chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pruritus, Pyrexia, Skin warm, Swelling face
Clinical narrative: She said on Saturday, 2/3/18, that her arm became hot and feverish with a hard lump at the injection site. Then her arm began to itch. However, when she woke up on Sunday morning, her face was also red and swollen with a burning sensation. In addition, she was having lots of chills. She went on to say that most of the above has subsided after taking benadryl. In addition she said today, Monday, 2/5/18, she was only experiencing some soreness and tenderness on the back side of her arm. The patient stated she was taking benadryl to help combat the reaction, and she was feeling much better since the swelling had subsided.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: She said on Saturday, 2/3/18, that her arm became hot and feverish with a hard lump at the injection site. Then her arm began to itch. However, when she woke up on Sunday morning, her face was also red and swollen with a burning sensation. In addition, she was having lots of chills. She went on to say that most of the above has subsided after taking benadryl. In addition she said today, Monday, 2/5/18, she was only experiencing some soreness and tenderness on the back side of her arm. The patient stated she was taking benadryl to help combat the reaction, and she was feeling much better since the swelling had subsided.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient reported loss of mobility, soreness and pain radiating from injection site distally to fingers.  These effects were estimated by patient to have begun about 4 hours after receiving shot. Patient observed to be unable to lift arm above shoulder level. She reported that this effect was worse prior to today's reporting. Patient demonstrated ability to lift left arm (no injections in left arm) above head.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the pharmacy on 2/5/18 to state that she had a reaction to her ZOSTAVAX injection which was administered on 2/2/18. She developed a hot, red, raised, itchy area surrounding the injection site. The size is approximately 10cm by 8 cm. Patient will contact her physician 2/6/18.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Employee states flu shot was more painful than previous years. Site was bruised, arm was stiff and sore, had difficulty moving arm for 2 wks. At this time pain improved but still she (4 wks after vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Pt. rec'd. 5 yr. routine vaccines in office on 01-31-18. Seen again 02/02/18 for S/S = (LT) arm with redness/warmth; no induration; afebrile. Area 9 x 15 cm. Dx as local reaction to KINRIX. Tx - BENADRYL if achy. Monitor and C/B for fever/worsening.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shivering in a adult male patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shivering, injection site bruising, injection site erythema, injection site swelling and night sweat. On an unknown date, the outcome of the shivering, injection site bruising, injection site erythema, injection site swelling and night sweat were recovered/resolved. The reporter considered the shivering and night sweat to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site bruising, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: This report was reported by a medical doctor who himself was the patient. The age at vaccination was not reported. The healthcare professional (HCP) reported that, post SHINGRIX vaccination, on the same day, he experienced a strong local reaction which consisted of injection site redness, swelling and bruise. The HCP inquired if this reaction to the 1st dose is predictive to a strong local reaction for dose number 2 of SHINGRIX. The HCP reported for his own reaction to SHINGRIX and asked about himself and for future patients as well. The HCP declined to provide any further adverse event details.
