chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, Pain in extremity
Clinical narrative: This initial spontaneous case, was received on 08-Oct-2017, from a pharmacist, concerning a 54-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 07-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178302A, expiry date: Apr-2018). It was reported that, the vaccine was given to a 54-year-old patient (explicitly coded as inappropriate age at vaccine administration) and had soreness in the arm (began on an unknown date). The outcome of the event was not reported. The reporter considered the report as non-serious. Follow-up received on 18-Oct-2017: The reporter stated that the patient experienced soreness in the arm since an unknown date. The outcome was not reported. Narrative amended accordingly. Significant case correction received 18-Oct-2017: The event "no adverse event" was deleted.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This non-serious initial spontaneous case received on 11-Oct-2017, was reported by a pharmacist concerning a 70-year-old elderly, adult male patient. The patient's medical history was not reported. The patient's concomitant medications were CRESTOR and aspirin taken for unknown indication. On 09-Oct-2017 the patient received FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178301, expiry date: Apr-2018). On the same day after vaccination, the patient experienced redness and felt hot at the injection site. At the time of this report, the patient was feeling better. The outcome of the event injection site redness and injection site warmth was recovering. The reporter assessed the events as non-serious. Follow-up received on 20-Oct-2017: The outcome of the events was changed from not reported to recovering and the batch number of the suspect vaccine was added in the screen. The narrative was amended accordingly.
Age: 34.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 09-JUN-2017, the patient was inadvertently vaccinated with GARDASIL 9 (lot # M037770, expiration date: 01-JUN-2019) (dose and frequency were unspecified), subcutaneously (instead of intramuscularly), for prophylaxis. No adverse effect reported. No product quality complaint was involved. Follow up information has been received from the reporting physician and a Nurse on 12-DEC-2017, concerning to a 34 year old Asian female patient. The patient's medical history/allergies and concurrent conditions included allergy to pollen and allergy to penicillin G benzathine(EXTENCILLINE) (that caused rash on an unknown date). On 09-JUN-2017 at 11:30 am, the patient was vaccinated in error with the first dose of GARDASIL 9 lot number M041213 (reported previously as "lot # M037770") in the right arm, subcutaneously at the private doctor's office/hospital. On the same date on 09-JUN-2017 at 11:35 am, the patient received also the first dose of VARIVAX in the left arm (lot # M040137, expiration date: 01-JUN-2019) (dose and frequency were unspecified), subcutaneously, for prophylaxis. It was reported that the vaccines were purchased with public funds.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-JUL-2012, the patient was vaccinated by a medical assistant at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated by a physician for onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed prednisone, PERCOCET, and acyclovir for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-OCT-2011 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-DEC-2015 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 23-NOV-2012, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-SEP-2013, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Computerised tomogram head normal, Differential white blood cell count normal, Disorientation
Clinical narrative: Initially C/O (B) arm pain, nausea, and fatigue at 4pm. Next AM at 8am developed increased somnolence, decreased responsiveness, difficulty responding to questions, and disorientation.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Fatigue, Full blood count normal, Hyporesponsive to stimuli, Lumbar puncture normal, Metabolic function test normal
Clinical narrative: Initially C/O (B) arm pain, nausea, and fatigue at 4pm. Next AM at 8am developed increased somnolence, decreased responsiveness, difficulty responding to questions, and disorientation.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Nausea, Pain in extremity, Slow response to stimuli, Somnolence, Toxicologic test normal
Clinical narrative: Initially C/O (B) arm pain, nausea, and fatigue at 4pm. Next AM at 8am developed increased somnolence, decreased responsiveness, difficulty responding to questions, and disorientation.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-MAY-2012, at a clinic, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-MAR-2016, the female was treated by a physician/MD at an Ophthalmology group facility, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster on the eyelid, a damaging eye condition of zoster infections of the eye. The female patient has been prescribed tobramycin-dexameth for management of her painful conditions. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the event of Persistent strain of Herpes Zoster/treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster on the eyelid, a damaging eye condition of zoster infections of the eye (Herpes zoster ophthalmicus) was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 11-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of atypical herpes zoster. On or about 27-FEB-2016, the patient was treated by a physician for painful vesicular outbreak accompanied by symptoms of weakened immunity, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir and "Loritib" for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and require extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Injection site erythema
Clinical narrative: Initial unsolicited report received from a non-health care professional (office staff) on 27-Oct-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of  FLUZONE HIGH DOSE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced redness below the injection site that traveled towards the inner bicep area and both had swallowing issues but no real respiratory issues. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypertension, Swelling, Tremor
