chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Lacrimation increased, Mood swings, Nasal congestion, Photophobia, Rash
Clinical narrative: Experienced bad headaches, swollen itchy watering eyes, nasal congestion for the first two weeks following HPV vaccine. In August 2016, patient came home from school every day and slept and expressed significant fatigue. Patient has never done this before. He has always been very active (sports, hunting, etc.), so this was a new behavior for him. Patient experienced upper respiratory infections in October, November, then had the flu in December. Frequent complaints of headaches, rashes on abdomen and chest, complaints of eye sensitivity to light, swollen eyes. Developed genital warts in November (patient is not sexually active). Hair loss, receding hairline. Increased anxiety, anger, mood swings. Patient stated, "my body feels like an old man, I can't keep up with my buddies, I don't have any energy". Upper respiratory infections in May and June.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Upper respiratory tract infection
Clinical narrative: Experienced bad headaches, swollen itchy watering eyes, nasal congestion for the first two weeks following HPV vaccine. In August 2016, patient came home from school every day and slept and expressed significant fatigue. Patient has never done this before. He has always been very active (sports, hunting, etc.), so this was a new behavior for him. Patient experienced upper respiratory infections in October, November, then had the flu in December. Frequent complaints of headaches, rashes on abdomen and chest, complaints of eye sensitivity to light, swollen eyes. Developed genital warts in November (patient is not sexually active). Hair loss, receding hairline. Increased anxiety, anger, mood swings. Patient stated, "my body feels like an old man, I can't keep up with my buddies, I don't have any energy". Upper respiratory infections in May and June.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Fatigue, Nausea
Clinical narrative: March 30th, 2018: Experienced fatigue/sleepiness at 1:30 p.m. Experienced a lack of appetite at 5:30 p.m. Experienced nausea and abdominal pain at 6:30 p.m., experienced diarrhea beginning at 7:30 p.m. continuing through the evening into the next day. Experienced 3 bouts of vomiting: one at 8:30 p.m, one around 11:30 p.m., another at around 7:30 a.m. on March 31st, 2018. Fever of 100.1 at 9:00 p.m. on March 30th, fever of 102 on March 31st around 10:00 a.m., and fever of 101 at 10:00 p.m. on March 31st.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: March 30th, 2018: Experienced fatigue/sleepiness at 1:30 p.m. Experienced a lack of appetite at 5:30 p.m. Experienced nausea and abdominal pain at 6:30 p.m., experienced diarrhea beginning at 7:30 p.m. continuing through the evening into the next day. Experienced 3 bouts of vomiting: one at 8:30 p.m, one around 11:30 p.m., another at around 7:30 a.m. on March 31st, 2018. Fever of 100.1 at 9:00 p.m. on March 30th, fever of 102 on March 31st around 10:00 a.m., and fever of 101 at 10:00 p.m. on March 31st.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Anxiety, Arthralgia, Autonomic nervous system imbalance, Bartonella test positive, Blood test
Clinical narrative: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Borrelia test positive, Depression, Disturbance in attention, Dizziness, Dysmenorrhoea
Clinical narrative: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Eye swelling, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Hypotension, Immunology test, Lyme disease, Menorrhagia, Muscular weakness
Clinical narrative: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Myalgia, Mycoplasma test positive, Nausea, Panic attack, Photophobia
Clinical narrative: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Pneumonia mycoplasmal, Postural orthostatic tachycardia syndrome, Seizure, Syncope, Tilt table test positive
Clinical narrative: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Vision blurred
Clinical narrative: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform, Rhinitis, Viral rash
Clinical narrative: Clinically stable/well appearing 12 m.o. female with mild measles-like Sx(corrhiza, fever, viral exanthem) 11 days after receiving MMR. Exanthem today possibly due to intercurrent illness but Sx most suggestive for mild vaccine illness from live-virus vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Erythema, Injection site erythema, Injection site mass
