chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Rash macular, Vomiting
Clinical narrative: Pt. was given Tdap first in the right deltoid, MCV4 next in the right deltoid, then Hepatitis A was administered in the left deltoid. Pt. said his eyes "felt funny" and that he felt sick to his stomach. His skin then got white/pale and he started vomiting. Red blotchy spots popped up across his shoulders and he became very weak. I got him a cold wash cloth and wiped his face and on the back of his neck. After vomiting, his coloring started coming back and he stated he was ready for the last shot which would have been GARDASIL but I did not administer this vaccine. I gave him some cold water, a popsicle and mom requested a dose of BENADRYL. I gave him 25 m of BENADRYL. After the medication and a cold drink, the patient "felt" better. I did not see any immediate reactions locally where the vaccines were given nor did he seem to be in respiratory distress.
Age: 16.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Erythema, Injection site induration, Tenderness
Clinical narrative: Red, tender area on L upper arm, approximately 4.5 cm L and 6 cm wide. Small "hardended" area at injection site. Pt. reports it was only a small red area but worse this AM.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) upper arm swelling, redness, warmth and pain peaking 2 days following 2nd HPV. Monitored, ice, NSAIDS. Resolved w/in 3-5 days.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye pain, Headache, Herpes zoster, Lacrimation increased, Visual impairment
Clinical narrative: Ocular Herpes Zoster diagnosis. Location left side of head, face, left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Ocular Herpes Zoster diagnosis. Location left side of head, face, left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blepharospasm, Blood pressure increased, Corneal irritation, Eye disorder, Eye pain
Clinical narrative: Ocular Herpes Zoster diagnosis. Location left side of head, face, left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Lacrimation increased, Nasal discomfort
Clinical narrative: Ocular Herpes Zoster diagnosis. Location left side of head, face, left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia, Ocular hyperaemia, Skin lesion, Stomatitis, Tongue ulceration
Clinical narrative: Ocular Herpes Zoster diagnosis. Location left side of head, face, left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Visual acuity reduced
Clinical narrative: Ocular Herpes Zoster diagnosis. Location left side of head, face, left eye.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Anxiety, Arthralgia, Ataxia, Blood test, Borrelia test negative
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: CSF culture negative, CSF immunoglobulin, CSF protein increased, CSF white blood cell count increased, Chest X-ray
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Computerised tomogram head, Cryptococcus test, Culture negative, Diplopia, HIV antibody negative
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Laboratory test normal, Myalgia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging normal, Polymerase chain reaction
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Pyrexia, Treponema test negative, Yellow fever vaccine-associated neurotropic disease
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Anxiety, Arthralgia, Ataxia, Borrelia test negative, CSF culture negative
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: CSF protein increased, CSF white blood cell count increased, Chest X-ray, Computerised tomogram head, Cryptococcus test
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Culture negative, Diplopia, Flavivirus test, HIV antibody negative, Myalgia
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Pyrexia, Treponema test negative, Yellow fever vaccine-associated neurotropic disease
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18; MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Outbreak of shingles on the right side torso lasting thru today 3/19/18.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood HIV RNA, Blood bicarbonate normal, Blood calcium normal, Blood chloride normal, Blood creatinine increased
Clinical narrative: Disseminated rash (erythematous papules in various stages - some with ulceration and scab and some umbilicated. No vesicles or pustules) to face, trunk and bilateral upper extremities that started about 3 weeks after vaccination. Rash initially was not pruritic but became so as the rash progressed. Most pronounced lesions on right hand knuckles at areas of existing abrasions/cuts due to wrestling. Patient did not adhere to strict post-vaccination instructions. He did not keep vaccine site covered, was immediately involved in contact sport (wrestling) with shirt off sometimes and would constantly manipulating the vaccination site. + sexual contact just prior to rash and during rash. Never developed any systemic symptoms (fevers, chills, night sweats, fatigue, malaise). Was admitted to hospital for observation due to concern of possible generalized vaccinia as patient resides in military barracks with somewhat communal living and unclear if he could be adequately isolated. No treatment was symptom support for pruritus. Tissue biopsy performed by dermatology.