chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in jaw, Syncope
Clinical narrative: Around 12:20pm, patient came to the pharmacy to pick up a script for a family member and said he wanted a flu shot which is required for his place of employment. When he filled out the consent form, he did indicate he has history of fainting after receiving a vaccine. We counseled him that if he wants to continue with the vaccine, he can but will need to sit for a couple mins with us in case something similar happens. He felt anxious the whole time and was vocal about being scared of receiving vaccines and scared of needles in general. He received the vaccine, remained sitting and then after 2 mins he seemed to black out and passed out onto the floor. He fell and did hurt his jaw but was awake and communicated the whole time. We called 911 and they arrived and did some checks and said he was okay. After about a half and hour he said he was okay, his BP was normal and left. Was not upset and the paramedics said he was cleared to leave on his own.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus, Tenderness
Clinical narrative: Inflamed and very itchy arm. Red and tender
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Patient has been experiencing a red arm from her hand to her elbow as well as itching in the vaccinated arm.  The itching has improved on 11.1.20, but there is still some redness on the arm.
Age: 58.0
Sex: M
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Dyspnoea, Loss of consciousness, Syncope
Clinical narrative: Patient fainted after receiving the Flublok, Pneumovax-23 and Shingrix vaccinations in the left deltoid muscle. Patient complained of shortness of breath after regaining consciousness and requested oxygen. EMS service was called and patient was taken to the hospital.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Reported on 11/1/2020. Patient reports redness, swelling, hardness, and burning at site of injection. She is taking ibuprofen, applying heat and cold, and will contact PCP.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported redness, swole , sore, ?hurts to touch? at injection site
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: cellulitis like symptoms around vaccine site
Age: 49.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient came into pharmacy on 10/31/2020 and stated his arm was still hurting from his flu shot on 10/17/2020. He said he felt the pain immediately upon getting the injection on 10/17/2020.  He took photos of the injection site and called his physician, who said it might possibly be SIRVA. Patient has not been physically seen by a physician at this time. He states he still has pain in the shoulder  and movement that is restricted by pain
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema
Clinical narrative: pt had redness at the site of injection about the size of a quarter the morning following the injection. She called in the morning and was advised to ice the site and mark the perimeter so she would know if it was getting better or worse. She was also instructed to take an over the counter pain reliever if needed but she cannot do do intolerance. Pt called sunday am and the reaction was no better or worse so she was instructed to go to an urgent care or her md to have it checked.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Blood test, Chest X-ray, Dizziness, Dyspnoea
Clinical narrative: Extreme fatigue, weakness, leg muscle pains/pins and needles, lightheadedness, shortness of breath, tingling lips, hand tremors
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Magnetic resonance imaging spinal, Myalgia, Paraesthesia, Paraesthesia oral
Clinical narrative: Extreme fatigue, weakness, leg muscle pains/pins and needles, lightheadedness, shortness of breath, tingling lips, hand tremors
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: SARS-CoV-2 test, Spinal X-ray, Tremor
Clinical narrative: Extreme fatigue, weakness, leg muscle pains/pins and needles, lightheadedness, shortness of breath, tingling lips, hand tremors
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site inflammation, Nausea, Pruritus
Clinical narrative: Inflammation on the site of injection, Nausea, Fever, generalized itching,  erythema and headache. Patient felt better on the third day after injection.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Inflammation on the site of injection, Nausea, Fever, generalized itching,  erythema and headache. Patient felt better on the third day after injection.
Age: 77.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Blood pressure abnormal, Nausea
Clinical narrative: Patient received vaccine about 11:30 am on 10-31-20.  Woke up on 11-1-20 feeling extremely nauseous and with a blood pressure at 70/40. She called her physician who instructed her to try and eat and call her daughter-in-law.  About an hour and a half after eating, her blood pressure was normal again though patient felt very nauseous and weak.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: The patient complained of a itchy rash and swelling on  left bicep on arm where vaccine was given.  The vaccine was given in the left Deltoid IM.  She was told to monitor it  and ice it as necessary ,take a pain reliever and put a anti itch cream like Benadryl  cream on if necessary for up to a couple of days. If it continues or gets worse she should check with her doctor.
