chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis.  On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011274: US-009507513-1710USA011275.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011275.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 72 year-old female patient received, on 12Oct2017 at 14:30, PREVNAR 13 in the right upper arm, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient reported that she did not experience any reaction in the past after her flu shot (that received every year) and after her first pneumonia shot (received 5 or 6 years before this report). It was confirmed that the patient received pneumococcal 13-val conj vac (dipht crm197 protein) on 12Oct2017 and that first day it was fine. But the next day she had some swelling and a few days after that she had worse swelling and itching. The patient experienced also redness at the injection site (about the size of a silver dollar) which spread from her shoulder to her elbow to cover her entire upper arm. It was also very warm to the touch. The patient was recovering from vaccination site swelling and vaccination site pruritus (her swelling and itchiness was a little less at time of this report). The patient did not recover from redness (at the injection site which spread from her shoulder to her elbow); while clinical outcome of vaccination site warmth was unknown.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: Swelling, redness, soreness at injection site. Upper arm soreness. Headache. Itching all over body.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Tachycardia, Throat irritation
Clinical narrative: Immediate tachycardia, diaphoresis, scratchy throat, light headiness.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Participant complained of tingling in the neck and shoulder after receiving the flu vaccine. After the participant alerted the staff, they continued to note that the participants arm and leg as well as behind the left earlobe was still tingling. No dizziness, swelling, redness, or pain. Participant was asked to sit down with the nurse and given water. The stated the symptoms began to resolve. They returned at the end of the event stating that the symptoms had resolved and had no further complaints.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient woke up the morning after receiving his Flu vaccine with redness and swelling and itching in his upper right arm. The second day after receiving the vaccine the entire upper arm and redness, and swelling.
Age: 52.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Arthralgia, Axillary pain, Hypoaesthesia, Lymphadenopathy, Rash
Clinical narrative: Woke up with a swollen and sore spot under my left arm. Throughout the day, the soreness moved and affected the outside of my wrist (from my pinkie) up the inside of my arm, armpit, left chest, breast and around to the left side of my upper back. I went to the doctor 6 days after the vaccination and  was told I had swollen lymph nodes under my left arm and that the effects could last 2 weeks. I also have a rash on my left arm. The pain is dull and feels like a bad sunburn. There is numbness in the area of the rash. I was told to take Ibuprofen for the pain, which is constant.
Age: 52.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Swelling
Clinical narrative: Woke up with a swollen and sore spot under my left arm. Throughout the day, the soreness moved and affected the outside of my wrist (from my pinkie) up the inside of my arm, armpit, left chest, breast and around to the left side of my upper back. I went to the doctor 6 days after the vaccination and  was told I had swollen lymph nodes under my left arm and that the effects could last 2 weeks. I also have a rash on my left arm. The pain is dull and feels like a bad sunburn. There is numbness in the area of the rash. I was told to take Ibuprofen for the pain, which is constant.
Age: 52.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: Woke up with a swollen and sore spot under my left arm. Throughout the day, the soreness moved and affected the outside of my wrist (from my pinkie) up the inside of my arm, armpit, left chest, breast and around to the left side of my upper back. I went to the doctor 6 days after the vaccination and  was told I had swollen lymph nodes under my left arm and that the effects could last 2 weeks. I also have a rash on my left arm. The pain is dull and feels like a bad sunburn. There is numbness in the area of the rash. I was told to take Ibuprofen for the pain, which is constant.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Dizziness, Flushing, Mouth swelling, Pharyngeal oedema
Clinical narrative: Complain of fever, facial flushing, dizziness; tachycardia; month and throat swelling.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Complain of fever, facial flushing, dizziness; tachycardia; month and throat swelling.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity
Clinical narrative: 24 hours after vaccination, patient experienced left arm pain that has lasted for > 2 weeks (Constant throbbing and aching). No redness, swelling or deformity noted. Normal muscle strength. Somewhat diminished range of motion due to discomfort.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis in left arm from shoulder to elbow.
Age: 38.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Client was given MMRV when single antigen MMR was indicated. No adverse reaction has occurred. No treatment was needed.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Decreased appetite, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red bump developed on the injection site (thigh). Bump was 1 inch in diameter and hot to the touch. It started at day 6. The baby was irritable, had 100 degree temperature every day, and lost appetite. We are on day 13 and the symptoms continue.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Irritability
Clinical narrative: Large red bump developed on the injection site (thigh). Bump was 1 inch in diameter and hot to the touch. It started at day 6. The baby was irritable, had 100 degree temperature every day, and lost appetite. We are on day 13 and the symptoms continue.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain, limited use of arm.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Papule
Clinical narrative: Large, papules coalesced into large patches on chin, neck, chest and on b/l axilla.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Hot flush, Hyperhidrosis, Malaise
Clinical narrative: 10/18/17 -3:30PM - Headache - took Tylenol. 10/18/17 -5:00PM - Beginning of strong migraine - went home and to sleep. 10/19/17 -12:30PM - Took off sick from work after 15Hrs+ of sleep in a migraine state - Took Aleve + Tylenol. Nauseous with some hot flashes at times and a bit of a fever. Went through the swets twice. Had the shivers as well. 10/20/17 - 8:00AM - Went back to work. Though head still wasn't great leaning over or sneezing really hurts my head. 10/21-22/17  Not feeling all that great still. Very much physical motion makes me nauseous and head hurts. Sneezing hurts badly. 10/23/17 - 5:30AM - Wake up with a small migraine. Took migraine over the counter medicine. Nauseous while still being very physical or hitting bumps in the road. Neck still feels tense and not much is needed to cause head to hurt.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Migraine, Muscle tightness, Nausea, Pyrexia
Clinical narrative: 10/18/17 -3:30PM - Headache - took Tylenol. 10/18/17 -5:00PM - Beginning of strong migraine - went home and to sleep. 10/19/17 -12:30PM - Took off sick from work after 15Hrs+ of sleep in a migraine state - Took Aleve + Tylenol. Nauseous with some hot flashes at times and a bit of a fever. Went through the swets twice. Had the shivers as well. 10/20/17 - 8:00AM - Went back to work. Though head still wasn't great leaning over or sneezing really hurts my head. 10/21-22/17  Not feeling all that great still. Very much physical motion makes me nauseous and head hurts. Sneezing hurts badly. 10/23/17 - 5:30AM - Wake up with a small migraine. Took migraine over the counter medicine. Nauseous while still being very physical or hitting bumps in the road. Neck still feels tense and not much is needed to cause head to hurt.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site, started out with 2 small red spots and has grown. No overall fever, itching, heat to touch on area. Redness had grown to about the size of baseball around injection site.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Exaggerated startle response, Hyperreflexia, Injection site erythema, Injection site irritation
Clinical narrative: 10/27 at site on left arm skin irritated red then bubbled up blisters, about 4 fluid filled. Then 11/7 left arm blisters turned to scabs, fever 103, no appetite, overnight had overreactive startle reflex, staring into space and fever between 102 and 103 until 11/11.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site scab, Injection site vesicles, Pyrexia, Staring
Clinical narrative: 10/27 at site on left arm skin irritated red then bubbled up blisters, about 4 fluid filled. Then 11/7 left arm blisters turned to scabs, fever 103, no appetite, overnight had overreactive startle reflex, staring into space and fever between 102 and 103 until 11/11.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Amnesia, Arthralgia, Back pain, Cat scratch disease
Clinical narrative: Symptoms: headache, stomach ache, muscle pains, joint pains, she had troubles walking, diarrhea, dizziness, sore throat, numbness and tingling in hands and feet, pain in left side of stomach, neck and back pain, fatigue, insomnia, hyper sensitive to senses, memory loss, brain fog, tics, vibrations in body, hard time breathing, lymph nodes hurt, and ringing in ears. Treatment: This vaccine injury activated Lyme disease, Mycoplasma, and Bartonella. She had 16 months of antibiotics, supplements, and probiotics, Then patient had 90 silver, UVI, ozone, Vitamin C, and Meyer's cocktail IVs to kill the organisms and boost her immune system. Now she is on an herbal protocol. Patient has been in treatment for over 2 years. She is still in treatment recovering from the HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Dysgeusia, Dyspnoea, Fatigue
Clinical narrative: Symptoms: headache, stomach ache, muscle pains, joint pains, she had troubles walking, diarrhea, dizziness, sore throat, numbness and tingling in hands and feet, pain in left side of stomach, neck and back pain, fatigue, insomnia, hyper sensitive to senses, memory loss, brain fog, tics, vibrations in body, hard time breathing, lymph nodes hurt, and ringing in ears. Treatment: This vaccine injury activated Lyme disease, Mycoplasma, and Bartonella. She had 16 months of antibiotics, supplements, and probiotics, Then patient had 90 silver, UVI, ozone, Vitamin C, and Meyer's cocktail IVs to kill the organisms and boost her immune system. Now she is on an herbal protocol. Patient has been in treatment for over 2 years. She is still in treatment recovering from the HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Gait disturbance, Headache, Hyperacusis, Hyperaesthesia
Clinical narrative: Symptoms: headache, stomach ache, muscle pains, joint pains, she had troubles walking, diarrhea, dizziness, sore throat, numbness and tingling in hands and feet, pain in left side of stomach, neck and back pain, fatigue, insomnia, hyper sensitive to senses, memory loss, brain fog, tics, vibrations in body, hard time breathing, lymph nodes hurt, and ringing in ears. Treatment: This vaccine injury activated Lyme disease, Mycoplasma, and Bartonella. She had 16 months of antibiotics, supplements, and probiotics, Then patient had 90 silver, UVI, ozone, Vitamin C, and Meyer's cocktail IVs to kill the organisms and boost her immune system. Now she is on an herbal protocol. Patient has been in treatment for over 2 years. She is still in treatment recovering from the HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Insomnia, Laboratory test, Lyme disease, Lymph node pain
Clinical narrative: Symptoms: headache, stomach ache, muscle pains, joint pains, she had troubles walking, diarrhea, dizziness, sore throat, numbness and tingling in hands and feet, pain in left side of stomach, neck and back pain, fatigue, insomnia, hyper sensitive to senses, memory loss, brain fog, tics, vibrations in body, hard time breathing, lymph nodes hurt, and ringing in ears. Treatment: This vaccine injury activated Lyme disease, Mycoplasma, and Bartonella. She had 16 months of antibiotics, supplements, and probiotics, Then patient had 90 silver, UVI, ozone, Vitamin C, and Meyer's cocktail IVs to kill the organisms and boost her immune system. Now she is on an herbal protocol. Patient has been in treatment for over 2 years. She is still in treatment recovering from the HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Mycoplasma infection, Neck pain, Oropharyngeal pain, Paraesthesia
Clinical narrative: Symptoms: headache, stomach ache, muscle pains, joint pains, she had troubles walking, diarrhea, dizziness, sore throat, numbness and tingling in hands and feet, pain in left side of stomach, neck and back pain, fatigue, insomnia, hyper sensitive to senses, memory loss, brain fog, tics, vibrations in body, hard time breathing, lymph nodes hurt, and ringing in ears. Treatment: This vaccine injury activated Lyme disease, Mycoplasma, and Bartonella. She had 16 months of antibiotics, supplements, and probiotics, Then patient had 90 silver, UVI, ozone, Vitamin C, and Meyer's cocktail IVs to kill the organisms and boost her immune system. Now she is on an herbal protocol. Patient has been in treatment for over 2 years. She is still in treatment recovering from the HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Parosmia, Photophobia, Tic, Tinnitus, Vibratory sense increased
Clinical narrative: Symptoms: headache, stomach ache, muscle pains, joint pains, she had troubles walking, diarrhea, dizziness, sore throat, numbness and tingling in hands and feet, pain in left side of stomach, neck and back pain, fatigue, insomnia, hyper sensitive to senses, memory loss, brain fog, tics, vibrations in body, hard time breathing, lymph nodes hurt, and ringing in ears. Treatment: This vaccine injury activated Lyme disease, Mycoplasma, and Bartonella. She had 16 months of antibiotics, supplements, and probiotics, Then patient had 90 silver, UVI, ozone, Vitamin C, and Meyer's cocktail IVs to kill the organisms and boost her immune system. Now she is on an herbal protocol. Patient has been in treatment for over 2 years. She is still in treatment recovering from the HPV vaccine.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Urticaria
Clinical narrative: REDNESS TO FACE, NECK, HIVES.
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 41-year-old non-pregnant female patient. She had no pertinent medical history, no drug reactions or allergies. On 19-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 subcutaneously, lot # N010105, expiration date 15-NOV-2018 (dose was not provided), for pneumonia prevention. Concomitant therapy included influenza virus vaccine. On the same date, she developed injection site pain, redness, swelling and the injection site was warm to touch later that night. The patient sought medical attention and went to the doctor's, was diagnosed with cellulitis (start date on approximately 19-AUG-2017) and treated with antibiotics. It was unknown if lab diagnostic studies were performed. Product quality complaint was not involved. The patient recovered from the events a few days after receiving treatment (in approximately August 2017). The relatedness between the vaccine and the events was not provided. Upon internal review, the event of cellulitis was determined to be medically significant.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a properly stored PNEUMOVAX 23 lot # N013521, expiration date 23-JAN-2019, one dose (route of administration not specified) for prophylaxis. The patient was administered FLUZONE HIGH-DOSE (dose, route of administration, lot # and expiry date were not reported) on the same day. The reporter was unable to specify if it was administered in the same arm as PNEUMOVAX 23. On an unknown date, the patient had a local injection site reaction described as itchiness, swelling, redness and welt around injection site. The patient sought medical attention from primary care physician and was prescribed hydroxyzine 25 mg for itchiness. The outcome of the events was reported as recovered on an unknown date. The relatedness between the treatment with PNEUMOVAX 23, FLUZONE HIGH-DOSE and the events was not specified. The reporter requested the lot check for PNEUMOVAX 23 with lot # N013521. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA005621: Original Case: 1710USA005621.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a properly stored PNEUMOVAX 23 lot # N013521, expiration date 23-JAN-2019, one dose (route of administration not specified) for prophylaxis. The patient was administered FLUZONE HIGH-DOSE (dose, route of administration, lot # and expiry date were not reported) on the same day. The reporter was unable to specify if it was administered in the same arm as PNEUMOVAX 23. On an unknown date, the patient had a local injection site reaction described as itchiness, swelling, redness and welt around injection site. The patient sought medical attention from primary care physician and was prescribed hydroxyzine 25 mg for itchiness. The outcome of the events was reported as recovered on an unknown date. The relatedness between the treatment with PNEUMOVAX 23, FLUZONE HIGH-DOSE and the events was not specified. The reporter requested the lot check for PNEUMOVAX 23 with lot # N013521. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA005621: Original Case: 1710USA005621.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Malaise, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a phlebotomist and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-OCT-2017, the patient was vaccinated with unknown vaccines which possibly included a hepatitis b vaccine (recombinant) (manufacturer unknown) for prophylaxis (dose, frequency, lot#, expiration date and route of administration were not provided). On 15-OCT-2017, four hours after the vaccination, the patient came in non-responsive and very sick. The patient was also in distress. It was unknown if she had come in to a hospital or if the child was admitted to a hospital. At the reporting time, it was unknown if the child would continue to take unknown vaccines, including possibly a hepatitis b vaccine (recombinant) (manufacturer unknown). The outcome of the events and the causal relationship between the events and a hepatitis b vaccine (recombinant) (manufacturer unknown) were not provided. Upon internal review, the event of non-responsive was considered as medically significant.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site haematoma, Injection site nodule, Lethargy, Malaise
Clinical narrative: Initial information regarding this unsolicited case was received from a consumer (patient) on 04-Oct-2017. This case involved a 70-years-old female patient who had chills, began vomiting every 10 minutes few months after and had hematoma at the related injection site unknown duration after receiving alirocumab (Praluent) delivered via alirocumab prefilled pen. No past drugs were reported. In Jul-2017, patient started to receive subcutaneous alirocumab injection, solution at a dose of 75 mg every other week (strength: 75 mg/ml) delivered via prefilled pen for elevated cholesterol. On Thursday, 21-Sep-2017 in the afternoon the patient self-injected alirocumab 75 mg into an unknown injection site. Then 2.5 hours later she began vomiting about every 10 minutes which lasted for 4 hours (latency: few months). Then she experienced chills which lasted throughout the night (latency: few months). The patient also experienced a hematoma at the related injection site (event onset: 2017 and latency: unknown). Two days earlier on 19-Sep-2017, she self-injected dulaglutide (Trulicity) at a different injection site; she had been receiving dulaglutide for about 1.5 years. On 07-Sep-2017, she received her flu vaccine. Other concomitant medications, all of which are taken orally: acetylsalicylic acid (Aspirin) 81 mg daily for cardioprotection, losartan potassium (Losartan) 25 mg daily for hypertension; and omeprazole (Prilosec) 20 mg daily for acid reflux. Action taken: no action taken and therapy was ongoing Corrective treatment: not reported Outcome: unknown Follow up report received from a consumer (patient) on 04 Oct 2017. It was reported as patient was vaccinated with a fourth injection of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 07 Sep 2017. (It was reported as patient received the flu-shot in between her third and fourth injection). On 21 Sep 2017, 14 days after the vaccination and about two hours after her fourth Praluent injection, patient vomited repeatedly for about 4 hours, and then Fell Asleep, and when she woke up patient was shivering, and could not get up to get her robe on. Patient also developed a Big Knot or Bulge on her arm at the Injection Site that stayed there for a week. On an unknown date, the day after the vaccination, patient was sick and lethargic, and could not get out of bed. On an unknown date, after the vaccination, patient also developed a huge Reaction. On an unknown date, patient recovered from the events lethargic, big knot or bulge on her arm at the injection site, huge reaction, could not get up to get her robe, terribly sick and chills/shivering. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Initial information regarding this unsolicited case was received from a consumer (patient) on 04-Oct-2017. This case involved a 70-years-old female patient who had chills, began vomiting every 10 minutes few months after and had hematoma at the related injection site unknown duration after receiving alirocumab (Praluent) delivered via alirocumab prefilled pen. No past drugs were reported. In Jul-2017, patient started to receive subcutaneous alirocumab injection, solution at a dose of 75 mg every other week (strength: 75 mg/ml) delivered via prefilled pen for elevated cholesterol. On Thursday, 21-Sep-2017 in the afternoon the patient self-injected alirocumab 75 mg into an unknown injection site. Then 2.5 hours later she began vomiting about every 10 minutes which lasted for 4 hours (latency: few months). Then she experienced chills which lasted throughout the night (latency: few months). The patient also experienced a hematoma at the related injection site (event onset: 2017 and latency: unknown). Two days earlier on 19-Sep-2017, she self-injected dulaglutide (Trulicity) at a different injection site; she had been receiving dulaglutide for about 1.5 years. On 07-Sep-2017, she received her flu vaccine. Other concomitant medications, all of which are taken orally: acetylsalicylic acid (Aspirin) 81 mg daily for cardioprotection, losartan potassium (Losartan) 25 mg daily for hypertension; and omeprazole (Prilosec) 20 mg daily for acid reflux. Action taken: no action taken and therapy was ongoing Corrective treatment: not reported Outcome: unknown Follow up report received from a consumer (patient) on 04 Oct 2017. It was reported as patient was vaccinated with a fourth injection of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 07 Sep 2017. (It was reported as patient received the flu-shot in between her third and fourth injection). On 21 Sep 2017, 14 days after the vaccination and about two hours after her fourth Praluent injection, patient vomited repeatedly for about 4 hours, and then Fell Asleep, and when she woke up patient was shivering, and could not get up to get her robe on. Patient also developed a Big Knot or Bulge on her arm at the Injection Site that stayed there for a week. On an unknown date, the day after the vaccination, patient was sick and lethargic, and could not get out of bed. On an unknown date, after the vaccination, patient also developed a huge Reaction. On an unknown date, patient recovered from the events lethargic, big knot or bulge on her arm at the injection site, huge reaction, could not get up to get her robe, terribly sick and chills/shivering. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Hypotension, Immediate post-injection reaction, Injection site urticaria, Wheezing
Clinical narrative: Initial unsolicited case received from a physician on 09 Oct 2017. This case involves 41-year-old female patient who was vaccinated with 0.1 ml one dose of FLUZONE INTRADERMAL QUADRIVALENT (Batch number: UT5903AA, Expiry date: 06 Mar 2018, dose in series not reported) via Intradermal route in left deltoid on 09 Oct 2017. Patient had a history of Alpha Gal allergy and other medical history was not reported. Concomitant medications were not reported. On 09 Oct 2017, immediately after the vaccination, patient experienced wheezing, hypotension, abdominal pain, and hives below the injection site. Relevant lab tests were not reported. As a corrective treatment patient was treated with epinephrine and Benadryl (diphenhydramine hydrochloride) with resolution of symptoms, and was discharged home. On an unknown date, patient recovered from all the events. The case was considered as serious by the reporter due to life threatening events. List of documents held by sender: none.; Sender's Comments: Reported symptoms (immediate wheezing, hypotension, abdominal pain, and hives below the injection site) and time to onset are consistent with anaphylaxis. Anaphylaxis is listed following FLUZONE QIV ID and time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode and allergic test result are needed for complete assessment. It has to be noted that the patient has an history of alpha Gal allergy. Based on the available information and considering the time to onset and nature of the event, a role of vaccine cannot be excluded.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Nausea, Pharyngeal oedema, Vomiting
Clinical narrative: Initial unsolicited case received from a nurse on 10 Oct 2017. This case involves 39-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE QIV (Batch number: UT5949PA, expiry date and dose in series not reported) intramuscularly in left deltoid on 09 Oct 2017. Patient medical history was not reported. It was reported as patient has multiple allergies but none to any of the components of the vaccine. No other vaccines were administered at the time. Concomitant medications were not reported. On 09 Oct 2017, same day following the vaccination, patient experienced an anaphylactic reaction of throat swelling, nausea and vomiting. Patient went to emergency room and kept for observation, and after the symptoms resolved, patient was discharged from doctor's office. Patient lab tests were not reported. As a corrective treatment patient was treated with 0.3 ml epinephrine, 50 mg BENADRYL and 60 mg prednisone. On an unknown date, patient recovered from all the events. Upon internal review, the company decided to consider the case as serious due to important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: The patient experienced anaphylactic reactions of of throat swelling, nausea and vomiting after receiving FLUZONE QIV. Time to onset is not reported. The patient was reported to have multiple allergies. Specific information regarding allergies was not reported. Anaphylactic reaction in this case could have been triggered due to any of the preexisting conditions. Detailed investigation of patient's allergic condition along with condition at the time of vaccination would be required to further assess the case.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: 10/14/2017 0400hrs - had red welt on right breast. Later in the morning, welts had spread across chest and abdomen. Started Benadryl and calamine lotion. Later that afternoon, went to urgent care,  was put on meds. Welts spread to arms, legs, and feet even on the meds. Went to ER on 10/15/17 afternoon. Was treated and released early evening.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Injection site erythema, Injection site warmth, Nausea, Pain
Clinical narrative: Patient reports warmth and redness at the injection site. Patient also reports cold sweats, body aches, and nausea after vaccination. Patient reported to PCP on 10/21 and was told to take ZYRTEC and ice the area. Patient was prescribed cephalexin but told only to take if reaction becomes worse.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Limb discomfort, Musculoskeletal discomfort, Nausea
Clinical narrative: Employee indicated that immediately after receiving vaccine felt a sensation go up the right side of her neck followed by tingling and numbness in bilateral hands, blurred vision and nausea. Employee placed on stretcher for recovery, Benadryl 25 mg PO administered. Employee continues to voice complaints of numbness and tingling in hands, with discomfort in feet 4 days post receiving vaccine.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: Employee indicated that immediately after receiving vaccine felt a sensation go up the right side of her neck followed by tingling and numbness in bilateral hands, blurred vision and nausea. Employee placed on stretcher for recovery, Benadryl 25 mg PO administered. Employee continues to voice complaints of numbness and tingling in hands, with discomfort in feet 4 days post receiving vaccine.
Age: 61.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Initially normal soreness at the injection site. A slight fever and lightheadedness was experienced approximately 3 hours after the injection which increased to a flu-like feeling (fever, chills, etc.) as the day wore on. At approximately 2:00am after urinating, while walking back to the bedroom, the lightheadedness returned and resulted in a 'gray-out' condition which resulted in my collapsing to a sitting position on the floor. The lightheaded condition passed in seconds and I was able to return to bed. The flu-like symptoms continue through the next day but were mostly gone the third day.
Age: 61.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Initially normal soreness at the injection site. A slight fever and lightheadedness was experienced approximately 3 hours after the injection which increased to a flu-like feeling (fever, chills, etc.) as the day wore on. At approximately 2:00am after urinating, while walking back to the bedroom, the lightheadedness returned and resulted in a 'gray-out' condition which resulted in my collapsing to a sitting position on the floor. The lightheaded condition passed in seconds and I was able to return to bed. The flu-like symptoms continue through the next day but were mostly gone the third day.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dizziness
Clinical narrative: High-grade fever (for 7+ hours, eventually subsiding), chills, extreme nausea, migraine, severe low back pain, joint aches, muscle weakness, dizziness. Headache, back pain, weakness, and slight nausea ongoing for 3 days with today being the 4th day; other symptoms appear to have dissipated while current symptoms are moderate in nature (from 10/10 to 6/10 on the pain scale).
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Migraine, Muscular weakness, Nausea, Pyrexia
Clinical narrative: High-grade fever (for 7+ hours, eventually subsiding), chills, extreme nausea, migraine, severe low back pain, joint aches, muscle weakness, dizziness. Headache, back pain, weakness, and slight nausea ongoing for 3 days with today being the 4th day; other symptoms appear to have dissipated while current symptoms are moderate in nature (from 10/10 to 6/10 on the pain scale).
Age: 32.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful left shoulder. Arm with swelling, erythema and bruising at the left deltoid site. Pt c/o pain limited mobility. Treatment: Start Doxy 100mg bid, Ice packs, drew line around area to monitor for worsening.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Blood glucose decreased, Chills, Fatigue, Feeling abnormal
Clinical narrative: Pt states that about 30 minutes after the shot that she took a walk during her break, which is normal, and when she got back she felt as if her blood sugar was off, she felt  very shaky. She took her B/S and it was 54. At this time the pt ate her lunch. She states she still did not feel right. She went ahead and walked again on her afternoon break, but was just feeling very tired and draggey. That evening after her supper she started chilling and her heart was racing. She did not take her temp but her b/p was 150/90 and heart rate was 90-100. She took 2 Ibuprofen and in 30 min took her b/p and heart rate again. B/P was 130/80 and Heart rate was down to 80. States she still was not feeling right. About 30 minutes after this she took her B/P again and ir was 130/72 and heart rate was down to 70. She says that she was still feeling very weak and tired. The next morning she was still feeling tired and weak and all throughout the day. but by the day after that she was feeling much better and was back to normal.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Palpitations, Tremor
Clinical narrative: Pt states that about 30 minutes after the shot that she took a walk during her break, which is normal, and when she got back she felt as if her blood sugar was off, she felt  very shaky. She took her B/S and it was 54. At this time the pt ate her lunch. She states she still did not feel right. She went ahead and walked again on her afternoon break, but was just feeling very tired and draggey. That evening after her supper she started chilling and her heart was racing. She did not take her temp but her b/p was 150/90 and heart rate was 90-100. She took 2 Ibuprofen and in 30 min took her b/p and heart rate again. B/P was 130/80 and Heart rate was down to 80. States she still was not feeling right. About 30 minutes after this she took her B/P again and ir was 130/72 and heart rate was down to 70. She says that she was still feeling very weak and tired. The next morning she was still feeling tired and weak and all throughout the day. but by the day after that she was feeling much better and was back to normal.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood pressure increased, Chills, Fatigue, Palpitations, Pyrexia
Clinical narrative: Pt states that about 30 minutes after the shot that she took a walk during her break, which is normal, and when she got back she felt as if her blood sugar was off, she felt  very shaky. She took her B/S and it was 54. At this time the pt ate her lunch. She states she still did not feel right. She went ahead and walked again on her afternoon break, but was just feeling very tired and draggey. That evening after her supper she started chilling and her heart was racing. She did not take her temp but her b/p was 150/90 and heart rate was 90-100. She took 2 Ibuprofen and in 30 min took her b/p and heart rate again. B/P was 130/80 and Heart rate was down to 80. States she still was not feeling right. About 30 minutes after this she took her B/P again and ir was 130/72 and heart rate was down to 70. She says that she was still feeling very weak and tired. The next morning she was still feeling tired and weak and all throughout the day. but by the day after that she was feeling much better and was back to normal.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Blood glucose decreased, Chills, Fatigue, Feeling abnormal
Clinical narrative: 3:15PM - low blood sugar episode (54 mg/dl), ate yogurt and felt fine. 7:30PM-sudden onset of chills, fever, racing heart (over 90 bpm), elevated blood pressure (166/90). Blood pressure taken again at: 8:20PM, 166/85. 9:15PM-136/73. 10:40PM-125/68 and heart rate 76, so both were returning to normal. I also experience extreme fatigue at the end of this occurrence when I went to bed.  I continued to feel chilled and took 2 Ibuprofen before going to bed. This has never happened before. I have had a flu shot for several years (probably the last 15 years) with no adverse effects. I did not seek medical attention since my blood pressure and heart rate began returning to normal.