chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Mouth injury, Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son. A 16 year-old male patient received the first dose of TRUMENBA and the second dose of MENACTRA, both intramuscular in the arm on 22Jun2017 approximately between 18:00 and 18:30 at 0.5 ml, single for vaccination. Medical history was none. There were no concomitant medications. The patient had received for immunization the first dose of meningococcal vaccine a/c/y/w conj (dip tox) on 19Jul2012 without adverse event. The patient experienced syncope on 22Jun2017 within 15-30 second after having received the vaccines and also incurred in a head injury as a result of the syncope event. The patient went to the emergency room where CT scan of head, electrocardiogram and x-ray of left shoulder were performed and all had negative results. The patient was not hospitalized due to the events. He recovered the same day, on 22Jun2017.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Death
Clinical narrative: Initial unsolicited report received from a healthcare professional (claims adjuster) on 12-Sep-2017. This case involves an 81-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI808AA, expiration date: 28-Feb-2018, dose, dose in series, route and site of administration were not reported) on 16-Aug-2017. It was unknown it the patient had any pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination. Concomitant medications were not reported. On 16-Aug-2017, 8 to 12 hours after the vaccination, the patient developed red rash over her body, legs, and face. Laboratory investigations and corrective treatment were not reported. The outcome of the event red rash over her body, legs, and face was reported as not recovered. On 23-Aug-2017, the patient died. It was unknown if autopsy was performed or not. List of documents held by sender: none.; Sender's Comments: This is a poorly documented death case of patient, who passed away 7 days after receiving Fluzone high dose vaccine. The patient had developed red rash over her body, legs, and face 8 to 12 hours after receiving vaccination. No information is provided on conditions at the patient's medical history, previous vaccination history, circumstances at time of event, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration.; Reported Cause(s) of Death: Death NOS.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Death, Rash erythematous, Rash generalised
Clinical narrative: Initial unsolicited report received from a healthcare professional (claims adjuster) on 12-Sep-2017. This case involves an 81-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI808AA, expiration date: 28-Feb-2018, dose, dose in series, route and site of administration were not reported) on 16-Aug-2017. It was unknown it the patient had any pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination. Concomitant medications were not reported. On 16-Aug-2017, 8 to 12 hours after the vaccination, the patient developed red rash over her body, legs, and face. Laboratory investigations and corrective treatment were not reported. The outcome of the event red rash over her body, legs, and face was reported as not recovered. On 23-Aug-2017, the patient died. It was unknown if autopsy was performed or not. List of documents held by sender: none.; Sender's Comments: This is a poorly documented death case of patient, who passed away 7 days after receiving Fluzone high dose vaccine. The patient had developed red rash over her body, legs, and face 8 to 12 hours after receiving vaccination. No information is provided on conditions at the patient's medical history, previous vaccination history, circumstances at time of event, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration.; Reported Cause(s) of Death: Death NOS.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, PPV
Symptoms: Infection, Injection site erythema, Injection site swelling, Sepsis
Clinical narrative: We did not give the injection. Dr did. Not sure which PNA vaccine it was. She came here with redness and swelling to her right upper arm. Dx with cellulitis. Clindamycin was prescribed x 1 week. Dr. saw the patient at treatment center on 9/5/17. Was supposed to return 9/11/17 for a recheck. She did not.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: We did not give the injection. Dr did. Not sure which PNA vaccine it was. She came here with redness and swelling to her right upper arm. Dx with cellulitis. Clindamycin was prescribed x 1 week. Dr. saw the patient at treatment center on 9/5/17. Was supposed to return 9/11/17 for a recheck. She did not.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient of an unspecified ethnicity received PREVNAR 13 lot S39564 exp date Sep2018, intramuscular in deltoid on 07Sep2017 2:20 at 0.5 ml, single for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm was like red and hot to the touch between her shoulder and elbow (vaccination site warmth) (non-serious) on 12Sep2017 with outcome of not recovered , arm was like red and hot to the touch between her shoulder and elbow (vaccination site erythema) (non-serious) on 12Sep2017 with outcome of not recovered. Pharmacist recommended her to take some paracetamol (TYLENOL) and then visit the doctor's office. It was unknwon if the patient started the treatment.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient of an unspecified ethnicity received PREVNAR 13 lot S39564 exp date Sep2018, intramuscular in deltoid on 07Sep2017 2:20 at 0.5 ml, single for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm was like red and hot to the touch between her shoulder and elbow (vaccination site warmth) (non-serious) on 12Sep2017 with outcome of not recovered , arm was like red and hot to the touch between her shoulder and elbow (vaccination site erythema) (non-serious) on 12Sep2017 with outcome of not recovered. Pharmacist recommended her to take some paracetamol (TYLENOL) and then visit the doctor's office. It was unknwon if the patient started the treatment.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Pain in extremity
