chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 11-APR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ, lot number M038846 expiration date 26-JUN-2018) and PEDVAXHIB lot number M034189, expiration 23-MAY-2019 for prophylaxis (strength and route were not provided). The vaccine was exposed to a temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit for 2 hours. The call was placed because of a Digital data logger. No previous temperature excursions and no adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On multiple unspecified dates, patients were vaccinated with improperly stored dose of VARIVAX lot# M035140 expiration date 03-AUG-2018) and PROQUAD Lot # L040411 expiration 13-APR-2017; lot# M034692 expiration 24-JAN-2018 and properly stored DILUENT MRK lot number unknown. No adverse events reported. The vaccines were exposed to a temperature excursion minus 8.8 degrees Celsius for 1 hour 14 minutes. The call was placed because of a Digital data logger. Previous temperature excursions on 23-MAR-2017 (- 11.3 degrees Celsius) for 1 hour 43 minutes; 22-MAR-2017 (-11.9  degrees Celsius) for 1 hour 15 minutes and on 26-JAN-2017 2017 (- 11.2 degrees Celsius) for 1 hour 23 minutes. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M024261, expiration date:30-JUL-2018 and lot # M009378, expiration date: 23-APR-2018, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion of 28 Fahrenheit degrees for 7 days. No previous temperature excursions were reported. Data logger was not involved. No adverse effects were reported. A phone call was placed on 22-MAR-2017 to the medical assistant, who reported that, she was waiting for the office manager to download the information and then she would fax it in. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US0095075131701USA005974. The WWID US009507513 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US0095075131704USA006956). Additional information has been requested.; Sender's Comments: US-009507513-1701USA005974: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1704USA007611:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.     On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M037011, expiration date:21-FEB-2018, lot # M031943, expiration date: 27-DEC-2017 and lot # M035145, expiration date: 30-JAN-2018, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion between 5 and 14 Fahrenheit degrees for 48 hours. No previous temperature excursions were reported. Data logger was not involved. No adverse effects were reported. A phone call was placed on 22-MAR-2017 to the medical assistant, who reported that, she was waiting for the office manager to download the information and then she would fax it in. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US0095075131701USA005974. The WWID US009507513 1701USA005974 refers to the linked report (and therefore not being nullified).. The correct WWID is now referenced in this safety report (US0095075131704USA006957). Additional information has been requested.; Sender's Comments: US-009507513-1701USA005974: US-009507513-1704USA006956: US-009507513-1704USA006958:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M027345, expiration date: 01-JUN-2018, lot # M020900, expiration date: 27-APR-2018, lot # M033212, expiration date: 13-JUL-2018, lot # M034586, expiration date: 27-JUL-2018 and lot # M027885, expiration date: 03-JUN-2018, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion between 5 and 14 Fahrenheit degrees for 48 hours. No previous temperature excursions were reported. Data logger was not involved. No adverse effects were reported. A phone call was placed on 22-MAR-2017 to the medical assistant, who reported that, she was waiting for the office manager to download the information and then she would fax it in. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US0095075131701USA005974. The WWID US009507513 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US0095075131704USA006958). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957:  US-009507513-1701USA005974:
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 17 year old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L007560, as prophylaxis (Strength, route, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US-009507513-1701USA005974. The WWID US-009507513-1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US-009507513-1704USA007611). Additional information has been requested. Sender's Comments: US-009507513-1701USA005974: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1704USA006956.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 4 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US-009507513-1701USA005974. The WWID US-009507513- 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US-009507513-1704USA007664). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1704USA007655: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673: US-009507513-1701USA005974:
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 3 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US-009507513-1701USA005974. The WWID US-009507513- 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US-009507513-1704USA007665). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1704USA007655: US-009507513-1701USA005974: US-009507513-1704USA007664: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the improperly stored doses of VARIVAX (dose, lot # and expiration date were not reported) subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered dose of vaccine experienced the temperature excursion between -9 to 8 degrees Celsius for 5 hours and 15 minutes. Data logger was involved. There were no previous excursions  reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Papilloma viral infection
