chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported swelling and redness in right arm day after administration of vaccine. Patient instructed to take antihistamine orally and ibuprofen orally OTC and follow up with Dr if swelling does not subside. Patient has latex allergy important to note vinyl gloves were used. Tried to follow up next day with patient, no answer.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Nasopharyngitis
Clinical narrative: Morning after vaccination had severe diarrhea lasting 1 day then moderate diarrhea for the next 2 days. Had headache and cold symptoms which lasted a total of 9 days.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation
Clinical narrative: 2" redness on ZOSTAVAX (L) arm. 10-12" redness/inflammation from underarm to below elbow on R PNEUMOVAX side.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Right hand at the site of Injection Red, lightly swollen, hard and hot. She is experiencing slight pain. Redness over half of upper top portion of hand surrounding site of Injection and reporting soreness too.
Age: 82.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: 10-12" redness swelling from upper arm past elbow to lower arm.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site pain, Injection site pruritus
Clinical narrative: Pt reported itching and then burning at injection site on Wednesday 9/27/17. After scratching, a white line appeared and she was bleeding. Pt. went to urgent care and was prescribed SSD 1% cream.
Age: 1.5
Sex: F
Vaccine: MMR, MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: MMR administered inadvertently at 18 mo. visit. Child already received MMR at 15 mo. visit. Hep A ordered, but MMR given.
Age: 1.5
Sex: F
Vaccine: MMR, MMR
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: MMR administered inadvertently at 18 mo. visit. Child already received MMR at 15 mo. visit. Hep A ordered, but MMR given.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Burning sensation, Discomfort, Erythema, Insomnia
Clinical narrative: Hives, burning arm, extreme pain when touching or moving arm, fever of 100.4, aching body, including legs and left and right arm. Nausea, dis ease, weak, uncomfortable, insomnia, I think from the pain, couldn't get comfortable in any position, everything ached.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain, Pyrexia, Rash erythematous, Tenderness
Clinical narrative: Hives, burning arm, extreme pain when touching or moving arm, fever of 100.4, aching body, including legs and left and right arm. Nausea, dis ease, weak, uncomfortable, insomnia, I think from the pain, couldn't get comfortable in any position, everything ached.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Hives, burning arm, extreme pain when touching or moving arm, fever of 100.4, aching body, including legs and left and right arm. Nausea, dis ease, weak, uncomfortable, insomnia, I think from the pain, couldn't get comfortable in any position, everything ached.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Employee developed itching which developed into hives approximately 4 hours after administration of vaccine.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: UPPER ARM IS RED AND ITCHING.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a pharmacist who heard from a nurse, regarding a 17 year old female patient. The patient's medical history and concurrent condition included an allergy to latex and penicillin G. Concomitant therapies included MENVEO and HAVRIX. On 06-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot number N013278 and expiration date 26-JUL-2018 (dose, frequency route of administration were not provided) for prophylaxis which was reconstituted with a sterile diluent (manufacturer unknown) instead of received a second dose of VARIVAX (frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported. There was no illness at the time of vaccination. The reporter stated that the patient was recovered from the adverse events.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M037248 and expiration date 21-FEB-2019 (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1709USA005381: US-009507513-1709USA002048: US-009507513-1709USA005382: US-009507513-1709USA005379:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # M039202 and expiration date 11-MAR-2018 and lot # N008823 and expiration date 26-MAY-2018  (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA002048: US-009507513-1709USA005380: US-009507513-1709USA005382: US-009507513-1709USA005379:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II lot # M029919 and expiration date 13-JUN-2018 (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005381: US-009507513-1709USA005380: US-009507513-1709USA002048: US-009507513-1709USA005379:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored multiple doses of GARDASIL 9 lot # M016193, expiration date: 24-APR-2018 (dose was not provided). There were no adverse effects reported. Administered doses of vaccines were stored in a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit for 120 hours. Digital data logger was used to capture temperature excursion. There were no previous temperature excursions. Sender's Comments: US-009507513-1709USA015134.