Age: 33.0
Sex: F
Vaccine: FLUA3
Symptoms: CSF protein increased, Diplopia, Gait disturbance, Hand-eye coordination impaired, Immunoglobulin therapy
Clinical narrative: Diplopia started on 10/9/2020, unsteady gait on 10/10/2020.  Diagnosed with. Miller Fisher variant of Guillain Barre by neurology on 10/13/2020.  Hospitalized 10/13-22, treated with 5 day course of IVIG and PT/OT.  At discharge, still with paresthesias to feet, diplopia.  Able to walk independently, but with unsteady gait and decreased fine motor coordination, ongoing outpatient PT?OT and on short term disability.
Age: 33.0
Sex: F
Vaccine: FLUA3
Symptoms: Miller Fisher syndrome, Paraesthesia
Clinical narrative: Diplopia started on 10/9/2020, unsteady gait on 10/10/2020.  Diagnosed with. Miller Fisher variant of Guillain Barre by neurology on 10/13/2020.  Hospitalized 10/13-22, treated with 5 day course of IVIG and PT/OT.  At discharge, still with paresthesias to feet, diplopia.  Able to walk independently, but with unsteady gait and decreased fine motor coordination, ongoing outpatient PT?OT and on short term disability.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Limb injury, Vaccination complication
Clinical narrative: Patient reports an shoulder injury due to vaccination. Left shoulder has been in pain since injection date 10/21/2020. Patient also stated the pain has traveled to the right shoulder as well. Patient was informed to contact primary health as soon as possible
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Muscle spasms, Pallor, Tension, Tremor
Clinical narrative: PASSED OUT, PALE, CRAMPING IN RIGHT LEG, SHAKING, TENSED UP
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye movement disorder, Feeling abnormal, Hypoaesthesia oral, Loss of consciousness, Nervousness
Clinical narrative: About 5 minutes after administration, the pt passed out, eyes rolled back, and he began shaking briefly.  He revived almost immediately and said that his tongue felt numb and his legs felt weird. He admitted that he was very nervous to get the shot.  EMS was called and he was checked out.  Blood pressure and vitals were normal, he was not admitted or taken to the hospital.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Tremor
Clinical narrative: About 5 minutes after administration, the pt passed out, eyes rolled back, and he began shaking briefly.  He revived almost immediately and said that his tongue felt numb and his legs felt weird. He admitted that he was very nervous to get the shot.  EMS was called and he was checked out.  Blood pressure and vitals were normal, he was not admitted or taken to the hospital.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Started gettting right frontal headaches the afternoon on the date I receiveed my Flu shot. I never get headaches.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site rash, Pain in extremity
Clinical narrative: soreness in arm rash with bumps on arm below injection site stomach ache fatigue headache
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Pain
Clinical narrative: patient experienced pain that has lasted for at least two weeks.  reports going to see her dr. and had what she claimed is a diagnosis of cellulitis.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Injection site soreness Headache  Muscle aches Slight nausea  Joint pain
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza, Injection site pain, Malaise
Clinical narrative: Flu symptoms: low grade fever (100.6), mild muscle aches (all over, not just injection site), headache, exhaustion, malaise
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Flu symptoms: low grade fever (100.6), mild muscle aches (all over, not just injection site), headache, exhaustion, malaise
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Within 1 hour site if injection began to turn red and swell. Swelling continued for 24 hours. Red, warm to the touch, pain and itchiness.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Within 1 hour site if injection began to turn red and swell. Swelling continued for 24 hours. Red, warm to the touch, pain and itchiness.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Within 2 hours of injection, site began to turn red and swell. Swelling continued to grow for 48 hours before decrease. Red, warm to the touch, pain, itchiness.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Hallucination, Hemiplegia, Transient ischaemic attack, Vaccine positive rechallenge
Clinical narrative: 10 hour mini-stroke paralysis of left side, followed by 8 hours of hallucinations.  I waited it out since my cell phone was out of reach.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Haemorrhage, Injection site pruritus, Injection site swelling, Scab
Clinical narrative: 2-3 days after receiving shot, patient reported itching and swelling at site of injection. I observed a nickel-sized area on right upper deltoid upon patient's presentation two weeks after presentation. Patient stated it was no longer causing pain, but that it had been itchy for at least a week and the patient's itching had caused the area to bleed and scab over.
