chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Memory impairment, Myalgia, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration in left arm on 31Jul2017 13:00 at 0.5 ml single for dr. recommended. She received the vaccine at Physician Office. No additional vaccine was administered on same date. Medical history included colon cancer from 2009 and got blockages because of the adhesions in her stomach and was in the hospital 3 weeks prior to getting the shot, compromised immune system, urinary tract infection. There was no family medical history relevant to AE. Prior vaccinations (within 4 weeks) was none. The patient's concomitant medications were not reported. The patient experienced very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills on 02Aug2017, fell twice while getting up, scratched her arm when she fell, bruising, didn't remember a lot from the past 2 weeks on an unspecified date. She stated that she had the worst reaction and thought she was dying. She was so sick and couldn't bring herself to go to the hospital. She stated she didn't remember a lot from the past 2 weeks. She said she fell twice. She scratched her arm when she fell. She hit the side of her dresser. She has bruising as well. She had a history of colon cancer and got blockages because of the adhesions in her stomach. She questioned her doctor before she took it the shot. She called him after she got the shot and he told her to take MOTRIN and BENADRYL. She started taking Cephalexin 500mg four times a day for a urinary tract infection on 02Aug2017. She would like to know if this medication and the shot were contraindicated for each other. She didn't take relevant tests. She was too weak to visit Emergency Room. On 14Aug2017 (yesterday) was the first day that she felt like getting up and going to the living room. She had an appointment with Doctor on 15Aug2017. The outcome of events very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills was recovering, outcome of other events was unknown.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised, Scratch
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration in left arm on 31Jul2017 13:00 at 0.5 ml single for dr. recommended. She received the vaccine at Physician Office. No additional vaccine was administered on same date. Medical history included colon cancer from 2009 and got blockages because of the adhesions in her stomach and was in the hospital 3 weeks prior to getting the shot, compromised immune system, urinary tract infection. There was no family medical history relevant to AE. Prior vaccinations (within 4 weeks) was none. The patient's concomitant medications were not reported. The patient experienced very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills on 02Aug2017, fell twice while getting up, scratched her arm when she fell, bruising, didn't remember a lot from the past 2 weeks on an unspecified date. She stated that she had the worst reaction and thought she was dying. She was so sick and couldn't bring herself to go to the hospital. She stated she didn't remember a lot from the past 2 weeks. She said she fell twice. She scratched her arm when she fell. She hit the side of her dresser. She has bruising as well. She had a history of colon cancer and got blockages because of the adhesions in her stomach. She questioned her doctor before she took it the shot. She called him after she got the shot and he told her to take MOTRIN and BENADRYL. She started taking Cephalexin 500mg four times a day for a urinary tract infection on 02Aug2017. She would like to know if this medication and the shot were contraindicated for each other. She didn't take relevant tests. She was too weak to visit Emergency Room. On 14Aug2017 (yesterday) was the first day that she felt like getting up and going to the living room. She had an appointment with Doctor on 15Aug2017. The outcome of events very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills was recovering, outcome of other events was unknown.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A 18-years-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that patient kept complaining his arm hurt but he is kind of a baby about shots but today he just showed the consumer that on his biceps it's like a big round red mark, doesn't look really like swollen but is obviously red maybe it is like 6 inches by 4 inches, like his whole biceps. Outcome of events was not reported.
