chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: pH urine increased
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient appeared fine immediately after vaccination.  He shopped around the store.  He was talking to his the staff at the front counters and then passed out.  He came to rather quickly.  An ambulance was called.  He refused to go to the hospital and appeared fine.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Vomiting projectile
Clinical narrative: Projectile Vomiting
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Diarrhoea, Eyelid margin crusting, Injection site pain
Clinical narrative: Four hours after injection:   Grit in the eyes, weakness, achiness, deep cough, vomiting, diarrhea.  Lasted 1 hour.  Weakness, aching muscles lasted into following day.  Soreness at site of injection lasted for two days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vomiting
Clinical narrative: Four hours after injection:   Grit in the eyes, weakness, achiness, deep cough, vomiting, diarrhea.  Lasted 1 hour.  Weakness, aching muscles lasted into following day.  Soreness at site of injection lasted for two days.
Age: 1.58
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: WHOLE BODY RASH WITH A FEVER
Age: 34.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Arthralgia, B-lymphocyte count, Biopsy skin abnormal, Blister, C-reactive protein normal
Clinical narrative: Generalized dermatitis with an onset day 17. The dermatitis is very pruritic, nontender, and presents to chest, back, trunk and extremities x4 including fingers but not palms. Lesions are discrete and he has developed new lesions over several days. He denied vesicles or pustules. He feels well and denies fever, chills, malaise, headache, myalgias or arthralgias. He denies vision changes, eye pruritis, pain, blurring, erythema or edema. He denies oral lesions. PE: dermatitis with discrete erythematous round raised  lesions with central shallow depressions in varying sizes and fewer small papules.  Affected areas are chest, back, trunk, upper and lower extremities including hands. No vesicles or pustules seen. No scale or eschars. Left upper arm SPV inoculation site with intact dark dry scab. The  dermatitis was somewhat but not fully consistent with either EM, BAPE and generalized vaccinia (GV). Followup  2 days later P/E documented. Skin:       dermatitis with discrete scattered erythematous annular papules & plaques, some with central shallow depressions; in varying sizes and fewer small papules. Some are confluent and lesions are in varying stages.  Affected areas are chest, back, trunk, upper and lower extremities including hands, fingers, but only periphery of palms. No vesicles or pustules seen. No scale or eschars. He then complained of notable arthralgias to PIP joints of hands.
Age: 34.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: CD4 lymphocytes, CD8 lymphocytes, Dermatitis, Eczema, Eosinophilic cellulitis
Clinical narrative: Generalized dermatitis with an onset day 17. The dermatitis is very pruritic, nontender, and presents to chest, back, trunk and extremities x4 including fingers but not palms. Lesions are discrete and he has developed new lesions over several days. He denied vesicles or pustules. He feels well and denies fever, chills, malaise, headache, myalgias or arthralgias. He denies vision changes, eye pruritis, pain, blurring, erythema or edema. He denies oral lesions. PE: dermatitis with discrete erythematous round raised  lesions with central shallow depressions in varying sizes and fewer small papules.  Affected areas are chest, back, trunk, upper and lower extremities including hands. No vesicles or pustules seen. No scale or eschars. Left upper arm SPV inoculation site with intact dark dry scab. The  dermatitis was somewhat but not fully consistent with either EM, BAPE and generalized vaccinia (GV). Followup  2 days later P/E documented. Skin:       dermatitis with discrete scattered erythematous annular papules & plaques, some with central shallow depressions; in varying sizes and fewer small papules. Some are confluent and lesions are in varying stages.  Affected areas are chest, back, trunk, upper and lower extremities including hands, fingers, but only periphery of palms. No vesicles or pustules seen. No scale or eschars. He then complained of notable arthralgias to PIP joints of hands.
