chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer concerning a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 10-MAR-2010, the patient was vaccinated with ZOSTAVAX as recommended for routine 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 and chronic strain of herpes zoster.  On or about 15-MAY-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied symptoms of weakened immunity, and severe discomfort and distress, which was diagnosed as severe herpes on the face. The patient was referred to an ophthalmologist for this encounter, in which the blistering vesicles were in and around the eye. On or about 14-AUG-2015, the patient was treated by the physician for new and worsening outbreaks, which were diagnosed as herpes zoster. On or about 28-JAN-2016, he was again treated by the physician for shingles that had transferred to new locations on the body, including the arm and chest. On or about 06-JUN-2016, the patient was again treated for similar and worsening symptoms, at which time his condition was diagnosed as recurrent and chronic herpes zoster. He was prescribed acyclovir and acetaminophen and PERCOCET to manage his painful and persistent 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 and proximate result, the patient has suffered and will continue to suffer significant, medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Disorientation, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: This spontaneous report was received from an unknown healthcare provider via a physician and a company representative, who referred to an unspecified group of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) as prophylaxis. On unknown dates, the patients experienced a slight headache, were disoriented, very tired, their arms swelled up from the injection site down to the elbow and were red and very painful after receiving ZOSTAVAX. The unknown healthcare provider reported that this happened all the time to patients at their clinic after getting the vaccine. The outcome of the reported events was unknown. No product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA009805:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from an unknown healthcare provider via a physician and a company representative, who referred to an unspecified group of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) as prophylaxis. On unknown dates, the patients experienced a slight headache, were disoriented, very tired, their arms swelled up from the injection site down to the elbow and were red and very painful after receiving ZOSTAVAX. The unknown healthcare provider reported that this happened all the time to patients at their clinic after getting the vaccine. The outcome of the reported events was unknown. No product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA009805:
Sex: U
Vaccine: VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis.  On an unknown date the patient experienced incorrect product storage and poor quality drug administered.  The outcome of poor quality drug administered is unknown. The reporter considered incorrect product storage and poor quality drug administered to be not related to VARIVAX.; Sender's Comments: US-009507513-1707USA001045: US-009507513-1707USA001046: US-009507513-1706USA007156:
Sex: U
Vaccine: VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age.  On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced incorrect product storage and poor quality drug administered. The outcome of poor quality drug administered is unknown. The reporter considered incorrect product storage and poor quality drug administered to be not related to VARIVAX.    ; Sender's Comments: US-009507513-1707USA001044: US-009507513-1707USA001046: US-009507513-1706USA007156:
Sex: U
Vaccine: VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced incorrect product storage and poor quality drug administered. The outcome of poor quality drug administered is unknown. The reporter considered incorrect product storage and poor quality drug administered to be not related to VARIVAX.    ; Sender's Comments: US-009507513-1707USA001044: US-009507513-1707USA001045: US-009507513-1706USA007156:
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-JUN-2017, the pharmacist was administering a dose of ZOSTAVAX to the patient (route, lot# and expiry date were unknown) for routine vaccine, when some of the ZOSTAVAX squirted in the eye of the pharmacist. The physician was unaware if the patient received the full dose of ZOSTAVAX (accidental underdose). This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1706USA007755:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no information about medical history, concomitant medication or concurrent condition. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose and route unknown, lot# reported as N000678, expiration date 05-JUL-2018) for prophylaxis. The vaccine was exposure to 15 Fahrenheit degree (F) to 46F for 2 hours. The previous excursion was 6F to 14F for 12 hours. Data logger was involved. No adverse event was reported. This is one of the reports received from the same reporter (MARRS# 1706USA007809).; Sender's Comments: US-009507513-1706USA007809:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients 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 improperly stored doses of PNEUMOVAX 23 ( lot #L019836, expiration date 24-MAR-2017 (dose and route of administration were not reported). The reporter was unable to confirm if the expired doses were administered after their expiration date. There was no adverse effect reported. There was no adverse effect reported. Administered doses of PNEUMOVAX 23 from 32 to 35 degrees Fahrenheit for 8 hours and form 47 to 77 degrees Fahrenheit for 8 hours. Data logger was not 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-009507513-1707USA001092: US-009507513-1707USA001093: US-009507513-1706USA010602:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients 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 improperly stored doses of VAQTA, lot # L023936, expiration date 15-MAR-2017 (dose and route of administration were not reported). The reporter was unable to confirm if the expired doses were administered after their expiration date. There was no adverse effect reported. Administered doses of VAQTA experienced the temperature excursion from 32 to 35 degrees Fahrenheit for 8 hours and form 47 to 77 degrees Fahrenheit for 8 hours. Data logger was not 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-009507513-1706USA010602: US-009507513-1707USA001093: US-009507513-1707USA001091:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients 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 improperly stored doses of LIQUID PEDVAXHIB, lot # L035878, expiration date 11-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of LIQUID PEDVAXHIB experienced the temperature excursion from 32 to 35 degrees Fahrenheit for 8 hours and form 47 to 77 degrees Fahrenheit for 8 hours. Data logger was not 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-009507513-1707USA001092: US-009507513-1706USA010602: US-009507513-1707USA001091:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (dose, frequency, route, lot # and expiration date were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were no adverse effects reported. The temperature excursion, time frame, previous temperature excursion were unknown. There were no data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA007786.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # M007963 for prophylaxis. 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 PROQUAD. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, TD
Symptoms: Chest discomfort, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received a TENIVAC vaccine and a PNEUMOVAX 23 vaccine yesterday in office. This morning she came into the office complaining of right deltoid pain, swelling and redness, dizziness, chest tightness, and nausea. Only the arm which the PNEUMOVAX was given in had the local reaction. No adverse reaction in the left arm where Td was given.
Age: 50.0
Sex: F
Vaccine: PPV, TD
Symptoms: Nausea
Clinical narrative: Patient received a TENIVAC vaccine and a PNEUMOVAX 23 vaccine yesterday in office. This morning she came into the office complaining of right deltoid pain, swelling and redness, dizziness, chest tightness, and nausea. Only the arm which the PNEUMOVAX was given in had the local reaction. No adverse reaction in the left arm where Td was given.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 24-year-old female patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. Approximately in 2010 (reported as "7 years ago"), the patient was vaccinated with the first dose of GARDASIL injection, intramuscularly (exact dose, lot # and expiry date were not reported). On 27-DEC-2016 the patient was vaccinated with another dose of GARDASIL injection, intramuscularly (exact dose, lot # and expiry date were not reported). No known adverse effects were reported. Product quality complaint was not involved. Additional information is not expected as no consent for further contact was granted.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 23-JUN-2017, the patient was vaccinated with an expired dose of VAQTA, lot # K018181 with expiry date on 04-JUN-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Anion gap, Blood glucose normal, Haemoglobin normal, Lethargy, Malaise
Clinical narrative: Pt was given above vaccines on 7/10/17. On 7/11/17 Pt was seen in  the ER due to feeling lethargic, generalized malaise and a near syncope episode at home.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Presyncope, Protein urine present, Urine ketone body present, White blood cell count increased
Clinical narrative: Pt was given above vaccines on 7/10/17. On 7/11/17 Pt was seen in  the ER due to feeling lethargic, generalized malaise and a near syncope episode at home.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site urticaria, Rash