Age: 0.75
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Developmental delay, Eczema, Erythema, Pyrexia
Clinical narrative: Televisit on 10/17/20 with patient's mom. Patient received routine one year old immunization of MMR/Varivax/Hept A + flu shots on 10/4/20. PE at that time was WNL except mild development delay. According to Mother, he developed fever + small, red spot on face 2 days after the shots, then faded away in a few days. Again he developed low grade fever (99-100 degrees F) on 10/16/20 with slightly bumpy rash all over the body. He was doing ok, not fussy but slightly decreased appetite. No vomiting or diarrhea. On Televist screen I observed generalized maculopapular rash (not the best screen) over face, trunk + some over the extremities No blisters or petechiae. I explained to the mother that the rash seems most possibly MMR reaction. If so pt is not contagious and advised mother to observe. I again talked with mother next day (10/17/20) She said that patient has no fever for today. Rash was slightly getting better. I advised to get Covid test but mother declined. I talked with mother on 10/23/20 Mother said that rash faded away after 2 - 3 days but the 2 - 3 days after that another eczema like rash appeared on face She used Hydrocortisone cream + it faded away in 2 - 3 days Currently patient was doing fine, no complaints
Age: 0.75
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Televisit on 10/17/20 with patient's mom. Patient received routine one year old immunization of MMR/Varivax/Hept A + flu shots on 10/4/20. PE at that time was WNL except mild development delay. According to Mother, he developed fever + small, red spot on face 2 days after the shots, then faded away in a few days. Again he developed low grade fever (99-100 degrees F) on 10/16/20 with slightly bumpy rash all over the body. He was doing ok, not fussy but slightly decreased appetite. No vomiting or diarrhea. On Televist screen I observed generalized maculopapular rash (not the best screen) over face, trunk + some over the extremities No blisters or petechiae. I explained to the mother that the rash seems most possibly MMR reaction. If so pt is not contagious and advised mother to observe. I again talked with mother next day (10/17/20) She said that patient has no fever for today. Rash was slightly getting better. I advised to get Covid test but mother declined. I talked with mother on 10/23/20 Mother said that rash faded away after 2 - 3 days but the 2 - 3 days after that another eczema like rash appeared on face She used Hydrocortisone cream + it faded away in 2 - 3 days Currently patient was doing fine, no complaints
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site cellulitis, Vaccination site vesicles
Clinical narrative: cellulitis + large blister formed at vaccine site 24 hours after influenza vaccine
Age: 69.0
Sex: M
Vaccine: FLU4, PPV, FLU4
Symptoms: Erythema, Extensive swelling of vaccinated limb, Localised infection
Clinical narrative: upper arm was swollen / lower arm was also swollen/his lower arm was also swollen and red; upper arm was / red / lower arm was / red / redness / redness started to go into his shoulder/his lower arm was also swollen and red; Cellulitis / go to the emergency room / admitted overnight.; pain in the upper part of his left arm; problem sleeping because of the pain/ sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 69-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 15th October 2020, the patient received FluLaval Tetra 2020-2021 season (intramuscular). On 15th October 2020, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant), pain in arm (serious criteria hospitalization) and difficulty sleeping (serious criteria hospitalization). On 16th October 2020, the patient experienced swelling arm (serious criteria hospitalization) and erythema of extremities (serious criteria hospitalization). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the cellulitis, pain in arm, difficulty sleeping, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the cellulitis, pain in arm, difficulty sleeping, swelling arm and erythema of extremities to be related to FluLaval Tetra 2020-2021 season.  Additional details were reported as follows: The patient was the reporter and has had many flu vaccines over the years.  When patient got flu shot, he started to immediately experience pain in the upper part of his left arm which did not get better. He had a problem sleeping because of the pain.  On 16th October 2020, his upper arm was swollen and red.  On 17th October 2020, his lower arm was also swollen and red. The patient called his primary doctor who told him to go to an urgent care clinic.  On 24th October 2020, the patient was diagnosed with Cellulitis and given antibiotics. When he did not get any better and the redness started to go into his shoulder, he was told to go to the emergency room which he did and was admitted overnight. The reporter did not consent to follow-up. The emergency room visit required.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV, FLU4
