chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Increased upper airway secretion, Ocular hyperaemia, Oculorespiratory syndrome
Clinical narrative: This spontaneous consumer report (initial receipt 23-Oct-2013), concerns a 43-year-old female patient. The patient had medical history of allergies, asthma and drug reactions/allergies to sulfas. The patient also took unspecified concomitant medications. On 19-Oct-2013, the patient received AFLURIA (Batch: R56108). On the same day, the patient experienced that the whites of her eyes were bright red, she was spitting out green 'junk' and her asthma had worsened. The patient stated that she had looked into this and found out that she had developed oculorespiratory syndrome. The patient was self-medicated with erythromycin. Within 6 hours, the respiratory symptoms had recovered. It was reported that it took two days for her eyes to return to normal. Outcome was reported as recovered.
Age: 8.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Henoch-Schonlein purpura.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/itching post-dose. Patient received Influenza Quadrivalent (P-free) vaccine 0.5 mL IM in left arm. Patient stated that he took 25-50 mg of BENADRYL daily for 3 days in order for the hives to disappear. He reported his reaction to the nurse at his next clinic visit on 10-3-13.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from Nursing Services refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored vaccine of M-M-R II (lot # H020255, expired date 08-NOV-2014). The original reporter is unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives. Stayed in office x 1 hr to watch pt. Sent home told to take BENADRYL. Referred to allergist. F/U after 24 hrs no rash/hives.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Decreased Range of motion and pain.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from Nursing Services refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored vaccine of M-M-R II (lot # J002502, expired date 28-FEB-2015). The original reporter is unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a Registered Pharmacist who placed patient on the phone to provided adverse event information refers to a 57 year old female consumer reporting on herself with no pertinent medical history or drug allergies/reactions. On 18-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J006155, exp. date: 30-AUG-2014) 0.65 ml, subcutaneous in the left arm. There were no concomitant medications. On 20-OCT-2013, the patient experienced a big red spot at the left upper arm injection site, described as raised, tender to the touch and four inches in length, "about the size of a silver dollar". The patient did not seek medical attention. There was not given any treatment for the events and no laboratory tests were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On an unknown date the patient was accidentally vaccinated with VARIVAX (merck) (dose and lot# not reported) instead of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route unknown) (lot # H014649, expiry date: 03-AUG-2014), which was improperly stored vaccine. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route unknown) (lot # H020255, expiry date: 08-NOV-2014), which was improperly stored vaccine. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route unknown) (lot # H020255, expiry date: 08-NOV-2014), which was improperly stored vaccine. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple patients of unknown age and gender. It was reported that on unknown dates, multiple unspecified patients may have been administered with an improperly stored VAQTA (lot number, expiry date, dose and route unspecified). VAQTA was exposed to 30 degrees Fahrenheit for 11.5 hours which was not supported. The nurse was unsure if this improperly stored vaccine was administered. No concomitant therapy was reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX into the inner aspect of the upper arm, rather than the deltoid region, lot#, dose, frequency and route unspecified. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). On an unknown date, the patient developed shingles rash at the injection site after receiving a dose of ZOSTAVAX. The outcome of shingles rash at the injection site was unknown. 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 nurse refers to an unspecified gender patient of unknown age. On 19-APR-2012, the patient was vaccinated with the first dose of GARDASIL, (lot#, indication and anatomical location not reported), 0.5ml, intramuscular. On 26-JUL-2013, the patient was vaccinated with the second dose of GARDASIL, (lot#, dose, strength, indication and anatomical location not reported). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Sneezing and runny nose.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Incomplete course of vaccination, Meniscus injury, Vomiting
Clinical narrative: This spontaneous report as received from the consumer's mother refers to a 16 year old female patient with medical history of café au lait spots and strabismus. There were no drug reactions or allergies. On 12-JUL-2013, the patient was vaccinated with GARDASIL, first dose, route reported as injections (lot and dose not reported). Concomitant therapies included Tramadol started approximately on 04-OCT-2013 (reported as 2 weeks ago). On 12-JUL-2013, after the patient received GARDASIL she started immediately having adverse experiences, the patient had dizzy spells and throws up every week or two at random. The patient also tore out her meniscus and needed to have surgery in the future. The patient sought for medical attention (called the office). No treatment given for the events. No lab diagnostics performed. The reporter (patient's mother) did not plan on continuing with the treatment since the patient is about 5 weeks late for the second dose. The reporter also did not know how having the late dose two of GARDASIL would react with the patient having surgery. Therapy with GARDASIL was discontinued. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On 28-SEP-2013 (sometime towards the end of September 2013, possibly the 28th of September) the patient was vaccinated with a dose of VARIVAX (merck), (lot#, dose, route, strength and indication not reported). On 13-OCT-2013, the patient discovered that she had conceived. No adverse event (AE) reported. The patient's date of last menstrual period was on 29-SEP-2013, and the estimated delivery date would be on 06-JUL-2014. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Patient has received influenza vaccine in the past without adverse reactions. Reported very itchy rash on arms, legs, between buttocks and groin. Patient works in the healthcare field and regularly receives annual influenza vaccine. Treatment: Prednisone take tablet(s) by mouth daily, Cetirizine 10 mg AM, diphenhydramine 50 mg hs.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient was at clinic for routine visit to review labs and receive vaccinations. Swelling and erythema was still present 2 days after injection but was reduced. Treated with unknown doses of diphenhydramine and acetaminophen. Also given a prescription for KEFLEX 500 TID 7d to start if any worsening, but hold if continues to improve. Antibiotic not filled. It is unknown if it was filled at another pharmacy. Treatment: Diphenhydramine, Acetaminophen.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 2 patients of unknown age and gender. On 22-OCT-2013, the 2 patients were vaccinated accidentally with a dose of VARIVAX (merck) (Lot number, expiry date were not reported), 0.5 ml, subcutaneously instead of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reported refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H020255, expiry date: 08-NOV-2014) which reported as 08-NOV-2011, therapy type, dose, route were unknown), which was improperly stored vaccine. The outcome of the event was unknown. This is one of several reports that received from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
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-OCT-2013 the patient was vaccinated with an expired dose of ROTATEQ (Lot# 0283AE, expiration date 24-OCT-2013), dose, frequency and route unspecified. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. ON an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, (lot number, expiry date and route was not reported). On an unknown date, the patient complained of arm pain at the injection site that lasted more than 6 months. The patient was receiving physical therapy for her arm, but it was unknown whether she started receiving therapy before or after administration of PNEUMOVAX 23. The outcome of the event was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pruritus generalised, Urticaria
Clinical narrative: Patient received influenza vaccination on 10/18. Shortly after the injection, the patient experienced swelling at the injection site, hives, and itching all over. Patient reported to urgent care, who transferred patient to ER. Patient was treated with dexamethasone and diphenhydramine and released.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test, Chills, Hepatitis A virus test, Hepatitis B virus test, Hyperhidrosis
Clinical narrative: Patient started getting flu like symptoms (chills, fever, sweats) 5-7 days. Patient went to PCP and was tested negative for flu. Patient also tested for Lyme, Flu, hep A and B.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Influenza virus test negative, Pyrexia
Clinical narrative: Patient started getting flu like symptoms (chills, fever, sweats) 5-7 days. Patient went to PCP and was tested negative for flu. Patient also tested for Lyme, Flu, hep A and B.
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 22-OCT-2013, the patient was vaccinated with a last dose (third dose) of oral ROTATEQ (Lot number and expiry date were not reported), 2 milliliter (ml), orally at age of 9 months old and no adverse effect was reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Medication error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient with high blood pressure, high cholesterol and sulfa allergy. The patient's medical history included thyroid disorder (reported as thyroid). On 25-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23) (lot # H021941, 11-JUL-2014) and FLUVIRIN intramuscularly in the right arm at different injection sites. Concomitant medications included unspecified medications. On 25-OCT-2013, the patient arm became red and swollen at the injection site (unable to discern if it was the site of the PNEUMOVAX-23 or the FLUVIRIN). Over the weekend approximately on 26-OCT-2013, the patient arm had gotten progressively worse, the redness had spread from the deltoid down past the elbow. No treatment was given. No laboratory tests were performed. Patient sought medical attention. The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Clostridium test negative, Culture stool negative, Haematochezia, Occult blood positive
Clinical narrative: Child has a history of milk protein intolerance/bloody stools - had improved on neutramigen but stools still guaiac (+) - 1 day after 2 month vaccines (rotavirus not given) child developed grossly blood stools which have not resolved - stool cx and c diff sent at that time were negative.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 29-OCT-2013, the patient was vaccinated with an expired dose of 0.2 milliliter (ml) of PNEUMOVAX 23 (lot number and expiry date were reported as 1947AA and 20-OCT-2013 respectively), intramuscularly. On 29-OCT-2013, the patient was also vaccinated with 0.3 ml of PNEUMOVAX 23 (lot number and expiry date were reported as J004332 and 26-SEP-2014 respectively), intramuscularly. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 17-SEP-2013 the patient was vaccinated with a first dose of RECOMBIVAX HB (dose, route and lot # not reported). On 01-NOV-2013 the patient was at the pharmacy to receive the second dose of RECOMBIVAX HB (dose, route and lot # not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, HPV4, MMR, VARCEL
Symptoms: Burning sensation, Erythema, Headache, Injection site oedema, Pain
Clinical narrative: Large swelling, burning, red, itching, aches. Started a few hours after vaccinations, treated w/ ice on Thursday night, and ADVIL daily. Swelling, redness, slight burning still continuing. Still itching. Headache intermittent. (R) arm edema where vaccine placed.