Age: 34.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Erythema, Erythema multiforme, Full blood count normal, Granuloma annulare, Immunoglobulins normal
Clinical narrative: Generalized dermatitis with an onset day 17. The dermatitis is very pruritic, nontender, and presents to chest, back, trunk and extremities x4 including fingers but not palms. Lesions are discrete and he has developed new lesions over several days. He denied vesicles or pustules. He feels well and denies fever, chills, malaise, headache, myalgias or arthralgias. He denies vision changes, eye pruritis, pain, blurring, erythema or edema. He denies oral lesions. PE: dermatitis with discrete erythematous round raised  lesions with central shallow depressions in varying sizes and fewer small papules.  Affected areas are chest, back, trunk, upper and lower extremities including hands. No vesicles or pustules seen. No scale or eschars. Left upper arm SPV inoculation site with intact dark dry scab. The  dermatitis was somewhat but not fully consistent with either EM, BAPE and generalized vaccinia (GV). Followup  2 days later P/E documented. Skin:       dermatitis with discrete scattered erythematous annular papules & plaques, some with central shallow depressions; in varying sizes and fewer small papules. Some are confluent and lesions are in varying stages.  Affected areas are chest, back, trunk, upper and lower extremities including hands, fingers, but only periphery of palms. No vesicles or pustules seen. No scale or eschars. He then complained of notable arthralgias to PIP joints of hands.
Age: 34.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Metabolic function test normal, Natural killer T cell count, Papule, Polymerase chain reaction, Pruritus
Clinical narrative: Generalized dermatitis with an onset day 17. The dermatitis is very pruritic, nontender, and presents to chest, back, trunk and extremities x4 including fingers but not palms. Lesions are discrete and he has developed new lesions over several days. He denied vesicles or pustules. He feels well and denies fever, chills, malaise, headache, myalgias or arthralgias. He denies vision changes, eye pruritis, pain, blurring, erythema or edema. He denies oral lesions. PE: dermatitis with discrete erythematous round raised  lesions with central shallow depressions in varying sizes and fewer small papules.  Affected areas are chest, back, trunk, upper and lower extremities including hands. No vesicles or pustules seen. No scale or eschars. Left upper arm SPV inoculation site with intact dark dry scab. The  dermatitis was somewhat but not fully consistent with either EM, BAPE and generalized vaccinia (GV). Followup  2 days later P/E documented. Skin:       dermatitis with discrete scattered erythematous annular papules & plaques, some with central shallow depressions; in varying sizes and fewer small papules. Some are confluent and lesions are in varying stages.  Affected areas are chest, back, trunk, upper and lower extremities including hands, fingers, but only periphery of palms. No vesicles or pustules seen. No scale or eschars. He then complained of notable arthralgias to PIP joints of hands.
Age: 34.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Rash erythematous, Rash papular, Red blood cell sedimentation rate normal, Skin lesion, Skin plaque
Clinical narrative: Generalized dermatitis with an onset day 17. The dermatitis is very pruritic, nontender, and presents to chest, back, trunk and extremities x4 including fingers but not palms. Lesions are discrete and he has developed new lesions over several days. He denied vesicles or pustules. He feels well and denies fever, chills, malaise, headache, myalgias or arthralgias. He denies vision changes, eye pruritis, pain, blurring, erythema or edema. He denies oral lesions. PE: dermatitis with discrete erythematous round raised  lesions with central shallow depressions in varying sizes and fewer small papules.  Affected areas are chest, back, trunk, upper and lower extremities including hands. No vesicles or pustules seen. No scale or eschars. Left upper arm SPV inoculation site with intact dark dry scab. The  dermatitis was somewhat but not fully consistent with either EM, BAPE and generalized vaccinia (GV). Followup  2 days later P/E documented. Skin:       dermatitis with discrete scattered erythematous annular papules & plaques, some with central shallow depressions; in varying sizes and fewer small papules. Some are confluent and lesions are in varying stages.  Affected areas are chest, back, trunk, upper and lower extremities including hands, fingers, but only periphery of palms. No vesicles or pustules seen. No scale or eschars. He then complained of notable arthralgias to PIP joints of hands.