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: upper arm was swollen / lower arm was also swollen/his lower arm was also swollen and red; upper arm was / red / lower arm was / red / redness / redness started to go into his shoulder/his lower arm was also swollen and red; Cellulitis / go to the emergency room / admitted overnight.; pain in the upper part of his left arm; problem sleeping because of the pain/ sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 69-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 15th October 2020, the patient received FluLaval Tetra 2020-2021 season (intramuscular). On 15th October 2020, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant), pain in arm (serious criteria hospitalization) and difficulty sleeping (serious criteria hospitalization). On 16th October 2020, the patient experienced swelling arm (serious criteria hospitalization) and erythema of extremities (serious criteria hospitalization). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the cellulitis, pain in arm, difficulty sleeping, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the cellulitis, pain in arm, difficulty sleeping, swelling arm and erythema of extremities to be related to FluLaval Tetra 2020-2021 season.  Additional details were reported as follows: The patient was the reporter and has had many flu vaccines over the years.  When patient got flu shot, he started to immediately experience pain in the upper part of his left arm which did not get better. He had a problem sleeping because of the pain.  On 16th October 2020, his upper arm was swollen and red.  On 17th October 2020, his lower arm was also swollen and red. The patient called his primary doctor who told him to go to an urgent care clinic.  On 24th October 2020, the patient was diagnosed with Cellulitis and given antibiotics. When he did not get any better and the redness started to go into his shoulder, he was told to go to the emergency room which he did and was admitted overnight. The reporter did not consent to follow-up. The emergency room visit required.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV, FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: upper arm was swollen / lower arm was also swollen/his lower arm was also swollen and red; upper arm was / red / lower arm was / red / redness / redness started to go into his shoulder/his lower arm was also swollen and red; Cellulitis / go to the emergency room / admitted overnight.; pain in the upper part of his left arm; problem sleeping because of the pain/ sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 69-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 15th October 2020, the patient received FluLaval Tetra 2020-2021 season (intramuscular). On 15th October 2020, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant), pain in arm (serious criteria hospitalization) and difficulty sleeping (serious criteria hospitalization). On 16th October 2020, the patient experienced swelling arm (serious criteria hospitalization) and erythema of extremities (serious criteria hospitalization). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the cellulitis, pain in arm, difficulty sleeping, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the cellulitis, pain in arm, difficulty sleeping, swelling arm and erythema of extremities to be related to FluLaval Tetra 2020-2021 season.  Additional details were reported as follows: The patient was the reporter and has had many flu vaccines over the years.  When patient got flu shot, he started to immediately experience pain in the upper part of his left arm which did not get better. He had a problem sleeping because of the pain.  On 16th October 2020, his upper arm was swollen and red.  On 17th October 2020, his lower arm was also swollen and red. The patient called his primary doctor who told him to go to an urgent care clinic.  On 24th October 2020, the patient was diagnosed with Cellulitis and given antibiotics. When he did not get any better and the redness started to go into his shoulder, he was told to go to the emergency room which he did and was admitted overnight. The reporter did not consent to follow-up. The emergency room visit required.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Confusional state, Disorientation, Dizziness, Dysstasia
Clinical narrative: Patient complained of severe flu-like symptoms, such as fever, as well as loss of control of his right arm and torso.  Patient did call his primary care physician to explain side effects he experienced.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysuria, Gait inability, Myalgia, Pyrexia, Rash
Clinical narrative: Patient complained of severe flu-like symptoms, such as fever, as well as loss of control of his right arm and torso.  Patient did call his primary care physician to explain side effects he experienced.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyskinesia, Influenza like illness, Pyrexia
Clinical narrative: Patient complained of severe flu-like symptoms, such as fever, as well as loss of control of his right arm and torso.  Patient did call his primary care physician to explain side effects he experienced.
