chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urine analysis
Clinical narrative: Per patient's mom. Patient begin a fever around 7pm after receiving the shot at 11:15 am. His mom gave him took 2 TYLENOL tablets. Then about 2:20 am patient started feeling worse. He had 101 temp and his heart rate was up to 170 according to his watch. His parents them took him to the ER. They gave him fluids and ran a variety of test EKG, urine test, blood work and could not find anything. They kept him in the ER until they released him at 9:30 am. His mom stated that the ER doctor was treating him as if he had the flu and gave him an RX for TAMIFLU. His heart rate was down to 120 by the time he left and that if in a few days his heart rate was not lower he would need to see a cardiologist. Mom stated when she came in to pick up his TAMIFLU rx his heart rate was down to 100.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dizziness, Feeling cold, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: Immediately after the immunization, the injection site bled & showed signs of swelling & raised up. Pt's blood pressure dropped to 70s/50s & started to feel dizzy, get cold, & couldn't bare to get up. Roughly 10-15 min passed & pt's face started to feel puffy & throat felt tighter. 911 was called. She took a 25mg BENADRYL & started to feel better in 5-10 min. Paramedics showed up after & assessed her vitals & past history. She improved in the time they were there and went home shortly after.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Swelling face, Throat tightness
Clinical narrative: Immediately after the immunization, the injection site bled & showed signs of swelling & raised up. Pt's blood pressure dropped to 70s/50s & started to feel dizzy, get cold, & couldn't bare to get up. Roughly 10-15 min passed & pt's face started to feel puffy & throat felt tighter. 911 was called. She took a 25mg BENADRYL & started to feel better in 5-10 min. Paramedics showed up after & assessed her vitals & past history. She improved in the time they were there and went home shortly after.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt experienced increased soreness, redness and warmth to the touch. This was her 2nd dose and she stated not experiencing any of this with her first dose.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Ataxia, Injection site bruising, Injection site reaction, Rash macular
Clinical narrative: Patient reports traveling to a different state and signs of weakness and ataxia on both legs occurred around 10/12/18. Left arm below the injection site have few blotch bruising.
Age: 19.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pallor, Presyncope, Throat clearing, Vision blurred
Clinical narrative: Patient received vaccines, walked out of the booth to wait for a relative who was getting the same vaccines. He said his vision was blurring, so he walked back around and his relative saw he looked pale and like he was going to fall, so he grabbed him before he hit the floor. This occurred within 5 minutes after receiving the vaccine. We placed the patient in a sitting position and I had a technician reach for a bp cuff and EPIPENS. The patient removed his hoodie, his bp was 124/65 with a pulse of 86. He was alert and speaking, periodically clearing his throat. He regained his coloring and waited on the floor for about 20 minutes. There was no progression or signs of anaphylaxis. We helped him up and he was able to walk without assistance. His relative drove home with him. The patient states he has no previous history of fainting or allergic reaction to vaccines, he was just embarrassed.
Age: 59.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Rash papular
Clinical narrative: Red, painful area surrounding injection site. Small, bumpy rash from elbow to injection site.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Dr, patient's regular physician, told the patient that the usual duration of pain after injection is 2-3 days. Patient will be scheduled for an MRI to rule out after contributory factors. Patient stated that he can't be sure that his continued muscle pain in his arm is related to having received the vaccine, but is scheduled for an MRI to rule out other contributing causes.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states she has a dull pain when raising her arm ever since she got the shot. She states the shot was in the middle of the deltoid area and has consulted a doctor who said it may be nerve pain. She has used TYLENOL, ibuprofen, and heating pad, none of which have taken the pain completely away.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Tinnitus, Vision blurred