Age: 34.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: T-lymphocyte count, T-lymphocyte count normal, Viral test
Clinical narrative: Generalized dermatitis with an onset day 17. The dermatitis is very pruritic, nontender, and presents to chest, back, trunk and extremities x4 including fingers but not palms. Lesions are discrete and he has developed new lesions over several days. He denied vesicles or pustules. He feels well and denies fever, chills, malaise, headache, myalgias or arthralgias. He denies vision changes, eye pruritis, pain, blurring, erythema or edema. He denies oral lesions. PE: dermatitis with discrete erythematous round raised  lesions with central shallow depressions in varying sizes and fewer small papules.  Affected areas are chest, back, trunk, upper and lower extremities including hands. No vesicles or pustules seen. No scale or eschars. Left upper arm SPV inoculation site with intact dark dry scab. The  dermatitis was somewhat but not fully consistent with either EM, BAPE and generalized vaccinia (GV). Followup  2 days later P/E documented. Skin:       dermatitis with discrete scattered erythematous annular papules & plaques, some with central shallow depressions; in varying sizes and fewer small papules. Some are confluent and lesions are in varying stages.  Affected areas are chest, back, trunk, upper and lower extremities including hands, fingers, but only periphery of palms. No vesicles or pustules seen. No scale or eschars. He then complained of notable arthralgias to PIP joints of hands.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Full blood count, Metabolic function test, Pain, Tenderness, X-ray
Clinical narrative: Pain with movement, without injury. Has tenderness to area from shoulder to lower part of humorous on left arm.
Age: 1.42
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Product administered to patient of inappropriate age, Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: My son was given the FluMist even though he was not the recommended minimum age (2yo). Prior to the administration of the FluMist the provider deferred to my judgement about the route of administration. A conversation was had about the benefits/costs of both mist and injection. The provider repeatedly said it was the same and continued to defer to my judgment. After she administered the FluMist she "remembered" that the minimum age for FluMist was 2yo and informed me that they would follow up with us about best course of action. Needless to say, I was furious.   My son started to experience significant symptoms 48 hours later, including coughing, congestion, mucous, and sneezing. My son is fairly healthy and has never experienced symptoms as significant as he did after receiving the FluMist. His symptoms lasted approximately 7 days. Because my son is only 1.5yo we only used babyVicks, humidifier, and childrens strength Sambucas (elderberry extract) as forms of treatment. My son is now fully recovered and does not appear to having any residual symptoms.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MENB
Symptoms: Headache, Pain in extremity
Clinical narrative: The day after receiving vaccines, patient came to the school health suite complaining of pain in both arms. School nurse administered 650mg Acetaminophen. Patient returned after 2 hours saying that acetaminophen did not help arm pain, and was now complaining of headache. Patient dismissed from school early. Patient returned to school the following day (2days after receiving vaccines).
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Allergic Reaction- small bruise at injection site (left deltoid) , pain, swelling  from the site towards the elbow joint, skin hot to touch, skin redness
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Allergic Reaction- small bruise at injection site (left deltoid) , pain, swelling  from the site towards the elbow joint, skin hot to touch, skin redness
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Received influenza vaccine at medical clinic where she is employed. Later reported administration was much more painful than usual. She also reported vaccine was administered higher on arm than usual. She expected pain to decrease after a couple of days, but pain has continued until present, nearly a month after administration.  She has not been seen by a provider so outcome is not yet known.  Symptoms are also being reported to  human resources department as possible workplace injury.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Complication associated with device, Culture negative, Joint swelling, Neutrophil percentage increased, Polymerase chain reaction
Clinical narrative: for the past 2 years the patient had her right knee prosthesis swell up 10-14 days after a flu shot.  She ended up in surgery for washout each time.  Cultures/Crystals, PCR all negative
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Surgery, Vaccine positive rechallenge
Clinical narrative: for the past 2 years the patient had her right knee prosthesis swell up 10-14 days after a flu shot.  She ended up in surgery for washout each time.  Cultures/Crystals, PCR all negative
