chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Scar, Skin lesion
Clinical narrative: Initial report received from healthcare professional on 16 January 2013. A 61-year-old female patient, who had medical history of sulfa allergies, GERD (Gastroesophageal reflux disease), osteopenia and dermatitis and concomitant medication included CENTRUM SILVER, Vitamin D3, Vitamin E and fish oil, had received an intradermal dose of FLUZONE ID (lot number: UT4473AA) in left deltoid on 22 October 2012. On 22 October 2012, the patient experienced redness and swelling at the injection site. On 16 January 2013, patient claimed of a flat lesion with a slight white scale at the injection site. The patient had not received any corrective treatment by physician and laboratory details were not reported. At the time of this report, the patient's outcome of the event was unknown. Follow up information received from a healthcare professional on 24 January 2013. The reporter's (physician) address was changed. Follow-up information received from a healthcare professional on 05 April 2013. The patient had developed permanent scar. Documents held by sender: Photo of the affected site. Follow-up information received on 05 June 2013 and 06 June 2013 from a healthcare professional. On an unspecified date, the patient had round erythematous area approximately of 1 cm in diameter consistent with post-inflammatory erythema. The patient also had a flat lesion with slight white scale at the vaccination site. It was reported that this post-inflammatory erythema will take some time to resolve. The physician advised the patient to refer to the dermatology for evaluation and management of lesion. The adverse event permanent scar was no longer reported, so this event was deleted from database. The patient was evaluated but didn't receive any treatment.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Grip strength decreased, Insomnia, Pain in extremity
Clinical narrative: Initial report was received from a healthcare professional on 10 January 2013. A 24-year-old female patient, who had no relevant medical history with not any illness at the time of vaccination and concomitant medications were not reported, had received intradermal FLUZONE ID (Batch number UT4466BA, expiration date 04/02/2013) in left arm on 09 January 2013 in the evening. On 09 January 2013 at night, the patient felt her skin like sandpaper and had difficulty in sleeping. On 10 January 2013, the patient had pain in both palms and fingers and had hard time holding her toothbrush. The corrective treatment and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site warmth
Clinical narrative: Initial information received from a healthcare professional on 21 January 2013. A 34-year-old female patient, had received an intradermal dose 1 of FLUZONE ID (lot number: UT4465BA) in the left deltoid on 19 January 2013. The patient had past medical history of gestational diabetes with two previous pregnancies. The patient denied any illness at the time of vaccination and did not have any pre-existing physician diagnosed allergies, birth defects or medical conditions. The patient's concomitant medications were not reported. On 20 January 2013, the patient developed an area of redness size of a half dollar and warm to touch at the reaction site. The patient was 11 weeks pregnant. The last menstrual period date was unknown and estimated date of delivery was August 2013. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome of events and pregnancy was unknown. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin induration, Skin mass, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 14 January 2013. A 62-year-old female patient, who had no pre-existing physician diagnosed allergies, birth defects and medical conditions and her concomitant medications were not reported, had received first dose of FLUZONE (batch number: UT4466BA, route of administration was not reported) in left arm on 10 January 2013. The patient had no other illness at the time of vaccination. On 11 January 2013, the patient experienced area of redness with a hard lump under the skin, very warm to touch. Not getting larger. Corrective treatment was not reported. The patient had no laboratory investigations/relevant diagnostic tests. At the time of this report, the patient had not recovered from the event. Documents held by sender: None. Follow-up information was received from a healthcare professional on 15 April 2013. The patient had no further problems with no need for medical attention.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 06 December 2012. A 58-year-old male patient, who had no known allergies and whose concomitant medications were not reported, had received an intradermal dose of FLUZONE vaccine (lot number: UT4464AA) on the right arm on 06 December 2012. The patient had no illness at the time of vaccination. The patient had received many flu doses previously. On 06 December 2012 immediately after vaccination, the patient's injection site became swollen and was itchy. In 5 minutes, the site was still itchy and there was a rash at the site about 3 inches in diameter. In half an hour, the itching got less and the red rash did not get any larger. Corrective treatment and laboratory data were not reported. At the time of this report, the patient had not recovered from the events. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 08 January 2013. A 45-year-old female patient, with allergy to latex and codeine, who had no illness at the time of vaccination and whose concomitant medications were not reported, had received first dose of FLUZONE ID vaccine in left arm (Lot number: UT4470BA, route of vaccination ws not reported) on 05 January 2013. On 06 January 2013, the patient developed 4-incd red area, hot to touch. Corrective medications were not reported. No laboratory investigations were done. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: A 43-year-old female patient had received an intradermal dose 1 of FLUZONE ID (batch number UT4470BA with expiration date 03/31/2013) in left arm on 08 January 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Concomitant medications were not reported. On 09 January 2013, 1 day after vaccination, the patient experienced redness and swelling 'size of fist' and a big welt. The corrective treatment and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Diarrhoea