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shivering in a adult male patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shivering, injection site bruising, injection site erythema, injection site swelling and night sweat. On an unknown date, the outcome of the shivering, injection site bruising, injection site erythema, injection site swelling and night sweat were recovered/resolved. The reporter considered the shivering and night sweat to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site bruising, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: This report was reported by a medical doctor who himself was the patient. The age at vaccination was not reported. The healthcare professional (HCP) reported that, post SHINGRIX vaccination, on the same day, he experienced a strong local reaction which consisted of injection site redness, swelling and bruise. The HCP inquired if this reaction to the 1st dose is predictive to a strong local reaction for dose number 2 of SHINGRIX. The HCP reported for his own reaction to SHINGRIX and asked about himself and for future patients as well. The HCP declined to provide any further adverse event details.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt developed pain and redness at injection site that traveled to his bicep.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injected limb mobility decreased, Injection site erythema, Injection site pain, Migraine
Clinical narrative: Fever 101, achy, pain, large redness and pain at site (4" x 3"), unable to move arm. No anaphylaxis but SOB with activity. Migraine.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 101, achy, pain, large redness and pain at site (4" x 3"), unable to move arm. No anaphylaxis but SOB with activity. Migraine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in unknown arm. About a day after receiving SHINGRIX, the patient experienced pain at the injection site. The 50 something female stated it felt like they had been pushed into a corner to describe the pain. The patient went on to state out of all vaccines she has received, this was the most painful. The pain resolved after about two days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Adverse effect of vaccines and biological substances, subs on 2018-02-01.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, subs on 2018-02-01.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contusion, Erythema, Immediate post-injection reaction, Injection site pain, Livedo reticularis
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site warmth in a 68-year-old male patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In January 2018, several days after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. The reporter considered the injection site warmth, injection site erythema and injection site swelling to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that in the last week the patient was given SHINGRIX subcutaneously on an unknown arm, which led to intramuscular formulation administered by other route. The pharmacist stated that she was just used to giving the other shingles vaccine subcutaneously and realized her mistake afterwards. The patient called back to the pharmacy over the weekend and noted he had warmth, redness and swelling at the site. This case was linked with US2018GSK018446 (wife's case) reported by the same reporter. Medical science liaison reported the pharmacist told him she was going to report it to GSK also. The sales representative might had also taken a report from the patient himself as this was very familiar to this representative. However, no duplicate cases were found.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Local reaction, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site warmth in a 68-year-old male patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In January 2018, several days after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. The reporter considered the injection site warmth, injection site erythema and injection site swelling to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that in the last week the patient was given SHINGRIX subcutaneously on an unknown arm, which led to intramuscular formulation administered by other route. The pharmacist stated that she was just used to giving the other shingles vaccine subcutaneously and realized her mistake afterwards. The patient called back to the pharmacy over the weekend and noted he had warmth, redness and swelling at the site. This case was linked with US2018GSK018446 (wife's case) reported by the same reporter. Medical science liaison reported the pharmacist told him she was going to report it to GSK also. The sales representative might had also taken a report from the patient himself as this was very familiar to this representative. However, no duplicate cases were found.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site warmth in a 68-year-old male patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In January 2018, several days after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. The reporter considered the injection site warmth, injection site erythema and injection site swelling to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that in the last week the patient was given SHINGRIX subcutaneously on an unknown arm, which led to intramuscular formulation administered by other route. The pharmacist stated that she was just used to giving the other shingles vaccine subcutaneously and realized her mistake afterwards. The patient called back to the pharmacy over the weekend and noted he had warmth, redness and swelling at the site. This case was linked with US2018GSK018446 (wife's case) reported by the same reporter. Medical science liaison reported the pharmacist told him she was going to report it to GSK also. The sales representative might had also taken a report from the patient himself as this was very familiar to this representative. However, no duplicate cases were found.