chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Throat tightness, Vomiting
Clinical narrative: At approx. 1540 CMS gave patient her third Hep. B vaccine. Following the vaccine the CMS waited the 15 minutes to watch for possible reaction to the vaccine. Patient did not display any signs at that time. Approx. 1610 she approached the same CMS saying she was going home and that she did not feel great. She told him that she was light headed, warm and had shortness of breath. Another CMS tried to call the nurse number. We were on hold for about 20 minutes and a message came on to put in the number to have the nurse return the phone call but no return call was returned. Employee was advised to lie down for a few minutes and was given a granola bar and Capri sun. The symptoms persisted for about 15 minutes when patient started feeling much better and was back to normal. She had called her husband to come pick her up "just in case" and went home feeling well. No medical treatment was needed as the symptoms had subsided. Patient was advised prior to leaving if the symptoms come back or get worse to come call the center. Patient later that evening felt sick and vomited. She went to the emergency room. They said they were not sure if it was a reaction to the shot. She received saline and during that time started to get a tight feeling in her chest and felt her airway closing. They gave her two doses of epinephrine 15 minutes apart. After that she felt fine and the observed her for a couple hours. Today patient is feeling better.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient states symptoms appeared immediately after injection but postponed care.  States that the injection "hurt" and he has been unable to move his left arm above his head.  Report requested by provider.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Sore muscle, having pain upon resting on shoulder and moving arm. Injection placed in upper deltoid.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness/pain/swelling around injection site.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Rash approx. 4"x 2" oval shape, raised, warm, itchy.  Mother gave child hydrocortisone cream and antihistamine.  Itching stopped, rash cooled down, still quite large, raised and red.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm became swollen and red. Patient went to primary physician and was given antibiotics.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Fever to 102.1. Tempra administered. Fever resolved. Then on 7/17/15 develop rash that started on face & spread to trunk.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site urticaria
Clinical narrative: 3 hours inconsolable crying. Large "golf ball size" welts on the thighs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received Tdap and MCV in left thigh on 8/11/15.  The next day he awoke with left thigh pain.  Later in the day he developed increased redness around the area where the vaccine was given as well as increased pain.  Presented to clinic 08/12/2015 and noted to have pain with bearing weight on left leg, also with approximately 10 x 10 cm area of erythema and warmth surrounding area of vaccine administration of left thigh.  Vaccines appear to have been administered slightly medially of thigh muscles.  He had a previous similar reaction with IPV.  He was treated with Tylenol, hot/warm compresses, and rest.
Age: 21.0
Sex: F
Vaccine: MEN
Symptoms: Local swelling, Neck pain, Urticaria
Clinical narrative: Hives on my leg, my neck is swollen and sore.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Large swollen red mark around injection site. Very warm to touch. Very itchy.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Right atrial dilatation, Stillbirth
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included venlafaxine, prenatal vitamins, Krill oil, diphenhydramine, cinnamon capsules, ondansetron, docusate, TUMS, paracetamol, iron, fibre laxative/supplement and trazodone. The 35-year-old mother had a medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The mother also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014), 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). The mother had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. (Refer to the mother case: 2015052801). On 01-Oct-2014, the patient received AFLURIA injection (batch number T56905) at 1 shot a day, in utero via the mother. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day, in utero via the mother. On 29-Oct-2014, the patient's mother underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient's mother developed a respiratory infection. The patient was born/stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams), and was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending. The outcome was not reported. Reporter comments: The reporter assessed the event as serious (congenital anomaly).
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Exposure during pregnancy, Glucose tolerance test normal, Respiratory tract infection, Stillbirth
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included venlafaxine, prenatal vitamins, Krill oil, diphenhydramine, cinnamon capsules, ondansetron, docusate, TUMS, paracetamol, iron, fibre laxative/supplement and trazodone. The 35-year-old mother had a medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The mother also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014), 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). The mother had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. (Refer to the mother case: 2015052801). On 01-Oct-2014, the patient received AFLURIA injection (batch number T56905) at 1 shot a day, in utero via the mother. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day, in utero via the mother. On 29-Oct-2014, the patient's mother underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient's mother developed a respiratory infection. The patient was born/stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams), and was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending. The outcome was not reported. Reporter comments: The reporter assessed the event as serious (congenital anomaly).
