chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Approx 3 hours after receiving vaccine - face became red and facial whelts-- itchy. Denied use of any other meds or supplements --OTC or prescribed. Pt used allegra and the sx subsided by next am-- no office visit indicated -- telephone triage.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Headache, Heart rate increased, Hot flush
Clinical narrative: IT STARTED WITH EXTREME ARM PAIN THEN EXTREME NAUSEA DIZZINESS FAST HEART RATE HEADACHE VOMITING DIARRHEA STIFF AND SORE NECK HOT AND COLD FLASHES I LEFT WORK AND WENT STRAIGHT HOME TO BED I DID NOT START FEELING BETTER FOR 5 DAYS.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity, Vomiting
Clinical narrative: IT STARTED WITH EXTREME ARM PAIN THEN EXTREME NAUSEA DIZZINESS FAST HEART RATE HEADACHE VOMITING DIARRHEA STIFF AND SORE NECK HOT AND COLD FLASHES I LEFT WORK AND WENT STRAIGHT HOME TO BED I DID NOT START FEELING BETTER FOR 5 DAYS.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: A few hours post injection, she noticed a lump and swelling. On 10/25/17 she noticed a baseball size lump, redness and warm.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Patient came back on Sunday 10/07/2017 complaining of could not move her arm, or change her clothing.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a pharmacist and refers to a 40-year-old male patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 09-OCT-2017, the patient was vaccinated with the first dose of the immunization series of GARDASIL 9 intramuscular (lot number: N014470 with expiration date: 17-JUN-2017, dose was not provided) as prophylaxis, based on prescription received by the physician. No adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a female non-pregnant patient (physician) via a company representative, who was reporting on herself. The physician is a female on unknown age. Her concurrent condition included sinusitis. The patient's medical history and drug reactions or allergies were not reported. On unknown date, reported as "in the fall 1999", the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dosage, route of administration, lot# and expiration date were not reported). Concomitant therapies included cefuroxime axetil (CEFTIN). In approximately fall, reported as "within 24 hours of the administration", the patient developed swelling of her arm where the PNEUMOVAX 23 was administered and fever of 104 degrees (degree not specified). In approximately 1999, the patient sought for medical attention and was taken to the hospital, where the diagnosis was determined to be acellular cellulitis and allergic reaction to PNEUMOVAX 23. The therapy for sinusitis with with cefuroxime axetil (CEFTIN) was continued. Ibuprofen and TORADOL were given for the fever. In approximately 1999, reported as after 4 days, the patient was discharged from the hospital. The outcome of injection site swelling, allergic reaction to PNEUMOVAX 23 and acellular cellulitis was reported as recovered/resolved (exact date was not specified). The causality assessment between the injection site swelling, acellular cellulitis and therapy with PNEUMOVAX 23 was not reported. The causality assessment between the allergic reaction  and therapy with PNEUMOVAX 23 as related. Upon internal review, the event of acellular cellulitis was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age, who was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 27-JUN-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-NOV-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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: 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 of unknown age, who was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 10-DEC-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-APR-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX and Acyclovir for management of her symptoms and pain. 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.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Initial unsolicited report received from a nurse on 11-Oct-2017. This case is linked to case 2017SA201143 (same reporter and same vaccine). This case involves a 42-year-old male patient who was vaccinated with 0.1 ml single intradermal dose of FLUZONE QIV (Batch number: UT5903AA, expiration date, dose in series were not reported) in the right deltoid on 04-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, after the vaccination, the patient developed a very large area of redness, swelling and hardness with possible cellulitis with no confirmed culture. It was reported that the diagnosis was based on overt symptoms. Reporter stated she was referring the person to an urgent care center called City MD for antibiotics. Laboratory investigations and other corrective treatment were not reported. The outcome of all the events was reported as unknown. Upon internal review, the company decided to consider the case as serious due to important medical event: possible cellulitis with no confirmed culture. List of documents held by sender: none; Sender's Comments: The patient experienced very large area of redness, swelling and hardness with possible cellulitis with no confirmed culture post vaccination with FLUZONE QIV ID. Time to onset was not reported. No information regarding patients medical history or ongoing medical condition or tolerance to previous vaccinations was reported. There could be an underlying etiology or the evnts could be related to improper aseptic technique followed by the administrator that led to ingress of surface pathogens into deeper layers of skin. Based upon reported information the role of the vaccine can not be assessed.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Musculoskeletal pain, Tendonitis, X-ray