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous report as received from a lawyer refers to a 71 year old female patient with hypertension, blood cholesterol abnormal and herpes zoster. The patient's medical history included gout, hip arthroplasty (twice), chicken pox and macular degeneration. Pt was a non-smoker. Concomitant therapies included simvastatin and amlodipine.  On approximately 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration date were not provided).   On approximately 2018, the patient experienced sore arm. The outcome of pain in extremity was unknown. The reporter considered pain in extremity to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  This is one of 2 reports for this patient (linked with US-009507513-1810USA004448).; Sender's Comments:  US-009507513-1810USA004448:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; a patient received improperly stored PROQUAD on 10/30/2019.; This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender.   The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent.  On 30-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA), lot # S021617, expiration date 09-JAN-2021 (dose and route of administration were not provided), as prophylaxis; which was reconstituted with a properly stored sterile diluent.  The administered dose of the vaccine experienced a temperature excursion from -14 Celsius degree (°C)  to -10 °C (-11.7 °C), during 2 hours and 35 minutes. No previous temperature excursion was reported. This report was called because of a data logger. There was no adverse effect reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 05-MAY-2015, she was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and will 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 will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to 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 will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to 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 the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to 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 will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to 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 unknown. The causality was related.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; received first dose of gardasil 9 7 years ago and that she received the second dose of the series today; This spontaneous report was received from medical assistant referring to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reaction/allergies and concomitant medications were not reported. On 11-NOV-2012, (reported as 7 years ago) the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and on 11-NOV-2019 (reported as today), the patient received second dose of the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R024259, expiry date: 30-MAY-2021, for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported in the patient. The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Back pain, Hypoaesthesia, Insomnia, Motor dysfunction
Clinical narrative: Parsonage-Turner syndrome; This is a serious spontaneous case reported by other health care professional (nurse) to Regulatory Authority (reference number: SEQ19-06209) and initially received on 05-Nov-2019, concerning a 55-year-old, male patient.  The patient's medical history was not provided. The patient did not take any concomitant medications.  On 30-Sep-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261211 and expiration date: Jun-2020] for prevention of seasonal influenza.  On an unspecified date in Oct-2019, about week and a half after vaccination, the patient experienced pain in back by left should blade. The patient stated that his left hand went numb and he had no strength. The patient also reported pain and loss of motor skills in his left arm. It was stated that doctors were calling this Parsonage-Turner syndrome. The patient consulted with Sports Medicine Doctor as the pain in his left arm was preventing him from sleeping.  At the time of initial reporting, event outcome was considered not recovered/not resolved since it was reported that the syndrome would be resolved within 3 years, according to patient's physician.  The reporter assessed the case as serious and did not provide causality assessment to Flucelvax QIV.  Company comment: The patient experienced neuralgic amyotrophy week and a half after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Reportedly, the patient did not take any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced neuralgic amyotrophy week and a half after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Reportedly, the patient did not take any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Sex: M
Vaccine: FLUC4
Symptoms: Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Parsonage-Turner syndrome; This is a serious spontaneous case reported by other health care professional (nurse) to Regulatory Authority (reference number: SEQ19-06209) and initially received on 05-Nov-2019, concerning a 55-year-old, male patient.  The patient's medical history was not provided. The patient did not take any concomitant medications.  On 30-Sep-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261211 and expiration date: Jun-2020] for prevention of seasonal influenza.  On an unspecified date in Oct-2019, about week and a half after vaccination, the patient experienced pain in back by left should blade. The patient stated that his left hand went numb and he had no strength. The patient also reported pain and loss of motor skills in his left arm. It was stated that doctors were calling this Parsonage-Turner syndrome. The patient consulted with Sports Medicine Doctor as the pain in his left arm was preventing him from sleeping.  At the time of initial reporting, event outcome was considered not recovered/not resolved since it was reported that the syndrome would be resolved within 3 years, according to patient's physician.  