chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (incorrect product storage) lot# M047666, expiration date: 24-OCT-2019 for prophylaxis (strength, dose, frequency, and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with improperly stored GARDASIL 9 (incorrect product storage) lot#: N004798, expiration date: 31-OCT-2019 for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Digital Data logger was involved. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA010758: US-009507513-1709USA010561:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with improperly stored GARDASIL 9 lot#: N004798, expiration date: 31-OCT-2019 for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Digital Data logger was involved. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758: US-009507513-1709USA010561.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, regarding a to a male patient of unknown age (over the age of 65). The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, which had a lot # N022303 with an expiry date on 01-MAR-2018, (dose, frequency, anatomical location of administration were not provided) for prophylaxis. On an unspecified date after vaccination the patient experienced "had an allergic reaction". He received BENADRYL as a treatment and fully recovered in about a day. The causal relationship between vaccination with PNEUMOVAX 23 and the event was not mentioned. This is one of two reports received from the same source. Sender's Comments: US-009507513-1710USA008403.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot# reported as N1046004, expiration date: 18-NOV-2018 (dose and route of administration were not reported) or lot#M049127, expiration date: 15-DEC-2018 and/or an improperly stored dose of PROQUAD lot# N013864, expiration date: 31-OCT-2018 or lot# N001490, expiration date 12-JUL-2018 (dose and route of administration were not reported). The vaccines were stored in the temperature of 13.4 degrees Fahrenheit for 1 hour. Digital Data Logger was involved. There was no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA000520: US-009507513-1711USA000521: US-009507513-1710USA002215.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot# reported as N1046004, expiration date: 18-NOV-2018 (dose and route of administration were not reported) or lot# M049127, expiration date: 15-DEC-2018 and an improperly stored dose of PROQUAD lot# N013864, expiration date: 31-OCT-2018 or lot# N001490, expiration date 12-JUL-2018 (dose and route of administration were not reported). The vaccines were stored in the temperature of 13.4 degrees Fahrenheit for 1 hour. Digital Data Logger was involved. There was no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA002215: US-009507513-1711USA000521: US-009507513-1711USA000519.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot# reported as N1046004, expiration date: 18-NOV-2018 (dose and route of administration were not reported) or lot# M049127, expiration date: 15-DEC-2018 and/or an improperly stored dose of PROQUAD lot# N013864, expiration date: 31-OCT-2018 or lot# N001490, expiration date 12-JUL-2018 (dose and route of administration were not reported). The vaccines were stored in the temperature of 13.4 degrees Fahrenheit for 1 hour. Digital Data Logger was involved. There was no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA000520: US-009507513-1710USA002215: US-009507513-1711USA000519.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram, Dizziness, Dysacusis, Hypoacusis, Nausea
Clinical narrative: Left ear diminished hearing, echo's, ringing in the ears. Severe vertigo, nausea and dizziness starting the Friday after the shot and continues still today. Went to clinic Saturday the 28th of October. My ear showed no sign of infection or fluids. He gave me Meclizine. I went to the Neurologist 11-1-17 and was ordered an MRI/MRA of the Brain and IAC's.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain, Tinnitus, Vertigo
Clinical narrative: Left ear diminished hearing, echo's, ringing in the ears. Severe vertigo, nausea and dizziness starting the Friday after the shot and continues still today. Went to clinic Saturday the 28th of October. My ear showed no sign of infection or fluids. He gave me Meclizine. I went to the Neurologist 11-1-17 and was ordered an MRI/MRA of the Brain and IAC's.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient was administered a flu shot in deltoid left arm on 11/1/2017. He returned to pharmacy about 8 minutes later complaining of injection site pain. Patient had no signs of inflammation, swelling, or rash, I had him hold a ice pack on injection site for 10 minutes and pain subsided. Patient felt ok to leave after the ice pack and his mother and him left. I followed up with a call to patient before closing and mother believed the ice pack fixed him up. I recommended Ibuprofen for the the pain  due to injection, and mother said ok.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Condition aggravated, Cough, Dizziness, Fatigue, Malaise
Clinical narrative: Awoke at  1:00a.m. on the 25th of October after the shots at 10:a.m on the 24th of October; went to bathroom and bent down to adjust my slipper. Terrible vertigo (swirling in head) and fell over (Did not injure myself). Vertigo so bad, I stayed in bed the next day. Slightly better, but still had vertigo second day. 3rd and 4th day I could get up. Each day got better, but even on the 8th day I still was slightly dizzy. Also a  terrible fatigue and general malaise. On the 9th day, as I write this, I still do not feel great. I should add that I had my complete  annual exam on the 24th and the doctor pronounced me "healthy" as my blood tests revealed. I attribute all the above symptons to the vaccines, one or the other or both!
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vertigo
Clinical narrative: Awoke at  1:00a.m. on the 25th of October after the shots at 10:a.m on the 24th of October; went to bathroom and bent down to adjust my slipper. Terrible vertigo (swirling in head) and fell over (Did not injure myself). Vertigo so bad, I stayed in bed the next day. Slightly better, but still had vertigo second day. 3rd and 4th day I could get up. Each day got better, but even on the 8th day I still was slightly dizzy. Also a  terrible fatigue and general malaise. On the 9th day, as I write this, I still do not feel great. I should add that I had my complete  annual exam on the 24th and the doctor pronounced me "healthy" as my blood tests revealed. I attribute all the above symptons to the vaccines, one or the other or both!
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Loss of personal independence in daily activities, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Severe joint and muscle pain in right hip area- radiating down the right leg; Severe pain in left neck, shoulder and scapula; Unable to carry out normal daily activities.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Severe joint and muscle pain in right hip area- radiating down the right leg; Severe pain in left neck, shoulder and scapula; Unable to carry out normal daily activities.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: PATIENT STATES SHE HAD A BUMPY RASH START IN ARMPIT AREA AND GROIN AREA - EXTENDING DOWN INNER ARMS AND INNER THIGHS. PATIENT WILL CONTACT HER PCP FOR FOLLOW UP.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pt received the vaccine on 10/25/2017, returned to the clinic on 10/27/17 for nausea and pain at the injection site with redness, tenderness and swelling at the site. Much tenderness to touch reported.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Swelling
Clinical narrative: The patients shoulder area is very swollen and somewhat painful, she states. She says it hurts to try to raise her arm over her head. The vaccine was placed in a normal position on the shoulder and pt has never had this reaction to any vaccine previously. Pt has not seen a doctor or any other medical professional for this event at this point, other than returning to the pharmacy.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a female consumer of an unknown age, reporting on herself. Last menstrual period (LMP), estimated date of delivery (EDD) and date of conception were not provided. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in July 2017, the patient was vaccinated with a dose of VARIVAX (route, anatomical location, lot# and expiration date were not reported) for prophylaxis. The patient was vaccinated with another dose of VARIVAX (route, anatomical location, lot# and expiration date were not reported) on 03-AUG-2017. On an unknown date in September 2017, the patient became pregnant. The pregnancy outcome was unknown.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site oedema, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report as received from a retired nurse refers to a 67 year old male patient with fatty liver disease, pulmonary embolism, deep vein thrombosis and allergy to penicillin. On 02-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml for prophylaxis (lot # and expiration date were not reported). Concomitant therapies included argatroban and unspecified statin medication. On 02-OCT-2017, the patient experienced chills, peripheral edema at the injection site, the swelling in his arm which was more pronounced from the injection site to the elbow but the swelling went all the way down to his hand and he had also decreased mobility in his arm. The patient did not seek medical attention. No treatment was given for the adverse events. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Anal incontinence, Dizziness, Hyperventilation, Loss of consciousness, Muscle rigidity
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 17 year old male patient. The patient's concurrent conditions included Gardner's syndrome (familial polyposis). The patient's medical history included esophagitis issues and routine colonoscopies. The patient had no history of fainting with other shots. The patient had eaten on the day of vaccine administration. On an unknown date in approximately 2017 (reported as "recently"), the patient was vaccinated with his first dose of GARDASIL 9 intramuscularly (lot# and expiration date were not reported) for prevention of HPV. The patient was concomitantly vaccinated with MENVEO. Each vaccination was administered in the deltoid of a different arm. The patient's concomitant therapies included omeprazole. While in the waiting area following the administration of GARDASIL 9, the patient began to be lightheaded, he passed out, slumped over in his chair and was unresponsive. The patient began to have a seizure, was stiff, rigid, experienced fecal incontinence and deep nasal breathing. The patient recovered from the events in 30 minutes (in approximately 2017). The patient received a treatment for the events. He was "hydrated and given crackers" in the physician's office. The relatedness between the events and therapy with GARDASIL 9 was not reported. Upon internal review, the event of seizure was considered to be medically significant.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Musculoskeletal stiffness, Posture abnormal, Seizure, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 17 year old male patient. The patient's concurrent conditions included Gardner's syndrome (familial polyposis). The patient's medical history included esophagitis issues and routine colonoscopies. The patient had no history of fainting with other shots. The patient had eaten on the day of vaccine administration. On an unknown date in approximately 2017 (reported as "recently"), the patient was vaccinated with his first dose of GARDASIL 9 intramuscularly (lot# and expiration date were not reported) for prevention of HPV. The patient was concomitantly vaccinated with MENVEO. Each vaccination was administered in the deltoid of a different arm. The patient's concomitant therapies included omeprazole. While in the waiting area following the administration of GARDASIL 9, the patient began to be lightheaded, he passed out, slumped over in his chair and was unresponsive. The patient began to have a seizure, was stiff, rigid, experienced fecal incontinence and deep nasal breathing. The patient recovered from the events in 30 minutes (in approximately 2017). The patient received a treatment for the events. He was "hydrated and given crackers" in the physician's office. The relatedness between the events and therapy with GARDASIL 9 was not reported. Upon internal review, the event of seizure was considered to be medically significant.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis. The administered vaccine underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA014890.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis. The administered vaccine had underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1710USA014890.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis (incorrect product storage). The administered vaccine had underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008666: US-009507513-1710USA014890:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis. The administered vaccine had underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1710USA014890.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Angiopathy, Dizziness, Feeling abnormal, Feeling cold, Hyperhidrosis
Clinical narrative: Participant confirmed they never had a flu shot before, and when they instructed to wait around a bit. They went to there office which was in view of the screening area. Nurse observed participant as pale and dizzy. He was laid on the ground with his legs elevated. He was chilled with diaphoresis. BP was 102/72. At biometric screening before shot it was 128/78. 10 mintues later, participant still complains of feeling "weird". Nurse suggested he go to walk-in clinic. Co-worker takes him. Nurse gives co-worker phone number so she can be updated on outcome: participant feeling much better and was diagnosed with vascular response to the injection.   Urgent care the participant went to is unknown. Participant can be contacted if that information is needed.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor
Clinical narrative: Participant confirmed they never had a flu shot before, and when they instructed to wait around a bit. They went to there office which was in view of the screening area. Nurse observed participant as pale and dizzy. He was laid on the ground with his legs elevated. He was chilled with diaphoresis. BP was 102/72. At biometric screening before shot it was 128/78. 10 mintues later, participant still complains of feeling "weird". Nurse suggested he go to walk-in clinic. Co-worker takes him. Nurse gives co-worker phone number so she can be updated on outcome: participant feeling much better and was diagnosed with vascular response to the injection.   Urgent care the participant went to is unknown. Participant can be contacted if that information is needed.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Participant received flu shot at 7:25 am. At around 10 am, she complained that her left cheek and face felt tingly. Normal vital signs. No trouble breathing, no swelling, itching, redness. Participant was monitored for adverse reaction. She was observed for approximate 20-30 minutes. Participant says she may have pulled a muscle in her neck earlier. Participant was told to see primary care if issues occured later.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Cough, Dizziness, Headache
Clinical narrative: I have soreness in the area of injection - both at the site and surrounding tissues and joints. Last night I had hives on my abdomen, chest, & back. I took BENADRYL and ZYRTEC & TYLENOL yesterday. This is worse than what I would expect. My boss ultimately sent me home today- because of this. I have chills, muscle and joint pain, new today. My hands are white and cold. My injected arm is warm to the touch. I am experiencing intermittent dizziness. Also mild nausea - although maybe secondary to pain-?. I have decreased range of motion in rt shoulder. It is difficult to don a jacket and shirt.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: I have soreness in the area of injection - both at the site and surrounding tissues and joints. Last night I had hives on my abdomen, chest, & back. I took BENADRYL and ZYRTEC & TYLENOL yesterday. This is worse than what I would expect. My boss ultimately sent me home today- because of this. I have chills, muscle and joint pain, new today. My hands are white and cold. My injected arm is warm to the touch. I am experiencing intermittent dizziness. Also mild nausea - although maybe secondary to pain-?. I have decreased range of motion in rt shoulder. It is difficult to don a jacket and shirt.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Loss of personal independence in daily activities, Myalgia, Myosclerosis, Nausea, Peripheral coldness
Clinical narrative: I have soreness in the area of injection - both at the site and surrounding tissues and joints. Last night I had hives on my abdomen, chest, & back. I took BENADRYL and ZYRTEC & TYLENOL yesterday. This is worse than what I would expect. My boss ultimately sent me home today- because of this. I have chills, muscle and joint pain, new today. My hands are white and cold. My injected arm is warm to the touch. I am experiencing intermittent dizziness. Also mild nausea - although maybe secondary to pain-?. I have decreased range of motion in rt shoulder. It is difficult to don a jacket and shirt.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: I have soreness in the area of injection - both at the site and surrounding tissues and joints. Last night I had hives on my abdomen, chest, & back. I took BENADRYL and ZYRTEC & TYLENOL yesterday. This is worse than what I would expect. My boss ultimately sent me home today- because of this. I have chills, muscle and joint pain, new today. My hands are white and cold. My injected arm is warm to the touch. I am experiencing intermittent dizziness. Also mild nausea - although maybe secondary to pain-?. I have decreased range of motion in rt shoulder. It is difficult to don a jacket and shirt.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: RED, WARM TO TOUCH AT INJECTION SITE, JOINTS ACHY, NAUSEA.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Vaccine was given 10/26/17. That evening patient stating area became a bit red, also slight fever and chills. Continued to worsen/enlarge, painful and itchy, was seen in PCP office 10/27 and Keflex 500 mg qid x 10 days was started. 10/28 she went to Urgent Care as area was worsening in redness, itching and pain were some improved. Area was circled and patient was to watch for worsening redness.  Patient called office the next day as area again was increasing some. Was instructed to monitor and continue Keflex. Have had no further communication from patient regarding this matter.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Gait disturbance, Musculoskeletal pain
Clinical narrative: Severe low back pain. Pain in right buttock. Gait unsteadiness. Pain is persistent three weeks after receiving shot, though less severe.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Disorientation, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: I received my flu shot in the morning, around 1:30 p.m. I began to feel extremely tired. Around 2:30 p.m. I had a feeling of being disoriented where I felt like the room became fuzzy.  My boss went and got me a glass of water. I was slightly worried about driving home, so I stayed at work until about 4:30. I did have more pain in my arm than usual from the flu shot. I went home and went to bed early and was feeling better by the next day. Patient did not require any further treatment for this as she felt better within 24 hours.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Feeling cold, Hypersensitivity, Injection site discomfort, Injection site erythema
Clinical narrative: Received flu vaccine at 8:00 a.m. At approx. 9:15 a.m. my heart started racing in to 140s, this lasted about an hour. Approx. 10:15 a.m. heart rate came back down to around 100-110 ans started palpitating, this lasted about 3 hours til 1 pm. It felt like my heart was a bowl of jello, it felt like it was jiggling. Through this 3 hours I felt chilled, shaky and tired. My bottom lip lip felt tingly and slightly swollen. I felt slightly wheezy but not enough to use an inhaler. I had no difficulty breathing or swallowing. Also, from 11 a.m. to 12:30 p.m. my bladder filled to the point of being uncomfortable and I urinated a very marked amount 3 times, marked for me because I do not urinate that often and I hadn't drank any more fluids than is ordinary for me.  I did not know until I searched the internet after all this stopped that racing heart is listed under "severe allergic reaction" on the CDC website and that was something I should have gone to the ED for.  On 10/18 the site was very sore, red, warm & started itching.  On 10/19 the site was still sore, pink, warm & itching intensely, also coughing up green gunk (I had no cough or production previous to the vaccine)  On 10/20 there was a little discomfort at the site but still itching but less intensely, no more coughing or production  On 10/21 a little discomfort at the site with slight itching  On 10/22 all symptoms gone
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Lip swelling, Palpitations
Clinical narrative: Received flu vaccine at 8:00 a.m. At approx. 9:15 a.m. my heart started racing in to 140s, this lasted about an hour. Approx. 10:15 a.m. heart rate came back down to around 100-110 ans started palpitating, this lasted about 3 hours til 1 pm. It felt like my heart was a bowl of jello, it felt like it was jiggling. Through this 3 hours I felt chilled, shaky and tired. My bottom lip lip felt tingly and slightly swollen. I felt slightly wheezy but not enough to use an inhaler. I had no difficulty breathing or swallowing. Also, from 11 a.m. to 12:30 p.m. my bladder filled to the point of being uncomfortable and I urinated a very marked amount 3 times, marked for me because I do not urinate that often and I hadn't drank any more fluids than is ordinary for me.  I did not know until I searched the internet after all this stopped that racing heart is listed under "severe allergic reaction" on the CDC website and that was something I should have gone to the ED for.  On 10/18 the site was very sore, red, warm & started itching.  On 10/19 the site was still sore, pink, warm & itching intensely, also coughing up green gunk (I had no cough or production previous to the vaccine)  On 10/20 there was a little discomfort at the site but still itching but less intensely, no more coughing or production  On 10/21 a little discomfort at the site with slight itching  On 10/22 all symptoms gone
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral, Productive cough, Tremor, Wheezing
Clinical narrative: Received flu vaccine at 8:00 a.m. At approx. 9:15 a.m. my heart started racing in to 140s, this lasted about an hour. Approx. 10:15 a.m. heart rate came back down to around 100-110 ans started palpitating, this lasted about 3 hours til 1 pm. It felt like my heart was a bowl of jello, it felt like it was jiggling. Through this 3 hours I felt chilled, shaky and tired. My bottom lip lip felt tingly and slightly swollen. I felt slightly wheezy but not enough to use an inhaler. I had no difficulty breathing or swallowing. Also, from 11 a.m. to 12:30 p.m. my bladder filled to the point of being uncomfortable and I urinated a very marked amount 3 times, marked for me because I do not urinate that often and I hadn't drank any more fluids than is ordinary for me.  I did not know until I searched the internet after all this stopped that racing heart is listed under "severe allergic reaction" on the CDC website and that was something I should have gone to the ED for.  On 10/18 the site was very sore, red, warm & started itching.  On 10/19 the site was still sore, pink, warm & itching intensely, also coughing up green gunk (I had no cough or production previous to the vaccine)  On 10/20 there was a little discomfort at the site but still itching but less intensely, no more coughing or production  On 10/21 a little discomfort at the site with slight itching  On 10/22 all symptoms gone
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache
Clinical narrative: MOTHER RETURNED WITH STUDENT AT 1:00 PM STATING THAT HE HAD A HEADACHE. DENIED MUSCLE ACHES, DENIED UPSET STOMACH. TEMP 97.8.  MOTHER STATED THAT HE DID NOT EAT OR DRINK WATER THE ENTIRE DAY BEFORE THE HEADACHE STARTED. PATIENT STATED THAT AFTER EATING LUNCH HEADACHE WENT FROM AN 8 TO A 5 ON THE PAIN SCALE. STUDENT RETURNED TO THE CLINIC ON 11-2-17 AND STATED THAT HEADACHE WENT AWAY ON 10-30-17 AND THERE HAVE BEEN NO FURTHER ISSUES.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site warmth, Local reaction
Clinical narrative: Localized reaction in right deltoid, inflamed and hot to touch near injection site, afebrile and does not seem to bother him nor itch.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1709USA008861.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis (incorrect product storage). The vaccine underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008666: US-009507513-1710USA014905: US-009507513-1710USA014904:  US-009507513-1710USA014903: US-009507513-1710USA014906:
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration from an unspecified date for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fatigue and headache on an unspecified date after receiving. Patient was out of school for 3 days. Outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Hyperhidrosis, Lip swelling, Pruritus
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on Oct2017 at a single dose for pneumococcal shot/pneumonia. The patient's medical history and concomitant medications were not reported. The patient reported she got a pneumococcal shot the previous week or so and on an unspecified date was having itching, lips were swollen, had fatigue, and sweats. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat, and pain at the injection site and radiating down to elbow starting shorty after injection and got progressively worse until then next day. Dr prescribed Keflex.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess
Clinical narrative: Patient reported abscess at site of injection.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Crying, Emotional distress, Speech disorder, Thinking abnormal
Clinical narrative: Crying uncontrolablly and acting irrational. Was very upset and saying things that did not make sense.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Full blood count, Injected limb mobility decreased, Injection site abscess, Injection site cellulitis, Injection site inflammation
Clinical narrative: PATIENT EXPERIENCED LOCALIZED PIN AND SWELLING IN THE RIGHT DELTOID REGION AND THIS INCREASED OVER TIME UNTIL SHE HAD LOSS OF THE ABILITY TO USE THE ARM DUE TO PAIN AND INFLAMMATION. DIAGNOSED WITH BICEPS TENDONITIS WITH CELLULITIS/ ABSCESS.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Tendonitis, Ultrasound scan
Clinical narrative: PATIENT EXPERIENCED LOCALIZED PIN AND SWELLING IN THE RIGHT DELTOID REGION AND THIS INCREASED OVER TIME UNTIL SHE HAD LOSS OF THE ABILITY TO USE THE ARM DUE TO PAIN AND INFLAMMATION. DIAGNOSED WITH BICEPS TENDONITIS WITH CELLULITIS/ ABSCESS.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction. Warm to touch, Swelling, Pain.
Age: 63.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain below the injection site, swelling. Issue with PNEUMOVAX 23 site only.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm pain at time of injection, continuing at pain scale grade 7 for 20 day. Limited range of motion.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Hypoaesthesia oral
Clinical narrative: Numbness in mouth and upset stomach.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, PAIN R. DELTOID, HARDNESS, HOT TO TOUCH.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Patient felt achy, fever, and fatigue for 2 days. Symptoms resolved without treatment.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chills, Headache, Influenza virus test negative, Pain in extremity
Clinical narrative: Started with chills, fever, headache, followed by arm pain and swelling from shoulder to just above elbow. Got medical treatment on 11/2/17 and dr prescribed doxycycline and tylenol with codeine for cellulitis.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Started with chills, fever, headache, followed by arm pain and swelling from shoulder to just above elbow. Got medical treatment on 11/2/17 and dr prescribed doxycycline and tylenol with codeine for cellulitis.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Tenderness
Clinical narrative: Localized tenderness, induration to injection site.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat around injection site.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Pyrexia, Tremor
Clinical narrative: Patient's mom called this morning, said child was texting her last night c/o severe joint pain, shakes, weakness, and fever was 101.7. I told patient's mom to give TYLENOL or Ibuprofen for the pain, and fever. If patient gets worried to go to the ER, asked if patient was having difficulty breathing, fast heart rate, dizziness, said no just severe weakness, and joint pain.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Burning sensation, Herpes simplex test, Muscle twitching, Neuropathy peripheral, Pain
Clinical narrative: This was the THERAVAX herpes HSV-2 vaccine. The vaccine was not supposed to be able to reactivate but it did reactivate on my leg at or near the injection site. Symptoms ever since have been massive tingles in both legs, burning, pain, weird sensations, twitching. My regular doctor calls it some kind of neuropathy. I was also vaccinated with a booster in November of 2013 along with a few others. This was an informal trial for Dr. to gather data to get investors to do another trial which they did do in 2016 I believe.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: This was the THERAVAX herpes HSV-2 vaccine. The vaccine was not supposed to be able to reactivate but it did reactivate on my leg at or near the injection site. Symptoms ever since have been massive tingles in both legs, burning, pain, weird sensations, twitching. My regular doctor calls it some kind of neuropathy. I was also vaccinated with a booster in November of 2013 along with a few others. This was an informal trial for Dr. to gather data to get investors to do another trial which they did do in 2016 I believe.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Blood test normal, Dizziness, Fall, Fatigue
Clinical narrative: Patient had been feeling like she wanted to faint, tired and fatigue from the time she started her day at school. Once arrived home, she was weakened to the point that she couldn't hold herself up and kept falling to the floor. She was feeling hot as well. She laid out in the floor and didn't have the strength to get up. The EMS was called and she was transported to ER. She had an EKG done and she was administered 1,000 mL via IV Sodium Chloride 0.9%IV. She had blood drawn as well as a urine sample test completed. All results we negative. She was discharged the same day later that night. Upon arriving home, she complained of headache and body ache. She was given TYLENOL. On 9/14/15, she was doing better, but still somewhat tired. On 9/15/17, she returned to school and seemed to have no other problems from that point on.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Feeling hot, Headache, Pain, Urine analysis normal
Clinical narrative: Patient had been feeling like she wanted to faint, tired and fatigue from the time she started her day at school. Once arrived home, she was weakened to the point that she couldn't hold herself up and kept falling to the floor. She was feeling hot as well. She laid out in the floor and didn't have the strength to get up. The EMS was called and she was transported to ER. She had an EKG done and she was administered 1,000 mL via IV Sodium Chloride 0.9%IV. She had blood drawn as well as a urine sample test completed. All results we negative. She was discharged the same day later that night. Upon arriving home, she complained of headache and body ache. She was given TYLENOL. On 9/14/15, she was doing better, but still somewhat tired. On 9/15/17, she returned to school and seemed to have no other problems from that point on.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pt received PREVNAR 13 on 10/20/17. Reports that she developed fever, chills starting 10/20/17 PM, along with redness, swelling and itching at site of vaccine injection. Called office 10/24/17 to report worsening redness, swelling and itching, fever gone, seen in office 10/25/17 with erythema and induration on R upper arm measuring 15 x 18 cm, mild tenderness at center where shot given. Prescribed 7 days of KEFLEX by MD.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Pt received PREVNAR 13 on 10/20/17. Reports that she developed fever, chills starting 10/20/17 PM, along with redness, swelling and itching at site of vaccine injection. Called office 10/24/17 to report worsening redness, swelling and itching, fever gone, seen in office 10/25/17 with erythema and induration on R upper arm measuring 15 x 18 cm, mild tenderness at center where shot given. Prescribed 7 days of KEFLEX by MD.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Limb immobilisation, Pain
Clinical narrative: Fluid shift developed under nerve cluster in high part of left shoulder, neck. Lots of pain. Increased BP. Hospitalization. Arm sling.
Age: 25.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 25 years old female patient. No information on the patient's pertinent medical history, current conditions, drug reactions and allergies was provided. On 10-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (lot# N022704, expiry date: 27-FEB-2019), dose was not reported, subcutaneously, to prevent pneumonia. Concomitant therapies included influenza virus vaccine inactivated (unspecified). On the same day (reported as "later that evening"), the patient developed: fever, hot sweats, injection site redness, swelling, pain and it was hot to touch. The patient sought medical attention and went to the doctor's office. She was treated with unspecified antibiotics and was instructed to stay home from work for an unspecified time. She was scheduled for a future appointment on an unspecified date, to be tested for methicillin-resistant Staphylococcus aureus (MRSA). Product quality complaint (PQC) was not involved.  At the moment of reporting, the patient had not recovered from the events. The causality assessment was not reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA007624: US-009507513-1710USA007828: US-009507513-1710USA008051:
Age: 25.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 25 years old female patient. No information on the patient's pertinent medical history, current conditions, drug reactions and allergies was provided. On 10-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (lot# N022704, expiry date: 27-FEB-2019), dose was not reported, subcutaneously, to prevent pneumonia. Concomitant therapies included influenza virus vaccine inactivated (unspecified). On the same day (reported as "later that evening"), the patient developed: fever, hot sweats, injection site redness, swelling, pain and it was hot to touch. The patient sought medical attention and went to the doctor's office. She was treated with unspecified antibiotics and was instructed to stay home from work for an unspecified time. She was scheduled for a future appointment on an unspecified date, to be tested for methicillin-resistant Staphylococcus aureus (MRSA). Product quality complaint (PQC) was not involved.  At the moment of reporting, the patient had not recovered from the events. The causality assessment was not reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA007624: US-009507513-1710USA007828: US-009507513-1710USA008051:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a pharmacist and refers to two unspecified 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 ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion of 18 degrees Fahrenheit for 1 hour and 36 minutes. Data logger was involved. There were no previous excursions reported.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Exposure during pregnancy, Pruritus
Clinical narrative: Patient is 20 weeks pregnant, vaccine was given at 10:30 am and itching and redness began in 5 minutes. Patient was given 10ml(25mg) of generic Benadryl at 10:37am. Patient stated no trouble breathing during the entire adverse reaction. Blood Pressure was 135/84 at 10:42, 130/84 at 10:52, 145/91 at 11am and 136/87 at 11:05(opposite arm this time). Patient's spouse picked her up at 11:15am to drive her to nursing school for exam. Spoke to Layla at 11:25 at the OBGYN office.  She advised to check her BP several more times throughout the day. She also advised for patient to take another dose of Benadryl at normal sched time.    I called patient at 11:49 to check on her and she stated the itching has subsided more and she would take her BP as soon as arriving at campus.    Patient spoke to the doctor's office and they advised her to continue to check her BP and go to nearest emergency room if she had difficultly breathing.    Layla was my contact the Longstreet Clinic, a registered nurse