chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report Was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided.     On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, for prophylaxis, that underwent a temperature excursion of 9 degrees Celsius during a time frame of 1 hour, (dose, route, dose number, lot number and expiration date were not provided). No adverse effects were reported, no product quality complaint (PQC) was involved. There was no previous temperature excursion and the call was not because a digital data logger. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001148: US-009507513-1706USA005169:
Age: 29.0
Sex: F
Vaccine: PNC13
Symptoms: Rash macular
Clinical narrative: Splotchy rash on chest, arms, neck, and legs. The rash was strongest on my chest. No itching. Slowly went away by 6/7/17. Took BENADRYL at night.
Age: 29.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Influenza like illness, Muscular weakness, Pharyngitis streptococcal, Weight decreased
Clinical narrative: Strep throat and flu like symptoms. Weakness in arms and legs. Chronic fatigue. Rapid weight loss with no change in diet.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. There was no information regarding patient's concomitant medications, drug reactions or allergies provided. On 19-NOV-2014 the patient was administered PREVNAR 13 (dose and route not provided) and on 09-JAN-2015, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (route of administration, lot number and expiration date were not provided). There was no adverse effect reported. There was no product quality complaint involved. 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 physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. ; Sender's Comments: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. ; Sender's Comments: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 28-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 27-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1704USA001661:
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms
Clinical narrative: This spontaneous report was received from a currently 66 years old female patient via Pharmaceuticals (manufacturer control# 2017TAR00369), reporting on herself. The patient's concurrent conditions included diabetes, high blood pressure, kidney stones, gastrooesophageal reflux disease (GERD), cancer. The patient had a port placed in the right shoulder and developed a clot post port insertion. The patient's historical drug included lovenox taken until approximately July 2016. On an unknown date, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) injection (lot#, expiration date, dose and route of administration were not reported). Concomitant therapies included warfarin, irbesartan, glimepiride, sodium bicarbonate and omeprazole. On an unknown date, the patient experienced muscle spasms. The outcome of muscle spasms and the causality between the event and hepatitis b vaccine (manufacturer unknown) were unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant who reported that multiple unspecified patients on multiple unspecified dates were vaccinated with improperly stored ROTATEQ lot #M019706, expiration date 24-OCT-2017; lot #L035510, expiration date 13-MAY-2017; lot #L048854, expiration date 31-AUG-2017; lot #M025565, expiration date 06-NOV-2017 (dosages not provided); or VAQTA lot #M021124, expiration date 28-FEB-2018 (dosages and routes of administration not provided). No adverse effects reported.  Excursion information: Names of vaccines involved: ROTATEQ and VAQTA Temperature:  32.01°F Time frame: 18 Hours Previous temperature excursion: No  "Data logger" involved: Yes  No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on patient's concurrent conditions, medical history and concomitant medications was reported. On 31-MAY-2017, the patient was vaccinated with an expired dose of VAQTA 50/1 U/ml, 1 ml, intramuscular, lot # M022556, expiry date: 26-MAY-2017. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 demographics. No information about the patients' pertinent medical history, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored PROQUAD, lot # M044575 with expiration date on 04-MAY-2018 (dose and route of administration were not reported) reconstituted with properly stored concomitant of sterile diluent (MERCK). The vaccine underwent a temperature excursion of -14 to -10 degree Celsius for 204 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1705USA011819: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1706USA001281:
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse via a field employee and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient was vaccinated with GARDASIL 9 dose 1 and dose 2 (exact dose, route of administration, anatomical location, lot numbers and expiration dates were not provided) for prevention of human papilloma virus (HPV). On unspecified dates, the patient experienced a rash after his first dose of GARDASIL 9 and had to go to the hospital after the second dose. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not provided. 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 licensed practical nurse (LPN) and refers a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M022947 with an expiration date 12-NOV-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Administered doses of PNEUMOVAX 23 experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 4 full days. There was no previous temperature excursion. A digital data logger was not in involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004379: US-009507513-1706USA004378: US-009507513-1706USA002585: US-009507513-1706USA004377:
Age: 1.33
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received a medical assistant and refers to a 16-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 12-JUN-2017, the patient was 16 months old and was inadvertently administered one dose of GARDASIL 9 injection (lot # N001533 with expiration date at 16-OCT-2019; exact dose, route of administration and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report was received from consumer concerning a patient of unknown gender and age. Patient's relevant history, concurrent diseases and concomitant drugs were not provided. Patient received nasal FLUMIST QUADRIVALENT (intranasal) for alternative to other flu vaccination. The patient stated that she had been getting Flu vaccines for two to three years and the flu reoccurred numerous times. The outcome of flu recurred numerous times was unknown. The company physician considered flu recurred numerous times to be non-serious.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Induration, Skin warm, Swelling, Tenderness
Clinical narrative: Entire upper arm red, induration, warm, swollen, tender.