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site swelling
Clinical narrative: It became red and hot at the injection site at around one hour after the vaccination. Patient said it start like a half dollar size but it got bigger. Patient went to the doctor who told her she got an infection at the injection site and was going to prescribe antibiotics to her.
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: It became red and hot at the injection site at around one hour after the vaccination. Patient said it start like a half dollar size but it got bigger. Patient went to the doctor who told her she got an infection at the injection site and was going to prescribe antibiotics to her.
Age: 11.0
Sex: F
Vaccine: HPV9, JEV1, MNQ, TDAP
Symptoms: Anxiety, Pallor, Syncope
Clinical narrative: Pt underwent a syncope 5 minutes after the vaccination. Pt was pale but conscious when notified by the parent, and the vital signs were stable. Pt was laid flat and was able to drink water. History and physical is consistent with vasovagal syncope.  No concerns identified on history and physical.  There is no evidence for this being an anaphylaxis reaction by referred doctor.  The parents admitted that there was some perceived situational anxiety just prior to the injection.  Pt  recovered and left the facility after about 15 minutes observation.
Age: 50.0
Sex: F
Vaccine: FLUA3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Influenza, Lethargy, Malaise, Nasopharyngitis
Clinical narrative: Felt like a combination of flu and cold and other.  Meaning, no fever or chills, but very very lethargic.  Overall unwell feeling.  Claminess.  The way that I felt for 3 weeks after was unlike anything I've felt before with the combination of symptoms.  Started feeling pretty normal after about 3.5 weeks.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Altered state of consciousness, Deafness, Electrocardiogram abnormal, Hypotension, Nausea
Clinical narrative: orthostaic hypotension; vasovagal syncope: Nausea, pale skin, wavering consciousness, hypotensive; sinus bradycardia; seizure; Hearing loss; Information has been received from the regulatory authority on 18-AUG-2020.   This spontaneous report as received from two healthcare professionals refers to a 12 year old female patient with lactose intolerance, and penicillin allergy.      On 21-AUG-2019,  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 1, intramuscularly, lot # R016971, in the left arm), diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (dose 1, intramuscularly, lot # 2E3EH, in the left arm) and meningococcal acyw conj vaccine (crm197) (MENVEO) (dose 1, intramuscularly, lot # AMVA12EA, in the right arm) all for prophylaxis.  Three minutes after vaccination the patient experienced a syncopal episode lasting 5 -10 seconds, wavering consciousness for 8 minutes after waking up until the emergency services (EMS) arrived.  Hypotensive from EMS vitals.  Sinus bradycardia on electrocardiogram (ECG) in ER.  Persistent orthostatic hypotension despite 1800 ml of Isotonic fluid boluses (NS) led to pediatrics admission.  The patient was diagnosed with vasovagal syncope.   It was also reported by another healthcare professional (discrepant information) that few minutes after vaccination, the patient and her father walked to consultation window for paperwork.  The patient then went through a seizure for no more than 1 minute.  The patient then woke up, unaware of what happened.  They remained on permanent alert until EMS came.  The patient complained of nausea, hearing loss and was pale. The patient required an emergency room or emergency department visit.   The outcome of the events and the causality assessment between the events and the suspect products were unknown.  As of 28-OCT-2020, all telephone attempts to obtain follow up information had been unsuccessful. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R016971; expirationdate: 22-MAR-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 suggest a causal association with the device or device constituent