Age: 20.0
Sex: F
Vaccine: HEP, HPV4, MMR, VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Large swelling, burning, red, itching, aches. Started a few hours after vaccinations, treated w/ ice on Thursday night, and ADVIL daily. Swelling, redness, slight burning still continuing. Still itching. Headache intermittent. (R) arm edema where vaccine placed.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of erythema and warmth at injection site.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt is doing well, acting normal, smiling playing and responsive. Parent has not reported any abnormality.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Local swelling, Pain in extremity
Clinical narrative: I have been in a lot of pain. Right arm turned red and swollen. The shot has caused to hurt my right shoulder and right arm.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Face injury, Fall, Lacrimation increased
Clinical narrative: Patient fell and hit chin 30 seconds after receiving vaccine. Patient's mom thought he may have been goofing around but patient says no he had fell. Patient stated he felt fine. Had patient sit for 10 minutes. No flushing, fever or dizziness per patient. Normal appearance. Patient's mom taking him home to give him BENADRYL for watery eyes. Patient's 2 sisters declined flu shots.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: The location of the injection has turned into a knot about an inch in diameter with another half inch around that area being red. The entire site has fever in it. It is still this way 48 hours after the injection. Dr. is prescribing KENALOG.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling abnormal, Local swelling, Nausea, Vomiting
Clinical narrative: 10/16/13 at 3:55PM patient called and talked with a nurse:  Patient had flu and PPSV23 vaccines on 10/14/13, developed swelling in arm Monday evening and increased swelling and redness on Tuesday.  States that today that entire arm is red and it feels like my arm is going to fall off.  Also has nausea and vomiting today.  Recommended to go to the ER/Urgent Care and schedule a follow-up visit (here) for later this week; patient voiced understanding and transferred to scheduler for appointment. At 8:58AM patient returned my call and said he did go to Urgent Care.  Was informed by them that it was just a fluke with the injections to the muscle - might have flinched when got the injection.  He said it resolved in 4-5 days and completely normal in 7-8 days. He said symptoms started that evening (14th) and definitely the next day. Note:  Patient no showed follow-up appointment with us and there is no documentation that he went to the ER/Urgent Care anytime that week.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Headache, Injection site reaction, Malaise, Pyrexia
Clinical narrative: 101.7 fever for two days (in bed-malaise).  Red rash around Pneumococcal vaccine injection site.  Mild headaches for about 10 days.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: 101.7 fever for two days (in bed-malaise).  Red rash around Pneumococcal vaccine injection site.  Mild headaches for about 10 days.