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood glucose normal, Blood magnesium normal, Blood phosphorus normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Disseminated rash (erythematous papules in various stages - some with ulceration and scab and some umbilicated. No vesicles or pustules) to face, trunk and bilateral upper extremities that started about 3 weeks after vaccination. Rash initially was not pruritic but became so as the rash progressed. Most pronounced lesions on right hand knuckles at areas of existing abrasions/cuts due to wrestling. Patient did not adhere to strict post-vaccination instructions. He did not keep vaccine site covered, was immediately involved in contact sport (wrestling) with shirt off sometimes and would constantly manipulating the vaccination site. + sexual contact just prior to rash and during rash. Never developed any systemic symptoms (fevers, chills, night sweats, fatigue, malaise). Was admitted to hospital for observation due to concern of possible generalized vaccinia as patient resides in military barracks with somewhat communal living and unclear if he could be adequately isolated. No treatment was symptom support for pruritus. Tissue biopsy performed by dermatology.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood urea normal, Discharge, HIV antibody negative, Haematocrit normal, Haemoglobin normal
Clinical narrative: Disseminated rash (erythematous papules in various stages - some with ulceration and scab and some umbilicated. No vesicles or pustules) to face, trunk and bilateral upper extremities that started about 3 weeks after vaccination. Rash initially was not pruritic but became so as the rash progressed. Most pronounced lesions on right hand knuckles at areas of existing abrasions/cuts due to wrestling. Patient did not adhere to strict post-vaccination instructions. He did not keep vaccine site covered, was immediately involved in contact sport (wrestling) with shirt off sometimes and would constantly manipulating the vaccination site. + sexual contact just prior to rash and during rash. Never developed any systemic symptoms (fevers, chills, night sweats, fatigue, malaise). Was admitted to hospital for observation due to concern of possible generalized vaccinia as patient resides in military barracks with somewhat communal living and unclear if he could be adequately isolated. No treatment was symptom support for pruritus. Tissue biopsy performed by dermatology.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: High risk sexual behaviour, Molluscum contagiosum, Platelet count normal, Rash papular, Rash pruritic
Clinical narrative: Disseminated rash (erythematous papules in various stages - some with ulceration and scab and some umbilicated. No vesicles or pustules) to face, trunk and bilateral upper extremities that started about 3 weeks after vaccination. Rash initially was not pruritic but became so as the rash progressed. Most pronounced lesions on right hand knuckles at areas of existing abrasions/cuts due to wrestling. Patient did not adhere to strict post-vaccination instructions. He did not keep vaccine site covered, was immediately involved in contact sport (wrestling) with shirt off sometimes and would constantly manipulating the vaccination site. + sexual contact just prior to rash and during rash. Never developed any systemic symptoms (fevers, chills, night sweats, fatigue, malaise). Was admitted to hospital for observation due to concern of possible generalized vaccinia as patient resides in military barracks with somewhat communal living and unclear if he could be adequately isolated. No treatment was symptom support for pruritus. Tissue biopsy performed by dermatology.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Scratch, Skin lesion, Staphylococcal infection, Treatment noncompliance, White blood cell count decreased
Clinical narrative: Disseminated rash (erythematous papules in various stages - some with ulceration and scab and some umbilicated. No vesicles or pustules) to face, trunk and bilateral upper extremities that started about 3 weeks after vaccination. Rash initially was not pruritic but became so as the rash progressed. Most pronounced lesions on right hand knuckles at areas of existing abrasions/cuts due to wrestling. Patient did not adhere to strict post-vaccination instructions. He did not keep vaccine site covered, was immediately involved in contact sport (wrestling) with shirt off sometimes and would constantly manipulating the vaccination site. + sexual contact just prior to rash and during rash. Never developed any systemic symptoms (fevers, chills, night sweats, fatigue, malaise). Was admitted to hospital for observation due to concern of possible generalized vaccinia as patient resides in military barracks with somewhat communal living and unclear if he could be adequately isolated. No treatment was symptom support for pruritus. Tissue biopsy performed by dermatology.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin, Polymerase chain reaction, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Disseminated rash (erythematous papules in various stages - some with ulceration and scab and some umbilicated. No vesicles or pustules) to face, trunk and bilateral upper extremities that started about 3 weeks after vaccination. Rash initially was not pruritic but became so as the rash progressed. Most pronounced lesions on right hand knuckles at areas of existing abrasions/cuts due to wrestling. Patient did not adhere to strict post-vaccination instructions. He did not keep vaccine site covered, was immediately involved in contact sport (wrestling) with shirt off sometimes and would constantly manipulating the vaccination site. + sexual contact just prior to rash and during rash. Never developed any systemic symptoms (fevers, chills, night sweats, fatigue, malaise). Was admitted to hospital for observation due to concern of possible generalized vaccinia as patient resides in military barracks with somewhat communal living and unclear if he could be adequately isolated. No treatment was symptom support for pruritus. Tissue biopsy performed by dermatology.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Scab, Sexually active, Skin lesion, Skin ulcer, Treatment noncompliance