Clinical narrative: Shoulder pain especially with rotation.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Arthralgia, Body temperature increased, Chills, Dizziness
Clinical narrative: Started following morning with mild flu like symptoms which continued to worsen to the point that I could barely walk, chills, dizzy, tempature 100.1, entire body ached especially joints, injection arm turn deep red burning hot to touch lump spread the size of 5 inch diameter. Could not stand to walk more than a few feet for 24 hours. After 24 hours sweating, stomach pain, headache, joint pain for 24 more hours. Third day after vaccine injection started to symptoms began to subside continuing until fourth day felt almost normal, still dizzy at times. Arm is still red and hot but not as much.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dysstasia, Erythema, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: Started following morning with mild flu like symptoms which continued to worsen to the point that I could barely walk, chills, dizzy, tempature 100.1, entire body ached especially joints, injection arm turn deep red burning hot to touch lump spread the size of 5 inch diameter. Could not stand to walk more than a few feet for 24 hours. After 24 hours sweating, stomach pain, headache, joint pain for 24 more hours. Third day after vaccine injection started to symptoms began to subside continuing until fourth day felt almost normal, still dizzy at times. Arm is still red and hot but not as much.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Limb mass, Pain, Skin warm
Clinical narrative: Started following morning with mild flu like symptoms which continued to worsen to the point that I could barely walk, chills, dizzy, tempature 100.1, entire body ached especially joints, injection arm turn deep red burning hot to touch lump spread the size of 5 inch diameter. Could not stand to walk more than a few feet for 24 hours. After 24 hours sweating, stomach pain, headache, joint pain for 24 more hours. Third day after vaccine injection started to symptoms began to subside continuing until fourth day felt almost normal, still dizzy at times. Arm is still red and hot but not as much.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: EMPLOYEE STATES "AFTER FLU SHOT HAVING NUMBNESS IN LEFT SIDE OF MOUTH/TONGUE." SENT FOR EVALUATION.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm is red, swollen and warm to the touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling and redness at injection site, fever.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: 3 in x 3.5 inch rash at site with a second, connected 3 in x 3.5 inch rash below it, both red and warm.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Malaise, Migraine, Nausea, Pain
Clinical narrative: Migraine, nausea, sore/achiness, general malaise.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient received FLUZONE HD on right arm and PNEUMOVAX 23 on left arm. The next day she woke up with pain on left arm. It was warm to touch and swollen and hard at injection site. There were red freckles (rash) around the injection site at down to her elbow. She put heating pad on it and took ALEVE. The next day it was one big rash on arm. Talked to her today (third day) and the rash is fading, but when press on injection site it is tender. It is getting better. She currently does not have a primary care physician. No problem with right arm where FLUZONE HD was administered.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Patient received FLUZONE HD on right arm and PNEUMOVAX 23 on left arm. The next day she woke up with pain on left arm. It was warm to touch and swollen and hard at injection site. There were red freckles (rash) around the injection site at down to her elbow. She put heating pad on it and took ALEVE. The next day it was one big rash on arm. Talked to her today (third day) and the rash is fading, but when press on injection site it is tender. It is getting better. She currently does not have a primary care physician. No problem with right arm where FLUZONE HD was administered.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Aphasia, Respiratory distress
Clinical narrative: Patient experienced respiratory distress and unable to speak at about 12 PM on 10/14/17. Ambulance called. Patient treated at Hospital. Kept overnight.