Clinical narrative: Patient got lightheadedness, blurred vision and ringing in ears. Gave her diphenhydramine and offer a water. Her symptoms got better gradually. She stayed at the pharmacy about 25mins and left after her symptoms gets cleared.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: Pt called stating his arm was very sore, could hardly reach over his head. Advised him to use an ice pack and take tylenol, had a fever and chills as well, feeling light headed and fatigued. But feeling slightly better than this morning. Last night after the shot was the worst.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Pt called stating his arm was very sore, could hardly reach over his head. Advised him to use an ice pack and take tylenol, had a fever and chills as well, feeling light headed and fatigued. But feeling slightly better than this morning. Last night after the shot was the worst.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Upper arm swelling towards arm fold and extending towards forearm. The arm at 24 hours had a light red rash. It was also hot to the touch. Unable to comfortably bend elbow or lay on left side. At 48 hours, the arm swelled more with the redness deepening. Still difficulty bending elbow, area is hot to the touch.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Severe chills, nausea and vomiting. Patient got immunization at 5p.m. Started having chills after about 10 minutes and within 1/2 hour was vomiting. Chills, nausea and vomiting throughout night. Pharmacist called at 10:45 a.m. the next morning and she was feeling slightly better. Had not vomited for 4 hours. Will follow up tomorrow morning.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Feeling cold, Headache, Nausea
Clinical narrative: I have had two, in the series of two, injections of SHINGRIX, approximately 2-2 1/2 months apart. Both resulted in the same side effects: fever, violent chills, headache, nausea, bone/joint pain. Side effects last approximately 24 hrs.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: I have had two, in the series of two, injections of SHINGRIX, approximately 2-2 1/2 months apart. Both resulted in the same side effects: fever, violent chills, headache, nausea, bone/joint pain. Side effects last approximately 24 hrs.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular
Clinical narrative: Patient called pharmacy on 10/28/208 complaining of itching and noticing small, red bumps. Patient had mild itching after receiving injection, which worsened and got better over few days. Upon speaking to the patient she has developed small, red bumps that are itching. I advised patient that this may be an allergic reaction and to take Benadryl and urged the patient to seek medical attention. We will follow up with patient's primary care physician on 10/29/2018 as the office was closed over the weekend.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Increased upper airway secretion, Myocardial infarction, Pneumonia
Clinical narrative: PATIENT CONTACTS ME (THE PHARMACIST) AT PHARMACY ON 10/27/18 TO REPORT THAT THE FOLLOWING DAY AFTER HER FLU VACCINE, SHE DEVELOPED A INCREASE IN MUCUS PRODUCTION. SHE WENT ON TO EXPLAIN THAT SHE COULD NOT BREATHE WELL AND DECIDED TO VISIT THE EMERGENCY ROOM FOR MEDICAL EVALUATION. ONCE SHE WAS SEEN BY THE MEDICAL STAFF SHE WAS ADMITTED TO THE HOSPITAL. SUBSUQUENTLY, SHE DEVELOPED A PNEUMONIA AND A HEART ATTACK ALSO OCCURED WHILE IN THE HOSPITAL. THE PATIENT WAS AT HOME ON 10/27/18 WHEN SHE NOTIFIED ME OF THE INCIDENT. ALL INFORMATION IS FROM THE PATIENT'S TESTIMONY AND HAS NOT BE INDEPENDENTLY VERIFIED.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Within 10-15 minutes after getting the vaccination the patient developed itching and a rash to the left arm. She states that due to her seasonal allergies she carried BENADRYL and CLARITIN with her. She took both medicines and the itchy spots resolved within a few hours.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Fatigue, Urticaria
Clinical narrative: After giving the shot the patient developed hives on face and arms and began to cough. Mother returned to the pharmacy where the pharmacist inject IM diphenahydramine 50mg/ml IM into right arm. Dose given was 0.5ml or 25mg (westward brand Lot #117340 exp 11/19) Pharmacist monitored vital signs every 10 minutes while the medication took effect. EPIPEN was available in case of worsening condition but was not needed. After 20 minutes the hives were gone and the patient was not experiencing any other adverse effects other than being tired. Patient on mother left pharmacy and was told to take diphenahydramine as needed and if any worsening condition to go to emergency room. Called mother on 10/28/18 at 10:00am to see how patient was doing and she stated that other than being tired from the diphenahydramine there were no additional adverse reactions.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Infection, Peripheral swelling
Clinical narrative: Pt was at doctor for normal visit when she noticed her arm was red and swollen and very painful. she drew a line around the spot the was about the size of her hand and it did get bigger md said it was clearly infected and wanted to give meds but pt refused to see how it would do and it has finally started to come down.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Discomfort, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: Throbbing, ache, decreased range of motion, decreased strength, constant discomfort, sleep interruption due to pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypotension, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills, hypotension.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Malaise, Myalgia
