chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature 6.5 Fahrenheit, for 6 months) doses of PROQUAD, lot # L021599, expiry date 10-DEC-2016 and lot # L024123, expiry date 30-DEC-2016, (dose, frequency and route of administration not reported). No adverse effects reported. Vaccines were back in range. Previous temperature excursion was reported as no. It was because of a data logger. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature 6.5 Fahrenheit, for 6 months) doses of VARIVAX, lot # L037561, expiry date 29-SEP-2017 and lot # L020002, expiry date 02-JUN-2017, (dose, frequency and route of administration not reported). No adverse effects reported. Vaccines were back in range. Previous temperature excursion was reported as no. It was because of a data logger. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Inappropriate schedule of drug administration, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse (also the patient's mother and the company employee) refers to a 16 month old male patient. the patient's concurrent conditions included asthma, chronic idiopathic urticaria, allergy to sulfonamides and allergy to clindamycin. On 29-MAR-2008, the patient was vaccinated with the first dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported). On 06-AUG-2008, the patient was vaccinated with the second dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported). The vaccines were administered within a shorter interval than it was recommended, but no adverse effects were reported. On 08-JUN-2016, the patient was vaccinated with the first 0.5 ml dose of GARDASIL 9 (lot # M003659, expiry date, 20-SEP-2017; route and site of administration were not reported). Concomitant therapies include PROAIR HFA, SINGULAIR, QVAR, loratadine (manufacturer unknown), ZYRTEC and BENADRYL. On 08-JUN-2016, a few hours after vaccination, the patient experienced stomach pain. On 09-JUN-2016 in the morning, the patient started vomiting. The patient did not seek medical attention and no treatment was given for the events. No lab diagnostics studies were performed. The outcome of the stomach pain and vomiting was reported as recovered on an unknown date in June 2016. The relatedness between stomach pain and vomiting and VAQTA and GARDASIL 9 was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician via a field representative concerning a 19 year old female patient. There was no concurrent condition, medical history or concomitant therapy reported. On an unknown date, the patient received a dose of GARDASIL 9 injection (lot #, dosage and route not provided). After received the third injection of the series of the vaccine, the patient felt dizzy. She experienced syncope on 09-JUN-2016. The outcome of the events and the causality was not reported. Additional information has been requested
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a female patient of unknown demographics regarding herself. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. The patient reported that she had shingles 12 years prior to receiving ZOSTAVAX vaccine, which is other than indicated in the prescribing information. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). After receiving the ZOSTAVAX vaccine, the next day (unspecified date), she had a fever blister on her lip. She then had painful, inches rashes over her trunk area. The patient sought medical attention for the adverse events. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was filed. Additional information is not expected because the reporter details were not provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M003659, expiration date reported as 20-SEP-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L040458, expiration date reported as 04-FEB-2018, lot # K018180, expiration date reported as 17-SEP-2016, lot # L03343, expiration date reported as 13-SEP-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # L040459, expiration date reported as 06-APR-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, Urticaria
Clinical narrative: Information has been received from a consumer referring to her son, a 12 year old male patient. The patient was allergic to KEFLEX. The patient received the first dose in the GARDASIL series in 2015 (reported as about one year ago) (lot #, dose and route unknown). It could  not be confirmed if this dose was GARDASIL or GARDASIL 9. The patient had no adverse reaction to the first dose in the GARDASIL series. The patient had the second dose in the series on 02-JUN-2016 (inappropriate schedule of drug administration, possible interchange of vaccine products). This second dose was confirmed as GARDASIL 9 (lot #, dose and route unknown). On 03-JUN-2016, the patient presented with hives from head to toe. The physician prescribed an unspecified dose of BENADRYL on that day. The hives were so bad that the reporter took the patient to see the physician on 04-JUN-2016. The physician prescribed an unspecified dose of prednisone (manufacturer unknown). No lab tests were performed for the event. The hives had cleared up on 08-JUN-2016. The reporter did not provide the causal relationship assessment. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017) (dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccine experienced the temperature excursion of 0 degrees Celsius for 6 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L039298, expiration date 27-JUN-2017 (dose was not reported), oral. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L024268, expiration date reported as 01-JUL-2017, lot # L030162, expiration date reported as 11-AUG-2017 (therapy type, dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician via a company representative refers to a 6 month old patient of unknown gender. The patient had no drug reactions/allergies. On 10-JUN-2016 the patient was accidentally vaccinated with GARDASIL 9 (1 shot, subcutaneous, lot number unknown). The medical assistant administering the vaccine had mistakenly done so believing it to be an injection of PEDVAXHIB. No treatment was given to the patient for the incorrect vaccine. No lab diagnostic studies performed. No adverse effect reported. The outcome of wrong drug administered was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unknown age and gender. On 15-JUN-2016, the patient was vaccinated with expired dose of M-M-R II (lot # K012472 and expiry date: 11-JUN-2016). No adverse effects were reported. No product quality complaint was reported for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Medical Assistant (R.M.A) concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II (rHA) (Lot # L012479; expiration date: 10-APR-2017) (dose was not provided) which were improperly stored at 34.7F for 2 hours and 23 minutes. There was no data logger nor PQC involved. No adverse effects were reported. This is one of two cases from the same source (MARRS # 1606USA010502). Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Small 1 cm area of erythema at site of right lateral thigh where previous injection administered three days after vaccine. Area of erythema has persisted, but non-tender. No treatment indicated at this time.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Laboratory test, Pyrexia, Rash, Viral rash
Clinical narrative: PEDIARIX, PREVNAR given 6/17/16 - Started with fever and rash 6/18/16. BENADRYL and TYLENOL/MOTRIN given, helped with fever, rash worse. Seen back in office 6/20/16, sent to ER for evaluation. Dx.  suspected viral exanthema.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash morbilliform
Clinical narrative: Rash-morbilliform; started 6/18
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Approximately 8 inch length of left upper arm became red, swollen, heated the night of immunization and continued until Day 4 post immunization. Fever presented for 3 days (post) approximate 100.2 overall muscle aches, lethargy (tiredness) still present Day 6.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Approximately 8 inch length of left upper arm became red, swollen, heated the night of immunization and continued until Day 4 post immunization. Fever presented for 3 days (post) approximate 100.2 overall muscle aches, lethargy (tiredness) still present Day 6.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient is very red around the area of injection. It is a large red area, swollen possible infection per Dr pt went to see-got antibiotic to treat-Black and blue at site of injection.
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: (R) upper arm pain and significant redness/tenderness covering 80% proximal (R) arm. No open skin lesions.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Patient said rash developed on chest on 6-13-16, looked maculopapular, had vaccine 5-24-16
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Myalgia
Clinical narrative: Patient has redness around injection area and has pain in the left arm with some swelling the day after injection. Has headache and muscle pain that radiates to the left side of back. Took aspirin 325 mg x 3 doses, then took 2 doses on Saturday, 2 doses Sunday, and 1 dose Monday. Symptoms improving. Patient advised to take BENADRYL and TYLENOL instead of aspirin due to blooding thinning of ASA.
Age: 1.13
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Malaise, Pyrexia, Rash papular
Clinical narrative: Fever, malaise, papular diffuse rash. Rx with TYLENOL.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen red and warm arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had red and puffy area on (R) leg that was larger than a fifty cent piece.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Full blood count normal, Hyperaesthesia, Pain
Clinical narrative: Pt received TRUMENBA 6/17/16, developed left knee pain 6/20/16 - woke on 6/21/16 with body aches, joint aches, increased skin sensitivity. Seen in office 6/22 still with body aches.
Age: 1.1
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Pt developed a 103 fever 8 days after getting a PROQUAD vaccine. Has no other symptoms per mom. Per doctor advised to give TYLENOL or MOTRIN and continue to monitor.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Contusion, Skin disorder
Clinical narrative: Case number PHHY2015US163474, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 577979) website on 24 Nov 2015. This report refers to a 66-years-old male patient. Past medical history included sleeve gastrectomy (Feb 2015). Current conditions included diabetes mellitus, blood pressure high (hypertension), renal cancer and artificial cardiac pacemaker (cardiac device use since 2005). Concomitant medications included ACTOS, lisinopril (manufacturer unknown) and NORVASC. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 01 Oct 2014. The patient also received VOTRIENT tablet for lung disorder at a dose of 800 mg once daily orally in May 2014. On 01 Oct 2014, the patient experienced contusion, skin disorder and bruising on arms and hands. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was reported to be suspected. Following an internal review done for data received on 24 Nov 2015, significant case correction was done: The co suspect drug VOTRIENT was recoded with Novartis product dictionary.
