chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Pruritus, Seroma, Swelling face, Ultrasound scan normal
Clinical narrative: The patient is a 46 yo female professional emergency room registered nurse with a history of hypothyroidism and cosmetic breast implants in 1998 with revision in 2012, who required drainage of a seroma and removal of a left breast implant with symptoms onset temporarily associated with receipt of employer mandated IIV FLUARIX (lot # 7AJ5J) to her left deltoid. She states the vaccine was given at approximately 10 om on 23 Sept 2015. She states she experienced immediate pain during injection and felt that it was incorrect technique (needle placed against skin then pushed in rather than smooth motion) but appropriate placement in her deltoid. She states the pain is localized to the upper arm, sensitive to pressure and had a continuous ache of sufficient intensity to wake her from sleep. She states the shoulder was not affected and had normal range of motion. She states several days later she noted mild edema to her axilla and her left breast experienced intermittent sharp pains, but denies lymphadenopathy. On October 3 she noted a continuous ache on her left breast and it was slightly hard and erythematous. Within 12 hours she had severe pain and was seen in the emergency room at hospital. Ultrasound was normal and she was treated with KEFLEX and released. She had no fever chills malaise arthralgias or myalgias. She states she had no fever on arrival to ER, but self checked because she felt hot while she was there and registered a temperature of 101.7. In 24 hours she developed erythema on the outer aspect of her left breast and was again seen by her surgeon and received IM ROCEPHIN and prescription for SEPTRA and AUGMENTIN. She was scheduled for surgical exploration and possible I and D on Thursday, October 8. On Tuesday, October 6 she woke with 'angioedema' described as edema to her upper lip and puffiness to her chin and mild pruritus to her lower extremities. She denies urticarial lesions, oral lesions, throat edema, conjunctivitis, rhinorrhea, dyspnea. Wheezing, chest pain cough, nausea, or emesis. She stated had mild anxiety but attributes to concerns for her health. She felt generalized malaise. She was seen in ER and again ultrasound did not demonstrate abnormalities. On Wednesday, October 7 the surgery center performed I and D and reported she had a sterile seroma. The culture was negative,  and the implant was intact but they remove the implant anyway. She reports the surgeon stated he has seen seromas secondary to vaccine receipt.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wrong technique in product usage process
Clinical narrative: The patient is a 46 yo female professional emergency room registered nurse with a history of hypothyroidism and cosmetic breast implants in 1998 with revision in 2012, who required drainage of a seroma and removal of a left breast implant with symptoms onset temporarily associated with receipt of employer mandated IIV FLUARIX (lot # 7AJ5J) to her left deltoid. She states the vaccine was given at approximately 10 om on 23 Sept 2015. She states she experienced immediate pain during injection and felt that it was incorrect technique (needle placed against skin then pushed in rather than smooth motion) but appropriate placement in her deltoid. She states the pain is localized to the upper arm, sensitive to pressure and had a continuous ache of sufficient intensity to wake her from sleep. She states the shoulder was not affected and had normal range of motion. She states several days later she noted mild edema to her axilla and her left breast experienced intermittent sharp pains, but denies lymphadenopathy. On October 3 she noted a continuous ache on her left breast and it was slightly hard and erythematous. Within 12 hours she had severe pain and was seen in the emergency room at hospital. Ultrasound was normal and she was treated with KEFLEX and released. She had no fever chills malaise arthralgias or myalgias. She states she had no fever on arrival to ER, but self checked because she felt hot while she was there and registered a temperature of 101.7. In 24 hours she developed erythema on the outer aspect of her left breast and was again seen by her surgeon and received IM ROCEPHIN and prescription for SEPTRA and AUGMENTIN. She was scheduled for surgical exploration and possible