Clinical narrative: I had this reaction to both shots: chills, fever, whole body muscle aches, headache, general malaise,  sore arm, large red circle at site....lasting 2.5 days with still some mild symptoms present.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: I had this reaction to both shots: chills, fever, whole body muscle aches, headache, general malaise,  sore arm, large red circle at site....lasting 2.5 days with still some mild symptoms present.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous case, initially received from other non-health professional on 17-Oct-2018, concerns a 27-year-old, adult female patient. On 19-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported]. Within 3 to 4 hours after vaccination, the patient began to experience muscle soreness. Since the day of vaccination, muscle soreness worsened progressively that the patient was unable to lift her arm anymore. On an unspecified date, the patient had consulted healthcare professional (HCP), who stated that she might have received the vaccine in the joint instead of in the muscle (coded as vaccine administered at inappropriate site). At the time of this report, the outcome of the event muscle soreness was not reported, while the event injected limb mobility decreased had not recovered. The reporter assessed this case as non-serious.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Chills, Dysuria, Micturition urgency, Pain
Clinical narrative: Per nursing note, patient reports urgency, burning, urinary frequency, umbilical pain fever of 101, chills, body aches. UA negative.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Pollakiuria, Pyrexia, Urine analysis normal
Clinical narrative: Per nursing note, patient reports urgency, burning, urinary frequency, umbilical pain fever of 101, chills, body aches. UA negative.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Syncope
Clinical narrative: Syncope or loss of consciousness about 10 min from receiving flu shot (FLUZONE HD) and 3 min from receiving pneumonia vaccine (PNEUMOVAX 23).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. C/O red area over vaccine site. Approximately 8 cm diameter. Red and warm painful.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Immobile, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt received vaccine 10/22/18 11:30 AM. Pt first experienced soreness at 10/22/18 7:00pm in deltoid. The adverse symptoms later worsened to extreme muscle stiffness in the lower back and lower extremities. The pt described the muscle stiffness resulting in immobility. All symptoms gradually resolved by 10/26/18.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Limb discomfort, Paraesthesia
Clinical narrative: Patient reported initial "tingling" in injection arm which improved a few minutes post immunization. Sensation seemed to resolve. Husband reported 10/24/18 that patient experienced "tingling" and "dead arm" in other extremities. Follow up with patient 10/27/18 patient reports an "easement" of symptoms for a period but relief gone and "fatigue", "dead arm/leg" resumed. 10/28/18 - patient has been advised to contact her PCP and Intermed of this VAERS report with suspicion of GBS like symptoms. Husband contacted Intermed and advised that there was no concern. The contact was made before weekend 10/27/18 - I am advising patient to be reevaluated.
Sex: F
Vaccine: HPV4
Symptoms: Basedow's disease, Bedridden, Fibromyalgia, Immediate post-injection reaction, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) concerning a currently 28 years old non-pregnant adult female patient. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not reported. Sometime in 2009, the patient was vaccinated with GARDASIL (strength, indication, frequency, dose number, route, lot# and expiry date was unknown). Following vaccination (approximately in 2009) with GARDASIL, the patient was immediately bedridden (disability), developed systemic lupus (Systemic lupus erythematosus), hives, fibromyalgia, issues with her thyroid and Graves' disease (Basedow's disease). The patient was taken to the clinic for medical assistance and unspecified treatment. The reporter did not provide contact information of the physician. At the time of this report, the patient had not recovered from the events. Causality of the events was not provided. No product quality complaint (PQC) was involved. Upon internal review, the events Systemic lupus erythematosus and Basedow's disease were determined to be medically significant. This is one of two reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder, Urticaria
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) concerning a currently 28 years old non-pregnant adult female patient. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not reported. Sometime in 2009, the patient was vaccinated with GARDASIL (strength, indication, frequency, dose number, route, lot# and expiry date was unknown). Following vaccination (approximately in 2009) with GARDASIL, the patient was immediately bedridden (disability), developed systemic lupus (Systemic lupus erythematosus), hives, fibromyalgia, issues with her thyroid and Graves' disease (Basedow's disease). The patient was taken to the clinic for medical assistance and unspecified treatment. The reporter did not provide contact information of the physician. At the time of this report, the patient had not recovered from the events. Causality of the events was not provided. No product quality complaint (PQC) was involved. Upon internal review, the events Systemic lupus erythematosus and Basedow's disease were determined to be medically significant. This is one of two reports received from the same reporter.