Age: 84.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Case number PHHY2016US024962, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 604179) on 19 Feb 2016. This report refers to an 84 years old female patient. Medical history was not reported. Her vaccination history included administration of PREVNAR (batch number: not reported, other manufacturer) in 2014. Concomitant medication include ZOCOR. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on 24 Sep 2015. On the same day the patient was also vaccinated with booster dose of PNEUMOVAX 23 (batch number: K009874, other manufacturer) intramuscularly into the same arm. On the same day after vaccinations the patient experienced bruising and swelling in her vaccinated arm. The patient sought medical attention with her sister who was a nurse practitioner; she was treated with BENADRYL, TYLENOL and ice on the area. On 29 Sep 2015 the patient went to pharmacy with swelling in the lower part of her arm showing some improvement. The outcome of bruising in her arm was reported as recovering. The case was assessed as non-serious. The reporter considered bruising and swelling in her arm was related to PNEUMOVAX 23. Causality for seasonal influenza vaccine was not reported.
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chills, Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: Case number PHHY2016US025851, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 605029) website on 19 Feb 2016. This report refers to a 69 years old female patient. Past medical history was not reported. Historical medication included as penicillin. Concomitant medications included as prednisone (manufacturer unknown), fluconazole (manufacturer unknown), VENTOLIN and MACROBID. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date in Oct 2015. The patient also vaccinated with PREVNAR 13 vaccine (other manufacturer, batch number: M06898) into right arm, intramuscularly on an unspecified date in Oct 2015. On an unknown date in Oct 2015, the patient experienced symptoms of chills, fever, malaise and cold. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non-serious. The causality of the events was not reported.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test normal, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2016US028003, is an initial spontaneous report received Vaccine Adverse Event Reporting System (reference number: 606720) website on 19 Feb 2016. This report refers to a 06 years old male patient. Past medical history was not reported. Current condition included as prophylaxis and asthma. Concomitant medications was not reported. Prior vaccination history included as, the patient vaccinated with first dose of PNEUMOVAX 23 vaccine (other manufacture, batch number: not reported) on an unspecified date in approximately Oct 2014 (reported as a year ago). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PREVNAR 13 vaccine (other manufacture, batch number: not reported), on an unspecified date in approximately Oct 2015 (reported as within about 2 weeks). The patient also vaccinated with second dose of PNEUMOVAX 23 vaccine (other manufacture, batch number: L022262 and expiry date: 05 Nov 2016) at a dose of 0.5 ml, intramuscularly on 26 Oct 2015. On 27 Oct 2015, the patient right arm from shoulder to elbow was swollen and hot to touch. On an unspecified date, the patient antibody test performed and showed that, no immunity. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2016US025237, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606915) website on 19 Feb 2016. This report refers to a 15 years old female patient. Historical condition was not reported. Current condition included prophylaxis. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on the arm and GARDASIL (batch number: K010215, expiry date May 2017) on the other arm on 19 Oct 2015. The physician reported that the patient experienced a syncope expressed as passed out 15 seconds after getting the shot while using GARDASIL. The patient did not seek medical attention and no treatment was given for syncope. The patient recovered of syncope the same day on 19 Oct 2015. The outcome of the event passed out was not reported. Seriousness of the events was reported as non serious and causality was not reported. The reporter did not assess the relatedness of GARDASIL to syncope. Additional information was not expected because the physician did not have specific information to provide. Seriousness of events syncope and loss of consciousness was upgraded based on information available in source documents.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Eye pruritus, Malaise, Pain, Productive cough, Rhinitis
Clinical narrative: Case number PHHY2016US025852, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 609694) on 19 Feb 2016. This report refers to a 74 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 14 Nov 2015. After vaccination, on the same day, he experienced productive cough, diffuse body aches, coryza, itchy eyes and severe malaise. The outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, Pain, Tenderness
