chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Eye allergy, Eye disorder
Clinical narrative: Eye allergies and issues.
Age: 27.0
Sex: M
Vaccine: ADEN_4_7, HEPA, IPV, MNQ, MNQ, TDAP, VARCEL
Symptoms: Demyelinating polyneuropathy, Guillain-Barre syndrome
Clinical narrative: Patient diagnosed with an autoimmune demyelinating polyneuropathy on 19 Nov, suspected GBS.  Adenovirus, influenza, IPV, TdAP given 11/02. Hep A and Varicella given 11/07.
Age: 67.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash
Clinical narrative: Patient is describing a rash that began in the lower extremities and has spread/also appeared from the neck around the shoulders to the arms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Induration, Pain, Skin warm
Clinical narrative: Hard, swollen, red, and painful several hours after injection. At home patient self administered hot compress. She called around 4pm to report her symptoms. Patient came into the office to be evaluated. Dr. looked at the injection site and noted that injection was given in the correct place and the correct medication was given. Vitals were normal. She was advised to go home and use cool compress. She returned to the office the next day and was sent to ER due to being allergic to several antibiotics, in hope that they could administer and watch her. She was having bright, hot redness down her arm with pain into her wrist. She was sent home with an oral abx that she did not take. Patient came in the next day and the redness, swelling, and pain and reduced.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Hard, swollen, red, and painful several hours after injection. At home patient self administered hot compress. She called around 4pm to report her symptoms. Patient came into the office to be evaluated. Dr. looked at the injection site and noted that injection was given in the correct place and the correct medication was given. Vitals were normal. She was advised to go home and use cool compress. She returned to the office the next day and was sent to ER due to being allergic to several antibiotics, in hope that they could administer and watch her. She was having bright, hot redness down her arm with pain into her wrist. She was sent home with an oral abx that she did not take. Patient came in the next day and the redness, swelling, and pain and reduced.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms, except no fever. Headache, muscle ache, chills, shivering.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site cellulitis, Injection site pain, Muscle fatigue, Myalgia
Clinical narrative: Fever, joint pain, muscle aches and fatigue started the following morning, arm pain below site of injection that developed into cellulitis that needed antibiotics to treat.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, joint pain, muscle aches and fatigue started the following morning, arm pain below site of injection that developed into cellulitis that needed antibiotics to treat.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA (unable to life arm pass shoulder, pain  from shoulder to lower arm, limited motion).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nocturia, Polyuria
Clinical narrative: Polyuria and nocturia.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen and painful right arm.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Read the order incorrectly and gave an extra Polio and was supposed to get a Pneumococcal.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: PATIENT HAD NO PAIN AT TIME OF INJECTION. THAT SAME EVENING SHE DEVELOPED SOME ARM PAIN. BY MONDAY AM, PATIENT SAID SHE COULD NOT RAISE ARM ABOVE HEAD AND ARM FROM ELBOW TO SHOULDER WAS RED AND WARM. SHE WENT TO THE EMERGENCY ROOM AND WAS GIVEN AN ANTIBIOTIC AND BENADRYL.
Age: 37.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediately after administering FLULAVAL in RIGHT Deltoid, patient's arm developed swelling soft non-erthyrometis egg sized at injection site. Patient was evaluated by MD and remained in clinic for 15 minutes and was explained what to look out for and that his arm would be sore.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Nerve injury, Pain, Wrong technique in product usage process
Clinical narrative: Pt is having pain, decreased ROM, and nerve damage. 1.5 inch needle used - staff were out of 1 inch.  She has been seen by 3 MD's.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain, Blood test abnormal, Lymphadenitis, Pain in extremity, Peripheral swelling
Clinical narrative: Sore, swollen, hot arm with a hard knot in it for 3 weeks and counting (still has not resolved). 3 days after vaccine, intense abdominal pain identified as lymphatic inflammation, not fully resolved until after 2 weeks. No fever, no nausea (excellent appetite), but blood work six days later showed three measures of inflammatory response.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Skin induration, Skin mass, Skin warm, Ultrasound scan normal
Clinical narrative: Sore, swollen, hot arm with a hard knot in it for 3 weeks and counting (still has not resolved). 3 days after vaccine, intense abdominal pain identified as lymphatic inflammation, not fully resolved until after 2 weeks. No fever, no nausea (excellent appetite), but blood work six days later showed three measures of inflammatory response.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a physician via an issue of magazine refers to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported.  It was reported that, the GARDASIL had absolutely no effect on cervical cancer (Vaccination failure) and it had very many adverse effects which destroys lives and also even kills (adverse event) (life threatening and death). It was also reported that cases of Guillian-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis could be found whatever the vaccine. The outcome of many adverse effects which destroys lives and also even kills was reported as fatal. The outcome of the other events were unknown. Upon internal review, Guillian-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis were considered to be medically significant. Additional information has been requested. This case was previously considered valid, but per current process it was determined to be non-valid as no patient identifier. Therefore, it is being sent to distribution for the last time to notify all recipients. This is an amended report. The case will be sent to distribution (previously sent to non-valid).