chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a 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 (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 (Merck) VARIVAX on 10-AUG-2015. It was reported that the vaccine was 1012 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.
Sex: U
Vaccine: HEPA
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, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of VAQTA (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
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, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of (Merck) VARIVAX (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a 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 (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 (Merck) VARIVAX on 14-AUG02015. It was also reported that the vaccine was 1224 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: 0.5
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient. On an unknown date, the patient was vaccinated with ROTATEQ but the baby spit up ROTATEQ. The physician wanted to know if the dose to be repeated or not. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt. reports swollen, tender arm at injection site x 4 days.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 63 year old female patient. No medical history and drug allergies were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No concomitant therapy was reported. On an unknown date the patient developed an unspecified cancer. The patient would start an unspecified chemotherapy soon. The patient sought medical attention-unspecified. The outcome of unspecified cancer was reported as not recovered/not resolved. The action taken was not applicable. The causality of the reported event was unknown. Upon internal review, the event unspecified cancer was considered to be medically significant. Additional information has been requested.
Age: 1.03
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 (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 patient 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 20-JUN-2015, the patient was vaccinated with improperly stored dose of (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.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave expired vaccine (4/15) (no effects).
Age: 4.0
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 (Merck) VARIVAX, lot number L003775 and expiry date: 04-FEB-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. Lot number L003775 with an expiry date of 04-FEB-2017 has been verified to be a valid lot number for (Merck) VARIVAX. 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 patient 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 4-year-old patient of unknown gender. On 21-SEP-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot number was confirmed as L003775 with an expiry date of 04-FEB-2017. This is one of several reports received from the same reporter. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Feet broke out in Hives several hours after receiving Flu shot on 10/26 feet very itchy red and covered in welts per mom's description, mom gave bath and treated with BENADRYL.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient did not have any pertinent medical history and drug reactions/allergies. The patient's concomitant medications were not reported. On 25-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, subcutaneous, lot # L016284, expiration date 07-AUG-2016). On an unspecified date following the vaccination, in October 2015 (on or after 25-OCT-2015), the patient developed pain, redness, bruising, and itching at the injection site. The patient sought medical attention by visiting the pharmacist. There was no treatment given for the adverse events. No laboratory tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: Oct 6 she woke up with pain when she moved her arm over her head or behind her. She is currently seeing her ortho MD and getting an MRI.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2016, strength, dose, lot#, expiration date and route were unknown. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Cough, Eye pruritus, Myalgia, Oropharyngeal pain
Clinical narrative: Symptoms started 10-26-15 - date vaccine. Fever, arthralgia, myalgia, sore throat, itchy eyes, dry cough.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Symptoms started 10-26-15 - date vaccine. Fever, arthralgia, myalgia, sore throat, itchy eyes, dry cough.
Age: 1.01
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 (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 patient 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 24-JUN-2015, the patient was vaccinated with improperly stored dose of (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.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Eye pain, Nasopharyngitis
Clinical narrative: 2 day after flu shot I had sore eyes. 3 day coughing. 4 day coughing, hoarseness. Cold like for days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date 17-SEP-2016, strength, dose, lot#, expiration date and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB with lot number L014429 and expiry date- 15-MAR-2018 (dosing regimens unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to PEDVAXHIB. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reaction - redness, warmth, and itchiness widespread over upper arm around injection site.
Age: 1.04
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 23-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. Patient's details, product, event and narrative were updated.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Mother reported child with full body rash 1 day after admin of flu vacc. Child without fever or any other symptoms especially site specific reaction.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 22-OCT-2015, the patient was accidentally vaccinated with an expired dose of M-M-R II lot # J013069, expiration date 16-OCT-2015, (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Information has been received from a physician via Pfizer referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot#, dose and route were unknown) and experienced a arthus reaction with this vaccine. The patient's concomitant medication was not reported. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 0.15
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: Flu shot administered 10/17/15 at 3PM. By 11 PM chills, fever (100.1) general weakness were experienced. Weakness lasted five days along with pain in left arm. Arm extremely sore and felt very heavy.
Sex: U
Vaccine: PPV
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 PNEUMOVAX 23 (lot # K018183, expiration date 04-MAY-2016) (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.