Clinical narrative: Painful aches in arm and back and leg on left side where vaccine was injected.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder is still sore.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain of skin
Clinical narrative: Soreness on scalp started Tues. 9/12, Blisters began on 9/14. P/A confirmed Shingles diagnosis. Visit to Dr. on 9/16.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Blood potassium, Blood test, Computerised tomogram, Facial paralysis, Fatigue
Clinical narrative: Patient received vaccine in the morning on Friday 9/8. On Saturday 9/9 patient woke up with a bad headache and fatigue. By Monday 9/11, patient had numbing in the lower lips and beginning on Tuesday 9/12 patient started to experience left facial drooping. Patient went to the emergency room on Tuesday 9/12 following recommendation from family physician and spent the night until Wednesday 9/13 in the afternoon. Stroke was ruled out. Patient followed up with a neurologist this morning on 9/18 and was instructed to come to the pharmacy and report the adverse event. We are unsure if the flu shot is the direct cause at this point. Patient was diagnosed with Bell's Palsy and gave patient a loading dose of 60mg of prednisone in the hospital followed by prednisone 20mg daily for 1 week and valacyclovir 500mg twice daily for 10 days.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Glycosylated haemoglobin, Headache, Hypoaesthesia oral, Laboratory test, Lipids
Clinical narrative: Patient received vaccine in the morning on Friday 9/8. On Saturday 9/9 patient woke up with a bad headache and fatigue. By Monday 9/11, patient had numbing in the lower lips and beginning on Tuesday 9/12 patient started to experience left facial drooping. Patient went to the emergency room on Tuesday 9/12 following recommendation from family physician and spent the night until Wednesday 9/13 in the afternoon. Stroke was ruled out. Patient followed up with a neurologist this morning on 9/18 and was instructed to come to the pharmacy and report the adverse event. We are unsure if the flu shot is the direct cause at this point. Patient was diagnosed with Bell's Palsy and gave patient a loading dose of 60mg of prednisone in the hospital followed by prednisone 20mg daily for 1 week and valacyclovir 500mg twice daily for 10 days.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Patient received vaccine in the morning on Friday 9/8. On Saturday 9/9 patient woke up with a bad headache and fatigue. By Monday 9/11, patient had numbing in the lower lips and beginning on Tuesday 9/12 patient started to experience left facial drooping. Patient went to the emergency room on Tuesday 9/12 following recommendation from family physician and spent the night until Wednesday 9/13 in the afternoon. Stroke was ruled out. Patient followed up with a neurologist this morning on 9/18 and was instructed to come to the pharmacy and report the adverse event. We are unsure if the flu shot is the direct cause at this point. Patient was diagnosed with Bell's Palsy and gave patient a loading dose of 60mg of prednisone in the hospital followed by prednisone 20mg daily for 1 week and valacyclovir 500mg twice daily for 10 days.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Activated partial thromboplastin time, Blood magnesium, Blood potassium, Computerised tomogram head, Facial paralysis
Clinical narrative: Patient received vaccine in the morning on Friday 9/8. On Saturday 9/9 patient woke up with a bad headache and fatigue. By Monday 9/11, patient had numbing in the lower lips and beginning on Tuesday 9/12 patient started to experience left facial drooping. Patient went to the emergency room on Tuesday 9/12 following recommendation from family physician and spent the night until Wednesday 9/13 in the afternoon. Stroke was ruled out. Patient followed up with a neurologist this morning on 9/18 and was instructed to come to the pharmacy and report the adverse event. We are unsure if the flu shot is the direct cause at this point. Patient was diagnosed with Bell's Palsy and gave patient a loading dose of 60mg of prednisone in the hospital followed by prednisone 20mg daily for 1 week and valacyclovir 500mg twice daily for 10 days.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Full blood count, Glycosylated haemoglobin, International normalised ratio, Lipids, Metabolic function test