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site warmth in a 68-year-old male patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In January 2018, several days after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. The reporter considered the injection site warmth, injection site erythema and injection site swelling to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that in the last week the patient was given SHINGRIX subcutaneously on an unknown arm, which led to intramuscular formulation administered by other route. The pharmacist stated that she was just used to giving the other shingles vaccine subcutaneously and realized her mistake afterwards. The patient called back to the pharmacy over the weekend and noted he had warmth, redness and swelling at the site. This case was linked with US2018GSK018446 (wife's case) reported by the same reporter. Medical science liaison reported the pharmacist told him she was going to report it to GSK also. The sales representative might had also taken a report from the patient himself as this was very familiar to this representative. However, no duplicate cases were found.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Back pain, Contusion, Erythema, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Eldon had vaccine on 1/31/18 reports swelling and arm pain within 5 hours of getting vaccine.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Skin warm, Vascular injury
Clinical narrative: Eldon had vaccine on 1/31/18 reports swelling and arm pain within 5 hours of getting vaccine.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Eldon had vaccine on 1/31/18 reports swelling and arm pain within 5 hours of getting vaccine.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Cold sweat, Gait inability, Hunger, Nuclear magnetic resonance imaging
Clinical narrative: WEAKNESS, CLAMMY HEAD SWEAT, HUNGER, COULDN'T BEND MY LEGS, STARTED IN ONE LEG THEN WENT TO THE OTHER, COULDN'T WALK, TOOK A LOT OF PAIN PILLS AND GABEPENTIN.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antinuclear antibody increased, C-reactive protein increased, Cough, Decreased appetite, Dehydration
Clinical narrative: Fever of 104 by the morning of November 2nd (1 day after the shot). Rash over whole body classified as a symptom of mono. Diagnosis of Mono by hospital despite having a negative mono test from doctor's office. Dehydration. No appetite. Sore throat. Suppressed immune system. Multiple sinus infections and respiratory infections. Constant cough. High CRP and ANA lab tests. Constant rash around eyes that spreads if not controlled with high strength steroid creams. Rash on the body in patches of very dry skin. I haven't gotten well since the shot and it is now February 6th.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Dry skin, Immunosuppression, Infectious mononucleosis, Mononucleosis heterophile test negative, Oropharyngeal pain
Clinical narrative: Fever of 104 by the morning of November 2nd (1 day after the shot). Rash over whole body classified as a symptom of mono. Diagnosis of Mono by hospital despite having a negative mono test from doctor's office. Dehydration. No appetite. Sore throat. Suppressed immune system. Multiple sinus infections and respiratory infections. Constant cough. High CRP and ANA lab tests. Constant rash around eyes that spreads if not controlled with high strength steroid creams. Rash on the body in patches of very dry skin. I haven't gotten well since the shot and it is now February 6th.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash generalised, Respiratory tract infection, Sinusitis
Clinical narrative: Fever of 104 by the morning of November 2nd (1 day after the shot). Rash over whole body classified as a symptom of mono. Diagnosis of Mono by hospital despite having a negative mono test from doctor's office. Dehydration. No appetite. Sore throat. Suppressed immune system. Multiple sinus infections and respiratory infections. Constant cough. High CRP and ANA lab tests. Constant rash around eyes that spreads if not controlled with high strength steroid creams. Rash on the body in patches of very dry skin. I haven't gotten well since the shot and it is now February 6th.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Influenza virus test negative, Injection site scar, Lymph node pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: 1 Feb 2018 patient states he developed a sore throat with left axillary lymph node tenderness and swelling, states that on 2 Feb he noticed that the left cervical lymph nodes started to become tender and swollen. States that on 3 Feb he felt feverish and had body aches. 4 Feb indicates that he developed a spot type rash across his trunk/back/flanks. Patient was evaluated on 5 Feb due to clinic not open due to work hours. Upon evaluation patient had papulovesicular lesions (40-50 lesions) that all looked to be in the same stage. Injection site looked on par for 2 weeks post smallpox vaccine via scar. Upon noticing this contact state health department who then contacted CDC. Patient has non-viral pustulosis and is being treated with antihistamines and conservatively. No contact precautions other than those previously given to patient for the smallpox vaccine. Patient will follow up if worsening.  Informed to follow up in 2 weeks to see how he is doing. CDC with no concerns unless this becomes worse.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Pyrexia, Rash, Rash papular, Streptococcus test negative
