, 5 to 10 minutes after the shot, she felt dizzy while in waiting room, The patient was brought back into the treatment room. and was alert, oriented and talking in complete sentences. She appeared well and sat up. On the same date at 10:30, her blood pressure was128/88 and pulse 71 and at 10:45, her blood pressure was 125/88 and pulse 73 (units were not provided for all).    The outcome of dizziness and blood pressure increased was reported as recovered/resolved.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Swollen tongue
Clinical narrative: Vaccination @ 2:30, at 6:00 started having sore throat, chest congestion and difficulty breathing Went to ER and received Benadryl and Epinephrine.  Released 2 hours later and no continuing effects.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Lower respiratory tract congestion, Oropharyngeal pain
Clinical narrative: Vaccination @ 2:30, at 6:00 started having sore throat, chest congestion and difficulty breathing Went to ER and received Benadryl and Epinephrine.  Released 2 hours later and no continuing effects.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Vertigo
Clinical narrative: violent vomiting; severe diarrhea; violent shivering; head-spinning dizziness, almost like a drug overdose; weakness; mild fever (99.8); lost 7 lbs. in 36 hours; This case was reported by a other health professional and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (No adverse reaction to first shot).   On 8th September 2020, the patient received the 2nd dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. On an unknown date, the outcome of the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. No adverse reaction to first shot. Did not visit any restaurant or eat out that day.  Home eating same food as girlfriend. No respiratory distress or coughing and did not believe it was Covid. The reporter was an EMT and thought this was a very extreme reaction.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: violent vomiting; severe diarrhea; violent shivering; head-spinning dizziness, almost like a drug overdose; weakness; mild fever (99.8); lost 7 lbs. in 36 hours; This case was reported by a other health professional and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (No adverse reaction to first shot).   On 8th September 2020, the patient received the 2nd dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. On an unknown date, the outcome of the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. No adverse reaction to first shot. Did not visit any restaurant or eat out that day.  Home eating same food as girlfriend. No respiratory distress or coughing and did not believe it was Covid. The reporter was an EMT and thought this was a very extreme reaction.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Pyrexia
Clinical narrative: violent vomiting; severe diarrhea; violent shivering; head-spinning dizziness, almost like a drug overdose; weakness; mild fever (99.8); lost 7 lbs. in 36 hours; This case was reported by a other health professional and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (No adverse reaction to first shot).   On 8th September 2020, the patient received the 2nd dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. On an unknown date, the outcome of the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. No adverse reaction to first shot. Did not visit any restaurant or eat out that day.  Home eating same food as girlfriend. No respiratory distress or coughing and did not believe it was Covid. The reporter was an EMT and thought this was a very extreme reaction.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting, Weight decreased
Clinical narrative: violent vomiting; severe diarrhea; violent shivering; head-spinning dizziness, almost like a drug overdose; weakness; mild fever (99.8); lost 7 lbs. in 36 hours; This case was reported by a other health professional and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (No adverse reaction to first shot).   On 8th September 2020, the patient received the 2nd dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. On an unknown date, the outcome of the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had vomiting, diarrhea, shivering, dizziness, weakness, fever and weight loss. No adverse reaction to first shot. Did not visit any restaurant or eat out that day.  Home eating same food as girlfriend. No respiratory distress or coughing and did not believe it was Covid. The reporter was an EMT and thought this was a very extreme reaction.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles one week after dose one of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 15th September 2020, 7 days after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed shingles one week after dose one of Shingrix.  The diagnosis was confirmed by the dermatologist and the patient has been placed on anti-viral therapy, unspecified.  The patient reported that he used VAERS to report his event as well.  His VAERS case number was 196497. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Headache, Pruritus
Clinical narrative: Patient developed extreme itching all over her body 2 days after receiving her 1st dose of Shingrix. She also had a headache that has gotten progressively worse. Itching behind the right eye with visible redness of the eye. She contacted her doctor 5 days after receiving shot but has not heard back. She had been using acetaminophen for the headache and was asking if Benadryl is okay to use for the itching. Recommended using Benadryl + famotidine until she can speak with the doctor.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Gastroenteritis viral
Clinical narrative: Hardness in the pit of my stomach within a couple of hours that felt like a stomach virus. I took a Pepcid AC tablet to see if it would help, and it did relieve the problem within the hour.
