chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Culture, Infection, Intensive care
Clinical narrative: Per husband patient got first dose of SHINGRIX on 09/13/2018, after vaccine patient had chills and weakness. After 2nd dose on 11/20/18, around 10 PM husband found patient on the floor unresponsive. When EMT arrived blood pressure was at 50/35. Patient was admitted to hospital where she spent a week, followed by rehab. During hospital stay patient was told that she has an infection going on, but no tests or cultures were able to determine the source or type of infection. Patient spent 4 days in intensive care, and 5 more days on the hospital floor followed by rehab 6 days
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Unresponsive to stimuli
Clinical narrative: Per husband patient got first dose of SHINGRIX on 09/13/2018, after vaccine patient had chills and weakness. After 2nd dose on 11/20/18, around 10 PM husband found patient on the floor unresponsive. When EMT arrived blood pressure was at 50/35. Patient was admitted to hospital where she spent a week, followed by rehab. During hospital stay patient was told that she has an infection going on, but no tests or cultures were able to determine the source or type of infection. Patient spent 4 days in intensive care, and 5 more days on the hospital floor followed by rehab 6 days
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: At the time on injection it burned for about 2 days, now 2 years later it itches with a lump at the shot sight and small rash.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient called stating she had quite a reaction to the SHINGRIX vaccination, that the day of the vaccination she developed a 50 cent piece size reddened and swollen area at site of vaccination. Also stated that it is very sore. She said today, (4 days post vaccination), that it is now a darker red, and the swelling goes down her arm. Did not state what treatment she has tried for relief.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Pain in extremity
Clinical narrative: Shivering overnight, sore arm, and sore armpit for 2 days.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Left arm swollen hot red and tender. Started after shots last week. Taking BENADRYL and TYLENOL. Feels like things are improving, not as itchy or red today. No throat swelling, difficulty breathing, tongue, or lip swelling.
Age: 34.0
Sex: F
Vaccine: FLU4, HEP, HEPA, MMR, PPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient received multiple vaccines on 12/14/18. She received varicella in L arm SQ. Two days later, she developed fever for about 12 hours with swelling/redness at injection site. She took ibuprofen that helped improve symptoms. On Monday, 12/17/18, she returned to clinic with swelling mostly gone and some remaining pinkness at injection site. Tenderness improving per patient.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: Local irritiation of skin over area of injection.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Capillary nail refill test, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: 23-year-old female sought treatment in the ER with complaints of numbness in the entirety of her left arm after receiving the Hep B shot earlier in the day. Per ER report, she had full strength and reflexes in both upper extremities. She reported decreased sensation throughout left upper extremity, but stated she could feel the Dr. pinch her and has sensation when cap refill tested. There were no signs of infection at the vaccine site. ER stated that it may be a side effect from the Hep B vaccine, but did not see evidence of an emergent problem at that time. She was discharged in stable and improved condition.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: Headache, nausea, dizziness and bad body aches. Patient reported feeling better on the 3rd day.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Decreased appetite, Diarrhoea, Injection site rash, Rash
Clinical narrative: Parent states she developed a rash on her chest and some temperature of about 101. She had some diarrhea that night and was not eating from that night through the next day. She had at least 9 episodes of diarrhea through the next day. The rash extended from the chest down to the upper legs. The diarrhea abated over next several days and gradually began to take more food.
Age: 29.0
Sex: F
Vaccine: ANTH, FLU3, JEV1, SMALL, TYP
Symptoms: Arthralgia, Contusion, Cough, Dyspnoea, Increased bronchial secretion
Clinical narrative: She states on day 18 she noted unusual sensations to her hands. She was seen at sick call, who instructed her to wear gloves. She states there may have been some tiny papules but the more significant lesion eruptions and involvement to her ears started day 21. They were pruritic, but not painful. Sites include her hands including bilateral palms, wrists, left elbow, bilateral ears, and a small site on her lower lip, although that singular site did not itch. She denies lesions to oral cavity, torso, back, legs, groin or genitals. She reports systemic symptoms of myalgias arthralgias feeling feverish over the past week. She reports cough increased shortness of breath with increased mucus production over the past 2 weeks which she attributes to mild viral illness. She denies chest pain, chest tightness or pressure. She denies any eye symptoms including erythema, edema, discharge or crusting, blurred vision, pain or vision changes. Physical exam noted: Skin: Erythema across helix bilat, with tiny papules, one site of coalescent lesions on each ear appears papular versus early vesicle formation. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow; erythematous to flesh-colored. Treated with topical steroid and cetirizine. On follow up at one week (day 27) She reports the lesions are overall improved, in particular the ear lesions are much improved. Her hand lesions however have some sites that look bruised. She has developed new lesions above her left knee and one on her lower lip, but not at the original site of concern. Per P/E: Skin: helix bilat tiny papules, erythema resolved, no vesicles, pustules, crust or drainage. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow and above left knee; erythematous to flesh-colored. Several finger sites, particularly distal #3 5 digit left hand, and 2 digit right hand with erythematous ecchymotic/vasculitis appearance at the lesion base, blanches, non-palpable. Lip lesion left lower, papule, not erythematous or vesicular. SPV site dry, pink open wound bed, not epithelialized. Treated with prednisone 60x5 then taper over 6 days. Mostly resolved at day 34. Fully resolved without recurrence per report on 48. DX BAPE, but atypical timing & presentation.