Clinical narrative: Patient received vaccine in the morning on Friday 9/8. On Saturday 9/9 patient woke up with a bad headache and fatigue. By Monday 9/11, patient had numbing in the lower lips and beginning on Tuesday 9/12 patient started to experience left facial drooping. Patient went to the emergency room on Tuesday 9/12 following recommendation from family physician and spent the night until Wednesday 9/13 in the afternoon. Stroke was ruled out. Patient followed up with a neurologist this morning on 9/18 and was instructed to come to the pharmacy and report the adverse event. We are unsure if the flu shot is the direct cause at this point. Patient was diagnosed with Bell's Palsy and gave patient a loading dose of 60mg of prednisone in the hospital followed by prednisone 20mg daily for 1 week and valacyclovir 500mg twice daily for 10 days.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Nuclear magnetic resonance imaging brain
Clinical narrative: Patient received vaccine in the morning on Friday 9/8. On Saturday 9/9 patient woke up with a bad headache and fatigue. By Monday 9/11, patient had numbing in the lower lips and beginning on Tuesday 9/12 patient started to experience left facial drooping. Patient went to the emergency room on Tuesday 9/12 following recommendation from family physician and spent the night until Wednesday 9/13 in the afternoon. Stroke was ruled out. Patient followed up with a neurologist this morning on 9/18 and was instructed to come to the pharmacy and report the adverse event. We are unsure if the flu shot is the direct cause at this point. Patient was diagnosed with Bell's Palsy and gave patient a loading dose of 60mg of prednisone in the hospital followed by prednisone 20mg daily for 1 week and valacyclovir 500mg twice daily for 10 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Pt presented day after shot admin with a small bruise at area of injection (on lower half of left deltoid). Below this bruise was a large, red rash that extended down to the patient's elbow. Upon physical exam this rash had significant heat. Pt stated it also had a slight itch. Recommended to patient that she go home and take Benadryl and call the next day. She did so and stated the rash had reduced. Spoke with patient today (9/18) and she stated the rash had completely dissipated.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Insomnia, Joint range of motion decreased, Pain
Clinical narrative: Per patient report: Soreness and pain in right away after injection. That night severe pain and difficulty sleeping related to pain. Decreased of ROM and decreased weight bearing. Increased pain with elevated of arm and needed to provide support to raise arm. Injection was to close too shoulder. 9/15/2017 Today slow improvement but still pain decreased ROM and problems occasionally sleeping related to pain. Would like PT/OT order.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Weight bearing difficulty
Clinical narrative: Per patient report: Soreness and pain in right away after injection. That night severe pain and difficulty sleeping related to pain. Decreased of ROM and decreased weight bearing. Increased pain with elevated of arm and needed to provide support to raise arm. Injection was to close too shoulder. 9/15/2017 Today slow improvement but still pain decreased ROM and problems occasionally sleeping related to pain. Would like PT/OT order.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Injection site pain, Insomnia
Clinical narrative: Within 12 hours of the injection I became achy, had pain in left upper arm and had insomnia. As the next 12 hours progressed, I developed worsening chills, body aches, dizziness, nausea, severe headache and fever of at least 103.5. There was a point when I wanted to take my temperature but I was literally too ill to get out of the bed to get the thermometer. MOTRIN only reduced fever to 101.3. Within 72 hours, the symptoms gradually subsided with just a little bit of dizziness and headache persisting. There was never any redness or swelling at the injection site, just pain all the way to the elbow.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Within 12 hours of the injection I became achy, had pain in left upper arm and had insomnia. As the next 12 hours progressed, I developed worsening chills, body aches, dizziness, nausea, severe headache and fever of at least 103.5. There was a point when I wanted to take my temperature but I was literally too ill to get out of the bed to get the thermometer. MOTRIN only reduced fever to 101.3. Within 72 hours, the symptoms gradually subsided with just a little bit of dizziness and headache persisting. There was never any redness or swelling at the injection site, just pain all the way to the elbow.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Acne, Furuncle, Injection site rash, Injection site reaction, Scar
Clinical narrative: Broke out in pimples, boils, and rash like bumps on my right deltoid and spread down my bicep. Ended up with scars on my arm from picking and scratching.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Menstrual disorder, Smear cervix normal, Weight increased