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Headache, Mobility decreased, Myalgia, Pain
Clinical narrative: fever, body aches, muscle aches, fatigue, rash on inner arms, skin sensitive to the touch, headaches.  Unable to do anything for 2+ days.  This is the most extreme reaction I've ever had to a vaccine; it's worse than having the flu.  The nurse who administered the shots said there would be unlikely to be any reaction.
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pain of skin, Pyrexia, Rash
Clinical narrative: fever, body aches, muscle aches, fatigue, rash on inner arms, skin sensitive to the touch, headaches.  Unable to do anything for 2+ days.  This is the most extreme reaction I've ever had to a vaccine; it's worse than having the flu.  The nurse who administered the shots said there would be unlikely to be any reaction.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not receive their 2nd dose of GARDASIL 9 on schedule; This spontaneous report was received from a pharmacist and refers to a 34-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 11-DEC-2009, the patient was vaccinated with the first dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. On an unknown date, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1614897, expiry date 20-SEP-2021, for prophylaxis. The second dose was not administered on schedule. 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: 1614897; expirationdate: 20-SEP-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
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered to patient; This spontaneous report has been received from a physician concerning a 66 year old patient with unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 24-AUG-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T009744, expiration date on 28-JAN-2022, 0.5 milliliter for prophylaxis (product storage error). Dose number, route of administration and anatomical location were not provided.  It was reported that on an unspecified date, the vaccine was exposed to a temperature of 48.39 Fahrenheit degrees for 1 hour and 45 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-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: M
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: pain in the arm which he received the vaccine.; muscle aching; This spontaneous report has been received from a 72 year old male patient, who was also a medical doctor, reporting on himself. The patient had no pertinent medical history. His concurrent conditions included drug reaction/allergy to penicillin. His concomitant therapies included ibuprofen, unspecified daily vitamins and a daily unspecified prostate pill.  On 29-AUG-2020 (reported as "10 days ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one time intramuscular injection for prophylaxis (reported as recommended vaccine). Dose, dose number, anatomical location, lot number and expiration date were not provided.      The patient stated that on 01-SEP-2020, after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, he experienced muscle aching (myalgia) and pain in the arm which he received the vaccine (pain in extremity). He was asked if he was experiencing any other side effects or generalized muscle aching and he denied any other side effects. He had been taking ibuprofen to help with the pain but stated that after the medication wore off, the pain flared back up. There was never any swelling or redness, just muscle ache/pain in the entire upper arm where it was administered. No lab diagnostics or studies were performed. The patient did not seek medical attention.  At the time of reporting, the patient had not recovered from pain in extremity and myalgia and the causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient had not experienced any symptoms related to vaccine; accidentally given VAQTA after having received 2 previous doses of pediatric Hep A vaccine; This spontaneous report as received from a Medical Assistant and was referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, or concomitant therapies were not reported.      On 14-AUG-2014, the patient was vaccinated with hepatitis a vaccine (manufacturer unknown), pediatric first dose (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported), as prophylaxis. On 27-MAR-2015, the patient was vaccinated with hepatitis a vaccine (manufacturer unknown), pediatric second dose (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported), as prophylaxis.   On 17-AUG-2020, the patient was "accidentally" vaccinated with hepatitis a vaccine, inactivated(VAQTA), third dose (strength, dose, frequency, route, and anatomical location were not reported), lot # S017741, expiration date 26-AUG-2020, as prophylaxis (inappropriate schedule of product administration). At the time of reporting, the patient had not experienced any symptoms related to the vaccine. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S017741; expirationdate: 26-AUG-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
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; An expired PROQUAD was administered to a patient; This spontaneous report as received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 10-SEP-2020 the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (rHA) (PROQUAD) 0.5 milliliter, once, lot # S006832, expiration date 02-SEP-2020 (route of administration was not provided) for prophylaxis. There were no prior temperature excursions. No additional adverse event reported.
