chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Local reaction, Pain
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 15 year old female patient. No medical history or concurrent conditions were reported. Approximately in June 2014, reported as 2 months ago, the patient was vaccinated with the third dose of GARDASIL, injection (dose, route of administration and lot number not provided). Co-suspect or concomitant therapies were not reported. Approximately in June 2014, reported as 2 months ago, the patient was vaccinated with the third dose of GARDASIL, injection (dose, route of administration and lot number not provided). Co-suspect or concomitant therapies were not reported. Approximately on 2014, the patient experienced pain and a localized reaction at the injection site after received the third dose of GARDASIL. At the time of the report, the outcome of the events was unknown. The causal relationship between GARDASIL and the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's mother refers to a female patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL, injection (dose, dose number, strength and lot number were not provided). Co-suspect or concomitant therapies were not reported. On an unknown date, the patient tested positive for pregnancy with unknown LMP (last menstrual period), EDD (estimated delivery date) and date of conception after received GARDASIL. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 27-AUG-2014, the patient was vaccinated with PNEUMOVAX23, injection, (lot # J004080, Exp. Date: 22-AUG-2014) (strength and dose not provided). Co-suspect or concomitant therapies were not reported. On 27-AUG-2014, at the time of the vaccination the dose of PNEUMOVAX23 was expired. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age. Multiple patients were vaccinated with GARDASIL (dose, lot no. unknown). No concomitant medication was reported. The medical assistant reported that multiple patients have received GARDASIL off schedule. Medical assistant reported that there were multiple patients who get their first dose and wait for a year or longer to get their second dose. No adverse effect was reported. The outcome of events was unknown. Product quality complaint was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL, (route, lot numbers and expiration dates not reported). The reporter stated that the patients received GARDASIL off schedule. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The pharmacist reported to the company representative that an unspecified patient has been administered ZOSTAVAX three times in the last three years. The pharmacist stated that two of the ZOSTAVAX administrations look place on unspecified dates in recent months. No adverse effects reported.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with an expired dose of M-M-R II lot # H015826 and expiration date 24-AUG-2014 (strength and route not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker reporting an unspecified number of patients of unknown age and genders. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported). 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that (Oka/Merck) VARIVAX that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On 27-AUG-2014 the patient ws vaccinated with an expired vaccine of M-M-R II lot #H011907, expiration date 03-JUL-2014 (strength and route not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On approximately 11-AUG-2014 (reported as since 11-AUG-2014) the patients were vaccinated with an improperly storage (Oka/Merck) VARIVAX, subcutaneous (lot numbers and expiration dates not reported). No adverse effect reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Mumps antibody test negative, Rubella antibody negative, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a nurse regarding a 22 year old female patient. The patient had an undocumented case of chicken pox as child on an unspecified date. On an unknown date in 1993, the patient was vaccinated with M-M-R II (dose, product lot#, expiry date, route not reported) dose 1 and dose number 2 on an unknown date in 1997 and on 15-AUG-2014, the patient was vaccinated with third dose of M-M-R II (dose, product lot#, expiry date, route not reported). Other suspect therapies included VARIVAX dose 1 (dose, product lot#, expiry date, route not reported) vaccinated on 15-AUG-2014. The patient had never received VARIVAX in the past. The nurse stated that the on an unknown date, patient had titer results low for varicella, mumps and rubella. No intervention was done to prevent seriousness criteria. There was no product quality complaint involved. The outcome and causality of the event titer results low for varicella, mumps and rubella was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Blood glucose normal, Dizziness, Dyspnoea, Fatigue, Feeling jittery
Clinical narrative: Within ten minutes of vaccination I was dizzy and shaking. Within thirty minutes I was having difficulty breathing. When I went back to have the nurse and doctor check to see what was wrong they said my heart rate was elevated. They also check my blood sugar and found it to be normal. The next day I was jittery the whole day. I was tired for several days after.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Heart rate increased, Tremor
Clinical narrative: Within ten minutes of vaccination I was dizzy and shaking. Within thirty minutes I was having difficulty breathing. When I went back to have the nurse and doctor check to see what was wrong they said my heart rate was elevated. They also check my blood sugar and found it to be normal. The next day I was jittery the whole day. I was tired for several days after.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pruritus
Clinical narrative: Pain, rash (silver dollar size) at injection site, itch.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red warm area to LEFT arm at site of VARICELLA injection. Area sore to the touch. Mom took her to see MD. No treatment given per MD. Mom states the area was clear by the am 8/29/2014.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Pain, Tenderness
Clinical narrative: Tenderness in left axilla radiating down left inner arm with a "pinching" type pain in left inner elbow when elbow extended.