Age: 11.0
Sex: U
Vaccine: FLU4, HEPA, MNQ, TDAP, HEPA
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant referring to a 11 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 10-OCT-2018 the patient was inadvertently administered an adult formulation of VAQTA (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 11.0
Sex: U
Vaccine: FLU4, HEPA, MNQ, TDAP, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant referring to a 11 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 10-OCT-2018 the patient was inadvertently administered an adult formulation of VAQTA (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot number, expiry date and route of administration were not reported) in left upper leg on 16-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to overdose (patient received a 0.5 ml FLUZONE QUADRIVALENT but should have had a 0.25 ml). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, chills, achiness.
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Insomnia, Pain, Pain in extremity
Clinical narrative: I have had chronic pain in my left arm that some days I can barely lift it and others a pain in the whole arm down to the hand. It. I can't sleep on my left side and I am left handed so I use this side more which is hard with pain. It started the afternoon of the day I got my shot.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Less than 24 hours after injection, full body muscle aches, fever, fatigue, headache.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: I experienced extreme pain while attempting to sleep on the night of the 26th of the vaccination.  Pain lasted for approximately 36 hours. According to my FitBit, I slept 3 hours. Pain subsided on Sunday morning. I will; l notify the Pharmacy and Dr. treating my fractured wrist. I am covered by the medical center.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Oropharyngeal pain, Pallor, Tremor
Clinical narrative: Patient received her flu vaccine and seemed in good spirits as we left the facility. While in the car driving away (within about 5 min of vaccine administration) pt complained of a painfully sore throat, shaking, and "feeling funny". Her hands would tremble if she tried to hold them steady and she became very pale. She needed to sit and rest for several minutes before she felt well enough to walk around. She gradually improved over the course of an hour and had no further issues.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache
Clinical narrative: Extreme fatigue and headache starting evening of vaccination and lasting the entire following day.
Sex: F
Vaccine: HPV4
Symptoms: Death, Fatigue, Loss of personal independence in daily activities, Pain
Clinical narrative: This spontaneous report as received from a mother refers to a 15 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (lot number not reported) for prophylaxis.  On an unknown date after the first dose of the vaccine, the patient experienced unexplained pain and fatigue. After the second dose, the pain (disability) and fatigue (disability) worsened to the point patient could not attend school. It was reported at first the family did not suspect the vaccine. Doctors couldn't explain her reaction either. However, when the family mapped out her absences from school, they realized they started and intensified in the days after receiving the vaccine. The reporter stated that there's a big difference between correlation and causation and she understand that. But it seemed very clear at that point. Doctors told reporter that reactions to the vaccine do happen. The family filed a report with the FDA's Vaccine Adverse Event Reaction System (VAERS). The outcome of unexplained pain, fatigue, the pain (disability) and fatigue (disability) worsened to the point patient could not attend school was unknown. The reporter considered the events to be related to GARDASIL. Follow-up information has been received on 25-OCT-2018 in the form of a social media post. It was noted that this was in memory of the female patient. No specific details were provided regarding date of death or cause of death. Upon internal review in memory of the patient (death) was considered a medically significant event. Pain and fatigue worsened to the point patient could not attend school were considered disabling. Additional information is not expected. It has been determined that case#1404USA003032 is a duplicate of case#1404USA005105. Therefore, case#1404USA003032 is being deleted from our files and consolidated into case#1404USA005105.; Sender's Comments:  US-009507513-1404USA003032: voided case; Reported Cause(s) of Death: death.