chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV4
Symptoms: Headache, Hyperhidrosis, Hypopnoea, Laboratory test normal, Loss of consciousness
Clinical narrative: 5 - 10 minutes after vaccines administered patient stood and took 3 steps and fell into sink, was unconscious. We lowered to floor, color pale, lips and nail beds cyanotic, skin diaphoretic. Eyes open - staring. Pulse faint - respiratory shallow. 1-7-19, 1 PM, Patient vaccinated with Hep A, FLULAVAL and HPV (GARDASIL 9) in (L) thigh and (R) thigh per mother and patients request. Stated "That is where she always gets vaccine. 1:10 PM, Patient stood and took 3 steps and fell into sink, unconscious. We lowered her to floor and her eyes were open in a blank stare. Color pale - lips bluish - very shallow breathing - faint radial pulse - carotid pulse 60-70 regular. Skin diaphoretic. 1:15, Did a FSBS = 80. She is able to grip my hands weakly. Gave her a lollipop to suck on. She will not verbalize. Shakes her head yes and no. 1:20, Gave her some sips of soda. No nausea, still pale, hands cold - nail bed cyanotic. Moves all 4 extremities. Understands my commands and mother's. 1:30, Still will not verbalize. I called 911 to get help. 1:45, Still no change, still very pale and unable to stand or verbalize. EMT arrives - did pulse ox = 89%. Put her on O2 and lifted her onto cot for transport. 4 PM, I phoned mother, they were still at ER. Can't find anything abnormal. She is able to speak and much better. 1-8-19, 10 AM, Phoned mother - patient still tired and more quiet than usual. Otherwise OK. Home meds - FOCLAN 30 mg p.o. qd for ADHD, ZYRTEC 10 mg p.o. qd for headaches, B12 qd, Mag. oxide qd.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV4
Symptoms: Pallor, Peripheral coldness, Pulse abnormal, Speech disorder, Staring
Clinical narrative: 5 - 10 minutes after vaccines administered patient stood and took 3 steps and fell into sink, was unconscious. We lowered to floor, color pale, lips and nail beds cyanotic, skin diaphoretic. Eyes open - staring. Pulse faint - respiratory shallow. 1-7-19, 1 PM, Patient vaccinated with Hep A, FLULAVAL and HPV (GARDASIL 9) in (L) thigh and (R) thigh per mother and patients request. Stated "That is where she always gets vaccine. 1:10 PM, Patient stood and took 3 steps and fell into sink, unconscious. We lowered her to floor and her eyes were open in a blank stare. Color pale - lips bluish - very shallow breathing - faint radial pulse - carotid pulse 60-70 regular. Skin diaphoretic. 1:15, Did a FSBS = 80. She is able to grip my hands weakly. Gave her a lollipop to suck on. She will not verbalize. Shakes her head yes and no. 1:20, Gave her some sips of soda. No nausea, still pale, hands cold - nail bed cyanotic. Moves all 4 extremities. Understands my commands and mother's. 1:30, Still will not verbalize. I called 911 to get help. 1:45, Still no change, still very pale and unable to stand or verbalize. EMT arrives - did pulse ox = 89%. Put her on O2 and lifted her onto cot for transport. 4 PM, I phoned mother, they were still at ER. Can't find anything abnormal. She is able to speak and much better. 1-8-19, 10 AM, Phoned mother - patient still tired and more quiet than usual. Otherwise OK. Home meds - FOCLAN 30 mg p.o. qd for ADHD, ZYRTEC 10 mg p.o. qd for headaches, B12 qd, Mag. oxide qd.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site nodule, Joint range of motion decreased, Pain
Clinical narrative: Patient stated increasing soreness started "a couple days" after the shot and continued to increase for several weeks. She still has soreness, a knot at injection site, and reduced range of motion. She has not seen her PCP for the issue. She said she mentioned it to the orthopedist while on a visit for an unrelated issue, but has received no treatment.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia test, C-reactive protein, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: 3 weeks of muscle pain and stiffness. After second SHINGRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Red blood cell sedimentation rate