Sex: U
Vaccine: HPV4
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 GARDASIL (lot # K006960, expiration date 18-FEB-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: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 month 17 day, old female patient. The patient had received birth dose of Hepatitis B vaccine. The patient was born with anti-kell (isoimmune haemolytic disease) but had no complications. Patient's mother was concerned about a rash spreading down her legs from the groin area. The patient was a well-baby, well developed and well nourished. Upon general examination, the patient was found to be alert and active. Patient had normal muscle tone and strength, normal sensations, no ataxia and no abnormal reflexes. The patient had no known drug allergy. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015 (also reported that date of visit was 31-AUG-2015), the patient was vaccinated with improperly stored (incorrect product storage) (Merck) VARIVAX lot # L008273, 0.5 ml in the left vastus lateralis. Patient was concomitantly vaccinated with MMR II and HAVRIX. The patient's other medications included cetirizine when required for allergies, nystatin and fluoride. Outcome of the incorrect product storage was not known. There were no adverse effects. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients pertinent medical history and drug allergies were not reported. On unknown dates, the patients received either one or two doses of GARDASIL (dose, strength and route unknown). On  unspecified dares, the patients were administered either one or two doses GARDASIL 9 (dose, strength and route unknown), to complete their three-dose HPV vaccination series (interchange of vaccine products). No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Ear discomfort, Tinnitus, Tympanic membrane disorder
Clinical narrative: Pt rec'd vaccine on 10/12/15. On 10/29/15 he complained of an increase in his preexisting condition of tinnitus and new onset pressure in left ear. Exam reveals both eardrums are not WNL - sent him to his PCP. Doubtful caused by vaccination.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pain at site of injection, shoulder area, lower arm area. Rash at site of injection; outer arm, inner arm, at wrist, inside of left thumb. Injection was on the left arm. I went to the pharmacy where I received the Flu vaccine on 11/2/15. I reported to the pharmacist about the pain (sometimes extreme) and showed her the rash. She, I was told, reported it to the manufacturer. I was told to take Ibuprofen for the pain and BENADRYL for the rash, as directed. My only concern at this time is for the pain and rash to go away and not have any adverse effect on my health.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Flushing, Injection site erythema
Clinical narrative: States received flu vaccine around 10 AM and approx 3 hours later (1:00 pm) developed flushing, hot feeling to neck. Went to ED for evaluation: noted flushing to upper chest and under neck. (L) upper arm erythema approx 4-5 cm diameter. No wheals or other rash. Denies prior h/o allergy or reaction to flu shot or eggs.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness in arm continued for over 3 weeks and hurt when raising arm above head.
Age: 2.0
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. 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 2-year-old patient of unknown gender. On 29-JUN-2015, the patient was vaccinated with a dose of (Merck) VARIVAX (lot number 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.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nodule, Pruritus
Clinical narrative: I was to get a yearly physical and lab work done. I was asked if I wanted the pneumonia vaccine, and I decided to have this injection. I did not sign a form that vaccine could have any side effects. I went home and several hours later I began to itch. I then called the doctor's office and they said to take some BENADRYL. I again called the office the next day (August 12th), and they told me that I should go to the E.R. I talked to the guy on the phone, and ask him to please talk to the doctor. I received no call that evening, but I found out later that they had called me Thursday morning (August 13th). I was on the way to their office, because I wanted one of them to look at my arm. It was then red all the way down my arm with a huge know below my elbow. They reminded me that this was not a walk-in clinic and they took appointments. Of course, I though they might make an exception because of the severity of my arm. The office told me that I could have an appointment at 1:00 p.m., but I had an appointment with an orthopedic doctor. I asked if I could wait and see if they could work me in. She reminded me again that they only took appointments, and I could see the doctor at 1:00 p.m. They had not any cancellations. I had waited for two hours, and left approximately at 11:35 a.m. I called my husband, and he told me to go back in the office and ask for the office manager. When I went back in the office, the gal at the front desk told me that she had just called my name. I finally saw the office manager and not the doctor. I ask for my medical records since I could not see the doctor. She told me that there would be a charge for my medical records. I told her no since they had not treated me like a doctor should treat a patient. Later in the afternoon, I went to E.R. I did have cellulitis in my arm and they had to give me an IV of antibiotics. They did a test to make sure there was not a blockage in the blood flow of my arm. I was also sent home with a bacterial antibiotics and pain medicine to take at home. I believe I was treated unfairly and they did not have me sign any form. This is very serious and if it is not treated you could die. I now have received a certified letter that they would only treat me on an emergency basis for approximately 30 days. They did not see me on an emergency basis when I had a reaction to a vaccine that the doctor's office administered.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of an unknown age. The patient's concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9, both, intramuscularly (unknown strength and lot#). Concomitant medications were not reported. The physician stated that after receiving the injection, the patient fainted on an unknown date. It could not be determined if the injection was GARDASIL or GARDASIL 9. The outcome of the event was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored M-M-R II injection (lot # K021151, expiry date: 02-NOV-2016, strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.07
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 been 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 01-AUG-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot # L003775. The vaccine was. 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: 1.15
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 been 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 13-month-old (reported as 1-year-old) patient of unknown gender. On 01-OCT-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 a 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: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes virus infection, Influenza, Rash, Skin infection, Testicular swelling
Clinical narrative: I have had four (4) flu shots over the last 35 plus years with three (3) different doctors. Dr who retired Sept. 1994, from family practice was my doctor for 30 years. He passed away recently. He gave me my first two shots, both times I came down almost immediately with the flu. These shots were given years apart because when I came down with the flu the first time, I was hesitant to get another shot. He said it was just a coincidence until I got the flu again. Another Dr moved into his offices. He was my doctor from Sept. 1994 to March 2000, he gave a shot between those years and again I got the flu. Yet another Dr has been my doctor since Jan. 2014. I had no medical coverage between the two. He gave me the flu shot Sept. 16, 2015. He was told about the first three (3) shots. This was the first time I have received an information sheet. I did have flu symptoms, but not full blown flu. I also got a severe rash/infection at my surgical site for my left hip replacement scar. This procedure was performed July 2014, also sustained severe swelling and hardness of my testicles similar to that of a regulation size soft ball and a rash on my buttocks. I do have a small case of herpes that doesn't affect my testicles or my entire buttock region. I had to take two antibiotics for three weeks to clear these conditions. As it stands now, I know I cannot or will not take any flu shots in the future. Apparently, I am one of a few people who should not receive these shots.