Clinical narrative: This prospective pregnancy report has been received from the patient's mother and referred to a 26-year-old female patient. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. In approximately 2002 (reported as "at age 11 or 12"), the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot number, and expiration date were not reported) for the prevention of human papillomavirus (HPV). On an unknown date, the patient became pregnant (last menstrual period (LMP) and estimated due date were not reported). On an unknown date, the patient was diagnosed by an unspecified method with an unspecified strain of HPV (Human papilloma virus test positive) as well as cervical cancer. The patient did not have any treatment for this, at the time of the report; however a biopsy would be performed after the patient's delivery to determine the course of treatment. At the time of this report, the outcome of papilloma viral infection and cervix carcinoma was unknown. The causality assessment between papilloma viral infection and cervix carcinoma with GARDASIL was unknown. Upon internal review, the event of cervix cancer was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via interpreter, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On an unknown date in 2017 (reported as "on an unspecified date after 19-MAR-2017"), the patient was vaccinated with an expired dose of M-M-R II injection (dose, and anatomical location were not reported) lot number L009544; expiration date 19-MAR-2017 for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Gastric disorder, Psoriasis, Vomiting
Clinical narrative: A spontaneous report was received from a Pharmacist concerning, female patient. No information regarding relevant medical history, concomitant medication or concomitant disease was provided.     The patient received FLUMIS QUADRIVALENT (intranasal), on 17-Oct-2015, and said 3 days later she was in the emergency room, on 20-OCT-2015, for stomach pain (Preferred Term: Abdominal pain upper) and vomiting (Preferred Term: Vomiting). She could not stop throwing up and her stomach hurt. She had a stomach issue (Preferred Term: Gastric disorder) that had put her in the emergency room 6 times in the last year and a half. She had the Flu shot in Aug-2016, and was in the emergency room in Nov-2016. She had an endoscopy also. She also had psoriasis (Preferred Term: Psoriasis), which was an autoimmune issue that may be causing problems also. The outcome of stomach pain, vomiting/could not stop throwing up, has psoriasis and has a stomach issue was unknown. The company physician considered stomach pain, vomiting/could not stop throwing up, has psoriasis and has a stomach issue to be non-serious.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Injection site swelling, Rash
Clinical narrative: Initial unsolicited report received from a nurse via other company, Pfizer (Reference number- 2017116576) on 14-Apr-2017. This case involves a 65-year-old female patient who was vaccinated with a dose of TETANUS TOXOID (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unspecified date. The medical history and the concomitant medications were not reported. On 07-Feb-2017, following the vaccination, the patient developed allergy (rash and site swelling). The laboratory test and the corrective treatment was not reported. The outcome of the events was not reported. List of the documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PNC, VARZOS
Symptoms: Contusion, Increased tendency to bruise, Nodule, Pruritus, Rash
Clinical narrative: Patient presented with a 3 inch bruise/rash that she said was not painful and rarely if any itches. She bruises easily while taking blood thinners. She felt a knot in the area on Saturday morning (4/22/2017) and bruising/rash. She talked with a nurse at a local clinic her daughter uses and was directed to return to us to look at the site of the ZOSTAVAX administration.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Blister, Crying, Erythema, Eyelid oedema, Oedema peripheral
Clinical narrative: Patient Crying, redness/edema from feet to middle of shins. Small blisters noted to both lower extremities. Edema to eyelids. Q-dryl 12.5mg/5 ml 3ml given orally at 2:35pm. Patient taken too emergency room where treatment and evaluation was continued at 2:45pm. ER was called patient recovered all edema/redness/and blisters gone before going home (about 45 minutes. ER treated patient with Predisalone.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Rash
Clinical narrative: RASH TO SITE OF INJECTION FOR 2 DAYS THEN SPREAD TO OTHER LEG AND ABDOMEN, BENADRYL GIVEN FOR 1 DAY, DOING BETTER, STOPPED THE BENADRYL THEN RASH RETURN TO TORSO AREA ON 4/25/2017. SEEN IN DOCTORS OFFICE 4/26/2017, PLACED ON ORAPRED 15MG/5ML 2.5 MLS PO BID FOR 3 DAYS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction. Patient was given KINRIX when INFARIX should of been administered. Patient in addition received a dose of IPV.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Headache
Clinical narrative: Went to the clinic at school with "the worst throbbing headache of his life", and very weak.  Clinic staff took his BP and it was 150/90, pulse 120.  EMS was called and arrived.  Father arrived and called pediatrician and was instructed to monitor him at home.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash at injection site.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, swelling, and itching. Spreading since onset. No fevers, bleeding, or discharge. Seen in office 4/26/17 for the issue and will start antibiotics due to concern for cellulitis. Plan for close follow up.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Pruritus
Clinical narrative: Swollen, itchy arm.Patient having trouble moving arm.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Dyskinesia, Mobility decreased, Peripheral swelling, Speech disorder
Clinical narrative: Swelling of arm, could not move arm, could not control hand, difficulty speaking, dizziness.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Bump at site of injection and pain upon touch to site.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site, swelling and tenderness at deltoid mm origin, limited range of motion- left shoulder.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Muscular weakness, Pyrexia, Vaccination site swelling
Clinical narrative: Swelling of vaccine area and redness, associated with fever - patient also reports weakness of left upper extremity.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Classic injection site reaction-redness swelling, warm to touch appeared 48H after receiving ZOSTAVAX SQ in Right arm.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site swelling, Nausea, Vomiting
Clinical narrative: Swelling (bruising (L) deltoid beginning same day as vaccine (given 4/24) in evening, lessened by next day. Vomiting - 2x evening after vaccine, C/O nausea today with no vomiting. (Child reported she started yesterday after vaccine given-but vaccine actually given 2 days ago).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pain, Pyrexia
Clinical narrative: Pt was given PCV13 at pharmacy Pt came in 3 days later w/fever, body aches and rash at injection site.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Asterixis, Autism spectrum disorder, Constipation, Cow's milk intolerance, Crying
Clinical narrative: Patient received these vaccines listed below on 3/16/2012 and developed a fever immediately after receiving them. He then developed a prolonged illness of fatigue, poor appetite, poor sleep and a high pitched cry. By 5/13/2012 he was unable to say "MaMa" like he had said previously. By 6/2012 he developed bowel problems such as frequent vomiting, poor appetite, food intolerances to dairy/gluten, weight loss, chronic loose stool often with blood and sometimes constipation. By 18 months (8/2012) he had regressed into autism: lost functional play, lost social skills, lost language, stopped responding to his name, and engaged in spinning/flapping of his hands.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Disturbance in social behaviour, Fatigue, Functional gastrointestinal disorder
Clinical narrative: Patient received these vaccines listed below on 3/16/2012 and developed a fever immediately after receiving them. He then developed a prolonged illness of fatigue, poor appetite, poor sleep and a high pitched cry. By 5/13/2012 he was unable to say "MaMa" like he had said previously. By 6/2012 he developed bowel problems such as frequent vomiting, poor appetite, food intolerances to dairy/gluten, weight loss, chronic loose stool often with blood and sometimes constipation. By 18 months (8/2012) he had regressed into autism: lost functional play, lost social skills, lost language, stopped responding to his name, and engaged in spinning/flapping of his hands.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Gluten sensitivity, Haematochezia, Immediate post-injection reaction, Language disorder, Movement disorder
Clinical narrative: Patient received these vaccines listed below on 3/16/2012 and developed a fever immediately after receiving them. He then developed a prolonged illness of fatigue, poor appetite, poor sleep and a high pitched cry. By 5/13/2012 he was unable to say "MaMa" like he had said previously. By 6/2012 he developed bowel problems such as frequent vomiting, poor appetite, food intolerances to dairy/gluten, weight loss, chronic loose stool often with blood and sometimes constipation. By 18 months (8/2012) he had regressed into autism: lost functional play, lost social skills, lost language, stopped responding to his name, and engaged in spinning/flapping of his hands.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Poor quality sleep, Pyrexia, Regressive behaviour, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient received these vaccines listed below on 3/16/2012 and developed a fever immediately after receiving them. He then developed a prolonged illness of fatigue, poor appetite, poor sleep and a high pitched cry. By 5/13/2012 he was unable to say "MaMa" like he had said previously. By 6/2012 he developed bowel problems such as frequent vomiting, poor appetite, food intolerances to dairy/gluten, weight loss, chronic loose stool often with blood and sometimes constipation. By 18 months (8/2012) he had regressed into autism: lost functional play, lost social skills, lost language, stopped responding to his name, and engaged in spinning/flapping of his hands.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Weight decreased
Clinical narrative: Patient received these vaccines listed below on 3/16/2012 and developed a fever immediately after receiving them. He then developed a prolonged illness of fatigue, poor appetite, poor sleep and a high pitched cry. By 5/13/2012 he was unable to say "MaMa" like he had said previously. By 6/2012 he developed bowel problems such as frequent vomiting, poor appetite, food intolerances to dairy/gluten, weight loss, chronic loose stool often with blood and sometimes constipation. By 18 months (8/2012) he had regressed into autism: lost functional play, lost social skills, lost language, stopped responding to his name, and engaged in spinning/flapping of his hands.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, Redness at injection site (DTaP site).
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Cough, Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Pt seen in ER 4/1/17 at 20:51 for C/O "cough, congestion x 1 week, fever starting tonight, 101 at home TYLENOL given. Skin problem: vaccines received on Friday redness/swelling to right leg." Given Ibuprofen in ER. "Moderate local immunization reaction." Pt seen in clinic 4/4/17 at 15:40 for 2cm X 2cm firm area at injection site on right thigh. Note: Vaccines were documented as PEDIARIX, Varicella >Left thigh, MMR -right thigh, IPV - Right arm, However when patient returned on 4/4/17 for follow-up she had the following, 2-injection sites - right thigh, 1 injection site - Left thigh, 1- injection site- Right arm. We believe the MA that gave and documented the vaccines reversed the thigh given. DTaP component of PEDIARIX most likely cause of reaction.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Respiratory tract congestion, Skin disorder
Clinical narrative: Pt seen in ER 4/1/17 at 20:51 for C/O "cough, congestion x 1 week, fever starting tonight, 101 at home TYLENOL given. Skin problem: vaccines received on Friday redness/swelling to right leg." Given Ibuprofen in ER. "Moderate local immunization reaction." Pt seen in clinic 4/4/17 at 15:40 for 2cm X 2cm firm area at injection site on right thigh. Note: Vaccines were documented as PEDIARIX, Varicella >Left thigh, MMR -right thigh, IPV - Right arm, However when patient returned on 4/4/17 for follow-up she had the following, 2-injection sites - right thigh, 1 injection site - Left thigh, 1- injection site- Right arm. We believe the MA that gave and documented the vaccines reversed the thigh given. DTaP component of PEDIARIX most likely cause of reaction.
Age: 6.0
Sex: M
Vaccine: DTAP, FLUX, DTAP, FLUX
Symptoms: Administration site pain, Administration site swelling, Injection site erythema
Clinical narrative: Redness. Swelling. Pain at administration site. Inj. done at HD - lot/location unknown unavailable.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness. Swelling and pain at DTaP injection site.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt given DTaP instead of TDaP. No adverse reaction.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: Can't use my left arm now the joint in my arm hurt and the muscle in my arm the movement in my (L) arm can't work. Use my right arm to move my Left arm.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Dermatitis diaper, Haematochezia, Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: Rash in diaper blood present after visit for shots but either spread or new rash developed on trunk and URI and fever.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Gave patient the immunization. About 40 minutes later she came back to the pharmacy and said her chest felt tight and she was having difficulty taking a deep breath. Also bright red patchy swelling around injection site.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccines given too early.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Flu vaccine administered 9/16 - Subseq. Acute pain for 1 week at inj. site. Thereafter worsening pain in (L) arm and limited R.O.M. Misdiagnosed by family Dr. and properly diagnosed by Orth. surgeon after x-ray and MRI. -Cortisone inj. and PT.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dry throat, Euphoric mood, Feeling abnormal
Clinical narrative: Hepatitis B vaccine given at 1657; 1707 employee complained of "feeling funny", medicine head like, "head rush" Blood pressure 129/79, pulse 78 at 1708. Complained of dry throat, given water, denied any other symptoms. Stated "feel high". Employee stated at end of reaction she had felt faint at the beginning of her reaction. 1722, employee denied any symptoms. 1735, agency notified, no further treatment needed.
Age: 1.25
Sex: M
Vaccine: HIBV, TDAP, HIBV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.25
Sex: M
Vaccine: HIBV, TDAP, HIBV, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given expired vaccine. No adverse reaction.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given expired vaccine. No adverse reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Abdominal pain upper, Headache, Influenza virus test negative, Pain in extremity, Pyrexia
Clinical narrative: Mom reports child woke up 4/14/17 with fever of 101 F. Headache, stomach ache, legs hurting and "can't see". Advised to take to Dr or urgent care clinic. Parent took him to ER. Temp was 101 F. Mom says ER physician suspected strep or influenza (both tests negative). 4/17/17 spoke to mom, child doing fine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Streptococcus test negative, Visual impairment
Clinical narrative: Mom reports child woke up 4/14/17 with fever of 101 F. Headache, stomach ache, legs hurting and "can't see". Advised to take to Dr or urgent care clinic. Parent took him to ER. Temp was 101 F. Mom says ER physician suspected strep or influenza (both tests negative). 4/17/17 spoke to mom, child doing fine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Reaction on right deltoid; MENACTRA was given, arm was red, swollen, stated itchy. Skin felt hard. Temperature 97.6, Respirations 20, Oxygen 98%. Treatment: Continue taking KEFLEX, should cover both UTI and arm. Recommend cool compresses and BENADRYL for itching.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash, Urticaria
Clinical narrative: Patient states she had rash on legs and hives spread over body. This resolved after one day. Patient still has rash near site of injection after 6 days. She states it still itches, but has improved in appearance.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient reported 8/10 pain at injection site hours after receiving flu and PNEUMOVAX vaccine. She self treated with TYLENOL on 4/6/17 (late evening) and came in to care on 4/7 at 2pm for evaluation. Ice pack applied, continued TYLENOL for pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling (R) thigh. 2 days post administration. Denies fever.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Started with diarrhea 0500 today. Stomach feels like aliens inside it.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pyrexia, Tremor
Clinical narrative: Adverse effects were fever of 102, shaky, chills, body aches. Redness.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Irregular, erythematous patch over left outer arm at injection site.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, emesis.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: MCV4 #1 was administered on L/arm. Pt. had a local reaction to site (red swollen).
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: Administered PENTACEL instead of HIB.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Nausea
Clinical narrative: 12 noon received shot 4-25-17. 8 pm - metallic taste and severe nausea. Called 911 - Ambulance to E.R.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood alcohol normal, Cerebrovascular accident, Computerised tomogram normal, Drug screen negative, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 638734) under the Freedom of Information Act refers to a 12 year old female patient. There were no current illnesses. She had a history of migraine headaches. The patient's other medications included topiramate (manufacturer unknown) (25 mg by mouth every night at bedtime). On 08-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 (lot # L045700, expiry date: not provided) via intramuscular route, for unknown indication. On the same day after vaccination, the patient experienced nausea, vomiting, numbness and tingling. She also developed stroke like symptoms which caused her mother to report to hospital. While the patient was inpatient, her computed tomography (CT) scan was completed and was found within normal limits. Magnetic resonance angiography (MRA)/ magnetic resonance venography (MRV), urine drug screen, blood alcohol were also evaluated and found within normal limits. A urine pregnancy test was completed which was also negative. The patient was treated with 25 mg Topiramate by mouth every night at bedtime. On 10-JUN-2016 at around 2:00 pm, the patient was discharged from the hospital. Outcome of the events were reported as recovered. Causality assessment was not provided. Reporter considered all the events to be serious due to hospitalization. Additional information is not expected as no information can be obtained from the local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Pregnancy test urine negative, Venogram normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 638734) under the Freedom of Information Act refers to a 12 year old female patient. There were no current illnesses. She had a history of migraine headaches. The patient's other medications included topiramate (manufacturer unknown) (25 mg by mouth every night at bedtime). On 08-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 (lot # L045700, expiry date: not provided) via intramuscular route, for unknown indication. On the same day after vaccination, the patient experienced nausea, vomiting, numbness and tingling. She also developed stroke like symptoms which caused her mother to report to hospital. While the patient was inpatient, her computed tomography (CT) scan was completed and was found within normal limits. Magnetic resonance angiography (MRA)/ magnetic resonance venography (MRV), urine drug screen, blood alcohol were also evaluated and found within normal limits. A urine pregnancy test was completed which was also negative. The patient was treated with 25 mg Topiramate by mouth every night at bedtime. On 10-JUN-2016 at around 2:00 pm, the patient was discharged from the hospital. Outcome of the events were reported as recovered. Causality assessment was not provided. Reporter considered all the events to be serious due to hospitalization. Additional information is not expected as no information can be obtained from the local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 638734) under the Freedom of Information Act refers to a 12 year old female patient. There were no current illnesses. She had a history of migraine headaches. The patient's other medications included topiramate (manufacturer unknown) (25 mg by mouth every night at bedtime). On 08-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 (lot # L045700, expiry date: not provided) via intramuscular route, for unknown indication. On the same day after vaccination, the patient experienced nausea, vomiting, numbness and tingling. She also developed stroke like symptoms which caused her mother to report to hospital. While the patient was inpatient, her computed tomography (CT) scan was completed and was found within normal limits. Magnetic resonance angiography (MRA)/ magnetic resonance venography (MRV), urine drug screen, blood alcohol were also evaluated and found within normal limits. A urine pregnancy test was completed which was also negative. The patient was treated with 25 mg Topiramate by mouth every night at bedtime. On 10-JUN-2016 at around 2:00 pm, the patient was discharged from the hospital. Outcome of the events were reported as recovered. Causality assessment was not provided. Reporter considered all the events to be serious due to hospitalization. Additional information is not expected as no information can be obtained from the local health authority.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Cellulitis to left upper thigh. Induration, erythema, and warmth to site. Approximately 10cm x 10cm. DTaP & Hep A were administered to left thigh.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: MOTHER REPORTED THAT DURING INFANTS VISIT AN OLDER SIBLING WAS ALSO TO BE VACCINATED. MOTHER STATES THAT NURSE PREPARED THE VACCINES AND PLACED THEM IN AN ENVELOPE FOR PHYSICIAN TO ADMINISTER DURING VISIT, MOTHER STATES PHYSICIAN DID NOT EXAMINE EACH VACCINE AND ADMINISTERED 4 DOSES (HPV, ROTAVIRUS & 2 OTHERS). WHEN PHYSICIAN CONCLUDED THE VISIT, MOTHER STATES SHE ASKED ABOUT HER 13 YO SON'S VACCINES AND THE MISTAKE WAS THEN REALIZED. MOTHER REPORTED THAT INFANT RAN FEVER FOR SEVERAL DAYS FOLLOWING VACCINE ADMIN, SHE TOOK THE INFANT TO THE EMERGENCY ROOM ON 12/29/16. MOTHER STATES SEVERAL OTHER ER VISITS MADE. INFANT CONTINUED TO HAVE FEVER ON AND OFF, BEGAN HAVING WHAT APPEARED TO BE LIMB WEAKNESS AND A DECREASED APPETITE. INFANT WAS BOTTLE AND BREAST FED WITHOUT ISSUE BEFORE VACCINE INCIDENT BUT HAD FEEDING DIFFICULTIES AFTER. A NEW PEDIATRICIAN WAS SOUGHT AND STARTED SEEING DR ABOUT THE ISSUES. INFANT WAS NOT PROGRESSING/GROWING WELL AND NOT ACHIEVING AGE MILESTONES. AT TIME OF VACCINE RECEIPT (12/29/16) INFANT WAS 11 LBS, DURING PHONE CALL W MOTHER (3/21/17) INFANT WAS 13 LBS AND NOT GAINING WEIGHT DUE TO FEEDING PROBLEMS/WEAKNESS. DR REFERRED PATIENT TO HOSPITAL TO RULE OUT HYPONEUTREMIA. INFANT WAS SEEN BY DR, NEUROBIOLOGIST, INFANT WAS ADMITTED 2/17/17 AND DISCHARGED 2/24/17. A GASTRIC FEEDING TUBE WAS ADMINISTERED, BLOOD TESTS INDICATED PATIENT HAD HYPONEUTREMIA, SODIUM LEVELS WERE HIGH. THE INCIDENT WAS REPORTED TO MERCK. MOTHER IS CONCERNED ABOUT ALUMINUM LEVELS IN HPV VACCINE ADMINISTERED. MOTHER STATES A FOLLOW UP EEG IS PLANNED IN MAY FOR THE INFANT.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Blood sodium increased, Decreased appetite, Developmental delay, Drug administered to patient of inappropriate age, Failure to thrive
Clinical narrative: MOTHER REPORTED THAT DURING INFANTS VISIT AN OLDER SIBLING WAS ALSO TO BE VACCINATED. MOTHER STATES THAT NURSE PREPARED THE VACCINES AND PLACED THEM IN AN ENVELOPE FOR PHYSICIAN TO ADMINISTER DURING VISIT, MOTHER STATES PHYSICIAN DID NOT EXAMINE EACH VACCINE AND ADMINISTERED 4 DOSES (HPV, ROTAVIRUS & 2 OTHERS). WHEN PHYSICIAN CONCLUDED THE VISIT, MOTHER STATES SHE ASKED ABOUT HER 13 YO SON'S VACCINES AND THE MISTAKE WAS THEN REALIZED. MOTHER REPORTED THAT INFANT RAN FEVER FOR SEVERAL DAYS FOLLOWING VACCINE ADMIN, SHE TOOK THE INFANT TO THE EMERGENCY ROOM ON 12/29/16. MOTHER STATES SEVERAL OTHER ER VISITS MADE. INFANT CONTINUED TO HAVE FEVER ON AND OFF, BEGAN HAVING WHAT APPEARED TO BE LIMB WEAKNESS AND A DECREASED APPETITE. INFANT WAS BOTTLE AND BREAST FED WITHOUT ISSUE BEFORE VACCINE INCIDENT BUT HAD FEEDING DIFFICULTIES AFTER. A NEW PEDIATRICIAN WAS SOUGHT AND STARTED SEEING DR ABOUT THE ISSUES. INFANT WAS NOT PROGRESSING/GROWING WELL AND NOT ACHIEVING AGE MILESTONES. AT TIME OF VACCINE RECEIPT (12/29/16) INFANT WAS 11 LBS, DURING PHONE CALL W MOTHER (3/21/17) INFANT WAS 13 LBS AND NOT GAINING WEIGHT DUE TO FEEDING PROBLEMS/WEAKNESS. DR REFERRED PATIENT TO HOSPITAL TO RULE OUT HYPONEUTREMIA. INFANT WAS SEEN BY DR, NEUROBIOLOGIST, INFANT WAS ADMITTED 2/17/17 AND DISCHARGED 2/24/17. A GASTRIC FEEDING TUBE WAS ADMINISTERED, BLOOD TESTS INDICATED PATIENT HAD HYPONEUTREMIA, SODIUM LEVELS WERE HIGH. THE INCIDENT WAS REPORTED TO MERCK. MOTHER IS CONCERNED ABOUT ALUMINUM LEVELS IN HPV VACCINE ADMINISTERED. MOTHER STATES A FOLLOW UP EEG IS PLANNED IN MAY FOR THE INFANT.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Gastrointestinal tube insertion, Hyponatraemia, Muscular weakness, Pyrexia, Selective eating disorder
Clinical narrative: MOTHER REPORTED THAT DURING INFANTS VISIT AN OLDER SIBLING WAS ALSO TO BE VACCINATED. MOTHER STATES THAT NURSE PREPARED THE VACCINES AND PLACED THEM IN AN ENVELOPE FOR PHYSICIAN TO ADMINISTER DURING VISIT, MOTHER STATES PHYSICIAN DID NOT EXAMINE EACH VACCINE AND ADMINISTERED 4 DOSES (HPV, ROTAVIRUS & 2 OTHERS). WHEN PHYSICIAN CONCLUDED THE VISIT, MOTHER STATES SHE ASKED ABOUT HER 13 YO SON'S VACCINES AND THE MISTAKE WAS THEN REALIZED. MOTHER REPORTED THAT INFANT RAN FEVER FOR SEVERAL DAYS FOLLOWING VACCINE ADMIN, SHE TOOK THE INFANT TO THE EMERGENCY ROOM ON 12/29/16. MOTHER STATES SEVERAL OTHER ER VISITS MADE. INFANT CONTINUED TO HAVE FEVER ON AND OFF, BEGAN HAVING WHAT APPEARED TO BE LIMB WEAKNESS AND A DECREASED APPETITE. INFANT WAS BOTTLE AND BREAST FED WITHOUT ISSUE BEFORE VACCINE INCIDENT BUT HAD FEEDING DIFFICULTIES AFTER. A NEW PEDIATRICIAN WAS SOUGHT AND STARTED SEEING DR ABOUT THE ISSUES. INFANT WAS NOT PROGRESSING/GROWING WELL AND NOT ACHIEVING AGE MILESTONES. AT TIME OF VACCINE RECEIPT (12/29/16) INFANT WAS 11 LBS, DURING PHONE CALL W MOTHER (3/21/17) INFANT WAS 13 LBS AND NOT GAINING WEIGHT DUE TO FEEDING PROBLEMS/WEAKNESS. DR REFERRED PATIENT TO HOSPITAL TO RULE OUT HYPONEUTREMIA. INFANT WAS SEEN BY DR, NEUROBIOLOGIST, INFANT WAS ADMITTED 2/17/17 AND DISCHARGED 2/24/17. A GASTRIC FEEDING TUBE WAS ADMINISTERED, BLOOD TESTS INDICATED PATIENT HAD HYPONEUTREMIA, SODIUM LEVELS WERE HIGH. THE INCIDENT WAS REPORTED TO MERCK. MOTHER IS CONCERNED ABOUT ALUMINUM LEVELS IN HPV VACCINE ADMINISTERED. MOTHER STATES A FOLLOW UP EEG IS PLANNED IN MAY FOR THE INFANT.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Wrong patient received medication
Clinical narrative: MOTHER REPORTED THAT DURING INFANTS VISIT AN OLDER SIBLING WAS ALSO TO BE VACCINATED. MOTHER STATES THAT NURSE PREPARED THE VACCINES AND PLACED THEM IN AN ENVELOPE FOR PHYSICIAN TO ADMINISTER DURING VISIT, MOTHER STATES PHYSICIAN DID NOT EXAMINE EACH VACCINE AND ADMINISTERED 4 DOSES (HPV, ROTAVIRUS & 2 OTHERS). WHEN PHYSICIAN CONCLUDED THE VISIT, MOTHER STATES SHE ASKED ABOUT HER 13 YO SON'S VACCINES AND THE MISTAKE WAS THEN REALIZED. MOTHER REPORTED THAT INFANT RAN FEVER FOR SEVERAL DAYS FOLLOWING VACCINE ADMIN, SHE TOOK THE INFANT TO THE EMERGENCY ROOM ON 12/29/16. MOTHER STATES SEVERAL OTHER ER VISITS MADE. INFANT CONTINUED TO HAVE FEVER ON AND OFF, BEGAN HAVING WHAT APPEARED TO BE LIMB WEAKNESS AND A DECREASED APPETITE. INFANT WAS BOTTLE AND BREAST FED WITHOUT ISSUE BEFORE VACCINE INCIDENT BUT HAD FEEDING DIFFICULTIES AFTER. A NEW PEDIATRICIAN WAS