Clinical narrative: Disseminated rash (erythematous papules in various stages - some with ulceration and scab and some umbilicated. No vesicles or pustules) to face, trunk and bilateral upper extremities that started about 3 weeks after vaccination. Rash initially was not pruritic but became so as the rash progressed. Most pronounced lesions on right hand knuckles at areas of existing abrasions/cuts due to wrestling. Patient did not adhere to strict post-vaccination instructions. He did not keep vaccine site covered, was immediately involved in contact sport (wrestling) with shirt off sometimes and would constantly manipulating the vaccination site. + sexual contact just prior to rash and during rash. Never developed any systemic symptoms (fevers, chills, night sweats, fatigue, malaise). Was admitted to hospital for observation due to concern of possible generalized vaccinia as patient resides in military barracks with somewhat communal living and unclear if he could be adequately isolated. No treatment was symptom support for pruritus. Tissue biopsy performed by dermatology.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Pain, Pruritus, Urticaria
Clinical narrative: Pain, hot, itchy hives.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Pain, hot, itchy hives.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient reported severe right arm pain that started the day after her vaccine was given. She was encouraged to take ibuprofen as needed and reassured that the pain typically resolved in 72 hours. Nearly completely resolved by 3/20/18.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from an office manager via company representative referring to a 67 year old female patient. The patient's concurrent and historical conditions, as well as the concomitant medications, were not reported. On 21-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N025384, expiration date 19-APR-2019,(unknown strength, route of administration) for prophylaxis. On the same day, after the vaccination was received,  the patient experienced swelling and pain in her left arm (peripheral swelling and pain in extremity). The patient was hospitalized from 28-FEB-2018 to 01-MAR-2018. The outcome and the causality of the events in regards the therapy PNEUMOVAX 23 was not reported.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dyspnoea, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: The date symptoms began is March 7th and approximately 3 hours after the shot was given (approximately 3pm). Patient reports fever of 101.8,  severe chills, some difficulty breathing and intense pain and redness at the site of injection as well as up and down her arm. Most symptoms subsided on the 9th of March around noon. The redness at the site of injection and down my arm lasted until the next day, March 10.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash on trunk, arms, legs, face.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Skin warm, Tenderness
Clinical narrative: Erythema , tenderness, inflammation, and warm to touch.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Urticaria, Vaccination site rash, Vaccination site reaction
Clinical narrative: Patient developed a welt and rash around the vaccine site, I waited a few days to see if it would go away before coming in to see the doctor. The day of the visit (03/09), patient had 104.9 fever and had bumps that had developed around the welt at the injection site. By 03/11/2018 patient was covered head to toe in the chicken pox rash and had several days of fever and the typical symptoms of chicken pox.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient developed a welt and rash around the vaccine site, I waited a few days to see if it would go away before coming in to see the doctor. The day of the visit (03/09), patient had 104.9 fever and had bumps that had developed around the welt at the injection site. By 03/11/2018 patient was covered head to toe in the chicken pox rash and had several days of fever and the typical symptoms of chicken pox.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Urticaria, Vaccination site rash, Vaccination site reaction
Clinical narrative: Patient developed a welt and rash around the vaccine site approximately 5-6 days after  the vaccine. As with her twin sister, I waited a few days to see if it would resolve before scheduling a visit with her doctor. The day of the visit (03/09), pt had 102.2 fever and had bumps that had developed around the injection site. By 03/11/2018 pt had developed a few more bumps around her chest and back. She developed a milder version of chicken pox than her sister did and by Monday was doing fine. For reference, her sister's E-Report Number is 135180.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient developed a welt and rash around the vaccine site approximately 5-6 days after  the vaccine. As with her twin sister, I waited a few days to see if it would resolve before scheduling a visit with her doctor. The day of the visit (03/09), pt had 102.2 fever and had bumps that had developed around the injection site. By 03/11/2018 pt had developed a few more bumps around her chest and back. She developed a milder version of chicken pox than her sister did and by Monday was doing fine. For reference, her sister's E-Report Number is 135180.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Skin burning sensation, Skin warm