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Congenital anomaly, Foetal death, Foetal exposure during pregnancy, Right atrial dilatation
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included venlafaxine, prenatal vitamins, Krill oil, diphenhydramine, cinnamon capsules, ondansetron, docusate, TUMS, paracetamol, iron, fibre laxative/supplement and trazodone. The 35-year-old mother had a medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The mother also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014), 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). The mother had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. (Refer to the mother case: 2015052801). On 01-Oct-2014, the patient received AFLURIA injection (batch number T56905) at 1 shot a day, in utero via the mother. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day, in utero via the mother. On 29-Oct-2014, the patient's mother underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient's mother developed a respiratory infection. The patient was born/stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams), and was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending. The outcome was not reported. Reporter comments: The reporter assessed the event as serious (congenital anomaly).
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Right atrial dilatation, Stillbirth
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a 35-year-old pregnant female patient. She had medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The patient also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014, 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). She had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. Her concomitant medications included venlafaxine for depression, prenatal vitamins, vitamin D, Krill oil, diphenhydramine to sleep, cinnamon capsules, ondansetron, docusate, TUMS for indigestion, paracetamol for headache, iron for low iron, fibre laxative/supplement, and trazodone for insomnia. Her DOC (date of conception) was 07-Apr-2014. The EDC (estimated date of confinement) was 29-Dec-2014. She had the first trimester serum screen on 28-Jun-2014 (normal result) and ultrasound on 22-May-2014 (normal result) and 04-Aug-2014 (normal result). On 01-Oct-2014, the patient received AFLURIA vaccine injection (batch number T56905) at 1 shot a day. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day. On 29-Oct-2014, the patient underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient developed a respiratory infection. On 09-Dec-2014, she had a stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams). The baby was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending (refer to case: 2015052802). The outcome was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Exposure during pregnancy, Glucose tolerance test normal, Respiratory tract infection, Stillbirth
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a 35-year-old pregnant female patient. She had medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The patient also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014, 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). She had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. Her concomitant medications included venlafaxine for depression, prenatal vitamins, vitamin D, Krill oil, diphenhydramine to sleep, cinnamon capsules, ondansetron, docusate, TUMS for indigestion, paracetamol for headache, iron for low iron, fibre laxative/supplement, and trazodone for insomnia. Her DOC (date of conception) was 07-Apr-2014. The EDC (estimated date of confinement) was 29-Dec-2014. She had the first trimester serum screen on 28-Jun-2014 (normal result) and ultrasound on 22-May-2014 (normal result) and 04-Aug-2014 (normal result). On 01-Oct-2014, the patient received AFLURIA vaccine injection (batch number T56905) at 1 shot a day. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day. On 29-Oct-2014, the patient underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient developed a respiratory infection. On 09-Dec-2014, she had a stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams). The baby was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending (refer to case: 2015052802). The outcome was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Congenital anomaly, Foetal death, Foetal exposure during pregnancy, Right atrial dilatation
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a 35-year-old pregnant female patient. She had medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The patient also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014, 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). She had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. Her concomitant medications included venlafaxine for depression, prenatal vitamins, vitamin D, Krill oil, diphenhydramine to sleep, cinnamon capsules, ondansetron, docusate, TUMS for indigestion, paracetamol for headache, iron for low iron, fibre laxative/supplement, and trazodone for insomnia. Her DOC (date of conception) was 07-Apr-2014. The EDC (estimated date of confinement) was 29-Dec-2014. She had the first trimester serum screen on 28-Jun-2014 (normal result) and ultrasound on 22-May-2014 (normal result) and 04-Aug-2014 (normal result). On 01-Oct-2014, the patient received AFLURIA vaccine injection (batch number T56905) at 1 shot a day. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day. On 29-Oct-2014, the patient underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient developed a respiratory infection. On 09-Dec-2014, she had a stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams). The baby was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending (refer to case: 2015052802). The outcome was not reported.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal pain, Blood test, Colonoscopy abnormal, Laboratory test normal, Pruritus