Clinical narrative: Case number PHHY2016US026705, is an initial spontaneous report received Vaccine Adverse Event Reporting System (reference number: 609708) website on 19 Feb 2016. This report refers to a 51 years old female patient. Past medical history included as sarcoidosis. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 13 Nov 2015. On 14 Nov 2015, the patient experienced very large swollen lymph nodes around collar bone with pain whenever it is touched or if she move left arm or turn her neck to that side, pain/tenderness going up into neck. The outcome of the events was not reported. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Following an internal review done for the data received on 19 Feb 2016, the following non-significant correction was done: Event coding changed from swollen lymph nodes to lymph nodes cervical swollen.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cold sweat, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Case number PHHY2016US025879, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 609954) website on 19 Feb 2016. This report refers to a 44-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in right arm on 16 Nov 2015 at 10:45 AM. On the same day at 19:45 PM (reported as 07:45 evening), she suddenly experienced feeling of weakness, dizziness, nausea, clammy and sweating around forehead. She also developed body ache from head to toe. It was reported that her body ache lasted for several hours and nausea and light headedness went away after she laid down. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Case number PHHY2016US025879, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 609954) website on 19 Feb 2016. This report refers to a 44-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in right arm on 16 Nov 2015 at 10:45 AM. On the same day at 19:45 PM (reported as 07:45 evening), she suddenly experienced feeling of weakness, dizziness, nausea, clammy and sweating around forehead. She also developed body ache from head to toe. It was reported that her body ache lasted for several hours and nausea and light headedness went away after she laid down. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Gait disturbance, Tunnel vision, Vertigo
Clinical narrative: Case number PHHY2016US024649, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 609958) website on 19 Feb 2016. This report refers to a 34-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscular in left arm on 05 Nov 2015. On 06 Nov 2015, she woke up with vertigo and difficulty walking. As her usual wake up time was not until 11 a.m. she went back to sleep and when she woke up she felt a bit better but continued to experience vertigo, dizziness, light headedness and tunnel vision off and on for the remaining day. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Feeling hot, Immediate post-injection reaction, Pruritus, Psychomotor hyperactivity
Clinical narrative: Case number PHHY2016US026651, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609976) website on 19 Feb 2016. This report refers to a 66 years old female patient. Past medical history included kidney stones. Vaccination history included administration of seasonal influenza vaccine and experienced red and itching (reported as itchy). Current condition included allergic to sulfa, penicillin and carbocaine, cirrhosis of liver. Concomitant medications included levothyroxine (manufacturer unknown), atorvastatin (manufacturer unknown), NEXIUM, montelukast (manufacturer unknown), Aspirin and Vitamin D3. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) in left arm along with PREVNAR 13 (manufacturer unknown, batch number: M16258) into right arm both on 04 Nov 2015. Immediately after vaccination, her arm started itching then redness and fever began. The patient was treated with BENADRYL 5 day later (Nov 2015). BENADRYL controlled itching but redness and heat was continued. On 14 Nov 2015, she visited the emergency room and confirmed that it was a reaction and gave her ranitidine and prednisone; seems to have helped but it made her hyper. Emergency room physician noticed that redness spreading down arm. The final outcome of the events was unknown. The seriousness of the events was reported not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Case number PHHY2016US026651, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609976) website on 19 Feb 2016. This report refers to a 66 years old female patient. Past medical history included kidney stones. Vaccination history included administration of seasonal influenza vaccine and experienced red and itching (reported as itchy). Current condition included allergic to sulfa, penicillin and carbocaine, cirrhosis of liver. Concomitant medications included levothyroxine (manufacturer unknown), atorvastatin (manufacturer unknown), NEXIUM, montelukast (manufacturer unknown), Aspirin and Vitamin D3. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) in left arm along with PREVNAR 13 (manufacturer unknown, batch number: M16258) into right arm both on 04 Nov 2015. Immediately after vaccination, her arm started itching then redness and fever began. The patient was treated with BENADRYL 5 day later (Nov 2015). BENADRYL controlled itching but redness and heat was continued. On 14 Nov 2015, she visited the emergency room and confirmed that it was a reaction and gave her ranitidine and prednisone; seems to have helped but it made her hyper. Emergency room physician noticed that redness spreading down arm. The final outcome of the events was unknown. The seriousness of the events was reported not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2016US027371, is an initial spontaneous report received Vaccine Adverse Event Reporting System (reference number: 610054) website on 19 Feb 2016. This report refers to a 38 years old female patient. Past medical history included as depression. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm (left deltoid), intramuscularly on 11 Nov 2015. On 13 Nov 2015, the patient experienced skin numbness left anterior knee, numbness left lower leg, today advancing across right knee and into left thigh. The outcome of the events was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Erythema, Urticaria, Wheezing