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. On an unknown date, a week after receiving the ZOSTAVAX, the patient developed shingles. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Headache, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and concomitant therapies was provided. The patient had a gluten allergy and drug reactions or allergy for penicillin. On 14-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot # and expiration date were not reported). On 15-SEP-2017, the patient experienced swelling of arm and shoulder to softball size, nausea, headache, joint ache, shoulder and neck pain. The patient stated the events lasted until 18-SEP-2017. No treatment was provided for the events, but the patient recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and concomitant therapies was provided. The patient had a gluten allergy and drug reactions or allergy for penicillin. On 14-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot # and expiration date were not reported). On 15-SEP-2017, the patient experienced swelling of arm and shoulder to softball size, nausea, headache, joint ache, shoulder and neck pain. The patient stated the events lasted until 18-SEP-2017. No treatment was provided for the events, but the patient recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 19-SEP-2017, the patient was vaccinated with a dose of VARIVAX injection, lot # M041081 with expiration date on 06-OCT-2017 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 53 hours. No previous excursions were reported. Digital Data Logger was involved in recording the temperature excursion. The vaccine was reconstituted with correctly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA015132:
Sex: F
Vaccine: VARCEL
Symptoms: Dysphagia, Inflammation, Mouth ulceration
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's concurrent condition included hypothyroidism since an unknown date. No information regarding the patient's concomitant medications was provided. On an unspecified date in May 2017, the patient was vaccinated with the first dose of VARIVAX injection, lot # M035688 with expiration date on 18-AUG-2018 (dose and route of administration was not reported) for prophylaxis and the second dose of the vaccine on an unknown date in June 2017. Within three days after the first dose, the patient experienced ulcers in the mouth, cheeks and palate. The patient sought for medical attention at the ear, nose and throat (ENT) specialist, dentist and oral surgeon. Two biopsies have been sampled on unknown dates, one of which showed inflammation and the other one's results were pending at the time of the report. The reporter also stated that the patient had difficulties swallowing even her own saliva so methylprednisolone (MEDROL DOSEPAK) was prescribed as a treatment which has helped for this event, however it was not specified if the patient fully recovered. The reporter mentioned that the patient was not able to work, but did not disclose the timeframe. The patient did not recover from the ulcers in mouth, cheeks and palate at the time of the report. The outcome of the inflammation and problems swallowing was unknown. The relatedness between the event and VARIVAX was not reported.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 6 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-JUN-2017 the patient was inadvertently administered a dose of VAQTA lot # N005274, expiration date 03-APR-2018, for prophylaxis (dose, route and site of administration were not reported). No adverse effects were reported.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient with high blood pressure,high cholesterol and diabetes. The pharmacist reported that the patient received a dose of PNEUMOVAX 23 (dose was not reported, unknown lot#/exp. date) on 27-SEP-2016 against pneumonia and patient over 65 years old. Concomitant therapies included lisinopril (manufacturer unknown), metformin, amlodipine and glimepiride. The patient received a second dose of PNEUMOVAX 23 (unknown lot#/exp.date) on 21-SEP-2017 concomitantly with an unspecified flu vaccine. The pharmacist stated that the patient woke up on 22-SEP-2017 and had trouble getting up and felt dizzy. On the same day, the patient called into the pharmacy. None lab diagnostic studies were performed and no treatment was given for adverse events. The outcome of adverse event and dizziness was not recovered. Causality assessment was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose and route of administartion were not reported). The second dose was administered after 5 years, 0.5 ml administered to prevent of pneumococcal disease. On an unknown date, after receiving the second dose, the patient's the injection site, was hot to touch, painful and it almost looked like cellulitis. The outcome of the event was reported as recovered/resolved on an unknown date. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date in 2017 (reported since 14-AUG-2017), the patient was vaccinated with improperly stored dose of VAQTA (lot # N003194, expiration date was not reported) (dosage and route of administration were not reported) for prophylaxis. The vaccine underwent temperature 32°F to 35°F (34.9F) for two minutes. Data logger was involved. There was no adverse effects reported.