Age: 4.0
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 referring to a 4-year-old female patient. Information regarding the patient's pertinent medical history and drug reactions/allergies was not provided.  On 20-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose schedule and anatomical location were not reported; lot # T005406 with expiration date 12-AUG-2021) subcutaneously for "well check" (prophylaxis) (product storage error). This vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The administered dose of the vaccine experienced multiple temperature excursions which went from -14 degrees Celsius (C) to -10 C for 116 hours; and from -9 C to 8 C (-6.1 C) for 13 hours, as recorded by a data logger. There was no previous temperature excursion.  This is one of multiple reports sent by the same reporter.; Sender's Comments:  US-009507513-2009USA005503: US-009507513-2009USA005097: US-009507513-2009USA005124: US-009507513-2009USA005141: US-009507513-2009USA005142: US-009507513-2009USA005258: US-009507513-2009USA005382: US-009507513-2009USA005515: US-009507513-2009USA005526:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Laboratory test, Pruritus, Swelling of eyelid
Clinical narrative: she had a reaction to ZOSTAVAX. The reaction is itching and swollen eyelids; she had a reaction to ZOSTAVAX. The reaction is itching and swollen eyelids; ear infection; she had pain at the injection site; This spontaneous report has been received from a currently 61 years-old female consumer concerning herself. The patient's concomitant therapies included rosuvastatin calcium (CRESTOR), fish oil, ezetimibe (manufacturer unknown), aspirin, probiotics and milk thistle. The patient's concurrent  conditions included a shellfish allergy. The patient's historical drugs and medical history were not reported.     On an unknown date,  the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dosage regimen, Lot # and expiration date were not provided)for shingles' prophylaxis.      On an unknown date, the patient experienced pain at the injection site, swelling of eyelid and itching (pruritus).      On 09-SEP-2020, the patient started using ear drops called hydrocortisone (+) neomycin sulfate (+) polymyxin B sulfate) otic suspension, 3 ear drops, twice per day, Expiration date June 2022 for an ear infection.  On 14-SEP-2020, the patient experienced the same aforementioned reaction.  On an unknown date, the patient underwent a blood work ( name of the laboratory test, units and results were not reported) and the patient was planning to visit her health care provider.  At the time of reporting, the patient had not recovered from pain at the injection site, swelling of eyelid, itching and the ear infection.    The consumer  considered injection site pain, swelling of eyelid and pruritus were related to zoster vaccine live (ZOSTAVAX). The causal relationship between zoster vaccine live (ZOSTAVAX) and the ear infection was not reported.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; recieved dose five years after the first dose; This spontaneous report  was received from a consumer concerning to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unspecified date in 2015, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   On 11-JUL-2020 , the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614898 for prophylaxis, five years after the first dose (inappropriate schedule of product administration).  However, at the reporting time, the patient had not reported adverse events. 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: 1614898; expirationdate: 15-NOV-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: 0.5
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 6 month old patient received GARDASIL 9 due to human error; This spontaneous report has been received from a physician referring to a 6 month old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On 14-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) due to human error (product administered to patient of inappropriate age).
Sex: F
Vaccine: HPV9
Symptoms: Dizziness postural, Syncope
Clinical narrative: Received her first GARDASIL 9 shot "last week" and after 10 minutes stood up, told the NP that she was feeling dizzy and then fainted; This spontaneous report was received from a physician concerning an adolescent female patient. The patient's concurrent conditions, medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On approximately 08-SEP-2020 (reported as "last week"), 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) (Route of administration, lot number and expiration date were not provided) for prophylaxis. On the same date, 10 minutes after, the patient stood up, and told the reporter that she was feeling dizzy and then fainted (syncope).  At the time of the report it was unknown if the patient had recovered from the syncope. The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the syncope was unknown.  Upon internal review it was considered the syncope to be medically significant.; Sender's Comments:  US-009507513-2009USA007009:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: chicken pox; This spontaneous report was received from a lawyer and the patient, reporting on herself. A 5 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unspecified date in 1954 (also reported as "maybe 1954"), the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unspecified date in 1954, the patient was diagnosed with chickenpox (varicella).    The outcome of varicella and the causality assessment between the event and therapy with varicella virus vaccine live (oka/merck) (manufacturer unknown) was not provided.         On approximately 2016, the patient experienced events related to zoster vaccine live (ZOSTAVAX) (Captured in: 2006USA003705).; Sender's Comments:  US-009507513-2006USA003705:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient has not reported any side effects; a patient received PROQUAD vaccine instead ofMMR2 today; This spontaneous report was received from a medical assistant referring to a female patient (age reported 47 (unit unknown)). Information regarding to the patient's medical history, drug reactions/ allergies and concomitant medication was unknown.  On 16-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status of rHA (recombinant human albumin))(PROQUAD) (lot # S038146, expiration date 25-MAY-2021; strength, dose and route were unknown) instead of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were unknown)for prophylaxis (wrong vaccine administered). The patient had not reported any side effects