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site induration, Injection site swelling, Wrong drug administered
Clinical narrative: Initial unsolicited case received from a physician on 04-AUG-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (batch number was unknown) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number not reported) (expiry date, dose, dose in series, route and side of administration was not reported for all vaccines) in the arm on an unknown day in early JUN-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had swelling and redness from the shoulder to the elbow of her arm with induration at injection site. The patient required a visit to the doctor. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from all the events (reported as symptoms had all resolved). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical erroris in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Autonomic nervous system imbalance, Autonomic neuropathy, Biopsy lip abnormal, Blood test abnormal
Clinical narrative: I had an influenza vaccine, but I don't have the exact name. I received it at our local health department at the time. I got ill with a fever, vomiting, dizziness etc... facility told me it was normal. From there, I developed severe anemia. I had tons of work-ups, because I never recovered after the vaccine. It took years of getting worse for doctors to take me seriously.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Cancer surgery, Computerised tomogram, Demyelinating polyneuropathy, Dizziness, Gastrointestinal stromal tumour
Clinical narrative: I had an influenza vaccine, but I don't have the exact name. I received it at our local health department at the time. I got ill with a fever, vomiting, dizziness etc... facility told me it was normal. From there, I developed severe anemia. I had tons of work-ups, because I never recovered after the vaccine. It took years of getting worse for doctors to take me seriously.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test abnormal, Malaise, Paraneoplastic syndrome, Postural orthostatic tachycardia syndrome, Pyrexia
Clinical narrative: I had an influenza vaccine, but I don't have the exact name. I received it at our local health department at the time. I got ill with a fever, vomiting, dizziness etc... facility told me it was normal. From there, I developed severe anemia. I had tons of work-ups, because I never recovered after the vaccine. It took years of getting worse for doctors to take me seriously.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Sjogren's syndrome, Transfusion, Vomiting
Clinical narrative: I had an influenza vaccine, but I don't have the exact name. I received it at our local health department at the time. I got ill with a fever, vomiting, dizziness etc... facility told me it was normal. From there, I developed severe anemia. I had tons of work-ups, because I never recovered after the vaccine. It took years of getting worse for doctors to take me seriously.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: I have had pain in my right arm at injection site (tender, nothing serious). Recently I noticed a lump the size of a grape in my right arm at the injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Patient returned to work here at store, and said she started to feel lightheaded, dizzy, and feverish about 4 hours after she received her IMZ. She complained of an upset stomach and/or diarrhea into the following Monday. She had off that Tuesday, and returned to work yesterday (Wednesday) still feeling queasy but improving.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient presents with a large, red rash in the area surrounding where she had the vaccine the day that she received the vaccine until present (8/17/17). Patient states that it was sore the first day but pain has since ceased (8/17/17).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, Paraesthesia
Clinical narrative: Dr. gave patient two doses of Tdap and Meningococcal vaccine within 5 months of each other.
Age: 23.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Flushing, Nausea, Pruritus, Rash vesicular
Clinical narrative: Shot given at 1557 hours. That evening at home, patient felt flushed and nauseated without any other new symptoms. Went to bed. Awoke the next day with numerous small, round, fluid-filled bumps on the arms, legs, chest and back. Lesions were itchy and minimally erythematous. They drained clear fluid when opened. When scratched they seemed to turn more red and enlarge. Nausea persisted for 4 days. Lesions persisted for 6-7 days. Treated pruritus with OTC BENADRYL and then sought care on day #5 and was given ZYRTEC. Took one dose and next day or two the lesions had resolved. Still has some residual hyperpigmentation at the lesion sites 2 day later.
Age: 23.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Skin hyperpigmentation, Skin lesion
Clinical narrative: Shot given at 1557 hours. That evening at home, patient felt flushed and nauseated without any other new symptoms. Went to bed. Awoke the next day with numerous small, round, fluid-filled bumps on the arms, legs, chest and back. Lesions were itchy and minimally erythematous. They drained clear fluid when opened. When scratched they seemed to turn more red and enlarge. Nausea persisted for 4 days. Lesions persisted for 6-7 days. Treated pruritus with OTC BENADRYL and then sought care on day #5 and was given ZYRTEC. Took one dose and next day or two the lesions had resolved. Still has some residual hyperpigmentation at the lesion sites 2 day later.