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 (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 certified medical assistant via telephone call. The Certified Medical Assistant reported that she would have to research the request made for patient 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 22-JUN-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot number was confirmed as L001325 with an expiry date of 13-JAN-2017. This is one of several reports received from the same reporter. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Dizziness, Malaise, Pain, Syncope
Clinical narrative: Aches, malaise, chills, syncope, dizziness, urinary incontinence.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urinary incontinence
Clinical narrative: Aches, malaise, chills, syncope, dizziness, urinary incontinence.
Age: 1.02
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 been 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 11-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: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: "I also received a flu shot and the pain has not gone away.  Although I thought it was just me & old age, it turns out others have the same symptoms.  Someone mentioned info about an incident report."  "I wish I would've taken a picture but had a bruise was on my arm for 2 weeks."
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inflammation, Skin warm, Swelling, Trismus
Clinical narrative: On evening of 11/05 patient noticed her right jaw cramping.  It continued to cramp intermittently while eating.  Significant swelling approximetly 1 inch out beginning at front of right ear to middle of her cheek.  Swollen area was inflamed with heat.  By am 11/06 swelling had gone done to normal, jaw with no discomfort on eating.  Swelling on same side as Prevnar 13 vaccine.  Patient feels the vaccine caused the reaction.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Haematochezia, Malaise, Pain, Pyrexia
Clinical narrative: Did not feel well, mild fever of 100.4, seemed achy, blood in stool next morning and for 2 days, but not in every stool.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection, it swelled up ALOT and became very itchy and warm to the touch.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed pain in her right shoulder and swelling and redness at the injection site. Treated with ABX by her PCP. Still having pain in the right shoulder and now in the right elbow.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Cold sweat, Erythema, Nausea, Skin warm, Urticaria
Clinical narrative: Redness, welps, warm, she felt clammy and nauseous.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Fever of 100+, chills, muscle aches, pain at site of injection, extreme fatigue, unable to lift arm lasting for over 24 hours.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever of 100+, chills, muscle aches, pain at site of injection, extreme fatigue, unable to lift arm lasting for over 24 hours.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site with pain. Redness spread down arm toward bicep.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient woke up with arm soreness and a swollen hand.  He states that hand is swollen difficult to close.  Right hand, same arm as Afluria administered previous day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Injection site pain, Mobility decreased
Clinical narrative: Nausea, chills, extreme fatigue, intense pain at site of injection, headache, unable to lay on left side, unable to lift arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Nausea, chills, extreme fatigue, intense pain at site of injection, headache, unable to lay on left side, unable to lift arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: Patient stopped by pharmacy on 11/6 to let us know that she had developed an injection site reaction. The site was red and inflamed. Patient noted that it was significantly larger yesterday. In addition, she noted that she had developed blisters on the roof of her mouth, a headache and achy joints. She noted that this all occurred on 11/5 (she was vaccinated on 11/2 without incident). She was advised to notify her PCP of the reaction as well. She is better today. Injection site still reddened.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering
Clinical narrative: Patient stopped by pharmacy on 11/6 to let us know that she had developed an injection site reaction. The site was red and inflamed. Patient noted that it was significantly larger yesterday. In addition, she noted that she had developed blisters on the roof of her mouth, a headache and achy joints. She noted that this all occurred on 11/5 (she was vaccinated on 11/2 without incident). She was advised to notify her PCP of the reaction as well. She is better today. Injection site still reddened.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Tremor
Clinical narrative: PATIENT HAD NO REACTION RIGHT AFTER VACCINE WAS ADMINISTERED AND ROUGHLY 20 MINUTES LATER HAD FLUSHING SHAKINESS AND FELT LIKE MAYBE SHE WOULD PASS OUT BECAUSE OF THE UNEASY FEELING - EMS CAME AND TOOK HER TO HOSPITAL BUT DOCTOR WAS NOT SURE WHY SHE HAD REACTION -- NO ALLERGIES TO MEDICATIONS.