Sex: U
Vaccine: HPV9, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Customer reporting an expired dose of GARDASIL 9 given to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 14-SEP-2020, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R000303, expiration date: 29-AUG-2020) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events 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. ; devicelotnumber: R000303; expirationdate: 29-AUG-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: 26.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE reported; a adult patient may have received a pediatric dose; Information has been received from a registered nurse regarding a 26-years-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 20-FEB-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis, lot number R025518 with expiration date not reported but upon internal validation established as 15-NOV-2019 (strength, dose, frequency, route of administration and anatomical location were not reported) (inappropriate dose of drug administered).  No adverse events were reported.
Age: 0.08
Sex: U
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of VARIVAX was mistakenly given to a 1 month old patient; This spontaneous report was received from a physician regarding a 1 month old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 18-SEP-2020, a dose of varicella virus vaccine live (oka/merck) (VARIVAX) was mistakenly given to the patient due to human error (strength, dose, route of administration, lot number and expiration date were not reported).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a nurse, referring to a 4-year-old patient of unknown gender. Information regarding the patient's medical history and historical drugs was not provided.   On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of virus varicella virus vaccine live (oka/merck) (VARIVAX) lot # S025609, expiration date 18-AUG-2021, subcutaneous for immunisation (reported as "booster shot") (dose, vaccination scheme frequency and anatomical site of vaccination were not reported). Concomitant therapies included properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was stored in temperatures of  6 degree Fahrenheit (°F) to 14°F (7.9F) for 25 hours (multiple excursions) as recorded by a data logger. There was no previous temperature excursion reported.
Sex: M
Vaccine: MMR
Symptoms: Vaccination site pain
Clinical narrative: when he received the MMRII vaccination, "it was quite painful"; This spontaneous report was received from a field representative on behalf of the patient, who was a male physician of unknwon age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 18-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The patient reported that when he received the vaccination, "it was quite painful" (vaccination site pain).   At the time of reporting, the outcome of vaccination site pain was unknown. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and vaccination site pain was unknown.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; pertussis 3 months after my tdap booster; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, 3 months after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Tdap Vaccine.  Additional details were provided as follows: This case was reported by patient his/herself. The age at vaccination was not reported. The patient received booster dose of Tdap Vaccine. After receiving Tdap Vaccine, the patient caught pertussis. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation for pertussis was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Fibromyalgia
Clinical narrative: Diagnosed with fibromyalgia; Joint pain; This case was reported by a pharmacist via sales rep and described the occurrence of fibromyalgia in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHingrix (1st dose received in December 2019).   In March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced fibromyalgia and joint pain. On an unknown date, the outcome of the fibromyalgia and joint pain were unknown.   It was unknown if the reporter considered the fibromyalgia and joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 56 or 57 years old. A little over one month after 2nd dose, patient started experiencing joint pain and had since been diagnosed with fibromyalgia. Patient called doctors office wondering if there was a potential that her joint pain was a lasting side effect from Shingrix immunizations. Blood work and testing had been done to determine what could be causing the patients recent on set of joint pain. Nothing had been determined as a cause. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain
Clinical narrative: Excessively tired; Pain at vaccination site; This case was reported by a consumer and described the occurrence of tiredness in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   On 15th September 2020, the patient received Fluarix Tetra 2020-2021 season. On 17th September 2020, 2 days after receiving Fluarix Tetra 2020-2021 season, the patient experienced tiredness and injection site pain. On an unknown date, the outcome of the tiredness and injection site pain were not recovered/not resolved.   The reporter considered the tiredness and injection site pain to be possibly related to Fluarix Tetra 2020-2021 season.  Additional information was provided as follows: The case was reported by the spouse of the patient. The age at vaccination was not reported. The patient complained of being excessively tired and pain at vaccination site, assumed both are due to vaccine. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister infected, Pruritus, Rash, Rash follicular