Clinical narrative: Case number PHHY2016US030457, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 610128) on 29 Feb 2016. This report refers to a female patient of an unknown age. Past medical history was not reported. Current conditions included many food allergies (unspecified) and seasonal allergy. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination, she experienced hives, redness, trouble breathing and wheezing. The outcome, seriousness and causality of the events were not reported. The seriousness assessment of the events urticaria, erythema, dyspnoea and wheezing were upgraded (medically significant) based on the information available in the source document.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Pain, Sinus congestion, Throat irritation
Clinical narrative: Case number PHHY2016US024498, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 610216) on 19 Feb 2016. This report refers to a 65 years old male patient. Medical history was none. The patient had no current illness. Concomitant medication included terazosin at a dose of 2 mg daily for over 10 years. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Nov 2015. On 17 Nov 2015 the patient experienced headache, sinus congestion, body aches and scratchy throat. No action was taken. Outcome of the events was unknown. The case was assessed the non-serious. Causality of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Pain
Clinical narrative: Case number PHHY2016US024513, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 610453) on 19 Feb 2016. This report refers to a 63 years old female patient. The patient had no medical history and no current illness. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Nov 2015. On 08 Nov 2015 the patient developed a dull ache which had continued to increase to a more intense ache. The patient was taking ADVIL to be able to sleep. The case was assessed as non-serious. Outcome and causality of the events was not reported.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2016US024312 is an initial spontaneous report received from a consumer (patient's relative) via Vaccine Adverse Events Reporting System (reference number: 610777) on 19 Feb 2016. This report refers to a 3 year old male patient. His medical history, current condition and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Jan 2014 at 10:15 am. On the same day approximately 12 hours after vaccination, the patient experienced fever with a body temperature of 101.5 degree Celsius. Laboratory investigations were not reported. The patient was treated with ADVIL on an unknown date. The event outcome was reported as complete recovery on 02 Jan 2014. The event was reported as non-serious. The causality of the event was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Migraine
Clinical narrative: Case number PHHY2016US024949 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 610812) on 19 Feb 2016. This report refers to a 63 year old female patient. Her medical history included migraine headache in the childhood and she did not have it for the past 7 to 8 years. She had a bypass surgery on an unknown date. Her current conditions included allergies and birth defects. Her concomitant medications were LIPITOR, metoprolol, Aspirin 81 mg and some unspecified medications. She had no illness at the time of vaccination and there was no other vaccine administered 4 weeks prior to the vaccination date. There was no adverse event prior to the vaccination. She was vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Oct 2014. Immediately after vaccination, she had a severe headache. The headache continued for 2 days. The headache was severe and even after taking ADVIL as corrective treatment; it came back within few hours and continued in the night as well. The patient did not perform any laboratory investigations. The outcome of the event was reported as complete recovery. The events were reported as non-serious. The reporter stated that the influenza vaccination triggered migraine as it was as severe as patient's migraine headache. No further information was provided.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary mass, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US025551 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (reference number: 610850) on 19 Feb 2016. This report refers to a 53 year old female patient. Her medical history was not reported. She had no current conditions. Her concomitant medications included amoxicillin trihydrate-potassium clavulanate which finished up a week prior vaccination. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 03 Nov 2015. On 04 Nov 2015, the patient experienced sharp aching pain in and all around deltoid and shoulder. The following morning when she applied deodorant, she noticed a lump underneath her left arm pit. She went to emergency room of the employee health department as well as to her private physician. The events outcome was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia, Rhinorrhoea, Sleep disorder
Clinical narrative: Case number PHHY2016US024753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 611021) website on 19 Feb 2016. This report refers to a 61 years old male patient. Current condition included hypertension controlled. Past medical history was not reported. Concomitant medication include TOPIROL and REQUIP. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 16 Nov 2015. On 18 Nov 2015, he had muscle pain, runny nose, low grade fever and muscle pain interfered with sleep. The outcome of the events was complete recovery. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Neck pain, Vaccination site pain
