chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009213 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009213 is being deleted from our files and the case is consolidated into case # 1711USA003923 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009214 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009214 is being deleted from our files and the case is consolidated into case # 1711USA003933 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009215 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009215 is being deleted from our files and the case is consolidated into case # 1711USA003937 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009216 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009216 is being deleted from our files and the case is consolidated into case # 1711USA003944 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Burning sensation, Chills, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 19-year-old female patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th October 2017, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash and skin lesion. On 13th October 2017, the patient experienced back pain, fever, chills, sweating and burning leg. The patient was treated with acyclovir and Aloe Vera Gel. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the skin lesion was unknown and the outcome of the back pain, chills, sweating and burning leg were recovered/resolved and the outcome of the fever was recovered/resolved. The reporter considered the rash, back pain, fever, sweating and burning leg to be unrelated to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the skin lesion and chills to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient experienced a rash on her back. On 12th October 2017, the patient was acting as a caregiver for another patient that was diagnosed with shingles and the patient had Ramsey Hunt Syndrome but that patient never had a flu shot. On 13th October 2017, the patient was seen in the emergency room with complaints of her back hurting, she felt bad with fever, chills, sweating, pain and her rash still presented on her back and right chest and right front shoulder and she had burning down her legs. She was treated with Acyclovir and pain medications. She also used 100 per cent aloe vera gel and the live plant on her lesions. The reporter stated that the patient's condition had improved now. The lesion on her back was pretty much gone with a couple of red spots remaining. The patient lost two days off of work. The reporter also indicated that the patient had stressors with her Mom passing last year.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Rash erythematous, Skin lesion
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 19-year-old female patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th October 2017, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash and skin lesion. On 13th October 2017, the patient experienced back pain, fever, chills, sweating and burning leg. The patient was treated with acyclovir and Aloe Vera Gel. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the skin lesion was unknown and the outcome of the back pain, chills, sweating and burning leg were recovered/resolved and the outcome of the fever was recovered/resolved. The reporter considered the rash, back pain, fever, sweating and burning leg to be unrelated to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the skin lesion and chills to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient experienced a rash on her back. On 12th October 2017, the patient was acting as a caregiver for another patient that was diagnosed with shingles and the patient had Ramsey Hunt Syndrome but that patient never had a flu shot. On 13th October 2017, the patient was seen in the emergency room with complaints of her back hurting, she felt bad with fever, chills, sweating, pain and her rash still presented on her back and right chest and right front shoulder and she had burning down her legs. She was treated with Acyclovir and pain medications. She also used 100 per cent aloe vera gel and the live plant on her lesions. The reporter stated that the patient's condition had improved now. The lesion on her back was pretty much gone with a couple of red spots remaining. The patient lost two days off of work. The reporter also indicated that the patient had stressors with her Mom passing last year.