Clinical narrative: Initial report received from a healthcare professional on 05 December 2012. A 22-year-old female patient had received an intradermal second dose of FLUZONE intradermal vaccine (lot number UT4473AA) in left deltoid on 03 December 2012 at 12:45PM. Patient had no known allergies and illness at the time of vaccination, concomitant medications, adverse event following previous vaccination were none. The patient had received first dose of FLUZONE ID vaccine at age 12-year-old. On 03 December 2012 by 2 pm, the patient had first episode of diarrhea and the patient complained of low abdominal pain. The patient had no vomiting or nausea. Corrective treatments were not reported. Relevant diagnostic tests/laboratory data were none. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 15 March 2013. The patient had received an intramuscular flu vaccine shot in her life at the age of 12. No medical treatment was given. The patient's outcome was recovered on 05 December 2012.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: A 48-year-old female patient, had received first dose of FLUZONE ID (lot number: UT4474AA, site of administration: "right:) intradermally on 16 October 2012. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown and illness at time of vaccination was reported to be none. No concomitant medications were reported. On 18 October 2012 i.e. 2 days after the vaccination, the patient experienced right upper arm and torso pain which persisted till the time of reporting. It was reported that, the patient required emergency room/doctor visit. Corrective treatment and relevant diagnostic tests/laboratory data were not reported. At the time of this report, the patient had not recovered from the events. Follow up information received from a healthcare professional on 25 April 2013. The patient address, responsible physician and reporter details were updated. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Joint swelling
Clinical narrative: A 52-year-old female patient, had received an intradermal dose of FLUZONE ID (lot number: UT4467AA, site of administration was not reported) on 12 December 2012. The patient had no allergies and no illness at the time of vaccination. The patient had history of fibromyalgia. The patient did not receive any other vaccinations within 4 weeks of vaccination on 12 December 2012. On 12 December 2012, after vaccination, the patient developed half dollar size red area and soreness at injection site. The patient also experienced swelling of knees when standing on them for length of time. Laboratory data and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Initial report received from a health care professional on 19 November 2012. A 21-year-old female patient, whose concurrent condition included adrenal insufficiency and concomitant medication Hydrocortisone, "Thyroid 1.50 mg", PREVACID and Desmopressin; had received a dose of FLUZONE ID (dose number 3, Lot number UT4470AA, route of administration was not reported) in right deltoid on 16 November 2012 at 06:45 PM. On 17 November 2012 at 10:30 AM, the patient experienced hives all over body. The patient was taken to urgent care and was treated with Hydroxyzine HCL 25 mg thrice in day and PEPCID BID on unspecified date. No laboratory tests were done. The patient had not recovered. Documents held by sender: none. Follow up information received from a healthcare professional on 26 March 2013: Patient had no illness at time of vaccination and had no adverse event following prior vaccination. The patient also received fludrocortisone as concomitant medication. The patient's outcome was recovered on 24 November 2012.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pain, Local reaction, Pallor, Syncope
Clinical narrative: Child had syncopal event during the observation period following vaccines. This was witnessed by MD and mother. Child had complained of pain at site of HPV vaccine prior to becoming pale and fainting from the seated position. He was observed further and sent home. He had not eaten breakfast prior to AM visit. He returned to the office 2 days later for a large local reaction at the site of his Tdap vaccine. Family checked on by phone. No further problems.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: JEV1, TYP, YF
Symptoms: Fatigue, Headache, Nausea, Tremor
Clinical narrative: Severe fatigue & H/A since vaccination on 7/31/15 she experienced an extremely painful headache, nausea & hand tremors (she has not begun oral typhoid).
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Somnolence
Clinical narrative: Patient developed severe fatigue and drowsiness about 2 hrs after vaccination. She then fell asleep in the afternoon after fighting sleep for a few hours. She reports feeling "unusually drowsy" for at least 24 hours following vaccination. She was alarmed by this reaction.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Eosinophil count normal, Escherichia test negative, Giardia test negative, Helicobacter test negative
Clinical narrative: Diarrhea x 16 days, started one day after Rota, PENTACEL and PCV13 vaccines. Probiotic given. Improved after change to soy formula (now back on cow milk based formula and fine). (We do not really think vaccine is the cause, but reporting due to diarrhea.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Occult blood negative, Rotavirus test negative
Clinical narrative: Diarrhea x 16 days, started one day after Rota, PENTACEL and PCV13 vaccines. Probiotic given. Improved after change to soy formula (now back on cow milk based formula and fine). (We do not really think vaccine is the cause, but reporting due to diarrhea.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling and erythema started 24 hours post injection. Not painful not pruritic, neurovascular function normal.