Age: 1.07
Sex: M
Vaccine: DTAP, HEPA, HIBV, MM, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: rash on cheeks fever
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye discharge, Eye pain, Lip swelling, Paraesthesia
Clinical narrative: Lips swollen, full feeling under tongue, eyes red et painful with greenish discharge. Some coughing et facial paresthesias. Symptoms started at 2:30 pm. Took Benadryl 50 at 4 pm and 7:15 pm. Went to hospital.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Purulent discharge, Swollen tongue
Clinical narrative: Lips swollen, full feeling under tongue, eyes red et painful with greenish discharge. Some coughing et facial paresthesias. Symptoms started at 2:30 pm. Took Benadryl 50 at 4 pm and 7:15 pm. Went to hospital.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test abnormal, Colitis ulcerative, Colonoscopy abnormal, Diarrhoea, Fatigue
Clinical narrative: Patient exhibited fatigue, diarrhea, cramps, fever, blood in stool, night sweats. Patient met with Pediatrician on 10/21/2013. Blood and stool samples taken. Pediatrician recommended patient see a Gastroenterologist. Patient met with Gastroenterologist on 10/25/2013. Blood and stool samples taken. Physician felt patient showed signs of Ulceration Colitis. Patient received colonoscopy and upper GI on 10/30/2013. Colonoscopy showed inflammation of the entire colon.  Upper GI was normal.  Patient was diagnosed with ulcerative colitis.  Patient given Prednisone and Balsalazidr disodium.  Symptoms finally started improving on 11/1/2013. As of today, 11/6/2013, patient still has diarrhea.  Symptoms continued for almost a month.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Haematochezia, Muscle spasms, Night sweats, Pyrexia, Stool analysis abnormal
Clinical narrative: Patient exhibited fatigue, diarrhea, cramps, fever, blood in stool, night sweats. Patient met with Pediatrician on 10/21/2013. Blood and stool samples taken. Pediatrician recommended patient see a Gastroenterologist. Patient met with Gastroenterologist on 10/25/2013. Blood and stool samples taken. Physician felt patient showed signs of Ulceration Colitis. Patient received colonoscopy and upper GI on 10/30/2013. Colonoscopy showed inflammation of the entire colon.  Upper GI was normal.  Patient was diagnosed with ulcerative colitis.  Patient given Prednisone and Balsalazidr disodium.  Symptoms finally started improving on 11/1/2013. As of today, 11/6/2013, patient still has diarrhea.  Symptoms continued for almost a month.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: White blood cell count increased, X-ray gastrointestinal tract normal
Clinical narrative: Patient exhibited fatigue, diarrhea, cramps, fever, blood in stool, night sweats. Patient met with Pediatrician on 10/21/2013. Blood and stool samples taken. Pediatrician recommended patient see a Gastroenterologist. Patient met with Gastroenterologist on 10/25/2013. Blood and stool samples taken. Physician felt patient showed signs of Ulceration Colitis. Patient received colonoscopy and upper GI on 10/30/2013. Colonoscopy showed inflammation of the entire colon.  Upper GI was normal.  Patient was diagnosed with ulcerative colitis.  Patient given Prednisone and Balsalazidr disodium.  Symptoms finally started improving on 11/1/2013. As of today, 11/6/2013, patient still has diarrhea.  Symptoms continued for almost a month.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Decreased appetite, Diarrhoea, Weight decreased
Clinical narrative: Patient exhibited fatigue, diarrhea, cramps, fever, blood in stool, night sweats. Patient met with Pediatrician on 10/21/2013. Blood and stool samples taken. Pediatrician recommended patient see a Gastroenterologist. Patient met with Gastroenterologist on 10/25/2013. Blood and stool samples taken. Physician felt patient showed signs of Ulceration Colitis. Patient received colonoscopy and upper GI on 10/30/2013. Colonoscopy showed inflammation of the entire colon.  Upper GI was normal.  Patient was diagnosed with ulcerative colitis.  Patient given Prednisone and Balsalazidr disodium.  Symptoms finally started improving on 11/1/2013. As of today, 11/6/2013, patient still has diarrhea.  Symptoms continued for almost a month.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral, Rash, Rash pruritic
Clinical narrative: Her upper lip felt tingly and swelled a little. Then next day a rash on her chest that itched which lasted several days then the itch stopped but the rash is still there 2 weeks later.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Barium double contrast, Diarrhoea, Irritability, Ultrasound scan, Vomiting
Clinical narrative: Began with fussiness, inconsolable, vomiting at 7pm q 20 mins; called our night answering service at 2:28am; bright red watery stools as well; seen at ER ~ 3am.
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain lower, Blood test abnormal, Coeliac disease, Cow's milk intolerance
Clinical narrative: Lower Abdominal Pain (stabbing pain that radiates)Happened sporadically for a month. Client took herself off gluten products and pain went away. Pain returned one month later. Client stopped dairy products and pain went away. Client has seen Gastroenterologist who wanted to test for celiac disease. Client also seen by Ob Gyn and Nutritionist.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Nausea, Pallor
Clinical narrative: Patient c/o abdominal pain, nausea and being pale 2 hours after influenza vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immobile, Myalgia, Paraesthesia
Clinical narrative: Patient states she is experiencing numbness, tingling, achy muscles, immobility.