Clinical narrative: 1 day post vaccination 3/30, developed at injection site a large edematous, not, solid lump measure 3in x1in. Constant Pain with redness. At 2pm 3/30, developed low grade fever 99 degrees Fahrenheit. Nausea, severe joint and generalized muscle pain as well as dizziness- had to leave work. Relieved moderately with MOTRIN 400mg. 8hours later on 3/30 pain in arm and severe joint and muscle pain returned. On 3/31 redness on arm and swelling measured 3in by 2 in, painful to light touch, still very firm. Muscle pain relieved with MOTRIN, able to work. Fatigued, no fever. Sun 4/1 severe arm pain, still red 3in x 2in firm, painful to light touch, TYLENOL minimize pain. No further joint, muscle pain nor any fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site oedema, Injection site pain, Myalgia, Nausea, Pain in extremity
Clinical narrative: 1 day post vaccination 3/30, developed at injection site a large edematous, not, solid lump measure 3in x1in. Constant Pain with redness. At 2pm 3/30, developed low grade fever 99 degrees Fahrenheit. Nausea, severe joint and generalized muscle pain as well as dizziness- had to leave work. Relieved moderately with MOTRIN 400mg. 8hours later on 3/30 pain in arm and severe joint and muscle pain returned. On 3/31 redness on arm and swelling measured 3in by 2 in, painful to light touch, still very firm. Muscle pain relieved with MOTRIN, able to work. Fatigued, no fever. Sun 4/1 severe arm pain, still red 3in x 2in firm, painful to light touch, TYLENOL minimize pain. No further joint, muscle pain nor any fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 1 day post vaccination 3/30, developed at injection site a large edematous, not, solid lump measure 3in x1in. Constant Pain with redness. At 2pm 3/30, developed low grade fever 99 degrees Fahrenheit. Nausea, severe joint and generalized muscle pain as well as dizziness- had to leave work. Relieved moderately with MOTRIN 400mg. 8hours later on 3/30 pain in arm and severe joint and muscle pain returned. On 3/31 redness on arm and swelling measured 3in by 2 in, painful to light touch, still very firm. Muscle pain relieved with MOTRIN, able to work. Fatigued, no fever. Sun 4/1 severe arm pain, still red 3in x 2in firm, painful to light touch, TYLENOL minimize pain. No further joint, muscle pain nor any fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Local redness, pain, swelling began after ~12 hours. Flu-like symptoms (serious myalgia, fatigue, 101-degree fever, chills) began ~24 hours after injection, lasted 48 hours, resolved completely.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Local redness, pain, swelling began after ~12 hours. Flu-like symptoms (serious myalgia, fatigue, 101-degree fever, chills) began ~24 hours after injection, lasted 48 hours, resolved completely.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENTS ARM WAS SWOLLEN AND RED. CALLED PATIENT ON 04012018 AND PATIENT SAID HER ARM WAS MUCH BETTER/FINE BUT WOULD CONTINUE TO TAKE ANTIBIOTICS FOR THE 7 DAY THERAPY.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got the shingles on Labor Day 2017 (September 4th, 2017).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Peripheral swelling, Rash, Tenderness
Clinical narrative: Pt reported swollen, hard, tender, rash, going down arm.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Malaise, Pyrexia
Clinical narrative: Symptom onset started 5-6 hours after injection. Sxs included large red welt (~2inches in diameter) that was warm to touch and swollen, a low grade fever, chills, lack of appetite, general malaise.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Symptom onset started 5-6 hours after injection. Sxs included large red welt (~2inches in diameter) that was warm to touch and swollen, a low grade fever, chills, lack of appetite, general malaise.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Induration, Peripheral swelling, Skin warm
Clinical narrative: Very swollen arm, red, hot to touch, hard, flu like symptoms, extreme fatigue.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Computerised tomogram, Dysphagia, Electroencephalogram, Hemiparesis
Clinical narrative: Ischemic stroke on 11/13/2016 at 4 AM resulting in right hemiparesis (dominant side). Now can only walk with a cane for limited distance, balance problems, swallowing/speaking problems. No longer employed, had to give up most all normal activities (tennis, ballroom dancing, etc.).