Sex: M
Vaccine: PPV
Symptoms: Injection site abscess
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a male patient of unknown age. On 26-AUG-2014 the patient was vaccinated intramuscularly with PNEUMOVAX 23 (injection, 0.5 ml, once) (lot # reported as K004483, exp date: 16-AUG-2015). In approximately 26-AUG-2014 (specific date not provided) the patient experienced abscess at the PNEUMOVAX 23 injection site. On 27-AUG-2014, he was admitted to the hospital and had not yet been discharged (reported as had not been discharged "as of today"). The outcome of abscess at the PNEUMOVAX 23 injection site was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Induration, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient's arm became very sore, rock hard and pain radiated down under armpit, up into neck and shoulder, lasted for 4 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Hyperaesthesia, Induration, Pruritus
Clinical narrative: Started out as a wheal, hot and red.  Ended up after 3 days, a wheal about 10 cm, hard, hot, red and 60% of upper arm reddened, itchy, sensitive.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Started out as a wheal, hot and red.  Ended up after 3 days, a wheal about 10 cm, hard, hot, red and 60% of upper arm reddened, itchy, sensitive.
Age: 80.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills
Clinical narrative: Started with chills, but by 8 PM had temp of 102.  Lasted into next AM when it subsided.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: RAISED RASH TO SITE, ITCHY.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives developed on legs and trunk and back. 25 mg Benadryl given and observed for 30 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Loss of consciousness
Clinical narrative: Pt was given DTAP and Polio injections in both thighs she was fine when they were given and when they proceeded to the checkout the little girl passed out immediate attention was given and the on call doctor followed up with that family the next day.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and small amount of vomiting.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and small amount of vomit.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling with redness over most of left upper arm from shoulder to elbow.  Warm to the touch & painful.  Child did not alert mother to situation until late in the evening 8/26 & mother took child to ER where child was given an antibiotic & pain medication prescriptions.
Age: 69.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Erythema, Rash macular, Vibratory sense increased
Clinical narrative: Intermittent vibrations in foot following same path each time. MD noticed blotches on arms and legs. Pt taking BENADRYL for red areas on body.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Pt. has redness and warmth around injection site, and painful arm. 10 cm area of erythema, tenderness and increased warmth to surrounding injection site.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Local swelling
Clinical narrative: 2 yo child received Dtap #4 in left deltoid on 08/20/14 at 10:00 am. MOC called RN to report left arm swelling about "1/2 the size of a tennis ball and a rash (red and bumpy around the site of injection" on 08/21/2014. MOC stated arm was not hot and child was acting normally.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local reaction, Skin warm
Clinical narrative: Patient was given KINRIX (Dtap/IPV) on 8/25/14. Had reaction redness and swelling at injection site on 8/27/14. 5 1/4 x 4 in. erythematous warm localized reaction.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Upper extremity mass
Clinical narrative: Lump on arm (from ZOSTAVAX vaccination possibly).
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Incorrect dose administered, Pain
Clinical narrative: Administered MMRV and a varicella vaccine, mistake was not notified until the next morning: 8/26/14. Called patient, spoke with grandmother, who was with the patient. Grandmother stated patient is sore but doing fine, eating pizza and watching TV.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site urticaria
Clinical narrative: Large, roughly 8 cm wheal on left thigh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Per mother patient had a fever 8/22 in the evening she noticed that her left arm was swollen, red and hot. She gave her TYLENOL. On 8/23 and 8/24, she felt warm. On 8/24 area was itchy - she applied anti-itch cream. 8/25 - area still red, hard, and hot. Approx 1 1/2" diameter. "It's getting better" 8/27 per mother.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Per mother patient had a fever 8/22 in the evening she noticed that her left arm was swollen, red and hot. She gave her TYLENOL. On 8/23 and 8/24, she felt warm. On 8/24 area was itchy - she applied anti-itch cream. 8/25 - area still red, hard, and hot. Approx 1 1/2" diameter. "It's getting better" 8/27 per mother.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Mouth ulceration
Clinical narrative: She c/o HA evening of 08/01 -> resolved 08/02/14. She c/o onset severe fatigue 08/02/14, resolved by 08/05. She c/o onset of multiple oral ulcers on 08/02/14 which resolved by 08/06/14.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Large local reactions - warmth, swelling, redness around both sites.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Anxiety, Fall, Muscle rigidity
Clinical narrative: Approximately 5 minutes after receiving injections, pt. fell to the floor from a seated position. Her body became rigid for about 30 sec then she was able to sit up. She had no recollection of the event. ER no diagnosed. Pt: with anxiety RT receiving shots for school.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Weakness for two (2) days sick to my stomach. The site where vaccine admin. turned red, itch, hives, wept, dizziness, swelling at site of vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Nausea, Urticaria, Vaccination site reaction
Clinical narrative: Weakness for two (2) days sick to my stomach. The site where vaccine admin. turned red, itch, hives, wept, dizziness, swelling at site of vaccine.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Night injection administered (approx 9-10 hrs after) pt began fevering temp >99.7, arm became stiff no swelling, pt reported a decrease in ability to move limb, chills, fever.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Feeling hot, Hyperhidrosis, Malaise, Nausea
Clinical narrative: After receiving Tdap/MENACTRA/HPV (GARDASIL), within minutes patient became sweaty, hot, nauseous, malaise. 1st BP was 78/43.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction, swollen, red, itching.