I and D on Thursday, October 8. On Tuesday, October 6 she woke with 'angioedema' described as edema to her upper lip and puffiness to her chin and mild pruritus to her lower extremities. She denies urticarial lesions, oral lesions, throat edema, conjunctivitis, rhinorrhea, dyspnea. Wheezing, chest pain cough, nausea, or emesis. She stated had mild anxiety but attributes to concerns for her health. She felt generalized malaise. She was seen in ER and again ultrasound did not demonstrate abnormalities. On Wednesday, October 7 the surgery center performed I and D and reported she had a sterile seroma. The culture was negative,  and the implant was intact but they remove the implant anyway. She reports the surgeon stated he has seen seromas secondary to vaccine receipt.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Breast pain, Breast prosthesis removal, Discomfort, Injection site pain, Mastitis
Clinical narrative: The patient is a 46 yo female professional emergency room registered nurse with a history of hypothyroidism and cosmetic breast implants in 1998 with revision in 2012, who required drainage of a seroma and removal of a left breast implant with symptoms onset temporarily associated with receipt of employer mandated IIV FLUARIX (lot # 7AJ5J) to her left deltoid. She states the vaccine was given at approximately 10 om on 23 Sept 2015. She states she experienced immediate pain during injection and felt that it was incorrect technique (needle placed against skin then pushed in rather than smooth motion) but appropriate placement in her deltoid. She states the pain is localized to the upper arm, sensitive to pressure and had a continuous ache of sufficient intensity to wake her from sleep. She states the shoulder was not affected and had normal range of motion. She states several days later she noted mild edema to her axilla and her left breast experienced intermittent sharp pains, but denies lymphadenopathy. On October 3 she noted a continuous ache on her left breast and it was slightly hard and erythematous. Within 12 hours she had severe pain and was seen in the emergency room at hospital. Ultrasound was normal and she was treated with KEFLEX and released. She had no fever chills malaise arthralgias or myalgias. She states she had no fever on arrival to ER, but self checked because she felt hot while she was there and registered a temperature of 101.7. In 24 hours she developed erythema on the outer aspect of her left breast and was again seen by her surgeon and received IM ROCEPHIN and prescription for SEPTRA and AUGMENTIN. She was scheduled for surgical exploration and possible I and D on Thursday, October 8. On Tuesday, October 6 she woke with 'angioedema' described as edema to her upper lip and puffiness to her chin and mild pruritus to her lower extremities. She denies urticarial lesions, oral lesions, throat edema, conjunctivitis, rhinorrhea, dyspnea. Wheezing, chest pain cough, nausea, or emesis. She stated had mild anxiety but attributes to concerns for her health. She felt generalized malaise. She was seen in ER and again ultrasound did not demonstrate abnormalities. On Wednesday, October 7 the surgery center performed I and D and reported she had a sterile seroma. The culture was negative,  and the implant was intact but they remove the implant anyway. She reports the surgeon stated he has seen seromas secondary to vaccine receipt.
Age: 27.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Dyspnoea, Malaise, Sensation of foreign body, Throat tightness
Clinical narrative: Patient felt a hair like sensation in throat. Difficulty breathing. Felt like throat was closing. Thinks it was caused from Varicella vaccine that was administered 3 days prior. Patient did not feel well after Vaccines were administered on 10/22/15. She called Vaccine hot line and was instructed to see physician.
Age: 56.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: PREVNAR and TDAP both reaction red warm and a knot underneath skin.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: The injection was too high on the deltoid muscle. The bursa fluid isn't meant to have a flu virus antigen mixed in with it. I may need an MRI to see if my rotator cuff is damaged and physical therapy. (SIRVA).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (lot # L01067, expiration date 14-APR-2017, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent for follow-up.