Clinical narrative: Rash on abdomen, hives on upper left thigh. 5ml of Benadryl given. Rash developed within 2 hours of receiving vaccines, patient came back into office. Vital signs were stable. Provider saw patient.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: CLIENT STATED SHE AWOKE ON 7/11/17 WITH HIVE TO THE ANTICUBITAL AREA OF LEFT ARM. CLIENT STATED SHE NOTED MORE HIVES ON 7/12/17. CLIENT STATED SHE IS GOING TO HER PRIMARY.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Eye movement disorder, Face injury, Fall, Immediate post-injection reaction, Laceration
Clinical narrative: Vaqta and Gardasil administered in left deltoid without incident. Bexsero administered in right deltoid.  Immediately patient stated he didn't feel well, approximately 5 seconds later his eyes rolled up, he stiffened. Nurse attempted to restrain patient in chair, but patient jerked very hard away from nurse, fell out of chair, hitting face and chin on wall.  Fell face down. Appeared to have lost consciousness for approximately five seconds. Did not respond to verbal commands. Rolled to back by nurse. Quickly began speaking. Patient sustained small abrasions to lip and tip of nose. A larger cut, approximately 2.5 inches below chin, open. Area cleaned and ice applied. No other abrasions or cuts identified. Able to move all extremities. He may have chipped a tooth. He complained of left jaw pain but denied headache. Patient denied prior history of fainting or problems with vaccinations. Mother contacted and came to health department.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Loss of consciousness, Malaise, Musculoskeletal stiffness, Pain in jaw, Skin abrasion
Clinical narrative: Vaqta and Gardasil administered in left deltoid without incident. Bexsero administered in right deltoid.  Immediately patient stated he didn't feel well, approximately 5 seconds later his eyes rolled up, he stiffened. Nurse attempted to restrain patient in chair, but patient jerked very hard away from nurse, fell out of chair, hitting face and chin on wall.  Fell face down. Appeared to have lost consciousness for approximately five seconds. Did not respond to verbal commands. Rolled to back by nurse. Quickly began speaking. Patient sustained small abrasions to lip and tip of nose. A larger cut, approximately 2.5 inches below chin, open. Area cleaned and ice applied. No other abrasions or cuts identified. Able to move all extremities. He may have chipped a tooth. He complained of left jaw pain but denied headache. Patient denied prior history of fainting or problems with vaccinations. Mother contacted and came to health department.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Unresponsive to stimuli
Clinical narrative: Vaqta and Gardasil administered in left deltoid without incident. Bexsero administered in right deltoid.  Immediately patient stated he didn't feel well, approximately 5 seconds later his eyes rolled up, he stiffened. Nurse attempted to restrain patient in chair, but patient jerked very hard away from nurse, fell out of chair, hitting face and chin on wall.  Fell face down. Appeared to have lost consciousness for approximately five seconds. Did not respond to verbal commands. Rolled to back by nurse. Quickly began speaking. Patient sustained small abrasions to lip and tip of nose. A larger cut, approximately 2.5 inches below chin, open. Area cleaned and ice applied. No other abrasions or cuts identified. Able to move all extremities. He may have chipped a tooth. He complained of left jaw pain but denied headache. Patient denied prior history of fainting or problems with vaccinations. Mother contacted and came to health department.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pruritus, Pruritus, Rash
Clinical narrative: Every four or five days for the past month I broke out with an itchy place or places on my limbs. First on the left elbow and left foot, then right elbow, then left elbow again and left calf,  then right elbow again, then right thigh and right calf, then right upper arm.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Blood iron decreased, Fatigue, Influenza like illness, Iron deficiency anaemia, Lethargy