The reporter assessed the case as serious and did not provide causality assessment to Flucelvax QIV.  Company comment: The patient experienced neuralgic amyotrophy week and a half after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Reportedly, the patient did not take any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced neuralgic amyotrophy week and a half after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history and diagnostic findings were provided. Reportedly, the patient did not take any concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Redness, hot to touch rash that has spread past immediate injection site- probably about 10 cm. Noticed about 30-36 hours after the injection.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt came to clinic for flu vaccine. pt completed vaccine consent form and his "62" was mistakenly read as "67". pt given High Dose FLuzone to which pt consented. NO harm reported. PT when contacted was actually thankful he got the higher dose and NP explained indications. NP had also contacted CDC vaccine hotline and spoke with an employee who reported no expected harm and should be counted as flu vaccine for this season.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient with complaint of left shoulder pain day after receiving vaccination.  C/O sharp pain, not being able to move arm forward above the chest without much pain.  Bruised area noted at top of left arm.  Patient states has Physical Therapist look at home, believe pain is consistent with SIRVA.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: pt said they had terrible arm pain after the shot for 7 months, specially when raising arm, did not follow up with md. feels perfect now
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: Pt c/o Fatigue, headache Nausea + Fever 10/25/2019, and Erythema, warmth. Tenderness on (L) arm BUT below Inj. site
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Skin warm
Clinical narrative: Pt c/o Fatigue, headache Nausea + Fever 10/25/2019, and Erythema, warmth. Tenderness on (L) arm BUT below Inj. site
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall, Headache, Nausea, Vision blurred
Clinical narrative: Pt called this morning at 10:46am to notify us of his adverse reaction to the vaccine.  Received vaccine 11/8/19 and on 11/9/19-11/10/19 he woke up with an odd headache, extremely blurry vision, and nausea.  Stated he was walking to his mailbox and his knees buckled as he got dizzy and fell into the snow (no reported injuries).  He said he continued falling after he got up and had to crawl into his house.  He has notified his MD and waiting to hear back.  I asked if he had checked his BP, he stated it was around 115/48 when he had checked that day.  I asked if he could have taken his BP medications twice on accident.  He said he is unsure and it was a possibility but he feels it was unlikely due to the BP meds and more of a reaction to the vaccination.  He has been advised to reach out to his MD and continue to monitor his BP.  Asked pt if he has had flu vaccinations in the past and he said "yearly with no issues."
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Immediate post-injection reaction, Irritability, Pain, Pyrexia
Clinical narrative: Low grade fever immediately. Pain, irritability within one day. Within 2 days diarrhea. Within 3 days vomiting. Symptoms have yet to resolve 5 days later.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Low grade fever immediately. Pain, irritability within one day. Within 2 days diarrhea. Within 3 days vomiting. Symptoms have yet to resolve 5 days later.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Severe rash at injection site and spread about 5" radius.  Red, raised, warm; grapefruit sized.  Started shortly after vaccine and continue for 2+ weeks as severe, then now more mild but still present.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip pain, Oral pain
Clinical narrative: Patient experienced increased sensitivity around mouth/lips/oral mucosa.  Using chapstick to lips does limit symptoms.  As of 11-13-19, pt stated his symptoms are subsiding.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased
Clinical narrative: Redness and swelling at site, decreased ROM Placed on Bactrim
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: The patient was given MMRV by mistake and was supposed to only get MMR
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Injection site pain, Insomnia, Pain
Clinical narrative: Pain in right shoulder, body aches, low grade fever, headache, difficulty sleeping/ then slept most of the next day.  2O hrs discomfort  after injection
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pain in right shoulder, body aches, low grade fever, headache, difficulty sleeping/ then slept most of the next day.  2O hrs discomfort  after injection
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypokinesia, Musculoskeletal pain
Clinical narrative: pain in the shoulder and can not move
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Migraine, Pain in extremity
Clinical narrative: My arm hurts like someone punched me. Yesterday, I had a migrane. Today I am washed out and tired. I thought "only" a rash could ensue.  I was thinking that how the provider administered the vaccine might impact; I didn't know it was intramuscular and would have preferred someplace besides my arm, if that was the case.