Clinical narrative: Initial unsolicited report received from a Nurse on 03-Nov-2017. This case involves a female patient of unknown age, who was vaccinated with a dose of FLUZONE HIGH-DOSE (batch number, expiry date, dose, dose in series, route and site of administartion were not reported) on an unknown day. The patient's medical history and concomitant medication was not reported. On an unknown day, following the vaccination, the patient developed severe uncontrollable shaking, chills and hypertension to 180 over 111 more swelling than normal. On an unspecified date, the patient needed doctor visit. Also reported that the patient had never had reaction in prior years. Laboratory investigation and corrective treatment was not reported. Outcome of the event for hypertension was recovering and for other events were not reported. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cough, Dizziness, Dysphonia, Headache
Clinical narrative: Initial unsolicited report received from a pharmacist on 10-Nov-2017. This case involves 73-year-old female patient, who was vaccinated with 0.5ml dose of FLUZONE HIGH-DOSE (batch number, expiry date and dose in series, site of administartion were not reported) via intramuscular route once, on 11-Oct-2017. The patient's medical history included allergy to codeine and heart issue and concomitant medication was not reported. On an unknown day, the day after following the vaccination, the patient experienced a cough, hoarsness, fever, headache, dizziness, tachycardia, racing heartbeat, irregular heartbeat and increased BP. Laboratory investigation and corrective treatment was not reported. Outcome of all the events were resolved on an unspecified day. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate irregular, Palpitations, Pyrexia, Tachycardia
Clinical narrative: Initial unsolicited report received from a pharmacist on 10-Nov-2017. This case involves 73-year-old female patient, who was vaccinated with 0.5ml dose of FLUZONE HIGH-DOSE (batch number, expiry date and dose in series, site of administartion were not reported) via intramuscular route once, on 11-Oct-2017. The patient's medical history included allergy to codeine and heart issue and concomitant medication was not reported. On an unknown day, the day after following the vaccination, the patient experienced a cough, hoarsness, fever, headache, dizziness, tachycardia, racing heartbeat, irregular heartbeat and increased BP. Laboratory investigation and corrective treatment was not reported. Outcome of all the events were resolved on an unspecified day. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This initial spontaneous case was received from other-non-health professional on 11-Oct-2017, concerning a 42-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date and month of 2015, the patient was administered with influenza vaccine (dose, batch number, manufacturer, trade name, route of administration, anatomical location: not reported). On an unspecified date and month of 2015, after the vaccination, the patient felt unwell with aches and low-grade fever for couple of days. It was reported that, the patient did not want to receive another flu shot. On an unspecified date and month of 2015, the patient was recovered from the events. The reporter assessed the report as non-serious. Significant case correction received 11-Oct-2017: The causality of the events was corrected to related from unassessable.
Age: 55.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (nurse) on 27-Sep-2017, concerning a 55-year-old adult male patient. The patient's medical history and concomiant medications were not reported. On 20-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number 18703 (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: right deltoid). The patient received the vaccine under 65 years of age, which was considered as inappropriate age at vaccine administration it was reported that, no adverse event was experienced by the patient. The reporter assessed the report as non-serious. Follow-up recieved on 13-Oct-2017: The vaccine administration details were updated (route of administration: intramuscular and anatomical location: right deltoid). New event no adverse event was coded. Narrative amended accordingling.
Age: 23.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial non-serious spontaneous case, was received on 27-Sep-2017, from other health professional concerning a 23-year-old female adult patient. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 18703 (as reported), expiry date: Apr-2018). It was reported that the patient under 65 years of age was administered with vaccine (explicitly coded as inappropriate age at vaccine administration). It was reported that, no reactions or no adverse event were observed after the administration of the vaccine. The reporter assessed the events as non-serious. Follow-up received from the reporter on 13-Oct-2017: The suspect vaccine route of administration and anatomical location were updated. Significant case correction received 27-Sep-2017: The event term from No reactions to No AE was corrected.
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, Hypersomnia
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist, on 25-Sep-2017, concerning an adult female patient in her mid-20's (as reported). On 23-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178503, expiry date: Apr-2018). It was reported that FLUAD was suggested for age 65 years and over (explicitly coded to Inappropriate age at vaccine administration). The patient slept for 16 hours a few hours after receiving the vaccine (sleep excessive). The outcome of the event sleep excessive was recovered. The reporter did not provided the seriousness criteria of the event. Follow-up report received from the reporter on 05-Oct-2017: Suspect product details (route of administration, anatomical location, batch number, expiry date) were updated. Event onset date was added. Outcome of the events was updated from not reported to recovered. Amended narrative accordingly. Significant case correction received 05-Oct-2017: The outcome of event Inappropriate age at vaccine administration was changed from recovered to unknown and outcome of the event sleep excessive was changed from not reported to recovered. The narrative was amended accordingly.