Age: 29.0
Sex: F
Vaccine: ANTH, FLU3, JEV1, SMALL, TYP
Symptoms: Myalgia, Pyrexia, Rash papular, Rash pruritic, Sensory disturbance
Clinical narrative: She states on day 18 she noted unusual sensations to her hands. She was seen at sick call, who instructed her to wear gloves. She states there may have been some tiny papules but the more significant lesion eruptions and involvement to her ears started day 21. They were pruritic, but not painful. Sites include her hands including bilateral palms, wrists, left elbow, bilateral ears, and a small site on her lower lip, although that singular site did not itch. She denies lesions to oral cavity, torso, back, legs, groin or genitals. She reports systemic symptoms of myalgias arthralgias feeling feverish over the past week. She reports cough increased shortness of breath with increased mucus production over the past 2 weeks which she attributes to mild viral illness. She denies chest pain, chest tightness or pressure. She denies any eye symptoms including erythema, edema, discharge or crusting, blurred vision, pain or vision changes. Physical exam noted: Skin: Erythema across helix bilat, with tiny papules, one site of coalescent lesions on each ear appears papular versus early vesicle formation. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow; erythematous to flesh-colored. Treated with topical steroid and cetirizine. On follow up at one week (day 27) She reports the lesions are overall improved, in particular the ear lesions are much improved. Her hand lesions however have some sites that look bruised. She has developed new lesions above her left knee and one on her lower lip, but not at the original site of concern. Per P/E: Skin: helix bilat tiny papules, erythema resolved, no vesicles, pustules, crust or drainage. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow and above left knee; erythematous to flesh-colored. Several finger sites, particularly distal #3 5 digit left hand, and 2 digit right hand with erythematous ecchymotic/vasculitis appearance at the lesion base, blanches, non-palpable. Lip lesion left lower, papule, not erythematous or vesicular. SPV site dry, pink open wound bed, not epithelialized. Treated with prednisone 60x5 then taper over 6 days. Mostly resolved at day 34. Fully resolved without recurrence per report on 48. DX BAPE, but atypical timing & presentation.
Age: 29.0
Sex: F
Vaccine: ANTH, FLU3, JEV1, SMALL, TYP
Symptoms: Viral infection
Clinical narrative: She states on day 18 she noted unusual sensations to her hands. She was seen at sick call, who instructed her to wear gloves. She states there may have been some tiny papules but the more significant lesion eruptions and involvement to her ears started day 21. They were pruritic, but not painful. Sites include her hands including bilateral palms, wrists, left elbow, bilateral ears, and a small site on her lower lip, although that singular site did not itch. She denies lesions to oral cavity, torso, back, legs, groin or genitals. She reports systemic symptoms of myalgias arthralgias feeling feverish over the past week. She reports cough increased shortness of breath with increased mucus production over the past 2 weeks which she attributes to mild viral illness. She denies chest pain, chest tightness or pressure. She denies any eye symptoms including erythema, edema, discharge or crusting, blurred vision, pain or vision changes. Physical exam noted: Skin: Erythema across helix bilat, with tiny papules, one site of coalescent lesions on each ear appears papular versus early vesicle formation. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow; erythematous to flesh-colored. Treated with topical steroid and cetirizine. On follow up at one week (day 27) She reports the lesions are overall improved, in particular the ear lesions are much improved. Her hand lesions however have some sites that look bruised. She has developed new lesions above her left knee and one on her lower lip, but not at the original site of concern. Per P/E: Skin: helix bilat tiny papules, erythema resolved, no vesicles, pustules, crust or drainage. Scattered papules singular & discrete to hands including palms, wrists with several clustered groups below left elbow and above left knee; erythematous to flesh-colored. Several finger sites, particularly distal #3 5 digit left hand, and 2 digit right hand with erythematous ecchymotic/vasculitis appearance at the lesion base, blanches, non-palpable. Lip lesion left lower, papule, not erythematous or vesicular. SPV site dry, pink open wound bed, not epithelialized. Treated with prednisone 60x5 then taper over 6 days. Mostly resolved at day 34. Fully resolved without recurrence per report on 48. DX BAPE, but atypical timing & presentation.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Musculoskeletal pain, Rash
