chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Feeling hot, Pain
Clinical narrative: Based on the information received on 19 June 2015 the case is now medically confirmed. Initial unsolicited report received from non-healthcare professional on 20 May 2015. A 42-year-old male patient, whose medical history was reported as allergies to azithromycin and IVP dye, had received a third dose of MENACTRA (batch number: U4986CA, expiration date and dose not reported) intramuscularly in left deltoid on 19 May 2015 at 10:00 hours. Previously patient had received MENACTRA vaccine on 17 May 2012 at the age of 39 years. The patient had not received any vaccine within 4 weeks prior to vaccination. Illness at the time of vaccination and other medication were reported as none. Patient denied receiving any other medication. On 19 May 2015 at 20:00 hours, ten hours after vaccination patient was feeling hot, had chills and body aches. Laboratory investigations were not required. Patient had received MOTRIN as a corrective treatment on 20 May 2015. At the time of this report, patient was recovered from all events on an unspecified date. List of documents held by sender: none. Follow-up information received from physician on 19 June 2015. A patient had received 0.5 ml dose MENACTRA vaccine on 19 May 2015. It was not known if patient experienced any delayed reaction. No additional information reported. List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Based on the follow-up information on 8 June 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 30 April 2015. A 18-year-old female patient had received a dose of MENACTRA (batch number: U5068AB, dose, dose in series and expiry date were not reported) intramuscularly in left arm on 20 April 2015. Number of previous doses for MENACTRA was reported as one. The patient had medical history of asthma. Concomitant medications were not provided. On 20 April 2015, four hours after vaccination, the patient developed nausea and vomited. After 28 hours of vaccination, the patient had developed migraine headache. On 29 April 2015, the patient had second occurrence of migraine headache. Patient required ER/doctor visit. Laboratory investigations were not reported. The patient was seen in Urgent Care setting for first incidence of migraine headache where the patient was treated and released. For second occurrence of migraine headache, the patient was prescribed (RX) IMITREX. At the time of report, the outcome of the event was unknown. Documents held by sender: none. Follow-up information received from a physician on 8 June 2015. Patient name was corrected. Patient had received 0.5 ml dose of MENACTRA. Name of person who administered the vaccine was corrected. Vaccine was administered at private doctor's office/hospital. At the time of report, the outcome of the events was reported as unknown. List of documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Based on additional received on 22 June 2015, this case became medically confirm. Initial unsolicited report received from a non-healthcare professional on 01 May 2015. The case is linked with 2015SA0058582 (same reporter, same vaccine, same batch number and different patient). A 12-year-old female patient had received a dose of MENACTRA (batch number: U5026CA, Expiry date: 24 August 2016, dose and dose in series were not reported) via intramuscular route in left deltoid on 29 April 2015 and GARDASIL (Manufacturer: Merck, batch number: K006960, Expiry date, dose, dose in series and route of administration were not reported) in left deltoid on 29 April 2015.  Patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as Allergies: none and no medical conditions. Concomitant mediations were not reported. On 29 April 2015, within hours after vaccination, the patient experienced pain, itching, redness, hard, warm to touch, area at injection site of MENACTRA which progressed to pain, swelling, redness, hot to touch, area of upper left arm. Patient required ER/doctor visit on 30 April 2015. Laboratory investigations were not reported. The patient was treated with BENADRYL, ZYRTEC, ice to arm, and MOTRIN. At the time of this report, the outcome of the events were unknown. Documents held by sender: none. Follow-up report received from a physician on 22 June 2015. On an unspecified date, the patient recovered from all the events. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site warmth
Clinical narrative: Based on additional received on 22 June 2015, this case became medically confirm. Initial unsolicited report received from a non-healthcare professional on 01 May 2015. The case is linked with 2015SA0058582 (same reporter, same vaccine, same batch number and different patient). A 12-year-old female patient had received a dose of MENACTRA (batch number: U5026CA, Expiry date: 24 August 2016, dose and dose in series were not reported) via intramuscular route in left deltoid on 29 April 2015 and GARDASIL (Manufacturer: Merck, batch number: K006960, Expiry date, dose, dose in series and route of administration were not reported) in left deltoid on 29 April 2015.  Patient's illness at the time of vaccination reported as none. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as Allergies: none and no medical conditions. Concomitant mediations were not reported. On 29 April 2015, within hours after vaccination, the patient experienced pain, itching, redness, hard, warm to touch, area at injection site of MENACTRA which progressed to pain, swelling, redness, hot to touch, area of upper left arm. Patient required ER/doctor visit on 30 April 2015. Laboratory investigations were not reported. The patient was treated with BENADRYL, ZYRTEC, ice to arm, and MOTRIN. At the time of this report, the outcome of the events were unknown. Documents held by sender: none. Follow-up report received from a physician on 22 June 2015. On an unspecified date, the patient recovered from all the events. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Based on the follow up information received on 22 June 2015 the case is now medically confirmed. Initial unsolicited report received from non-healthcare professional on 1 May 2015. This case is linked to 20158A058589 due to same reporter and same lot number of the vaccine. A 11-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of MENACTRA (batch number: U5026CA and expiry date: 24 Aug 2016) in the left deltoid on 28 April 2015. Illness at the time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. On 28 April 2015 within hours after vaccination, the patient experienced itching, hard, pain, redness, warm to touch, area at injection site which progressed to pain, swelling, redness and hot to touch area of left upper arm. Corrective treatment included BENADRYL, ZYRTEC, ice to arm, and MOTRIN. Laboratory investigations were not reported. The patient was seen by physician for upper left arm swelling, pain, mild erythema and hot to touch area on 29 April 2015 and again on 30 April 2015. It was reported that on 30 April 2015 swelling, redness, warn to touch area had enlarged. The patient required ER/doctor visit. At the time of this report, the outcome of the events were unknown. Documents held by sender: none. Follow-up report received from a healthcare professional on 22 June 2015. The patient required three emergency room and doctor visits. At the time of this report, the patient had recovered from all the events on an unspecified date. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site warmth
Clinical narrative: Based on the follow up information received on 22 June 2015 the case is now medically confirmed. Initial unsolicited report received from non-healthcare professional on 1 May 2015. This case is linked to 20158A058589 due to same reporter and same lot number of the vaccine. A 11-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of MENACTRA (batch number: U5026CA and expiry date: 24 Aug 2016) in the left deltoid on 28 April 2015. Illness at the time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. On 28 April 2015 within hours after vaccination, the patient experienced itching, hard, pain, redness, warm to touch, area at injection site which progressed to pain, swelling, redness and hot to touch area of left upper arm. Corrective treatment included BENADRYL, ZYRTEC, ice to arm, and MOTRIN. Laboratory investigations were not reported. The patient was seen by physician for upper left arm swelling, pain, mild erythema and hot to touch area on 29 April 2015 and again on 30 April 2015. It was reported that on 30 April 2015 swelling, redness, warn to touch area had enlarged. The patient required ER/doctor visit. At the time of this report, the outcome of the events were unknown. Documents held by sender: none. Follow-up report received from a healthcare professional on 22 June 2015. The patient required three emergency room and doctor visits. At the time of this report, the patient had recovered from all the events on an unspecified date. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blindness, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 18 November 2015. Manufacturer Report Number: 2015390253. This case involves a male patient (age reported as "18") who was vaccinated with a dose of MENACTRA and a dose of TRUMENBA (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's face was pale, he was sweaty, dizzy, had cold hands, nauseous and he could not see. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Peripheral coldness
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 18 November 2015. Manufacturer Report Number: 2015390253. This case involves a male patient (age reported as "18") who was vaccinated with a dose of MENACTRA and a dose of TRUMENBA (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's face was pale, he was sweaty, dizzy, had cold hands, nauseous and he could not see. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 28.0
Sex: M
Vaccine: PNC13, YF
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Initial unsolicited report received from a nurse on 9 December 2015. This case involves a 28-year-old male patient who was vaccinated with a first dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number: LU5180AA, expiration date, dose were not reported) intramuscularly in right deltoid on 20 November 2015, a first dose of yellow fever vaccine (Manufacturer: Sanofi Pasteur, batch number: UI095AA, expiration date, dose were not reported) subcutaneously in left forearm on 4 December 2015 and a first dose of TDAP (manufacturer: Sanofi Pasteur, batch number: U5263AA, expiration date, dose were not reported) intramuscularly in left deltoid on 20 November 2015. The patient also received a first dose of PREVNAR 13 (manufacturer: Wyeth, batch number: L60103, expiration date: December 2016, dose were not reported) intramuscularly in right deltoid on 7 December 2015 at 08:00 hours. The patient did not have pre-existing physician diagnosed allergies, birth defects, medical conditions. There was no illness at time of vaccination. Concomitant medication was not reported. On 8 December 2015 at 16:00 hours, 18 days following the vaccination, the patient developed 2.5 x 2.5 cm erythema in the right arm, it was warm and tender to touch and pain "2/10" with which had elevated right arm up. No laboratory investigation performed. The body temperature was 97 (unit not provided). Corrective treatment was not reported. On an unspecified date, the patient recovered from the events. Follow-up information received from a nurse on 05 January 2016. The patient's illness at the time of vaccination and other medications were reported as none. The patient did not require any treatment. On 14 December 2015, the patient was recovered from all the events. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 09 December 2015. This case involves an 11-year-old female patient who was vaccinated with a dose of MENACTRA (batch number-U5216AA) intramuscularly in right deltoid on 03 November 2015 in the morning. The patient's medical history was not reported. She was previously vaccinated with Tdap vaccine on July 2015 and had experienced arm pain but was less severe. The patient's concomitant medications were not reported. On 03 November 2015 in the evening, few hours following vaccination, the vaccination site was sore. On 04 November 2015, the event worsened and the patient was crying due to the arm pain. Her right anterior shoulder (larger (approximately 6x10cm) vertically oriented) area developed swelling/erythema/warmth/tenderness which extended downward from shot site (right deltoid). The patient had experienced itching. Laboratory data was not reported. The patient's corrective treatment included ice pack for swelling, Ibuprofen for pain and BENADRYL for itching. It was reported that it was not recommended to withhold the dose 2. The outcome of the events was not reported. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: Initial unsolicited report received from a nurse on 09 December 2015. This case involves an 11-year-old female patient who was vaccinated with a dose of MENACTRA (batch number-U5216AA) intramuscularly in right deltoid on 03 November 2015 in the morning. The patient's medical history was not reported. She was previously vaccinated with Tdap vaccine on July 2015 and had experienced arm pain but was less severe. The patient's concomitant medications were not reported. On 03 November 2015 in the evening, few hours following vaccination, the vaccination site was sore. On 04 November 2015, the event worsened and the patient was crying due to the arm pain. Her right anterior shoulder (larger (approximately 6x10cm) vertically oriented) area developed swelling/erythema/warmth/tenderness which extended downward from shot site (right deltoid). The patient had experienced itching. Laboratory data was not reported. The patient's corrective treatment included ice pack for swelling, Ibuprofen for pain and BENADRYL for itching. It was reported that it was not recommended to withhold the dose 2. The outcome of the events was not reported. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Initial unsolicited case received from a non-healthcare professional (healthcare worker) on 11-Sep-2015. This case involves a male patient (age not reported) who was vaccinated with a second dose of MENACTRA (batch number, expiry date, route and site of administration were not reported) on 31-Aug-2015. Medical history and concomitant medications were not reported. On unspecified date, after vaccination patient developed breaking out in rash from top to bottom that appeared as raised hive-like welts that were very much swollen. Patient was taken to emergency room. Patient had previously received MENACTRA when he was "11 years old" on unspecified date. Lab tests and corrective treatments were not reported. Outcome of the events was not reported. Documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 8 September 2015. This case involves a 17 years old male patient who was vaccinated with a third intramuscular dose of MENACTRA (batch number U5186AA, dose was not reported) in right deltoid on 31 August 2015. The patient did not have illness at time of vaccination and had no known allergy. The patient previously received two doses of MENACTRA "10 September 2011". Concomitant medications were not reported. On 3 September 2015, three days following the vaccination, the patient experienced swelling of legs, arms and welts on entire body. The patient required emergency room and physician visit. Lab data and corrective treatments were not reported. The patient was recovered from the events on an unspecified date. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Malaise, Neck pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 2 September 2015. This case involves a 17-year-old female patient who had received a dose (route of administration unknown) of MENACTRA (batch number U5178AA, expiry date: 17 January 2017) in right deltoid on 1 September 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies (NKA) none and illness at time of vaccination was none. Concomitant medications were reported as none. On 2 September 2015, one day after the vaccination the patient experienced headache and neck pain and also felt generally ill. The patient required ER visit. Laboratory investigations were reported as none. Corrective treatments were not reported. The event outcome was unknown. Documents held by sender: none. Follow-up information received from a pharmacist on 29 September 2015. It was reported that patient did not require ER doctor visit. Patient had followed up with school nurse. Stated and country where vaccine administered was reported. Follow-up information received from a pharmacist on 2 November 2015. No new information reported.