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The injection site grew up (swollen) "red" first night and next day changed to blue color about 1/2 of upper arm and "warm" all over-my doctor told me to put warm towel, but don't take any antihistamine.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Fatigue, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Runny nose, cold like symptoms, fatigue, lasted 3 weeks.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Immediate vomiting after dose was given, intermittent vomiting for 24 hours after dose given.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyskinesia, Ear pain, Eye pain, Fatigue
Clinical narrative: 10-6-17 vaccine given in Rt upper arm. About 30min notice pain and didn't go away. Fri. the next day I call the office and report the problem and told the office person I had pain all night the site was swollen, red and take two TYLENOL only help the pain for two house. Very much in pain with arm movement, fever, chills ear aches muscle aches headaches fatigue when told the office person the condition she said to use warm compresses. It didn't sound right so I ask her to let me speak to provider she stated to use cold not warm. Two weeks later having some of the problems eye pain and movement of lower lip sore arm.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: 10-6-17 vaccine given in Rt upper arm. About 30min notice pain and didn't go away. Fri. the next day I call the office and report the problem and told the office person I had pain all night the site was swollen, red and take two TYLENOL only help the pain for two house. Very much in pain with arm movement, fever, chills ear aches muscle aches headaches fatigue when told the office person the condition she said to use warm compresses. It didn't sound right so I ask her to let me speak to provider she stated to use cold not warm. Two weeks later having some of the problems eye pain and movement of lower lip sore arm.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 10-6-17 vaccine given in Rt upper arm. About 30min notice pain and didn't go away. Fri. the next day I call the office and report the problem and told the office person I had pain all night the site was swollen, red and take two TYLENOL only help the pain for two house. Very much in pain with arm movement, fever, chills ear aches muscle aches headaches fatigue when told the office person the condition she said to use warm compresses. It didn't sound right so I ask her to let me speak to provider she stated to use cold not warm. Two weeks later having some of the problems eye pain and movement of lower lip sore arm.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives, sudden onset, given BENADRYL 50 mg IM, DECADRON 4 mg IM.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Blood pressure immeasurable, Electrocardiogram, Full blood count, Injection site mass, Injection site pruritus
Clinical narrative: FOUR HOURS AFTER VACCINATION, PATIENT DEVELOPED A LUMP BELOW INJECTION SITE ON RIGHT ARM (PNEUMOVAX SITE). THE AREA BETWEEN THE INJECTION SITE AND ELBOW BECAME ITCHY AND HOT TO THE TOUCH WITH RASH. THE FOLLOWING MORNING, PATIENT'S BLOOD PRESSURE WAS TOO LOW TO READ ON A MONITOR...EXPERIENCED BLACK OUT. PARAMEDICS TRANSPORTED PATIENT TO HOSPITAL FOR LABS AND EKG TO ELIMINATE POSSIBILITY OF CLOT. PATIENT CHECKED OUT OK AND WAS RELEASED. TWO DAYS LATER PATIENT STILL EXPERIENCING SWELLING DOWN TO WRIST IN RIGHT ARM BUT SYMPTOMS ARE IMPROVING. PATIENT IS FOLLOWING UP WITH PCP TOMORROW.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site rash, Injection site warmth, Loss of consciousness, Peripheral swelling, Ultrasound scan
Clinical narrative: FOUR HOURS AFTER VACCINATION, PATIENT DEVELOPED A LUMP BELOW INJECTION SITE ON RIGHT ARM (PNEUMOVAX SITE). THE AREA BETWEEN THE INJECTION SITE AND ELBOW BECAME ITCHY AND HOT TO THE TOUCH WITH RASH. THE FOLLOWING MORNING, PATIENT'S BLOOD PRESSURE WAS TOO LOW TO READ ON A MONITOR...EXPERIENCED BLACK OUT. PARAMEDICS TRANSPORTED PATIENT TO HOSPITAL FOR LABS AND EKG TO ELIMINATE POSSIBILITY OF CLOT. PATIENT CHECKED OUT OK AND WAS RELEASED. TWO DAYS LATER PATIENT STILL EXPERIENCING SWELLING DOWN TO WRIST IN RIGHT ARM BUT SYMPTOMS ARE IMPROVING. PATIENT IS FOLLOWING UP WITH PCP TOMORROW.