Clinical narrative: blisters look more like chicken pox; rash / was on the patients hip / on feet, knees, buttocks, and few on elbow; new clusters developed / and in hair; blister starts as a red bump with a white center; the blister scabs over with a yellow cru; Extremely itchy; yellow crust; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 15th February 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 4th September 2020, the patient received the 2nd dose of Shingrix. On 5th September 2020, 1 days after receiving Shingrix and Shingrix, the patient experienced chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust. On an unknown date, the outcome of the chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust were unknown.   It was unknown if the reporter considered the chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After the second Shigrix injection, the patient developed a rash the next day.  The rash was not at the injection site. The first cluster was on the patients hip. 4 days later the original cluster had scabbed and were clearing up However, as they cleared up, new clusters developed on feet, knees, buttocks, and few on elbow and in hair. The blister starts as a red bump with a white center. After scratched, the blister scabs over with a yellow crust. Extremely itchy first 48 hours.  The reporter consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Varicella
Clinical narrative: blisters look more like chicken pox; rash / was on the patients hip / on feet, knees, buttocks, and few on elbow; new clusters developed / and in hair; blister starts as a red bump with a white center; the blister scabs over with a yellow cru; Extremely itchy; yellow crust; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 15th February 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 4th September 2020, the patient received the 2nd dose of Shingrix. On 5th September 2020, 1 days after receiving Shingrix and Shingrix, the patient experienced chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust. On an unknown date, the outcome of the chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust were unknown.   It was unknown if the reporter considered the chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After the second Shigrix injection, the patient developed a rash the next day.  The rash was not at the injection site. The first cluster was on the patients hip. 4 days later the original cluster had scabbed and were clearing up However, as they cleared up, new clusters developed on feet, knees, buttocks, and few on elbow and in hair. The blister starts as a red bump with a white center. After scratched, the blister scabs over with a yellow crust. Extremely itchy first 48 hours.  The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: facial swelling; This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had facial swelling after receipt of the Shingrix vaccine in April 2019.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Fluzone pre-filled syringe was apparently leaked while patient was receiving the vaccine/ NO AE; Fluzone pre-filled syringe was apparently leaked while patient was receiving the vaccine/ NO AE; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a female patient (age unknown) who while receiving 0.5 mL INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe) (batch number, expiry date, route and site of administration not reported) was apparently leaked (syringe issue and underdose) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of syringe leak and vaccine underdose.  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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: second dose of rabiesx vaccine was scheduled on 13th Aug, but that patient may not be able to receive this dose because of Covid-19/ no ae; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a female patient who missed second dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES], due to Covid-19 which was scheduled on 13-Aug-2020 for (Product dose omission) for pre-exposure immunization.  Medical history, concomitant therapy, past medical treatment, past vaccinations and family history were not provided.  This was potential medication error case due to missed dose.  It was not reported that the patient had start her pre-exposure rabies vaccine series and second dose was scheduled for the 13th, but she had not received that dose because of Covid-19. The patient had reported no adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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 on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the third dose of Pentacel was administered incorrectly to a patient/No AE; Initial information was received on 18-Aug-2020 regarding an unsolicited valid non-serious case from an other health professional .  This case involves patient with unknown demographics who received third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number and expiry date not reported] incorrectly via an unknown route at an unknown administration site, on an unknown date for prophylactic vaccination (Incorrect dosage administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was also a case of actual medication error due to inappropriate age at vaccine administration. (Latency: at the same time of vaccination)  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: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received Menactra less than 4 years from a previous dose of Menveo, no AE; Initial information was received on 24-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 15 year old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] less than 4 years from a previous dose of menveo (inappropriate schedule of product administration).  The past vaccination(s) included Menveo for prophylactic vaccination.  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.   On 21-Aug-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6691AA, expiry date: 21-Aug-2021) via unknown route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.