Clinical narrative: This spontaneous report was received from a 64 year old patient referring to herself. The patient's concurrent conditions and medical history were not reported. On 27-OCT-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration and lot number not reported). On the same date, the patient also received unspecified Flu shot. Concomitant medications were not reported. On an unknown date in early November 2014, the patient experienced itching and scratching and went to the physician. The patient reported that on an unknown date in November 2014, before Thanksgiving, she experienced horrible abdominal pain and was admitted into the hospital for a week. Several tests were run and all tests results were negative. The patient continued to have same abdominal symptoms after Christmas and was readmitted into the hospital for another week. On an unknown date, additional tests were run and all tests results were negative. The patient was still having abdominal pain and was again readmitted to the hospital on an unknown date in mid-January 2015 for a week. The patient was given two colonoscopies and the tests found several ulcers. On unspecified date blood test was done, results was not reported. All medication prescribed during the patient's hospitalization are unspecified. At the present time, the ulcers were gone. Patient also had unspecified skin problems due to which she couldn't wear clothes and nothing could touch her skin. The patient had to buy extra-large clothes. The patient's present status was reported as recovering. The causality assessment was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Scratch, Skin disorder, Skin sensitisation, Ulcer
Clinical narrative: This spontaneous report was received from a 64 year old patient referring to herself. The patient's concurrent conditions and medical history were not reported. On 27-OCT-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration and lot number not reported). On the same date, the patient also received unspecified Flu shot. Concomitant medications were not reported. On an unknown date in early November 2014, the patient experienced itching and scratching and went to the physician. The patient reported that on an unknown date in November 2014, before Thanksgiving, she experienced horrible abdominal pain and was admitted into the hospital for a week. Several tests were run and all tests results were negative. The patient continued to have same abdominal symptoms after Christmas and was readmitted into the hospital for another week. On an unknown date, additional tests were run and all tests results were negative. The patient was still having abdominal pain and was again readmitted to the hospital on an unknown date in mid-January 2015 for a week. The patient was given two colonoscopies and the tests found several ulcers. On unspecified date blood test was done, results was not reported. All medication prescribed during the patient's hospitalization are unspecified. At the present time, the ulcers were gone. Patient also had unspecified skin problems due to which she couldn't wear clothes and nothing could touch her skin. The patient had to buy extra-large clothes. The patient's present status was reported as recovering. The causality assessment was not provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Mobility decreased, Pyrexia
Clinical narrative: This spontaneous report was received from a physician concerning a 22 year old female not pregnant patient with none pertinent medical history, concurrent conditions, drug reactions or allergies. On 03-AUG-2015, the patient was vaccinated with the first dose of GARDASIL or GARDASIL 9, intramuscular in her left deltoid area, (dose, lot number and expiration date were not reported). There was no concomitant medication reported. The reporter physician was uncertain whether the patient received a dose of GARDASIL or GARDASIL 9. On the same date in the evening, the patient developed a "low-grade" fever and fatigue. Furthermore on 08-AUG-2015, the patient developed a "pronounced" lymphadenopathy in her "axillary area, supraclavicular and infraclavicular areas and posterial cervical area"; it was unspecified on which side of the patient's body the lymphadenopathy developed. The patient sought medical attention by visited the physician and no treatment was given. No hospitalization or life threatening were reported. The physician further described the patient's lymphadenopathy as being painful and limiting her neck movement and stated he therefore considered the lymphadenopathy to be significant disability to the patient. At the time of the report, the outcome of the fever, fatigue, lymphadenopathy in her axillary area, supraclavicular and infraclavicular areas and posterial cervical area was reported as not recovered. The reporter considered the lymphadenopathy to be significant disability due to painful and limiting the patient's movement. The relatedness between the events and therapy with GARDASIL or GARDASIL 9 was not reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: (L) upper arm pain every morning since had PREVNAR 13 vaccine requiring Ibuprofen.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Vaccination complication, Vomiting