Clinical narrative: Case number PHHY2016US025604, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 611042) website on 19 Feb 2016. This report refers to a 31 years old male patient. Historical condition was not reported. Current conditions included allergy to minocycline, hypertension, high cholesterol and hypothyroid. Concomitant medication included SYNTHROID, benazepril, fluoxetine, LIPITOR. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in to left arm on 19 Nov 2015. On same day after vaccination, the patient developed severe neck and left shoulder pain radiating into the area of the vaccination site on left arm, neck stiffness. The patient was treated with pantoprazole sodium sesquihydrate. The final outcome of the events was not reported. Seriousness of the events was reported as non serious and causality not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Crying, Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2016US025899, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 611056) website on 19 Feb 2016. This report refers to a 37 years old female patient. Past medical history was not reported. Concomitant medication included alprazolam, buspirone, topiramate and duloxetine. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) into left arm on 17 Nov 2015. On 19 Nov 2015, she had excruciating pain in the arm that the flu shot was given and had almost no range of motion. She was unable to do everyday activities. She took pain reliever (paracetamol), heat/cold compresses, tiger balm patches (camphor, eucalyptus globulus oil, menthol, syzygium aromaticum oil) and massages, nothing was helping her out for more than 30 minutes to hour. At night she wakes up in tears because the pain was so unbearable. On an unknown date, she went to emergency room. The outcome of the events was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Case number PHHY2016US024688, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 611062) website on 19 Feb 2016. This report refers to a 01 years old male patient. Past medical history and concomitant medications were not reported. This 01 year old patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and HEPA/Hepatitis A (manufacturer unknown and batch number: not reported) in the left gluteus on 10 Nov 2015. On 18 Nov 2015, he had fever over 101 for 3 days. On 21 Nov 2015, rash developed on stomach. Outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Hypoaesthesia, Pain
Clinical narrative: Case number PHHY2016US024580, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (611065) website on 19 Feb 2016. This report refers to a 34 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 30 Oct 2015. The patient experienced discomfort, pain and slight numb after sleeping on left side, on an unknown date. The outcome and causality of the events were not reported. Seriousness of the events was reported as non serious.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Case number PHHY2016US024669, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 611083) website on 19 Feb 2016. This report refers to a 42 years old female patient. Past medical history was not reported. Concomitant medication included levothyroxine. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 13 Nov 2015, intramuscularly on left arm. On 14 Nov 2015, she had left arm pain side where injection was administered, pain on lifting at shoulder, towards the front of arm and near shoulder joint and she cannot sleep on left side. Pain was still present after 9 days of injection. The outcome of the events was not reported (missing). The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Drug administered at inappropriate site, Injection site bruising, Injection site pain
Clinical narrative: Case number PHHY2016US025142, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 611153) website on 19 Feb 2016. This report refers to a 52 years old female patient. Current condition included allergic to penicillin causes hives. Past medical history was not reported. Concomitant medication include acyclovir and fluoxetine. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) into left arm on 03 Nov 2015. The shot was given too high up on left shoulder resulted in a dark bruise. On an unknown date, about a week later when bruise finally went away, began noticing pain and loss of strength in left shoulder. On 23 Nov 2015, she had extreme pain and loss of strength in left shoulder. The outcome of the event administration site bruise was reported as complete recovery on an unknown date. The outcome of the events was not reported for other events. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Dysgeusia
Clinical narrative: Case number PHHY2016US025229, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS 611193) website on 19 Feb 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza (manufacturer unknown, batch number: not reported), on an unknown date. The patient experienced a metallic taste in her mouth following flu vaccine. The outcome of the events was reported as condition unchanged (reported as not recovered). Seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2016US025086, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS 611259) website on 19 Feb 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medications included low pressure (unspecified medication), ALLEGRA and NASONEX. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 20 Oct 2015. The patient's arm was swelling very big, very painful and itching. The outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US02453, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 611286) website on 19 Feb 2016. This report refers to a 55 years old female patient. Past medical history was not reported. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 27 Oct 2015. On same day, she had soreness in upper arm and shoulder, constant pain and limited range of motion. The outcome of the events was not reported (missing). The seriousness of the events was reported as non serious. The causality of the events was not reported.