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Ischaemic stroke, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging, Speech disorder, Walking aid user
Clinical narrative: Ischemic stroke on 11/13/2016 at 4 AM resulting in right hemiparesis (dominant side). Now can only walk with a cane for limited distance, balance problems, swallowing/speaking problems. No longer employed, had to give up most all normal activities (tennis, ballroom dancing, etc.).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient noticed bruising and swelling in the evening of 3/29/18. In the evening of 3/30/18 patient experienced more swelling and redness. In the morning of 3/31/18 patient observed more swelling and the area was warm to the touch. The arm was very sore and tender when touched.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient noticed bruising and swelling in the evening of 3/29/18. In the evening of 3/30/18 patient experienced more swelling and redness. In the morning of 3/31/18 patient observed more swelling and the area was warm to the touch. The arm was very sore and tender when touched.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash
Clinical narrative: Rash between 3 to 6 inches reported by patient around injection site about two days after shot. Called to check with patient Sunday 4-1-18 and she said rash is slowly getting better. She did report chills and possible headache as a possible side effect as well. Patient contacted dr office on 3-30-18 and they told her to take BENADRYL and will see her this week sometime according to patient.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Patient experienced soreness on the right upper arm approximately 4 hours after administration. Patient also noticed the next day that the swelling moved towards the lower part of her arm (towards the elbow).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling cold, Injection site pain, Myalgia
Clinical narrative: Awoke at 1 am and felt like I was freezing. My teeth were chattering, and I was shivering. The temperature in the room was normal, 68-70F and I had a blanket on the bed. I got up, put sweats on, and another heavy blanket and laid shivering until 5:00 am when I dozed off again. I had to get up at 6am so that didn't last long. This was the worst reaction I have ever had to a vaccine. The aching muscles and joints lasted another 48 hours. Even today, over a week later, the injection site is still sore.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: PT WOKE THIS MORNING, 4/1/18 AT AROUND 8AM & EXPERIENCED: ACHES, CHILLS, TEMP OF 100.7 TO 101. PT CALLED INTO PHARMACY AROUND 12 NOON. ADVISED PT TO TAKE IBUPROFEN BASED NSAID W/ FOOD OR MILK TO HELP W/ ACHES, PAINS, & CHILLS. REMINDED PT IT IS COMMON SIDE EFFECT OF THE VACCINATION.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pallor, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: After dose 3/20, her arm became swollen and painful and her ears were ringing. She did not seek medical attention until 3/22 when she noticed a red dotted non-pruritic rash that was spreading. Patient stated that the maculopapular rash clustered under her breasts and blanched. Her primary doctor recommended she be seen at urgent care. She was prescribed ZYRTEC and ranitidine and MEDROL dose pack (5 day). She reported improvement after starting the steroid with near resolution after the last dose of steroid. Only new medication has been a supplemental sleep aid "Gaba gamma aminobutyric ".
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash maculo-papular, Tinnitus
Clinical narrative: After dose 3/20, her arm became swollen and painful and her ears were ringing. She did not seek medical attention until 3/22 when she noticed a red dotted non-pruritic rash that was spreading. Patient stated that the maculopapular rash clustered under her breasts and blanched. Her primary doctor recommended she be seen at urgent care. She was prescribed ZYRTEC and ranitidine and MEDROL dose pack (5 day). She reported improvement after starting the steroid with near resolution after the last dose of steroid. Only new medication has been a supplemental sleep aid "Gaba gamma aminobutyric ".
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal disorder, Myalgia, Pain
Clinical narrative: Intense muscle pain and soreness. Could not use my arm. Basically had to keep it in one position at my side. Tried Extra Strength TYLENOL with very little relief. I switched to 750 Mg Nabumetone twice a day. It took 3 days to feel better. There is still minor soreness when raising my arm above my head. I also had shivers the first evening and overnight. I had a dull headache for around 24 hours. I will not have the 2nd phase of the shot. I will not take a chance of going through that again.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Headache, Chills, Muscle pain and Body aches.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Flushing