Age: 1.76
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Back pain, Confusional state, Cough, Crying
Clinical narrative: Symptoms included fever (max >101F), extreme distress (crying/screaming), irritability, appetite loss, unusual tiredness, weakness, drowsiness, somnolence, confusion, extreme mood change (stopped smiling), vomiting, hallucinations, red/irritated eyes, runny nose, cough, slight bloody nose, tachycardia, unsteady gait, white spot inside mouth, back pain. Physician-ordered treatment for acute symptoms was rest and fluids (plus NSAID if fever causing distress). Acute symptoms peaked on 07/09 and 07/10 and then gradually resolved over about 1.5 weeks -- except for the back pain, which the patient never had mentioned previously but has mentioned almost daily ever since (current date: 09/02/2014). As of 08/29/2014, patient is being medicated for slow/incomplete stool transit in large intestine (found upon x-ray 08/25) in hopes that will help the back pain.
Age: 1.76
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Emotional distress, Fatigue, Gait disturbance, Gastrointestinal hypomotility
Clinical narrative: Symptoms included fever (max >101F), extreme distress (crying/screaming), irritability, appetite loss, unusual tiredness, weakness, drowsiness, somnolence, confusion, extreme mood change (stopped smiling), vomiting, hallucinations, red/irritated eyes, runny nose, cough, slight bloody nose, tachycardia, unsteady gait, white spot inside mouth, back pain. Physician-ordered treatment for acute symptoms was rest and fluids (plus NSAID if fever causing distress). Acute symptoms peaked on 07/09 and 07/10 and then gradually resolved over about 1.5 weeks -- except for the back pain, which the patient never had mentioned previously but has mentioned almost daily ever since (current date: 09/02/2014). As of 08/29/2014, patient is being medicated for slow/incomplete stool transit in large intestine (found upon x-ray 08/25) in hopes that will help the back pain.
Age: 1.76
Sex: F
Vaccine: MMR
Symptoms: Hallucination, Heart rate increased, Irritability, Mood altered, Ocular hyperaemia
Clinical narrative: Symptoms included fever (max >101F), extreme distress (crying/screaming), irritability, appetite loss, unusual tiredness, weakness, drowsiness, somnolence, confusion, extreme mood change (stopped smiling), vomiting, hallucinations, red/irritated eyes, runny nose, cough, slight bloody nose, tachycardia, unsteady gait, white spot inside mouth, back pain. Physician-ordered treatment for acute symptoms was rest and fluids (plus NSAID if fever causing distress). Acute symptoms peaked on 07/09 and 07/10 and then gradually resolved over about 1.5 weeks -- except for the back pain, which the patient never had mentioned previously but has mentioned almost daily ever since (current date: 09/02/2014). As of 08/29/2014, patient is being medicated for slow/incomplete stool transit in large intestine (found upon x-ray 08/25) in hopes that will help the back pain.
Age: 1.76
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rhinorrhoea, Screaming, Somnolence, Spinal X-ray abnormal
Clinical narrative: Symptoms included fever (max >101F), extreme distress (crying/screaming), irritability, appetite loss, unusual tiredness, weakness, drowsiness, somnolence, confusion, extreme mood change (stopped smiling), vomiting, hallucinations, red/irritated eyes, runny nose, cough, slight bloody nose, tachycardia, unsteady gait, white spot inside mouth, back pain. Physician-ordered treatment for acute symptoms was rest and fluids (plus NSAID if fever causing distress). Acute symptoms peaked on 07/09 and 07/10 and then gradually resolved over about 1.5 weeks -- except for the back pain, which the patient never had mentioned previously but has mentioned almost daily ever since (current date: 09/02/2014). As of 08/29/2014, patient is being medicated for slow/incomplete stool transit in large intestine (found upon x-ray 08/25) in hopes that will help the back pain.