Age: 32.0
Sex: F
Vaccine: FLU4, HIBV, MNQ, PPV
Symptoms: Asthenia, Erythema, Injection site erythema, Injection site pain, Nausea
Clinical narrative: C/O NAUSEA, VOMITING X 1, LEFT ARM SORENESS, REDNESS AND PAIN IN ENTIRE EXTREMITY, WEAKNESS.
Age: 32.0
Sex: F
Vaccine: FLU4, HIBV, MNQ, PPV
Symptoms: Pain in extremity, Vomiting
Clinical narrative: C/O NAUSEA, VOMITING X 1, LEFT ARM SORENESS, REDNESS AND PAIN IN ENTIRE EXTREMITY, WEAKNESS.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder pain on raising arm overhead. Continues and getting worse on day 12 after vaccine. Is now hurting on minor movements. On day 13 have taken 1 aspirin and 1 Neurontin.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Erythema, Nausea, Pain in extremity, Swelling
Clinical narrative: HUGE welt on my arm, the size of the opening of a solo cup.  Very red and puffy. VERY sore. Nauseous and dizzy.  Marked it on 11/5 and it has gotten bigger since.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: HUGE welt on my arm, the size of the opening of a solo cup.  Very red and puffy. VERY sore. Nauseous and dizzy.  Marked it on 11/5 and it has gotten bigger since.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis, Ultrasound scan, X-ray
Clinical narrative: Frozen shoulder. Chiropractor, therapeutic ultrasound, ice and heat.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Hyperaesthesia
Clinical narrative: Reported sensitivity right chest and flank on 10/23/2013.  Subsequently diagnosed with shingles and treated with anti-viral medication.
Age: 13.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Local swelling, Oedema peripheral, Pain in extremity, Skin hypertrophy, Ultrasound scan abnormal
Clinical narrative: Swelling to both arms - becoming painful by next day.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: High Fever 103-104F, Motrin prn.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: 1:00 AM: Severe chills, weakness of body. Two hours later, 3:00 AM, 102 grade fever.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Ear swelling, Lip swelling, Nausea, Pharyngeal oedema
Clinical narrative: Hives began on my neck & traveled down trunk (front & back), inside ears, face, hands, itchy throat, ears, lips swollen, throat felt 'thick' nauseated, tongue felt thick, difficult to breath. ER started IV, gave me IV Benadryl, Pepcid, prednisone, Ativan. BP was 98/110, pulse 110..Sent me home with 5 days prednisone 50mg 1/d; 5 Pepcid 1/d, Benadryl.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: Hives began on my neck & traveled down trunk (front & back), inside ears, face, hands, itchy throat, ears, lips swollen, throat felt 'thick' nauseated, tongue felt thick, difficult to breath. ER started IV, gave me IV Benadryl, Pepcid, prednisone, Ativan. BP was 98/110, pulse 110..Sent me home with 5 days prednisone 50mg 1/d; 5 Pepcid 1/d, Benadryl.