Age: 1.06
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: High fever 102 x 4 days after vaccination if continues will refer to ER.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site irritation, Injection site swelling, Pain, Peripheral swelling
Clinical narrative: Pt received MCV4 and Tdap 8/3/15 and 8/4/15 the injection site became irritated, and swollen. It is painful to lift left arm, and feels warm. 8/5/15 patient's palms on both hands became very itchy, swollen, with redness.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Skin warm
Clinical narrative: Pt received MCV4 and Tdap 8/3/15 and 8/4/15 the injection site became irritated, and swollen. It is painful to lift left arm, and feels warm. 8/5/15 patient's palms on both hands became very itchy, swollen, with redness.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: 4 hours after GARDASIL 9 administered, patient developed arm pain and axillary lymphadenopathy on the same side as injection. No fever no fatigue. Resolved completely in 4 days without treatment.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: 8/6/15 pt came in stating she started having pain and numbness in her left arm at 7pm on 8/03/15. This continued 8/4/15, 8/5/15 and 8/6/15. She can raise her arm only 20% and then there is pain in joint. She's been using BIOFREEZE on her own, along with TYLENOL. She's avoided Ibuprofen as she said it causes drowsiness.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 weeks old female patient. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 months old male patient. No relevant medical history or concurrent conditions were reported. On 23-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.48
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 5 months old female patient. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 0.61
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 7 months old male patient. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 months old male patient. No relevant medical history or concurrent conditions were reported. On 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 months old female patient. No relevant medical history or concurrent conditions were reported. On 09-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2015, the patient was vaccinated with an improperly stored doses of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 18-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.39
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 8 week old female patient. No relevant medical history or concurrent conditions were reported. On 09-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 months old male patient. No relevant medical history or concurrent conditions were reported. On 19-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 8 week old female patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were not reported. ON 23-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 11 week old male patient. No relevant medical history or concurrent conditions were reported. On 29-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 02-JUL-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been receive from a medical assistant referring to a 6 months old female patient. No relevant medical history or concurrent conditions were reported. On 04-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates since 13-JUL-2015, the patients were administered with PNEUMOVAX 23 lot # K007826 with expiration date of 03-FEB-2015, (strength, dose and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 weeks old female patient. No relevant medical history or concurrent conditions were reported. On 11-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.56
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 months old female patient. No relevant medical history or concurrent conditions were reported. On 03-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swelling face
Clinical narrative: Face and lips swollen.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K016152 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as receive from a registered nurse (R.N.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug allergies were not provided. It was reported that on an unknown date, the patients were late receiving their third dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). Information regarding the patient's first and second dose of GARDASIL was not provided. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same course. 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 nurse refers to unknown number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were inadvertently vaccinated with improperly stored MMR II injection, lot # K005574, exp. date: 17-APR-2016, lot# K003822, exp. date: 14-MAR-2016 and lot# K009192, exp. date: 27-JUN-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a nurse refers to unknown number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were inadvertently vaccinated with improperly stored GARDASIL injection, lot # K016966, exp. date: 10-MAY-2017 and lot# J002641, exp. date: 10-DEC-2015 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were inadvertently vaccinated with improperly stored PNEUNOVAX23 injection, lot # K023328, exp. date: 23-JUN-2016 and lot # K010522, exp. date: 25-FEB-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter.  Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA, TDAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via call representative and described the occurrence of allergic reaction in a patient who received BOOSTRIX. Co-suspect products included HAVRIX. Concomitant products included MENVEO. On an unknown date, the patient received BOOSTRIX at an unknown dose and HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX and HAVRIX, the patient experienced allergic reaction. The patient was treated with Antibiotic. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to BOOSTRIX and HAVRIX. Additional information provided: The field representative received a call from an allergy office where a patient
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 20-JAN-2015, 30-JUN-2015 and 21-JUL-2015 the patient was vaccinated with 2 doses of GARDASIL inj. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administered unspecified number of improperly stored doses of VAQTA (lot number K009506 - expiration date 22-SEP-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1507USA010114, 1507USA010882, 1507USA010883, 1507USA010884). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients (demographics unknown). On an unspecified date, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (Lot # K021444; expiration date: 17-SEP-2016) (route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients (demographics unknown). On an unspecified date, the patients were vaccinated with doses of improperly stored GARDASIL (Lot # K011562; expiration date: 08-APR-2017) (route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed hive and itching on her arms and legs.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Crying after imms. Temp 100.2.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No pertinent medical history was reported. On 31-JUL-2015, the patient was vaccinated with VARIVAX (Merck) (lot # L004653 and expiration date 11-FEB-2017) (strength, dose and route were not reported) which was improperly stored. No adverse events were reported. This is one of the two reprots received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Diet refusal, Rash
Clinical narrative: Pt developed scattered dime size and smaller rash, day after shots given, over face, arms, and torso. Ran low grade fever, laid around and wouldn't eat. Rash did not itch. Gave BENADRYL p.o.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No pertinent medical history was reported. On 29-JUL-2015, the patient was vaccinated with PROQUAD INJ (Merck) (lot # K020752 and expiration date 30-APR-2016) (strength, dose and route were not reported) which was improperly stored. No adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash generalised
Clinical narrative: Developed a rash on face and body. Re-examined by nurse practitioner pulse ox 98% pulse-105 BENADRYL 6ml and prednisolone 5 ml given at 11:40.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HAVRIX pediatric (batch number AZ54D, expiry date unknown). Previously administered products included HAVRIX pediatric (1st dose) and HAVRIX pediatric (2nd dose). On an unknown date, the patient received the 3rd dose of HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: On unknown dates, the patient had received the 1st and 2nd doses of HAVRIX pediatric. On an unknown date, the patient inadvertently received 3rd dose of HAVRIX pediatric, which led to extra dose administration. The reason for maladministration was that the 2nd dose of HAVRIX pediatric was not documented and so the 3rd dose was administered.