Clinical narrative: Pt Indicated Sx:rash on his shoulders and antecubital areas. He would get intermittent sharp pains on his shoulders and ankles. He also got headaches. This lasted for a week. Although the rash lasted a month. He kept applying OTC remedies and it finally went away.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: Headache, nausea, dizziness and general body aches. Starting feeling better on 3rd day of vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza, Pain
Clinical narrative: Flu symptoms for about 36 hours: chills, body aches, headache, exhaustion. Also sore arm.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Flu symptoms for about 36 hours: chills, body aches, headache, exhaustion. Also sore arm.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Pt jerked out of medical assistant's and mothers grasp while being vaccinated. The needle jerked out of patient's arm, scraped the back of medical assistant's thumb, and then back into her arm. The vaccine was squirted outside of the patient, so another dose had to be administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV
Symptoms: Idiopathic urticaria, Immunisation reaction, Urticaria
Clinical narrative: Impression Patient with generalized urticaria which began 24 hours after administration of KINRIX/PROQUAD/HiB and continues today. No swelling of lips or mouth. Differential diagnosis is immunization reaction versus idiopathic urticaria. Unusual that reaction started greater than 24 hours after immunization. Diphenhydramine 7.5 ml every 6 hours as needed. Call for worsening. Recommend allergy consultation regarding TdaP in the future (all other immunizations complete). Referrals: Allergy and Immunology. Consult within 4 Months.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date in November 2018, the patient was inadvertently vaccinated with RECOMBIVAX HB lot# M037771, expiration date: 21-FEB-2019, intramuscularly (exact dose and site of administration were not reported) for prophylaxis instead of PEDVAXHIB, concomitantly with PEDIARIX. No adverse events were reported.
Age: 13.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Electrocardiogram normal, Immediate post-injection reaction, Neurological examination normal, Sinus arrhythmia, Tremor
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 13-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (lot # R003557, expiration date: 20-NOV-2020, dose was not provided) for prevention of human papilloma virus (HPV) and influenza virus vaccine (unspecified) for prophylaxis. On the sam date, immediately afterwards, the patient began shaking. All neurological checks and vital signs were normal. Electrocardiography (EKG) was performed on the same date and revealed sinus arrhythmia, however it was hard to determine if accurate because patient was shaking and result might have been artifact. The patient was sent home with his mother with plans to repeat the EKG in one week. The patient recovered from shaking on the same date after 50-55 minutes. The outcome of sinus arrhythmia was unknown. The relatedness between the events and suspect therapies were not reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse referring to an approximately 13 year old male patient. The patient's concurrent conditions, medical history, concomitant therapies, drug history, and allergies were not reported. On an unknown date in October 2018, the patient was inadvertently vaccinated with PROQUAD (dose, frequency, route of administration, expiration date, and lot number were not reported) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a currently 12-month-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VARIVAX injection (lot # R011806 and expiration date: 23-APR-2018) (dose and route were unknown) for prophylaxis following a temperature excursion (product storage error). There were no adverse effects (no adverse event) reported. The temperature and timeframe excursion were at or above 15-degree Fahrenheit to 46-degree Fahrenheit (-9 degree Celsius to 8-degree Celsius) (19.3 Fahrenheit) for 40 minutes. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1812USA001527.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, Irritability, Somnolence
Clinical narrative: This spontaneous report was received from a consumer, and refers to her daughter of 6 months years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 04-DEC-2018, the patient was vaccinated with the third dose of LIQUID PEDVAXHIB intramuscularly, for accidental administration (strength, dosage, frequency, lot number and expiration date were not reported). On the same date, the patient experienced sleepiness, fussiness and inappropriate schedule of vaccine administered; after receiving LIQUID PEDVAXHIB. The patient did not receive any treatment for the events and did not sought medical attention. No laboratories test were performed. The outcome for the events somnolence and irritability were reported as not recovered. The causality assessment between the therapy and the events were not reported.
