chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 22-year-old female patient received the first dose of TRUMENBA (lot number: S56026; expiration date: 28Feb2019), intramuscularly in the left deltoid on 14Jun2018 at 0.5 ml, single as required for work physical at the physician's office. The patient had no medical and family medical history. Concomitant medication included GARDASIL (lot number: N029069, expiration date: 17May2020) on 14Jun2018 for immunization. The patient received her first meningococcal group b rlp2086 vaccine yesterday (14Jun2018) and noticed all of her symptoms this morning of 15Jun2018. The patient came back to the office today (15Jun2018) with a local reaction. She had redness at the area with swelling, the site was hot to the touch and painful and she had a low grade fever of 99.1. The patient was advised to use a cold compress to the site and use TYLENOL as needed for pain. The outcome of the adverse events was not recovered.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Patient reported adverse reaction to right arm after receiving pneumonia vaccine on 6/16/18. Per patient, she developed arm stiffness, warm and pain initiating at injection site on same day following injection. Patient seeked care at ER where she was diagnosed with cellulitis and received 2 rounds of IV ABX and oral ABX concurrently.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Irritability, Screaming
Clinical narrative: Immunizations given approx. 9:35 am. Mom nursed infant before leaving office. Approx. 11:30 started getting fussy, but infant refused nursing, and was crying, but started " screaming" around 12:30, inconsolable X 2 hours, started calming down for only a minute or two at a time. Called the office at 2:30pm, instructed to give TYLENOL and put cold cloths on legs, and let us know in 20 min. if any better. Called back, stated no Better, instructed to come in. Arrived crying at 3:35 pm,  and settled with gentle rocking. Injection sites clear; legs seem uncomfortable to touch. 4:00 nursing well. Quiet and content. Instructed to use TYLENOL for pain symptoms if needed, per 4 hours. Left office with parents.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dysphonia, Lip swelling, Urticaria
Clinical narrative: Joint ache, hives, swelling in outer edge of upper lip, raspy voice. Symptoms began around 6 pm with joint ache in the hip area.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, IPV, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Eye swelling, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Red swollen eyes. Throat swollen, hard to swallow. Gave 50 mg benadryl and told I would get checked out at ER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Skin irritation, Urticaria
Clinical narrative: Big red area and irritation on arm. Hives from head to toe, trouble breathing.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Migraine, Myalgia, Nausea
Clinical narrative: I had nausea, random muscular aches in legs, arms and fingers that night. It continued to get worse the next day. I was incapacitated. It ended with a migraine later that night. Acetaminophen  didn't help. The next day the symptoms had gone. I also had some small itchy spots on my upper left arm that have disappeared.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was given first GARDASIL 9 vaccination. Approximately 3 minutes after receiving injection, patient stated she was light headed. She was already seated on the exam table and was assisted to a supine position. Patient loss consciousness for approximately 60 seconds. A cool wash cloth was placed on her forehead, ice packs were placed behind  and around her neck, and her blood pressure was taken. Her blood pressure was 118/75. Patient stayed in the supine position for about additional minutes. Patient was assisted into a sitting position for another 5 minutes. At this time she states she is feeling much better. She is given some cold water to drink. She is assisted to her family car by her mom and this nurse. Patient is driven home by mother.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Injection site swelling, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: After 24 hrs, patient developed a fever, local swelling on injection site > than patient's hand, tenderness, flu-like symptoms. Swelling persisted for 3 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Pt experiencing radiating extreme soreness and pain starting in injection arm and spreading across whole body, "worse than the flu" a few hours after receiving the vaccination. She had chills and used an electric heating pad to help with chills, soaked in an Epsom salt bath. The extreme soreness persisted and pt is still experiencing side effects 2 days later though not as severe today.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Myalgia, Vaccination site discomfort, Vaccination site swelling
Clinical narrative: Extreme redness, swelling and discomfort at vaccine site and entire lateral L upper arm x 5 days). Whole-body fatigue and myalgias (x 36 hours).