Clinical narrative: 1 Feb 2018 patient states he developed a sore throat with left axillary lymph node tenderness and swelling, states that on 2 Feb he noticed that the left cervical lymph nodes started to become tender and swollen. States that on 3 Feb he felt feverish and had body aches. 4 Feb indicates that he developed a spot type rash across his trunk/back/flanks. Patient was evaluated on 5 Feb due to clinic not open due to work hours. Upon evaluation patient had papulovesicular lesions (40-50 lesions) that all looked to be in the same stage. Injection site looked on par for 2 weeks post smallpox vaccine via scar. Upon noticing this contact state health department who then contacted CDC. Patient has non-viral pustulosis and is being treated with antihistamines and conservatively. No contact precautions other than those previously given to patient for the smallpox vaccine. Patient will follow up if worsening.  Informed to follow up in 2 weeks to see how he is doing. CDC with no concerns unless this becomes worse.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in January 2018, the patient was vaccinated with expired dose of PROQUAD recombinant human albumin (rHA) 0.5 ml (lot # M032496, Expiry date : 02-JAN-2018) for prophylaxis (expired product administered). Concomitant therapies included sterile diluent(Manufacturer Unknown). The reporting nurse denied any adverse effects reported by patient.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-JAN-2018, the patient was vaccinated with M-M-R II injection via intramuscular route of administration in error (dose, frequency, lot# and expiration date were not reported). There were no known adverse effects. The relatedness between the event and M-M-R II was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 26-JAN-2018, the patient was vaccinated with an expired dose of M-M-R II lot # L032044 expiration date of 24-AUG-2017 (dose, route, anatomical place of vaccination and concentration were not provided), for prophylaxis. No adverse effects were reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness transient, Blindness unilateral, Intraocular pressure test
Clinical narrative: This spontaneous report was received from a 71 year old male patient, reporting on himself. The patient did not have any medical history to report. His concurrent conditions included a drug reaction or allergy to iodine; and his concomitant medications included LIPITOR, atorvastatin, "blood pressure pills", amlodipine, Metoprolol, allopurinol and escitalopram. On 24-NOV-2009, the patient was vaccinated with ZOSTAVAX one injection, for shingles (strength, dose, route of administration, lot number and expiration date were not reported). The patient informed that on 26-JAN-2018, he was temporary blind in one eye for 50 seconds after being vaccinated. The patient visited his eye doctor and a blood flow test was performed (results not provided). No treatment was given for the adverse event. On the same day, the patient recovered from the event. The causal relationship between the vaccination with ZOSTAVAX and the event was not provided by the reporter. Upon internal review, temporary blind in one eye was determined to be a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age. The patient had no concomitant medications, medical history and no drug reactions/allergies. No information about the patient's concurrent conditions was provided. On 30-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, for vaccination, (dose, frequency, route, strength, lot number and expiration date were not provided). On 30-JAN-2018 (reported as last night), the patient developed "redness and warmth at the injection site last night, which has now moved to a different part of the same arm today". Furthermore, it was reported that the patient sought medical attention by calling the pharmacist but it was reported that no treatment was prescribed and no laboratories were performed. At the time of reporting, the outcome of injection site erythema and injection site warmth was reported as not recovered. The causal relationship between PNEUMOVAX 23 and the reported events was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was inoculated with ZOSTAVAX vaccine on or about 26-MAY-2010 as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUN-2015, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir and LIDODERM for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Pruritus
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. On 12-NOV-2013 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-AUG-2016, the patient was treated by a Physician Assistant for the onset of a severe vesicular rash, pain and itching accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 22-AUG-2016 the patient sought subsequent treatment from a physician for ongoing and worsening pain and progressive symptoms unresponsive to treatment attempts, at which time she was diagnosed with herpes zoster in the right thoracic dermatome and post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections.  The patient has been prescribed tramadol, VICODIN, and hydrocodone for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