Age: 87.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient reports that arm where the PREVNAR vaccine is still sore to touch. He reports can move arm all around however if presses where vaccine was administered it is still sore (also when he lays down to sleep if on that side). There is no local reaction or nothing visible to report.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Chest discomfort, Chest pain, Fatigue, Flank pain
Clinical narrative: Pneumococcal vaccine: Arm swelling, pain, red rash, extreme pain down left armpit, side and chest, fatigue, nausea, muscle spasms, fainting, bad headache, stiff neck, muscle weakness, blurry vision, swollen lymph nodes, chest pain and pressure, muscle stiffness in arms and legs, vomiting.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Lymphadenopathy, Muscle spasms, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Pneumococcal vaccine: Arm swelling, pain, red rash, extreme pain down left armpit, side and chest, fatigue, nausea, muscle spasms, fainting, bad headache, stiff neck, muscle weakness, blurry vision, swollen lymph nodes, chest pain and pressure, muscle stiffness in arms and legs, vomiting.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain, Peripheral swelling, Rash erythematous, Syncope
Clinical narrative: Pneumococcal vaccine: Arm swelling, pain, red rash, extreme pain down left armpit, side and chest, fatigue, nausea, muscle spasms, fainting, bad headache, stiff neck, muscle weakness, blurry vision, swollen lymph nodes, chest pain and pressure, muscle stiffness in arms and legs, vomiting.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vision blurred, Vomiting
Clinical narrative: Pneumococcal vaccine: Arm swelling, pain, red rash, extreme pain down left armpit, side and chest, fatigue, nausea, muscle spasms, fainting, bad headache, stiff neck, muscle weakness, blurry vision, swollen lymph nodes, chest pain and pressure, muscle stiffness in arms and legs, vomiting.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Headache, Pain, Polyuria
Clinical narrative: Polyuria, headache, pt felt cold and clammy without a fever, felt achy.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site pruritus, Pruritus
Clinical narrative: Patient complained of itching at injection site 15 minutes after administration. Within 10 minutes (approximately 25 minutes post injection) patient complained of further itching to face and presented visible flushing of face.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Pertussis, Polymerase chain reaction positive, Post-tussive vomiting, Vaccination failure
Clinical narrative: Resident delivered and started coughing a few days prior to delivery. Symptoms progressed to post-tussive vomiting and paroxysmal coughing during duration of illness. Child had symptoms of Pertussis on 10/14/17 and tested PCR positive. The symptom start date for the mother in comparison to vaccine date indicates evidence of vaccine failure.
Age: 0.92
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Fatigue, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Runny nose. Cold like symptoms. Fatigue. Lasted 3 weeks.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Pain, Pruritus
Clinical narrative: Patient has a silver dollar size area of erythema and edema to the injection site (R) deltoid. Student states this occurs after every flu shot. Hydrocortisone cream applied and an ice pack due to c/o of pain and itching. Acetaminophen 325 mg PO for arm pain.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 101.8, aches, chills.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Blood culture negative, Electroencephalogram abnormal, Febrile convulsion, Nuclear magnetic resonance imaging normal, Seizure like phenomena
Clinical narrative: Per Hospital Discharge Summary: At 4 AM on 11/3/2017 patient vomited x1 then had a seizure like episode lasting approximately 45 minutes to 1 hour. Patient was taken by EMS to Medical Center and treated with 2 mg ATIVAN IV which stopped the seizure within a few minutes. Once stable, was transferred to another Hospital. Patient was diagnosed with febrile seizure with status epilepticus 2/2 MMRV vaccine. EEG and MRI were completed. EEG showed mild focal slowing in the left temporal region.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Status epilepticus, Vomiting
Clinical narrative: Per Hospital Discharge Summary: At 4 AM on 11/3/2017 patient vomited x1 then had a seizure like episode lasting approximately 45 minutes to 1 hour. Patient was taken by EMS to Medical Center and treated with 2 mg ATIVAN IV which stopped the seizure within a few minutes. Once stable, was transferred to another Hospital. Patient was diagnosed with febrile seizure with status epilepticus 2/2 MMRV vaccine. EEG and MRI were completed. EEG showed mild focal slowing in the left temporal region.