Clinical narrative: Flushing, shortness of breath. Diphenhydramine 50 mg once.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt came down with shingles 21 days after vaccine.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 51-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included carvedilol phosphate, ranitidine hydrochloride, LIPITOR, Metformin, BRILINTA, ENTRESTO and RANEXA. On 19th March 2018 10:25, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were recovering/resolving. The reporter considered the injection site swelling, injection site erythema and injection site warmth to be almost certainly related to SHINGRIX. Additional information was reported as follows: On 19th March 2018 at 10:25 hours, the patient received SHINGRIX on right deltoid. At the time of this report, the injection site was still puffy and felt like a balloon. On 22nd March 2018, the patient went to pharmacy.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 51-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included carvedilol phosphate, ranitidine hydrochloride, LIPITOR, Metformin, BRILINTA, ENTRESTO and RANEXA. On 19th March 2018 10:25, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were recovering/resolving. The reporter considered the injection site swelling, injection site erythema and injection site warmth to be almost certainly related to SHINGRIX. Additional information was reported as follows: On 19th March 2018 at 10:25 hours, the patient received SHINGRIX on right deltoid. At the time of this report, the injection site was still puffy and felt like a balloon. On 22nd March 2018, the patient went to pharmacy.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Culture positive, Gait disturbance, Hand-foot-and-mouth disease, Herpes zoster
Clinical narrative: Developed varicella 3 months after vaccine in leg. No adverse outcome. Child fully recovered.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Oral mucosal eruption, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Developed varicella 3 months after vaccine in leg. No adverse outcome. Child fully recovered.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Polymerase chain reaction positive, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Developed varicella 3 months after vaccine in leg. No adverse outcome. Child fully recovered.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. The patient's concomitant therapy included sterile diluent (DILUENT MRK INJ). On 22-MAR-2018, the patient was vaccinated with expired dose of VARIVAX (dose, units, frequency were unknown) (lot # M009766 and expiration date 23-FEB-2018) (expired product administered) and sterile diluent (DILUENT MRK INJ) (dose, units, frequency were unknown) (lot # M017519 and expiration date 15-OCT-2018). No adverse effects were reported. There was no product quality compliant reported. "Lot number [M017519] has been verified to be a valid lot number for [sterile diluent]."
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer via Pfizer refers to a male patient of unknown age. Information on pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dosing details not provided). On an unknown date, the patient experienced unknown side effects (adverse event). The outcome of adverse event was unknown. Causality of the event was not provided.
Sex: F
Vaccine: FLUR4
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Hypersensitivity, Hypertension
Clinical narrative: Initial unsolicited report received from a Nurse on 07-Nov-2017. This case involves 57-year-old female patient who was vaccinated with FLUBLOK VACCINE (batch number, expiry date, route, dose in series, was not reported) on 10-Oct-2017. Patient's medical history were not reported. Concomitant medications were not reported. It was also reported that patient experienced allergic reaction to the flu shot (last one received when she was 17 year). On an unknown date, one week after the vaccination patient had lethargy, high blood pressure, chest tightness, severe dyspnea, color was ashen without rash. Patient did see an Advanced Practice Registered Nurse, EKG, and lab work were all negative and corrective treatment were not reported. On an unknown date, patient got recovered from the events as symptoms lasted approximately 24-30 hours. Follow up report received from a nurse on 28-Mar-2018. The patient was vaccinated with a 0.5 ml dose of FLUBLOK VACCINE (batch number: QFAA1703, expiry date: 26-Mar-2018, dose in series was not reported) via intramuscular route in the right deltoid. The patient had no concurrent conditions and concomitant medications. The patient also had no pre-existing physician-diagnosed allergies or birth defects. On 19-Oct-2017, nine-days (reported as 'one-week') following the vaccination, the patient developed high blood pressure, lethargy, color was ashen, severe dyspnea and chest tightness. On 19-Oct-2017, the patient visited to ARNP and provider note stated that patient had symptoms two days prior after she took her dog for walk and no mention of FLUBLOK VACCINE was there. The patient's lab test includes EKG (electrocardiogram) showed sinus rhythm with ectopy or acute As (as reported). Documents held by sender: none
Sex: F
Vaccine: FLUR4
Symptoms: Laboratory test normal, Lethargy, Pallor