Clinical narrative: On 06/29/17, 72 yo F was seen in clinic for initial consult. During this visit, pt was ordered to receive IM PREVNAR 13 [IMM78]. Per immunization record, a volume of 0.5 mL was injected at 1058 AM into pt's left deltoid (NDC: 0005-1971-01; Lot #S06823). Pt was then discharged home. At 1822, pt called clinic and reported feeling fatigued described as run down feeling similar to having a cold or flu (pt reported that she napped twice today and felt she could go back to sleep) and forgetfulness (forgot where she put her cat's food). Pt thought this was related to immunization. This call was managed by triage RN. RN documented that the symptoms should be managed at home and "CARE ADVICE given per Immunization Reactions (Adult) guideline." On 07/11, pt sent an e-mail to provider stating "I had quite a reaction to the pneumonia shot--severe fatigue and lethargy such that all I wanted to do was sleep 10-11 hrs. at night, which I did, & rested during the day, I talked with a nurse in Call Center and she was very thorough in asking me questions. I'm over that now, , but it lasted through this past Saturday, (July 8) somewhat (began to taper off by then)." Of  Note: Pt's blood work showed mild iron deficiency anemia. On 06/30, a prescription was sent to pt's local pharmacy for ferrous sulfate 325 MG EC tablet with instructions to take one PO daily with breakfast.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Memory impairment, Viral upper respiratory tract infection
Clinical narrative: On 06/29/17, 72 yo F was seen in clinic for initial consult. During this visit, pt was ordered to receive IM PREVNAR 13 [IMM78]. Per immunization record, a volume of 0.5 mL was injected at 1058 AM into pt's left deltoid (NDC: 0005-1971-01; Lot #S06823). Pt was then discharged home. At 1822, pt called clinic and reported feeling fatigued described as run down feeling similar to having a cold or flu (pt reported that she napped twice today and felt she could go back to sleep) and forgetfulness (forgot where she put her cat's food). Pt thought this was related to immunization. This call was managed by triage RN. RN documented that the symptoms should be managed at home and "CARE ADVICE given per Immunization Reactions (Adult) guideline." On 07/11, pt sent an e-mail to provider stating "I had quite a reaction to the pneumonia shot--severe fatigue and lethargy such that all I wanted to do was sleep 10-11 hrs. at night, which I did, & rested during the day, I talked with a nurse in Call Center and she was very thorough in asking me questions. I'm over that now, , but it lasted through this past Saturday, (July 8) somewhat (began to taper off by then)." Of  Note: Pt's blood work showed mild iron deficiency anemia. On 06/30, a prescription was sent to pt's local pharmacy for ferrous sulfate 325 MG EC tablet with instructions to take one PO daily with breakfast.
Age: 54.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Amnesia, Aphasia, Blood test, Computerised tomogram, Hypoaesthesia
Clinical narrative: 5/20-Vaccine, 5/21-Fever-aches, 5/22-numbness in face/Left, 5/23 and 24 - loss of words/memory, speech, 5/24-Emergency Rm sent by Physician-CT scan, 5/25-MRI, 5/25-5/31-symptoms progress, 5/31-neurologist appt., 6/2-symptoms get worse hospital-4 days.
Age: 54.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: 5/20-Vaccine, 5/21-Fever-aches, 5/22-numbness in face/Left, 5/23 and 24 - loss of words/memory, speech, 5/24-Emergency Rm sent by Physician-CT scan, 5/25-MRI, 5/25-5/31-symptoms progress, 5/31-neurologist appt., 6/2-symptoms get worse hospital-4 days.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood pressure increased, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Patient received PCV23. Went to check out. Apprx 2-5 minutes after injection patient c/o feeling very hot, dizzy, fatigue, "funny", with upper back pain and spasms. BP became elevated.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Muscle spasms
Clinical narrative: Patient received PCV23. Went to check out. Apprx 2-5 minutes after injection patient c/o feeling very hot, dizzy, fatigue, "funny", with upper back pain and spasms. BP became elevated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Swelling
Clinical narrative: Rash, swelling and bump to left arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dermatitis bullous, Genital rash, Pruritus, Rash, Rash macular
Clinical narrative: Patient began developing itchy, small lesions on skin 2-4 days after she received the HPV vaccine.  New spots continued to appear over the past 10-12 days after the original spots. Patient states she has not been outdoors at all in that time frame or around any poison ivy, poison oak, or any other contact allergens. Patient didn't have cough, shortness of breath, tongue or lip swelling. Patient's rash is mainly on her neck and face, but she has some scattered lesions on her trunk and genitalia. Patient has numerous small MP/maculobullous lesions, and some hive-like.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Skin lesion, Urticaria
Clinical narrative: Patient began developing itchy, small lesions on skin 2-4 days after she received the HPV vaccine.  New spots continued to appear over the past 10-12 days after the original spots. Patient states she has not been outdoors at all in that time frame or around any poison ivy, poison oak, or any other contact allergens. Patient didn't have cough, shortness of breath, tongue or lip swelling. Patient's rash is mainly on her neck and face, but she has some scattered lesions on her trunk and genitalia. Patient has numerous small MP/maculobullous lesions, and some hive-like.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash papular