Clinical narrative: Patient was given her 6 month set of vaccines during her office visit on 8/11/15. Patient's mother called later that afternoon worried that patient was vomiting and lethargic. Patient was taken to her local ER and was told this was a reaction to the Rotavirus vaccine. She was given ZOFRAN and fluids. Today patient has returned to normal according to her mother.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Differential white blood cell count, Dyskinesia, Fall, Loss of consciousness, Metabolic function test
Clinical narrative: Passed out, was sitting in chair and fell in grandfathers lap. Nurse practitioner was called into room to assess patient noted was pale, not talking, was about to have BP checked, started jerking lasting 10-15 seconds fell into grandfathers lap again.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Speech disorder
Clinical narrative: Passed out, was sitting in chair and fell in grandfathers lap. Nurse practitioner was called into room to assess patient noted was pale, not talking, was about to have BP checked, started jerking lasting 10-15 seconds fell into grandfathers lap again.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right thigh area red, warm to touch, area measures 10 cm by 12 cm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: MENACTRA administered 8/10/15 in (L) deltoid started with numbness/weakness in (L) arm 8/12/15. Treatment: Ibuprofen and referral to pediatric neurology for follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Pharyngitis, Pyrexia
Clinical narrative: 7-28-15 started fever 6:00-6:30 pm  after receiving MENACTRA that morning 100? still running fever 100.4 and sore throat next AM. 7/29/15 Rx with ZITHROMAX for pharyngitis.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: No fever pt received KINRIX vaccine on 8-5-15. Family reports area was slightly pink on 8-6-15. Early afternoon of 8/7/15 (R) thigh became red and was warm to the touch. Area of induration measured 7-8 inches by 4 inches. Treated with cephalexin 125mg/5mL taking 10mL by mouth twice a day for 7 days.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Broke out with rash a little next day - then faded in a few days then full rash back on Monday Aug 3 arm warm and a little swollen went back to doctor on Aug 4th-put me on antibiotic-cephalexin. Today Aug 12th-rash very faded.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash 1.5 cm x 2.5 cm on (R) ant thigh developed 10 days after.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Palpitations, Paraesthesia
Clinical narrative: Patient had a racing heart, dizzy, nausea, tingling in arm, she almost passed out.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site swelling, Injection site warmth, Lethargy, Pain
Clinical narrative: By swellng at injection site, warm to the touch, dizzy, pain, lethargic all day.
Age: 56.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Large red area, with itchiness. Started with red spot then swelling to a large area. Has pain at the side.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: In first 24 hrs-mild redness, itching over course of 2 days redness increase with 6" by 5"-no fever no streaking redness, hot to touch pt will take BENADRYL and Ibuprofen and will ice arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap given 08/10/15 by MA at 1126. Pt's father called today (08/12/15 at 1145) complaining of red, swollen, hot upper arm at injection of Tdap side (Right). Triage nurse, RN, scheduled pt to see PA-C today at 1415 with instructions to go to ER if worsens before appt. Per PA-C, (+) allergic hypersensitivity reaction to Tdap.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Pain
Clinical narrative: Patient complains of body aches, joints, neck px. since 20:00 on 11th Aug 2015.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: The evening of the shot and through the night the patient experienced pain and itching in the upper third of her arm. Red dots developed. MD ordered antibiotic SMZ/TMP DS 1 BID x 10 days.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age. There was no information about the patient's medical history and concurrent condition. The patient was vaccinated with the first dose of GARDASIL (lot# J012438, expiration date: 05-OCT-2015, dose and route unknown) on 05-AUG-2014 and the second dose of GARDASIL (Lot# L009963, expired date unknown, confirmed not GARDASIL 9, dose and route unknown) on 05-AUG-2015 (inappropriate schedule of drug administration). At the time of reporting, no adverse effects was reported. Additional information is not expected as there is no consent for follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Peripheral swelling, Rash generalised