Clinical narrative: This spontaneous report has been received from a nurse practitioner concerning a 25 year old female patient. The patient did not have pertinent medical history and any drug reactions / allergies. Concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (lot# and expiration date unknown) for prevent against human papillomavirus (HPV). The patient had been received three doses of GARDASIL (each dose on a separate unspecified date). In approximately 2017 (reported as "recently"), the patient developed abnormal menstrual periods and weight gain. She had been trying to get pregnant for the "past year" but was unsuccessful. On 02-AUG-2017, the patient was seen in nurse practitioner's office due to the symptoms reported above and a Papanicolaou (Pap) smear was performed. The Pap smear result showed negative however was positive for 13 human papilloma virus (HPV) types. No treatment was given for the events. Outcome of the events was not recovered. This is one of two reports received from the same source. Sender's Comments: US-009507513-1708USA012191.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning unspecified number of patients of unknown age. The patients' medical history, and concurrent condition were not reported. Concomitant therapy included sterile diluent (manufacturer unknown). On unknown dates, unspecified patients administered of three doses of improperly stored PROQUAD (lot#N000336, expiration date 03-JUN-2018, 2 doses; lot# M049122, expiration date 13-JUN-2018, 1 dose) (dose, frequency were not reported), subcutaneously for prophylaxis. The vaccine was exposed to temperature excursion of 6 F to 14 F for 7.5 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). The patients received improperly stored doses of PEDVAXHIB (dose, frequency and route were unknown, lot # N000235, expiration date: 26-OCT-2019, lot # N003537, expiration date: 17-NOV-2019, lot # L014426, expiration date: 08-MAR-2018, lot # L004740, expiration date: 16-NOV-2017) for prophylaxis on multiple unknown dates between 01-JAN-2017 to 01-AUG-2017. The temperature excursion was at 32 Fahrenheit Degree to 35 Fahrenheit Degree for 24 hours and 47 Fahrenheit Degree to 77 Fahrenheit Degree for 32 hours. The previous temperature excursion was reported as yes. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008435: US-009507513-1709USA008436: US-009507513-1709USA008434.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 29-AUG-2017, the patient was vaccinated with a dose of improperly stored PROQUAD (dose and frequency were unknown; lot # N008826 with expiration date 12-SEP-2018) subcutaneously for prophylaxis, which was exposed to temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 114 hours. There were no previous temperature excursions. DILUENT was stored properly. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008515.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a unspecified number of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M048200 with expiration date 07-DEC-2018 and Lot# N004628 with expiration date 08-FEB-2019, for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F during a time frame of 5 hours and 50 minutes, which was detected by the data logger. There was a previous temperature excursion of 6°F to 14°F for 40 minutes. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in 2017, the patient may had received an unspecified improperly stored dose of VARIVAX lot # M039318 expired on 20-SEP-2018 for prophylaxis (strength, dose and route of administration were not reported) which was reconstituted with sterile diluent (manufacturer unknown) that was stored properly. On 14-JUL-2017, the vaccine was stored at a temperature of 15°F to 46°F during a time frame of 1 hour 40 minutes. On 15-JUL-2017, an excursion ocurred at a 15°F to 46°F for 3 hours 6 minutes. The call was due of a data logger and no adverse effects were reported.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX for prophylaxis, lot number: M033219, expiration date: 18-AUG-2017 (route of administration was not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a 2 patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (concentration, dose, route and anatomical place of vaccination were not reported), for prophylaxis. On an unknown date, the patients experienced shingles (herpes zoster). At the time of reporting, the outcome of herpes zoster was unknown. The reporter did not provide a causality assessment between ZOSTAVAX  and herpes zoster. This is one of several reports from same reporter.; Sender's Comments:  US-009507513-1709USA003161: US-009507513-1709USA004176:
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Disseminated varicella zoster vaccine virus infection, Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient with chronic hepatic failure, rosuvastatin hypersensitivity and blueberries hypersensitivity. It was reported that the patient was on the list for liver transplant. On 31-JUL-2017, the patient was vaccinated with VARIVAX lot # N012132 for prophylaxis and other suspect therapies included STERILE DILUENT. Concomitant therapies included calcium carbonate, ceftriaxone, folic acid, lactobacillus unspecified, lactulose, vitamins (unspecified), omeprazole and thiamine. On 15-AUG-2017, the patient experienced rash all over her body (disseminated varicella zoster vaccine virus infection). Later on 16-AUG-2017, she was admitted to the hospital for an unspecified reason (adverse event) and was prescribed with acyclovir and valacyclovir hydrochloride. Thereafter, on 22-AUG-2017, the physician sent samples from the rash to the CDC for typing on 22-AUG-2017, and on the same date, diagnosed the patient with "disseminated disease". The reporting physician mentioned that lab confirmed "samples of the patient's rash were the vaccine strain of varicella" on 06-SEP-2017. At the time of the report, the patient recovered of disseminated varicella zoster vaccine virus infection on an unspecified date in 2017. However, she continued hospitalized due to "unspecified medical reasons". Upon internal review, the event disseminated varicella zoster vaccine virus infection was considered to be medically significant. The causal relationship between disseminated varicella zoster vaccine virus infection, adverse event and VARIVAX and STERILE DILUENT was not provided. The reporting physician requested a lot check for VARIVAX lot # N012132. This is one of two reports received from the same source. Sender's Comments: US-009507513-1709USA004101.