Age: 59.0
Sex: M
Vaccine: RAB
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Complained of feeling feverish, queasy and nauseous since after receiving rabies vaccine. Complained of pain at injection site, states much more sore than previous vaccination. Denied any serious problems or severe allergic reaction.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Blood test, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: After the pt. received Havrix 0.5ml IM (ped dose), she started feeling unwell on the drive home. Symptoms reported are: nausea, fatigue, headache, vertigo, fever (100.5). The next morning she reported a bit of shortness of breath upon waking up, but that went away. There was no redness or swelling at the injection site. Mom called our office (11/5/15) and was encouraged to see her family doctor.  They went to Clinic 11/5/15. Lab testing showed a high white cell count and the provider prescribed a Z-pack. Mom reported that patient slept most of 11/5/15.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Pyrexia, Vertigo, White blood cell count increased
Clinical narrative: After the pt. received Havrix 0.5ml IM (ped dose), she started feeling unwell on the drive home. Symptoms reported are: nausea, fatigue, headache, vertigo, fever (100.5). The next morning she reported a bit of shortness of breath upon waking up, but that went away. There was no redness or swelling at the injection site. Mom called our office (11/5/15) and was encouraged to see her family doctor.  They went to Clinic 11/5/15. Lab testing showed a high white cell count and the provider prescribed a Z-pack. Mom reported that patient slept most of 11/5/15.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Vasculitis
Clinical narrative: Bruise upon injection almost - no tx redness below injection site - mild vasculitis - patient will continue to watch area.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Basophil percentage, Blood albumin, Blood alkaline phosphatase
Clinical narrative: Within 30 minutes after receiving Influenza vaccine, developed throat tightness, oral swelling, vocal change. See in E.D., received x 3 I.M. doses Epinephrine, then an Epinephrine infusion. Admitted to ICU. Discharged 10-16-15.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood glucose
Clinical narrative: Within 30 minutes after receiving Influenza vaccine, developed throat tightness, oral swelling, vocal change. See in E.D., received x 3 I.M. doses Epinephrine, then an Epinephrine infusion. Admitted to ICU. Discharged 10-16-15.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Blood potassium, Blood sodium, Blood urea, Carbon dioxide, Dysphonia
Clinical narrative: Within 30 minutes after receiving Influenza vaccine, developed throat tightness, oral swelling, vocal change. See in E.D., received x 3 I.M. doses Epinephrine, then an Epinephrine infusion. Admitted to ICU. Discharged 10-16-15.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Eosinophil percentage, Full blood count, Glomerular filtration rate, Haematocrit, Haemoglobin
Clinical narrative: Within 30 minutes after receiving Influenza vaccine, developed throat tightness, oral swelling, vocal change. See in E.D., received x 3 I.M. doses Epinephrine, then an Epinephrine infusion. Admitted to ICU. Discharged 10-16-15.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Intensive care, Lymphocyte percentage, Metabolic function test, Monocyte percentage, Mouth swelling
Clinical narrative: Within 30 minutes after receiving Influenza vaccine, developed throat tightness, oral swelling, vocal change. See in E.D., received x 3 I.M. doses Epinephrine, then an Epinephrine infusion. Admitted to ICU. Discharged 10-16-15.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Neutrophil percentage, Platelet count, Protein total, Throat tightness, White blood cell count
Clinical narrative: Within 30 minutes after receiving Influenza vaccine, developed throat tightness, oral swelling, vocal change. See in E.D., received x 3 I.M. doses Epinephrine, then an Epinephrine infusion. Admitted to ICU. Discharged 10-16-15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ with lot number K011663 and expiry date-24-MAY-2016 (dosing regimens unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to ROTATEQ. This is one of several reports received from the same reporter. 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 registered nurse refers to unspecified patients of unknown age and sex. On an unspecified date beginning in August 2015 and continued through October 2015, unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (lot # J015437 and expiry 09-OCT-2016). Concomitant medications were not reported. No symptoms were reported. No PQC were involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # L018499, expiration date 25-FEB-2017, strength, dose, lot#, expiration date and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L007560, expiration date 15-JUN-2017, strength, dose, lot#, expiration date and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.