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, Malaise
Clinical narrative: This initial non-serious spontaneous case, was received on 26-Sep-2017, from pharmacist and concerning a female patient of an unspecified age (reported as below 65 years). The patient's medical history and concomitant medications were not reported. On 06-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, batch number: (reported as 178502), expiry date, anatomical location not reported) which was characterized as inappropriate age at vaccination. As FLUAD was indicated in individuals 65 years of age and older. On an unspecified date, after vaccination, at the time of the report, the patient had been ill for three days. No treatment medications were administered. The outcome of the events was not reported. The reporter considered this case as non-serious. Significant case correction received on 26-Sep-2017: The listedness for the event malaise was corrected from listed to unlisted in flu vaccine.
Age: 1.33
Sex: U
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Approximately 4-5 hours after vaccines, (+) hives on Bilateral legs (no respiratory or GI Sx's). Hives resolved spontaneously.
Age: 30.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 12-Oct-2017, concerning a male, adult patient of unspecified age. It was reported that FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, approved for use in persons 65 years of age and older and not approved for use in adults 18-64 years of age. On 11-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, batch number, expiry date: not reported, anatomical location: deltoid). As the patient was below 65 years, considered as inappropriate age at vaccination. The patient did not experience any adverse event after administration of vaccine. The outcome of the events was not reported. The pharmacist considered the case as non-serious.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case was received from other health professional (pharmacist) on 25-Sep-2017, concerning a 77-year-old (age of vaccination), elderly, male patient. The patient had no medical history and he did not receive any concomitant medications. On 06-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 178303, expiry date: Apr-2018, route of administration: intramuscular and anatomical location: deltoid muscle of upper arm). On an unspecified date, after vaccination (06-Sep-2017), the patient had swelling throughout his upper arm. It was reported that, prior of 25-Sep-2017, the patient had recovered from the event. The reporter assessed the report as non-serious. Follow-up received on 05-Oct-2017: The route of administration: intramuscular and anatomical location: deltoid muscle of upper arm was provided. It was reported that the event swelling of arm occurred after 06-Sep-2017 and resolved before 25-Sep-2017. The causality was changed from unassessable to related. Narrative amended accordingly. Non-significant follow-up received on 16-Oct-2017: It was reported that the patient did not mention any medication for the event. Significant case correction received 25-Sep-2017: Listedness was changed from unlisted to listed for the event swelling arm. Significant case correction received 05-Oct-2017: Determined causality for the event was corrected to unassessable from related.
Sex: F
Vaccine: FLUX
Symptoms: Contraindicated product administered
Clinical narrative: This non-serious initial spontaneous case was received from Other-Non-Health Professional on 23-Oct-2017, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported). On an unspecified date, the patient was also administered with non-company suspect drug COSENTYX (dose, route of administration, anatomical location: not reported) for unknown indication. On an unspecified date, the patient took flu shot while she was on COSENTYX medication (explicitly coded as contraindicated product administered). The outcome of the event was not reported.
Age: 57.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This initial spontaneous case, was received from other health care professional (pharmacist) on 06-Nov-2017, concerns a 57-year-old adult male patient. On 05-Nov-2017, the patient was administered with FLUAD (route of administration: intramuscular, anatomical location: left deltoid, dose, batch number, expiry date: not reported). On the same day, 57-year-old patient received FLUAD instead of FLUCELVAX (explicitly coded as inappropriate age at vaccination. It was reported that, the patient did not experience any adverse event (uneventful). The outcome of the events was not reported. The reporter assessed this case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Swelling face
Clinical narrative: This non-serious initial spontaneous case was received on 28-Aug-2017 from a pharmacist, concerning a 71-year-old elderly, female patient. The patient had left side of her face swollen several weeks ago. Current condition included sleep problem from an unspecified date. Concomitant medication included BENADRYL for sleep. On 25-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch no. reported as 178301, expiry date: Apr-2018 and anatomical location: not reported). On 26-Aug-2017, one day after vaccination, the patient had facial swelling (reported as left side of her face was swollen). It was reported that she noticed that in the morning of 27-Aug-2017 when she woke up and was treated with BENADRYL for the same. The patient also had similar reaction several weeks ago and her physician was aware of that. At the time of this report, adverse reaction persisted and she had not yet recovered from the event. The reporter assessed the report as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: This initial non-serious spontaneous case was reported on 25-Sep-2017, from other non-health professional, concerning a pregnant female of unspecified age. On an unspecified date, the patient was administered with the influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). It was reported that a pregnant woman was administered with INN flu vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous non-serious case was received on 26-Oct-2017, from other non-health professional (consumer), concerning a female pregnant patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported).