Age: 6.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Myalgia, Pain in extremity
Clinical narrative: IgA deficiency and lactose intolerance. Saw allergist and ok'd admin of PNEUMOVAX and DTAP. Given 8/3/2015 PNEUMOVAX (L) deltoid DTAP (R) deltoid has had 5 cm redness and 3 cm induration (L) deltoid with fever up to 103 reported. 100.9 in office, pain in (L) arm, myalgias, arthralgias.
Age: 6.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pyrexia
Clinical narrative: IgA deficiency and lactose intolerance. Saw allergist and ok'd admin of PNEUMOVAX and DTAP. Given 8/3/2015 PNEUMOVAX (L) deltoid DTAP (R) deltoid has had 5 cm redness and 3 cm induration (L) deltoid with fever up to 103 reported. 100.9 in office, pain in (L) arm, myalgias, arthralgias.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old patient. No relevant medical history or concurrent conditions were reported. On 01-JUL-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reprot received from the same reproter. 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 registered nurse refers to a patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unkonwn date, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K002047, expiration date 10-FEB-2016 (strength, dose and route of administration were not reported) that were improperly stored. No information on patient's concomitant medication was provided. No adverse effects were reported. This is one of the two reports 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 registered nurse refers to a four patient of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, two patients were vaccinated with a dose of PROQUAD (Merck) injection, lot # L008354, expiration date 11-SEP-2016 (strength, dose and route of administration were not reported) that were improperly stored. On an unknown dates, two patients were vaccinated with a dose of PROQUAD injection, lot # L007230, expiration date 03-SEP-2016 (strength, dose and route of administration were not reported) that were improperly stored. No information on patients concomitant medication was provided. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. In October 2014 the patient was vaccinated with GARDASIL dose #1 (dose, route and frequency unspecified). In May 2015 the patient was vaccinated with GARDASIL dose #2. Other suspect therapies included in July 2015, GARDASIL 9 dose #3 in the HPV vaccination series (dose, route and frequency unspecified). No adverse effect reported. There was no product quality complaint involved. Outcome of medication error was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with fourth dose of GARDASIL (dose and route of administration not provided) in error (extra dose administered). No concomitant therapy was reported. The reporter had no information about patient identifiers, date of vaccination or lot number of vaccine administered. The reporter did not know if the patient had experienced any adverse effects. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness/swelling of the arm.
Sex: U
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from an unknown reporter regarding an unspecified number of children of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency and lot number not specified). No co-suspect medications or concomitant medications were reported. On an unknown date the children developed POTS (Postural orthostatic tachycardia syndrome) while on GARDASIL. No laboratory diagnostic studies were reported. At the time of reporting the outcome of the event was unknown. There was no Product quality complaint. The relatedness of the event to the suspect product GARDASIL was unknown. Additional information is not expected as no contact details were provided.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Crohn's disease, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old male patient. The patient's medical history and concomitant medications were not reported. His concurrent conditions included an idiopathic scoliosis and unspecified seasonal allergies. On 30-JUL-2012, the patient was vaccinated with the first dose of GARDASIL 9 (expiration date 11-JAN-2015, lot # reported as H009745; dose and route of administration were not reported). In March 2013, the patient was diagnosed with Crohn's disease. The patient sought an unspecified type of medical attention and he received the treatment with REMICADE (it was also reported as concomitant medication). On 31-JUL-2013, the patient was vaccinated with the second dose of GARDASIL 9 (expiration date 07-JAN-2015, lot # reported as J003727; dose and route of administration were not reported). On 05-AUG-2015, the patient was vaccinated with the third dose of GARDASIL 9 (expiration date 10-MAY-2017, lot # reported as K016966; dose and route of administration were not reported). The outcome of Crohn's disease was unknown. The relatedness between the adverse event and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.