Age: 67.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Severe muscle weakness diagnosed as Guillain Barre Syndrome.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV1
Symptoms: Cough, Decreased appetite, Nasal congestion, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, coughing, stuffy nose, loss of appetite.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Pt was given "high dose" influenza vaccine instead of regular dose.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: DIARRHEA-12 HOURS, MALAISE-12 HOURS, FATIGUE-12 HOURS, HEADACHE-2 HOURS.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure decreased, Confusional state, Heart rate decreased, Lethargy, Posture abnormal
Clinical narrative: Pt became very lethargic, confused, unable to hold herself up, BP dropped to 100/50 and HR to 48, spit up several times. First checked blood pressure and then decided to call EMT. EMT arrived and she became more awake and alert. Pt and son decided to go to urgent care to be seen.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Pt became very lethargic, confused, unable to hold herself up, BP dropped to 100/50 and HR to 48, spit up several times. First checked blood pressure and then decided to call EMT. EMT arrived and she became more awake and alert. Pt and son decided to go to urgent care to be seen.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Musculoskeletal stiffness, Peripheral swelling, Pruritus
Clinical narrative: Arm swelling, bruising, stiffness, itching.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Bump at injection site and red streaks down the arm. Physician prescribed cephalexin 500 mg tid for 10 days.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 76-year-old male patient. The patient's concurrent conditions included high blood pressure, high cholesterol and diabetes. Concomitant therapies included PLAVIX, atenolol, isosorbide mononitrate, gabapentin, TOUJEO, tramadol hydrochloride, HUMULIN R, nitroglycerin, cyclobenzaprine hydrochloride, lovastatin (manufacturer unknown), glimepiride and furosemide (manufacturer unknown). On 23-JUL-2009, the patient was vaccinated with a dose of ZOSTAVAX (reported lot # 1413X, expiration date: April 2010) (dose regiment and route of administration were not reported) dissolved in sterile diluent (MERCK). On 23-SEP-2017, the patient experienced painful rash that started at his naval and went around his back. The outcome of the event was not reported. The relatedness between vaccination with ZOSTAVAX and the event was not reported.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician and refers to a 23 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 01-SEP-2017, the patient was vaccinated with a second dose of GARDASIL 9 intramuscularly for prophylaxis (lot number and expiration date were not reported). On an unknown date in September 2017 (reported as after the injection), the patient experienced syncope. The physician did not provide information about specific treatment. On 13-SEP-2017, the patient visited physician's office. She was doing well and deemed as recovered. The relatedness between the event and GARDASIL 9 was assessed as related (physician stated that no other condition was found as possible reason for the syncope experience).
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Influenza like illness, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This spontaneous report has received from a pharmacist referring to a 73 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 06-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N013541, expiration date 23-JAN-2019 (strength was not provided) in the left arm for prophylaxis. The reporter stated that on 07-OCT-2017, the patient reported that she could barely move her left arm, felt sick like she was having the flu and was very tired. Furthermore, it was reported that the patient was instructed to take ibuprofen (unspecified details) as treatment for the events, however it was unknown if the patient actually took the medication. On 08-OCT-2017, the patient stated that she felt fine. Additionally, the patient woke up on 09-OCT-2017 and felt like she was going to pass out but she felt better, and on the same date, the reporter stated that he observed "slight redness around injection site. No laboratory diagnostics or studies were performed. The outcome of vaccination site movement impairment, dizziness, fatigue, influenza and malaise was reported as recovered. The outcome of injection site erythema was unknown. At the time of this report, the causality between the aforementioned events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report has received from a pharmacist referring to a 73 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 06-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N013541, expiration date 23-JAN-2019 (strength was not provided) in the left arm for prophylaxis. The reporter stated that on 07-OCT-2017, the patient reported that she could barely move her left arm, felt sick like she was having the flu and was very tired. Furthermore, it was reported that the patient was instructed to take ibuprofen (unspecified details) as treatment for the events, however it was unknown if the patient actually took the medication. On 08-OCT-2017, the patient stated that she felt fine. Additionally, the patient woke up on 09-OCT-2017 and felt like she was going to pass out but she felt better, and on the same date, the reporter stated that he observed "slight redness around injection site. No laboratory diagnostics or studies were performed. The outcome of vaccination site movement impairment, dizziness, fatigue, influenza and malaise was reported as recovered. The outcome of injection site erythema was unknown. At the time of this report, the causality between the aforementioned events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 12-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M042851 and expiration date 18-JAN-2018 (strength, dose number and route were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown), no adverse events were reported. The ZOSTAVAX was improperly stored with a temperature of 6 °F (Fahrenheit) to 14°F for 5 hours 15 minutes. The report was due to data logger. It was reported that there was a previous temperature excursion of 15° F to 46° F for 3 hours and 20 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA013116: US-009507513-1710USA013117.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 15-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 16-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot#, and expiration date were not provided). On 31-AUG-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot#, and expiration date were not provided). No adverse symptoms were reported.