Clinical narrative: About 40 minutes post vaccines mom noticed a raised, fine, red, papular rash on left leg. Upon observing leg had a few other sports on right leg and 1 spot on right arm. And a few spots on belly and back. Denies trouble breathing. Patient nursing from mother after vaccines. Mucous membranes intact, no change in behavior, no itching or bother to patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unknown number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history and concomitant medications was provided. On unknown dates in 2017 (reported as "on or after 20-FEB-2017"), the patients were vaccinated with improperly stored VARIVAX lot# M023382 and expiry date: 11-MAY-2018, lot# reported as: L046837, expiry date 23-NOV-2017 (dose and route of administration were not provided). Properly stored sterile diluent (manufacturer unknown) was used to reconstitute the vaccine. VARIVAX was improperly stored in temperature from -9 to 8 Celsius degrees for 8 hours. Digital data logger was involved in detecting the temperature excursion. No previous temperature excursion took place. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On 22-JUN-2017, the patient was inadvertently administered one expired dose of PROQUAD lot # L044058, expiration date: 02-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (dose and route of administration were not reported). No adverse effects were reported.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-JUL-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 (lot, expiration, dose and route not reported) vaccine on or about 23-APR-2014, administered by a physician as recommended for routine adult health maintenance 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 18-APR-2016, the patient was treated by her physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed gabapentin (manufacturer unknown), LYRICA and CYMBALTA 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 expense, pain and suffering and other damages. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site rash, Pyrexia, Rash generalised
Clinical narrative: Rash at injection site on L arm started 7/11/17. No other symptoms. On 7/12/17 rash spread over whole body sparing neck and head with behind the knees worse. Fever of 100. No pain or SOB.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient's arm is sore, little swollen and red and she said she itches a little.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Rash
Clinical narrative: Patient went to dr this moring because his arm was red/rash. It covered a fairly large area extending down upper arm to the back, interior area of left arm. Dr diagnosed as cellulitis and prescribed clindamycin for the patient.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Appendicectomy, Appendicitis
Clinical narrative: Appendicitis. Treatment Appendectomy.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt. presents to ED C/O redness, pain and swelling at injection site gradually getting worse. Diagnosed with injection site reaction to Rt. upper arm with early cellulitis. Pt given AUGMENTIN 825 mg PO BID, MOTRIN and advised warm compresses as prophylaxis.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Helicobacter gastritis, Helicobacter test positive, Vomiting, Weight decreased
Clinical narrative: Severe mid Epigastric pain, vomiting, wt loss. Diagnosed with H. pylori gastritis. Symptoms started 7/1/16, Diagnosed 8/5/16.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left upper arm swelling, warmth, tenderness since vaccine administration on 7/3/2017.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: (L) arm pain-deltoid-unable to raise arm.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Hypotonia
Clinical narrative: Patient given HPV injection. Then preceded with Second injection which was MENACTRA. While given MENACTRA patient was talking then became limp. He leaned forward with eyes closed. Was held upright until assistance arrived to help while holding him upright. Vitals were monitored Pt. fully recovered within 15 mins. and given snack. He was monitored 20 more mins.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Neuralgia, Pain, Pruritus, Skin warm
Clinical narrative: Hot area, raised area, itchy, size of donut, red painful for 1 week. used anti itch cream, ice, 21/2 Hydrocortisone cream, nerve pain down arm sensitive to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Hot area, raised area, itchy, size of donut, red painful for 1 week. used anti itch cream, ice, 21/2 Hydrocortisone cream, nerve pain down arm sensitive to touch.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red rash started about 1 wk. after receiving MMR vaccine. Prednisone Dose Pk prescribed, MEDROL injection given.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Dysaesthesia, Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Patient had PREVNAR vaccination (at PCP office) 4/6/2016. I do not have lot #. 4-5 days later, she had onset of numbness from chest down consistent with transverse myelitis. She was hospitalized 4/12/2016-4/15/2016 and received IV SOLU-MEDROL. Symptoms improved but she has continued dysesthesias.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot area 3 days post injection - resolving on own.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Bed sharing, Death, Laboratory test, Muscle rigidity