Age: 19.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt was administered ZOSTVAX instead of VARIVAX. Called Merck and the stated I needed to report to VAERS.
Age: 19.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was administered ZOSTVAX instead of VARIVAX. Called Merck and the stated I needed to report to VAERS.
Age: 65.0
Sex: M
Vaccine: PNC
Symptoms: Arthralgia, Headache, Loss of personal independence in daily activities, Mobility decreased, Nausea
Clinical narrative: As stated, had bad ache in arm the night of the injection of PREVNAR 13.  By the next morning was achey in all joints. Had some nausea, No vomiting. Headache was bad enough that was not able to go to work and layed on bed or couch all day.
Age: 65.0
Sex: M
Vaccine: PNC
Symptoms: Pain, Pain in extremity
Clinical narrative: As stated, had bad ache in arm the night of the injection of PREVNAR 13.  By the next morning was achey in all joints. Had some nausea, No vomiting. Headache was bad enough that was not able to go to work and layed on bed or couch all day.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Autoimmune disorder, Injection site pain, Joint swelling, X-ray
Clinical narrative: Painful area on right shoulder where vaccine was administered. It would flare up from time to time. Come and go. This went on for some time; perhaps 6 months or so. As of today, 6/13/2017, this same area is still tender. In 2016 I started developing swelling and painful joints. Shoulders, elbows, wrists, ankles, hips. It is like I am having some sort of autoimmune response from the vaccine.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Conversion disorder, Dizziness, Mobility decreased, Musculoskeletal stiffness, Nausea
Clinical narrative: Within 30 seconds after getting the shot, I felt nauseous, dizzy, blurred vision and fainted. I was given water and told to lay down for 10 minutes. After 10 minutes.... no improvement. My vitals were monitored. After 20 minutes, no improvement --- still nauseous, lightheaded, dizzy. My arms and legs began to stiffen and within 40 minutes after the shot, I couldn't move my arms or legs. I was transported to two hospitals. After 10 hours not being able to move and physical exams, it was determined that I had Conversion Disorder as a result of "trauma" of the shot. The question is what's in the shot that caused me to faint and become so ill, that my brain shut my arms and legs down for 10 hours!
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Vision blurred
Clinical narrative: Within 30 seconds after getting the shot, I felt nauseous, dizzy, blurred vision and fainted. I was given water and told to lay down for 10 minutes. After 10 minutes.... no improvement. My vitals were monitored. After 20 minutes, no improvement --- still nauseous, lightheaded, dizzy. My arms and legs began to stiffen and within 40 minutes after the shot, I couldn't move my arms or legs. I was transported to two hospitals. After 10 hours not being able to move and physical exams, it was determined that I had Conversion Disorder as a result of "trauma" of the shot. The question is what's in the shot that caused me to faint and become so ill, that my brain shut my arms and legs down for 10 hours!
