chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of VARIVAX (lot# L045956 with expiration date 17-NOV-2017; lot# L046888 with expiration date 23-NOV-2017; lot# M004662 with expiration date 27-JAN-2018; lot# M025867 with expiration date 24-MAY-2018; lot# M037008 with expiration date 25-AUG-2018; lot# M039318 with expiration date 20-SEP-2018; and lot number reported as L035141 with expiration date 03-AUG-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 15 and 46 Fahrenheit degrees for 7 hours (also reported as "23.9 F"); and between 6 and 14 Fahrenheit degrees for 8 hours and 30 minutes; digital data logger was involved. No adverse effects were reported. Additionally, it was reported that the sterile diluent (unspecified) used to reconstitute the administered vaccine did not undergo a temperature excursion (Lot # M015992 with expiration date 26-NOV-2018; Lot # L037795 with expiration date 04-MAY-2018; Lot # L019306 with expiration date 04-MAR-2018; Lot # L006552 with expiration date 12-NOV-2017; Lot # M001834 with expiration date 08-MAR-2018; Lot # M022946 with expiration date 17-DEC-2018; Lot # M024781 with expiration date 21-FEB-2019. There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1703USA010175: US-009507513-1704USA001190:
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Joint swelling, Mobility decreased
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring herself. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date in May 2011, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported), for prevention of shingles. On an unknown date, the patient experienced swelling of her wrist (joint swelling) and her hands were "useless" (adverse event). She did not know if ZOSTAVAX "has caused her misery" (feeling abnormal). At the time of the report, she had not recovered from the adverse events. The causality between the adverse event and ZOSTAVAX was unknown. Upon internal review, the event of "her hands were useless" was considered to be serious due to disability. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site bruising
Clinical narrative: This information has been received from a pharmacist, via a company representative concerning several patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. In approximately 2016 (reported as "after receiving PNEUMOVAX injections last year"), the patient were vaccinated with PNEUMOVAX23 1 injection "yearly" (dose, dose number, lot number, expiration date, route of administration and anatomical location were not provided), administered for immunization against Pneumonia. The pharmacist reported that the patients "appeared in the pharmacy this year" with bruising at the injection site; however he did not report the dates that the patients received the vaccine, nor the dates that he observed the injection site bruising on the patients. In addition, the pharmacist did not report the dates that the patients received the vaccine, nor the dates that he observed the injection site bruising on the patients. In addition, the pharmacist did not report if the patients received medical attention or if any of the patients recovered from the adverse effect. No product quality complained was involved. The causal relationship between bruising at the injection site and PNEUMOVAX23 was unknown.   Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This information has been received from an office administrator concerning unspecified patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on an unknown date, the patients were vaccinated with two pediatric doses of VAQTA in place of one adult dose of VAQTA "20/0.5" (dose number, lot number, expiration date, route of administration and anatomical location were not provided), administered for prophylaxis. No product quality complained was involved. No adverse experience was reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old non-pregnant female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. None drug reactions/allergies were reported. On 06-MAR-2017, the patient was vaccinated with a dose of properly stored ZOSTAVAX (for prevention of shingles, lot # M035696, expiration date 07-NOV-2017, subcutaneously; dose was not reported) reconstituted with properly stored sterile diluent (subcutaneously, lot # reported as M016886, expiration date 07-DEC-2018; dose was not reported). On 15-MAR-2017, the patient experienced tuberculin (TB) test like bump at the injection site. The patient sought medical attention via calling the pharmacist. No treatment was given for the adverse event and none lab diagnostics studies were performed. The outcome of TB test like bump at the injection site was reported as recovered on an unknown date in 2017. The relatedness between the adverse event and the suspect therapies was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-APR-2017, the patient was vaccinated with the expired dose of PROQUAD (lot # L032759, expiration date 24-FEB-2017; dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as M041514, expiration date: 11-OCT-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion of 46 Fahrenheit degrees for 4 hours and 15 minutes and then  53.6 Fahrenheit degrees for 14 hours and 15 minutes. No previous temperature excursions were reported. Data logger was involved. The patient's concomitant therapies included sterile diluent lot # reported as M045717, expiration date 31-MAY-2019. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient' medical history, concurrent conditions and drug reactions/allergies were not reported.     On an unknown date in April 2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 plaque forming units (PFU) lot # M001747, expiration date: 07-APR-2017, as prophylaxis (Dose and route were not reported). The patient's concomitant therapies included sterile diluent lot # reported as M019490, expiration date: 09-OCT-2018. No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Abscess, Culture wound positive, Erythema, Local swelling, Pyrexia
Clinical narrative: Red bump progressing to large abscess with associated fever of 105.8, cultured MSSA requiring surgical removal; pediatric PACU RN reporting this.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Staphylococcus test positive, Surgery