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Dysgeusia, Flushing, Headache
Clinical narrative: 60 seconds to one minute after IM administration, the patient experienced very sudden onset dizziness, flushing, and a strange taste in his mouth. A few minutes later he reported a large headache. We asked if he was having any trouble breathing and he stated no. We checked on him numerous times over the next few minutes until he notified us all but the headache had disappeared. We are notifying the patients physician.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient wife came in stating adverse reaction to same vaccine. She had a bright red circular injection site type reaction that was 3 to 4 inches in diameter. Stating that it was itchy. It was 3 days post vaccination. Was given 6/16 patient did not come in until 6/19. The wife came in but stated her husband, this patient, had same reaction but spot was larger. Recommended to call MD, take Benadryl, and place ice pack on area. I tried calling md's office but they closed early at noon this day and patient came in at 330.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Donor was immunized on 06/01/18, experienced symptoms on 06/02/18, and reported the symptoms to the donor center on 06/18/18. Donor stated that when she woke up on 06/02/18 with a fever of 100.2 and experienced flu-like symptoms. Donor stated that the symptoms subsided on the evening of 06/02/18.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site reaction, Mass, Rash macular
Clinical narrative: About 48 hours after this booster of SHINGRIX (the prime was received about 2 months ago), I noticed by left arm had red splotches below the injection site that felt like bruising. A few hours later, I found a round lump near my left collar bone. It was approximately half an inch in diameter, red, and warm and tender to the touch. I took an ibuprofen. Over the next 3 days, it gradually reduced in size and became less tender, but is not yet completely gone.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: About 48 hours after this booster of SHINGRIX (the prime was received about 2 months ago), I noticed by left arm had red splotches below the injection site that felt like bruising. A few hours later, I found a round lump near my left collar bone. It was approximately half an inch in diameter, red, and warm and tender to the touch. I took an ibuprofen. Over the next 3 days, it gradually reduced in size and became less tender, but is not yet completely gone.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Patient experienced adverse allergic reaction to vaccine consisting of hives, itching, and swelling face and lips.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Prurigo, Pyrexia, Swelling face, Urticaria
Clinical narrative: Patient experienced adverse allergic reaction to vaccine consisting of hives, itching, and swelling face and lips.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Patient came into the pharmacy two weeks after the vaccination to report that she had had significant swelling, bruising and what she described as "hematoma" at the injection site, beginning shortly after the vaccination (she thinks same evening). Examination of the injection site (at the two week post-vaccination time point) showed a large area, about 3-4 inches in diameter of healing (yellow) bruised area, with some residual dark red areas. She indicated that it had been somewhat painful but was getting better. Unknown if this was a possible Arthus reaction. Suggested she contact primary care doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Patient woke up in the early morning and used the restroom. Shortly after that her husband was holding her up trying to wake her. She was only out of it for a few seconds, but has no memory of the event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported fever and chills lasting about 3-4 days and bright red, swollen, itchy, painful, hot to the touch area around injection site lasting about 5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient reported fever and chills lasting about 3-4 days and bright red, swollen, itchy, painful, hot to the touch area around injection site lasting about 5 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: Body Aches, Flu-like symptoms, chills, sweating.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Overall fatigue, pain, achy symptoms not relieved by TYLENOL.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Pain
Clinical narrative: EXTREME SORENESS AND FATIGUE, CAN BARELY LIFT HIS ARM.
Age: 42.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Excessive eye blinking, Hyperhidrosis, Influenza like illness
Clinical narrative: SHINGRIX was administered approximately one month after the pt had Shingles of the left-side of the face and ear. Pt is under 50, but was prescribed the vaccine by Dr. as he had a severe case of shingles and his PCP wanted to prevent another occurrence. Pt recovered from Shingles last month, but noted that he had permanent facial neuropathy. Administered a SHINGRIX vaccine on 6/15. Pt noted on 6/19 that on 6/15/18 at 13:00 (approx. 3.5 hours after administration), he started to have trouble involuntarily blinking (he reported that he could voluntarily blink though). Pt reports that that particular AE has improved as time went on, but still hasn't fully resolved. He reports he also had sweats - flu-like symptoms on 6/16 and 6/17. I talked to the patient today, (it was initially reported yesterday, 6/18, to another pharmacist), and recommended that he notify his PCP, Dr., who had wrote the prescription and had treated his Shingles. He agreed to my request, and told me he'll contact her tomorrow (6/20). Lot # of Shingles powder: Z9RR4 (exp 11/15/20). Lot # of Shingles Adj. Diluent: 32PE4 (exp 1-23-21).