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received from pharmacist on 13-Nov-2017, concerning a 55-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 13-Nov-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178302A and expiry date: Apr-2018) under the age of 65-year-old (explicitly coded as: inappropriate age at vaccine administration. It was reported that, the patient had not experienced any adverse event after the administration of the vaccine. The reporter assessed the case as non-serious. Follow up received on 04-Dec-2017: The reporter confirmed that, the patient had not experienced any adverse event after the administration of the vaccine. The narrative was amended accordingly.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: This non-serious initial spontaneous case, was received from other Non-health professional on 04-Oct-2017, concerning a 67-year-old elderly female patient. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, manufacturer, trade name: not reported). On the same day, at 3:00 am, the patient experienced severe diarrhea which lasted till 6 pm and was suggested for colonoscopy. The outcome of the event was recovered. The reporter assessed the report as non-serious.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, Influenza, Influenza virus test positive, Serology test, Vaccination failure
Clinical narrative: This spontaneous case, initially received on 30-Mar-2017 was reported by a Other non-health professional (consumer) and concerns a 8 years old female patient. Administration of Company suspect drug: On 04-Oct-2016, FLUVIRIN was administered (dosage: 0.5ml, frequency, duration and batch number: not reported, route of administration: intramuscular). Adverse reactions/events and outcomes: Patient received FLUVIRIN on 04-Oct-2016 at pharmacy and was diagnosed with influenza on 08 March 2017. On 08Mar2017 Influenza was diagnosed. Patient was treated with TAMIFLU. On 24-Mar-2017 the events was reported as recovered and the event vaccination failure was updated to unknown. Reporter's Assessment: The other non Healthcare Professional assessed the causality as related. This report was serious (medically significant). Follow-up report received on 24-Apr-2017: It was confirmed that patient had no any medical history. Patient was healthy at the time of vaccination (immunological status). It was reported that patient has been previously immunised and first flu vaccine was of two doses. Nasopharyngeal swab,  blood culture and serology were performed, but diagnosis of influenza was confirmed with nasal swab. Follow up received on 09-May-2017: Batch review report (reference number [1021187] received from quality assurance department on [09-May-2017]: Based on the document review, it was stated that the concerned [FLUVIRIN]  was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Case number PHEH2016US030194, is an initial spontaneous report from a consumer received on 15 Nov 2016. This report refers to an 82 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618501) into left arm, at a dose of 0.5 ml, intramuscularly on 24 Oct 2016. On 05 Nov 2016, the patient left knee started hurting and having excruciating pain. The outcome of the events was reported as unknown. The seriousness of the event was reported as serious (disability). The causality of the events was not reported. This case was lost to follow up.
Age: 28.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Dizziness
Clinical narrative: Patient became very dizzy after receiving second vaccine (TWINRIX), no medical treatment needed. Patient was given glass of water. His legs were elevated on the chair, and he rested for about 30 minutes.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Laboratory test normal, Lip swelling, Nasal congestion
Clinical narrative: Pt states he had SOB, swelling of nose/lips the evening of getting vaccine. He went to ER for treatment. They ran test and didn't find anything, so they kept him for observation until he felt better.
Age: 1.33
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Computerised tomogram, Laboratory test, Seizure
Clinical narrative: Seizure.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Blood magnesium, Blood uric acid, Full blood count, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at the injection site. Limited range of motion with pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test, Pain
Clinical narrative: Pain at the injection site. Limited range of motion with pain.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient's arm was reported to be very sore for days and not getting much better. The arm was still bright pink about the size of a softball around the area.