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 65-year-old female patient. The patient had no medical history, concomitant therapies and concurrent conditions. On an unknown date in November 2018, "one to two weeks ago" from the reporting time, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, frequency, route of administration, lot# and expiration date were not reported) as vaccination. On an unknown date in 2018, the patient developed a rash on her face and all over her body. The patient planned to make an appointment and visit an unspecified physician for treatment. The outcome of rash generalised was unknown. The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's medical history, concomitant therapies and concurrent conditions was provided. On 05-DEC-2018, the pregnant patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration was not reported) for prophylaxis. The reporter stated, that the medical assistant had intended to give the patient the "flu shot", but inadvertently gave GARDASIL 9. The date of last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were not know and could not be calculated. The pregnancy outcome was pending. The outcome of the events and the causality assessment was not provided.; Sender's Comments: US-009507513-1812USA004514:
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse concerning a 24 year old female patient. No pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were reported. On 16-OCT-2018, the patient was vaccinated with VARIVAX for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided); it was reported that lot # and expiry date of sterile diluent (MERCK) was not provided. On an unspecified date, the patient carried out an unspecified pregnancy test. Subsequently, on 19-OCT-2018, the patient found out she was pregnant. The patient became pregnant with an estimated last menstrual period (LMP) of 05-OCT-2018 and an estimated date of delivery (EDD) of 12-JUL-2019. The initial exposure to VARIVAX was approximately at 1 week. No treatment nor hospitalization or adverse effects were reported. The pregnancy outcome was pending.
Sex: M
Vaccine: PPV
Symptoms: Injection site infection
Clinical narrative: This spontaneous report was received from a pharmacist regarding to an elderly male patient. The patient's concurrent conditions, historical conditions, past drugs and concomitant drugs were unknown. On an unknown date in 2018 (reported as within the past few months) the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date in 2018 the patient experienced an infection at the injection site (injection site infection) which the reporter was learned weeks later and reported on reporting day (07-DEC-2018). The patient sought medical attention (contacted pharmacist). The patient was fine then. The outcome of injection site infection was reported as recovered. The causality of event was not reported. This is one of the two reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Dehydration, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a physician and refers to a 12 month old female patient. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 16-NOV-2018, the patient was vaccinated with PROQUAD lot # R020676, expiration date 15-JAN-2020 (albumin status, exact dose and route of administration were not reported) for prophylaxis. On 20-NOV-2018, the patient experienced a fever between 102 to 105 degrees Fahrenheit. The patient was seen in the emergency room on 29-NOV-2018 and was admitted to hospital on 30-NOV-2018. The patient was found to have dehydration and a "rash on her stomach" in the hospital in 2018 (exact date unknown). The outcome of the events was reported as recovered. The relatedness between the events and PROQUAD was not reported.
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Disturbance in attention
Clinical narrative: This spontaneous report was received from a consumer and refers to her currently 8-year-old step-son. The patient's concurrent condition included fish allergy and concomitant medication included CLARITIN. He had no drug reaction/allergies. The patient's medical history was not reported. On an unknown date in 2010 (reported as "sometime around 2010"), the patient was vaccinated with a dose of M-M-R II intramuscularly (exact dose, dose number, site of administration, lot # and expiration date were not reported) for routine vaccination. On an unknown date around 2010 or 2011, he developed autistic tendencies and issues with focus and attention. The treatment was not given for the events. No laboratory test was performed. The reporter also stated that the patient was incredibly intelligent and brilliant. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and M-M-R II was not provided. Upon internal review, the event of autistic tendencies was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 11-DEC-2018 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In JANUARY 2017, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In JANUARY 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 11-DEC-2018 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician/MD for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 16-MAR-2012, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 12-DEC-2016, the patient was treated by a physician at a medical clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about in 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by a physician at an internal medicine office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2016, the patient's healthcare provider at an outpatient clinic administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 30-AUG-2012, the patient's healthcare provider at a primary care office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 09-FEB-2017, the patient was treated by a physician at a primary care office for Bell's palsy and shingles. The patient was diagnosed with Bell's palsy and shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Upon internal review, Bell's palsy was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 18-MAR-2013, the patient's healthcare provider at a medical center administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 10-DEC-2016, the patient was treated by a physician the same medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster including, but not limited to cellulitis.  Shortly after receiving ZOSTAVAX, the patient developed burning, itching, redness and warmth at the site of the injection. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from cellulitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Causality assessment was considered to be related. Upon internal review, cellulitis was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster including, but not limited to cellulitis.  Shortly after receiving ZOSTAVAX, the patient developed burning, itching, redness and warmth at the site of the injection. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from cellulitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Causality assessment was considered to be related. Upon internal review, cellulitis was determined to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2014, the patient's healthcare provider at a primary care office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 27-APR-2017, the patient was treated by a physician at the primary care office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 28-MAY-2015, a physician at a clinic administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On 11 and 26-JAN-2017, the patient was treated by a physician for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and post herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In October 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In April 2017, the patient was treated by a physician at an office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.