Age: 42.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: SHINGRIX was administered approximately one month after the pt had Shingles of the left-side of the face and ear. Pt is under 50, but was prescribed the vaccine by Dr. as he had a severe case of shingles and his PCP wanted to prevent another occurrence. Pt recovered from Shingles last month, but noted that he had permanent facial neuropathy. Administered a SHINGRIX vaccine on 6/15. Pt noted on 6/19 that on 6/15/18 at 13:00 (approx. 3.5 hours after administration), he started to have trouble involuntarily blinking (he reported that he could voluntarily blink though). Pt reports that that particular AE has improved as time went on, but still hasn't fully resolved. He reports he also had sweats - flu-like symptoms on 6/16 and 6/17. I talked to the patient today, (it was initially reported yesterday, 6/18, to another pharmacist), and recommended that he notify his PCP, Dr., who had wrote the prescription and had treated his Shingles. He agreed to my request, and told me he'll contact her tomorrow (6/20). Lot # of Shingles powder: Z9RR4 (exp 11/15/20). Lot # of Shingles Adj. Diluent: 32PE4 (exp 1-23-21).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient had fairly severe soreness on both left and right upper arm that persisted for 2 weeks.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Groin pain, Pain, Urine analysis normal
Clinical narrative: Proximally 24 hours post vaccine administration patient developed sudden onset lower back muscular pain radiating to the groin.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Erythema, Fall, Fatigue
Clinical narrative: PT FELT A SHARP PAIN RIGHT AFTER THE INJECTION FOLLOWED BY REDNESS AROUND 10 PM. PT TOOK A BENADRYL AND HAD TO WAKE UP AT 6 AM  DUE TO PAIN AND SWELLING. THE FOLLOWING DAY PATIENT HAD VERY FATIGUE, NAUSEA, BODY PAIN AND DIARRHEA AND WAS DIZZY AND FELL DUE THE DIZZINESS. TODAY IS THE 5TH DAY AND PATIENT STILL FEELS DIZZY AND INJECTION SITE REMAINS VERY RED AND SWELLED.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: PT FELT A SHARP PAIN RIGHT AFTER THE INJECTION FOLLOWED BY REDNESS AROUND 10 PM. PT TOOK A BENADRYL AND HAD TO WAKE UP AT 6 AM  DUE TO PAIN AND SWELLING. THE FOLLOWING DAY PATIENT HAD VERY FATIGUE, NAUSEA, BODY PAIN AND DIARRHEA AND WAS DIZZY AND FELL DUE THE DIZZINESS. TODAY IS THE 5TH DAY AND PATIENT STILL FEELS DIZZY AND INJECTION SITE REMAINS VERY RED AND SWELLED.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: PT FELT A SHARP PAIN RIGHT AFTER THE INJECTION FOLLOWED BY REDNESS AROUND 10 PM. PT TOOK A BENADRYL AND HAD TO WAKE UP AT 6 AM  DUE TO PAIN AND SWELLING. THE FOLLOWING DAY PATIENT HAD VERY FATIGUE, NAUSEA, BODY PAIN AND DIARRHEA AND WAS DIZZY AND FELL DUE THE DIZZINESS. TODAY IS THE 5TH DAY AND PATIENT STILL FEELS DIZZY AND INJECTION SITE REMAINS VERY RED AND SWELLED.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hiccups
Clinical narrative: Patient said that he had hiccups for several days after getting the SHINGRIX vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Pt said immediately felt pain and sick. Pt states had 103 fever and vomiting soon after vaccine for days.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood test normal, Electrocardiogram normal, Hyperhidrosis, Palpitations
Clinical narrative: Patient went home after injection and about an hour later felt very weak. He then started to feel his heart rate race and started sweating. His wife then took him to the emergency room. They had given him an EKG and blood work and found no cardiac abnormalities. They kept him overnight for observation. The symptoms disappeared after a while at his stay in the hospital.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Fatigue, Heart rate increased, Lethargy
Clinical narrative: Patient went home after injection and about an hour later felt very weak. He then started to feel his heart rate race and started sweating. His wife then took him to the emergency room. They had given him an EKG and blood work and found no cardiac abnormalities. They kept him overnight for observation. The symptoms disappeared after a while at his stay in the hospital.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: PATIENT EXPERIENCED INTENSE PAIN, SWELLING, REDNESS AND RASH WHICH COVERED HIS ENTIRE LEFT ARM. THE SYMPTOMS STARTED IN THE AFTERNOON AFTER HE RECEIVED THE SHOT THAT MORNING.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: PATIENT EXPERIENCED INTENSE PAIN, SWELLING, REDNESS AND RASH WHICH COVERED HIS ENTIRE LEFT ARM. THE SYMPTOMS STARTED IN THE AFTERNOON AFTER HE RECEIVED THE SHOT THAT MORNING.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Headache, stiffness in neck.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Injection site warmth
Clinical narrative: Eight days of flu symptoms. Injection site was red and warm for eight days. I'm no hypochondriac or weeny. Was truly shocked at this reaction.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers 61 of 84 patients. On an unspecified date in Oct-2017 (between  25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: After vaccine had severe arm pain and difficulty morning and raising arm above head. States did not have this kind of pain after getting the 1st dose of TRUMENBA. The following day had redness and swelling of arm. Seen on 6/16/18 in office. Still had redness below injection site with swelling noted. Stated pain improving as of the morning of 6/14/18.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain
Clinical narrative: After vaccine had severe arm pain and difficulty morning and raising arm above head. States did not have this kind of pain after getting the 1st dose of TRUMENBA. The following day had redness and swelling of arm. Seen on 6/16/18 in office. Still had redness below injection site with swelling noted. Stated pain improving as of the morning of 6/14/18.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: After vaccine had severe arm pain and difficulty morning and raising arm above head. States did not have this kind of pain after getting the 1st dose of TRUMENBA. The following day had redness and swelling of arm. Seen on 6/16/18 in office. Still had redness below injection site with swelling noted. Stated pain improving as of the morning of 6/14/18.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 54 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 55th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 and 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 62 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 51 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 547of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult female patient of unspecified age. This refers 56 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 53rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow-up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 59 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 58 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 52 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 49 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Electrocardiogram abnormal, Influenza like illness, Laboratory test normal, Loss of consciousness, Malaise