Clinical narrative: Red bump progressing to large abscess with associated fever of 105.8, cultured MSSA requiring surgical removal; pediatric PACU RN reporting this.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Nodule, Pain in extremity
Clinical narrative: Pain started at the spot I was given the injection. I have a knot about a size of a dime. When you touch it the pain is unbearable. The pain is now to my shoulder and goes to my fingers, cant put my arm over my head and is constantly hurting.  I put heat on it and that didn't help. Its been 6 months and still not better some days I think its worse.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tenderness
Clinical narrative: Pain started at the spot I was given the injection. I have a knot about a size of a dime. When you touch it the pain is unbearable. The pain is now to my shoulder and goes to my fingers, cant put my arm over my head and is constantly hurting.  I put heat on it and that didn't help. Its been 6 months and still not better some days I think its worse.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: Pain started at the spot I was given the injection. I have a knot about a size of a dime. When you touch it the pain is unbearable. The pain is now to my shoulder and goes to my fingers, cant put my arm over my head and is constantly hurting.  I put heat on it and that didn't help. Its been 6 months and still not better some days I think its worse.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practitioner nurse (L.P.N.) and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The nurse reported that on unspecified dates since 15-FEB-2017, an unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (lot # M042499, expiration date 17-APR-2018; lot # M035144, expiration date 30-JAN-2018; lot # M017334, expiration date 05-OCT-2017; doses, routes of administration, and frequencies were not reported) for prophylaxis which were reconstituted with an sterile diluent (DILUENT MRK) injection (lot numbers and expiration dates were not reported). The vaccine data logger measured a temperature range from 15°F to 46°F for a total time frame of 10 hours and 4 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001635.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were subcutaneously vaccinated with improperly stored doses of ZOSTAVAX lot # M019645, expiration date 18-JUL-2017, for prophylaxis (dose was not reported). The ZOSTAVAX were reconstituted with properly stored diluent (lot number and expiration date were unknown). No side effects were reported. Administered doses of vaccine were improperly stored for 2 hours and 30 minutes in a temperature range of 15.1 degrees Fahrenheit. There were previous temperature excursions of 14.9 degrees Fahrenheit for 9 hours and 8 degrees Fahrenheit for 3 hour and 15 minutes. Data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M019645, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to sterile diluent(STERILE DILUENT) and ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practitioner nurse (L.P.N.) and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The nurse reported that on unspecified dates since 15-FEB-2017, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # M033214, expiration date 13-JUL-2018; lot # M031970, expiration date 30-JUN-2018; lot # M027343, expiration date 01-JUN-2018) (doses, routes of administration, and frequencies were not reported) for prophylaxis which were reconstituted with an sterile diluent(DILUENT MRK) injection (lot numbers and expiration dates were not reported). The vaccine data logger measured a temperature range from 15°F to 46°F for a total time frame of 10 hours and 4 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009968:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 25 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates in 2013, the patient received the first and second doses of GARDASIL (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. Later, on 04-APR-2017, the patient received a dose of GARDASIL 9 (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of injectable ZOSTAVAX (lot# M032360, expiration date 18-AUG-2017; and lot# M034764, expiration date 26-OCT-2017) for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 19.4 Fahrenheit degrees in a time frame of 3 hours and 45 minutes; digital data logger was involved and previous temperature excursion was confirmed. No adverse effects were reported. Reportedly, the vaccine doses were reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were unknown). This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002390: US-009507513-1704USA001051:
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients (3 or 4) of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with PNEUMOVAX23 intramuscularly (lot # M032635, expiration date: 05-MAY-2018; dose was not reported) for prophylaxis. On an unknown dates, the patients experienced adverse reactions that were not further specified by the reporter. The outcome of adverse reactions was unknown. No causality assessment was provided. Reporter additionally stated that these adverse events were reported from pharmacy to Vaccine Adverse Event Reporting System (VAERS) about a year before the report's date. No Product Quality Complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye laser surgery, Eye pruritus, Eye swelling, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning female patient currently 66 years old. Patient was not taking any concomitant medication, and had no medical history, drug reactions or allergies. In approximately April 2016, (reported as "approximately one year ago") the patient received a dose of ZOSTAVAX with a concentration of 19,400 plaque-forming units (PFU) for prophylaxis (route of administration, dosage information, lot number, expiration date and anatomical location were not provided). On an unknown, date the patient had laser surgery to her eye (not specified if one eye or both eyes), then developed shingles around one of her eyes (unspecified which eye), which involved swelling and itching (Ophthalmic herpes zoster). It was reported that the patient had received treatment for those events. Upon internal review ophthalmic herpes zoster was considered to be a medically significant event. At the time of reporting the patient had not recovered from the events. Additionally, the reporter provided no causal relationship between the events and vaccination with ZOSTAVAX. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Hypertension, Hypotension, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from an approximately 81 year old male patient, reporting on himself. The patient's pertinent medical history included blood pressure issues (unspecified). He was allergic to SULFA. The patient did not have any concomitant therapies. In October 2015 (reported as 1 year and 6 months ago), the patient was vaccinated with a dose of ZOSTAVAX 1 time vaccine for shingles prophylaxis (lot #, expiration date, site, dose and route of administration were not reported). In January 2016 (reported as 3 months after getting the vaccine), the patient got shingles in his left eye. On unknown dates, the patient experienced high blood pressure of 200/200 (unit not provided), low blood pressure below the 30s (unit not provided), he was losing sight in his left eye and did go to the hospital for an unspecified reason. The patient sought medical attention, spoke with his physician and an unspecified treatment was given for the events. No lab diagnostic studies were performed. At the time of report, the patient was concerned the shingles was spreading to his right eye and that he would start to lose sight in that eye as well as his left eye. The only relief he had was from cold compresses. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not assessed. Upon internal review, the events of ophthalmic herpes zoster and high blood pressure of 200/200 (unit not provided) were determined to be medically significant. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness. Swelling.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Decreased appetite, Injection site pain, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Pain and swelling at injection site, fever, loss of appetite and vomiting.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Ageusia, Biopsy bone marrow, Biopsy peripheral nerve, Biopsy skin
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Bladder catheterisation, Bladder scan, Blister, Blood test, Borrelia test
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Chemotherapy, Chest X-ray, Computerised tomogram, Hypoaesthesia, Immune system disorder
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: LE cells, Liver function test abnormal, Mobility decreased, Muscle spasms, Nausea
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging, Oxygen saturation abnormal, Pain, Peripheral swelling
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumothorax, Pruritus, Rash generalised, Renal function test abnormal, Secretion discharge
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation, Skin warm, Splenomegaly, Tongue ulceration, Tonsillar ulcer
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor, Treponema test, Urinary retention, Urticaria
Clinical narrative: My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, or concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, lot number, and expiration date were not reported), intramuscularly instead of subcutaneously, for prophylaxis. No adverse effects were reported. Follow up information has been received from the registered nurse via a phone call on 11-APR-2017. A request was made for additional information on the vaccines that were administered via the incorrect route, specifically the lot numbers, expiration dates, patient identifiers and dates of administration. A form which was needed to complete would be faxed to the nurse. Follow up information was received from a licensed nurse practitioner on 14-APR-2017, concerning a 66 years old male patient. It was reported that the ZOSTAVAX (Lot#: M041669) was received on 08-MAR-2017, and was stored in the refrigerator instead of the freezer and the vaccine was inactive. On 31-MAR-2017 at 12:17 pm. The patient was vaccinated with the ZOSTAVAX (Lot#: M041669) intramuscularly in the left arm.. This is one of two reports from the same reporter. Additional information is not expected as all schedule follow up information was received.; Sender's Comments: US-009507513-1704USA007589:
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on 16-MAR-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # L033690, expiration date 14-JUN-2018; dose and frequency was not reported) intramuscularly, for prophylaxis. On that date the patient was also vaccinated with a dose of an also improperly stored ROTATEQ, orally (lot number: M014755, expiration date: 30-OCT-2017). This information was discovered as a digital data logger measured temperatures of 47.5 °F, 47°F to 77°F for a total time frame of 16 hours. There was no previous temperature excursion. No adverse side effects were reported, and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013286: US-009507513-1703USA013277:
Sex: M
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: Information was received from a physician via a company representative concerning an adolescent male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The physician reported that at an unspecified time, the anonymous male was vaccinated with an unspecified dose of GARDASIL 9 (lot number and dosage not provided), intramuscularly for prevention of HPV. On an unknown date (reported as "a time thereafter"), the patient experienced hair loss on his head. The outcome of the hair loss was reported as "hair grew back." Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74-year-old female patient. The patient did not have any drug reactions and allergies. No information regarding the patient's pertinent medical history or concomitant medications was provided. On 21-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration and expiration date were not provided; lot # M037653). On 31-MAR-2017, the patient experienced localized swelling, redness, itchy and warm to touch at the injection site. Pharmacist advised the patient to place ice on the area and to see her primary care physician. No other treatment was given for the adverse events. No laboratory diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between all adverse events and ZOSTAVAX was not provided. Additional information has been requested.