Age: 38.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a 38 year old male patient refers to himself. The patient had unspecified seasonal allergies. He had no pertinent medical history nor concomitant medications. On 12-JUL-2017, the patient was vaccinated with the first dose of VARIVAX (single injection in the left arm; route of administration, lot#, and expiration date were not provided) as required vaccine. On 23-JUL-2017, the patient experienced 7 lesions on his right leg. The lesions go from the ankle to mid thigh. The patient sought medical attention and called his physician's nurses hotline at the office. No treatment was given for the adverse event and no laboratory studies were performed. At the time of the report, the patient did not recover from the adverse event. The relatedness between the adverse event and VARIVAX was not provided.
Age: 38.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Rash, Skin lesion, Swelling
Clinical narrative: This spontaneous report as received from a 38 year old male patient refers to himself. The patient had unspecified seasonal allergies. He had no pertinent medical history nor concomitant medications. On 12-JUL-2017, the patient was vaccinated with the first dose of VARIVAX (single injection in the left arm; route of administration, lot#, and expiration date were not provided) as required vaccine. On 23-JUL-2017, the patient experienced 7 lesions on his right leg. The lesions go from the ankle to mid thigh. The patient sought medical attention and called his physician's nurses hotline at the office. No treatment was given for the adverse event and no laboratory studies were performed. At the time of the report, the patient did not recover from the adverse event. The relatedness between the adverse event and VARIVAX was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Pain, Post herpetic neuralgia
Clinical narrative: Information was received on 23-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 20-JUN-2016 at a pharmacy, 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. About a week after being vaccinated, the patient began to experience painful symptoms. On or about 28-JUN-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as herpes zoster or shingles. On or about 08-OCT-2016, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles and nerve pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to zoster infections. The patient has been prescribed gabapentin (manufacturer unknown) for management of his painful 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received on 23-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 20-JUN-2016 at a pharmacy, 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. About a week after being vaccinated, the patient began to experience painful symptoms. On or about 28-JUN-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as herpes zoster or shingles. On or about 08-OCT-2016, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles and nerve pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to zoster infections. The patient has been prescribed gabapentin (manufacturer unknown) for management of his painful 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. Additional information has been requested.
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 of unknown age, who was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-OCT-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-FEB-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 26-MAY-2016, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles infections. The patient was prescribed VALTREX for management of her 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: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-APR-2010, the patient was inoculated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-MAR-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed gabapentin and VALTREX for management of his painful 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, pain and suffering and other damages. Additional information has been requested.