Clinical narrative: Baby was co-sleeping between parents and was found unresponsive and already rigid at around 6:30 am. Last known awake time was 3-3:30 am. Resuscitation attempted by unsuccessful. Full autopsy report is not completed at this time but the latest I heard from the mother of the baby is that there was no obvious cause on the exam of the baby and internal organs. There are tissue sample tests pending.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: Baby was co-sleeping between parents and was found unresponsive and already rigid at around 6:30 am. Last known awake time was 3-3:30 am. Resuscitation attempted by unsuccessful. Full autopsy report is not completed at this time but the latest I heard from the mother of the baby is that there was no obvious cause on the exam of the baby and internal organs. There are tissue sample tests pending.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dry mouth, Ear pain, Injection site erythema, Lip dry
Clinical narrative: Starting at 3:00 pm on 7/11 right upper arm started hurting. By early evening I developed chills, body ache, dry mouth & lips, fever, some shooting ear pain (left side), which seemed strange).  Early morning on  7/12 I started to feel better. A red area around the shot area is still visible which is 2 x 3 inches.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Starting at 3:00 pm on 7/11 right upper arm started hurting. By early evening I developed chills, body ache, dry mouth & lips, fever, some shooting ear pain (left side), which seemed strange).  Early morning on  7/12 I started to feel better. A red area around the shot area is still visible which is 2 x 3 inches.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient passed out and hit her head on the back of a chair.  Recovered after a few seconds and awoke laughing.  Gave crackers and fluids po.  Patient states she felt fine after just a few minutes.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Swelling
Clinical narrative: Vaccine was given on 7/10/2017. Patient reports redness ans mild swelling 1-2 inches below injection site later in the day. 7/11/2017, area was raised and painful. 7/12/2017 she is seen in clinic, area of erythema and mild swelling  to left upper arm starting 2 inches from injection site measuring 16cmx 22cm.  TX: ice, NSAID, Benadryl.
Age: 17.0
Sex: M
Vaccine: FLUN4, MENB, MNQ
Symptoms: Activated partial thromboplastin time, Diarrhoea haemorrhagic, Full blood count, Prothrombin time
Clinical narrative: 5/17 - Episodes of bloody diarrhea intermittently - did not draw to med attention until 7/5/16. Denies abdominal pain. Referred to gastroenterology.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age, who was the reporter's husband. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 09-APR-2013, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration date were not reported). On 15-JUN-2017, the patient received another dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to patients of unknown demographics. On an unknown date(s) on or after 17-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lots # M047661, expiry date: 02-DEC-2018, M038856, expiry date: 14-SEP-2018, M033907, expiry date: 20-JUL-2018 and M025864, expiry date: 24-MAY-2018) for prophylaxis. The temperature excursion details for lots # M047661 (expiry date: 02-DEC-2018), M038856 (expiry date: 14-SEP-2018), M033907 (expiry date: 20-JUL-2018) and M025864 (expiry date: 24-MAY-2018) included: Temperature range: 15 degree Fahrenheit (F) to 46 degree F (-9 degree Centigrade (C) to 8 degree C): 5 hours 44 minutes on 17-MAY-2017. Temperature range: 6 degree F to 14 degree F (-14 degree C to 10 degree C): 9 hours 47 minutes on 18-MAY-2017, 9 hours 7 minutes on 19-MAY-2017, 9 hours 37 minutes on 20-MAY-2017, 9 hours 35 minutes on 21-MAY-2017, 9 hours 7 minutes on 22-MAY-2017,  9 hours 19 minutes on 23-MAY-2017, 9 hours 42 minutes on 24-MAY-2017, 9 hours 39 minutes on 25-MAY-2017, 9 hours 21 minutes on 26-MAY-2017, 9 hours 57 minutes on 27-MAY-2017, 10 hours 5 minutes on 28-MAY-2017, 10 hours 1 minutes on 29-MAY-2017, 9 hours 50 minutes on 30-MAY-2017, 9 hours 32 minutes on 31-MAY-2017, 9 hours 26 minutes on 01-JUN-2017, 7 hours 0 minutes on 02-JUN-2017, 6 hours 30 minutes on 21-JUN-2017, 11 hours 3 minutes on 22-JUN-2017 and 6 hours 43 minutes on 23-JUN-2017. Cumulative totals: 175 hours 35 minutes Information regarding previous temperature excursion was reported as undetermined. The call was due to a Digital Data Logger. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 06-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 27-JAN-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 16-APR-2016, the patient was treated by a physician of an urgent care facility for the onset of a vesicular rash accompanied by symptoms of weakened immunity, which was diagnosed as severe Herpes Zoster, or shingles. The female patient has been prescribed gabapentin, VALTREX, LYRICA, VESICARE, "NERONTIN", and oxycodone-acetaminophen to help manage her painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Emotional distress, Herpes zoster, Pain