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. On 12-NOV-2013 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-AUG-2016, the patient was treated by a Physician Assistant for the onset of a severe vesicular rash, pain and itching accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 22-AUG-2016 the patient sought subsequent treatment from a physician for ongoing and worsening pain and progressive symptoms unresponsive to treatment attempts, at which time she was diagnosed with herpes zoster in the right thoracic dermatome and post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections.  The patient has been prescribed tramadol, VICODIN, and hydrocodone for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 18-JUL-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-NOV-2016, the patient was treated by a physician at a hospital emergency department, for a painful and blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed famciclovir, VALTREX, prednisone and MEDROL Dose pack for management of his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Vasculitis
Clinical narrative: Information has been received on 02-FEB-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 12-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed shingles on his face, scalp, foot and inside of his ear. Thereafter, he was diagnosed with vasculitis in his legs. On 20-JUN-2016, the patient presented to his primary care physician and was diagnose with Ramsey Hunt Syndrome and continues to suffer from complications of this condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, Ramsey Hunt syndrome was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-APR-2015 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 08-FEB-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, 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. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak, mental and emotional distress, physical limitations and vaccination failure were reported to be disabling. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Inconsolable crying which is still occurring as of the date of this report.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Very sore muscles at injection site 1 hr. later, 10 hrs. later woke up with fever, chills, shaking, headache. Lasted for about 3 hrs. I took 2, 200mg, ibuprofen for headache and chills then went to sleep. In the morning I was ok but my arm was still very sore.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Very sore muscles at injection site 1 hr. later, 10 hrs. later woke up with fever, chills, shaking, headache. Lasted for about 3 hrs. I took 2, 200mg, ibuprofen for headache and chills then went to sleep. In the morning I was ok but my arm was still very sore.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anion gap, Blood chloride normal, Blood creatinine normal, Blood electrolytes normal, Blood glucose increased
Clinical narrative: Approximately 3.5 hours after receiving the vaccines, my baby became unresponsive, lost all color in her face, and was barely breathing. We rushed her to the hospital across the street where they gave her oxygen and critical care. Her color returned and she was breathing normally after 10 minutes or so, but she seemed dazed for hours. She was  transferred to Hospital that evening. They monitored her overnight with no episodes. She was released the following day. I am happy to include hospital notes. From the emergency room: Procedure The patient received 5 minutes of critical care excluding separately billable procedures and family discussion judging an infant with an altered mental status episode. The child also had decreased tone and cyanosis all of which has resolved. The child is interactive and is breast-fed and clinically has nothing to suggest meningitis and therefore a lumbar puncture has not been performed. We have discussed this with the pediatrician at Hospital and they have accepted this child in transfer. Mom is aware of the need for transfer for further observation. The patient has a slightly elevated white count normal hemoglobin and slightly elevated platelets. Differential is pending. Electrolytes are normal. Random glucose is 111 with the electrolytes. BUN is 7 and creatinine is 0.31. Medical Decision Making Child improved in the ED after having a 10 minutes episode of AMS with decreased responsiveness with cyanosis and pale appearance. Her blood sugar was normal at 114. We have instituted a septic work up that includes, labs, urine, and an x-ray. Portable chest x-ray reveals no infiltrate or other significant abnormalities per EDP Reexamination/Reevaluation Heart is markedly improved. She will however need observation and monitoring. This was more than a very brief episode. Urinalysis is also pending. X-ray per EDP and per radiology reveals no infiltrate.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Chest X-ray normal