Age: 51.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, and swelling at injection site in 4x4 inch size.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient has pain and soreness in arm for 4 weeks.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site nodule, Injection site pain
Clinical narrative: Pt reports numbness on the left side of his face and the fingers on his left hand. He reports this feeling lasted "most of the day, but is better now." He reports he continues to have significant soreness in his left deltoid and states "I can't raise it as high as I was able to before." He denies bruising, but reports a "knot" at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness (4.5 x 9cm) and warmth at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 11/9 AM noticed redness, warmth at injection site. At time of evaluation 4.5 x 9 cm.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Fatigue, Myalgia
Clinical narrative: First, very strong muscle pain. 99.8 F on October 8. Fatigue and Muscle pain. Much worse than before quitting CRESTOR, especially the fatigue. Especially mornings.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Patient left Consultation Room without cane accompanied by Lady friend. They proceeded to shop in the aisle of the store, then came back to Pharmacy Waiting area after 10 to 15 minutes. Patient complained of neck and shoulder pain. She sat down. I asked if she wanted me to call 911 she said yes. She had no complaints of allergic reactions. No wheezing, no redness, was able to speak clearly. EMTs arrived urged patient to go to ER, but patient declined. I spoke to her about 3 to 4 hours later via phone, she was fine.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen at site of injection, hard in the middle, painful.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Per patient stated fever, redness lt del. - the day after for 3 days.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Shot on Tues. evening-nothing unusual. Wed am area slightly outlined in red-Wed pm while bathing noticed arm red, swollen, hard from shoulder to elbow-hurts and itches-gave MOTRIN-intents to give BENADRYL. He may have had a similar reaction last year-not sure which kid. Will call PCP on Fri if no better.
Age: 90.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Joint swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 90 year old female patient.  The patient's medical history and concurrent conditions were not provided. It was reported no drug reactions or allergies. On unknown date, the patient was vaccinated with PREVNAR 13 (formulation, strength, dose number, dose, administration route, indication, lot number and expiration date were not reported) and she was due to be vaccinated with PNEUMOVAX 23. On 17-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose number and dose were not reported) intramuscularly in the left arm, lot number M038216, expiration date 09-MAY-2019, for prophylaxis. Concomitant therapies included FLUZONE, which was administered in the right arm on the same date. Subsequently on 18-OCT-2017, the patient came into the pharmacy with swelling "the size of a golf ball" around the elbow area in the left arm. It was reported that it was nowhere near where PNEUMOVAX 23 was administered. The pharmacist stated that the area was also warm to touch. No treatment was given for the adverse event and lab diagnostics or studies were not performed. The outcome of skin warm and peripheral swelling was reported as not resolved. The causality assessment between PNEUMOVAX 23, skin warm and peripheral swelling was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 24-OCT-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection lot # N007931 with expiration date on 17-NOV-2019 (dose and route of administration were not reported). The administered vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 3 hours and 15 minutes. There was a previous temperature excursion of 9 to 25 degrees Celsius for 15 minutes. Digital data logger was involved in recording of the excursions. No adverse effects were reported.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 06-NOV-2017, the patient received an expired improperly stored dose of VARIVAX lot # L042266 and expiration date 27-OCT-2017 for prophylaxis (strength, dose, anatomical location, route of administration were not reported) with sterile diluent (lot number and expiration date were not reported). It was reported that on an unspecified date, the vaccine and the sterile diluent were exposed to a temperature of 35 degrees Fahrenheit for 23 hours. The reporter stated that there was no previous temperature excursion. It was unknown by the reporter if the call was placed because of a Digital Data logger report.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown) on or about 22-JAN-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2016, the patient was treated at an urgent care center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 51 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046376 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # reported as M046376. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32° F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009217 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009217 is being deleted from our files and the case is consolidated into case # 1711USA003950 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 15 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009218 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009218 is being deleted from our files and the case is consolidated into case # 1711USA003957 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Patient with swelling and pain in right upper arm from pneumococcal polysaccharide PPSV23 shot given on 9/22. Patient states that after injection on Friday, he developed fever of 101.0, shaking chills, pain at site of injection. Patient denies fever or chills today (09/25/2017) during phone f/u but does have redness and swelling of injection site. Myalgia, fever and right arm swollen and sore. Acetaminophen 650 mg prn.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient with swelling and pain in right upper arm from pneumococcal polysaccharide PPSV23 shot given on 9/22. Patient states that after injection on Friday, he developed fever of 101.0, shaking chills, pain at site of injection. Patient denies fever or chills today (09/25/2017) during phone f/u but does have redness and swelling of injection site. Myalgia, fever and right arm swollen and sore. Acetaminophen 650 mg prn.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed Wed afternoon that (L) deltoid was red, swollen and warm to touch - no c/o pain; (positive) itch.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site nodule, Pain in extremity
Clinical narrative: Patient woke up with a painful arm after receiving FLULAVAL and GARDASIL on 11/7/17. Patient's arm was very red around the site with a knot that was about an inch wide and 3 1/2 inches long. Child did not have a fever and is currently eating and drinking well.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Within 24 hrs. developed erythema and induration around injection site. Expanded to 6 cm x 3.5 cm by 48 hrs. Mild tenderness and warmth. Ibuprofen and ice as needed. Monitor symptoms and call if worse.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Ultrasound abdomen normal, Vomiting projectile
Clinical narrative: Projectile vomiting with lethargy x 24 hours. Started 3 days after DTap vaccine.
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of allergic reaction in a female patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to DTaP vaccine. Additional details were reported as follows: On an unknown date, an unspecified patient experienced an allergic reaction to DTaP. No further information was provided.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Visual impairment
Clinical narrative: I received shot in left arm - 45 min later I felt dizzy and faint. I ate lunch, waited another hour and 45 min - still really dizzy and started seeing white spots. Went to nurse at 2:00 pm.
Age: 70.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: On 11/6 redness, swelling at injection site, body aches, headaches. 11/7 pt. doing better and less symptoms. 11/9 per pt everything is gone and she feels fine.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling hot, Flushing, Injection site discomfort, Injection site erythema
Clinical narrative: Injection site swollen, firm, red, hot, very painful arm, feels heavy painful down to elbow. Day after injection chills, aches, feeling warm, flushed.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Injection site swollen, firm, red, hot, very painful arm, feels heavy painful down to elbow. Day after injection chills, aches, feeling warm, flushed.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Site becomes warm, very red/purple, itchy, blisters. On 10/29/17 noticed around noon, the site was 5"x4". By 6pm had increased another inch. By 8am on 10/30/17 the site was 8"x? and still growing. Received Prednisolone from Doctor. The same thing happened last year.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain. Primary care physician prescribed an antibiotic (Clindamycin) for treatment.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough
Clinical narrative: Moderate to severe coughing episodes when laying down. Symptoms last for approximately 24 hours. Over-the-counter cough medication helped to alleviate symptoms.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient was scheduled to come in on 11/7/2017 for shots (consent on file for both shots). Report pulled afternoon of 11/6/17, still showed Hep A and HPV (as well as flu) due. Patient absent on 11/7/17, rescheduled shots for 11/9/17. Reviewed report and consent, but did not run a report that day. Shots given to child (she did not mention going to the doctor or getting shots this week). After charting shots, ran new report and discovered shots given 3 days previously at doctor's office. Call made to both contact persons on contact information. Left message to call clinic. Notified supervisor and health department.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Sore arm, limited range of motion.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Muscle tightness, Pain in extremity
Clinical narrative: Patient arrived at clinic informing that approximately ten minutes after immunization administration, she started feeling a sensation of right arm soreness with muscle tightening and right hand joints hurting. Patient informs of no longer having arm soreness with muscle tightening. After two hours, still remains with right hand joints hurting. Nurse evaluated injection site, compared both arms/hands/finger joints and no swelling observed. Right hand fingernails with less than three second capillary refill. Patient has mobility of each right hand joint. Nurse explained to patient of reporting condition and completing a VAERS form. Patient was advised to contact or see primary care physician, or attend minor or hospital emergency for evaluation. Patient informs of already calling Lupus doctor and leaving a message.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itchiness and swelling in MENVEO injection site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I contracted shingles from the vaccine.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large area of erythema, warmth, tenderness, swelling extending from left deltoid to antecubital area that began about 8 hours after vaccination.
Age: 21.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Erythema, Swelling
Clinical narrative: Redness, swelling, dizziness.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt school nurse called and stated that where pt received her flu shot yesterday there is an oblong red area that is about 2" long and 1 1/4" wide. Stated that the area is red and slightly warm. Using warm compresses and monitor the area.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Gait disturbance, Headache, Malaise, Migraine, Myalgia
Clinical narrative: Thursday evening after vaccines slight headache, was a little achy. Friday and Saturday pt felt the same, slight headache and achy, Sunday, pt was feeling even better, however around 4 PM patient fainted unexpectedly without any forewarning. Followed by full blown instant migraine (most severe she has ever had) that lasted all night. Pt took IMITREX Sunday evening (95 mg), which did not completely resolve the headache then pt had 2 incidents of vomiting and did not feel well all night. Pt felt better Monday but was shaky, no appetite, Tues pt felt better but not completely well with what she considered a normal headache. Patient has had some degree of headache each day including up to the time of this report. Today, 1 week later, patient is having increased thigh/ muscle pain, lameness, and headache and is feeling worse than yesterday, headache is much worse.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Nervousness, Pain, Pain in extremity, Syncope
Clinical narrative: Thursday evening after vaccines slight headache, was a little achy. Friday and Saturday pt felt the same, slight headache and achy, Sunday, pt was feeling even better, however around 4 PM patient fainted unexpectedly without any forewarning. Followed by full blown instant migraine (most severe she has ever had) that lasted all night. Pt took IMITREX Sunday evening (95 mg), which did not completely resolve the headache then pt had 2 incidents of vomiting and did not feel well all night. Pt felt better Monday but was shaky, no appetite, Tues pt felt better but not completely well with what she considered a normal headache. Patient has had some degree of headache each day including up to the time of this report. Today, 1 week later, patient is having increased thigh/ muscle pain, lameness, and headache and is feeling worse than yesterday, headache is much worse.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Within a couple of hours of administration, patient's arm swelled up and got red within a couple of hours. Patient took shirt off at home and RXN had progressed and was hot to touch that evening. Patient ran temp of 101.4. Patient saw Dr. the next day (Friday) and who diagnosed the patient with cellulitis, started cephalexin 500 QID. Arm was red and warm to touch from shoulder to elbow. By Sunday, redness was going away and continued to decrease.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Face injury, Fall, Loss of consciousness, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Child passed out, fell down off of a step face first and was rigid on the ground, unresponsive for less than 1 minute. Came to, became responsive after placing cold washcloth on forehead and calling her name. Child also lost control of urine while she passed out. Child was able to sit up and walk to the nurses room shortly after regaining consciousness and was sitting reading a book when her mother was called.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Patient had PNEUMOVAX and flu this week. She states that she got a fever and pain that night. She states that she feels better today. Redness is decreasing but still warm. Arm ROM better.
Age: 29.0
Sex: M
Vaccine: FLU4, HEP, HEPA
Symptoms: Expired product administered
Clinical narrative: Hepatitis B Vaccine was expired. Vaccine expired 11/4/17.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy, Drug administered at inappropriate site, Injected limb mobility decreased, Nuclear magnetic resonance imaging, Periarthritis
Clinical narrative: The shot was administered too high on my arm. Next day I could barely move arm. Developed frozen shoulder. Feb 2016 had surgery to release frozen shoulder. Oct 2017 had surgery to remove diseased synovium. I had developed synovitis from flu shot injury. Surgeon also had to remove 4 inches of inflamed tendons that had attached itself to my bicep.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder operation, Synovitis, Tendon sheath incision, Tendonitis
Clinical narrative: The shot was administered too high on my arm. Next day I could barely move arm. Developed frozen shoulder. Feb 2016 had surgery to release frozen shoulder. Oct 2017 had surgery to remove diseased synovium. I had developed synovitis from flu shot injury. Surgeon also had to remove 4 inches of inflamed tendons that had attached itself to my bicep.