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report as received from a female physician of unknown age via a company representative refers to herself. The patient's medical history was not reported. On an unknown date (reported as years ago), the patient was vaccinated with GARDASIL on month 0, month 2 and month 6, intramuscular for prophylaxis and it hurt. She had injection site pain and it was hard to lift her arm afterwards for a day or two. The outcome of events was reported as recovered/resolved (date unspecified). The patient did not receive any treatment. The relatedness between the events and GARDASIL was not reported.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 22-JUN-2017 at 13:20, the patient was vaccinated with improperly stored VARIVAX, in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, first dose; exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The patient was concomitantly vaccinated with a dose of VAQTA and M-M-R II. There were no adverse events. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1706USA009938:
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 28-JUN-2017 at 11:45, the patient was vaccinated with improperly stored VARIVAX, in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018, second dose; exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The patient was concomitantly vaccinated with a dose of VAQTA. There was no adverse event. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1706USA009938:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On an unknown date, the patient might have received an improperly stored dose of ROTATEQ, orally, lot # M038208 and expiration date: 04-MAY-2018. Administered dose of vaccine experienced the temperature excursions in the range of 32 degrees Fahrenheit to 35 degrees Fahrenheit and in the range of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 14 hours in each range. Digital Data Logger was not involved. There was no previous excursions. No adverse effect was reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007465: US-009507513-1708USA007464: US-009507513-1708USA007466: US-009507513-1708USA007463:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 20 year old male patient. On 11-MAY-2017, the patient was vaccinated with a first dose of GARDASIL 9 lot # M035486, expiration date 05-JUN-2019 (route of administration and anatomical location were not reported). On 15-JUN-2017, the patient was vaccinated with a second dose of GARDASIL 9 lot # N001533, expiration date 16-OCT-2019 (route of administration and anatomical location were not reported). The drug was administered to the patient of inappropriate age. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received 15-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 11-OCT-2012 at a pharmacy in his residing state, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused him to contract a persistent strain of herpes zoster. On or about 08-SEP-2015, the plaintiff was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The plaintiff had been prescribed acyclovir (ZOVIRAX) for management of his painful breakouts. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received 15-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX in 2013 at a pharmacy in his residing state, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused him to contract a persistent strain of herpes zoster. On or about 02-JAN-2014, the plaintiff was seen by a dermatology physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 01-JAN-2013 the patient was vaccinated with ZOSTAVAX, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her excruciating nerve pain and 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: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (Strength, dose, frequency, route and anatomical location were not reported) of lot # M002268 with an expiry date of 20-SEP-2017, for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 21 hours and 6 minutes. There was previous temperature excursion which involved exposure to 47°F to 77°F for 6 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006435: US-009507513-1708USA007256:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (Strength, dose, frequency, route and anatomical location were not reported) of lot # M002268 with an expiry date of 20-SEP-2017, for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 21 hours and 6 minutes. There was previous temperature excursion which involved exposure to 47°F to 77°F for 6 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA007255: US-009507513-1708USA006435:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, Feeling cold, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient with blood pressure abnormal. On 10-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M020902 for prophylaxis. Concomitant therapies included aspirin (manufacturer unknown) and losartan potassium(COZAAR). On 10-AUG-2017 the patient experienced expired product administered. On AUG-2017 the patient experienced injection site swelling, chills and injection site pain. The outcome of chills, injection site pain and injection site swelling was reported as recovered/resolved. The outcome of expired product administered is unknown. The reporter considered expired product administered to be not related to ZOSTAVAX. The reporter considered injection site swelling, chills and injection site pain to be related to ZOSTAVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007456:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # N008823, expiry date: 26-MAY-2018) (route: subcutaneous) reconstituted with sterile water diluent. The vaccine was stored at a temperature of 0 to 1°C (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA007422: US-009507513-1708USA007198: US-009507513-1708USA007441: US-009507513-1708USA007438.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age.    On 10-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M020902 for prophylaxis. On 10-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. No adverse event was reported. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007378:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot#, expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007465: US-009507513-1708USA007464: US-009507513-1708USA007466: US-009507513-1708USA005855:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of VAQTA (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007465: US-009507513-1708USA005855: US-009507513-1708USA007463: US-009507513-1708USA007466:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005855: US-009507513-1708USA007464: US-009507513-1708USA007466: US-009507513-1708USA007463:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 09-AUG-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 11 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007465: US-009507513-1708USA007464: US-009507513-1708USA005855: US-009507513-1708USA007463:
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Around 1 pm the day after my daughter received the vaccine, her leg was swollen about twice it's normal size. It was red and warm to the touch. I sent a picture to her doctor's phone. She instructed me to give her BENADRYL every 4 hours and to keep her informed of any symptoms she may have. The swelling lasted roughly 48 hours. She complained of her leg feeling like it was burning inside.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apparent life threatening event, Seizure, Unresponsive to stimuli
Clinical narrative: Unresponsive event, (ALT)event-possible seizure 5-6 hours after administration.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Cyanosis, Musculoskeletal stiffness, Seizure, Urine analysis
Clinical narrative: Seizure lasting approx. 1 minute. Lips turned blue. Stiff muscles. Patient visited the ER. Referral to neurologist/primary doctor for follow up.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Bed rest, Blood thyroid stimulating hormone, Computerised tomogram, Full blood count, Headache
Clinical narrative: My healthy daughter began showing signs of a headache 3 weeks after the shot. For the last month she has had several trips to the ER, is now on 17 medications with migraine and high blood pressure that is unresolved. Today she is at the Neurologist with a series of 3 days of outpatient IVs to try and decrease her pain. She has been on bed rest for over a month and is not able to participate in daily activities or soccer.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Hypertension, Loss of personal independence in daily activities, Metabolic function test, Mononucleosis heterophile test, Pain
Clinical narrative: My healthy daughter began showing signs of a headache 3 weeks after the shot. For the last month she has had several trips to the ER, is now on 17 medications with migraine and high blood pressure that is unresolved. Today she is at the Neurologist with a series of 3 days of outpatient IVs to try and decrease her pain. She has been on bed rest for over a month and is not able to participate in daily activities or soccer.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Thyroxine
Clinical narrative: My healthy daughter began showing signs of a headache 3 weeks after the shot. For the last month she has had several trips to the ER, is now on 17 medications with migraine and high blood pressure that is unresolved. Today she is at the Neurologist with a series of 3 days of outpatient IVs to try and decrease her pain. She has been on bed rest for over a month and is not able to participate in daily activities or soccer.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Fairly significant area of redness and swelling to injection site. Redness, swelling and itching at injection site and surrounding area.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a nurse and described the occurrence of allergy in a adult female patient who received Flu Seasonal QIV Dresden. Concurrent medical conditions included systemic lupus erythematosus, obesity, fall, drug allergy (was allergic to BENLYSTA, Codeine, Compazine, TIGAN) and food allergy (no known food allergy). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The patient's concurrent condition included cholecystectomy. This case has been linked with case US2017093096, pharma case.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Demyelination, Hypoaesthesia, Immunoglobulin therapy, Nuclear magnetic resonance imaging thoracic abnormal, Paraesthesia
Clinical narrative: 6 days after receiving the vaccine, numbness and tingling on feet bilateral that progressed in couple of days to the waist. MRI demonstrated a demyelinating lesion at the level of T8-T9. Immediate treatment with corticosteroids and follow-up with IVIG.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: TENDER AND REDNESS ON THE INJECTION SITE THAT IS PAINFUL- RECOMMENDED TO TAKE BENADRYL AND TYLENOL TO COUNTERACT THE EFFECT AND TO SEE THE DOCTOR RIGHT AWAY.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Cyanosis, Immediate post-injection reaction, Moaning, Muscle rigidity, Muscle twitching
Clinical narrative: My son had both Meningococcal vaccines on his left arm without problems. The GARDASIL vaccine was administered in his right arm and Band Aid applied. Immediately after this injection, (he was seating on the exam table, legs dangling) his head dropped to his chest and was not responding. He then started to fall over to his left side. I grabbed his legs which became rigid-sticking straight out and nurse grabbed his upper body which was also rigid. He was unresponsive and started to groan. He became terrifyingly white and his lips turned blue. He had a few minor twitches in upper body. He then jerked his head up and screamed "What". We calmed him and he laid on the table a bit dazed for the next 10 minutes. He stayed in the doctor's office for another 20-30 minutes and completely recovered. The MD performed a neurological evaluation before he left.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: My son had both Meningococcal vaccines on his left arm without problems. The GARDASIL vaccine was administered in his right arm and Band Aid applied. Immediately after this injection, (he was seating on the exam table, legs dangling) his head dropped to his chest and was not responding. He then started to fall over to his left side. I grabbed his legs which became rigid-sticking straight out and nurse grabbed his upper body which was also rigid. He was unresponsive and started to groan. He became terrifyingly white and his lips turned blue. He had a few minor twitches in upper body. He then jerked his head up and screamed "What". We calmed him and he laid on the table a bit dazed for the next 10 minutes. He stayed in the doctor's office for another 20-30 minutes and completely recovered. The MD performed a neurological evaluation before he left.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Blood pressure decreased, Cyanosis, Dyskinesia, Fall, Immediate post-injection reaction