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication, medical history and drug reactions/allergies was not provided. On an unknown date the patient was concomitantly vaccinated with VARIVAX (strength, dose, route, lot # and expiration date were not reported) and PROQUAD (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (overdose). No adverse symptoms were reported. No product quality complaints (PQC) was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 15-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N032284, expiration date: 22-SEP-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007947: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007952: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007948.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-NOV-2018 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 (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 01-NOV-2017, a healthcare provider at a pharmacy administered the ZOSTAVAX vaccine to the patient. On 07-NOV-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 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: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 18-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA001303: US-009507513-1811USA007947.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 18-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA001303: US-009507513-1811USA007945: US-009507513-1811USA007947.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient (age not reported) who experienced large red and swollen area day after injection, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious large red and swollen area after injection (inflammation) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of lab data not provided. Final diagnosis was large red and swollen area after injection. It was not reported whether patient received any corrective treatment. The event outcome was not reported. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Psoriasis, Urticaria
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 61-years old female patient who experienced psoriasis and hives, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI998AC via unknown route in unknown administration site. On 14-Oct-2018, the patient developed a non-serious psoriasis and hives 11 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was hives and psoriasis. It was not reported if the patient received a corrective treatment. The patient was not recovered from the events (symptoms are continuing as of today (15 Nov 2018)). List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Moderate to severe pain of (L) arm with shooting pain down to (L) hand/wrist. Pain was constant and no relieved by Ibuprofen. Upon office visit with limited ROM due to pain. Recommended heat, movement, and ice. Symptoms improved 48 hrs after office visit. After speaking to mom pain started immediately after vaccine was given. Pain got significantly worse on 11/14 in the evening when a friend bumped into her arm. This is when the shooting pain started. Pain improved on 11/18 after office visit and heat was applied to injection site.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Moderate to severe pain of (L) arm with shooting pain down to (L) hand/wrist. Pain was constant and no relieved by Ibuprofen. Upon office visit with limited ROM due to pain. Recommended heat, movement, and ice. Symptoms improved 48 hrs after office visit. After speaking to mom pain started immediately after vaccine was given. Pain got significantly worse on 11/14 in the evening when a friend bumped into her arm. This is when the shooting pain started. Pain improved on 11/18 after office visit and heat was applied to injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Myalgia, Pyrexia
Clinical narrative: Over a week: 4 inch diameter reddened swelling; 2 or 3 days: shivering, muscle pain, low-grade fever, headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Over a week: 4 inch diameter reddened swelling; 2 or 3 days: shivering, muscle pain, low-grade fever, headache.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Injection site reaction, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Patient complained of soreness and stiffness at injection site to upper arm. She claims she had decreased range of motion to her left arm by 5pm that day. She followed up with her pcp and then Dr  who did an xray and claims she has bursitis and is in phtsical therapy 3 days a week.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: Patient complained of soreness and stiffness at injection site to upper arm. She claims she had decreased range of motion to her left arm by 5pm that day. She followed up with her pcp and then Dr  who did an xray and claims she has bursitis and is in phtsical therapy 3 days a week.
Age: 42.0
Sex: M
Vaccine: FLUN4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient states he received FLUMIST on 10/25/18 during his workday. On 11/5/18 he noticed numbness and tingling in his left index finger. Intensity increased on 11/8/18 and 11/9/18. Two years prior on 10/25/16, he had the same reaction when he received FLUBLOK.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reports red, hot, swollen area starting the day after PNEUMOVAX 23 was administered. It grew to the size of her upper arm. No pain associated with reaction. Resolved in 4 days.
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Pain in extremity, Radicular pain
Clinical narrative: Received flu shot from unknown location, arm pain immediately with persistent pain at 3 weeks out from vaccine, some radicular pain.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Patient described fatigue, ocassional fever, chills, headache and body aches for 4-5 days after immunization. No localized reaction.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression, Feeling abnormal, Injection site erythema, Nausea, Rash
Clinical narrative: PATIENT CAME INTO PHARMACY ON 11-20-2018 AT 11:30 AM AND INDICATED THAT SHE HAD A REACTION TO THE SHINGRIX VACCINE AS FOLLOWS: RASH ON STOMACH, SEVERE REDNESS AT SITE OF INJECTION; NAUSEA, DEPRESSION; AND JUST FELT TERRIBLE FOR A WEEK.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Blister, Chills, Fatigue, Malaise
Clinical narrative: 11/17/18, started around 2 a.m. and lasted till 2 p.m. on 11/17/18. Chills, fever of 103 orally, malaise, fatigue, reoccurring dreams each time I fell asleep of file cards with dead baby names, and names of immunizations. Blisters on outer lower lip started on 11/19/18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 11/17/18, started around 2 a.m. and lasted till 2 p.m. on 11/17/18. Chills, fever of 103 orally, malaise, fatigue, reoccurring dreams each time I fell asleep of file cards with dead baby names, and names of immunizations. Blisters on outer lower lip started on 11/19/18.