Clinical narrative: Initial unsolicited report received from a Nurse on 07-Nov-2017. This case involves 57-year-old female patient who was vaccinated with FLUBLOK VACCINE (batch number, expiry date, route, dose in series, was not reported) on 10-Oct-2017. Patient's medical history were not reported. Concomitant medications were not reported. It was also reported that patient experienced allergic reaction to the flu shot (last one received when she was 17 year). On an unknown date, one week after the vaccination patient had lethargy, high blood pressure, chest tightness, severe dyspnea, color was ashen without rash. Patient did see an Advanced Practice Registered Nurse, EKG, and lab work were all negative and corrective treatment were not reported. On an unknown date, patient got recovered from the events as symptoms lasted approximately 24-30 hours. Follow up report received from a nurse on 28-Mar-2018. The patient was vaccinated with a 0.5 ml dose of FLUBLOK VACCINE (batch number: QFAA1703, expiry date: 26-Mar-2018, dose in series was not reported) via intramuscular route in the right deltoid. The patient had no concurrent conditions and concomitant medications. The patient also had no pre-existing physician-diagnosed allergies or birth defects. On 19-Oct-2017, nine-days (reported as 'one-week') following the vaccination, the patient developed high blood pressure, lethargy, color was ashen, severe dyspnea and chest tightness. On 19-Oct-2017, the patient visited to ARNP and provider note stated that patient had symptoms two days prior after she took her dog for walk and no mention of FLUBLOK VACCINE was there. The patient's lab test includes EKG (electrocardiogram) showed sinus rhythm with ectopy or acute As (as reported). Documents held by sender: none
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy lymph gland abnormal, Computerised tomogram abdomen abnormal, Constipation, Duodenitis, Gastrointestinal disorder
Clinical narrative: Developed parotid enlargement with multiple sicca symptoms, digestive symptoms including constipation. No improvement on same until placed on prednisone some 6 months later, with recurrence of symptoms as prednisone was tapered.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Oesophagogastroduodenoscopy abnormal, Parotid gland enlargement, Serology negative, Sialoadenitis
Clinical narrative: Developed parotid enlargement with multiple sicca symptoms, digestive symptoms including constipation. No improvement on same until placed on prednisone some 6 months later, with recurrence of symptoms as prednisone was tapered.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Sjogren's syndrome
Clinical narrative: Developed parotid enlargement with multiple sicca symptoms, digestive symptoms including constipation. No improvement on same until placed on prednisone some 6 months later, with recurrence of symptoms as prednisone was tapered.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Fatigue, Head discomfort, Headache
Clinical narrative: Frequent urination in early evening, fever of over 101, uncontrollable shaking and chills, chattering teeth, extreme pressure in head, (fear of stroke), muscle pain, joint pain, red, swollen injection area, severe headache, pulse of over 140 continuous for two hours. Extreme fatigue for two days and joint and muscle pain. Fever subsided by afternoon the following day. This is day three and I still am not "normal"
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Myalgia, Pollakiuria
Clinical narrative: Frequent urination in early evening, fever of over 101, uncontrollable shaking and chills, chattering teeth, extreme pressure in head, (fear of stroke), muscle pain, joint pain, red, swollen injection area, severe headache, pulse of over 140 continuous for two hours. Extreme fatigue for two days and joint and muscle pain. Fever subsided by afternoon the following day. This is day three and I still am not "normal"
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Tremor
Clinical narrative: Frequent urination in early evening, fever of over 101, uncontrollable shaking and chills, chattering teeth, extreme pressure in head, (fear of stroke), muscle pain, joint pain, red, swollen injection area, severe headache, pulse of over 140 continuous for two hours. Extreme fatigue for two days and joint and muscle pain. Fever subsided by afternoon the following day. This is day three and I still am not "normal"
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: INJECTION SITE PAIN THAT DAY, BUT NEXT DAY HAS BEEN INCREASING INABILITY TO LIFE ARM WITHOUT PAIN, OR WITHOUT ASSISTANCE. IS NOT ABLE TO LIFT ARM VERY FAR AT ALL WITHOUT ASSISTANCE, AND AFTER A CERTAIN LEVEL OF HEIGHT HAS  INCREASING PAIN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to skin of right arm inferior to injection site of MMRV.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Started running fever on March, 29th at 11:00 pm. Fever persisted for 12 hours. Very tired for 12 hours. Redness and soreness at injection site for 4+ days. Muscle pain in back and neck for 4+ days.  Unable to do normal activities for 14 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Started running fever on March, 29th at 11:00 pm. Fever persisted for 12 hours. Very tired for 12 hours. Redness and soreness at injection site for 4+ days. Muscle pain in back and neck for 4+ days.  Unable to do normal activities for 14 hours.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Pyrexia, Syncope