Clinical narrative: Child felt fine after shots administered. That night at 8:30 PM he started to feel sick and had fever. At 11:00 PM he had flu like symptoms. The following morning he had body aches. At 11 AM when he went to bathroom he had episode of syncope and woke up on the floor. A neighbor took him to the ER. He never had arm pain/swelling to either vaccine site. ER did EKG - mild Tachy - norm Neuro exam.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Neurological examination normal, Pain, Pyrexia, Syncope, Tachycardia
Clinical narrative: Child felt fine after shots administered. That night at 8:30 PM he started to feel sick and had fever. At 11:00 PM he had flu like symptoms. The following morning he had body aches. At 11 AM when he went to bathroom he had episode of syncope and woke up on the floor. A neighbor took him to the ER. He never had arm pain/swelling to either vaccine site. ER did EKG - mild Tachy - norm Neuro exam.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Fall, Influenza like illness, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Child felt fine after shots administered. That night at 8:30 PM he started to feel sick and had fever. At 11:00 PM he had flu like symptoms. The following morning he had body aches. At 11 AM when he went to bathroom he had episode of syncope and woke up on the floor. A neighbor took him to the ER. He never had arm pain/swelling to either vaccine site. ER did EKG - mild Tachy - norm Neuro exam.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 54th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This initial non-serious spontaneous case, was received on 19-Sep-2017 from other health professional, concerns 33-year-old, adult, female patient. On 18-Sep-2017, the patient was inadvertently administered with expired AFLURIA (dose: 0.5 ml, expiry date: 30-Jun-2016, route of administration, anatomical location and batch no: not reported (coded as expired product administered). The outcome of event was unknown. The reporter assessed this case as non-serious.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: No adverse event
Clinical narrative: There was no adverse effects from vaccine.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult female patient of unspecified age. This refers 48 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Gait disturbance, Hyperhidrosis, Pallor
Clinical narrative: Client received all 3 vaccines. He was sitting at the time. About 2 min after administration. He stood up and came over to parent side while parent was speaking to me. I noticed him wobble a little and became pale and was weak in knees and going down - I caught him and lowered him to floor and laid him flat. He remained awake speaking slowly. Pupils reactive and round. Noticed sweating occurring to forehead after about 10 min parent help get him into chair prior to immunization administration I had asked if he at breakfast and he answered yes, I gave client a juice and granola bar to eat while he continued to recover. At about 20 min of event occurring he was speaking better, sweating continued. At about 30 min of event child was speaking and smiling explained "it just came on suddenly". Shared that he didn't eat all his cereal this morning. Child has never had this happen before. He is not diabetic - was unable to check his blood sugar at time of event. Client was able to walk out on his own at about 40 min since event occurred.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Pain in jaw
Clinical narrative: Patient noticed jaw/facial pain and called primary CP. They referred him to dentist over phone. Dentist prelim. Dx shingles. Pt. appt. w/PCP on 6/6/18 confirmed shingles.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This initial spontaneous case, was received from nurse on 06-Nov-2017, concerning a patient of unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA (expiry date: Jun-2017, dose, route of administration, anatomical location and batch number: not reported) (explicitly coded as expired vaccine used). The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 06-Nov-2017, from a pharmacist, concerning a 36-year-old adult male patient. On 05-Nov-2017, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that the AFLURIA was at a temperature of 57 F for a few hours (lasted for 4 hours). Hence, vaccine was outside the recommended range which was administered to the patient (explicitly coded as incorrect product storage and drug administration error). The reporter assessed the events as non-serious.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site infection, Pyrexia, Rash, Swelling
Clinical narrative: Swelling, fever, chilling, rash - 2 degree infection at site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin irritation
Clinical narrative: 6-8-18-pt received PNEUMOVAX 23 vaccine. 6-10-18-pt went to walk in clinic with irritation with redness-was given BACTRIM DS. Went to hospital later and was admitted. 6-11-18-pt doing better-was on IV antibiotics.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt called today 6-14-18 to say she broke out in hives over entire body 1 day after receiving vaccine.
Age: 48.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swell, itchy (L) cm warm approximately 9x9 with triamcinolone. Became painful on 6/9/18.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 09 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 07 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 14 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 12 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 27 of 84 patients. It was reported that, the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C) and was administered to the patient (explicitly considered as drug administration error). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow-up report received on 09-Nov-2017: It was reported that, the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discharged. Amended narrative accordingly.