Age: 1.04
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12 months-old patient of unknown gender. On 29-JUN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. On an unknown date, those patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX injection (strength, dose, route and site of administration were unspecified). No concomitant medications were reported. No adverse event were reported. This is one of several reports from the same source. Additional information is not expected as the reporter refused any further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (Merck) (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been receive don 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of VARIVAX (Merck) on 17-SEP-2015. It was also reported that the vaccine was 2470 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Follow-up information was received on 03-AUG-2105 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-months-old patient of unknown gender. On 26-JUN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event and narrative were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. On unknown date, those patients were vaccinated with the improperly stored doses of ZOSTAVAX injection (strength, dose, route and site of administration were unspecified). No concomitant medications were reported. No adverse event were reported. This is one of several reports from the same source. Additional information is not expected as the reporter refused any further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, two improperly stored dose of VAQTA (lot # L028666, expiration date 04-NOV-2016, exact doses and route of administration were not reported) had been administered to the patients. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent for follow-up.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration dates and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12 months-old patient of unknown gender. On 02-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, even and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, improperly stored doses of M-M-R II (lot # L001336, exp. 13-JAN-2017 (route of administration, dose were not reported) were administered to unspecified patients. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12 months-old patient of unknown gender. On 22-JUN-2015 the patient was vaccinated with a dose of (Merck) VARIVAX (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patients's details, product, event and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with the improperly stored doses of (Merck) VARIVAX (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot# L00827) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant,. The reporter provided that he patient of unknown age and gender was vaccinated with the improperly stored dose of VARIVAX (Merck) on 17-AUG-2015. It was also reported that the vaccine was 1296 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Patient had swelling; red patch and possible infection. MD gave her antibiotics.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypotonia, Radiculitis brachial
Clinical narrative: Patient reported arm being numb and limp. PCP dx as brachial neuritis.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Local reaction, Neck pain, Pain, Pyrexia
Clinical narrative: Local reaction - arm swollen at inj. site, vomiting, fever, achy, neck soreness.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Local reaction - arm swollen at inj. site, vomiting, fever, achy, neck soreness.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: Severe shingles outbreak on lower abdomen/low back (one of the worst cases provider has ever seen) started with severe back pain resulting in ER visit, then progressed to shingles rash 3-4 days later.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain in extremity, Poor quality sleep, Sleep disorder
Clinical narrative: Within several hours of receiving the Tdap vaccine, I had fierce pain in my right arm.  Having been advised of the potential pain, when scheduling the appointment for this vaccine, I assumed my symptoms were normal.  As a result, I did not seek medical treatment.  Over the next two days, the pain intensified to the point that I was unable to utilize my right arm.  On Tuesday, November 25, 2014, I returned to the employee health clinic.  I informed the nurse that I recently had a Tdap vaccine & asked to have my arm examined.  On a scale of one to ten, I described my pain as a ten.  The nurse did not examine my arm & informed me that "these symptoms are normal after a Tdap vaccine."  On Friday, December 12, 2014, I returned to the employee health clinic & asked to have my right arm examined.  I provided a brief history & expressed my concern about the excruciating pain & loss of functionality in my right arm.  The nurse did not examine my arm, but suggested that "you may have a blood clot under the skin."  I was instructed to take Motrin & apply a hot compress to the swollen & sore area of my right arm.  This comment just heightened my state of anxiety. Over the next seven months, I continued to suffer from excruciating pain in my right arm & shoulder.  I also lost a great deal of functionality in my right arm.  I truly can no longer perform activities of daily living.  The level of pain changes throughout the day.  If I happen to sleep on my right side, the intense pain will wake me from a deep sleep.  The pain & anxiety will last for several hours.  If I take Motrin & lay flat on my back, the pain will diminish but not disappear.  If I refrain from lifting anything with my right arm or performing activities with a repetitive motion, the pain is still chronic, but decreases to a minimal level.  On a scale of one to ten, I would describe minimal level as a three.  On most days, I take Motrin to alleviate the pain & utilize my right arm sparingly.  On Wednesday, June 24, 2015, I returned to the employee health clinic again & asked to have my arm examined.  The nurse did not examine my arm, but advised me to submit a claim with Workers Compensation.  Following the instructions provided by my employer, I scheduled a visit at Occupational Medicine.  An MRI was scheduled, but not completed.  At my next appointment, physical therapy & an orthopaedic consultation were ordered.  A few days later, I received a phone call from a claims representative at the insurance company.  The woman prefaced the conversation by saying "I am not a clinician."  She proceeded to inform me that "I have been doing this for a long time & there is no way that an injection in your arm could cause an injury to your shoulder."  She then advised me that my case was closed & any future appointments or treatments would be denied.  I canceled the physical therapy & orthopaedic consultation.  A year has passed since I received the Tdap injection.  The pain & loss of functionality in my right arm have caused a great deal of frustration & anxiety.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red and Hard Arm at injection site.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bacterial test negative, Central venous catheterisation, Diarrhoea, Diet refusal, Fatigue