Age: 1.25
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Asthenia, Decreased appetite, Lethargy, Pyrexia, Rhinorrhoea
Clinical narrative: Extremely lethargic, fever, runny nose, loss of appetite, weakness.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Pt. received vaccine on 9/19/17 - same pt. came by our pharmacy on 1/10/18 to say that she had issues with muscle pain/weakness from the TDAP (ADACEL) vaccine from 9/19. She asked for the Lot number, expiration date and manufacturer of the vaccine on 1/10/18 which I gave to her. She was going to speak with her doctor regarding the issue with the muscle weakness after reading online that was a potential side effect of the vaccine.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Pt reports redness that progressed over a 4 day period that covered the deltoid to the tricep/bicep region. The day after the shot pt had about a baseball sized knot at injection site. He states there was no pain but there was heat/fever among the red area. All symptoms subsided by 1-9-18.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Influenza virus test positive, Pyrexia
Clinical narrative: This spontaneous case, initially received on 30-Mar-2017 was reported by an other non-health professional (consumer) and concerns about 11 Years old male patient. Administration of Company suspect drug: FLUVIRIN was administered for Influenza immunization on 04-Oct-2016 (Dose: 0.5ml, via intramuscular route of administration, solution dosage form where frequency was one single dose and batch number was not reported). Patient was previously immunized with a first dose of flu vaccine. Adverse reactions/events and outcomes: On 04-Oct-2016, the patient received FLUVIRIN at pharmacy. On 11-Mar-2017 the patient also experienced fever and cough. He was diagnosed with influenza on an unspecified date in Mar 2017. At the time of vaccination the patient was healthy and had no medical history. Nasal swab confirmed influenza. The patient was treated with TAMIFLU. On 13-Mar-2017, the events were reported as recovered / resolved. Reporter's Assessment: The reporter assessed the causality as related. Follow up received on 24-Apr-2017: Patient's immunological status, prior vaccination details, information regarding medical history and lab test were updated. Follow up received on 09-May-2017: Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Blood test normal, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: This initial spontaneous case, received on 02-Nov-2017, reported by other non-health professional and concerns a 12-year-old female patient of weight: 48.3 kg, height: 148 cm. The patient's historical condition included stomach pain throughout the years. The patient's concomitant medications were not reported. On an unspecified date, the patient received Influenza vaccine (dose, route, anatomical location, trade name and manufacturer was not reported). On 20-Oct-2017, the patient was also received ILARIS (300 mg, subcutaneous, once a (as reported)) for TRAPS (tumor necrosis factor receptor associated periodic syndrome). On an unspecified date, after receiving INN flu vaccine seasonal (reported as two and half weeks ago) and ILARIS injection on 20-Oct-2017, the patient had bad injection site reactions. She used topical BENADRYL but it had no effect, hence it was replaced with oral BENADRYL which helped, but one of the reaction sites returned about in 10 days. On 29-Oct-2017, as soon as BENADRYL was stopped, since then she had bad stomach pain, was tired, appetite lost and was not going to school. It was also reported that, the site reaction that returned was  noticeable, burned and itched, but not as large as it originally was. The patient was not eating and sleeping all the time. She had an intense feet pain (pain level: 5.5). It was reported that, the patient had reoccurring stomach pain throughout the years, she was on ILARIS but not to the intensity that it  did not go away like it was then. She also felt like she was being punched in the stomach. The reporter also reported that, ILARIS reduced length of flare and blood work looked good a month ago, for the first time and had normal sedimentation rate. The outcome of the event injection site reaction was recovering and for events stomach pain, loss of appetite, tiredness and intense foot pain was not recovered (ongoing). The outcome of the other events was not reported.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This initial spontaneous case, received on 02-Nov-2017, reported by other non-health professional and concerns a 12-year-old female patient of weight: 48.3 kg, height: 148 cm. The patient's historical condition included stomach pain throughout the years. The patient's concomitant medications were not reported. On an unspecified date, the patient received Influenza vaccine (dose, route, anatomical location, trade name and manufacturer was not reported). On 20-Oct-2017, the patient was also received ILARIS (300 mg, subcutaneous, once a (as reported)) for TRAPS (tumor necrosis factor receptor associated periodic syndrome). On an unspecified date, after receiving INN flu vaccine seasonal (reported as two and half weeks ago) and ILARIS injection on 20-Oct-2017, the patient had bad injection site reactions. She used topical BENADRYL but it had no effect, hence it was replaced with oral BENADRYL which helped, but one of the reaction sites returned about in 10 days. On 29-Oct-2017, as soon as BENADRYL was stopped, since then she had bad stomach pain, was tired, appetite lost and was not going to school. It was also reported that, the site reaction that returned was  noticeable, burned and itched, but not as large as it originally was. The patient was not eating and sleeping all the time. She had an intense feet pain (pain level: 5.5). It was reported that, the patient had reoccurring stomach pain throughout the years, she was on ILARIS but not to the intensity that it  did not go away like it was then. She also felt like she was being punched in the stomach. The reporter also reported that, ILARIS reduced length of flare and blood work looked good a month ago, for the first time and had normal sedimentation rate. The outcome of the event injection site reaction was recovering and for events stomach pain, loss of appetite, tiredness and intense foot pain was not recovered (ongoing). The outcome of the other events was not reported.