Sex: U
Vaccine: RVX, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 25-SEP-2017, the patient was vaccinated with a dose of improperly stored  rotavirus vaccine, live, oral, ZOSTAVAX lot # N021171 and expiration date of 01-NOV-2018, (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees for 45 minutes.  No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) (dose and route of administration were unknown) either with lot number M041086 with expiration date of 03-JAN-2018 or lot number N020942 with expiration date of 26-OCT-2018 for prophylaxis, which were reconstituted with properly stored sterile diluent and stored in a temperature range from 15 Fahrenheit (°F) to 46°F (32 °F) for 13 hours and 45 minutes. The temperature excursion was not detected by a data logger. There was a previous temperature excursion from 15°F to 46°F  (23 °F) for 5 hours and 16 minutes. No adverse effects reported.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician who is a father of the patient via a company representative and refers to a 12-year-old male patient. The patient's concurrent conditions and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dosage, lot # and expiration date were not reported) intramuscularly for prophylaxis. After receiving the vaccine the patient fainted. The outcome of the event was not reported. The relatedness between vaccination with GARDASIL 9 and the event was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with expired dose of GARDASIL 9 (lot # L014415, expiration date: 25-JUL-2017) intramuscularly for prophylaxis. There was no adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a four patient of unknown age and gender. On an unknown dates in September 2017 (reported as since 09-SEP-2017), the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX (lot # N016090, expiration date: 23-AUG-2018) subcutaneously for prophylaxis. The vaccine underwent a temperature of 20 Fahrenheit degree for 1 hour and 15 minutes. There was no previous temperature excursion. Data logger was involved. The pharmacist could not provide the lot number and expiration date for the properly stored sterile water diluent used to reconstitute the doses of ZOSTAVAX. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a multiple unspecified number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) (dose and route of administration were unknown) either lot # M041085 with expiration date of 31-JAN-2018 or lot number  M044220 with expiration date of 03-JAN-2018 for prophylaxis, which were stored  from  -14 Celsius degrees (°C) to -10°C (-12.1 °C) for 30 minutes. The healthcare worker was unsure if sterile diluent (strength, dose, route of administration, lot number and expiration date were unkonwn) used to reconstitute the ZOSTAVAX was properly stored. The temperature excursions were detected by a data logger. There were no previous temperature excursions. No adverse effects were reported.
Age: 86.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 86 year old patient. The patient's medical history includes history of skin cancer, high blood pressure, diabetes, chronic obstructive pulmonary disease, heart failure, hyperplasia of the prostate. The patient's concomitant medications included 8 chronic medications and 5 medications as needed. Medications were not specified but ncluded a statin and diabetes medication. On 02-JUN-2016, the patient received the first dose of ZOSTAVAX subcutaneous for prophylaxis. On 27-SEP-2017, the patient was vaccinated with the second dose of ZOSTAVAX subcutaneous for prophylaxis. No adverse effects were reported. The patient did not seek medical attention.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses ROTATEQ lot # M043669 and expiration date on 15-JUN-2018; and lot # N005617 and expiration date on 03-OCT-2018 (strength and dose were not reported), administered for prophylaxis. The storage temperature was 9 to 25 degrees Celsius (°C) (9.8 °C), for a timeframe of 20 minutes and 9 to 25 °C (8.5 °C) for 7 minutes . There was previous temperature excursion at 9 to 25 °C for 3.31 hours. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA015077: US-009507513-1709USA013515:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 18--SEP-2017, the patient was vaccinated with a dose of VARIVAX injection, lot # M041081 with expiration date on 06-OCT-2017 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 53 hours. No previous excursions were reported. Digital Data Logger was involved in recording the temperature excursion. The vaccine was reconstituted with correctly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA010333:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored multiple doses of PNEUMOVAX 23 lot# M013156, expiration date: 15-OCT-2017 (dose was not provided). There were no adverse effects reported. Administered doses of vaccines were stored in a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit for 120 hours. Digital data logger was used to capture temperature excursion. There were no previous temperature excursions.; Sender's Comments: US-009507513-1709USA008757:
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Disorientation, Hypoaesthesia, Pain, Palpitations, Paraesthesia
Clinical narrative: "Just wanted to report I had a reaction to the flu shot I got yesterday. I received it around 3pm.  Around 9pm, my entire left side was tingly, numb, my heart was racing, I was extremely sore, and I was very disoriented. I had no fever, nausea, or vomiting. I was able to sleep it off with my husband keeping an eye on me. By 9am this morning, I felt fine and had absolutely no side effects at all. I?ve honestly never had a reaction to the flu shot ever before. Not sure if I needed to report it at all. "  reported by this individual.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination complication
Clinical narrative: "Just wanted to report I had a reaction to the flu shot I got yesterday. I received it around 3pm.  Around 9pm, my entire left side was tingly, numb, my heart was racing, I was extremely sore, and I was very disoriented. I had no fever, nausea, or vomiting. I was able to sleep it off with my husband keeping an eye on me. By 9am this morning, I felt fine and had absolutely no side effects at all. I?ve honestly never had a reaction to the flu shot ever before. Not sure if I needed to report it at all. "  reported by this individual.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Tenderness
Clinical narrative: C/O swelling @ injection site, redness and tenderness.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Eating disorder, Mouth ulceration, Myalgia, Oral pain, Oropharyngeal pain
Clinical narrative: Thursday night I had severe sore throat and muscle aches but a symptom I never had before was oral pain? hard and soft palate, tongue, all felt like I had ulcerations on them and made eating difficult. It is Monday October 2nd and that is my only symptom still.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Tongue ulceration
Clinical narrative: Thursday night I had severe sore throat and muscle aches but a symptom I never had before was oral pain? hard and soft palate, tongue, all felt like I had ulcerations on them and made eating difficult. It is Monday October 2nd and that is my only symptom still.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Severe soreness in arm since injection.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Dizziness, Headache, Impaired work ability, Malaise
Clinical narrative: Employee received flu vaccine on 09/26/2017 at 7:30 am. At 8:00 am, employee reports having a progressive headache, felt very ill, dizzy, cold sweats, shaky and nauseated. She was unable to work which prompted a visit to APRN, on 09/28/2017. APRN diagnosed as "dizziness, likely adverse reaction to influenza vaccine" and prescribed prednisone tab 20 mg daily for 5 days, Zofran for nausea and meclizine for dizziness. A note was given to this nurse stating employee is "ill, likely reaction to influenza vaccine. I would recommend that she not take influenza vaccine in future."
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Tremor, Vaccination complication
Clinical narrative: Employee received flu vaccine on 09/26/2017 at 7:30 am. At 8:00 am, employee reports having a progressive headache, felt very ill, dizzy, cold sweats, shaky and nauseated. She was unable to work which prompted a visit to APRN, on 09/28/2017. APRN diagnosed as "dizziness, likely adverse reaction to influenza vaccine" and prescribed prednisone tab 20 mg daily for 5 days, Zofran for nausea and meclizine for dizziness. A note was given to this nurse stating employee is "ill, likely reaction to influenza vaccine. I would recommend that she not take influenza vaccine in future."
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular, Urticaria
Clinical narrative: Severe rash and welts on right side of body between breast and knee. Did not erupt similar to shingles, more like chicken pox, but only on right side of body. 3 welts on right arm, about 12-20 on right thiegh, but most is on my tummy area. Was treated with Valtrex 3 times per day, and a Methyiprednisolone pack, and by Monday morning was calmed down a bit.  No pain whatsoever but very severe itching.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Mobility decreased, Pain, Swelling, Ultrasound scan
Clinical narrative: Per patient, she started w/symptoms of pain, swelling, irritability to lift arm after 3 days then presented w/bruising over 2 months later. Pt. claims there was no pain during the administration and had no reactions in past. She stated her family doctor said the pain/swelling may be due to improper administration.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Vaccination site pain
Clinical narrative: Patient developed pain in the are of vaccination on 9/14/2017, reported itching to area as well.  On evaluation, some warmth over the injection area noted, with erythema and mild swelling distal and more medial to the injection site.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Chest X-ray, Chills, Computerised tomogram head, Fatigue