Clinical narrative: 3 weeks of muscle pain and stiffness. After second SHINGRIX.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction on left arm swollen and red and swollen eyes almost closed. Patient received steroid and antibiotics from doctors.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Seen 1/2/19 for local reaction. 8x12 cm erythema and swelling. Puritic. Placed on oral steroids.  Swelling and redness increased for 1 day and then became to subside. He has no residual effects.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Seen 1/2/19 for local reaction. 8x12 cm erythema and swelling. Puritic. Placed on oral steroids.  Swelling and redness increased for 1 day and then became to subside. He has no residual effects.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Seen 1/2/19 for local reaction. 8x12 cm erythema and swelling. Puritic. Placed on oral steroids.  Swelling and redness increased for 1 day and then became to subside. He has no residual effects.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Began to feel fatigued with slight sore throat and headache approximately 7 hours after vaccination. Symptoms persisted into the evening feeling tired and as if it was the onset of cold or flu. Slightly elevated temperature (99.4 - typically my temperature is 97.6) at one point next morning. Symptoms remained on day 2 (Tuesday, Jan. 8) with mainly feeling tired, slight sore throat, headache. All were relieved with OTC severe cold and flu medicine and rest. By Tuesday evening I was feeling much better with symptoms abating to a great degree. By third day, symptoms have all but disappeared. I rested on Tuesday and did not go to work, more out of concern that I might have the flu or a cold, which I have no desire to share. I will return to work today since it is clear that I have not acquired the nasty cold that has afflicted my partner for more than three weeks.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Soreness at injection site lasting several days on 1st shot, still sore on second dose, 2nd dose 36 hours of flu like symptoms.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Allergy test, Aspiration, Chest X-ray, Endoscopy, Gastrointestinal tube insertion
Clinical narrative: Seizures, lethargy, high fever, aspiration, weakened muscles, stopped breathing.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Gastrostomy, Lethargy, Muscular weakness, Pyrexia, Rash
Clinical narrative: Seizures, lethargy, high fever, aspiration, weakened muscles, stopped breathing.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Respiratory arrest, Seizure, Swallow study, Vomiting
Clinical narrative: Seizures, lethargy, high fever, aspiration, weakened muscles, stopped breathing.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from pharmacist referring to unspecified patient. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported. The patient was inadvertently administered a dose of ZOSTAVAX (lot#/batch# reported as: M025699, expiration date: 16-DEC-2018) (strength, frequency, and route were not reported) on 27-DEC-2018, that was expired. No adverse effect reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse via a company representative and refers to 2 unspecified patients of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  An unknown dates in 2018 (reported as within the last 3 months), the patients were vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patients had a return visit to the practice and were diagnosed with cellulitis on an unknown date in 2018. One of the patients might have been admitted to the hospital due to the event, however it could not be confirmed. The patients were treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. Follow up information has been received from the registered nurse during a phone call on 31-DEC-2018. The registered nurse reported that one of two patients was 23 years old female and was vaccinated with PNEUMOVAX 23 on 06-NOV-2018 (lot # R018731, expiration date: 27-FEB-2020) in right deltoid. Cellulitis was developed on unspecified date. Treatment and current status were unknown to the reporter. The patient was not hospitalized. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1812USA008996: US-009507513-1812USA008994: US-009507513-1812USA008995: US-009507513-1812USA007804:
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a 17-year-old female patient. The patient's concurrent conditions, medical history, drug allergies and concomitant medications were not provided. On 03-JAN-2019, the patient was vaccinated with an expired dose of VAQTA 25/0.5 (units, dose and frequency were not provided), lot number N026997, expiration date 10-NOV-2018, intramuscular in the left arm, as prophylaxis. No adverse effects were reported.