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from an administrator regarding a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 25-SEP-2018, the patient was vaccinated with the first dose of ROTATEQ, lot # N022015, expiration date 10-MAR-2019 (strength, dose and route of administration were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist who refers to a patient of unknown age and gender. No information regarding the patients's pertinent medical history,concomitant therapies and drug reaction or allergies was provided. On 24-SEP-2018, the patient was vaccinated with PROQUAD (recombinant human albumin) lot # R001540, expiry date 15-JUL-2019, albumin status rHA (exact dose and route of administration were not reported) reconstituted with properly stored sterile diluent (lot and expiry date unknown) for prophylaxis. The dose of vaccine was stored between -14 and -10 Celsius degrees (C) for 53 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse referring to a 3 year old patient. Information about current condition, concomitant medication and medical history of patients was not provided. On an unknown date the patient was administered with PNEUMOVAX 23 lot # K004483, expiration date 16-AUG-2015 for prophylaxis (strength, dose, and frequency were not reported). No adverse event was reported. Action taken regarding therapy with PNEUMOVAX 23 was unknown.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to three patients of unknown demographics. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On unspecified dates, two patients were vaccinated with improperly stored GARDASIL 9 from lot # R011628, expiry date: 11-DEC-2020 (expiry date also reported as 02-OCT-2018) and one different patient was vaccinated with improperly stored VAQTA from lot # R010954, expiry date: 27-MAY-2019 (expiry date also reported as 02-OCT-2018 for prophylaxis (dosing details not reported) (Product storage error). No adverse effects were reported. The vaccines were exposed to a temperature below 32 degree Fahrenheit (F): 31.1 F for 8 hours and 57 minutes and 31.9 F for 9 hours and 57 minutes; exposed to temperature above 32 F: 35.0 F for 31 minutes; and exposed to temperature in range of 47F to 77F (48. 9F) for 1 hour and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This case is considered as non-valid due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from nurse on 12-OCT-2018 refers to a 13 year old male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored second dose of GARDASIL 9 (dose and frequency were not reported) (lot # R011628, expiry date: 11-DEC-2020) intramuscularly in the left arm for prophylaxis. The reporter spoke with company representative and refrigeration temperature was too low. Vaccine was not active need to be revaccinated. The reporter spoke with patient's mother and explained this to her. No reaction to vaccine except some soreness at injection site (vaccination site pain), on 02-OCT-2018. The outcome of event, vaccination site pain was reported as recovered/resolved. The relationship between the event, vaccination site pain and GARDASIL 9 was not provided. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient was administered with improperly stored VAQTA (lot # R017644, expiration date: 09-AUG-2019, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effect reported. The stored temperature was 32 -35 (33.6) Fahrenheit (F). The time frame was 220 minutes. There was no previous temperature excursion. The call was because of a data logger. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a approximately 16 years old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions and allergies was provided. An unspecified physician told the reporter that on an unknown date in January 2014, the patient (16 years old at that time) was vaccinated with a first dose of GARDASIL (exact dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date in March 2014, the patient was vaccinated with a second dose of GARDASIL (exact dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The reporter stated that she was not sure which human papillomavirus (HPV) vaccine was given for Dose 1 and Dose 2 but she said it was "probably" the GARDASIL. The patient did not return for dose 3 until the day of the report (04-OCT-2018). The reporter stated that the patient was in the physician's clinic on 04-OCT-2018 (reported as right now), to be vaccinated and the reporter stated that the physician would administer GARDASIL 9 to complete the HPV vaccination series. No symptoms reported.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician, referring to 9 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant therapy was unknown. On 05-OCT-2018, the patient was vaccinated with a dose of VAQTA (1DF; strength, route, frequency, lot # and expiration date unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 14-SEP-2018, the patient received improperly stored (-14 Celsius (C) degree to -10 C degree for 5 hours; there was no previous temperature excursion) VARIVAX (lot # R017636, expiration date auto-generated as 20-JUN-2020, also reported as 30-JUN-2018; strength, dose, frequency and route were not reported) for prophylaxis and was also reconstituted with sterile diluent (MERCK) (lot # R001089, expiration date 18-SEP-2020; strength, dose, frequency and route were not reported). No adverse effect was reported. It was not because of a data logger. Sender's Comments: US-009507513-1810USA011660: US-009507513-1810USA011661.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant via a field representative referring to a 15 year old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On an unspecified date when the patient was 11 years old, the patient was vaccinated with first dose of GARDASIL (lot number, expiration date, frequency and route were unknown) in the "HPV vaccination series" for prophylaxis. On an unspecified date in October 2018 when the patient was 15 years old, the patient received second dose GARDASIL 9 (lot number, expiration date, frequency and route were unknown) in the "HPV vaccination series" for prophylaxis (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects reported. It was not reported if treatment was given or if lab diagnostics or studies were performed for the events. It was not reported if the patient sought medical attention. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant referring to her 21 year old female daughter. The patient's concomitant medication, medical history drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9  (dosage, frequency, lot number and expiration date was not reported) indicated for prophylaxis. On an unknown date, the patient became pregnant (vaccine exposure during pregnancy) with last menstrual period (LMP) on an unspecified date in May or June 2018 and a estimated date of delivery (EDD) of March 2019. It was specified that no adverse effects were reported. The patient did not sought any type of medical attention, it was unknown by the reporter if laboratory diagnoses or studies were performed to the patient. The pregnancy outcome and the fetal outcome were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age. Information about concomitant medications and drug reactions was not provided. The patient's medical history included shingles. On an unspecified date in 2017, the patient was vaccinated with a dose of ZOSTAVAX (route reported as injection; lot # and expiration date were unknown) as a preventative measure for shingles, as she has had "shingles" previously before(Intentional misuse). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: Information has been received from a pharmacist via a field employee referring to a 65 year or older patient of unknown gender. The patient received PREVNAR two or three years ago. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date (reported as two or three years after receiving PREVNAR, the patient received vaccinated with PNEUMOVAX 23 (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 09-OCT-2018, the patient received a dose of expired VARIVAX (lot # M041079; expiration date 06-OCT-2018) intramuscularly for prophylaxis. No adverse effects reported. No temperature excursion reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a non-Merck clinical site coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 03-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ, orally (exact dose was not provided), lot # N030364, expiration date: 06-MAR-2019, for prophylaxis. The vaccine was stored at 11 Celsius degrees (C) for 1 hour 20 minutes and 8.7 C for 7 minutes. There were no other previous temperature excursions noted. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1810USA012273: US-009507513-1810USA012274.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Syncope, Tooth fracture
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 year old male patient. The patient did not have a history of fainting (was stated by physician). Information about concurrent condition and concomitant medication were not provided. On an unknown date, the patient was vaccinated with the first dose (was reported as company representative believed) of GARDASIL 9 for prophylaxis (strength, frequency, route, lot# and expiration date were not reported). When the patient was administered GARDASIL 9, he was sitting and leaning forward, he fainted and fell to the floor and chipped his tooth. The outcome of events and causality were not provided.
Sex: F
Vaccine: HEPA
Symptoms: Hepatic enzyme increased
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a female patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. The patient reported she received VAQTA on unspecified date (strength, dose, frequency, route, lot #, expiration date and indication were not reported) for prophylaxis and experienced elevated liver enzyme on unspecified date. The outcome of elevated liver enzyme was unknown. The causality was not provided.
Age: 65.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site abscess, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient's concurrent conditions included hypertension. The patient had no drug reactions or allergies. Concomitant therapies included amlodipine, atorvastatin and irbesartan. On 01-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R012632, expiration date: 15-JAN-2020, dose was not reported), intramuscularly in the left arm, as she was due for second pneumococcal dose after receiving PREVNAR 13 in 2017 (reported as one year ago). On 02-OCT-2018, the patient started having the following symptoms "chills, fever, unable to move injected arm, large red rash that is itchy and hot to touch on the injected arm". The pharmacist reported that on 01-OCT-2018 the patient also received FLUCELVAX (lot# 252228, expiration date: 31-MAY-2019) in the same arm, "but the injection site reaction appeared to be stemming from where the PNEUMOVAX 23 was injected." On an unknown date in October 2018, a white blood cell count (WBC) was examined, but no results were provided. The pharmacist reported that "the patient went to (an unspecified) emergency room and they prescribed an (unspecified) antibiotic. The outcome of all events was reported as recovered/resolved on an unknown date in October 2018. Causality assessment was not provided.