Age: 1.76
Sex: F
Vaccine: MMR
Symptoms: Tachycardia, Urine analysis normal, Vomiting
Clinical narrative: Symptoms included fever (max >101F), extreme distress (crying/screaming), irritability, appetite loss, unusual tiredness, weakness, drowsiness, somnolence, confusion, extreme mood change (stopped smiling), vomiting, hallucinations, red/irritated eyes, runny nose, cough, slight bloody nose, tachycardia, unsteady gait, white spot inside mouth, back pain. Physician-ordered treatment for acute symptoms was rest and fluids (plus NSAID if fever causing distress). Acute symptoms peaked on 07/09 and 07/10 and then gradually resolved over about 1.5 weeks -- except for the back pain, which the patient never had mentioned previously but has mentioned almost daily ever since (current date: 09/02/2014). As of 08/29/2014, patient is being medicated for slow/incomplete stool transit in large intestine (found upon x-ray 08/25) in hopes that will help the back pain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Greater than 15 x 16 cm area of erythema and induration at vaccine site; no treatment needed; parent did give BENADRYL and TYLENOL.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Pyrexia
Clinical narrative: High fevers.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Local swelling, redness and bruising at injection site.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at injection site and warm. Flu-like symptoms. Patient went to urgent care and told to watch for 48 hours and return if no better. She was better, but MD said it was an allergic rxn.
Age: 58.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asthenia, Brachial plexopathy, Long thoracic nerve palsy, Mobility decreased, Musculoskeletal pain
Clinical narrative: On July 23, 2012, I received the injections, on July 28, 2012, I began suffering from acute pain in my right arm, shoulder, and scapula. The acute pain lasted for two weeks. After two weeks, the acute pain turned to loss in strength and movement in my right arm, shoulder and scapula. I was diagnosed with brachial plexitis manifested by long thoracic nerve palsy.
Age: 58.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging, Pain, Pain in extremity, X-ray
Clinical narrative: On July 23, 2012, I received the injections, on July 28, 2012, I began suffering from acute pain in my right arm, shoulder, and scapula. The acute pain lasted for two weeks. After two weeks, the acute pain turned to loss in strength and movement in my right arm, shoulder and scapula. I was diagnosed with brachial plexitis manifested by long thoracic nerve palsy.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse drug reaction, Blindness, Breath odour, Cerebrovascular accident, Feeling abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of legally blind eye in a female patient who received ADVAIR multi dose powder inhaler for asthma and fall allergies. A physician or other health care professional has not verified this report. Co-suspect medication included VENTOLIN and azithromycin. Concurrent medications included blood pressure medication, NASONEX, PATADAY, SINGULAIR, ALLEGRA, PLAVIX, losartan, amlodipine and PROAIR. The patient's medical history included asthma, fall allergies and allergy to antibiotics. The patient started having allergies in her 40s. She got allergy shots in the past but they did not help. On an unknown date, the patient started ADVAIR (inhaled) at 1 puff(s) twice per day. Sometimes, the patient forgot to take ADVAIR and used VENTOLIN if ADVAIR did not work. The duration of therapy of ADVAIR was 8-10 years and the duration of therapy of VENTOLIN was 10 years or more. In 2008, the patient was diagnosed with non-Hodgkin's lymphoma which had weakened her immune system. In October 2013, the patient received an unspecified dose of influenza vaccine (unknown route and injection site). On 25 December 2013, at an unknown time after starting ADVAIR and VENTOLIN and 2 months after vaccination with influenza vaccine, the patient experienced influenza that turned into sinus infection. This case was considered as a vaccination failure. In June 2014, the sinus infection was diagnosed. The subject did not feel good and required to use more albuterol. She lost a lot of weight, legally blind eye, slime in throat, whole head feels plugged, headache that she felt like a balloon and bad breath. The patient also had 2 strokes in right retina. She had tests done on carotid arteries and the man pressed harshly and she believed something broke loose and resulted in stroke. The patient was treated with azithromycin for sinus infection which caused throwing up. This case was assessed as medically serious by GSK. At the time of reporting, the sinus infection was unresolved.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Immune system disorder, Increased upper airway secretion, Influenza, Laboratory test