Clinical narrative: This spontaneous report was received from a male patient of unknown age referring to himself. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, strength and route of administration were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced peripheral swelling, blister and rash generalised. It was reported that on an unspecified date, the patient sought medical attention. At the reporting time, the outcome of peripheral swelling, rash generalised and blister was unknown. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a male patient of unknown age. Medical history and concurrent conditions were not reported. On 07-JUL-2015, the patient received improperly stored PROQUAD (Merck) (lot number was reported as L009208, expiry date: 17-SEP-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 03-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 May 2013. It was reported that a dose that had expired on 2 May 2013 was given on 15 May 2013. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# K025765, expiry date: 08-JUN-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. The nurse reported that on unknown dates improperly stored (temperature excursion) ZOSTAVAX (lot # K021953, expiration 10-FEB-2016) (dosage, strength, and route were not reported) had been adminsitered to unspecified patients. Number of doses administered was unspecified. At the time of the report, no adverse effects reported. This is one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# K025766, expiry date: 08-JUN-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a female patient of unknown age. Medical history and concurrent conditions were not reported. On 02-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# K025766, expiry date: 08-JUN-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a male patient of unknown age. Medical history and concurrent conditions were not reported. On 02-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# K025766, expiry date: 08-JUN-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via Poison and Drug Center (PDC) refers to a patient of unknown gender between the age of 2 years and 5 years old child. The patient's relevant medical history, past drug history and concomitant medications were unknown. On 26-MAY-2015, the single dose vial of PROQUAD (Merck) underwent temperature excursions 5.3 degrees Celsius for 2 hours and 8 minutes. On 02-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K014798 and expiration date 12-MAR-2016) via injection (dose, frequency and indication were unknown). The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continues on PROQUAD (Merck). This is one of the eight reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 8 May 2013. It was reported that a patient might have received 2 dose of MENACTRA vaccine on 7 May 2013. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site joint pain, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 03 June 2013. A 58-year-old female patient had received an intramuscular second dose of MENACTRA vaccine (lot number- U4588AD) in right deltoid on 29 May 2013 at 11.00 AM. On 29 May 2013 at 01.00 PM, the patient had developed pain and edema to right deltoid and presented fever the following day. The patient also had right shoulder joint pain now. The patient had no concomitant medications, illness and no known allergy at the time of vaccination, and the patient's past medical history includes asthma. The patient had not experienced any adverse event following prior vaccination. The corrective treatments were not reported and no laboratory investigations were done. The patient's outcome was not recovered. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a consumer on 28 August 2013. A 22-year-old female patient had received an intramuscular dose 1 of MENACTRA vaccine (lot number- U4585AB, expiry date- 10/26/2014, anatomical site of administration was not reported) on 27 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was not reported and the estimated date of delivery was 17 January 2014. The patient had no risk factors (e.g.: alcohol, tobacco or recreational drugs). Patient's medical history, concomitant medications and treatment for infertility were not reported. Complementary tests were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 64 year old female patient. Medical history and concurrent condition were not reported. On 29-JUL-2015, the patient was vaccinated with ZOSTAVAX (lot # K009199; expiration date 27-SEP-2015), dose and route of administration were not reported, to prevent shingles. Concomitant medication was not reported. On 03-AUG-2015, the patient experienced "a mild case of shingles" after receiving ZOSTAVAX, the patient mentioned to the reporter that the shingles were itchy and painful. The reporter stated, the patient was prescribed with an unspecified antiviral medication from an unspecified physician, but the patient declined taking this medication at this time. The outcome of shingles was reported as not recovered/not resolved. The relatedness of the shingles of the ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot number L009203, expiry date 17-MAR-2017 (dose and route were not reported). There was no concomitant medication provided. No adverse experiences were reported. This is one of several reports received from the same reporter. Lot number L009203 is a valid lot number for (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient received the first dose in the HPV series with GARDASIL (dose, frequency were not reported). Then on an unspecified date, the patient received the second dose in the HPV series with GARDASIL 9 (dose, frequency were not reported) at another pharmacy. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2015 (also reported as "on unspecified dates since 27-JUL-2015") the patients were vaccinated with unspecified number of improperly stored doses of VARIVAX (Merck) injection, lot # L006386; expiry: 25-FEB-2017 (dose, route and frequency). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR, MNQ