Sex: M
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 male patient of unknown age, who was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 31-MAY-2012 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-OCT-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. The patient was prescribed Valacyclovir for management of his 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.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 06-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot # N013541 with expiration date: 23-JAN-2019 (dose and route of administration were not reported). The temperature excursion ranged to 31.2 degrees Fahrenheit for unknown time frame. There was no previous temperature excursion. Digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA009002.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M042851 and expiration date 18-JAN-2018 (strength, dose number and route were not provided). Concomitant therapies included sterile diluent (manufacturer unknown), no adverse events were reported. The ZOSTAVAX was improperly stored with a temperature of 6 °F (Fahrenheit) to 14°F for 5 hours 15 minutes. The report was due to data logger. It was reported that there was a previous temperature excursion of 15° F to 46 °F for 3 hours and 20 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA004870: US-009507513-1710USA013117.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M042851 and expiration date 18-JAN-2018 (strength, dose number and route were not provided) for prophylaxis. Concomitant therapies included sterile diluent, no adverse events were reported. The ZOSTAVAX was improperly stored with a temperature of 6 °F (Fahrenheit) to 14°F for 5 hours 15 minutes. The report was due to data logger. It was reported that there was a previous temperature excursion of 15° F to 46 °F for 3 hours and 20 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA013116: US-009507513-1710USA004870.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Oesophageal disorder, Pain in extremity, Pneumonia, Wrong technique in product usage process
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Glaxo Smith Kline (Manufacturer Report Number: US2017GSK155522). This case was reported by a contactable consumer (the patient) and described the occurrence of bilateral pneumonia in a 63-year-old female patient who received Anoro Ellipta inhalation powder (batch number 7ZP4569, expiry date Jun2019) for chronic obstructive pulmonary disease. Co-suspect products included Breo Ellipta inhalation powder (batch number unknown, expiry date unknown) for obstructive pulmonary disease and Prevnar 13 for product used for unknown indication. Concurrent medical conditions included chronic obstructive pulmonary disease. In 2017, the patient started Anoro Ellipta (inhaled) 1 puff(s) once daily (1 puff(s) daily) and Breo Ellipta (inhaled) 100/25 ug 1 puff(s) once daily (1 puff(s) daily). On 15Sep2017, the patient started PREVNAR 13 at single dose. In 2017, an unknown time after starting Anoro Ellipta and Breo Ellipta, the patient experienced esophageal disorder. On 15Sep2017, the patient experienced bilateral pneumonia, serious criteria hospitalization (GSK medically significant), pain in arm and wrong injection technique. The patient was treated with Prevacid. Anoro Ellipta was continued with no change. Breo Ellipta was discontinued in 2017. On an unknown date, the outcome of the bilateral pneumonia and wrong injection technique were recovering/resolving and the outcome of the esophageal disorder and pain in arm were unknown. The reporter considered the bilateral pneumonia and esophageal disorder to be unrelated to Anoro Ellipta. It was unknown if the reporter considered the pain in arm to be related to Anoro Ellipta and Breo Ellipta. The reporter considered the bilateral pneumonia to be unrelated to Breo Ellipta. The reporter considered the esophageal disorder to be related to Breo Ellipta. Additional Information: The consumer was transferred from the GSK Patient Assistance Program. She reported she was previously on Breo for chronic obstructive pulmonary disease (COPD) for approximately 8 month, but her physician observed white stuff was building up in her Esophagus (esophageal disorder), so her doctor discontinued Breo, treated her with Prevacid, and switched her to Anoro Ellipta sometime in the past few months, although the exact dates were unknown. The patient was getting her flu vaccine (brand and manufacturer, lot and exp unknown) and PREVNAR 13 (lot and expiration unknown) on 15Sep2017. The patient did not indicate at which facility she received these vaccines. The person administering the vaccines hit a tendon and caused pain in her arm, so she was taken to the emergency room. While there, her healthcare providers noticed respiratory symptoms and did a chest X-ray. She was diagnosed with double pneumonia and stayed in the hospital for 18 days while taking Anoro Ellipta.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Tenderness