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: This initial spontaneous case, received on 02-Nov-2017, reported by other non-health professional and concerns a 12-year-old female patient of weight: 48.3 kg, height: 148 cm. The patient's historical condition included stomach pain throughout the years. The patient's concomitant medications were not reported. On an unspecified date, the patient received Influenza vaccine (dose, route, anatomical location, trade name and manufacturer was not reported). On 20-Oct-2017, the patient was also received ILARIS (300 mg, subcutaneous, once a (as reported)) for TRAPS (tumor necrosis factor receptor associated periodic syndrome). On an unspecified date, after receiving INN flu vaccine seasonal (reported as two and half weeks ago) and ILARIS injection on 20-Oct-2017, the patient had bad injection site reactions. She used topical BENADRYL but it had no effect, hence it was replaced with oral BENADRYL which helped, but one of the reaction sites returned about in 10 days. On 29-Oct-2017, as soon as BENADRYL was stopped, since then she had bad stomach pain, was tired, appetite lost and was not going to school. It was also reported that, the site reaction that returned was  noticeable, burned and itched, but not as large as it originally was. The patient was not eating and sleeping all the time. She had an intense feet pain (pain level: 5.5). It was reported that, the patient had reoccurring stomach pain throughout the years, she was on ILARIS but not to the intensity that it  did not go away like it was then. She also felt like she was being punched in the stomach. The reporter also reported that, ILARIS reduced length of flare and blood work looked good a month ago, for the first time and had normal sedimentation rate. The outcome of the event injection site reaction was recovering and for events stomach pain, loss of appetite, tiredness and intense foot pain was not recovered (ongoing). The outcome of the other events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous case, initially received on 20-Jan-2017, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company 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 experienced the flu (medically significant, outcome: not reported).
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Crying, Decreased appetite, Diarrhoea, Injection site rash, Injection site reaction
Clinical narrative: Wasn't moving, crying a lot, not eating swelling right leg, rash on right leg, fever, diarrhea, dragging on (r) leg.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased, Pyrexia
Clinical narrative: Wasn't moving, crying a lot, not eating swelling right leg, rash on right leg, fever, diarrhea, dragging on (r) leg.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Crying, Decreased appetite, Injection site reaction, Injection site swelling, Mobility decreased
Clinical narrative: Wasn't moving, crying a lot, not eating, swelling right leg, fever, throwing up dragging on (r) leg.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Wasn't moving, crying a lot, not eating, swelling right leg, fever, throwing up dragging on (r) leg.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHEH2016US029867, is an initial spontaneous report received from a physician on 10 Nov 2016. This report refers to a 36 years old female patient. Past medical history and 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 16 Sep 2016. On an unspecified date 10 days after vaccination, the patient experienced dusky erythema,  edema and itchy, painful area a few inches below the injection site. The patient was treated with steroids (unspecified) and BACTRIM however symptoms did not changed with drug therapy. Upon follow up, the physician reported that, the patient was hospitalized after the initial adverse events and did not know if initial adverse event caused hospitalization. The outcome of the event dusky erythema was unknown. The final outcome of the events was condition unchanged. The causality of events were not reported. Follow up report received from a physician on 16 Nov 2016: Updated physicians seriousness comment.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient was called post discharge from hospital for a follow-up. He reports that right deltoid is red, swollen, rash, pain. States he thinks injection was given wrong.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 12 unspecified patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot number N004945 and expiration date of 09-OCT-2018 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. The patients received the vaccines after a prior temperature excursion of 32°F to 35°F (32.3°F), that occurred on 21-SEP-2017 with a time frame of 1 hour. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 01-JUL-2011, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) at physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-OCT-2017(conflicting dates), the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 06-NOV-2014 (conflicting dates), the patient received subsequent medical treatment from the physician for ongoing and worsening symptoms of shingles. On or about 14-NOV-2014,(conflicting dates), he was again treated by the physician for uncontrolled symptoms of zoster, at which time his medications were changed in attempts to curb his symptoms. The patient has been prescribed valacyclovir (VALTREX), acetaminophen and hydrocodone (NORCO), and gabapentin(NEURONTIN) for management of his painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.