Age: 65.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Rash erythematous, Rash pruritic, Skin warm, White blood cell count
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient's concurrent conditions included hypertension. The patient had no drug reactions or allergies. Concomitant therapies included amlodipine, atorvastatin and irbesartan. On 01-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R012632, expiration date: 15-JAN-2020, dose was not reported), intramuscularly in the left arm, as she was due for second pneumococcal dose after receiving PREVNAR 13 in 2017 (reported as one year ago). On 02-OCT-2018, the patient started having the following symptoms "chills, fever, unable to move injected arm, large red rash that is itchy and hot to touch on the injected arm". The pharmacist reported that on 01-OCT-2018 the patient also received FLUCELVAX (lot# 252228, expiration date: 31-MAY-2019) in the same arm, "but the injection site reaction appeared to be stemming from where the PNEUMOVAX 23 was injected." On an unknown date in October 2018, a white blood cell count (WBC) was examined, but no results were provided. The pharmacist reported that "the patient went to (an unspecified) emergency room and they prescribed an (unspecified) antibiotic. The outcome of all events was reported as recovered/resolved on an unknown date in October 2018. Causality assessment was not provided.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via an employee referring to a 73 year old male patient. Information about concurrent condition, concomitant medication and medical history was unknown. On 11-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis and an influenza virus vaccine (unspecified) concomitantly in the same arm. On the night of the same day, the patient experienced swelling and pain at the injection sites. The patient was informed to apply ice by the pharmacist. The outcome of swelling and pain at the injection sites was reported as recovering. The causality assessment was not provided.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin irritation
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 21-year-old female patient. The patient's concurrent conditions and concomitant therapy were not reported. On approximately 10-OCT-2018 (reported as two days ago), the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (manufacturer, lot #, expiration date and dosage regiment were not reported) for prophylaxis. On an unknown date in October 2018, the patient's arm had a raised, itchy, red, irritated area. Her mother witnessed the reaction through live social media with the patient on 11-OCT-2018.The outcome of the events was not reported. The relatedness between vaccination with varicella virus vaccine (manufacturer unknown) and the events was not reported.
Age: 1.58
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from the doctor's nurse regarding a 19-month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 22-OCT-2015,  the patient was vaccinated with the first dose of M-M-R II and second dose on 26-MAY-2016, (dose 0.5 ml, twice) strength, lot # and expiration date were not reported, for prophylaxis (reported as second dose given seven months after the first). No adverse event was reported. This report was not associated with a product quality complaint.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis of varicella virus. The patient became pregnant with last menstrual period (LMP) of 20-AUG-2018 and estimated date of delivery(EDD) of 27-SEP-2019 (reported the patient was 8 weeks pregnant at the time of this report). The pregnancy outcome was pending. On 03-SEP-2018, the patient was vaccinated with the second dose of VARIVAX (route, dose, batch/lot # and expiration date were not reported), and she was unknown she had been 2 weeks pregnant at the time of administration (vaccine exposure during pregnancy). At the reporting time, the outcome of the event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse referring to a 14 years old patient of unknown gender. Information about concurrent conditions, medical history and drug reactions was not provided. On 15-OCT-2018, the patient was vaccinated with a dose of PROQUAD (therapy type: recombinant Human albumin (rHA), lot # R008204, expiration date 16-SEP-2019) ) with sterile diluent (MERCK) (lot# reported as N029881 with expiration date May 2020 (reported as "34-MAY-2020")) subcutaneously for prophylaxis (drug administered to patient of inappropriate age). No Adverse effects were reported.
Age: 0.08
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 1-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 15-OCT-2018, the patient was vaccinated once with a 0.5 ml dose of GARDASIL 9 intramuscularly, lot# R001263, expiration date: 10-NOV-2020 for prophylaxis. No adverse effects were reported.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 82-year-old female patient. There were no concomitant medications, pertinent medical history and known drug reactions or allergies reported. On 10-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly, lot # R012632, expiration date 15-JAN-2020 (strength and dose were not reported), for prophylaxis. On the same date, the patient experienced area around injection site (reported as "4 inches below and to the right of injection site") being painful, red and warm. The patient sought medical attention and returned to the pharmacy on 12-OCT-2018. No lab diagnostics or studies were performed. It was reported that treatment was given for the events and the patient took an unspecified dose of TYLENOL or MOTRIN. The outcome of the events was unknown. Causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Information has been received from a nurse practitioner via a field representative, referring to a female patient of unknown age. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was unknown. On 11-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose detail and route were unknown) for prophylaxis. The patient was seen in the office on 12-OCT-2018 and the patient had a "local on site reaction that looked like cellulitis". The nurse practitioner informed the patient to come back to the office in 3 to 5 days if the reaction did not resolve. At this time, the patient had not been back to the office. The outcome of the event was unknown. The causality assessment was not provided by the reporter.