Age: 0.3
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 4 month immunization prepared and given, 2nd week in physician's office and administered combo DTaP/IPV (KINRIX) with medications.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Patient presented 2 days post vaccination with a red, raised bump at vaccination site. Told pt to monitor.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site induration, Injection site mass
Clinical narrative: Far more pain and burning than any previous flu shot. Injection was made too high and not in my muscle I believe. Shot given only 1 inch below top of shoulder. Burning and stinging are continuous. Hard lump where vaccine has not been incorporated into the muscle. Arm mobility is painful and limited. Injection location made above deltoid muscle near shoulder bone.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Far more pain and burning than any previous flu shot. Injection was made too high and not in my muscle I believe. Shot given only 1 inch below top of shoulder. Burning and stinging are continuous. Hard lump where vaccine has not been incorporated into the muscle. Arm mobility is painful and limited. Injection location made above deltoid muscle near shoulder bone.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Oropharyngeal pain, Rhinitis
Clinical narrative: Very shortly after getting flu shot on 10/17/13; child had (R) abd pain, rhinitis, sore throat. He did not tell teacher but told parents and was taken to ER. In clinic, 10/18/13 after taking 25 mg BENADRYL - subjective improvement by child and parent.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Slight fever and shakiness about 12 hours later. Then pt. took an ALEVE and the symptoms subsided.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness, tender.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 70 year old female patient. Medical history and drug reactions/allergies were not reported. On 23-OCT-2013, the patient was vaccinated with PNEUMOVAX23 lot # H013399 exp date 07-MAR-2014 (dose and route not reported). It was unknown if this was the patient's first administration of PNEUMOVAX23. There was no concomitant medication. In October 2013 (the patient called to the pharmacy on 28-OCT-2013), the patient was unable to move the arm that the PNEUMOVAX23 was administered. The patient sought for medical attention (pharmacy call). No treatment given for the events. No lab diagnostics performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt received flu shot in thigh and from his knee to hip was swollen and red and warm to touch. Positive fever. Use BENADRYL and MOTRIN.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity, Pruritus
Clinical narrative: Flu vaccine given on 10/15/13 at nurse visit. Arm pain, itching and swelling. No other symptoms. No infection present. Advised to use BENADRYL or CLARITIN for histamine response.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that doses of GARDASIL (lot number, expiry date, dose and route unspecified) were exposed to 80 degrees Fahrenheit for one day and above 46 degrees Fahrenheit for unspecified amounts of time from 01-OCT-2013 to 31-OCT-2013 which was not supported. It was unsure if any doses were administered. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that doses of M-M-R II (lot number, expiry date, dose and route unspecified) were exposed to 80 degrees Fahrenheit (F) for one day and above 46 degrees Fahrenheit (F) for unspecified amounts of time from 01-OCT-2013 to 31-OCT-2013 which was not supported. It was unsure if any doses were administered. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that doses of ROTATEQ (lot number, expiry date, dose and route unspecified) were exposed to 80 degrees Fahrenheit (F) for one day and above 46 degrees Fahrenheit (F) for unspecified amounts of time from 01-OCT-2013 to 31-OCT-2013 which was not supported. It was unsure if any doses were administered. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that doses of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) were exposed to 80 degrees Fahrenheit (F) for one day and above 46 degrees Fahrenheit (F) for unspecified amounts of time from 01-OCT-2013 to 31-OCT-2013 which was not supported. It was unsure if any doses were administered. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ill-defined disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history was not reported. There were no drug reactions or allergies. In approximately July 2013 (reported as 3 months ago), the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. In 2013 (reported as "now"), the patient experienced an unspecified condition. Unspecified corticosteroid medication was given as a treatment for the event. The patient sought for medical attention (unspecified method). The outcome of unspecified condition was not reported. The reporter considered unspecified condition to be not related to ZOSTAVAX. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Dermal cyst, Injection site mass
Clinical narrative: 3 days after vaccines given in (L) deltoid, pt dev a small "lump". Noted to have small dermal cyst to (L) axilla at time of visit today.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Musculoskeletal stiffness
Clinical narrative: Bruising reaction covers 6 inches in diameter and stiff neck; patient was prescribed anti-inflammatory and pain reliever by physician.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Chills, Lethargy
Clinical narrative: Vaccine admin on Mon 6pm 11/4/13. On Tues -> very lethargic, shivering, 100+ degree temp. On Wed still same. Missed 2 days of work.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Feeling cold, Musculoskeletal stiffness, Throat tightness
Clinical narrative: 10/30/13 FLUZONE administered approximately 1:30 pm. Approximately 5 to 5:30: felt cold, stiffness, strain to swallow. Pharmacist recommended going to ER for any throat closing issues pt went to bed. Felt fine next day.