Clinical narrative: Patient states around 2 hours after receiving vaccine, he experienced fatigue, went home, called off of work the following day due to chills, febrile to 104 F, came into ER with similar complaints, fatigue, muscle aches, tenderness at site of injection and WBC count to 30K, few hours later was 27K, patient was admitted to hospital, LP performed, blood cultures obtained, all tests negative. White count the following day was down to 16K.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Full blood count, Impaired work ability, Injection site pain, Laboratory test, Lumbar puncture normal
Clinical narrative: Patient states around 2 hours after receiving vaccine, he experienced fatigue, went home, called off of work the following day due to chills, febrile to 104 F, came into ER with similar complaints, fatigue, muscle aches, tenderness at site of injection and WBC count to 30K, few hours later was 27K, patient was admitted to hospital, LP performed, blood cultures obtained, all tests negative. White count the following day was down to 16K.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Metabolic function test, Myalgia, Procalcitonin, Pyrexia, White blood cell count increased
Clinical narrative: Patient states around 2 hours after receiving vaccine, he experienced fatigue, went home, called off of work the following day due to chills, febrile to 104 F, came into ER with similar complaints, fatigue, muscle aches, tenderness at site of injection and WBC count to 30K, few hours later was 27K, patient was admitted to hospital, LP performed, blood cultures obtained, all tests negative. White count the following day was down to 16K.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction, Tenderness
Clinical narrative: Large local reaction with erythema 5-6 inches long 4-5 inches wide with central firm area 2.5x2.5 inches very tender.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Injection was given too high on the upper arm. Symptoms include pain in the shoulder, inability to adduct or abduct that shoulder, inability to sleep on left side or back without significant pain, tingling and numbness in left arm radiating to left hand. Symptoms began same day as injection and have been ongoing for 2 weeks. When seen by a doctor, it was concluded that vaccine was given in bursa and not deltoid muscle.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Injection was given too high on the upper arm. Symptoms include pain in the shoulder, inability to adduct or abduct that shoulder, inability to sleep on left side or back without significant pain, tingling and numbness in left arm radiating to left hand. Symptoms began same day as injection and have been ongoing for 2 weeks. When seen by a doctor, it was concluded that vaccine was given in bursa and not deltoid muscle.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Vertigo
Clinical narrative: Vertigo for approximately 2 days.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching sensation (i.e. 'hives') in upper and lower extremities.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of M-M-R II which had the lot numbers reported as N010246, expiration date 25-SEP-2018, and N008825 expiration date 12-SEP-2018, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 35°F and the higher was 48°F for 68 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA012767: US-009507513-1709USA012769: US-009507513-1709USA012770: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012768:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unspecified dates multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB (lot # L030867, expiration date 09-JUN-2018; lot # K019701, expiration date 17-JUL-2017; lot # K025006, expiration date 22-JUL-2017; lot # L035878, expiration date 11-AUG-2018). PEDVAXHIB (lot # L030867, expiration date 09-JUN-2018 was stored in temperature 31°F or colder (31 F) for 77 hours 30 minutes and 47°F to 77°F (56 F) for 15 hours 30 minutes. No temperature timeframe was reported for PEDVAXHIB (lot # K019701, expiration date 17-JUL-2017; lot # K025006, expiration date 22-JUL-2017; lot # L035878, expiration date 11-AUG-2018). Digital Data Logger was involved. None of the vaccines was administered after their expiration dates. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA000208.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had the lot # reported as M046140, expiration date 27-SEP-2019, lot # N009802, expiration date 19-DEC-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 49°F for 68 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA007325: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766:
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eye swelling, Pain in extremity, Peripheral swelling
Clinical narrative: On 8/30, patient received two vaccines, TDaP on left arm, and flu vaccine on the right arm. She received the vaccine and after 30 minutes patient came and said her right arm felt swollen and sore. It didn't look swollen, but counseled pt. on using pain killer and told her to let me know how she feels, on 8/31 patient said right arm swollen and left eye swollen.