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (exact dose, dose number, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of vaccines experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred, but no details were provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008478: US-009507513-1709USA008479: US-009507513-1709USA008477.
Age: 61.0
Sex: F
Vaccine: DTOX, HEP, TTOX
Symptoms: Drug dispensing error, Underdose
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a 61 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-SEP-2017, the patient was vaccinated with RECOMBIVAX HB pediatric dose, lot # M023718, expiration date 09-AUG-2018 (route of administration was not reported) (it was also reported that on 08-SEP-2017, the patient was vaccinated with RECOMBIVAX HB pediatric dose, lot # reported as X9F7Y, intramuscularly in the left deltoid (dose was were not reported)). Concomitant therapies included diphtheria toxoid, tetanus toxoid vaccine. There were no illness at the time of vaccination and no adverse effects reported. There were also reported that the dispensing error occurred (onset date 08-SEP-2017). No digital data logger was involved. No product quality complaint has been filled.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, refers to a 4 year old patient of unknown gender. Medical history and current conditions were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of PROQUAD (lot # M043306, exp. date: 24-APR-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored under temperature from -14 degree Celsius (C) to -10 C with timeframe of 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No Product Quality Complaint (PQC) was involved. This is one of 11 reports received from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-1708USA001338: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included an sterile diluent (manufacturer unknown). On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N012615 with expiration date on 16-MAR-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 35 Fahrenheit (F) during a time frame of 30 hours. It was also reported that previous temperature excursions occurred of 22 F during 22 hours and a digital data logger was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008138: US-009507513-1709USA008138.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about pertinent medical history reported. The patient's concomitant therapies included sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N009773 with expiration date 20-SEP-2018 and lot number N012489 with expiration date 17-OCT-2018 or VARIVAX lot number N017701 with expiration date 09-JUN-2019 and lot number N12131 with expiration date N012131 (dose, route and anatomical location were not reported for the above vaccines described) all for prophylaxis. The vaccines were exposed to temperatures between 6 to 14 F (Fahrenheit) during 3 hours and 40 minutes. There was a previous temperature excursion at the range of 6 to 14 F (Fahrenheit) for 4 hours and 30 minutes. Data digital logger was filled. Lot number N017701 has been verified to be a valid lot number varicella virus vaccine live.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. In 2003 (reported as "14 years ago"), the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, for prophylaxis (dose number, route, lot # and expiration date were not reported). In 2012 (reported as "five years ago"), the patient developed shingles of an unspecified eye. The outcome of the shingles of an unspecified eye was unknown. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the shingles of an unspecified eye was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in August 2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M043424 with expiration date on 06-JUN-2018, (dose and  route of administration were not provided) for prophylaxis. The dose of PNEUMOVAX 23 was exposed to a temperature excursion of 31 degrees Fahrenheit (°F) or colder (26°F) during a time frame of 24 hours, with unknown number of cycles, which was detected by the data logger. There was no prior temperature excursion and no adverse events, neither product quality complaints were reported.; Sender's Comments: US-009507513-1709USA007929:
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Nodule