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MEN, TDAP, VARCEL
Symptoms: Lip pruritus, Lip swelling, Pruritus
Clinical narrative: Swelling of upper lip and itchy on lip and right side of neck.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Immediate post-injection reaction, Wheezing
Clinical narrative: Wheezing, SOB-almost immediately after vaccine given.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Contusion
Clinical narrative: Bruising in right arm on tricep near injection site.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who was referring to a patient of unknown age and gender. There was no information regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On 19-MAY-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, route of administration were not reported) lot # L040053, expiration date 10-MAY-2017 for prophylaxis. There was no adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of an unknown gender. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 14-OCT-2013, at the age of 11, the patient was vaccinated with a dose of GARDASIL (dose, route and site of vaccination, lot number and expiration date were not reported). Subsequently, on 23-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 lot number L037554 with expiration date on 25-DEC-2017 (dose, route and site of vaccination were not reported). No adverse events were reported. 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 physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M044399 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 10-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M044399 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA001661:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a female patient of an unknown age. No information on patient's concurrent conditions, medical history and concomitant medications was provided. On 22-NOV-2013, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot number and expiry date were not provided). On 30-MAY-2017, she received a dose of GARDASIL 9 (dose, route of administration, lot number and expiry date were not provided). No adverse effects were reported. Additional information is not expected as there was no consent to contact physician.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male neonate patient (currently 14 days old). Patient's concurrent condition and concomitant medication were not reported. No drug reactions/ allergies were reported. On an unknown date in 2017, the patient was vaccinated with RECOMBIVAX HB (lot# begins with "N00" and expiry date 08-NOV-2019) (strength, dosing details, anatomical location were unknown) for prophylaxis. The reporting nurse stated that when a dose of RECOMBIVAX HB was being administered to the newborn patient, the syringe separated from the needle and a small amount of the vaccine solution squirted in her eye. The vaccine dose was aspirated from a vial into an administration syringe and the needle was not firmly attached (product use issue). The patient received a partial dose of RECOMBIVAX HB. The patient did not experience any adverse event. The reporter doesn't know if the patient is going to receive another dose of RECOMBIVAX HB because she is at home at the time of this report. No PQC was involved. This report is cross linked with case#1706USA005501, due to the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1706USA005501.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 16 months old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On 04-APR-2017, an improperly stored dose of VARIVAX injection (lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown), was administered to the patient. No adverse effects were reported. Administered vaccine was exposed to temperatures between 6 and 14 degrees Fahrenheit for 30 minutes. No previous temperature excursion was reported. Data logger was involved  in recording the excursion. This was one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.; Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a 60 year old female with osteopenia reporting on herself.  The patient had no drug reactions or allergies. Approximately on 07-JUN-2017 (reported as "this Wednesday"), the patient was vaccinated with "1 dose vaccine" of ZOSTAVAX route: injected vaccine, (lot# and the expiration date were not reported) to protect herself. There was no concomitant medication provided. On 09-JUN-2017 (reported as "today"), the patient realized her skin was a little raised with redness around the injection side. The patient did not seek medical attention and there was no laboratory diagnostics studies performed. The outcome of injection site erythema was unknown. The relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information is not expected because the reporter refused additional contact.