Symptoms: Incorrect route of drug administration, No adverse event, Product preparation error
Clinical narrative: Initial misuse report received from a healthcare professional on 13 September 2013. MENACTRA vaccine was inadvertently used to reconstitute MMR powder component and was given SC to a patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 62 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2014 (reported as about 1 year ago) the patient was vaccinated with ZOSTAVAX (Lot# not reported). On an unknown date, the patient experienced outbreak of shingles in the abdominal region, while on therapy with ZOSTAVAX. The patient did not take any treatment medication for the event. The patient went to the physician on an unspecified date for medical attention. The outcome of herpes zoster was reported as recovering. The reproter did not provide the relatedness of event with ZOSTAVAX. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 01-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot # L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of improperly stored M-M-R II lot number K024038, expiry date 26-NOV-2016 (dose and route were not reported). There was no concomitant medication provided. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient. On 02-JUN-2015, the patient was vaccinated with the first dose of GARDASIL and on 03-AUG-2015, the patient received second dose of GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Nausea, Oedema peripheral, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 10 December 2013. A 5-year-old female who had history of sickle cell disease and concomitant medication were not reported, had received a dose of PPSV23 (manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported) and also received a dose of Meningococcal vaccine (Manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported) both vaccines on an unspecified date. On an unspecified date, 2.5 year before the patient had received a dose of PPSV23 (manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported). On an unspecified date after vaccination the patient experienced severe arm swelling with edema. The patient had received analgesics, antiemetics, and antibiotic as corrective treatments. On an unspecified date 24 hours later, the patient had recovered from event. Follow-up information received on 18 December 2013. The patient's immunization history included one dose of PPSV23 two and a half years earlier and a dose of the meningococcal conjugate vaccine 6 months prior to the event. She also had received four doses of 7-valent conjugated pneumococcal vaccine, one dose of the 13-valent conjugated pneumococcal vaccine, the hepatitis B vaccine series, and annual influenza vaccinations. Her mother had previously reported that she usually developed a low grade fever after receiving vaccinations, which she would treat at home with ibuprofen. The patient's past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, and asthma. She also had a history of urticarial response to fire ant bites and skin test confirmed allergies to dust, mold, mildew and cockroaches. The patient was treated with Ibuprofen for fever, ondansetron for nausea and ketorolac for pain. She was also treated with intravenous one dose of Ceftriaxone, but blood culture was subsequently negative. Patient was discharged from the clinic with ibuprofen and morphine for breakthrough pain. The swelling in the right arm resolved at home within 24 h.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 July 2013. It was reported that, it was not noted that the patient had received a dose of MENACTRA last year and hence was given another dose. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30 May 2013. Some vaccine squirted on a female patient's face and might be in her mouth while was taking the cap off. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot # L004740, expiry date 16-NOV-2017 (dose and route were not reported). There was no concomitant medication provided. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MNQ
Symptoms: Confusional state, Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 23 July 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of MENACTRA vaccine (lot number: U4611AA, dose in series, route and site of administration were not reported) on an unspecified date. On an unspecified date, post vaccination the patient experienced fever and sore neck. The patient had no "ED", vomiting, nausea or confusion. Laboratory investigations and corrective medication were not reported. At the time of this report, the outcome of events was not reported. Documents held by sender: None.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot number K011947 expiry date 07-JUN-2016 (dose was not reported). There was no concomitant medication provided. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.