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot T3 5 or S 176; Expiration Date 20Jan2020, NDC number 0005-1971-05), via an unspecified route of administration in right deltoid on 19Oct2017 17:30 at 0.5 ml, single for immunisation. Medical history included lupus, gastritis for which she took medications, gastrointestinal distress, allergy to sulfa, narcotics and a flu vaccine. In 1991 she received a flu vaccine and had pain and clamminess so she resulted allergic to flu vaccine. The patient previously took azathioprine, but had not taken that for several months. Concomitant medication were not reported, however she took a birth control pill. The patient experienced bruising line (non-serious) on 19Oct2017. The event was described as not raised or itching. It was tender, bright and intense and went from under her breast towards her navel. It was 4 inches long and it was fading at the time of the report. The outcome of the event was recovering.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after use of product, the patient experienced swelling, pain, redness at the injection site. Outcome of the events was unknown.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt. reported rash, swelling and redness 3 inches below injection site on Day 1, by Day 3, 6 inches below injection site. Pt. advised to seek treatment/evaluation from PCP.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Pt. reported rash, swelling and redness 3 inches below injection site on Day 1, by Day 3, 6 inches below injection site. Pt. advised to seek treatment/evaluation from PCP.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Since admin. of flu shot I have been experiencing shoulder issues. I am unable to raise my left shoulder fully over my head. I have decreased ROM with 8/10 when trying to raise arm. At rest pain is 2-3/10 in bicep shoulder area. This has been on going x 1 month.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal discomfort
Clinical narrative: Soreness at injection site on day following vaccination- ongoing "dull, achy pain" as of 10/20/2017. She reports a "history of shoulder problems" but has had no previous reactions to IM vaccination in deltoid. Did see her physician, has been treating with MOTRIN and ICY HOT which she states are effective.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Pain, Vaccination site induration, Vaccination site pain
Clinical narrative: Had arm pain in area of vaccine immediately after vaccine given. Later that day & 2 days following it still hurt the same. Since then has had ongoing pain worse in morning, an indurated area where vaccine seemed to be given; beneath the capsule & pain with range of motion. Limiting her activities: can't work out b/c of arm pain worsened by deltoid muscle movements. Seen for this concern 13 days after vaccination w/o improvement w/ ADVIL.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Nerve compression
Clinical narrative: Had soreness and decreased range of motion in shoulder- started approx. 2 hours after immunization.  Ongoing soreness and decreased ROM when crossing midline, worse in the morning.  Reports feeling "much better" as of 10/24/17.  States it felt "like a pinched nerve." No problems with previous IM vaccinations. Did not see any healthcare provider for evaluation or follow up. Has been taking OTC motrin at home and states it is effective.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bronchitis, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Arm sore, tired, running nose. I was told this would happen and to expect it. I continued for weeks and became worse with sore throat headache, no fever, and congestion. Then I finally had enough and was beginning to have trouble breathing at night and pain in chest. Sunday went to the ER walk-in and was diagnosed with Bronchitis. I was prescribed antibiotics (z-pack) and an inhaler. I began the z-pack, only to return to ER on Wednesday evening after Tuesday night to begin to have tightness in my neck.  Wednesday morning I couldn't move my neck from left to right or up and down. I lost feeling in my fingers, extreme pain in shoulder blade, neck, shoulder arm and wrists. It hurt to lay down to the point of tears. It hurt to relax my hand or arm. My arm was weak. At the ER I received pressure point injections, Tramadol, and Lidocaine patches as a prescription. I followed up with Neurologist and have an upcoming MRI. I was then prescribed muscle relaxer, steroid pack and given steroid shot and toradol shot at my appointment.  All of these occurred within 30 days of me receiving the flu vaccine. I still have pain in shoulder and tense, painful shoulder blade neck and experience weakness. I have missed an entire week of college. I still have issues. I am unsure if it is damage or what it is meaning for down the road but I have been told to start physical therapy.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Mobility decreased, Muscle tightness