Age: 25.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Dermatitis bullous, Injection site reaction
Clinical narrative: Two bullous lesions on lateral left upper arm 4cm where patient reports injection was given. Patient states that he received immunization 09/26/2017 and later that day he took of the band-aid and noticed 2 fluid-filled lesions.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Mobility decreased, Skin warm, Swelling
Clinical narrative: Started with warmth and swelling the evening of the immunization. Redness the following day when she came in for assessment. Was not able to get arm over head the night of the injection, but improved the following day. Area is red, warm and slightly indurated on day two. Advised to continue icing, tylenol and motrin.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Adenotonsillectomy, Attention deficit/hyperactivity disorder, Autism spectrum disorder, Blood test, Epiphyses delayed fusion
Clinical narrative: April 12, 2014 he spiked a 105 fever, brought to the ER, they gave him antibiotics through IV, go the fever to come down, sent us home. The fever came back on the 13th. We brought him to the Hospital and they admitted him for a day. They believed it was viral. The fevers came back monthly. Each time they came back it was between 103-105. Each and every time they said it was viral. It was not until October 2014 that we saw a Rheumatologist and she believe it was a Periodic fever syndrome known as PFAPA. The only treatment he got was TYLENOL and MOTRIN. We tried prednisone but it did not work. He had an emergency T and A done April 19, 2016. He only have a couple fever episodes after the T and A. He did have hallucinations with some of his fevers. He was also diagnosed with ADHD around 2.5 years old, ASD, ADHD, and ODD at 3 years 3 months old. He was also diagnosed with Hypothyroidism at 2 years old. He is currently on SYNTRHOID for the hypothyroidism and DEXEDRINE for the ADHD. He has been doing speech therapy, OT, and PT. He was diagnosed with a speech delay, fine and gross motor delay, and sensory processing issues as well. He is also delayed in bone age.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Fine motor delay, Gross motor delay, Hallucination, Hypothyroidism, Lumbar puncture
Clinical narrative: April 12, 2014 he spiked a 105 fever, brought to the ER, they gave him antibiotics through IV, go the fever to come down, sent us home. The fever came back on the 13th. We brought him to the Hospital and they admitted him for a day. They believed it was viral. The fevers came back monthly. Each time they came back it was between 103-105. Each and every time they said it was viral. It was not until October 2014 that we saw a Rheumatologist and she believe it was a Periodic fever syndrome known as PFAPA. The only treatment he got was TYLENOL and MOTRIN. We tried prednisone but it did not work. He had an emergency T and A done April 19, 2016. He only have a couple fever episodes after the T and A. He did have hallucinations with some of his fevers. He was also diagnosed with ADHD around 2.5 years old, ASD, ADHD, and ODD at 3 years 3 months old. He was also diagnosed with Hypothyroidism at 2 years old. He is currently on SYNTRHOID for the hypothyroidism and DEXEDRINE for the ADHD. He has been doing speech therapy, OT, and PT. He was diagnosed with a speech delay, fine and gross motor delay, and sensory processing issues as well. He is also delayed in bone age.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Nuclear magnetic resonance imaging brain, Oppositional defiant disorder, PFAPA syndrome, Pyrexia, Sensory processing disorder
Clinical narrative: April 12, 2014 he spiked a 105 fever, brought to the ER, they gave him antibiotics through IV, go the fever to come down, sent us home. The fever came back on the 13th. We brought him to the Hospital and they admitted him for a day. They believed it was viral. The fevers came back monthly. Each time they came back it was between 103-105. Each and every time they said it was viral. It was not until October 2014 that we saw a Rheumatologist and she believe it was a Periodic fever syndrome known as PFAPA. The only treatment he got was TYLENOL and MOTRIN. We tried prednisone but it did not work. He had an emergency T and A done April 19, 2016. He only have a couple fever episodes after the T and A. He did have hallucinations with some of his fevers. He was also diagnosed with ADHD around 2.5 years old, ASD, ADHD, and ODD at 3 years 3 months old. He was also diagnosed with Hypothyroidism at 2 years old. He is currently on SYNTRHOID for the hypothyroidism and DEXEDRINE for the ADHD. He has been doing speech therapy, OT, and PT. He was diagnosed with a speech delay, fine and gross motor delay, and sensory processing issues as well. He is also delayed in bone age.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Speech disorder developmental, Viral infection, X-ray limb