Age: 29.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash, Rash papular
Clinical narrative: Pt pt rash appeared during the evening of 11 Nov 19, on both upper arms in tricep area. Left arm with more lesions than right. Reports slight itching. No drainage. Had slight arm soreness for a couple of days following immunization. No fever, headache or chills. No other illness.  Currently feeling well.  Denies any problems with previous immunizations. He reports a history of rough bumps on the backs of his arms and thighs. Did use OTC steroid cream with improvement. Skin: multiple red raised papules on back of both arms. With excoriation. No drainage, no warmth. No lesions near vaccination site. Texture of both arms with fine rough bumps.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Aspartate aminotransferase increased, Asthenia, Blood creatinine increased, Blood culture negative, Blood lactic acid increased
Clinical narrative: Patient called on-call provider 10/23 to report weakness, fever, and fatigue.  Presented to PCP's office on 10/28 with fever of 102, weakness, and fatigue.  Fell in parking lot of hospital and was hospitalized for 4 days due to fever and weakness.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium decreased, Blood urea increased, Chest X-ray normal, Computerised tomogram thorax normal, Culture urine negative
Clinical narrative: Patient called on-call provider 10/23 to report weakness, fever, and fatigue.  Presented to PCP's office on 10/28 with fever of 102, weakness, and fatigue.  Fell in parking lot of hospital and was hospitalized for 4 days due to fever and weakness.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Fatigue, Influenza virus test negative, Pyrexia, White blood cell count increased
Clinical narrative: Patient called on-call provider 10/23 to report weakness, fever, and fatigue.  Presented to PCP's office on 10/28 with fever of 102, weakness, and fatigue.  Fell in parking lot of hospital and was hospitalized for 4 days due to fever and weakness.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Feeling hot, Flushing, Paraesthesia, Throat irritation
Clinical narrative: Patient presented to local ER at approx. 18:20 with complaints of flushing, hot, short of air, feelings of "pin-needles from mid chest up". Also C/O throat being "slightly scratchy". Symptoms were reported to have begun around 16:00. Noted on Emergency Provider Record dated 11/6/19, that client had flushing to face/neck/chest with no lesions noted. No Swelling of the neck, trachea midline, no respiratory distress, heart regular rate rhythm. "Adverse Drug Reaction: - suspect Pneumonia Shot, was discharge diagnosis. Continue steroid use + Claritin daily x1 week was discharge meds. Patient discharged home on 11/6/19 @ 22:10.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Patient presented to local ER at approx. 18:20 with complaints of flushing, hot, short of air, feelings of "pin-needles from mid chest up". Also C/O throat being "slightly scratchy". Symptoms were reported to have begun around 16:00. Noted on Emergency Provider Record dated 11/6/19, that client had flushing to face/neck/chest with no lesions noted. No Swelling of the neck, trachea midline, no respiratory distress, heart regular rate rhythm. "Adverse Drug Reaction: - suspect Pneumonia Shot, was discharge diagnosis. Continue steroid use + Claritin daily x1 week was discharge meds. Patient discharged home on 11/6/19 @ 22:10.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Body temperature increased, Erythema, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: It started with a headache on Sat. at 11:00. I took Tylenol twice that day. That evening I felt worse and was running a temp. I continued to run a temp until Monday noon w/the highest recorded at 102.8. My arm became more sore and had a large red patch of skin It was very warm to the touch and burned. The patch became much larger and began traveling down my arm. I tried warm compresses and ice packs with no relief. I returned to work on Tues. as a teacher (10-8-19 and had my temp. taken in the morning. It was still at 99.5; I still did not feel 100%. The redness and swelling in my arm was spreading down my arm. By, Wednesday evening (10-8-19) the redness was subsiding and the pain is less. On Sunday (10-6-19), I became worried and phoned call-a-doc to seek medical help. He advised me to take a pic of my arm and send it to them. He then asked me to take a marker and draw a line around the redness and let him know if it continued to spread. He also advised me to take 600mg of Motrin every 6 hrs. I took pictures of my arm again on Monday (10-7-19) after the redness and swelling had spread more than an inch beyond the marked outline. They called me back today (10-9-19) to see how I was doing. I told them that I felt like it was finally getting some better and the pain was getting better. I have never had a reaction to a shot in the past.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Peripheral swelling, Skin burning sensation, Skin warm