Clinical narrative: This case was reported by a consumer and described the occurrence of legally blind eye in a female patient who received ADVAIR multi dose powder inhaler for asthma and fall allergies. A physician or other health care professional has not verified this report. Co-suspect medication included VENTOLIN and azithromycin. Concurrent medications included blood pressure medication, NASONEX, PATADAY, SINGULAIR, ALLEGRA, PLAVIX, losartan, amlodipine and PROAIR. The patient's medical history included asthma, fall allergies and allergy to antibiotics. The patient started having allergies in her 40s. She got allergy shots in the past but they did not help. On an unknown date, the patient started ADVAIR (inhaled) at 1 puff(s) twice per day. Sometimes, the patient forgot to take ADVAIR and used VENTOLIN if ADVAIR did not work. The duration of therapy of ADVAIR was 8-10 years and the duration of therapy of VENTOLIN was 10 years or more. In 2008, the patient was diagnosed with non-Hodgkin's lymphoma which had weakened her immune system. In October 2013, the patient received an unspecified dose of influenza vaccine (unknown route and injection site). On 25 December 2013, at an unknown time after starting ADVAIR and VENTOLIN and 2 months after vaccination with influenza vaccine, the patient experienced influenza that turned into sinus infection. This case was considered as a vaccination failure. In June 2014, the sinus infection was diagnosed. The subject did not feel good and required to use more albuterol. She lost a lot of weight, legally blind eye, slime in throat, whole head feels plugged, headache that she felt like a balloon and bad breath. The patient also had 2 strokes in right retina. She had tests done on carotid arteries and the man pressed harshly and she believed something broke loose and resulted in stroke. The patient was treated with azithromycin for sinus infection which caused throwing up. This case was assessed as medically serious by GSK. At the time of reporting, the sinus infection was unresolved.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Non-Hodgkin's lymphoma, Retinal disorder, Sinus congestion, Sinusitis, Ultrasound Doppler
Clinical narrative: This case was reported by a consumer and described the occurrence of legally blind eye in a female patient who received ADVAIR multi dose powder inhaler for asthma and fall allergies. A physician or other health care professional has not verified this report. Co-suspect medication included VENTOLIN and azithromycin. Concurrent medications included blood pressure medication, NASONEX, PATADAY, SINGULAIR, ALLEGRA, PLAVIX, losartan, amlodipine and PROAIR. The patient's medical history included asthma, fall allergies and allergy to antibiotics. The patient started having allergies in her 40s. She got allergy shots in the past but they did not help. On an unknown date, the patient started ADVAIR (inhaled) at 1 puff(s) twice per day. Sometimes, the patient forgot to take ADVAIR and used VENTOLIN if ADVAIR did not work. The duration of therapy of ADVAIR was 8-10 years and the duration of therapy of VENTOLIN was 10 years or more. In 2008, the patient was diagnosed with non-Hodgkin's lymphoma which had weakened her immune system. In October 2013, the patient received an unspecified dose of influenza vaccine (unknown route and injection site). On 25 December 2013, at an unknown time after starting ADVAIR and VENTOLIN and 2 months after vaccination with influenza vaccine, the patient experienced influenza that turned into sinus infection. This case was considered as a vaccination failure. In June 2014, the sinus infection was diagnosed. The subject did not feel good and required to use more albuterol. She lost a lot of weight, legally blind eye, slime in throat, whole head feels plugged, headache that she felt like a balloon and bad breath. The patient also had 2 strokes in right retina. She had tests done on carotid arteries and the man pressed harshly and she believed something broke loose and resulted in stroke. The patient was treated with azithromycin for sinus infection which caused throwing up. This case was assessed as medically serious by GSK. At the time of reporting, the sinus infection was unresolved.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Upper respiratory tract congestion, Vaccination failure, Vomiting, Weight decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of legally blind eye in a female patient who received ADVAIR multi dose powder inhaler for asthma and fall allergies. A physician or other health care professional has not verified this report. Co-suspect medication included VENTOLIN and azithromycin. Concurrent medications included blood pressure medication, NASONEX, PATADAY, SINGULAIR, ALLEGRA, PLAVIX, losartan, amlodipine and PROAIR. The patient's medical history included asthma, fall allergies and allergy to antibiotics. The patient started having allergies in her 40s. She got allergy shots in the past but they did not help. On an unknown date, the patient started ADVAIR (inhaled) at 1 puff(s) twice per day. Sometimes, the patient forgot to take ADVAIR and used VENTOLIN if ADVAIR did not work. The duration of therapy of ADVAIR was 8-10 years and the duration of therapy of VENTOLIN was 10 years or more. In 2008, the patient was diagnosed with non-Hodgkin's lymphoma which had weakened her immune system. In October 2013, the patient received an unspecified dose of influenza vaccine (unknown route and injection site). On 25 December 2013, at an unknown time after starting ADVAIR and VENTOLIN and 2 months after vaccination with influenza vaccine, the patient experienced influenza that turned into sinus infection. This case was considered as a vaccination failure. In June 2014, the sinus infection was diagnosed. The subject did not feel good and required to use more albuterol. She lost a lot of weight, legally blind eye, slime in throat, whole head feels plugged, headache that she felt like a balloon and bad breath. The patient also had 2 strokes in right retina. She had tests done on carotid arteries and the man pressed harshly and she believed something broke loose and resulted in stroke. The patient was treated with azithromycin for sinus infection which caused throwing up. This case was assessed as medically serious by GSK. At the time of reporting, the sinus infection was unresolved.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Injection site swollen.