Clinical narrative: My son had both Meningococcal vaccines on his left arm without problems. The GARDASIL vaccine was administered in his right arm and Band Aid applied. Immediately after this injection, (he was seating on the exam table, legs dangling) his head dropped to his chest and was not responding. He then started to fall over to his left side. I grabbed his legs which became rigid-sticking straight out and nurse grabbed his upper body which was also rigid. He was unresponsive and started to groan. He became terrifyingly white and his lips turned blue. He had a few minor twitches in upper body. He then jerked his head up and screamed "What". We calmed him and he laid on the table a bit dazed for the next 10 minutes. He stayed in the doctor's office for another 20-30 minutes and completely recovered. The MD performed a neurological evaluation before he left.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Joint hyperextension, Mental status changes, Muscle rigidity, Musculoskeletal stiffness, Neurological examination normal
Clinical narrative: My son had both Meningococcal vaccines on his left arm without problems. The GARDASIL vaccine was administered in his right arm and Band Aid applied. Immediately after this injection, (he was seating on the exam table, legs dangling) his head dropped to his chest and was not responding. He then started to fall over to his left side. I grabbed his legs which became rigid-sticking straight out and nurse grabbed his upper body which was also rigid. He was unresponsive and started to groan. He became terrifyingly white and his lips turned blue. He had a few minor twitches in upper body. He then jerked his head up and screamed "What". We calmed him and he laid on the table a bit dazed for the next 10 minutes. He stayed in the doctor's office for another 20-30 minutes and completely recovered. The MD performed a neurological evaluation before he left.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Pallor, Posture abnormal, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: My son had both Meningococcal vaccines on his left arm without problems. The GARDASIL vaccine was administered in his right arm and Band Aid applied. Immediately after this injection, (he was seating on the exam table, legs dangling) his head dropped to his chest and was not responding. He then started to fall over to his left side. I grabbed his legs which became rigid-sticking straight out and nurse grabbed his upper body which was also rigid. He was unresponsive and started to groan. He became terrifyingly white and his lips turned blue. He had a few minor twitches in upper body. He then jerked his head up and screamed "What". We calmed him and he laid on the table a bit dazed for the next 10 minutes. He stayed in the doctor's office for another 20-30 minutes and completely recovered. The MD performed a neurological evaluation before he left.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: THE PATIENT HAD NUMBNESS AND TINGLING IN THE LEFT HAND (SPECIFICALLY PROMINENT IN THE #4 DIGIT) THAT RADIATED UP THE LEFT ARM INTO THE RIGHT SIDE OF THE NECK.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Mother of patient noticed redness, edema, and pain on right upper arm after he got home from school on 8/16/17, approximately 3:30-4:00pm. Mom gave patient TYLENOL for pain in arm. Patient says it hurts to move his arm, but pain is not as bad as yesterday. No fever noted at home, but mom stated that patient felt warm last night. No fever today. On exam today, Right upper arm (deltoid site) with 12cm x 12cm site of induration, redness, edema. Area warm to touch and tender to palpation.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Mother of patient noticed redness, edema, and pain on right upper arm after he got home from school on 8/16/17, approximately 3:30-4:00pm. Mom gave patient TYLENOL for pain in arm. Patient says it hurts to move his arm, but pain is not as bad as yesterday. No fever noted at home, but mom stated that patient felt warm last night. No fever today. On exam today, Right upper arm (deltoid site) with 12cm x 12cm site of induration, redness, edema. Area warm to touch and tender to palpation.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old patient.    On 25-JUL-2017, the patient was vaccinated with a dose of M-M-R II and VARIVAX and on 04-AUG-2017, the patient was vaccinated with a dose of PROQUAD lot # M042500 for prophylaxis (inappropriate schedule of drug administration). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a female patient in her sixties with breast disorder, diabetes mellitus and asthma. On 08-AUG-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis. Concomitant therapies included prednisone (manufacturer unknown) and metformin. On AUG-2017 the patient experienced injection site urticaria and injection site erythema. The outcome of injection site urticaria and injection site erythema is unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. On 01-MAY-2017 the patient was vaccinated with ZOSTAVAX dose 1 for prophylaxis. In approximately May 2017 the patient experienced bruising. In 2017 the patient experienced pain. The outcome of bruising and pain is unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received 15-AUG-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 06-OCT-2009 and again on 06-DEC-2012 at the same pharmacy in her residing state, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 04-SEP-2015, the plaintiff was treated in the emergency department of a hospital for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 07-SEP-2015 the plaintiff was treated by a physician for ongoing and worsening symptoms of shingles. She was prescribed acyclovir (ZORIVAX), oxycodone (+) acetaminophen and prednisone for management of her painful symptoms.  It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 15-AUG-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 13-SEP-2015 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. On or about 11-JUN-2016, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune system which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) and hydrocodone (manufacturer unknown), 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, 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 was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 16-SEP-2009 at a medical facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-DEC-2013, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (manufacturer unknown) for management of her painful breakouts. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 14-FEB-2009 the patient was vaccinated by a physician with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles that had significant involvement on her scalp. The patient has been prescribed valacyclovir and codeine 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.