Clinical narrative: Information had been received on 06-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 15-SEP-2011 at a medical group office facility, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 20-JAN-2014, the patient broke out with a blistering vesicular rash accompanied by symptoms of weakened immunity. On or about 12-JAN-2015 the male was treated (Treatment not specified) by a physician at the medical group office facility (same place where he received vaccination on or about 15-SEP-2011) in which his condition was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information had been received on 06-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 15-SEP-2011 at a medical group office facility, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 20-JAN-2014, the patient broke out with a blistering vesicular rash accompanied by symptoms of weakened immunity. On or about 12-JAN-2015 the male was treated (Treatment not specified) by a physician at the medical group office facility (same place where he received vaccination on or about 15-SEP-2011) in which his condition was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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, Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 06-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 03-JAN-2011 by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 17-JUN-2014, the patient was treated by a physician for a vesicular rash accompanied by symptoms of weakened immunity, which was diagnosed as severe Herpes Zoster, or shingles. The  patient was prescribed clotrimazole betamethasone cream for management of these painful symptoms. On or about 25-OCT-2015, the patient was treated by a physician at a Urgent Care facility for new and worsening symptoms of shingles outbreaks. The patient was then prescribed VALTREX and prednisone for her condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Blister, Diplopia, Eye pain, Herpes zoster
Clinical narrative: Information was received on 06-JUL-2017 from an attorney in the form of an initial spontaneous report regarding a male patient (age not provided). On or about 06-NOV-2014 the patient was vaccinated with ZOSTAVAX 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 and chronic strain of herpes zoster and herpes zoster eye keratitis. On or about 03-APR-2015, the patient was treated by a physician assistant for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. On or about each of the date of 15-APR-2015 and 11-MAY-2015, the patient was treated again by the physician for continued and worsening symptoms of shingles outbreaks that had spread onto his face. On or about each of the dates of 21-JUL-2015, and 25-AUG-2015, the patient sought further treatment for the physician for new and worsening symptoms of shingles that had now spread to the eyes and scalp. He was then referred to an Ophthalmologic specialist for blurred and double vision. On or about 28-JUL-2015, the patient was treated by a physician for vision interruptions and painful blistering in the eye, which was diagnosed as herpes zoster eye keratitis. On or about 21-OCT-2015, 24-NOV-2015, and 22-DEC-2015 the patient had a medical encounter, during which he was treated by the physician to address symptoms of pain and interruptions in vision resulting from herpes zoster eye keratitis. On or about each of the dates of 26-JAN-2016, 29-FEB-2016, 25-MAR-2016, 19-APR-2016, 06-JUL-2016 and 15-NOV-2016 the patient received ongoing  treatment for worsening and uncontrolled herpes zoster eye keratitis which triggered an array of visual impediments and vision loss. On or about 21-MAR-2016 and 22-SEP-2016 the patient was evaluated by his primary care physician for new shingles outbreaks on his body in addition to the vesicles in his eyes and face. He was prescribed acyclovir, NEXIUM, LOTEMAX GEL, Refresh eye drops, PERCOCET, valacyclovir, ZOVIRAX CREAM and ZIRGRAN eye drops to attempt to manage and relieve his painful symptoms and damage to his eyes. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, the events of persistent and chronic herpes zoster eye keratitis and vision loss were determined to be medically significant. Additional information has been requested.