Age: 1.28
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Body temperature increased, Febrile convulsion, Somnolence
Clinical narrative: Had temperature to 102F that morning, family treated with Tylenol.  Had febrile seizure around 230 that was 1-2mins in length followed by drowsiness.  Temperature max was 104F.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Emotional distress, Insomnia
Clinical narrative: It started as a mild rash. However, other symptoms transpired eg itching, crying and screaming for hours and hours, loss of appetite, upset, not drinking from the breast as usual, biting the breast before latched, rash turned more pronounced and pronounced bumps all over his body. Scratching and itching out of control, not sleeping, throwing himself on the ground in fits.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pruritus, Rash generalised, Screaming
Clinical narrative: It started as a mild rash. However, other symptoms transpired eg itching, crying and screaming for hours and hours, loss of appetite, upset, not drinking from the breast as usual, biting the breast before latched, rash turned more pronounced and pronounced bumps all over his body. Scratching and itching out of control, not sleeping, throwing himself on the ground in fits.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling, Malaise, Pruritus, Pyrexia, Urticaria
Clinical narrative: Child received three vaccines: Polio, DTaP, and MMR (4th, 5th, and 2nd doses respectively). Proximal limb (Rt arm) swollen to twice diameter on 08/24/2014 when child woke up. Lasted four days then subsided.  8/23/2014 mild fever 101 degrees fahrenheit, previous history of fever with each vaccination. Child was not feeling well that day; felt better by 8/25/2014. 09/01/2014 beginning of itchy hives primarily on chest and abdomen and spreading to the areas surrounding the lymph nodes (groin, upper thighs, armpits, neck, and lower jaw.) Treatment for arm swelling was ice/cool cloths. Treatment for fever was rest and fluids. Treatment for hives is Benadryl (ongoing). Hives disappear with administration of Benadryl, resurface by the time next dose is due. Child has no history of allergies and no known new food, detergent etc. exposure.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: 5 minutes following vaccination patient became very dizzy and fainted.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Injection site erythema, Injection site reaction, Myalgia, Nausea
Clinical narrative: WOKE UP WITH SEVERE BODY ACHES, WITHIN AN HOUR DEVELOPED CHILLS, ROUGHLY 0500 IN THE AM BECAME NAUSEATED VOMITING ONCE. TOOK TEMP AT 0600 WITH MILD FEVER 100 DEGREE (F). WENT TO DOCTOR 0800 OF SAME DAY TREATED FOR WHAT WAS ASSUMED TO BE SIDE EFFECTS OF ANTHRAX VACCINE WITH 1000mg ACETAMINOPHEN.  BODY ACHES AND FEVER SUBSIDED, WITH RECURRING ONSET AT 1400 THAT AFTERNOON.  RE-ADMINISTERED ACETAMINOPHEN 800 MG AT 1600. NAUSEA SUBSIDED AROUND THE SAME TIME. THROUGH THE EVENING CONTINUED TO JUST HAVE BODY ACHES AND LOW FEVER AROUND 100 DEGREE (F).  NEXT MORNING WOKE FEELING SIGNIFICANTLY BETTER, WITH SYMPTOMS IMPROVING AND SUBSIDING COMPLETELY BY THAT EVENING.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: WOKE UP WITH SEVERE BODY ACHES, WITHIN AN HOUR DEVELOPED CHILLS, ROUGHLY 0500 IN THE AM BECAME NAUSEATED VOMITING ONCE. TOOK TEMP AT 0600 WITH MILD FEVER 100 DEGREE (F). WENT TO DOCTOR 0800 OF SAME DAY TREATED FOR WHAT WAS ASSUMED TO BE SIDE EFFECTS OF ANTHRAX VACCINE WITH 1000mg ACETAMINOPHEN.  BODY ACHES AND FEVER SUBSIDED, WITH RECURRING ONSET AT 1400 THAT AFTERNOON.  RE-ADMINISTERED ACETAMINOPHEN 800 MG AT 1600. NAUSEA SUBSIDED AROUND THE SAME TIME. THROUGH THE EVENING CONTINUED TO JUST HAVE BODY ACHES AND LOW FEVER AROUND 100 DEGREE (F).  NEXT MORNING WOKE FEELING SIGNIFICANTLY BETTER, WITH SYMPTOMS IMPROVING AND SUBSIDING COMPLETELY BY THAT EVENING.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Muscle rigidity, Staring, Unresponsive to stimuli