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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. 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 2009, a health care provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. 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 the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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 include 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. 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 05-JUL-2011, 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 06-DEC-2016, the patient was treated by a physician at a 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: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 10-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis. No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 10-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 19-NOV-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1812USA011184:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 16-NOV-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster meningitis
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. In 2016, the patient was inoculated by a pharmacist with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. On or about 04-JAN-2017, the patient was treated by a physician for herpes zoster meningitis. 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. Upon internal review, herpes zoster meningitis was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health care professional regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapy included properly stored sterile diluent. On 03-JAN-2019, the patient was vaccinated with improperly stored VARIVAX (strength, dose, frequency and route of administration not reported) lot # R010468 and expiry date: 10-APR-2020 (product storage error) for prophylaxis. No adverse effects were reported. The temperature at which the vaccine was stored was reported as 6 °F to 14 °F (7.41 °F) with a time frame of 20 minutes (multiple excursion). There was no previous temperature excursion reported. Digital data logger was present.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
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. On or about 10-APR-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 24-MAR-2017 and 30-JUN-2017, the patient was treated by a physician for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (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: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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. On or about 10-FEB-2009, a physician at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2011, the patient was treated by a physician at a physician's office 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, 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 include 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 is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In January 2017, the patient was treated by the patient's healthcare provider at a physician's office 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, 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 include 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 is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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 June 2015, a healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In June 2015, the patient was treated by a healthcare provider at a clinic 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, 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 include 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 is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Acute respiratory distress syndrome, Facial pain, Nerve compression, Pain, Pain in extremity
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. On or around 19-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered swelling of face, acute respiratory distress, serious pain in her right leg that radiated down her leg, and right sided facial pain. In or around May 2017, the patient presented to her physician for this injury and was diagnosed with compression of right sciatic nerve and trigeminal neuralgia. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered to be not recovered. Acute respiratory distress, swelling of face, compression of right sciatic nerve and trigeminal neuralgia were considered disabling. Upon internal review,  acute respiratory distress was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Trigeminal neuralgia
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. On or around 19-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered swelling of face, acute respiratory distress, serious pain in her right leg that radiated down her leg, and right sided facial pain. In or around May 2017, the patient presented to her physician for this injury and was diagnosed with compression of right sciatic nerve and trigeminal neuralgia. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered to be not recovered. Acute respiratory distress, swelling of face, compression of right sciatic nerve and trigeminal neuralgia were considered disabling. Upon internal review,  acute respiratory distress was determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an 18 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported) later than they were supposed to. No adverse effects were reported.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: A rash was observed on the belly and the thigh. Later, the rash disappear but a big branch spot appeared on its place.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Tachycardia for approximately 8 hours, from 8:00 AM (may have started earlier while asleep - don't know) until about 4:00 PM. Normal resting heart rate is 68-72. Heart rate was 105 for about four hours, dropped to 100 for an hour, then to 90 for another two hours, before dropping back to normal 71 late afternoon.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myocardial necrosis marker, Tachycardia