Clinical narrative: On the evening of receiving the vaccine, she reported that bilateral inner thighs and calves down to ankles became hot and burning. This has continued, comes and goes intermittently.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Nausea
Clinical narrative: Severe body aches, nausea, swollen glands under tongue, severe headache, fever of 101, sever pain and difficulty moving shoulder of arm were shot was given, fatigue and body chills.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia, Salivary gland enlargement
Clinical narrative: Severe body aches, nausea, swollen glands under tongue, severe headache, fever of 101, sever pain and difficulty moving shoulder of arm were shot was given, fatigue and body chills.
Age: 33.0
Sex: U
Vaccine: FLUR4
Symptoms: Injection site pruritus, Nausea, Pruritus
Clinical narrative: Itching at injection site and back. Nauseated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Culture, Erythema multiforme, Rash erythematous, Rash pruritic, Streptococcus test negative
Clinical narrative: Red, itchy, raised rash, probable erythema multiform noticed 48 hours after vaccination. Appeared of nose, neck, abdomen (belly and back) and posterior thighs. Resolving gradually without new lesions. Meds taken - BENADRYL.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Body temperature increased, No adverse event, Wrong drug administered
Clinical narrative: PENTACEL administered instead of PEDIARIX. No adverse events, mother reports child ran a low grade temperature on the morning of 3/17/18.
Age: 1.25
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ml administered as a 1st dose of flu vaccine for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reactions were noted. Parents have been notified to return to clinic for revaccination.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Swelling, redness, pain starting about 7 hours after injection. Applied ice and took ADVIL for four days until it abated. Swelling and redness from shoulder to elbow. Pain an 8 on scale from 1 to 10.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: .025 ml vaccine was administered as the first vaccine dose for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reactions were noted. Parent have been notified to bring infant to clinic for revaccination. This will be a no-cost visit.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Entire left thigh is extremely swollen, red, warm to the touch, and child is struggling to walk. When she attempts to walk she has to be on top toes on her left foot. Pain and swelling is interfering with sleep.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pain
Clinical narrative: Entire left thigh is extremely swollen, red, warm to the touch, and child is struggling to walk. When she attempts to walk she has to be on top toes on her left foot. Pain and swelling is interfering with sleep.
Age: 0.67
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ml administered as 1st dose influenza vaccine for the 2017-2018 Flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was noted. Parents were informed and asked to bring infant to clinic for revaccination at no cost.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ml influenza vaccine was administered as a first dose for the 2017-2018 flu season. The recommended dose for this vaccine was 0.5ml. No adverse reaction was observed. Parents have been notified and asked to return to clinic for revaccination at no cost.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ml influenza vaccine administered as first dose for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was observed or reported. Parents were contacted to return to clinic for re-vaccination at no cost.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous, Varicella virus test
Clinical narrative: Red bumps on both shoulders, chest and stomach.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ml influenza vaccine was administered as the first vaccine for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was observed or reported. Parents have been contacted to bring child to clinic for revaccination at no cost.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Feeling hot, Flushing
Clinical narrative: Hotness in face and flushing, did not feel good, per patient report. Occurred within minutes of shot. 9:05 shot given, 9:08 hotness and flushing feeling. Told patient to sit down. 9:09 Blood pressure reading was 150/90 and pulse 68. Offered a wet/cool compress and patient refused. 9:22-  pt reported feeling better, and left pharmacy.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ml influenza vaccine was administered as the first dose of the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was observed or reported. Parents have been notified to bring child to clinic for revaccination at no cost.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Fever of 104 11 days later with no cause; No other symptoms, No rash.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Cough, Muscle contractions involuntary, Muscle tightness, Respiratory tract congestion
Clinical narrative: Several minutes after the shots were given the child coughed a congested sounding cough complained his tummy hurt, he leaned back on grandfather's lap body straight arms drew up, jaw tighten seizure like twitching, no urinary incontinence, all happened within about 1 minutes time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Seizure like phenomena
Clinical narrative: Several minutes after the shots were given the child coughed a congested sounding cough complained his tummy hurt, he leaned back on grandfather's lap body straight arms drew up, jaw tighten seizure like twitching, no urinary incontinence, all happened within about 1 minutes time.