Clinical narrative: Patient became rigid, wide-open eyes, not responsive to mother's voice. Episode lasted approximately 7 seconds.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain
Clinical narrative: Pt has erythema, soreness.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain, Paralysis
Clinical narrative: Severe shoulder pain, transient paralysis of same shoulder of injection site. Chronic pain (mild since injection).
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Muscle spasms
Clinical narrative: 2 weeks after receiving TYPHIM injection her left arm developed muscle spasms that continue - PCP evaluated as anxiety?
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Left thigh red, warm to touch. Hardened itchy now, was painful. Physician diagnosed as abscess, prescribed antibiotics. Spoke with guardian 09-02-2014 site now clear.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Left thigh red, warm to touch. Hardened itchy now, was painful. Physician diagnosed as abscess, prescribed antibiotics. Spoke with guardian 09-02-2014 site now clear.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site oedema, Injection site papule, Injection site swelling
Clinical narrative: Edema, swelling, hard papules at injection site of (R) upper arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Lymphadenopathy
Clinical narrative: Pt developed itching and induration (R) upper thigh and redness extending to ant abd. - by 2nd day seen urgent care given antibiotic - seen in office 3-4th day reaction persist only locally. Also lymphadenopathy (R) groin.
Age: 44.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Hypersensitivity, Lip swelling, Oedema mouth
Clinical narrative: Lip and palate swelling given IV Prednisone. Prednisone 60 mg x 5 days finished course (per HC allergy site).
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Rash macular, Urticaria
Clinical narrative: Erythemic blotchy hives first noted on arms then legs - daily - 2 days after receiving TDAP and MENACTRA. Responds to ZYRTEC - must take daily or hives will reoccur. This reaction has persisted - last seen in office 8/11/14.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Briefly fainted after Tdap and MCV4 vaccine. Laid down and rested - Drank juice and water.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 10 patients of unknown demographics. On unknown dates patients were administered (Oka/Merck) VARIVAX (dose, lot., route of administration unknown). The medical assistant that these patients were administered (Oka/Merck) VARIVAX that was improperly stored. No adverse effects reported. Product quality complaint was not involved. Outcome of events was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Pt woke up on Saturday 8/30/14 feeling a sore arm. Noticed it was hot to touch, and felt chilled/malaise all day. Better with Ibuprofen. Arm sore, red, hot at injection site all wknd. Better today.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Pt woke up on Saturday 8/30/14 feeling a sore arm. Noticed it was hot to touch, and felt chilled/malaise all day. Better with Ibuprofen. Arm sore, red, hot at injection site all wknd. Better today.