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Orthostatic hypotension, Pallor, Seizure, Sinus bradycardia, Syncope
Clinical narrative: orthostaic hypotension; vasovagal syncope: Nausea, pale skin, wavering consciousness, hypotensive; sinus bradycardia; seizure; Hearing loss; Information has been received from the regulatory authority on 18-AUG-2020.   This spontaneous report as received from two healthcare professionals refers to a 12 year old female patient with lactose intolerance, and penicillin allergy.      On 21-AUG-2019,  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 1, intramuscularly, lot # R016971, in the left arm), diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (dose 1, intramuscularly, lot # 2E3EH, in the left arm) and meningococcal acyw conj vaccine (crm197) (MENVEO) (dose 1, intramuscularly, lot # AMVA12EA, in the right arm) all for prophylaxis.  Three minutes after vaccination the patient experienced a syncopal episode lasting 5 -10 seconds, wavering consciousness for 8 minutes after waking up until the emergency services (EMS) arrived.  Hypotensive from EMS vitals.  Sinus bradycardia on electrocardiogram (ECG) in ER.  Persistent orthostatic hypotension despite 1800 ml of Isotonic fluid boluses (NS) led to pediatrics admission.  The patient was diagnosed with vasovagal syncope.   It was also reported by another healthcare professional (discrepant information) that few minutes after vaccination, the patient and her father walked to consultation window for paperwork.  The patient then went through a seizure for no more than 1 minute.  The patient then woke up, unaware of what happened.  They remained on permanent alert until EMS came.  The patient complained of nausea, hearing loss and was pale. The patient required an emergency room or emergency department visit.   The outcome of the events and the causality assessment between the events and the suspect products were unknown.  As of 28-OCT-2020, all telephone attempts to obtain follow up information had been unsuccessful. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R016971; expirationdate: 22-MAR-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 suggest a causal association with the device or device constituent
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from an office manager referring to a 2-year-old male patient. The patient's concurrent condition, medical history and allergic histories were not reported.  On 06-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # was T003706 with an expiration date of 30-JAN-2022, dose and route were not reported) for prophylaxis.On the same date, the patient was also vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # was S029454 with an expiration date of 19-SEP-2021, dose and route were not reported) for prophylaxis.      On 30-SEP-2020, the above vaccines underwent temperature excursion of -14.27 degrees Celsius for 20 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA002670:
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: PROQUAD and VARIVAX were administered on the same day to an adult patient instead of VARIVAX and MMR II; PROQUAD and VARIVAX were administered on the same day to an adult patient instead of VARIVAX and MMR II; This spontaneous report has been received from a nurse referring to a 47-year-old male patient. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 08-OCT-2020, the patient was administered with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # S038146, expiration date 25-MAY-2021 (strength and route were not reported) (inappropriate age at vaccine administration) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # S019463, expiration date 24-JUN-2021 (strength and route were not reported) for prophylaxis, instead of varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong vaccine administered). The outcome of the events and the action taken with suspect therapies was not reported.