Sex: F
Vaccine: HEP
Symptoms: Exposure via eye contact, No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to herself, a female patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No drug reactions/ allergies were reported. On an unknown date in 2017, a newborn patient was being vaccinated with RECOMBIVAX HB (lot# begins with "N00" and expiry date 08-NOV-2019) by the nurse for prophylaxis. When the dose of RECOMBIVAX HB was being administered to the newborn patient, the syringe separated from the needle and a small amount of the vaccine solution squirted in her eye (Occupational exposure while administering product). The vaccine dose was aspirated from a vial into an administration syringe and the needle was not firmly attached (product use issue). The nurse did not experience any adverse event. No PQC was involved. This report is cross linked with case#1706USA001456, due to the same reporter source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001456:
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Medication Error- No adverse reaction-  17 year-old was given Hepatitis A Adult formulation instead of Pediatric formulation of Hepatitis A.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: ABOUT 6 INCHES RED CIRCLE AROUND INJECT SITE, AREA IS SWOLLEN AND TENDER.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Nausea, Pain
Clinical narrative: Severe body aches and joint pain, nausea, chills.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Decreased appetite, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient states that 8 hours after administration of PCV13 developed arthralgia, myalgia, anorexia, nausea, and fever.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever spiked to 102.7 and then dropped to 95.8 on 6/12.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician and refers to a 15-month-old patient of an unknown gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 02-MAR-2017, the patient was vaccinated with the first dose of VARIVAX, intramuscularly (strength, dose, frequency, lot number, and expiration date were not reported) for prophylaxis. Subsequently, on 23-MAY-2017, the patient received the second dose of VARIVAX intramuscularly (strength, dose, and frequency were not reported; lot number L038130 with and expiration date 29-SEP-2017) for prophylaxis that was reconstituted with a properly stored sterile diluent (DILUENT MRK), and which was inadvertently administered early. The patient had no side effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 24-MAY-2016, the patient was vaccinated with the first dose of GARDASIL (strength, dose, frequency, route of administration were not reported; lot number K016966 with an expiration date 10-MAY-2017) for prophylaxis. Then, on 25-MAY-2017, the patient presented to the nurse's office in order to get a dose of GARDASIL 9 as the second dose in the series (strength, frequency, route of administration, lot number and expiration date were not reported); however, it was unknown if this dose was administered to the patient. There were no adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 17-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 29-MAY-2017, the patient was vaccinated intramuscularly with an expired dose of GARDASIL 9 (lot # M014929, expiration date: 27-MAY-2017; exact dose was not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received on 01-JUN-2017 from a female medical assistant regarding an unspecified patient with age and gender unknown. The medical assistant reported that on 01-JUN-2017 an expired dose of VAQTA [Product reported as VAQTA  INJ 25/0.5](Lot number M022556, expiration date 26-MAY-2017) (Dose, route of administration, and site of administration were not reported) was administered to an unspecified patient for prophylaxis.  No adverse effects reported. 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 medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 09-MAY-2017, 10-MAY-2017, and 12-MAY-2017, unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N005597, expiration date: 19-OCT-2017) (dose, frequency and route of administration were unspecified) for prophylaxis. Additionally, it was reported that on 22-MAY-2017, 24-MAY-2017, and 25-MAY-2017, unspecified patients were also vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N010105, expiration date: 15-NOV-2017) (dose, frequency and route of administration were unspecified) for prophylaxis. No adverse effects or product quality complaints were reported. It was reported that all vaccines were exposed to a temperature between 48-50 Fahrenheit degrees, from 04-MAY-2017 until 25-MAY-2017 (21 days), that digital data logger was not involved, and that there were no previous excursions. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The medical assistant reported that some of the staff of her facility have been withdrawing only 0.5 ml of reconstituted volume of doses of M-M-R II and VARIVAX from the vial because that was the volume of the dose that was specified in the prescribing information for these products. She stated thet she did not have an exact number of doses that have been administered in this way (on unspecified dates). She was not aware of any adverse effects. No additional information was provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL (dose, frequency and route of administration were not reported) lot # K016966, expiration date 10-MAY-2017 for prophylaxis. No adverse effects were reported. No further information was provided. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On 06-JUN-2017 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and the expiration date were not reported) for "vaccine" (prophylaxis).  Other suspect therapies included sterile diluent (manufacturer unknown) lot# and the expiration date were not provided. There was no concomitant medication provided. The pharmacist reported "the patient called on 09-JUN-2017, and reported itching all over (pruritus generalized), injection site bump the size of a silver dollar (injection site mass) and injection site redness the size of a palm (injection site erythema)." The pharmacist also stated the patient was administering unspecified triple antibiotic cream. There was no Product Quality Complaint (PQC) involved. The outcome of pruritus generalised, injection site erythema and injection site mass was unknown. The relatedness between the therapy with ZOSTAVAX and the events was not reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a improperly stored lot of VARIVAX (incorrect product storage), but the reporter was not sure which of the lots the unspecified patient received: Lot# L044526, the expiration date: 09-NOV-2017, Lot# M047662, the expiration date: 02-DEC-2018, Lot# reported as N001528, the expiration date: 13-JAN-2019, Lot# M044349, the expiration date: 04-NOV-2018 or Lot# M038856, the expiration date: 14-SEP-2018 (dose was not reported) for prophylaxis. No adverse effect reported. The call was made due to a data logger with a temperature in the range of 6°F to 14°F during 30 minutes. There was no previous temperature excursion provided. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13 at single dose, PNEUMOVAX at an unspecified dose, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history was and concomitant medications were not reported. The patient has had both PNEUMOVAX as well as PREVNAR 13 and titers are showing non-immunity/lack of effect on an unspecified date.