Clinical narrative: Approximately 3.5 hours after receiving the vaccines, my baby became unresponsive, lost all color in her face, and was barely breathing. We rushed her to the hospital across the street where they gave her oxygen and critical care. Her color returned and she was breathing normally after 10 minutes or so, but she seemed dazed for hours. She was  transferred to Hospital that evening. They monitored her overnight with no episodes. She was released the following day. I am happy to include hospital notes. From the emergency room: Procedure The patient received 5 minutes of critical care excluding separately billable procedures and family discussion judging an infant with an altered mental status episode. The child also had decreased tone and cyanosis all of which has resolved. The child is interactive and is breast-fed and clinically has nothing to suggest meningitis and therefore a lumbar puncture has not been performed. We have discussed this with the pediatrician at Hospital and they have accepted this child in transfer. Mom is aware of the need for transfer for further observation. The patient has a slightly elevated white count normal hemoglobin and slightly elevated platelets. Differential is pending. Electrolytes are normal. Random glucose is 111 with the electrolytes. BUN is 7 and creatinine is 0.31. Medical Decision Making Child improved in the ED after having a 10 minutes episode of AMS with decreased responsiveness with cyanosis and pale appearance. Her blood sugar was normal at 114. We have instituted a septic work up that includes, labs, urine, and an x-ray. Portable chest x-ray reveals no infiltrate or other significant abnormalities per EDP Reexamination/Reevaluation Heart is markedly improved. She will however need observation and monitoring. This was more than a very brief episode. Urinalysis is also pending. X-ray per EDP and per radiology reveals no infiltrate.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Differential white blood cell count, Feeling abnormal, Haematocrit decreased, Haemoglobin normal
Clinical narrative: Approximately 3.5 hours after receiving the vaccines, my baby became unresponsive, lost all color in her face, and was barely breathing. We rushed her to the hospital across the street where they gave her oxygen and critical care. Her color returned and she was breathing normally after 10 minutes or so, but she seemed dazed for hours. She was  transferred to Hospital that evening. They monitored her overnight with no episodes. She was released the following day. I am happy to include hospital notes. From the emergency room: Procedure The patient received 5 minutes of critical care excluding separately billable procedures and family discussion judging an infant with an altered mental status episode. The child also had decreased tone and cyanosis all of which has resolved. The child is interactive and is breast-fed and clinically has nothing to suggest meningitis and therefore a lumbar puncture has not been performed. We have discussed this with the pediatrician at Hospital and they have accepted this child in transfer. Mom is aware of the need for transfer for further observation. The patient has a slightly elevated white count normal hemoglobin and slightly elevated platelets. Differential is pending. Electrolytes are normal. Random glucose is 111 with the electrolytes. BUN is 7 and creatinine is 0.31. Medical Decision Making Child improved in the ED after having a 10 minutes episode of AMS with decreased responsiveness with cyanosis and pale appearance. Her blood sugar was normal at 114. We have instituted a septic work up that includes, labs, urine, and an x-ray. Portable chest x-ray reveals no infiltrate or other significant abnormalities per EDP Reexamination/Reevaluation Heart is markedly improved. She will however need observation and monitoring. This was more than a very brief episode. Urinalysis is also pending. X-ray per EDP and per radiology reveals no infiltrate.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonia, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Approximately 3.5 hours after receiving the vaccines, my baby became unresponsive, lost all color in her face, and was barely breathing. We rushed her to the hospital across the street where they gave her oxygen and critical care. Her color returned and she was breathing normally after 10 minutes or so, but she seemed dazed for hours. She was  transferred to Hospital that evening. They monitored her overnight with no episodes. She was released the following day. I am happy to include hospital notes. From the emergency room: Procedure The patient received 5 minutes of critical care excluding separately billable procedures and family discussion judging an infant with an altered mental status episode. The child also had decreased tone and cyanosis all of which has resolved. The child is interactive and is breast-fed and clinically has nothing to suggest meningitis and therefore a lumbar puncture has not been performed. We have discussed this with the pediatrician at Hospital and they have accepted this child in transfer. Mom is aware of the need for transfer for further observation. The patient has a slightly elevated white count normal hemoglobin and slightly elevated platelets. Differential is pending. Electrolytes are normal. Random glucose is 111 with the electrolytes. BUN is 7 and creatinine is 0.31. Medical Decision Making Child improved in the ED after having a 10 minutes episode of AMS with decreased responsiveness with cyanosis and pale appearance. Her blood sugar was normal at 114. We have instituted a septic work up that includes, labs, urine, and an x-ray. Portable chest x-ray reveals no infiltrate or other significant abnormalities per EDP Reexamination/Reevaluation Heart is markedly improved. She will however need observation and monitoring. This was more than a very brief episode. Urinalysis is also pending. X-ray per EDP and per radiology reveals no infiltrate.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mental status changes, Pallor, Platelet count increased, Red blood cell count normal, Red cell distribution width normal