Clinical narrative: Arm sore, tired, running nose. I was told this would happen and to expect it. I continued for weeks and became worse with sore throat headache, no fever, and congestion. Then I finally had enough and was beginning to have trouble breathing at night and pain in chest. Sunday went to the ER walk-in and was diagnosed with Bronchitis. I was prescribed antibiotics (z-pack) and an inhaler. I began the z-pack, only to return to ER on Wednesday evening after Tuesday night to begin to have tightness in my neck.  Wednesday morning I couldn't move my neck from left to right or up and down. I lost feeling in my fingers, extreme pain in shoulder blade, neck, shoulder arm and wrists. It hurt to lay down to the point of tears. It hurt to relax my hand or arm. My arm was weak. At the ER I received pressure point injections, Tramadol, and Lidocaine patches as a prescription. I followed up with Neurologist and have an upcoming MRI. I was then prescribed muscle relaxer, steroid pack and given steroid shot and toradol shot at my appointment.  All of these occurred within 30 days of me receiving the flu vaccine. I still have pain in shoulder and tense, painful shoulder blade neck and experience weakness. I have missed an entire week of college. I still have issues. I am unsure if it is damage or what it is meaning for down the road but I have been told to start physical therapy.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal pain, Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: Arm sore, tired, running nose. I was told this would happen and to expect it. I continued for weeks and became worse with sore throat headache, no fever, and congestion. Then I finally had enough and was beginning to have trouble breathing at night and pain in chest. Sunday went to the ER walk-in and was diagnosed with Bronchitis. I was prescribed antibiotics (z-pack) and an inhaler. I began the z-pack, only to return to ER on Wednesday evening after Tuesday night to begin to have tightness in my neck.  Wednesday morning I couldn't move my neck from left to right or up and down. I lost feeling in my fingers, extreme pain in shoulder blade, neck, shoulder arm and wrists. It hurt to lay down to the point of tears. It hurt to relax my hand or arm. My arm was weak. At the ER I received pressure point injections, Tramadol, and Lidocaine patches as a prescription. I followed up with Neurologist and have an upcoming MRI. I was then prescribed muscle relaxer, steroid pack and given steroid shot and toradol shot at my appointment.  All of these occurred within 30 days of me receiving the flu vaccine. I still have pain in shoulder and tense, painful shoulder blade neck and experience weakness. I have missed an entire week of college. I still have issues. I am unsure if it is damage or what it is meaning for down the road but I have been told to start physical therapy.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Tearfulness
Clinical narrative: Arm sore, tired, running nose. I was told this would happen and to expect it. I continued for weeks and became worse with sore throat headache, no fever, and congestion. Then I finally had enough and was beginning to have trouble breathing at night and pain in chest. Sunday went to the ER walk-in and was diagnosed with Bronchitis. I was prescribed antibiotics (z-pack) and an inhaler. I began the z-pack, only to return to ER on Wednesday evening after Tuesday night to begin to have tightness in my neck.  Wednesday morning I couldn't move my neck from left to right or up and down. I lost feeling in my fingers, extreme pain in shoulder blade, neck, shoulder arm and wrists. It hurt to lay down to the point of tears. It hurt to relax my hand or arm. My arm was weak. At the ER I received pressure point injections, Tramadol, and Lidocaine patches as a prescription. I followed up with Neurologist and have an upcoming MRI. I was then prescribed muscle relaxer, steroid pack and given steroid shot and toradol shot at my appointment.  All of these occurred within 30 days of me receiving the flu vaccine. I still have pain in shoulder and tense, painful shoulder blade neck and experience weakness. I have missed an entire week of college. I still have issues. I am unsure if it is damage or what it is meaning for down the road but I have been told to start physical therapy.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Arrhythmia, Dizziness, Electrocardiogram, Nausea
Clinical narrative: Irregular heart rhythm, dizziness, nausea, anxiety.
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Fall, Hypersomnia, Meningitis, Mental status changes
Clinical narrative: Patient initially started developing weakness, sleeping more than usual, followed by falls. altered mental status patient was initially met criteria of SIRS and was admitted with suspected diagnosis of meningitis and treated with antibiotics  but despite receiving antibiotics patient was not improving. He started developing upper extremity rigidity, tremors noted in upper extremity. Neurologist called CDC and patient was transferred to hospital for further evaluation and management.
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Muscle rigidity, Systemic inflammatory response syndrome, Tremor
Clinical narrative: Patient initially started developing weakness, sleeping more than usual, followed by falls. altered mental status patient was initially met criteria of SIRS and was admitted with suspected diagnosis of meningitis and treated with antibiotics  but despite receiving antibiotics patient was not improving. He started developing upper extremity rigidity, tremors noted in upper extremity. Neurologist called CDC and patient was transferred to hospital for further evaluation and management.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient called me describing a red, baseball-sized circle at area of vaccination. not raised, and not especially painful. Told patient that it should resolve on its own, but if it progresses to seek consult of her PCP.