Age: 2.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: No adverse event
Clinical narrative: No adverse events noted.
Age: 66.0
Sex: F
Vaccine: PNC
Symptoms: Breast pain, C-reactive protein increased, Chest X-ray normal, Cough, Decreased appetite
Clinical narrative: Pt states that the needle hit the bone. States that she had symptoms of deltoid pain/shoulder/arm pain immediately following the vaccine. No home measures done to help the pain, pt rested in her chair for 4 days after the vaccine and was unable to lift arm due to pain. States that there was swelling to shoulder/arm and redness the first day along with pain.  States the excruciating pain and swelling lasted 3-4 days.  Experienced loss of appetite/fatigue the first day. Fever/night sweats started 3-4 days after vaccine was given. Cough started 5-6 days after vaccine was given. Arm remained sore x 12 days with pain progressing into left breast down rib cage to the side of chest wall.  Experienced a rash to the back of the arm 6/11/17 slightly red and bumpy/itchy.
Age: 66.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Fatigue, Immediate post-injection reaction, Mobility decreased, Musculoskeletal chest pain
Clinical narrative: Pt states that the needle hit the bone. States that she had symptoms of deltoid pain/shoulder/arm pain immediately following the vaccine. No home measures done to help the pain, pt rested in her chair for 4 days after the vaccine and was unable to lift arm due to pain. States that there was swelling to shoulder/arm and redness the first day along with pain.  States the excruciating pain and swelling lasted 3-4 days.  Experienced loss of appetite/fatigue the first day. Fever/night sweats started 3-4 days after vaccine was given. Cough started 5-6 days after vaccine was given. Arm remained sore x 12 days with pain progressing into left breast down rib cage to the side of chest wall.  Experienced a rash to the back of the arm 6/11/17 slightly red and bumpy/itchy.
Age: 66.0
Sex: F
Vaccine: PNC
Symptoms: Musculoskeletal pain, Night sweats, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt states that the needle hit the bone. States that she had symptoms of deltoid pain/shoulder/arm pain immediately following the vaccine. No home measures done to help the pain, pt rested in her chair for 4 days after the vaccine and was unable to lift arm due to pain. States that there was swelling to shoulder/arm and redness the first day along with pain.  States the excruciating pain and swelling lasted 3-4 days.  Experienced loss of appetite/fatigue the first day. Fever/night sweats started 3-4 days after vaccine was given. Cough started 5-6 days after vaccine was given. Arm remained sore x 12 days with pain progressing into left breast down rib cage to the side of chest wall.  Experienced a rash to the back of the arm 6/11/17 slightly red and bumpy/itchy.