Age: 73.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asthenia, Balance disorder, Fall, Malaise, Weight bearing difficulty
Clinical narrative: By night patient was not feeling well. By next evening around 7/8 pm fell down. Felt down 3 more nights. Felt unsteady, had to look ahead when walking otherwise would fall down. Took liquid ibuprofen to alleviate symptoms. Second fall occurred on 7/12. Third fall occurred on 7/13. Fourth fall occurred on 7/17 when walking 1/2 mile to store fell down and had to call a taxi to go back home. Very unusual since walks in general 2-3 miles a day and does 80 push ups/day. During this time legs couldn't really hold up weight. Had to lean against wall in shower not to fall down. Today is 100% back. Had similar episode in Fall 2003 after caught a virus, was weak for 3-5 days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (route, dose, and lot # were not reported) that was improperly stored. No adverse symptoms reported. The outcome of patients received improperly stored GARDASIL was unknown.This is one of several reports from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Pruritus, Rash
Clinical narrative: Itching and rash.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Pt was given Pneumovax in the left arm afterwards some swelling some arm pain.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Off label use
Clinical narrative: Gave adult dose for pediatric patient.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: Rash around injection site and anterior thigh.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: No adverse event, Unevaluable event
Clinical narrative: No known adverse effect of the vaccine given to the pt.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Paraesthesia, Vision blurred
Clinical narrative: Dizziness, tingling in feet, fuzzy vision.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Activities of daily living impaired, Anaemia, Arthralgia, Blood test abnormal, Fatigue
Clinical narrative: Severe joint pain with extreme fatigue.   Pain all over my body.  Blurred vision, back of head hurt constant aching.   I walked a lot for exercise I no longer could continue walking 2 to 3 miles a day.  Made appoint with GP doctor.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Fibromyalgia, Headache, Pain, Sleep disorder
Clinical narrative: Severe joint pain with extreme fatigue.   Pain all over my body.  Blurred vision, back of head hurt constant aching.   I walked a lot for exercise I no longer could continue walking 2 to 3 miles a day.  Made appoint with GP doctor.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Vision blurred
Clinical narrative: Severe joint pain with extreme fatigue.   Pain all over my body.  Blurred vision, back of head hurt constant aching.   I walked a lot for exercise I no longer could continue walking 2 to 3 miles a day.  Made appoint with GP doctor.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling around site of vaccine. No treatment. Patient got better the next day.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count increased, Cryptococcus test
Clinical narrative: Approximately 1 1/2 hours after receiving HPV vaccine developed headache. Next morning had fever, continued headache and neck pain. On 8/22 began vomiting, double vision. Has also been camping prior with bug bites.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Diplopia, Fungal test negative, Headache, Herpes simplex serology negative, Neck pain
Clinical narrative: Approximately 1 1/2 hours after receiving HPV vaccine developed headache. Next morning had fever, continued headache and neck pain. On 8/22 began vomiting, double vision. Has also been camping prior with bug bites.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Approximately 1 1/2 hours after receiving HPV vaccine developed headache. Next morning had fever, continued headache and neck pain. On 8/22 began vomiting, double vision. Has also been camping prior with bug bites.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Injection site pain, Vomiting
Clinical narrative: Patient reported that the day after receiving her vaccination, she experienced diarrhea/vomiting, headache, and sore arm where vaccinated.
Sex: M
Vaccine: HPV4
Symptoms: Eye pruritus, Ocular hyperaemia, Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Face swollen, face pruritic gone - maculo papular rash. Itchy pink eyes. BENADRYL given by uncle. Gave prednisone 40 mg, ATARAX symptoms (Epipen for emergency only). We saw after.
Sex: M
Vaccine: HPV4
Symptoms: Swelling face
Clinical narrative: Face swollen, face pruritic gone - maculo papular rash. Itchy pink eyes. BENADRYL given by uncle. Gave prednisone 40 mg, ATARAX symptoms (Epipen for emergency only). We saw after.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: 8/27/14 Mom noticed: Redness noticed on left deltoid.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Injected limb mobility decreased, Injection site dryness, Injection site reaction, Milia
Clinical narrative: 8/29/14 two hours after vaccination, site had a white circular area about the size of a quarter around it. 8/30/14 fever was 102 degrees. Arm had 2 raised, white heads, dry, near injection site. Severe bone pain. Couldn't raise arm. 8/31/14 fever subsided. 9/2/14 pain decreased can now raise arm better.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 8/29/14 two hours after vaccination, site had a white circular area about the size of a quarter around it. 8/30/14 fever was 102 degrees. Arm had 2 raised, white heads, dry, near injection site. Severe bone pain. Couldn't raise arm. 8/31/14 fever subsided. 9/2/14 pain decreased can now raise arm better.
Age: 54.0
Sex: F
Vaccine: HEP, TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles one day after the vaccine was adminstered.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. On 01-JUL-2014, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX vial 1350U  (dose, route, lot number and expiration date not reported). On 22-JUL-2014, three weeks after the first dose, the patient received the second dose of (Oka/Merck) VARIVAX vial 1350 U (dose, route, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23, 0.5 ml intramuscular, Lot # J009827, expiration date on 10-AUG-2014. No adverse effects were reported. Additional information has been requested.