Clinical narrative: April 12, 2014 he spiked a 105 fever, brought to the ER, they gave him antibiotics through IV, go the fever to come down, sent us home. The fever came back on the 13th. We brought him to the Hospital and they admitted him for a day. They believed it was viral. The fevers came back monthly. Each time they came back it was between 103-105. Each and every time they said it was viral. It was not until October 2014 that we saw a Rheumatologist and she believe it was a Periodic fever syndrome known as PFAPA. The only treatment he got was TYLENOL and MOTRIN. We tried prednisone but it did not work. He had an emergency T and A done April 19, 2016. He only have a couple fever episodes after the T and A. He did have hallucinations with some of his fevers. He was also diagnosed with ADHD around 2.5 years old, ASD, ADHD, and ODD at 3 years 3 months old. He was also diagnosed with Hypothyroidism at 2 years old. He is currently on SYNTRHOID for the hypothyroidism and DEXEDRINE for the ADHD. He has been doing speech therapy, OT, and PT. He was diagnosed with a speech delay, fine and gross motor delay, and sensory processing issues as well. He is also delayed in bone age.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on chest.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: itching and swelling at site of injection (left upper arm) 24 hours after injection. Subsequently developed diffuse itch from head to lower torso, Halo-type headache.No photophobia, phonophobia, hives, throat tightness, wheezing, chest congestion or shortness of breath.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pain, Skin warm
Clinical narrative: It started to become red and sore later in the day. Overnight it became more painful and the red area was hot to the touch and was approximately 2" in diameter. It stayed this way even after 2 days and continued to get bigger and more painful. It continued to be bright red in color and warm to the touch. I drew a black marker line around the edge of the red 48 hrs after injection, and the next morning it had spread beyond the borders of the black marker. I then made an appointment for later that day with my primary nurse practitioner. She indicated that a skin infection may have developed and prescribed Cephalexin 500mg for 7 days. She also encouraged warm compresses to ease the discomfort. 24 hours after starting the antibiotics, the pain and inflammation were reduced and are no longer visual after almost a week later.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Insomnia, Lymphadenopathy, Malaise, Rash
Clinical narrative: Mild rash, fatigue, insomnia, swelled lymph nodes, and malaise.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchospasm
Clinical narrative: Bronchospasm, resulting in administration of an allergic Rxn cocktail including epinephrine. She was  sent home with Steroids, as well as H1&H2 blockers.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Gait inability, Inflammation, Vaccination complication
Clinical narrative: Pt received flu vaccine 9/29/17 in R deltoid. Came into office today complaining of adverse reaction to vaccine. States when he woke up on Saturday morning, he fell and was unable to walk "I was practically crawling." Reports no change in normal routine (medications, new foods etc) except for flu vaccine on Friday. Did have consultation with dentist on Friday but states no med admin. Has history of sciatica in R lower extremity but states his last flare-up was years ago. Has been taking 600 mg ibuprofen due to feeling he has inflammation. Reports that each day his walking is improving. No reaction at injection site, denies fever, chills, nausea/vomiting, difficulty breathing, hives, racing heart rate.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash, Swelling
Clinical narrative: Day after vaccine patient had pain in arm after four days went to doctor because pain turned in to a severe rash. Md treated patient with minocycline 100mg  twice a day for 7 days, swelling has gone down rash is minimal at this time.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain, especially around injection site, site warm to touch 1 hour after injection, swelling , pain and warmth for 48 hours+, swelling and soreness into lower arm 6 hours after injection. Soreness over entire arm still present 96 hours after injection.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Right leg red at site of immunization 9/28/17  Size of a quarter with surrounding lighter red. Pt acting normal. Very active. Not limping mildly tender to touch Denied fever. Site of DTaP Reassured local reaction.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: PATIENT REPORTED TO PHARMACY INTENSE SWELLING FROM UPPER ARM DOWN BELOW ELBOW. THE AREA WAS WARM TO THE TOUCH. WE ADVISED PATIENT TO SEE A DOCTOR IMMEDIATELY AS IT APPEARED TO BE CELLULITIS.
Age: 37.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Hypoaesthesia, Injection site pain, Nausea, Pain
Clinical narrative: TDaP and Hep B 2 shots were given on the 9/28/17. By 5 PM on the 9/28/17 she was feeling swelling, pain, numbness, feeling lightheaded, vomiting. 9/29/17 no chest pain, no SOB, no wheezing, no rash, no abdominal pain, no dizziness, positive nausea and vomiting by 5 PM (9-28-17). Today (29 Sept 2017) she is here for her part II of her physical. She is complaining of pain in her (L) arm, swelling, numbness, feeling lightheaded and vomiting. She stated that "it was very painful receiving the shots. I did receive both shots in the same arm". After getting the shots she felt nauseous and lightheaded. By 5:00 PM she was vomiting and noticed swollen on her arm, hand, and fingers. She also states that the area around the injection site is very painful. After evaluating the injection (L) arm showed no redness, swelling, and is not warm to touch. After asking about symptoms of chest pain, shortness of breath, wheezing, rash, abdominal pain, or nausea, vomiting or dizziness, patient states that the symptoms that she experienced was nausea and vomiting (around 5 PM). I explained to her that the severe allergy reactions usually happens 15-20 after receiving the shots. I explained to her that patients may have some other side effects to include fever, redness, swelling and pain in the injection site, etc. I also explained that the risk of TDap causing serious harm or death is extremely small.