Clinical narrative: 06/01/15: Symptoms included diarrhea, vomiting, stopped nursing, extreme tiredness. Took him to the doctor's office on Monday afternoon, June 1, 2015. They said he may have a milk allergy and sent him home. The next day he was rushed to the ER and stayed in the hospital for the next 17 days.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Gastrointestinal tube insertion, Laboratory test normal, Transfusion, Viral test negative, Vomiting
Clinical narrative: 06/01/15: Symptoms included diarrhea, vomiting, stopped nursing, extreme tiredness. Took him to the doctor's office on Monday afternoon, June 1, 2015. They said he may have a milk allergy and sent him home. The next day he was rushed to the ER and stayed in the hospital for the next 17 days.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood test, Body temperature increased
Clinical narrative: HEADACHE-STOMACH ACHE-JOINT PAIN BACKACHE-NECK ACHE-ON 11/4-CHEST PAIN NAUSEA ALONG WITH OTHER SYMPTOMS TEMP 101 B/P 70 OVER 40 THOUGHT I WAS HAVING HEART ATTACK AMBULANCE CALL ENDED IN ER.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cardiovascular examination, Chest X-ray, Chest pain, Headache, Nausea
Clinical narrative: HEADACHE-STOMACH ACHE-JOINT PAIN BACKACHE-NECK ACHE-ON 11/4-CHEST PAIN NAUSEA ALONG WITH OTHER SYMPTOMS TEMP 101 B/P 70 OVER 40 THOUGHT I WAS HAVING HEART ATTACK AMBULANCE CALL ENDED IN ER.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: HEADACHE-STOMACH ACHE-JOINT PAIN BACKACHE-NECK ACHE-ON 11/4-CHEST PAIN NAUSEA ALONG WITH OTHER SYMPTOMS TEMP 101 B/P 70 OVER 40 THOUGHT I WAS HAVING HEART ATTACK AMBULANCE CALL ENDED IN ER.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red and Hard arm around injection site.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Pyrexia, Skin warm, Swelling
Clinical narrative: Swelling on arm, warm feeling, fever, itch.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 61 year old female patient with hypothyroidism. On 28-OCT-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously over her deltoid, lot # K020801, expiration date 31-JAN-2016 (dose was not reported). Concomitant therapies included hypothyroidism medication (unspecified). Nurse reported that within 24 hours of administration, the patient developed pain in her thigh. On 30-OCT-2015, the patient developed a rash at an unspecified location. It was reported that the patient sought medical attention by visiting her physician in the office on 31-OCT-2015 and was diagnosed with shingles. The patient was prescribed TYLENOL W to treat the pain and VALTREX to treat the rash. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered from pain in the thigh and shingles. The reporting nurse considered the events pain in the thigh and shingles as disabling as the patient missed work for couple of days. This is one of two report received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in October 2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # K019933 and expiration date 20-APR-2016; lot # reported as L014420 and expiration date 23-FEB-2017; exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received has been requested. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' history, concurrent conditions and concomitant therapies was provided. On unspecified dates in October 20115, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # J011963 and expiration date 20-JUN-2016; L004740 and expiration date 16-NOV-2017; lot # L014427 and expiration date 09-MAR-2018; exact doses and route of administration were not reported). No adverse effects were reported. No PQC (Product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in October 2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L001312 and expiration date 24-FEB-2017; lot # L007560 and expiration date 15-JUN-2017; lot # L013429 and expiration date 21-JUL-2017; exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were administered doses of improperly stored Oral, ROTATEQ lot # K015816, expiration date reported as 29-MAY-2016, (dose was not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in October 2015, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K015816 and expiration date 29-MAY-2016; lot # L008057 and expiration date 01-DEC-2016; lot # K016279 and expiration date 24-APR-2016; exact doses were not reported, route of administration defaulted to oral). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patients were administered doses of improperly stored GARDASIL lot # K007264, expiration date reported as 02-MAR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On an unknown date, the patient was vaccinated an improperly stored dose of RECOMBIVAX HB (lot # K010535 exp. 27-AUG-206) (dose, route and frequency were unspecified). Concomitant medication was not reported. no adverse event was informed. These was not a product quality complain involved. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient with penicillin allergy. On 13-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, route and site of administration were not reported). In approximately 2015, the patient experienced bronchitis. On 05-NOV-2015, she was seen in an unspecified urgent care center for bronchitis. The patient was released from the urgent care center and prescribed prednisone for treatment. The outcome of bronchitis was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Asthma, Circulatory collapse