Clinical narrative: March 30, 2018 at 4:00 am: vomited twice and was running fever. 6:00 am syncopal episode. Unable to do normal activities for 24 hours. Injection site swelling and muscle aches for 4 + days.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: March 30, 2018 at 4:00 am: vomited twice and was running fever. 6:00 am syncopal episode. Unable to do normal activities for 24 hours. Injection site swelling and muscle aches for 4 + days.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Full blood count, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema in a 5-year-old male patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). Concomitant products included MMR. On 2nd November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced erythema, pruritus and swelling. The patient was treated with BENADRYL and Steroids. On an unknown date, the outcome of the erythema, pruritus and swelling were recovered/resolved. The reporter considered the erythema and swelling to be related to FLUARIX QUADRIVALENT. The reporter considered the pruritus to be unlikely related to FLUARIX QUADRIVALENT.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test abnormal, Exposure during pregnancy, Haemorrhage in pregnancy, Pregnancy test positive, Product administered at inappropriate site
Clinical narrative: This is a prospective pregnancy case. This 36-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX .5 ml on 25th January 2018. Concurrent medical  conditions included miscarriage (February 2016 and November 2016) and crushing injury of finger. The subject's last menstrual period was on 4th January 2018 and estimated date of delivery was 11th October 2018. The subject received BOOSTRIX at week 3 of the pregnancy and during the first trimester of pregnancy. On an unknown date, less than a month after receiving BOOSTRIX, the subject developed hemorrhage in pregnancy. Serious criteria included GSK medically significant. Additional event(s) included subchorionic hemorrhage, vaccine exposure during pregnancy and vaccine administered at inappropriate site. The outcome of hemorrhage in pregnancy was unknown. The outcome(s) of the additional event(s) included subchorionic hemorrhage (unknown), vaccine exposure during pregnancy (unknown) and vaccine administered at inappropriate site (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the hemorrhage in pregnancy and subchorionic hemorrhage to be related to BOOSTRIX. Relevant Tests: On an unknown date the patient undergone blood test which showed that the patient had a subchorionic hemorrhage and the patient also underwent pregnancy test was resulted positive. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Blood test result was see text unknown. On an unknown date, Pregnancy test result was Positive unknown. See case US2018GSK055433 for details regarding the baby case. Additional details were reported as follows: The patient called to tell that she saw information online that there might be a pregnancy registry for the vaccine. The patient wanted to know about the registry and participate in it. This case was previously reported to physician. The patient was unaware that she was pregnant before she received the vaccine. The patient already had 1 child. The patient mashed her finger and was given the vaccine since she had not been vaccinated for over 10 years. The patient had a blood test taken due to heavy bleeding. At that time, she was told that she had a subchorionic hemorrhage and that was when the pregnancy was noticed. The patient was six weeks pregnant at that moment. The patient had a six-month-old infant and had been breast feeding. There had been no issues with the pregnancy since the vaccine. The patient was told that the vaccine was usually given later during the pregnancy, but it should not affect the baby. The patient did not mind being contacted during the pregnancy. The patient did not provide the information for the OB/GYN doctor except one. The patient had an appointment this Thursday and would speak to him about being contacted by the company. See case US2018GSK055433 for details regarding the baby case.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Subchorionic haemorrhage
Clinical narrative: This is a prospective pregnancy case. This 36-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX .5 ml on 25th January 2018. Concurrent medical  conditions included miscarriage (February 2016 and November 2016) and crushing injury of finger. The subject's last menstrual period was on 4th January 2018 and estimated date of delivery was 11th October 2018. The subject received BOOSTRIX at week 3 of the pregnancy and during the first trimester of pregnancy. On an unknown date, less than a month after receiving BOOSTRIX, the subject developed hemorrhage in pregnancy. Serious criteria included GSK medically significant. Additional event(s) included subchorionic hemorrhage, vaccine exposure during pregnancy and vaccine administered at inappropriate site. The outcome of hemorrhage in pregnancy was unknown. The outcome(s) of the additional event(s) included subchorionic hemorrhage (unknown), vaccine exposure during pregnancy (unknown) and vaccine administered at inappropriate site (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the hemorrhage in pregnancy and subchorionic hemorrhage to be related to BOOSTRIX. Relevant Tests: On an unknown date the patient undergone blood test which showed that the patient had a subchorionic hemorrhage and the patient also underwent pregnancy test was resulted positive. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Blood test result was see text unknown. On an unknown date, Pregnancy test result was Positive unknown. See case US2018GSK055433 for details regarding the baby case. Additional details were reported as follows: The patient called to tell that she saw information online that there might be a pregnancy registry for the vaccine. The patient wanted to know about the registry and participate in it. This case was previously reported to physician. The patient was unaware that she was pregnant before she received the vaccine. The patient already had 1 child. The patient mashed her finger and was given the vaccine since she had not been vaccinated for over 10 years. The patient had a blood test taken due to heavy bleeding. At that time, she was told that she had a subchorionic hemorrhage and that was when the pregnancy was noticed. The patient was six weeks pregnant at that moment. The patient had a six-month-old infant and had been breast feeding. There had been no issues with the pregnancy since the vaccine. The patient was told that the vaccine was usually given later during the pregnancy, but it should not affect the baby. The patient did not mind being contacted during the pregnancy. The patient did not provide the information for the OB/GYN doctor except one. The patient had an appointment this Thursday and would speak to him about being contacted by the company. See case US2018GSK055433 for details regarding the baby case.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, warm to touch about 2-3 inches below injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Fear, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Tdap and meningococcal were given at approximately 11:00am without incidence. Patient and mother then decided to do the HPV and at was given at 11:15am. Promptly after receiving the HPV vaccination patient became pale and stated she was dizzy. Patient then passed out while sitting in the chair and was safely brought to the floor. Patient remained out and her body became stiff and convulsed 2-3 times. Within 2 minutes patient woke up and was confused and scared. Saturations were checked at this time and were normal. Within 15 minutes patient was walking around and stated she felt fine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Seizure
Clinical narrative: Tdap and meningococcal were given at approximately 11:00am without incidence. Patient and mother then decided to do the HPV and at was given at 11:15am. Promptly after receiving the HPV vaccination patient became pale and stated she was dizzy. Patient then passed out while sitting in the chair and was safely brought to the floor. Patient remained out and her body became stiff and convulsed 2-3 times. Within 2 minutes patient woke up and was confused and scared. Saturations were checked at this time and were normal. Within 15 minutes patient was walking around and stated she felt fine.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Palpitations, Supraventricular tachycardia
Clinical narrative: My daughter received MMR, PCV13, and Varicella vaccinations on 3/28/2018 at her 12 month well visit.  At the visit, she was healthy with normal vital signs. The next day (3/29/18) I noticed that her heart was racing while holding her. She had no other symptoms, and no fever. On 3/30/18, I checked her heart rate while sleeping and it was >200. I took her to the ER where she was found to be in SVT with a rate of 233, otherwise well-appearing and stable. She responded to a vagal maneuver (ice) and her rate decreased to 150. She was admitted to the hospital for monitoring and did not have any repeat episodes. She was discharged the next day with outpatient follow up with pediatric cardiology.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Nausea, Tinnitus
Clinical narrative: Patient given TRUMENBA vaccine at 09:50am this morning. Immediately nauseated, dizziness, and ringing in ears. Patient kept for 30-40 minutes post vaccination for recovery. Given water and allowed to sit. Symptoms subsided within the 40 minutes.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Laboratory test, Nausea, Tinnitus
Clinical narrative: Patient given TRUMENBA vaccine at 09:50am this morning. Immediately nauseated, dizziness, and ringing in ears. Patient kept for 30-40 minutes post vaccination for recovery. Given water and allowed to sit. Symptoms subsided within the 40 minutes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Livedo reticularis, Pain in extremity, Peripheral swelling
Clinical narrative: Redness at site began 3/18/18. The redness area increased in size on 3/19/18. Arm very sore, hardened, and somewhat swollen. On 3/20/18, 8 cm x 8 cm size of redness. More mottled looking.  3/21/18, still sore but no redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This patient developed a severe local injection site reaction that eventually formed a hard mass. The patient was seen in the emergency room Monday morning following the injection and was treated there with corticosteroids and antihistamines. The patient was successfully treated in the ER and did not require admission to the hospital for further observation.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death