Clinical narrative: It started with a headache on Sat. at 11:00. I took Tylenol twice that day. That evening I felt worse and was running a temp. I continued to run a temp until Monday noon w/the highest recorded at 102.8. My arm became more sore and had a large red patch of skin It was very warm to the touch and burned. The patch became much larger and began traveling down my arm. I tried warm compresses and ice packs with no relief. I returned to work on Tues. as a teacher (10-8-19 and had my temp. taken in the morning. It was still at 99.5; I still did not feel 100%. The redness and swelling in my arm was spreading down my arm. By, Wednesday evening (10-8-19) the redness was subsiding and the pain is less. On Sunday (10-6-19), I became worried and phoned call-a-doc to seek medical help. He advised me to take a pic of my arm and send it to them. He then asked me to take a marker and draw a line around the redness and let him know if it continued to spread. He also advised me to take 600mg of Motrin every 6 hrs. I took pictures of my arm again on Monday (10-7-19) after the redness and swelling had spread more than an inch beyond the marked outline. They called me back today (10-9-19) to see how I was doing. I told them that I felt like it was finally getting some better and the pain was getting better. I have never had a reaction to a shot in the past.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Dizziness, Headache
Clinical narrative: Temp 100 Could not get out of Bed trembling Chills/Sweats Weak headache (Bad) Slept on + off for 17 hours Dizzy
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Tremor
Clinical narrative: Temp 100 Could not get out of Bed trembling Chills/Sweats Weak headache (Bad) Slept on + off for 17 hours Dizzy
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No advers effects reported; Medical assistant reports one expired dose of VARIVAX administered to patient; Medical assistant reports one expired dose of VARIVAX administered to patient; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.   On 01-NOV-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot # N029632 and expiration date on 23-OCT-2019 (dose, strength, frequency and route of administration were not provided) (expired product administered, and poor-quality product administered). There were no adverse effects reported.
Sex: M
Vaccine: PPV
Symptoms: Abnormal behaviour, Blood test, Inappropriate schedule of product administration, International normalised ratio, Musculoskeletal pain
Clinical narrative: shoulder pain; acting strange; a dose of aPNEUMOVAX 23 at unspecified time in 2018 then an additional dose in PNEUMOVAX 23 on 06-OCT-2019; This spontaneous report was received from a medical assistant referring to a 69-year-old male patient. The patient's concurrent condition, medical history and drug reactions/allergies were unknown by the reporter. The patient's historical vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The patient's concomitant medications included influenza virus split virion 3v vaccine inactivated (FLUZONE) and zoster rgE vaccine (mammalian) (SHINGRIX). On an unknown date in 2018, the patient was vaccinated with a dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose #, route of administration, lot/batch # and expiry date were not reported) for prophylaxis. On 06-OCT-2019, the patient was given additional dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose #, lot/batch # and expiry date were not reported) via intramuscular route for prophylaxis (inappropriate schedule of product administration). On 29-OCT-2019, the patient's wife reported that the patient was acting strange (abnormal behavior) and complained of shoulder pain (musculoskeletal pain). The patient sought medical attention and contacted unspecified clinician but it was also reported that no treatment was given for the adverse events. On an unknown date, the patient had blood work performed to check the international normalized ratio (INR) but the results of which was not provided. The reported adverse events were non-cancerous. There was no associated product quality complaint. It was reported that, the patient was doing fine (recovering). The reporter did not provide the causality assessment between the events and the suspect therapy.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Red at the injection site; Swollen at the injection site; Induration at the injection site; Pain at the injection site; Injection site lump; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season .5 ml. In October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site swelling, injection site induration, injection site pain and injection site lump. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site induration and injection site lump were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, injection site pain and injection site lump to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The patient received Fluarix Quadrivalent 2019-2020 season on left deltoid. Within 24 hours after receiving vaccine, the patient experienced red swollen soft ball size induration and pain at injection site.  The patient had to take Benadryl for days. The patient did seek medical attension at the medical practice she worked. The patient said that the pain resolved but still had slight lump.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives; allergy reaction; This case was reported by a consumer and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives and allergic reaction. On an unknown date, the outcome of the hives and allergic reaction were unknown.   It was unknown if the reporter considered the hives and allergic reaction 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 experienced hives. The reporter asked what are the components that can asked doctor to did allergy testing on. The patient was concerned about potential increased reactions of a second dose.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on torso - mid section; This case was reported by a physician via sales rep and described the occurrence of rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was approximately 70 to 75 years old at the time of reporting. The patient received dose of shingrix 2 to 3 weeks before the date of reporting. The patient experienced rash on torso-mid section. The reporter consented to follow up.