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in August 2017, reported as "within the last month", the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported) and the patient was also administered "an unknown influenza virus vaccine (unknown manufacturer)" at the same visit. On an unknown date in 2017, after receiving the dose of ZOSTAVAX, she developed a nodule on her arm on an unknown date which had resolved on its own on an unknown date in 2017. She did not go to the doctor because of the nodule. There was not a significant disability or incapacity, no hospitalization was need and no life threatening was present. The causality between nodule and ZOSTAVAX was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to 5 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On an unspecified date in August 2017, four patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M042853 with expiration date on 17-JUL-2019 and one patient received one improperly stored dose of GARDASIL 9 lot # N019923, with expiration date on 28-APR-2019, (dose and route of administration were not provided) for prophylaxis. The doses of GARDASIL 9 were exposed to a temperature excursion of 31 degrees Fahrenheit (°F) or colder (26°F) during a time frame of 24 hours, with unknown number of cycles, which was detected by the data logger. There was no prior temperature excursion and no adverse events, neither product quality complaints were reported. Sender's Comments: US-009507513-1709USA007254.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health care student referring to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions or concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 for prophylaxis (dosage information, route and lot number was not informed). Additionally, it was reported that and an unspecified patient was vaccinated with an improperly dose of ENGERIX-B. It was also reported that the temperature experienced was 47°F to 77°F, the time frame was 48 Hours, there was no previous temperature excursion. The call because was no of a "data logger".
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician 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 multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effects reported. No product quality complaint was involved. The vaccines were exposed to a temperature excursion of 51 Fahrenheit degrees for a time frame of 1.5 hours, identified because of a digital data logger. There was no previous temperature excursion. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA008156: US-009507513-1709USA008154: US-009507513-1709USA008155:
Age: 19.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) over six months after the third dose (extra dose). No adverse effects were reported. The physician confirmed that this event is a result of a human error and an issue with electronic records.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: Information has been received from a nurse practitioner, concerning a 74 year old female patient.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 11-SEP-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23, subcutaneous in an arm (strength, dose, exact anatomical location, lot number and expiration date were not provided) for prevention of pneumococcal disease (prophylaxis). Two hours after vaccination, the patient's arm, where the vaccination was applied, became swollen from shoulder to elbow, the patient called doctor's office and visited doctor on 12-SEP-2017. It was unknown if the patient received treatment for the adverse event or if laboratory studies were performed. At the time of the report, the patient was not recovered from the vaccination site swelling and the causal relationship between the adverse event and PNEUMOVAX 23 was not assessed.
Sex: M
Vaccine: HPVX
Symptoms: Back pain, Deafness unilateral, Disability, Fall, Head injury
Clinical narrative: This initial spontaneous report was received from an internet news article and social media blog and refers to a male patient of unknown age. The patient's mother is an attorney. On 12-SEP-2016, the mother took her son for a doctor's appointment due to a backache (he had been hiking and tripped). During the appointment, she was informed that her son was due for his vaccination for human papillomavirus (HPV). So the patient received the HPV vaccine (manufacturer not provided) that day (dose, route and lot # not provided). Not long after, the patient was unconscious and unresponsive on the floor. The mother said that one moment, he was standing there. Then he passed out, tumbling backwards without using his hands to break his fall. His head slammed full force onto the floor, which was like concrete. Within an hour, the patient's family learned that he suffered a severe skull fracture from the fall. And within weeks, they learned that the boy was now deaf in his right ear because of  the trauma he experienced when his head hit the ground. The mother stated her son was still distraught a year later. The mother retained a local lawyer to pursue medical malpractice against the facility where her son was vaccinated as she was not informed of the possible side effects and he was not observed after the vaccination. The attendants were also not prepared when he fainted. Soon after the vaccination, they left to have an x-ray taken for his backache, where he collapsed. They would also seek judgments arguing that the vaccine caused her son to faint and suffer permanent disability. The mother stated that her son was never going to be able to listen to music the same way again and had constant ringing in his ears. They asked a specialist he if would ever regain hearing in the right ear and were told "it would be one in a million chance". The events deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive/vaccine caused her son to faint were considered disabling.     Upon internal review, deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive /vaccine caused her son to faint were considered medically significant. Additional information is not expected.