Age: 34.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Erythema, Incorrect route of drug administration
Clinical narrative: Initial unsolicited misuse report received from a physician on 21 August 2015. A 34-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of TYPHIM VI (batch number K1536, expiry date 16 Sept 2016) in left deltoid and a subcutaneous dose of MENACTRA (batch number U5021AA, expiry date 14 July 2016) on 19 August 2015. Reporter denied to provide information regarding illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions. It was a case of inappropriate route of vaccination, as the patient received dose of MENACTRA via subcutaneous route instead of intramuscular route. On 21 August 2015, two days after vaccination, the patient developed an oval area of redness measuring 2.5 cm. The patient required emergency room or physician visit. Laboratory investigations were not reported. It was reported that the physician did not prescribe medical treatment to patient. At the time of this report, the outcome of event was unknown. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Dysphonia, Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 21-Oct-2015. This case involves a 48 years old female patient who was vaccinated with a first dose of MENACTRA in the right deltoid (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details and route of administration was not reported) on 20-Oct-2015. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. It was reported that the patient decided to take the vaccine due to a death in the area from meningitis. On 20-Oct-2015, immediately after vaccination. the patient experienced tingling in her right arm. Later that day it progressed with shoulder, neck and upper back pain on that side. On 21-Oct-2015, (day of reporting), she was worse. Her face felt numb and she had a horse voice. Patient stated that she would seek medical care in the future. No laboratory investigations were done and corrective treatment was not reported. The patient required ER/doctor visit. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Neck pain, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 21-Oct-2015. This case involves a 48 years old female patient who was vaccinated with a first dose of MENACTRA in the right deltoid (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details and route of administration was not reported) on 20-Oct-2015. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. It was reported that the patient decided to take the vaccine due to a death in the area from meningitis. On 20-Oct-2015, immediately after vaccination. the patient experienced tingling in her right arm. Later that day it progressed with shoulder, neck and upper back pain on that side. On 21-Oct-2015, (day of reporting), she was worse. Her face felt numb and she had a horse voice. Patient stated that she would seek medical care in the future. No laboratory investigations were done and corrective treatment was not reported. The patient required ER/doctor visit. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Chills, Injection site swelling, Migraine, Pain, Pruritus
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 10 November 2015. This case was linked to 2015SA182407 (same vaccine, different patient). This case involves a patient (age and gender not reported) who was vaccinated with a dose of MENACTRA and with a dose of TRUMENBA (batch number, dose, dose in series and route administration were not reported) on arm on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed migraine, swelling in the arm where the vaccination occurred, chills, pain and itchiness. Laboratory data and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
Sex: U
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 7 days after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were received as follows: The reporter stated that, 2 patients experienced soreness one week out after the vaccination with BEXSERO. The reporter stated that, very little information was known about the event was known and all other information including as batch number of vaccine, age of patient, date of vaccination, initials of patients and expiry date of vaccine were unknown. This case has been linked with the case US2016GSK015455 for the 2nd patient reported by the same reporter.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: Patient was seen at 0830. Reviewed what vaccines were going to be given and possible side effects. Patient was extremely anxious prior to shots being administered and was hyperventilating. Shots administered at approx. 0850. Pt felt nauseous and sat down. Patient became pale and vomited about an ounce, clear in color. After patient rested longer. The patient laid down on the bed with legs up. Vital signs were taken, doctor and nurse in room evaluating patient. Vital signs were stable. After 15 min of observation patient was advised to stay in clinic a complete 30 min. Patient went with guardian and attended appointment. No other signs or symptoms of reaction to vaccine occurred.
Age: 67.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Musculoskeletal pain, Pain in extremity, Vomiting
Clinical narrative: Case number PHHY2015US026371, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 547466) web site on 05 Mar 2015. This report refers to a 67-year-old male patient. Medical history included vaccination with flu shot and COPD (chronic obstructive pulmonary disease). Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine manufacturer and batch number: unknown) and zoster vaccine live (manufacturer and batch number: unknown) on 08 Oct 2014. On 08 Oct 2014, after the vaccination, she had diarrhea and vomiting all night. On 09 Oct 2014 she had pain in shoulders and hands. The final outcome of the events was not reported. The events were reported as non serious. Causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site warmth
Clinical narrative: Case number PHHY2015US008227 is an initial spontaneous report received via Vaccine Adverse Event reporting System (VAERS ID: 547966) on 06 Jan 2015. This report refers to a 37 years old female patient. Past medical history was not reported. Her concomitant medication were DEPO PROVERA, SUDAFED, Vitamin B12, GLUCOPHAGE, SINGULAIR and NASACORT. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date following which she experienced red, itchy, hot and firm site following vaccination (see related case number: PHHY2015US008233). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 13 Oct 2014. On 13 Oct 2014, she had itching and redness around the vaccination site. Redness continued to expand to 6 cm x8 cm over next few hours and it became hot and firm. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Underdose
Clinical narrative: Case number PHHY2015US014018, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 547967) on 03 Feb 2015. This report refers to an adult female patient of an unknown age. Medical history and concomitant medications were not reported. She was vaccinated with partial dose (1/8 of 0.5 cc dose) of seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced numbness and tingling in hers legs and arms. She also experienced swelling of feet. The outcome, seriousness and causality of the events were not reported. She was vaccination with FLUCELVAX (batch number: 161208) and experienced events (see case: PHHY2015US014022).
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, VARCEL
Symptoms: Blister, Erythema, Pain in extremity, Swelling
Clinical narrative: Case number PHHY2015US013461, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 547990) website on 06 Jan 2015. This report refers to a 64 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported), pneumococcal vaccine (other manufacturer, batch number: not reported) and varicella zoster vaccine (other manufacturer, batch number: not reported) all on 09 Oct 2014. On the same day after vaccination, she developed swelling, redness and blisters (site unspecified). She also experienced arm pain. She was taken to an emergency room and a varicella culture was performed (result was not given). Final outcome was condition unchanged. Events were reported as non-serious. Causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Case number PHHY2015US013464, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548052) website on 06 Jan 2015. This report refers to a 66 year old female patient (manufacturer and batch number: not reported) in right arm on 13 Oct 2014. On the same day after vaccination, she experienced fever, rapid heartbeat, chills, aches in all joints, extreme headache, fatigue and sleepiness. Final outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Somnolence
Clinical narrative: Case number PHHY2015US013464, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548052) website on 06 Jan 2015. This report refers to a 66 year old female patient (manufacturer and batch number: not reported) in right arm on 13 Oct 2014. On the same day after vaccination, she experienced fever, rapid heartbeat, chills, aches in all joints, extreme headache, fatigue and sleepiness. Final outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Disorientation, Eye discharge, Incoherent, Mobility decreased
Clinical narrative: Case number PHHY2015US013531, is an initial spontaneous report received from the vaccine adverse events reporting system (VAERS reference number: 548085) on 06 Jan 2015. This report refers to a 28 years old female patient. Her current condition included allergy to figs which was diagnosed by physician. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in the left arm on 15 Oct 2010. On 15 Oct 2014, she experienced weakness; white pus in eye, disoriented, incoherent and was immobile. All the events lasted for two days. The outcome of the events was reported as complete recovery. The events were reported as non-serious and causality of the event was not reported.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Feeling abnormal, Hyperhidrosis, Malaise
Clinical narrative: Case number PHHY2015US013532, is an initial spontaneous report received form the Vaccine Adverse Event Reporting System (VAERS reference number: 548088) website on 06 Jan 2015. This report refers to a 58 year old female patient. Current condition included diabetes type 2. Concomitant medication included CELEXA, metformin, glycerides, Synthroid, ZOCOR and fenofibrate and MOBIC. On 08 Oct 2014, she received seasonal influenza vaccine (manufacturer and batch number unknown) into left arm. On the same day post vaccination, she experienced severe weakness, a fainting feeling, profuse sweating, body aches and an all over feeling of unwell. She experienced a funny feeling of not being able to see or think straight. All of these effects went away within one and 1 half hours except the body aches. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Following an internal review on 27 Feb 2015, of the information received on 06 Jan 2015. The event verbatim "funny feeling of not being able to see or think straight" was combined and coded to one term "feeling abnormal".