Age: 43.0
Sex: F
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Reports have urticarial on right neck, bilateral forearm and lower abdomen the next morning after receiving the MMR injection. No reaction at the actual vaccine site.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11-year-old brought back with concerns of redness and swelling on the left upper arm. Had received vaccines on March 14. On the left arm he received the Tdap and meningitis vaccine. Has redness and swelling in the area feels warm since the last 2 days. The area of redness and warmth is increasing in size. Denies any respiratory difficulties, any generalized swelling, any difficulty with swallowing. Denies any previous reaction with the tetanus vaccine. No history of any fever. Has been having BENADRYL, TYLENOL and cold compresses to the local area.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: Two reactions. 1. I developed shingles on my right side. 2. Injection site continues to be red and sore.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Patient claimed that the vaccine was injected by the pharmacist at the back of the shoulder close to the joint  and he experienced pain afterwards.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Lethargy
Clinical narrative: She became lethargic and this lasted for three days. When she came out of it, ALL sounds and words stopped. There was another vaccine - probably either HiB or PCV13. I'm not certain of the manufacturer name.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Middle insomnia, Pain
Clinical narrative: Overwhelming pain at injection site. Localized pain for three days. I rubbed and moved my arm, took ibuprofen once before bedtime. Chills woke me up at 1am after the injection. I took two ibuprofen and bundled up.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Skin rash, Right arm.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Balance disorder, Dizziness, Dysstasia, Gait disturbance
Clinical narrative: A few weeks after receiving the flu vaccine, I began observing some unusual symptoms. I must first explain that I am on peritoneal dialysis for kidney disorder. Everything was going well until after receiving the flu vaccine. The first thing I noticed was that I stopped dialyzing properly, confirmed by tests. The PD nurse eventually had to reset to a more aggressive form of dialysis in order for it to be effective. While on dialysis, I still had some kidney function, that has ceased and my urine production has dried up. Many other symptoms came on gradually as the weeks went by. Some of these symptoms include numbness in my hands and feet, tingling, dizziness, weakness (mainly in my feet), loss of balance, extreme difficulty walking, even standing is a challenge at times, inability to grasp small objects, extreme difficulty buttoning my shirt, and sleep disturbance. I've also had a suspension of my preparation for a kidney transplant. The nephrologist wants to see certain of these conditions remediated before proceeding with the preparation. I desperately need help and want to emphasize that none of these symptoms was observed prior to receiving the flu vaccine.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Grip strength decreased, Hypoaesthesia, Laboratory test abnormal, Loss of personal independence in daily activities, Oliguria
Clinical narrative: A few weeks after receiving the flu vaccine, I began observing some unusual symptoms. I must first explain that I am on peritoneal dialysis for kidney disorder. Everything was going well until after receiving the flu vaccine. The first thing I noticed was that I stopped dialyzing properly, confirmed by tests. The PD nurse eventually had to reset to a more aggressive form of dialysis in order for it to be effective. While on dialysis, I still had some kidney function, that has ceased and my urine production has dried up. Many other symptoms came on gradually as the weeks went by. Some of these symptoms include numbness in my hands and feet, tingling, dizziness, weakness (mainly in my feet), loss of balance, extreme difficulty walking, even standing is a challenge at times, inability to grasp small objects, extreme difficulty buttoning my shirt, and sleep disturbance. I've also had a suspension of my preparation for a kidney transplant. The nephrologist wants to see certain of these conditions remediated before proceeding with the preparation. I desperately need help and want to emphasize that none of these symptoms was observed prior to receiving the flu vaccine.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Paraesthesia, Peritoneal dialysis complication, Renal impairment, Sleep disorder
Clinical narrative: A few weeks after receiving the flu vaccine, I began observing some unusual symptoms. I must first explain that I am on peritoneal dialysis for kidney disorder. Everything was going well until after receiving the flu vaccine. The first thing I noticed was that I stopped dialyzing properly, confirmed by tests. The PD nurse eventually had to reset to a more aggressive form of dialysis in order for it to be effective. While on dialysis, I still had some kidney function, that has ceased and my urine production has dried up. Many other symptoms came on gradually as the weeks went by. Some of these symptoms include numbness in my hands and feet, tingling, dizziness, weakness (mainly in my feet), loss of balance, extreme difficulty walking, even standing is a challenge at times, inability to grasp small objects, extreme difficulty buttoning my shirt, and sleep disturbance. I've also had a suspension of my preparation for a kidney transplant. The nephrologist wants to see certain of these conditions remediated before proceeding with the preparation. I desperately need help and want to emphasize that none of these symptoms was observed prior to receiving the flu vaccine.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Lipids, Nausea, Syncope, Visual impairment
Clinical narrative: Patient was given MCV4 in exam room, then brought to another room for a finger stick to obtain lipid panel. After obtaining capillary finger stick for lipid, patient said he felt nauseous. Had episode of syncope. Syncopal episode lasted about 5 seconds. Patient did not sustain any physical injury. A Physician was called to assess patient. After awakening, patient stated he felt dizzy, started seeing white spots, and stated that he was not able to see when handed alcohol swab. Had patient sniff smelling salts which resolved dizziness and visual disturbances. Patient was brought into exam room to lay down for about 20 minutes. Patient was given peanut butter and crackers and fruit juice. After eating and sx resolving, patient was sent home.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received pediatric dose. Patient called and advised will need to return to start over with adult dose.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX, lot # reported as N014485, expiration date reported as 10-MAY-2019, subcutaneous for prophylaxis. The vaccine underwent a temperature excursion of 26 degrees Celsius for 9 hours and 33 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Lot number N014485 is an invalid lot number for varicella virus vaccine live (oka/merck).
Age: 45.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Diarrhoea, Gastrointestinal disorder, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 45 year old female patient. The patient's medical history included treatment for pain management. The patient did not have any drug allergy. The patient's concomitant therapies included Sulindac. On 27-JAN-2018, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). On 28-FEB-2018, the patient received the second dose of RECOMBIVAX HB intramuscularly, lot# M039201, expiration date 14-NOV-2018, for prophylaxis (strength, dose and frequency were not reported) and PREVNAR 13 (strength, dose, route, frequency, lot#, expiration date and indication were not reported). On the same day, the patient started therapy with Sulindac. On 28-FEB-2018 on the evening, the patient experienced vomiting and diarrhea. The reporter stated that it was not sure if the gastrointestinal symptoms started before or after Sulindac. The patient stated drinking Gatorade and re-hydrates herself and felt better on 02-MAR-2018 (recovering). Diagnostic laboratories were not performed. The causality assessment between aforementioned events with RECOMBIVAX HB and PREVNAR 13 was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab
Clinical narrative: This spontaneous report as received from a employee refers to a 70 year old male patient (reporter's brother in law). The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On an unknown date the patient was vaccinated with shingles shot (Zoster Vaccine Live) (manufacturer unknown) subcutaneously (dose, units and frequency were unknown), (lot number and expiration date unknown). On an unknown date, it was reported that the shingles rash has started to scab over (herpes zoster and scab). The outcome of herpes zoster and scab was reported as recovering/resolving. The causal relationship between the events shingles rash has started to scab over and shingles shot (zoster Vaccine Live) (manufacturer unknown) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 15-NOV-2017 the patient was vaccinated with expired VAQTA intramuscular injection (dose, units and frequency were unknown) (lot # N003194 and expiration date 28-OCT-2017). No adverse effects were reported. There was no product quality compliant reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 12 month old patient of unknown gender. The patient's concomitant medications included HAVRIX and sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On an unspecified date, the patient was mistakenly vaccinated with PROQUAD injection, lot # N025929, expiration date 18-MAR-2019 (frequency, route and anatomical location were not provided) and VARIVAX injection, lot # N026999 expiration date 28-SEP-2019, both for prophylaxis (frequency, route and anatomical location were not provided). The mistake was discovered on 12-MAR-2018. No adverse effects reported.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, Pyrexia