Clinical narrative: This spontaneous report as received from a patient's parent via Sanofi Pasteur MDS refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb vaccine (manufacturer unknown) (dose, lot# and route of administration were not reported). On an unknown date, the patient collapsed and suffered from getting the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) shot. The patient was taken to emergency room (ER) and got asthma which she did not have prior to the vaccination. The outcome of the events was not reported. Relatedness between asthma and quadrivalent human polyomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) was not reported. Additional information is not expected because the reporter contact details were not provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. During the time period of 30-OCT-2015 through 04-NOV-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L014419, expiration date 15-APR-2017) (dose and route were not reported). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: 65 y/o male received TDAP vaccine and reported tingling feeling all over approximately 2-3 hours after vaccine. Has > 5 allergies to other medications- similar reactions reported. Diphenhydramien 25 mg other.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme, Pruritus, Urticaria
Clinical narrative: Erythema multiforme and urticaria pruritus.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received from 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doss of (Oka/Merck) VARIVAX (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of (Oka/Merck) VARIVAX on 01-SEP-2015. It was also reported that the vaccine was 1656 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: Headache.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Merck) VARIVAX. Follow up information has ben received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if the information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old (reported as 1-year-old) patient of unknown gender. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L003775. The vaccine was purchased with public funds as a part of vaccine program. This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Age: 1.28
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported.  Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 15 months-old patient of unknown gender. On 13-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified amount of improperly stored doses of PNEUMOVAX 23, lot # K007262, expiration date 25-NOV-2015 (dose, route of administration and indication were not provided). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and drug reactions or allergies was reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot number L001325 and expiry date: 13-JAN-2017, (dose, route of administration and injection site were not provided). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information has been received on 03-AUG-2015 informing that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received on 05-AUG-2015 from the reporting certified medical assistant via telephone call. The Certified Medical Assistant reported that she would have to research the request made for patients identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old patient of unknown gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot number was confirmed as L001325 with an expiry date of 13-JAN-2017. This is one of the several reports received from the same reporter. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
Sex: F
Vaccine: RV5
Symptoms: Dysphagia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple female infants between the ages of 2 and 4 months. It was reported that the patients had no medical history and no drug reactions or allergies. On an unknown date the patients were vaccinated with ROTATEQ, oral. It was reported that the patients were not on any medications concomitantly. On an unknown date the patients had difficulty swallowing during administration. It was reported that the patient sought medical attention and also reported that the event occurred in office. It was reported that no treatment was given for the events. There was no lab diagnostics studies performed. It was also reported that the did not experience any further difficulty with swallowing after administration. The action taken with the therapy with ROTATEQ was unknown. The outcome of dysphagia was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. There was no product quality complaint reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Dysphagia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple male infants between the ages of 2 and 4 months. It was reported that the patients had no medical history and no drug reactions or allergies. On an unknown date the patients were vaccinated with ROTATEQ, 2 ml, oral. It was reported that the patients were not on any medications concomitantly. On an unknown date the patients had difficulty swallowing (dysphagia) during administration. It was reported that the patients sought medical attention and also reported that the event occurred in office. It was reported that no treatment was given for the events. There was no lab diagnostics studies performed. It was also reported that the did not experience any further difficulty with swallowing after administration. The action taken with the therapy with ROTATEQ was unknown. The outcome of dysphagia was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. There was no product quality complaint reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Merck) VARIVAX. Follow up information has ben received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old (reported as 1-year-old) patient of unknown gender. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L003775. The vaccine was purchased with public funds as a part of vaccine program. This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot # L016428, expiration date: 30-JUL-2017, dose and route were unknown). The patients' concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to four patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with ROTATEQ orally (dose, dose number and lot# were not reported), which was improperly stored. No adverse effects were reported. On 19-OCT-2015, a phone call was placed to the registered nurse, who was unable to provide the patient's identifiers at that time. Follow-up information has been received from the registered nurse on 20-OCT-2015. A 11-week-old patient (gender unknown) was vaccinated with improperly stored doses of ROTATEQ lot# K016261, orally and RECOMBIVAX HB lot# L004754 (dose and route not reported), both administered on 31-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested.