chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Malaise, Pyrexia
Clinical narrative: Diarrhea, headache, insomnia, malaise, fatigue, and low grade fever started the day after the vaccine and continues.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Diarrhoea, Full blood count, Headache, Insomnia, Nausea
Clinical narrative: Diarrhea, headache, insomnia, malaise, fatigue, and low grade fever started the day after the vaccine and continues.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pyrexia, Somnolence
Clinical narrative: Diarrhea, headache, insomnia, malaise, fatigue, and low grade fever started the day after the vaccine and continues.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Autism spectrum disorder, Developmental delay, Developmental regression, Encephalopathy, Moaning
Clinical narrative: 2 days after vaccination developed somnolence, fever, rash, constant moaning. Before vaccination using 20+ words fluently, since 2/16/17 he is non-verbal. He has been diagnosed with speech regression, developmental delay, encephalopathy, autism spectrum disorder.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Somnolence, Speech disorder
Clinical narrative: 2 days after vaccination developed somnolence, fever, rash, constant moaning. Before vaccination using 20+ words fluently, since 2/16/17 he is non-verbal. He has been diagnosed with speech regression, developmental delay, encephalopathy, autism spectrum disorder.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 3 1/2" x 3 1/2" red, warm swollen area surrounding the vaccine site on left thigh. 2 1/2" 1 1/2" red, warm, swollen area surrounding the vaccine site on right thigh.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, pain and swelling that spread to wrist that lasted 3 weeks. Was seen by MD and prescribed oral steroids.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood count, Diabetes mellitus, Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: Redness at site, then a raised area, infection at site, (dead skin), which resulted in a wound, still in treatment, from September 6, 2017. Also after shot very sick, fever, sick to stomach, very sore arm red at site. The shot gave me a blood clot, which became infected. I have suffered from pain at site. Since the wound was so deep it has taken a very long time to heal, once it is healed it will take 6 months or a year to fully heal. Of course I will have a scar, left arm. I have had to buy supplies. Pain from healing. I feel as a older 66 years old, I would not had received this booster shot. I did recover somewhat. The effects rule my life. My arm will never be the same. The company needs to know this fact.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site scab, Injection site scar, Injection site swelling, Malaise
Clinical narrative: Redness at site, then a raised area, infection at site, (dead skin), which resulted in a wound, still in treatment, from September 6, 2017. Also after shot very sick, fever, sick to stomach, very sore arm red at site. The shot gave me a blood clot, which became infected. I have suffered from pain at site. Since the wound was so deep it has taken a very long time to heal, once it is healed it will take 6 months or a year to fully heal. Of course I will have a scar, left arm. I have had to buy supplies. Pain from healing. I feel as a older 66 years old, I would not had received this booster shot. I did recover somewhat. The effects rule my life. My arm will never be the same. The company needs to know this fact.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Thrombosis, Wound
Clinical narrative: Redness at site, then a raised area, infection at site, (dead skin), which resulted in a wound, still in treatment, from September 6, 2017. Also after shot very sick, fever, sick to stomach, very sore arm red at site. The shot gave me a blood clot, which became infected. I have suffered from pain at site. Since the wound was so deep it has taken a very long time to heal, once it is healed it will take 6 months or a year to fully heal. Of course I will have a scar, left arm. I have had to buy supplies. Pain from healing. I feel as a older 66 years old, I would not had received this booster shot. I did recover somewhat. The effects rule my life. My arm will never be the same. The company needs to know this fact.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Incorrect route of drug administration, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a male 4 years old patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 25-JUL-2017 at 12:58, the patient was inadvertently administered PROQUAD Therapy type rHA (recombinant human albumin), first dose, intramuscular (lot #M042500, expiration date, dose and schedule were not provided) instead of M-M-R II (lot #, expiration date, dose and schedule were not provided). On 25-JUL-2017 at 12:03, the patient also received VARIVAX second dose intramuscular (lot # M014309, expiration date, dose and schedule were not provided). Concomitant therapies included sterile diluent. The patient did not experience any adverse event.
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: This spontaneous case initially received on 12-Jan-2017, was reported by a health authority and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient was nauseated (outcome: not reported). Linked Case ID(s): US-BEH-2017077176 (same patient) 27-DEB-2017 (System Update): Linked Case ID(s):2017077176 (Patient Link).
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious intitial spontaneous case, was received on 11-Sep-2017 from pharmacist, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: not reported). The administered vaccine reached 64.9-degree F instead of storing at 36-46 degree F for up to 12 hours, which was considered as incorrect product storage and drug administration error. It was reported that, no adverse reactions were observed. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Age: 72.0
Sex: M
Vaccine: DTP
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: Rash, erythema multiforme and urticaria pruritus. Diphenhydramine 25 mg qid, Prednisone 25 mg every day, Ranitidine 150 mg bid.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2017US007591, is an initial spontaneous report received from a medical assistant on 09 Mar 2017. This report refers to 03 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 168905, Expiry date May 2017) at a dose of 0.5 ml intramuscularly on 08 Mar 2017. On the same day a 3.5 year old child patient received treatment with FLUVIRIN. No adverse event was reported following this medication error. The case was assessed as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: Case number PHEH2017US005404, is an initial spontaneous report received from a nurse on 17 Feb 2017. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (seasonal, batch number: not reported) at a dose of 0.5 ml on an unknown date in Sep 2016 subcutaneously. On an unknown date after vaccination, the patient developed red, raised rash from elbow to under arm of injection site. It was also reported that, the injection was given in a different physician office and nurse believed it might had been given subcutaneously instead of intramuscularly. The patient fully recovered from vaccination site rash, rash popular and rash erythematous on an unknown date. These events vaccination site rash, rash erythematous and rash papular were considered non-serious by the nurse. The causality of he events was not reported.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 06-Sep-2017 from pharmacist (pharmacy technician), concerning a 21-year-old adult male patient. On 06-Sep-2017, the patient was administered FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: Apr-2018, dose, route of administration: intramuscular and anatomical location: not reported). On an unspecified date, the vaccine underwent temperature excursion, which was considered as incorrect product storage. On 06-Sep-2017, the patient was administered with vaccine, which underwent temperature excursion instead of storing at 36-46 degree F (2-8 degree Celsius), which was considered as drug administration error. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US030151, is an initial spontaneous report received from a pharmacist on 14 Nov 2016. This report refers to a 49 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with a single dose of FLUVIRIN (seasonal, batch number: 1619021) at a dose of 0.5 ml intramuscularly on 14 Nov 2016. It was reported that the administered vaccine had a possible temperature excursion up to 54 Fahrenheit for up to 3 to 4 hours because of the power outage from 6:00 hours on 13 Nov 2016 to 09:00 hours on 14 Nov 2016. It was first time excursion and the patient had received the vaccine from the opened multi dose vial). No adverse event was reported following this medication error (incorrect storage of drug). The case was assessed as non serious by the pharmacist.
Sex: F
Vaccine: FLU3
Symptoms: Ear swelling, Fatigue, Influenza like illness, Oropharyngeal pain, Rash
Clinical narrative: Case number PHEH2016US032407, is an initial spontaneous report received from a consumer on 08 Dec 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Vaccination history included administration of flu shot (manufacturer unknown, batch number: not reported) from which the patient never had reaction. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1620201, expiry date: May 2017) at a dose of 0.5 ml intramuscularly on 08 Nov 2016. Two days after vaccination on 10 Nov 2016, the patient experienced flu like symptoms (sore throat, fatigue). On 25 Nov 2016, the patient broke out into bite like rash on neck, shoulder then moved to back, side of face and ear. On 28 Nov 2016, the patient developed ear swelling. On 30 Nov 2016, the patient went to physician and was misdiagnosed and given VALTREX 2 gm daily for Herpes which made rash worse. The patient went back to physician on 07 Dec 2016 and was given ZYRTEC and ZANTAC for rash. The outcome of the events was reported as complete recovery on 12 Nov 2016 for flu symptoms (sore throat, fatigue) and on 07 Dec 2016 for rash and ear swelling. The seriousness of the events was reported as non serious and causality not reported.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2017US002364, is an initial spontaneous report received from a nurse on 18 Jan 2017. This report refers to a 27 year old patient of unspecified gender. Medical history included prior vaccination and tolerated in past and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619224) intramuscularly in left deltoid at a dose of 0.5 ml on 06 Dec 2016 at 13.46. It was reported that the patient received the second dose of FLUVIRIN (batch number: 168904) intramuscularly in left deltoid at a dose of 0.5 ml on 04 Jan 2017 at 15.05 PM in same season. Nurse reported that a patient received two dose of FLUVIRIN in one season (inappropriate schedule of vaccine administered). No adverse reaction was reported following this administration error. The case was assessed as non-serious by the nurse. Follow up report received from a nurse on 09 Feb 2017: Medical history (prior vaccination and tolerated in past), patient details (weight and height), and dosage regimen anatomical location and time updated. Narrative amended accordingly.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial non-serious spontaneous case, was received on 03-Oct-2017, from other health professional, concerning a 68-year-old elderly male patient. The patient's medical history and medication history was not reported. On 03-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid muscle, batch number: 1620301, expiry date: May-2017, trade name, manufacturer: not reported). It was reported that last year's FLUVIRIN was administered to patient (explicitly coded as Expired vaccine used). Reporter stated that, the patient did not experience any adverse reaction. The reporter assessed this event as non-serious. Follow-up received on 12-Oct-2017: Reporter stated that, the vaccine was administered intramuscularly in the deltoid muscle of upper arm and confirmed that, the patient did not experience adverse reaction.
Sex: F
Vaccine: FLUX
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US001429, is an initial spontaneous report received from a nurse on 11 Jan 2017. This report refers to a female patient of an unspecified age. Prior vaccination history included as, patient vaccinated with FLUVIRIN vaccine and it was well tolerated. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618501 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 06 Jan 2017. It was reported that, FLUVIRIN MULTI DOSE vials (MDV) that reached 34.3 Fahrenheit for multiple excursions since 04 Jan 2017, was administered on 06 Jan 2017. It was reported that, patient was vaccinated with second flu shot with another flu vaccine. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse. Follow up reported received from a pharmacist on 02 Feb 2017: Added prior vaccination history and reporter comment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US032718, is an initial spontaneous report received from a pharmacist on 12 Dec 2016. This report refers to a 52 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated from multi dose vial of FLUVIRIN (batch number: 1619901, expiry date: May 2017) subcutaneously at a dose of 0.5 ml which was reached 69 Fahrenheit for no longer than 24 hours on 10 Dec 2016. No adverse event was reported following this administration error. The seriousness of the event was reported as non serious.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Product preparation error
Clinical narrative: Case number PHEH2016US030931, is an initial spontaneous report received from a nurse (patient's mother) on 21 Nov 2016. This report refers to a 30 years old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (seasonal, batch number: not reported) intramuscularly at a dose of 0.5 ml on an unknown date. It was reported, that the patient  received a vaccine that already had the needle on it from the refrigerator. The patient was overly tired and was afraid, as the vaccine sterile seal was broken, he might have been harmed. The reporter stated, that the patient taught school and college students and was exhausted from that. The outcome of the event overly tired was not reported. The seriousness of the event overly tired was not reported and for medication error it was reported on seriously and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHEH2016US030851, is an initial spontaneous report received from a physician via Pfizer Inc on 22 Nov 2016. This report refers to an adult female patient. Past medical history was not reported. Current condition included as allergy to LOVENOX, all calcium channel blocker, Vitamin C, Ferrous sulfate, Multiple Vitamin, Vitamin D3, ZYRTEC, NEURONTIN, REVATIO, Metoprolol ER, Tizanidine, Promethazine, Duloxetine, Dicyclomine, Pantoprazole, Amoxicillin, XARELTO, Bumetanide, Metolazone, Biotin, Pravastatin, NORCO, Calcitriol, HYSLINGA ER, Cyanocobalamin, Folic Acid, Calcium Citrate, VSL 3 Probiotic, VESICARE, SYMBICORT, SYNTHROID and Ondansetron. Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unspecified date, the patient had allergy to FLUVIRIN. The outcome, seriousness and causality of the event were not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US030914, is an initial spontaneous report received from a nurse on 22 Nov 2016. This report refers to a 56 years old female patient (non-pregnant). Past medical history and concomitant medication were not reported. The vaccine was well tolerated in the past (unspecified details). The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1516401, expiration date: Jun 2016) at 2:30 PM on 22 Nov 2016 at a dose of 0.5 ml, intramuscularly in right deltoid. On the same day at 2:45 PM the patient was revaccinated with FLUVIRIN in left deltoid. It was reported that the patient did not have an adverse reaction from outdated vial of FLUVIRIN. No adverse event was reported following this medication error. Follow up report received on 23 Dec 2016: added patient demographics (height and weight) and vaccination details.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2016US031011, is an initial spontaneous report received from a nurse on 24 Nov 2016. This report refers to a 91 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620501 and expiry date: Jun 2017) at a dose of 0.5 intramuscularly on 17 Nov 2016 and on 23 Nov 2016. The nurse stated that, no adverse effects were noted after this maladministration.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2016US031071, is an initial spontaneous report received from a nurse on 24 Nov 2016. This report refers to a 77 years old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620501, expiry date: Jun 2017) intramuscularly at a dose of 0.5 ml, twice in this flu season on 17 Nov 2016 and again on 23 Nov 2016, had an overdose accidental. No adverse event was reported following this medication error. The overdose accidental was reported as non serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2016US031991, is an initial spontaneous report received from a pharmacist on 05 Dec 2016. This report refers to a 55 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated FLUVIRIN (batch number: not reported) on 11 Nov 2016. On the same day while vaccination, the vaccine squirted on the husband of patient sitting beside her and ran down her arm. The pharmacist concerned that she did not receive enough vaccine to protect herself from the influenza. No adverse event was reported following this administration error. Follow up report received from a consumer on 15 Dec 2016: updated patient demographics (initials and age), suspect drug coding (changed from influenza vaccine to FLUVIRIN vaccine) and vaccination date.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Headache, Myalgia, Sensation of foreign body
Clinical narrative: Case number PHEH2016US032011, is an initial spontaneous report received from a consumer (patient's wife) on 05 Dec 2016. This report refers to a 38 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620501, expiration date: Jun 2017) on 26 Nov 2016 at a dose of 0.5 ml, intramuscularly. On an unknown date (few days after the injection), the patient had a headache and muscle pain in back of his neck. The patient went to a physician who diagnosed him with dysphagia. On an unknown date, the patient felt like a lump in his throat. The outcome of the event dysphagia was reported as condition unchanged and the outcome of the other events was not reported. The seriousness and outcome of the events were not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US032028, is an initial spontaneous report received from a medical assistant on 05, 2016. This report refers to a 46 years old female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer, batch number: not reported) at a dose of 0.5 ml intramuscularly into right arm on an unknown date with no side effects (well tolerated). Past medical history was not reported. Current condition included asthma. Concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (seasonal, batch number: not reported, Expiry date: Sep 2017) a t a dose of 0.5 ml subcutaneously into right arm on 01 Dec 2016 at 4:30 PM. It was reported that, the patient received FLUVIRIN as an injection in the back of the arm with a 1 inch 25 gauge needle, not in the deltoid muscle. The patient did not feel it was an intramuscular injection, reporter stated it was subcutaneous injection. No adverse event reported following this medication error (inappropriate route of vaccination and vaccine administered at inappropriate site). The Quality Assurance department confirmed that the initially reported batch number 1669901 and the follow up batch number Revie0018003 were not valid for FLUVIRIN. Follow up report received from a medical assistant on 06 Jan 2017: Updated reporter details (fax number), added patient demographics (height and weight), added prior vaccination history, current condition (asthma) and updated FLUVIRIN information (the dosage regimen anatomical location for FLUVIRIN and time of administration).
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US032279, is an initial spontaneous report received from a pharmacist on 07 Dec 2016. This report refers to a patient of unknown age and gender. Medical history included nursing home patient. Concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. The patient was administered last year vaccine by mistake. The pharmacist reported that, the 2015/2016 FLUVIRIN vaccine was still in the medicine refrigerator. No adverse event was reported following this maladministration (expired product administered).
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US032977, is an initial spontaneous report received from a pharmacist on 15 Dec 2016. This report refers to a 31 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901 and expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 15 Dec 2016. It was reported that, patient vaccinated with FLUVIRIN following a temperature excursion of 56.5 Fahrenheit for 7 hours on 15 Dec 2016. No adverse event was reported following this medication error.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Youth started complaining of feeling dizzy and weak and has a headache.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Blood test, Measles, Pyrexia, Rash, Urine analysis
Clinical narrative: She had fever for multiple days, a rash started and lasted for about a month, she was hospitalized for unknown upper respiratory virus and was put on oxygen.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Viral upper respiratory tract infection
Clinical narrative: She had fever for multiple days, a rash started and lasted for about a month, she was hospitalized for unknown upper respiratory virus and was put on oxygen.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: PT REPORTS RASH ARISING TWO HOURS AFTER INJECTION 2 INCHES BELOW INJECTION SITE. AREA WAS ALSO RED. ABOVE INJECTION SITE WAS "FEVERISH." APPLIED ICE Q2 HOURS FOR EVENING.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Left thigh was bright red. Left leg was swollen. Fever, lethargic from Thursday night 11/30/17 to Saturday 12/2/17.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainting immediately after vaccine administration.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: 27 YO FEMALE - 26.4 EGA - COMPLAINED OF PAIN AND SWELLING 3 DAYS AFTER THE INJECTION - COMPLAINED THAT IT SEEMED TO BE GETTING WORSE -  SPOKE WITH PRESCRIBING PHYSICIAN'S OFFICE AND THE ADVISED THE PATIENT TO US ICED PACKS AND TAKE TYLENOL.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, Clostridium test negative, Culture stool negative, Dermatitis diaper, Diarrhoea
Clinical narrative: Watery, green diarrhea 6-8 times per day for 3 weeks with abrupt onset and offset. Diaper rash associated with diarrhea frequency. No fever. No vomiting. No change in appetite. Diarrhea led to weight loss from 13.48 pounds on the day of vaccination to 13.38 pounds 17 days later dropping a full percentile group (from 75th percentile to 50th percentile) on the growth charts. Weight gain after resolution of diarrhea, but still not back to 75th percentile as of 1/4/18.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Escherichia test negative, Faeces discoloured, Full blood count normal, Metabolic function test normal, Weight decreased
Clinical narrative: Watery, green diarrhea 6-8 times per day for 3 weeks with abrupt onset and offset. Diaper rash associated with diarrhea frequency. No fever. No vomiting. No change in appetite. Diarrhea led to weight loss from 13.48 pounds on the day of vaccination to 13.38 pounds 17 days later dropping a full percentile group (from 75th percentile to 50th percentile) on the growth charts. Weight gain after resolution of diarrhea, but still not back to 75th percentile as of 1/4/18.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Weight gain poor
Clinical narrative: Watery, green diarrhea 6-8 times per day for 3 weeks with abrupt onset and offset. Diaper rash associated with diarrhea frequency. No fever. No vomiting. No change in appetite. Diarrhea led to weight loss from 13.48 pounds on the day of vaccination to 13.38 pounds 17 days later dropping a full percentile group (from 75th percentile to 50th percentile) on the growth charts. Weight gain after resolution of diarrhea, but still not back to 75th percentile as of 1/4/18.
Age: 16.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Large area of swelling followed by redness below the swollen site and pain.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Blood glucose normal, Chest X-ray normal, Computerised tomogram head normal, Decreased appetite, Disorientation
Clinical narrative: "Had her TRUMENBA and Flu shot yesterday and slept after that. She woke this AM and ate breakfast, Felt nauseated and did not eat any lunch. Presented to clinic due to numbness in her left arm from shoulder to elbow. This progressed over a couple of hours to weakness of her entire left arm. On arrival to clinic she started to have headache. Glucose was 96 and CBC and CMP are pending. She was given water and IV 1000 ml. During this time her headache escalated to pain of 10/10 and the very worst headache that she has ever had. As she continued to be disoriented and increasing headache as well as increasing weakness, she is transferred to the ED for CT scan and further work up. No fever, no diarrhea or vomiting--just nausea and unwilling to eat. Able to keep water down. Not wanting solids.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Full blood count normal, Headache, Human chorionic gonadotropin negative, Injection site hypoaesthesia, Metabolic function test normal
Clinical narrative: "Had her TRUMENBA and Flu shot yesterday and slept after that. She woke this AM and ate breakfast, Felt nauseated and did not eat any lunch. Presented to clinic due to numbness in her left arm from shoulder to elbow. This progressed over a couple of hours to weakness of her entire left arm. On arrival to clinic she started to have headache. Glucose was 96 and CBC and CMP are pending. She was given water and IV 1000 ml. During this time her headache escalated to pain of 10/10 and the very worst headache that she has ever had. As she continued to be disoriented and increasing headache as well as increasing weakness, she is transferred to the ED for CT scan and further work up. No fever, no diarrhea or vomiting--just nausea and unwilling to eat. Able to keep water down. Not wanting solids.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Muscular weakness, Nausea, Toxicologic test normal, Urine analysis normal
Clinical narrative: "Had her TRUMENBA and Flu shot yesterday and slept after that. She woke this AM and ate breakfast, Felt nauseated and did not eat any lunch. Presented to clinic due to numbness in her left arm from shoulder to elbow. This progressed over a couple of hours to weakness of her entire left arm. On arrival to clinic she started to have headache. Glucose was 96 and CBC and CMP are pending. She was given water and IV 1000 ml. During this time her headache escalated to pain of 10/10 and the very worst headache that she has ever had. As she continued to be disoriented and increasing headache as well as increasing weakness, she is transferred to the ED for CT scan and further work up. No fever, no diarrhea or vomiting--just nausea and unwilling to eat. Able to keep water down. Not wanting solids.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Laboratory test, Pallor, Seizure like phenomena, Syncope, Yawning
Clinical narrative: Shortly after vaccine was administered patient exhibited symtoms of seizure-like activity then fainted. Her mother was able to catch her and helped her to lay on floor. Withins a few seconds she woke up and was able to state her name and date of birth. Within a few minutes patient was placed in sitting position in a chair and observed for several minutes. She was pale, yawning, able to speak, able to take sips of water. Blood pressure was checked at approx. 5:15pm and was 97/67 with pulse 77. At approx. 5:30pm she was able to stand and walk out of store. Contacted patient's mother by phone at approx. 7:30pm to follow up and was informed by mother she took her to local Emergency room due to continued pallor and yawning. Mother reported tests were being ran. Contacted patient's primary care physician office 1/11/18 at 1:45pm and reported incident to employee in office. She reports patient was seen in office this morning for follow up to what was reported to them as fainting due to watching her little sister receive a vaccine. Per employee, patient appears to be doing okay.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Eye movement disorder, Full blood count normal, Loss of consciousness, Metabolic function test normal, Pallor
Clinical narrative: Shortly after vaccine was administered patient exhibited symtoms of seizure-like activity then fainted. Her mother was able to catch her and helped her to lay on floor. Withins a few seconds she woke up and was able to state her name and date of birth. Within a few minutes patient was placed in sitting position in a chair and observed for several minutes. She was pale, yawning, able to speak, able to take sips of water. Blood pressure was checked at approx. 5:15pm and was 97/67 with pulse 77. At approx. 5:30pm she was able to stand and walk out of store. Contacted patient's mother by phone at approx. 7:30pm to follow up and was informed by mother she took her to local Emergency room due to continued pallor and yawning. Mother reported tests were being ran. Contacted patient's primary care physician office 1/11/18 at 1:45pm and reported incident to employee in office. She reports patient was seen in office this morning for follow up to what was reported to them as fainting due to watching her little sister receive a vaccine. Per employee, patient appears to be doing okay.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Respiratory arrest, Skin discolouration, Syncope, Unresponsive to stimuli
Clinical narrative: Shortly after vaccine was administered patient exhibited symtoms of seizure-like activity then fainted. Her mother was able to catch her and helped her to lay on floor. Withins a few seconds she woke up and was able to state her name and date of birth. Within a few minutes patient was placed in sitting position in a chair and observed for several minutes. She was pale, yawning, able to speak, able to take sips of water. Blood pressure was checked at approx. 5:15pm and was 97/67 with pulse 77. At approx. 5:30pm she was able to stand and walk out of store. Contacted patient's mother by phone at approx. 7:30pm to follow up and was informed by mother she took her to local Emergency room due to continued pallor and yawning. Mother reported tests were being ran. Contacted patient's primary care physician office 1/11/18 at 1:45pm and reported incident to employee in office. She reports patient was seen in office this morning for follow up to what was reported to them as fainting due to watching her little sister receive a vaccine. Per employee, patient appears to be doing okay.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US033472, is an initial spontaneous report received from a pharmacist on 20 Dec 2016. This was also a quality complaint report. This report refers to 28 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620601, expiry date: Jun 2017) on 20 Dec 2016. It was reported that on the same day the plunger on the syringe was faulty and the patient received a partial dose. No product complaint was reported for FLUVIRIN. No adverse event was reported following this administration error. The pharmacist assessed the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via eye contact, No adverse event, Syringe issue
Clinical narrative: Case number PHEH2016US033577, is an initial spontaneous report received from a pharmacist on 20 Dec 2016. This report refers to a 35 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620601, expiry date: Jun 2017) at a dose of 0.5 ml intramuscularly on 20 Dec 2016. On the same day while administering the vaccine to patient, the pharmacist withdrew vaccine form multi dose vial (MDV) into syringe and then the vaccine splattered into pharmacist eye.  The pharmacist reported that, the plunger on the syringe was faulty. There was no product complaint for FLUVIRIN MDV. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm, soreness that did not subside.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Influenza virus test negative, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Swelling/redness at site of injection, fatique, overall muscle soreness.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Aphasia, Crying, Depressed mood, Dysstasia, Emotional distress
Clinical narrative: Stopped speaking, stopped standing, regressed in walking, mood changed to constantly unhappy and upset, always crying or grumpy.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Gait inability, Irritability, Mood altered
Clinical narrative: Stopped speaking, stopped standing, regressed in walking, mood changed to constantly unhappy and upset, always crying or grumpy.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt experienced redness and swelling in the arm after the injection. Pt was seen at PCP and it was thought to be maybe infection or allergy, but no antibiotic was prescribed.
Age: 3.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: AFLURIA was given to a 3 year old child by mistake.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram normal, Fall, Generalised tonic-clonic seizure, Head injury, Loss of consciousness
Clinical narrative: Received vaccine in seated position. Upon standing one minute later she experienced a syncopal episode followed by brief generalized tonic-clonic activity. Total duration of LOC less than one minute. No loss of bowel/bladder control or postictal state. She was evaluated in the ER due to having struck her head as she fell. She was observed in the ER and released to home.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Received vaccine in seated position. Upon standing one minute later she experienced a syncopal episode followed by brief generalized tonic-clonic activity. Total duration of LOC less than one minute. No loss of bowel/bladder control or postictal state. She was evaluated in the ER due to having struck her head as she fell. She was observed in the ER and released to home.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Rash erythematous, Rash macular
Clinical narrative: Right thigh with some induration, warmth and splotchy pink rash over injection site (DTaP 2 days ago). Rash over about 5cm diameter area. No fluctuance, purulence or cellulitis.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2016US033603, is an initial spontaneous report received from a pharmacist on 20 Dec 2016. This report refers to an unknown age of male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 01 Sep 2016. The patient received 02 flu shots for this season and all documentation had been lost. It was reported that, second vaccine administered 02 to 03 months ago (Sept 2016 or Oct 2016). No adverse event reported following this medication error. The case was assessed as non serious by the pharmacist.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Skin mass
Clinical narrative: Case number PHEH206US033909 is an initial spontaneous report received from physician via phone call on 28 Dec 2016. This report refers to 65 year old female patient. Medical history and concomitant medication was not reported, current condition included sulphur allergy, penicillin allergy, meat allergy, fish allergy, Chocolates allergy and macrolides allergy. The patient was vaccinated with FLUVIRIN (batch number: 16-2021) at a dose of 0.5 ml intramuscular on 19 Oct 2016. After vaccination a month later (date not reported) noticed a lump under her skin which was a size of pea and was not painful. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported. Follow up received from physician on 24 Jan 2017: Current condition added (sulphur allergy, penicillin allergy, meat allergy, fish allergy, chocolates allergy and macrolides allergy). Suspect drug details updated (lot number, start date, route of administration, dose) and updated narrative accordingly.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Device leakage, No adverse event
Clinical narrative: Case number PHEH2016US034237 is initial spontaneous report received from nurse on 27 Oct 2017. This is also a quality complaint report (QA reference number: 1017561). This report refers to 50 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619521, expiry date: 02 Apr 2017) at a dose of 0.5 ml intramuscular on 27 Oct 2016. The nurse reported that the patient received dose from leaking multi dose vial. The patient received a full dose. No vaccine leaked on patient or administrator. It was stated that, when drawing up vaccine out of multi dose vial it seems to be much pressure in the vial and the vaccine was dripping out from the rubber stopper; needle sized being used 25 gauge 1 inch. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse. Batch review report reference number [1017561] received from quality assurance department on 14 Dec 2016. Based on the document review, it was stated that the concerned FLUVIRIN batch number [1619521] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from Quality assurance department (QA reference number: 1017561) on 14 Dec 2016: Added QA investigation summary.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Vomiting, decrease appetite.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Feeling hot, Flushing, Malaise, Migraine
Clinical narrative: NOTE: Patient also received AFLURIA 2017-18 (Lot XT59606) simultaneously on the same left arm (higher location). Patient expressed symptoms of flushing on his face hours after receiving the vaccines. He also experienced warm sensation on his arm. He sensed he was going to get sick and bundled up for bed (jogging pants, thick socks, etc.). He woke up the next day feeling better but was experiencing a migraine which was a relieved with a dose of sumatriptan. Patient felt better/normal later that night 1/10/18.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Redness and induration 5 cm in size at injection site, fever as high as 102.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient had fever of 101.7 starting the night of receiving the shot and lasting for 2 days - no other problem or symptoms.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Pt states she had red spot about 1.5"x3/4" in size about 2" from site of vaccine. Denies pain or itching. Started today (one day after administration). Advised pt to use TYLENOL and BENADRYL if necessary as well as cool compresses and to advise if it gets worse.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood test, Burning sensation, Chromaturia, Rash generalised, Skin exfoliation
Clinical narrative: My father received the Flu vaccine on December 27, 2017. Per his verbalization, he did not get a vaccine information sheet nor was he given the option to decline the vaccine. On December 30, 2017, he states he developed a generalized rash, had an internal generalized burning sensation, voided urine that was red in color, and developed generalized skin peeling which has now worsened in his hands and his feet. He went to the ER on December 30, 2017 and they administered benadryl through injection. They prescribed him antihistamines and he followed up with his primary medical doctor a few days later. After seeing his primary medical doctor, he was referred to a dermatologist who prescribed him medications for the skin peeling. Per his verbalization, his doctor had him get blood work done recently and the results are pending.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Burning sensation, Chromaturia, Dermatitis, Haematuria
Clinical narrative: My father received the Flu vaccine on December 27, 2017. Per his verbalization, he did not get a vaccine information sheet nor was he given the option to decline the vaccine. On December 30, 2017, he states he developed a generalized rash, had an internal generalized burning sensation, voided urine that was red in color, and developed generalized skin peeling which has now worsened in his hands and his feet. He went to the ER on December 30, 2017 and they administered benadryl through injection. They prescribed him antihistamines and he followed up with his primary medical doctor a few days later. After seeing his primary medical doctor, he was referred to a dermatologist who prescribed him medications for the skin peeling. Per his verbalization, his doctor had him get blood work done recently and the results are pending.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pruritus generalised, Skin exfoliation
Clinical narrative: My father received the Flu vaccine on December 27, 2017. Per his verbalization, he did not get a vaccine information sheet nor was he given the option to decline the vaccine. On December 30, 2017, he states he developed a generalized rash, had an internal generalized burning sensation, voided urine that was red in color, and developed generalized skin peeling which has now worsened in his hands and his feet. He went to the ER on December 30, 2017 and they administered benadryl through injection. They prescribed him antihistamines and he followed up with his primary medical doctor a few days later. After seeing his primary medical doctor, he was referred to a dermatologist who prescribed him medications for the skin peeling. Per his verbalization, his doctor had him get blood work done recently and the results are pending.
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Macule, Rash, Skin exfoliation, Skin hyperpigmentation
Clinical narrative: Patient was here on MA schedule for second BEXSERO vaccination. However, he told the MA that he developed a rash on upper and lower extremities 2 weeks after the first injection. He did not have any breathing issues. Hyperpigmented macules with very mild scaling around the borders - located on both upper extremities and lower extremities. REFERRAL TO DERMATOLOGY.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Lip swelling
Clinical narrative: Swelling at local injection site and swelling of the lips.