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 to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, 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 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 (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 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. On or about 19-DEC-2012, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 13-OCT-2016, 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 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 (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 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 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 pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-OCT-2016, the patient was treated by a physician's assistant 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 (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 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 01-OCT-2011, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2012, 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 zoster vaccine live (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 (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 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 2014, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 23-DEC-2015, 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 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 (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: 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 pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-JAN-2015, 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, 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 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 the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 17-JUL-2009, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a 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 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 (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: 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 01-MAY-2012, a healthcare provider at a medical group administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On 22-DEC-2014, the patient was treated by a healthcare provider at the same medical group 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: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N032284, expiration date: 22-SEP-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA001303: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA001303: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 17-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA001303: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 16-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # R002344), expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA001303; US-009507513-1811USA007948; US-009507513-1811USA007949; US-009507513-1811USA007950; US-009507513-1811USA007951; US-009507513-1811USA007946; US-009507513-1811USA007945; US-009507513-1811USA007947.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a infant male patient who received ROTARIX for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, PENTACEL for prophylaxis and PREVNAR for prophylaxis.  On an unknown date, the patient received ROTARIX (oral), Hepatitis B vaccine at an unknown dose, PENTACEL at an unknown dose and PREVNAR at an unknown dose. On an unknown date, less than a year after receiving ROTARIX and not applicable after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and diarrhea rotavirus (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the diarrhea rotavirus was recovered/resolved. It was unknown if the reporter considered the vaccination failure and diarrhea rotavirus to be related to ROTARIX. It was unknown if the reporter considered the diarrhea rotavirus to be related to Hepatitis B vaccine. Additional details were reported as follows: The Registered Nurse (RN) reported that patient received ROTARIX along with the other infant vaccines (PENTACEL, PREVNAR, and Hepatitis B vaccine) and since then had diarrhea for the past 22 days. They had 2 positive cultures for rotavirus in their stool culture. The patient came to office for a 4th opinion. They received the vaccines at a different location so healthcare professional (HCP) had limited information. It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus and diarrhea to be related to PENTACEL and PREVNAR as well. Consent to follow up was given. This case was considered as suspected vaccination failure as time to onset for the event, and details regarding vaccination schedule was unknown.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Dizziness, Hypotension, Insomnia
Clinical narrative: Starting about 11pm the day of receiving the 2nd SHINGRIX vaccine, began to experience excessive urination that continued for 8 hours overnight. Could not sleep, partly due to the expected muscle aches & chills, but also the need to get up & urinate. On Oct 3, was excessively dehydrated with dizziness & low blood pressure - 86/50 -- and normal is at least 125/75. Realizing the problem - drank large amounts of fluid to rehydrate -- and found did not have a return to normal urinary patterns until about 6pm Oct 3 -- meaning did not urinate much during that day, but have been normal for about 12 hrs at this time. Muscle aches & fever has subsided. My main reason for reporting this side effect is that I have found no mention of excessive urination on any of the websites I consult for side effects from medications.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nocturia, Pyrexia
Clinical narrative: Starting about 11pm the day of receiving the 2nd SHINGRIX vaccine, began to experience excessive urination that continued for 8 hours overnight. Could not sleep, partly due to the expected muscle aches & chills, but also the need to get up & urinate. On Oct 3, was excessively dehydrated with dizziness & low blood pressure - 86/50 -- and normal is at least 125/75. Realizing the problem - drank large amounts of fluid to rehydrate -- and found did not have a return to normal urinary patterns until about 6pm Oct 3 -- meaning did not urinate much during that day, but have been normal for about 12 hrs at this time. Muscle aches & fever has subsided. My main reason for reporting this side effect is that I have found no mention of excessive urination on any of the websites I consult for side effects from medications.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Chest pain, Discomfort, Musculoskeletal pain, Neck pain
Clinical narrative: Member called to report one sided shoulder/neck/chest soreness 1 day after Anthrax vaccination. Patient denied any redness, swelling, signs of allergic reaction, fever, or any other symptoms aside from discomfort. Provided patient education on normal Anthrax vaccination side effects and advised member to report to ER if chest discomfort is present. Advised member that a VAERS will be submitted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, fatigue, aching.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient was given an adult dose of Hepatitis A.
Age: 69.0
Sex: M
Vaccine: FLUC4
Symptoms: Cardiac failure congestive, Condition aggravated, Heart rate decreased, Pulse abnormal
Clinical narrative: Patient had symptoms of Congestive Heart Failure about an hour after injections. Decreased heart rate and light pulse.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, three months after initial dose, the patient was vaccinated too early with a second dose of VAQTA intramuscularly (dose not reported, lot# R009799, expiration date 02-JUN-2019) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report as received from a consumer referring to herself a 79-year-old female patient. On 11-DEC-2014 the patient was vaccinated with pneumococcal vaccine. Then on 26-OCT-2017, PNEUMOVAX 23 injection (anatomical injection site, lot # and expiration date were not reported) unknown for prophylaxis. Then on 26-OCT-2017, the patient was vaccinated with PREVNAR 13 (anatomical injection site, lot # and expiration date were not reported) (Interchange of vaccine products). The outcome and causality assessment of the interchange of vaccine products were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information 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 2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2014, 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 unknown. The causality of the events is related. Additional information has been requested.