Clinical narrative: Approximately 3.5 hours after receiving the vaccines, my baby became unresponsive, lost all color in her face, and was barely breathing. We rushed her to the hospital across the street where they gave her oxygen and critical care. Her color returned and she was breathing normally after 10 minutes or so, but she seemed dazed for hours. She was  transferred to Hospital that evening. They monitored her overnight with no episodes. She was released the following day. I am happy to include hospital notes. From the emergency room: Procedure The patient received 5 minutes of critical care excluding separately billable procedures and family discussion judging an infant with an altered mental status episode. The child also had decreased tone and cyanosis all of which has resolved. The child is interactive and is breast-fed and clinically has nothing to suggest meningitis and therefore a lumbar puncture has not been performed. We have discussed this with the pediatrician at Hospital and they have accepted this child in transfer. Mom is aware of the need for transfer for further observation. The patient has a slightly elevated white count normal hemoglobin and slightly elevated platelets. Differential is pending. Electrolytes are normal. Random glucose is 111 with the electrolytes. BUN is 7 and creatinine is 0.31. Medical Decision Making Child improved in the ED after having a 10 minutes episode of AMS with decreased responsiveness with cyanosis and pale appearance. Her blood sugar was normal at 114. We have instituted a septic work up that includes, labs, urine, and an x-ray. Portable chest x-ray reveals no infiltrate or other significant abnormalities per EDP Reexamination/Reevaluation Heart is markedly improved. She will however need observation and monitoring. This was more than a very brief episode. Urinalysis is also pending. X-ray per EDP and per radiology reveals no infiltrate.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiration abnormal, Unresponsive to stimuli, Urine analysis, White blood cell count increased
Clinical narrative: Approximately 3.5 hours after receiving the vaccines, my baby became unresponsive, lost all color in her face, and was barely breathing. We rushed her to the hospital across the street where they gave her oxygen and critical care. Her color returned and she was breathing normally after 10 minutes or so, but she seemed dazed for hours. She was  transferred to Hospital that evening. They monitored her overnight with no episodes. She was released the following day. I am happy to include hospital notes. From the emergency room: Procedure The patient received 5 minutes of critical care excluding separately billable procedures and family discussion judging an infant with an altered mental status episode. The child also had decreased tone and cyanosis all of which has resolved. The child is interactive and is breast-fed and clinically has nothing to suggest meningitis and therefore a lumbar puncture has not been performed. We have discussed this with the pediatrician at Hospital and they have accepted this child in transfer. Mom is aware of the need for transfer for further observation. The patient has a slightly elevated white count normal hemoglobin and slightly elevated platelets. Differential is pending. Electrolytes are normal. Random glucose is 111 with the electrolytes. BUN is 7 and creatinine is 0.31. Medical Decision Making Child improved in the ED after having a 10 minutes episode of AMS with decreased responsiveness with cyanosis and pale appearance. Her blood sugar was normal at 114. We have instituted a septic work up that includes, labs, urine, and an x-ray. Portable chest x-ray reveals no infiltrate or other significant abnormalities per EDP Reexamination/Reevaluation Heart is markedly improved. She will however need observation and monitoring. This was more than a very brief episode. Urinalysis is also pending. X-ray per EDP and per radiology reveals no infiltrate.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Somnolence
Clinical narrative: At a recent visit (2/1/18), I recommended the second HPV vaccine. At that time mom reported to me that for two months after HPV#1, given on 9/27/16, patient had extreme fatigue and sleepiness. She believes it started right after receiving the HPV vaccine. It self-resolved after about 2 months. Per mom, there were no other illnesses or stressors occurring at that time. They did not seek any medical evaluation during this period and the first time I became aware of this was about 18 months later, at the 2/1/18 visit.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Fatigue, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: I had very mild discomfort the first day or two, but since then my arm hurts so bad that it affects my mobility. It has been 15 days now since I got the shot and I have a very difficult (and painful) time getting a shirt on and off, and it's difficult for me to carry my grandson. I also seem to have extreme fatigue at times.