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 month old male patient. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 19-FEB-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M007277, expiry date 09-FEB-2018, 0.5 ml/once, via a subcutaneous route for routine immunisation. At the same office visit, the patient was vaccinated with doses of VARIVAX lot# N022980, expiry date 23-AUG-2019 for prophylaxis (exact dose and route of administration were not reported), HAVRIX, and PREVNAR 13. Doses of M-M-R II and VARIVAX were reconstituted with sterile diluent (manufacturer unknown) (lot# and expiry date were unknown). On the same date, the patient experienced fever of 102.9 degrees Fahrenheit (F) and was given a treatment (unspecified). Diagnostic and laboratory tests were not provided. The outcome of fever was reported as resolved on an unknown date in 2018 and the patient was doing fine. Causality assessment was not provided.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Scab, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a company representative who was the patient's mother refers to a 2 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies and was not taking any concomitant medications. On 03-MAY-2016 the patient was vaccinated with VARIVAX injection (dose, frequency, lot # and expiry date were not reported) for prophylaxis. On approximately 27-FEB-2018 (reported as about 2 weeks ago), the patient had bumps on the back of his left arm. On 13-MAR-2018, the bumps were diagnosed as chicken pox. It was also reported that they have crusted over. It was reported that no lab diagnostic studies were performed. It was reported that the patient sought medical attention and visited an physician. On unknown dates the patient received unspecified treatment for the events. The action taken with the therapy with VARIVAX was unknown. The outcome of varicella was reported as recovering/resolving. The relationship between events and VARIVAX was not provided. No product quality complaint was involved. It was also reported that the patient attended a day care where another child had chicken pox on an unspecified date prior to the patient having bumps.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 8 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-MAR-2018, the patient was vaccinated with a dose of ZOSTAVAX lot number N020945 with expiration date on 26-OCT-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent (manufacturer unknown) used as reconstitution of the vaccine was properly stored (lot number and expiration date were not reported). There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT) lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 09-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1803USA003986: US-009507513-1803USA007256: US-009507513-1803USA007257: US-009507513-1803USA007258: US-009507513-1803USA007259:
Sex: M
Vaccine: HPV9
Symptoms: Foetal exposure during pregnancy, Growth retardation
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a male patient, he was 10 months old at the time of report. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 06-DEC-2016, a mother of the patient was vaccinated with a dose of GARDASIL 9 injection (dose number, rout of administration, lot number and expiration date were not provided) for vaccination, while she was five months pregnant and the patient was exposed via transplacental route to the vaccine. He was born on an unknown date. On an unknown date, the patient experienced growth retardation (reported as "he was not growing like he should") It was also reported, that the mother of the patient would be seeing a genetics. The outcome of growth retardation was unknown. The causality assessment was not provided. Upon internal review, the event of growth retardation was considered to be medically significant. This case is linked with the MARRS # 1803USA005894 case due to parent-child link.; Sender's Comments:  US-009507513-1803USA005894: Original Case : 1803USA005894.
Sex: F
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. The patient already had developed human papilloma viral infection (concurrent condition) prior to GARDASIL. Information on medical history, drug reactions/allergies and concomitant medications were not reported. The patient stated that she was vaccinated with first two doses of GARDASIL injection, unidentified Merck HPV vaccine administered (name and lot number not provided) (dose, route of administration, and expiry date were not reported) for prophylaxis in 2012 and received her last dose in 2016 (inappropriate schedule of drug administration). It was also reported that it could not be confirmed if the patient received GARDASIL 9 unidentified Merck HPV vaccine administered (name and lot number not provided) or GARDASIL unidentified Merck HPV vaccine administered (name and lot number not provided). No adverse effect was reported. No further adverse event information was provided. There was no product quality complaint (PQC) reported.