Sex: U
Vaccine: PPV, PPV
Symptoms: Pneumonia
Clinical narrative: NEW Years Eve LAST YEAR went into the hospital WITH PNEUMONIA; This spontaneous report has been received from a patient via Pfizer, referring to himself/herself, a patient of unknown age and gender. The patient got the influenza virus vaccine inactivated (unspecified) (reported as "flu shot") every year and this year it was a high dose one. The patient got flu big time at the year he/she did not got the flu vaccine. Information about concurrent conditions, concomitant therapies and drug allergies was not provided.     On unknown dates prior to last year, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, route and dose details were unknown) and pneumococcal 13v conj vaccine (crm197) (manufacturer unknown) (lot #, expiration date, route and dose details were unknown) for prophylaxis.      On approximately 31-DEC-2019 (reported as New Year's Eve last year), the patient went into the hospital with pneumonia (the actual event start date was not reported), which caused the patient hospitalized.      The outcome of the event was unknown. The causality assessment between the suspect products and the event was not provided.  Upon internal review, pneumonia was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: expired vaccine administration; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 16-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot # S003874, expiration date 15-OCT-2020, (frequency, route of administration and anatomical location were not reported) for prophylaxis. There was no temperature excursion and no product quality complaint.
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no side effects; vaccine doses at shorter interval than recimmended; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 10-FEB-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, lot #, expiration date, route of administration and anatomical location were not reported).On 26-SEP-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 injection, lot # T020638, expiration date 26-FEB-2020, (exact dose, frequency, route of administration and anatomical location were not reported). Both doses were administered as prophylaxis. The patient received the second dose at a shorten than recommended interval. However, the patient experienced no side effects from the vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-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: 0.17
Sex: U
Vaccine: HEP
Symptoms: Recalled product administered
Clinical narrative: patient was given RECOMBIVAX HB that was recalled; patient was given RECOMBIVAX HB that was recalled; This spontaneous report was received from a nurse, concerning a 11-weeks-old patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 23-OCT-2020, the patient was vaccinated with a dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) thimerosal free at the dose of 0.5 mL (frequency, strength, route of administration, anatomical injection site were not reported; lot number T007984 has been has been verified to be a valid lot number for hepatitis B vaccine (recombinant) with an expiration date on 01-NOV-2022) that was recalled (recalled product administered and product storage error). At the reporting time, the outcome of recalled product administered, and product storage error was unknown.; Sender's Comments:  US-009507513-2010USA009762: US-009507513-2010USA009831:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 28-APR-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for hearing loss. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 11-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a clinic for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician at a clinic for Bell's palsy. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of Bell's palsy to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: the patient threw up a white breast milk substance; This spontaneous report was received from a nurse referring to a 2-month-old male patient. The patient had no medical history, concomitant therapies or drug reactions/allergies.    On 22-OCT-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1676322, expiration date 21-APR-2021 at a dose of 2 milliliter, orally for immunization.   On the same date, after 1 minute of receiving the oral vaccine the patient threw up a white breast milk substance (Vomiting of medication).  The outcome of vomiting of medication was unknown.        The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and vomiting of medication was unknown.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Caller was reporting an expired PNEUMOV AX 23 that was administered to a 95 year old female.; This spontaneous report was received from a pharmacist referring to a 95-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 22-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5 milliliter (concentration, vaccination scheme frequency, route of administration and anatomical location were not reported; lot # S002640, expiration date reported 29-SEP-2020) (expired product administered).
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: VAQTA which had expired was given on OCT 26, 2020; No other issues were reported or verbalized; This spontaneous report was received from a certified medical assistant (also reported as (licensed nurse practitioner (LPN)) concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.    On 26-OCT-2020 the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe, lot # S024396, expiration date: 12-OCT-2020 for prophylaxis (dose, route of administration, and anatomical location were not reported). No other issues were reported or verbalized combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S024396; expirationdate: 12-OCT-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: 14.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This spontaneous report was received from a certified medical assistant referring to an 18 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unspecified date in 2016, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) pediatric dose, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were unknown). Then, on an unspecified date in 2017, patient received the second dose of hepatitis a vaccine, inactivated (VAQTA) pediatric dose, (strength, route of administration, anatomical location, lot # and expiration date were unknown).  On 27-OCT-2020, a third adult dose of hepatitis a vaccine, inactivated (VAQTA) 1 mL, lot #T014590 , expiration date on 15-APR-2021, (strength, route of administration and anatomical location were unknown) was given to the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014590; expirationdate: 15-APR-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