Clinical narrative: Tachycardia for approximately 8 hours, from 8:00 AM (may have started earlier while asleep - don't know) until about 4:00 PM. Normal resting heart rate is 68-72. Heart rate was 105 for about four hours, dropped to 100 for an hour, then to 90 for another two hours, before dropping back to normal 71 late afternoon.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine inadvertently administered. Patient was discharged at the clinic stable. No reports of any untoward reaction from mother yet.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Influenza like illness, Nausea, Pain
Clinical narrative: Not sure the lot number as typed above I typed in the RX #, I started feeling sore in left arm, my fingers and whole body was sore and felt nauseated the evening of the vaccine and all the next day. Also was weak and still sore, also cold, but no fever. I took TYLENOL and used warm pack on neck, back and just slept. The feeling I had was like I had the flu. By the next evening I was feeling better, although my arm still hurt for at least a week after the shot. I just didn't realize that I would feel this way after a shot, I expected my arm to hurt just like the influenza shot but not the feeling like I had the flu.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Not sure the lot number as typed above I typed in the RX #, I started feeling sore in left arm, my fingers and whole body was sore and felt nauseated the evening of the vaccine and all the next day. Also was weak and still sore, also cold, but no fever. I took TYLENOL and used warm pack on neck, back and just slept. The feeling I had was like I had the flu. By the next evening I was feeling better, although my arm still hurt for at least a week after the shot. I just didn't realize that I would feel this way after a shot, I expected my arm to hurt just like the influenza shot but not the feeling like I had the flu.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Headache, Neck pain, Pain
Clinical narrative: Severe pain in arm that vaccine was given, chills, hot/cold feeling, pain throughout body, neck pain, head pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm that vaccine was given, chills, hot/cold feeling, pain throughout body, neck pain, head pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fevers, headache, muscle ache, joint pain, nausea.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Chapped lips, Dizziness, Eye swelling, Lip swelling
Clinical narrative: Swelling of face, eyes, lips. Still having problem with lips cracked and rough, had some dizziness, nausea, sores on nose, stomach pressure all starting within 24 hrs of immunization. Symptoms resolved other than cracked lips.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nasal discomfort, Nausea, Swelling face
Clinical narrative: Swelling of face, eyes, lips. Still having problem with lips cracked and rough, had some dizziness, nausea, sores on nose, stomach pressure all starting within 24 hrs of immunization. Symptoms resolved other than cracked lips.
Sex: M
Vaccine: DTAP, MMR
Symptoms: Aggression, Autism spectrum disorder, Hyperacusis, Intentional self-injury, Pain
Clinical narrative: Information has been received from a consumer concerning her 2-year-old son who was vaccinated with "a whole bunch of vaccines" at unspecified times. At 2 years of age, he was diagnosed with autism. He was nine years old at the time of the report and his outcome was not reported. Follow-up was received on 07-JAN-2019 from the patient's mother concerning her currently 21 year old son. In 1997 (also reported as when the patient was an infant), the patient was vaccinated with M-M-R II (dose, route, and lot # not provided) and reported as DTaP; (manufacturer not specified). The mother reported that her son was developing normally when he was an infant but he began to have autism symptoms after the vaccination. The mother further reported that in approximately 1999 (reported as when he was at age 2 or 3), he was diagnosed with severe autism. She also reported that her son has been in a lot of pain over the years and he suffered from seizures (he was taking an unspecified medication to control this) (onset date for these were not provided). The patient was non-verbal, had sensory issues, had to cover his ears due to sound in the environment, and had aggressive episodes (these were considered symptoms of autism). In addition, on unspecified date(s), the patient was hospitalized in behavioral institutions for self-biting (considered symptom of autism) and other unspecified issues. When asked if the patient sought medical attention and if treatment was given for the events, the mother answered "yes" to both. She also stated that her son has never been able to have a normal life. When asked if the patient had any drug reactions or allergies, the mother's response was seasonal allergies (this was coded as an event since the patient received the vaccines as an infant and the onset date is unknown). The reporter believed that the Company's M-M-R II was responsible for her son's severe autism. She did not specify causality for the other events. She also stated that she was part of a class action lawsuit in 2005 filed against vaccine makers. The reporter also asked if the Company's vaccines contained thimerosal or preservatives. She believes pharmaceutical companies are "too big and strong" and that the federal government needs to protect children from receiving unsafe vaccines that contain toxins. The patient's present status was reported to be not recovered. The following events were considered disabling by the mother as she reported that her son was never able to live a normal life: autism, seizures, pain, and other unspecified issues for which he was hospitalized in behavioral institutions. Upon internal review, autism and seizures were considered to be medically significant. The mother also reported that another son was diagnosed with severe autism after vaccination with M-M-R II (see case # 0603USA04337). Additional information has been requested.