Age: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Allergy test positive, Angioedema, Drug administration error, Face oedema, Feeling hot
Clinical narrative: This 29 year old healthy male advised receipt of first injectable influenza vaccination on 3/7/2007 (unknown lot#) with TWINRIX, MMR and Td vaccinations and no reported adverse reactions. A review of his hard copy medical records noted complaints of sore throat and cough with diagnosis of URI on 3/9/2007 (day 2). He was treated with TYLENOL, SUDAFED, ROBITUSSIN DM/Codeine, rest, fluids, etc with full resolution of symptoms. On 11/7/2007 he received annual influenza vaccination with first FLUMIST (MedImmune 500497P). He advised he experienced a mild frontal headache and maybe some clear rhinorrhea self treating with MOTRIN and symptoms resolved within a few days. On 10/3/2008 he received FLUMIST (MedImmune 500554P) for annual influenza vaccination. Approximately 1-2 hours later a coworker advised his face appeared swollen. He recalls the right side of his face was swollen with no visual problems; he complained of a sore right nostril, runny nose, felt warm and had a headache 8-9/10 to frontal forehead area. He advised this headache felt twice as bad as the 2007 headache. He recalls the FLUMIST was inserted into only the right nostril and not both. He denied any chest pain, cough, shortness of breath, difficulty swallowing, tongue or swelling in his mouth, or hearing problems. He denied any egg allergy eating eggs daily without problems. He had no other immunizations with flu vaccinations. Providers documented 10/3/2008 mild photophobia, mild facial edema with swollen, red, shiny nares and clear rhinorrhea. He was diagnosed with a tension headache and treated with CLARITIN and BENADRYL with resolution of all symptoms within one week (per pt). Pt also reported the right nostril developed a sore inside his nose day after seeing doctor that also resolved. Providers submitted allergy to influenza vaccine 10/3/2008. Patient has not had any flu vaccinations since. 10/30/2013: patient received FLUZONE lot #UH908AB on without adverse reaction after skin/ID skin testing. Recommend no FLUMIST. Patient given diagnosis of angioedema, oral allergy syndrome (food reactions), and chronic rhinitis. MD note: Following receipt of FLUMIST vaccine in 2008. Given the temporal nature of his reaction following vaccination, it may be surmised that his facial swelling may have been associated with receipt of this vaccine. While his history does not strongly suggest an IgE-mediated process, it cannot be entirely ruled out on history alone. There is no standardized FLUMIST skin testing protocol. Therefore, he is tested today to injectable influenza vaccine both as a surrogate and to confirm the safe administration of future influenza prophylaxis (IM). His negative skin testing today does not suggest an IgE-mediated sensitization to the Seasonal Influenza vaccine or gelatin (which is found in other vaccines). The cause of his facial swelling temporally associated with his vaccination is unknown, but the risk of systemic reaction to subsequent vaccinations appears low.
Age: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Food allergy, Headache, Nasal discomfort, Nasal ulcer, Oral allergy syndrome
Clinical narrative: This 29 year old healthy male advised receipt of first injectable influenza vaccination on 3/7/2007 (unknown lot#) with TWINRIX, MMR and Td vaccinations and no reported adverse reactions. A review of his hard copy medical records noted complaints of sore throat and cough with diagnosis of URI on 3/9/2007 (day 2). He was treated with TYLENOL, SUDAFED, ROBITUSSIN DM/Codeine, rest, fluids, etc with full resolution of symptoms. On 11/7/2007 he received annual influenza vaccination with first FLUMIST (MedImmune 500497P). He advised he experienced a mild frontal headache and maybe some clear rhinorrhea self treating with MOTRIN and symptoms resolved within a few days. On 10/3/2008 he received FLUMIST (MedImmune 500554P) for annual influenza vaccination. Approximately 1-2 hours later a coworker advised his face appeared swollen. He recalls the right side of his face was swollen with no visual problems; he complained of a sore right nostril, runny nose, felt warm and had a headache 8-9/10 to frontal forehead area. He advised this headache felt twice as bad as the 2007 headache. He recalls the FLUMIST was inserted into only the right nostril and not both. He denied any chest pain, cough, shortness of breath, difficulty swallowing, tongue or swelling in his mouth, or hearing problems. He denied any egg allergy eating eggs daily without problems. He had no other immunizations with flu vaccinations. Providers documented 10/3/2008 mild photophobia, mild facial edema with swollen, red, shiny nares and clear rhinorrhea. He was diagnosed with a tension headache and treated with CLARITIN and BENADRYL with resolution of all symptoms within one week (per pt). Pt also reported the right nostril developed a sore inside his nose day after seeing doctor that also resolved. Providers submitted allergy to influenza vaccine 10/3/2008. Patient has not had any flu vaccinations since. 10/30/2013: patient received FLUZONE lot #UH908AB on without adverse reaction after skin/ID skin testing. Recommend no FLUMIST. Patient given diagnosis of angioedema, oral allergy syndrome (food reactions), and chronic rhinitis. MD note: Following receipt of FLUMIST vaccine in 2008. Given the temporal nature of his reaction following vaccination, it may be surmised that his facial swelling may have been associated with receipt of this vaccine. While his history does not strongly suggest an IgE-mediated process, it cannot be entirely ruled out on history alone. There is no standardized FLUMIST skin testing protocol. Therefore, he is tested today to injectable influenza vaccine both as a surrogate and to confirm the safe administration of future influenza prophylaxis (IM). His negative skin testing today does not suggest an IgE-mediated sensitization to the Seasonal Influenza vaccine or gelatin (which is found in other vaccines). The cause of his facial swelling temporally associated with his vaccination is unknown, but the risk of systemic reaction to subsequent vaccinations appears low.