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Mental impairment, Pain, Visual impairment
Clinical narrative: Case number PHHY2015US013532, is an initial spontaneous report received form the Vaccine Adverse Event Reporting System (VAERS reference number: 548088) website on 06 Jan 2015. This report refers to a 58 year old female patient. Current condition included diabetes type 2. Concomitant medication included CELEXA, metformin, glycerides, Synthroid, ZOCOR and fenofibrate and MOBIC. On 08 Oct 2014, she received seasonal influenza vaccine (manufacturer and batch number unknown) into left arm. On the same day post vaccination, she experienced severe weakness, a fainting feeling, profuse sweating, body aches and an all over feeling of unwell. She experienced a funny feeling of not being able to see or think straight. All of these effects went away within one and 1 half hours except the body aches. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Following an internal review on 27 Feb 2015, of the information received on 06 Jan 2015. The event verbatim "funny feeling of not being able to see or think straight" was combined and coded to one term "feeling abnormal".
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US013533, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548093) website on 06 Jan 2015. This report refers to a 32 year old female patient. No medical history and concomitant medication. On 15 Sep 2014, she received seasonal influenza vaccine (manufacturer and batch number unknown) intramuscular into left arm. On 16 Sep 2014, she experienced severe shoulder pain, difficulty moving, limited mobility in left shoulder and arm. Final outcome of the events was not reported. Causality assessment was not reported. Events were reported as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: Case number PHHY2015US013539, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548115) website on 06 Jan 2015. This report refers to a 59 year old female patient. Medical history was not reported. Concurrent conditions included sulfonamide and amoxicillin allergy. No concomitant medication was reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 14 Oct 2014. On 15 Oct 2014, she experienced dizziness for entire day, weakness, chills and slight nausea. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Flushing, Heart rate increased, Lymphadenopathy, Oral discomfort
Clinical narrative: Case number PHHY2015US013540, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548116) on 06 Jan 2015. This report refers to a 42 year old female patient. Medical history was not reported. Concurrent conditions included hypothyroidism, peanut allergy, gluten intolerance and lactose intolerance. Concomitant medications included levothyroxine and atentolol. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in right arm on 03 Oct 2014. On the same day after vaccination, she developed glands in neck, wheezing, cough, flushing of face, increased heart rate, discomfort in mouth and throat. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal discomfort, Wheezing
Clinical narrative: Case number PHHY2015US013540, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548116) on 06 Jan 2015. This report refers to a 42 year old female patient. Medical history was not reported. Concurrent conditions included hypothyroidism, peanut allergy, gluten intolerance and lactose intolerance. Concomitant medications included levothyroxine and atentolol. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in right arm on 03 Oct 2014. On the same day after vaccination, she developed glands in neck, wheezing, cough, flushing of face, increased heart rate, discomfort in mouth and throat. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US019598 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 548285) on 03 Feb 2015. This report refers to a 60 years old female patient. Her current conditions included chronic obstructive pulmonary disease (COPD) and macular degenerative disease. Her concomitant medications were CELEXA 20 mg daily and Vitamin D 50000 units monthly. She was vaccinated with AGRIFLU (batch number: 012031A) intramuscularly in the left arm on 14 Oct 2014. On 15 Oct 2014, her upper arm had a red, hot and swollen round area of diameter about 2 inches and it then dispersed into a 2 x 4 inches solid stripe across her upper arm. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: ADEN_4_7, FLUX
Symptoms: Cold sweat, Influenza
Clinical narrative: Case number PHHY2015US021387 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548325) on 03 Feb 2015. This report refers to a 62 years old female patient. Her current conditions included high blood pressure and high cholesterol. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and liver adenovirus type 4 and 7 oral vaccine (other manufacturer, batch number: not reported) on unknown dates in 2013. It was reported that after vaccinations, she had flu occurred thrice in 2013. She had no laboratory tests done. The final outcome of events seriousness and causality were not reported. She further received a dose of FLUCELVAX (batch number: not reported) on 09 Oct 2014 following which she experienced cold sweat (see related case number: PHHY2015US021356).
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Pruritus, Pyrexia
Clinical narrative: Case number PHHY2015US013393 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System website (VAERS ID: 548722) on 06 Jan 2015. This report refers to a 71 year old female patient. Her past medical history and concomitant medications were not reported. On 09 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into her right arm. On the same day, after the vaccination, she developed chills, slight fever, itching, could not get out of bed for 30 hours with weakness. The final outcome of the events was not reported. The events were reported as non serious and causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Case number PHHy2015US013406 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System website (VAERS ID: 548728) on 06 Jan 2015. This report refers to a 27 year old female patient. Her past medical history and concomitant medications were not reported. On 16 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into her left arm. On the same day, after the vaccination, she developed swelling, redness, itching and warmth. The final outcome of the events was unknown. The events were reported as non serious and causality of the events was not reported.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Case number PHHY2015US013417 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System website (VAERS ID: 548737) on 06 Jan 2015. This report refers to a 59 year old male patient. His past medical history was not reported. His concomitant medications included lamotrigine. On 17 Oct 2014, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into his left arm. On the same day, after the vaccination, he developed moderate dizziness. The final outcome of the events was condition unchanged. The events were reported as non serious and causality of the events was not reported.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Headache
Clinical narrative: Case number PHHY2015US008468 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 548834) on 06 Jan 2015. This report refers to a 58 years old male patient. His current condition included acid reflux. His concomitant medications were PRILOSEC, CRESTOR, Asacol and Amlodipine/Benzapril. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported)) on 14 Oct 2014. On 14 Oct 2014, he experienced extreme dizziness and headache which lasted for 2 days. It was reported that then the headache became extreme and lasted for another 2 days. He drank a ton of water and took an ADVIL. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the event was not reported.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US007551 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548849) on 06 Jan 2015. This report refers to a 33 years old male patient. His historical drug included penicillin. His concomitant medication were not reported. He was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2014. On 16 Oct 2014, he had fever, body ache and headache for 18 hours. The event outcome was reported as complete recovery. The event was reported as non-serious. The causality of the event was not reported.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Headache, Pain
Clinical narrative: Case number PHHY2015US007590 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548850) on 06 Jan 2015. This report refers to a 34 years old male patient. Past medical history was not reported. His concomitant medication included KLONOPIN. He was vaccinated with seasonal influenza vaccine )manufacturer and batch number: not reported) in the arm on 03 Oct 2014. On 03 Oct 2014 after vaccination, he had aches, fatigue, dizziness and headache which continued unabated. He went to emergency room. The events outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: Case number PHHY2015US007345 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548959) on 06 Jan 2015. This report refers to a 41 years old female patient. Her current conditions included bipolar disorder. Her concomitant medications were quetiapine and lorazepam. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 10 Oct 2014. On 11 Oct 2014, she experienced non-muscular joint pain in both elbows. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy, Breast pain, Lymphadenopathy, Mammogram, Pain in extremity
Clinical narrative: Case number PHHY2015US013467, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548989) website on 06 Jan 2015. This report refers to a 37 year old female patient. Her medical history and concomitant medication were none. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 16 Oct 2014. On 18 Oct 2014, she developed a golf ball size swelling of lymph nodes above clavicle (same side of vaccination) and pain radiating through arm and breast. After three days, she developed swollen lymph nodes in breast. She was taken to an emergency room where she was asked to do a biopsy and mammogram. Final outcome of the events was reported as condition unchanged. Events were reported as non-serious. Physician did not think that the events were related to vaccination.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Ocular hyperaemia, Pyrexia, Ventricular extrasystoles
Clinical narrative: Case number PHHY2015US013468, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549011) website on 06 Jan 2015. This report refers to a 55 year old female patient. Medical history was not reported. Concurrent conditions included hyperthyroidism and hypertension. No concomitant medication was reported. Her vaccination history included administration of typhoid vaccine (other manufacturer) which caused chills and fever at t18 year old her age and DT vaccine (other manufacturer) which caused the same events when she was 28 year old. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 20 Oct 2014. On the same day after vaccination, she developed red eyes, chills, fever at a body temperature of temperature 101.5 degree Fahrenheit and rapid heart rate (120 beats/min). Her premature ventricular contraction was 10/minute. Final outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Headache, Mobility decreased, Oropharyngeal pain
Clinical narrative: Case number PHHY2015US013475, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 549043) website on 06 Jan 2015. This report refers to a 71 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Oct 2014. On the same day after vaccination, she experienced sore arm and could not lift arm for a week. A week after vaccination, she developed sore throat, body ache, chills, headache, nonproductive cough and sinus pain. Final outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality was not reported.