Clinical narrative: 24-48 hours after patient received vaccines, Patient was found dead in crib, no clearly identifiable cause of death.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: This concerns the second dose, but effects were the same after the  first. Pain and redness at injection site. Pain initiated if area touched. Headache, effectively controlled by Tylenol. "Funny" feeling in head for several hours....felt like a mix of light headedness and dizziness, but not like either by itself. Red areas about 3-4" above injection site as well as around navel and band across chest under breasts.  Following the first vaccination, the "events" subsided in a couple of days, except for the red areas which lasted a week or so. None of the effects prohibited me from normal activities.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling cold, Hypoaesthesia
Clinical narrative: Shortly after receiving the flu vaccine, the client complained of dizziness and weakness. She was advised to sit with her feet up and given an orange. Symptoms not resolve and client then stated she had facial numbness and ringing in ears. Pulse was 84, capillary refill less than 3 seconds. Client became cold and pale, and complained of numbness in throat so EMS was called. While waiting for EMS to arrive, client stated she was having difficulty breathing and had rapid shallow respirations which seemed to resolve when EMS arrived. EMS reported good pulse and BP at site. Client was transported to ED.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypopnoea, Pallor, Pharyngeal hypoaesthesia, Respiratory rate increased, Tinnitus
Clinical narrative: Shortly after receiving the flu vaccine, the client complained of dizziness and weakness. She was advised to sit with her feet up and given an orange. Symptoms not resolve and client then stated she had facial numbness and ringing in ears. Pulse was 84, capillary refill less than 3 seconds. Client became cold and pale, and complained of numbness in throat so EMS was called. While waiting for EMS to arrive, client stated she was having difficulty breathing and had rapid shallow respirations which seemed to resolve when EMS arrived. EMS reported good pulse and BP at site. Client was transported to ED.
Age: 82.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Treated with BENADRYL (Pharmacist). Regarding injection and reaction received at same time from pneumonia PPSV23 and Recombinant Zoster Vaccine on 3/12/18 at 10 AM. Received both in left upper arm. 3/12/18 - Noticed swelling and redness that evening at injection sites. 3/13/18 - In morning swelling was 2" x 2" and bright red. Called drugstore and reported the reaction to the pharmacist. 3/14/18 - 9 PM, swelling was 3" x 4 1/2" x 3/8" thick and hard. Area was bright red, with rash, from injection site to elbow. 3/15/18 - 8 AM, Swelling was receding area becoming paler. Using BENADRYL as recommended by pharmacist. 3/16/18 - until. 3/23/18 - Swelling 1" in diameter and softer. Redness almost gone and rash area smaller. At the worst, pain was from top of shoulder to below elbow. 3/25/18 - The left arm and shoulder, which has always been the least painful for years, has become the worst since the vaccinations. Pain has increased and the limitation of motion has increased. Arm still itches, especially at night. 3/26/18 - Pain in left arm and shoulder has decreased some and motion has increased some. Although still itching the swelling has gone down to about 3/4". 3/27/18 - Pain has decreased and motion has increased. Swelling is down to about 5/8", there is still some itching.
Age: 82.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: Treated with BENADRYL (Pharmacist). Regarding injection and reaction received at same time from pneumonia PPSV23 and Recombinant Zoster Vaccine on 3/12/18 at 10 AM. Received both in left upper arm. 3/12/18 - Noticed swelling and redness that evening at injection sites. 3/13/18 - In morning swelling was 2" x 2" and bright red. Called drugstore and reported the reaction to the pharmacist. 3/14/18 - 9 PM, swelling was 3" x 4 1/2" x 3/8" thick and hard. Area was bright red, with rash, from injection site to elbow. 3/15/18 - 8 AM, Swelling was receding area becoming paler. Using BENADRYL as recommended by pharmacist. 3/16/18 - until. 3/23/18 - Swelling 1" in diameter and softer. Redness almost gone and rash area smaller. At the worst, pain was from top of shoulder to below elbow. 3/25/18 - The left arm and shoulder, which has always been the least painful for years, has become the worst since the vaccinations. Pain has increased and the limitation of motion has increased. Arm still itches, especially at night. 3/26/18 - Pain in left arm and shoulder has decreased some and motion has increased some. Although still itching the swelling has gone down to about 3/4". 3/27/18 - Pain has decreased and motion has increased. Swelling is down to about 5/8", there is still some itching.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMRV was given to a child older than 12 yrs of age. Family called and left message to call back so we can inform them of the incident.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2018-03-31.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Hepatitis B antibody negative, Measles antibody negative, Rubella antibody negative, Tuberculin test positive
Clinical narrative: Returns to facility to have TB skin test read and shows red, warm area that measures 50mm with additional surrounding area of 50mm wide ring that is pink but not red, itchy.