Age: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Photophobia, Rhinitis, Rhinorrhoea, Swelling face, Tension headache
Clinical narrative: This 29 year old healthy male advised receipt of first injectable influenza vaccination on 3/7/2007 (unknown lot#) with TWINRIX, MMR and Td vaccinations and no reported adverse reactions. A review of his hard copy medical records noted complaints of sore throat and cough with diagnosis of URI on 3/9/2007 (day 2). He was treated with TYLENOL, SUDAFED, ROBITUSSIN DM/Codeine, rest, fluids, etc with full resolution of symptoms. On 11/7/2007 he received annual influenza vaccination with first FLUMIST (MedImmune 500497P). He advised he experienced a mild frontal headache and maybe some clear rhinorrhea self treating with MOTRIN and symptoms resolved within a few days. On 10/3/2008 he received FLUMIST (MedImmune 500554P) for annual influenza vaccination. Approximately 1-2 hours later a coworker advised his face appeared swollen. He recalls the right side of his face was swollen with no visual problems; he complained of a sore right nostril, runny nose, felt warm and had a headache 8-9/10 to frontal forehead area. He advised this headache felt twice as bad as the 2007 headache. He recalls the FLUMIST was inserted into only the right nostril and not both. He denied any chest pain, cough, shortness of breath, difficulty swallowing, tongue or swelling in his mouth, or hearing problems. He denied any egg allergy eating eggs daily without problems. He had no other immunizations with flu vaccinations. Providers documented 10/3/2008 mild photophobia, mild facial edema with swollen, red, shiny nares and clear rhinorrhea. He was diagnosed with a tension headache and treated with CLARITIN and BENADRYL with resolution of all symptoms within one week (per pt). Pt also reported the right nostril developed a sore inside his nose day after seeing doctor that also resolved. Providers submitted allergy to influenza vaccine 10/3/2008. Patient has not had any flu vaccinations since. 10/30/2013: patient received FLUZONE lot #UH908AB on without adverse reaction after skin/ID skin testing. Recommend no FLUMIST. Patient given diagnosis of angioedema, oral allergy syndrome (food reactions), and chronic rhinitis. MD note: Following receipt of FLUMIST vaccine in 2008. Given the temporal nature of his reaction following vaccination, it may be surmised that his facial swelling may have been associated with receipt of this vaccine. While his history does not strongly suggest an IgE-mediated process, it cannot be entirely ruled out on history alone. There is no standardized FLUMIST skin testing protocol. Therefore, he is tested today to injectable influenza vaccine both as a surrogate and to confirm the safe administration of future influenza prophylaxis (IM). His negative skin testing today does not suggest an IgE-mediated sensitization to the Seasonal Influenza vaccine or gelatin (which is found in other vaccines). The cause of his facial swelling temporally associated with his vaccination is unknown, but the risk of systemic reaction to subsequent vaccinations appears low.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Approximately 30 minutes after receiving the Flu Mist vaccine, child returned to the vaccinating area with the school nurse. Child c/o itching in chin area. Chin red and hives present on chin and just under nose. No other symptoms present. BP 106/64. Benadryl 25 mg given IM in L arm. Within few minutes itching and hives resolved. BP recheck at 9:45 and was 98/66. Child observed/monitored for about 30 minutes... then sent back to classroom. Spoke with guardian on telephone re reaction. Recommended no further doses of flu vaccine without consultation with physician.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a influenza injection on 11/1/13. Patient had already had an influenza injection for 2013 on 10/1/13.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Erythema, Immediate post-injection reaction, Injection site swelling, Local swelling
Clinical narrative: Instant swelling at the injection site. Over time arm started turning red and overnight the whole upper arm swelled up, bruised and very painful to move or touch.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Instant swelling at the injection site. Over time arm started turning red and overnight the whole upper arm swelled up, bruised and very painful to move or touch.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Syncope
Clinical narrative: Fainted after administration of HPV4.