Sex: M
Vaccine: DTAP, MMR
Symptoms: Seizure, Sensory disturbance, Speech disorder
Clinical narrative: Information has been received from a consumer concerning her 2-year-old son who was vaccinated with "a whole bunch of vaccines" at unspecified times. At 2 years of age, he was diagnosed with autism. He was nine years old at the time of the report and his outcome was not reported. Follow-up was received on 07-JAN-2019 from the patient's mother concerning her currently 21 year old son. In 1997 (also reported as when the patient was an infant), the patient was vaccinated with M-M-R II (dose, route, and lot # not provided) and reported as DTaP; (manufacturer not specified). The mother reported that her son was developing normally when he was an infant but he began to have autism symptoms after the vaccination. The mother further reported that in approximately 1999 (reported as when he was at age 2 or 3), he was diagnosed with severe autism. She also reported that her son has been in a lot of pain over the years and he suffered from seizures (he was taking an unspecified medication to control this) (onset date for these were not provided). The patient was non-verbal, had sensory issues, had to cover his ears due to sound in the environment, and had aggressive episodes (these were considered symptoms of autism). In addition, on unspecified date(s), the patient was hospitalized in behavioral institutions for self-biting (considered symptom of autism) and other unspecified issues. When asked if the patient sought medical attention and if treatment was given for the events, the mother answered "yes" to both. She also stated that her son has never been able to have a normal life. When asked if the patient had any drug reactions or allergies, the mother's response was seasonal allergies (this was coded as an event since the patient received the vaccines as an infant and the onset date is unknown). The reporter believed that the Company's M-M-R II was responsible for her son's severe autism. She did not specify causality for the other events. She also stated that she was part of a class action lawsuit in 2005 filed against vaccine makers. The reporter also asked if the Company's vaccines contained thimerosal or preservatives. She believes pharmaceutical companies are "too big and strong" and that the federal government needs to protect children from receiving unsafe vaccines that contain toxins. The patient's present status was reported to be not recovered. The following events were considered disabling by the mother as she reported that her son was never able to live a normal life: autism, seizures, pain, and other unspecified issues for which he was hospitalized in behavioral institutions. Upon internal review, autism and seizures were considered to be medically significant. The mother also reported that another son was diagnosed with severe autism after vaccination with M-M-R II (see case # 0603USA04337). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report has been received from a nurse prescriber. On 27-DEC-2018, the nurse requested information regarding the dilution of a dose of GARDASIL 9 for prophylaxis (route, anatomical location, lot # and expiration date were not reported) with sterile diluent (MERCK STERILE DILUENT) lot # and expiration date were not reported (product preparation issue and product preparation error). Additionally, the nurse mentioned that this dose may have been administered to a patient of unknown age and gender (wrong technique in product usage process and product administration error), although this could not be confirmed at the reporting time, due to difference in time zone. No adverse effects were reported. This was a non valid case due to lack of patients identifiers and upon follow up this case is considered valid. Follow-up information has been received from the nurse prescriber (same reporter as before) on 03-JAN-2019. On 03-JAN-2019, a patient of undisclosed age and gender, received a dose of GARDASIL 9, for prophylaxis, administered intramuscularly (anatomical location not reported) lot # N035955, expiration date 09-OCT-2020 (wrong technique in drug usage process); this vaccine had been further diluted with sterile diluent (MERCK STERILE DILUENT) (inappropriate dilution of medication). This dose of GARDASIL 9 was the patient's third dose on the vaccination series. No adverse effects were reported in the patient.
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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. 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. On or about 07-JUL-2015, a physician administered ZOSTAVAX, (lot # and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On 14-NOV-2016, the patient was treated by a nurse practitioner 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. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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 include 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. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 14-NOV-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis. No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 23-OCT-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
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 2016, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient. On an unknown date 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 the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the his 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 earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.