Age: 66.0
Sex: F
Vaccine: PNC
Symptoms: Rash, Rash erythematous, Red blood cell sedimentation rate increased
Clinical narrative: Pt states that the needle hit the bone. States that she had symptoms of deltoid pain/shoulder/arm pain immediately following the vaccine. No home measures done to help the pain, pt rested in her chair for 4 days after the vaccine and was unable to lift arm due to pain. States that there was swelling to shoulder/arm and redness the first day along with pain.  States the excruciating pain and swelling lasted 3-4 days.  Experienced loss of appetite/fatigue the first day. Fever/night sweats started 3-4 days after vaccine was given. Cough started 5-6 days after vaccine was given. Arm remained sore x 12 days with pain progressing into left breast down rib cage to the side of chest wall.  Experienced a rash to the back of the arm 6/11/17 slightly red and bumpy/itchy.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Blister, Contusion, Erythema, Injection site vesicles, Skin swelling
Clinical narrative: Received HPV vaccine in her left arm on 05/22/17 and at night her arm looked burned. It was multiple shades of red, skin was raised and it looked bruised and blistered. Skin is no longer raised today and discoloration has faded some but it is still multiple shades with bruising above it and a blister where the needle went in.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a nurse referring to an 18 year old female patient. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient received a dose of injectable GARDASIL 9 for prophylaxis (lot # M044717 with expiration date on 19-JUL-2019) (strength, dose, frequency, route of administration and anatomical location were not reported). On 03-JUN-2017, the patient woke up and noticed red itchy bumps around her neck and under the arm. Moreover, it was reported that one of the bumps under her arm was painful. On the same date, the patient's mother called the doctor to report the experience. The patient's mother had given her BENADRYL to treat the itchy red bumps. At the time of reporting, the patient had not recovered from the events. The relationship between the events and the vaccination with GARDASIL 9 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2017, the patient was vaccinated with an expired dose of VARIVAX (dose and site of administration were not reported), lot # L017144, expiration date: 13-MAY-2017, subcutaneously for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) (lot number was not reported). No adverse effects were reported. No further information was provided. 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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The Medical Assistant reported that from 11-MAY-2017 to 09-JUN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ(strength, dose, frequency, lot number and expiration date were not provided) lot # M041765 with expiration date of 05-MAY-2018 and lot # M045545 with expiration date of 10-JUN-2018, orally for prophylaxis. No adverse reactions. No further information to report. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 1 hour 15 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling Right and Left deltoid. Left with induration of skin, heat and pain.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling above right knee today 6/12/17.
Age: 52.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site swelling, Local swelling, Pruritus, Tenderness
Clinical narrative: BEGAN WITH SMALL SWOLLEN AREA TO VARICELLA ADMINISTRATION SITE ON LEFT ARM. HAS INCREASED IN SIZE OVER THE PAST FEW DAYS. SWOLLEN, RED, RAISED AREA WITH ITCHING AND TENDERNESS.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: PATIENT WAS GIVEN INCORRECT VACCINE, NO ADVERSE REACTION WAS WITNESSED AT THE CLINIC AFTER PATIENT RECEIVED VACCINE.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dyspnoea, Pruritus, Rash erythematous
Clinical narrative: Pt developed pruritis, erythematous rash and SOB approx 10-20 min after administration. SpO2 remained >94%.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Inspection: erythema, swelling, and warmth on both anterior thighs; 4 cm x 2.5 cm induration L thigh and 1 cm x 0.7 cm R thigh. Swelling and erythema from Immunization site 3 days after vaccines.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Crying, Injection site erythema, Injection site paraesthesia, Injection site pruritus
Clinical narrative: 5 minutes after MENACTRA was given, she started crying. Localized redness noted at the injection which started to spread to elbow; also noted tingling and itching.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Rash, Testicular pain, Urticaria
Clinical narrative: Had TRUMENBA and MENACTRA vaccines on 6/6/17. That evening he noted his arms were sore, testicles were tender. Rash noted at 6 am on 6/7/17 involving both arms. He had urticarial eruptions on both thighs. He was seen by PCP at 12:30 pm on 6/7/17. He was prescribed MEDROL and ZYRTEC.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at immunization injection site. Hot to the touch. Itchy.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling, pain, bruising and hives at injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Cellulitis, Culture wound negative, Full blood count normal, Gram stain negative, Rash
Clinical narrative: Began to have Chicken Pox lesions (6-8) on various body parts 4 days after vaccination. 2 weeks later he continued having new lesions appear. On 06/08/17 he was admitted for right hand cellulitis and varicella rash.