SOUGHT AND STARTED SEEING DR ABOUT THE ISSUES. INFANT WAS NOT PROGRESSING/GROWING WELL AND NOT ACHIEVING AGE MILESTONES. AT TIME OF VACCINE RECEIPT (12/29/16) INFANT WAS 11 LBS, DURING PHONE CALL W MOTHER (3/21/17) INFANT WAS 13 LBS AND NOT GAINING WEIGHT DUE TO FEEDING PROBLEMS/WEAKNESS. DR REFERRED PATIENT TO HOSPITAL TO RULE OUT HYPONEUTREMIA. INFANT WAS SEEN BY DR, NEUROBIOLOGIST, INFANT WAS ADMITTED 2/17/17 AND DISCHARGED 2/24/17. A GASTRIC FEEDING TUBE WAS ADMINISTERED, BLOOD TESTS INDICATED PATIENT HAD HYPONEUTREMIA, SODIUM LEVELS WERE HIGH. THE INCIDENT WAS REPORTED TO MERCK. MOTHER IS CONCERNED ABOUT ALUMINUM LEVELS IN HPV VACCINE ADMINISTERED. MOTHER STATES A FOLLOW UP EEG IS PLANNED IN MAY FOR THE INFANT.
Age: 0.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: No adverse event, Wrong patient received medication
Clinical narrative: Information has been received from a medical assistant on 11-APR-2017, concerning a 4 day old female patient, who has 1 sibling and had a birth weight of 9 lb and 11 oz. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-MAR-2017 at 12:00 pm, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB via intramuscular in the left (site not specified), lot # M036056 (Strength, dose and expiration date were not reported. The patient's concomitant medications included ROTATEQ, PEDIARIX and pneumococcal 13v conj vaccine (crm197). No adverse reactions were reported. This is one of two reports received from the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006224:
Age: 0.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant on 11-APR-2017, concerning a 4 day old female patient, who has 1 sibling and had a birth weight of 9 lb and 11 oz. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-MAR-2017 at 12:00 pm, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB via intramuscular in the left (site not specified), lot # M036056 (Strength, dose and expiration date were not reported. The patient's concomitant medications included ROTATEQ, PEDIARIX and pneumococcal 13v conj vaccine (crm197). No adverse reactions were reported. This is one of two reports received from the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006224:
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Burning sensation, Bursitis, Diarrhoea, Gastrointestinal disorder
Clinical narrative: Pain and tingling/burning immediately in left arm following injection. Since then experienced tingling and same sensation in other arm, and started in legs about a month ago. Also had squeezing pressure at injection site. Doctor med NSAIDs.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Incorrect route of drug administration, Injected limb mobility decreased, Injection site cyst, Injection site pain
Clinical narrative: Pain and tingling/burning immediately in left arm following injection. Since then experienced tingling and same sensation in other arm, and started in legs about a month ago. Also had squeezing pressure at injection site. Doctor med NSAIDs.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nausea, Nuclear magnetic resonance imaging abnormal, Pain, Paraesthesia, Pharyngitis streptococcal
Clinical narrative: Pain and tingling/burning immediately in left arm following injection. Since then experienced tingling and same sensation in other arm, and started in legs about a month ago. Also had squeezing pressure at injection site. Doctor med NSAIDs.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Pain and tingling/burning immediately in left arm following injection. Since then experienced tingling and same sensation in other arm, and started in legs about a month ago. Also had squeezing pressure at injection site. Doctor med NSAIDs.