Sex: M
Vaccine: HPVX
Symptoms: Injury, Loss of consciousness, Skull fracture, Syncope, Tinnitus
Clinical narrative: This initial spontaneous report was received from an internet news article and social media blog and refers to a male patient of unknown age. The patient's mother is an attorney. On 12-SEP-2016, the mother took her son for a doctor's appointment due to a backache (he had been hiking and tripped). During the appointment, she was informed that her son was due for his vaccination for human papillomavirus (HPV). So the patient received the HPV vaccine (manufacturer not provided) that day (dose, route and lot # not provided). Not long after, the patient was unconscious and unresponsive on the floor. The mother said that one moment, he was standing there. Then he passed out, tumbling backwards without using his hands to break his fall. His head slammed full force onto the floor, which was like concrete. Within an hour, the patient's family learned that he suffered a severe skull fracture from the fall. And within weeks, they learned that the boy was now deaf in his right ear because of  the trauma he experienced when his head hit the ground. The mother stated her son was still distraught a year later. The mother retained a local lawyer to pursue medical malpractice against the facility where her son was vaccinated as she was not informed of the possible side effects and he was not observed after the vaccination. The attendants were also not prepared when he fainted. Soon after the vaccination, they left to have an x-ray taken for his backache, where he collapsed. They would also seek judgments arguing that the vaccine caused her son to faint and suffer permanent disability. The mother stated that her son was never going to be able to listen to music the same way again and had constant ringing in his ears. They asked a specialist he if would ever regain hearing in the right ear and were told "it would be one in a million chance". The events deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive/vaccine caused her son to faint were considered disabling.     Upon internal review, deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive /vaccine caused her son to faint were considered medically significant. Additional information is not expected.
Sex: M
Vaccine: HPVX
Symptoms: Unresponsive to stimuli, X-ray
Clinical narrative: This initial spontaneous report was received from an internet news article and social media blog and refers to a male patient of unknown age. The patient's mother is an attorney. On 12-SEP-2016, the mother took her son for a doctor's appointment due to a backache (he had been hiking and tripped). During the appointment, she was informed that her son was due for his vaccination for human papillomavirus (HPV). So the patient received the HPV vaccine (manufacturer not provided) that day (dose, route and lot # not provided). Not long after, the patient was unconscious and unresponsive on the floor. The mother said that one moment, he was standing there. Then he passed out, tumbling backwards without using his hands to break his fall. His head slammed full force onto the floor, which was like concrete. Within an hour, the patient's family learned that he suffered a severe skull fracture from the fall. And within weeks, they learned that the boy was now deaf in his right ear because of  the trauma he experienced when his head hit the ground. The mother stated her son was still distraught a year later. The mother retained a local lawyer to pursue medical malpractice against the facility where her son was vaccinated as she was not informed of the possible side effects and he was not observed after the vaccination. The attendants were also not prepared when he fainted. Soon after the vaccination, they left to have an x-ray taken for his backache, where he collapsed. They would also seek judgments arguing that the vaccine caused her son to faint and suffer permanent disability. The mother stated that her son was never going to be able to listen to music the same way again and had constant ringing in his ears. They asked a specialist he if would ever regain hearing in the right ear and were told "it would be one in a million chance". The events deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive/vaccine caused her son to faint were considered disabling.     Upon internal review, deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive /vaccine caused her son to faint were considered medically significant. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included an sterile diluent(manufacturer unknown). On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N007930 with expiration date on 08-MAR-2019 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 35 Fahrenheit (F) during a time frame of 30 hours. It was also reported that previous temperature excursions occurred of 22 F during 22 hours and a digital data logger was involved. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA005581: US-009507513-1709USA008139:
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a pharmacist, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis or with doses of VARIVAX (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) also for prophylaxis. On unspecified dates, the patients experienced an unspecified "swollen arm". The outcome of the swollen arm was unknown and the causality between the vaccination with ZOSTAVAX or with VARIVAX regarding the event was not reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1709USA005581: US-009507513-1709USA008138:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician 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 multiple unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effects reported. No product quality complaint was involved. The vaccines were exposed to a temperature excursion of 51 Fahrenheit degrees for a time frame of 1.5 hours, identified because of a digital data logger. There was no previous temperature excursion. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA008155: US-009507513-1709USA008156: US-009507513-1709USA007978: