chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Leg amputation, Pain in extremity, Peripheral coldness
Clinical narrative: Case number PHHY2016US106020, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637605) website on 01 Aug 2016. This report refers to a 61 years old female patient. Past medical history was not reported. Current conditions included as penicillin allergy and chronic idiopathic thrombocytopenic purpura. Concomitant medications included as calcium, vitamin and Vitamin D3. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: not reported) into left arm, intramuscularly, HAVRIX vaccine (other manufacture, batch number: A4M5L) into left arm, intramuscularly and YF-VAX (other manufacture, batch number: Ui095AA) into right arm, on 11 Dec 2015. On 22 Dec 2015, the patient experienced immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot, blood clot (no vascular disease) discovered and subsequent amputation below the knee. The patient visited the emergency room and was hospitalized for 15 days. The patient computed tomography (CT) scan was done subsequently tests to rule out other diagnoses. The outcome of events was reported as condition unchanged. The seriousness of events was reported as serious (hospitalized and disability). The causality of events was not reported. Follow up report received from a quality assurance (QA) department on 09 Aug 2016: QA confirmed that, previously reported batch number (151750) was not valid FLUVIRIN batch number.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Thrombosis
Clinical narrative: Case number PHHY2016US106020, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637605) website on 01 Aug 2016. This report refers to a 61 years old female patient. Past medical history was not reported. Current conditions included as penicillin allergy and chronic idiopathic thrombocytopenic purpura. Concomitant medications included as calcium, vitamin and Vitamin D3. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: not reported) into left arm, intramuscularly, HAVRIX vaccine (other manufacture, batch number: A4M5L) into left arm, intramuscularly and YF-VAX (other manufacture, batch number: Ui095AA) into right arm, on 11 Dec 2015. On 22 Dec 2015, the patient experienced immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot, blood clot (no vascular disease) discovered and subsequent amputation below the knee. The patient visited the emergency room and was hospitalized for 15 days. The patient computed tomography (CT) scan was done subsequently tests to rule out other diagnoses. The outcome of events was reported as condition unchanged. The seriousness of events was reported as serious (hospitalized and disability). The causality of events was not reported. Follow up report received from a quality assurance (QA) department on 09 Aug 2016: QA confirmed that, previously reported batch number (151750) was not valid FLUVIRIN batch number.
Age: 35.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Erythema, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a nurse on 28 July 2016. This case involves a male patient (age not reported) who was vaccinated with a 0.1 ml dose of MENACTRA (batch number, expiration date were not reported) intradermally in the left forearm on 20 July 2016 instead of TUBERSOL (batch number, expiration date, dose, site and route of vaccination were not reported). The patient Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies: none. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed injection site redness. It was also a case of wrong vaccine administered, wrong route of administration. It was reported that patient had returned back for reading of the TB Skin test on 22 July 2016, then the nurse did not discovered the error until doing inventory and stated that he has not called to report any other symptoms. Lab data and corrective treatment were not reported. Outcome of the event was reported as unknown. No other symptoms reported. List of documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a nurse on 28 July 2016. This case involves a male patient (age not reported) who was vaccinated with a 0.1 ml dose of MENACTRA (batch number, expiration date were not reported) intradermally in the left forearm on 20 July 2016 instead of TUBERSOL (batch number, expiration date, dose, site and route of vaccination were not reported). The patient Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies: none. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed injection site redness. It was also a case of wrong vaccine administered, wrong route of administration. It was reported that patient had returned back for reading of the TB Skin test on 22 July 2016, then the nurse did not discovered the error until doing inventory and stated that he has not called to report any other symptoms. Lab data and corrective treatment were not reported. Outcome of the event was reported as unknown. No other symptoms reported. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL, MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a 5 year old patient of unknown gender. On 04-AUG-2016, the patient was vaccinated with PROQUAD (lot # M003434, expiry date 09-JUL-2017), 0.5 ml, subcutaneous with VARIVAX (dose, route and lot# were not reported) due to human error. Nurse stated that the patient should have been vaccinated with M-M-R II with VARIVAX. No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL, MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a 5 year old patient of unknown gender. On 04-AUG-2016, the patient was vaccinated with PROQUAD (lot # M003434, expiry date 09-JUL-2017), 0.5 ml, subcutaneous with VARIVAX (dose, route and lot# were not reported) due to human error. Nurse stated that the patient should have been vaccinated with M-M-R II with VARIVAX. No adverse effects reported. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given, she received Pneumovax 23.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, PPV
Symptoms: Tendon sheath incision, Trigger finger, X-ray
Clinical narrative: Wrong vaccine given, she received Pneumovax 23.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received via company representative from a 65 year old non-pregnant female patient (office manager) who was reporting on herself. The patient's medical history included cellulitis after an unspecified tuberculosis injection. Her concurrent conditions and concomitant medications were not reported. On an unspecified date in 2014 (reported as 2 years ago), the patient was vaccinated with the first dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). On an unspecified date, the patient was diagnosed with cellulitis. She sought an unspecified type of medical attention and received unspecified antibiotics as a treatment. The outcome of cellulitis was reported as resolved on an unspecified date. The relatedness between the adverse event and ZOSTAVAX was not provided. Upon internal review, the adverse event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatosis, Full blood count normal, Purpura
Clinical narrative: Initial unsolicited report received from a physicianon 19 November 2015. This case involves a 78-year-old female patient who was vaccinated with a intramuscular dose of FLUZONE HD (batch number UI436AA, Expiration date 08 April 2016, dose, dose in series, site of administration were not reported) on November 2015 (unspecified date). Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as hypothyroidism, hypertension, and high cholesterol. Concomitant medications were not reported. On an unspecified date, couple of days post vaccination, the patient developed pigmented purpura dermatosis. Patient required emergency room and physician visit. Lab data included complete blood count which was reported as normal. Corrective treatments were not reported. Outcome of events was reported as unknown. List of documents held by sender: none. Follow up information received from a physician on 26 February 2016. No new information reported.
Sex: F
Vaccine: FLUX
Symptoms: Cyanosis, Skin discolouration
Clinical narrative: Initial unsolicited report received from a Consumer via non-healthcare professional on 10 November 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu SHOT) (batch number, dose, dose in series, expiration date, route and site of administration were not reported) on an unspecified date. The patient had a medical history of diabetes and neuropathy. It was reported that lantus did not really work for patient and sometimes made patients sugars drop really low. Patient did not drive anymore because of diabetes. Patient could hardly walk because of the neuropathy. Concomitant medications included Lantus, Humalog and metformin. On an unspecified date, following the vaccination, the patient experienced entire arm turned black and blue. Lab data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Initial unsolicited report received from a nurse on 18-Nov-2015. This case involves a 76-year-old female patient, who was vaccinated with FlLUZONE HD (Batch number: UI452AA, dose and dose in series not reported) via intramuscular route in left upper arm and 0.5 ml dose of PREVNAR 13 (manufacturer: Pfizer, Batch number: M13067, expiry date: Apr-2017) via intramuscular route in right upper arm on 22-Oct-2015 at 11:00 A.M.  Patient had no illness at the time of vaccination. Medical history and concomitant medication was not reported. On 22-Oct-2015, same day three minutes after vaccination, patient experienced dizziness and could hardly walk. It was reported that no Laboratory investigation and corrective treatment were required. On unspecified date patient was recovered from the events. Follow-up information received from a nurses on 22-Dec-2015. Patient's had medical history of anxiety disorder, Chronic obstructive pulmonary disease, coronary artery disease, aortic aneurysm, cerebro vascular disease, Gastro esophageal reflux disease, hypercholesterolemia, hypothyroidism, muscle cramps, osteoarthritis, peptic ulcer, peripheral vascular disease, Raynaud's syndrome, tobacco user and vertigo. It was reported that after the patient left pharmacy the dizziness continued throughout the night and then gradually tapered off throughout the next day. Since the patient had no problems. Documents held by Sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 November 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (flu shot) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient's arm was hurting and sore when opening door. Lab data and corrective treatments were not reported. Outcome of event was unknown. List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Acne, Blood test, Echocardiogram, Electrocardiogram, Rash pruritic
Clinical narrative: Initial unsolicited report received from a consumer on 30 November 2015. This case involves a 81 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (Manufacturer, Batch number, expiry date was unknown; dose, dose in series, route and site of administration were not reported) on 20 October 2015 and with an injection of PREVNAR 13 (Manufacturer: Pfizer; Batch number: Unknown; dose, dose in series, route and site of administration were not reported) on 20 October 2015. The patient had received vaccine in doctor's office. In 2002 the patient had realized that she had cervical stenosis and in 2013 the patient was diagnosed with L4-L5 lumbar stenosis and then in June and July 2014 she had lumbar laminectomies for L3-4, L4-5. It was reported that the patient rides her bike but can feel back problem (lower back problem) while walking (ongoing). The patient had some ongoing digestive problems and noticed that when she was around 40 years old she had constipation and laminectomy exacerbated the constipation. The patient had received fiber as concomitant medications. On an unknown date in 2015, one week following the vaccination, the patient had itchiness first and then rash like a pimple (hard and pink). It was reported that the rash was first on her hip, one on her right breast, one under her arm (very itchy) and one on her left arm (little itchy) with one or two of the pimples. Laboratory data included good EKG and blood work in last July and had a great echocardiogram recently, within the last month. The patient was treated with Caladryl for rash. The patient was not recovered from all the events. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Cervical radiculopathy, Neck pain
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 8 December 2015. This case involves a 62-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI482AA, expiration date: 30 June 2016, dose, dose number and route of administration were not reported) in left deltoid on 27 October 2015. The patient had medical history of diabetes, hypertension, pancreatitis and no known allergy (NKA). The patient illness at time of vaccination was none reported. Any other vaccinations within 4 weeks of vaccinations was unknown. Concomitant medication was not reported. On 28 October 2015, one day following the vaccination, the patient experienced left sided neck pain. The patient saw her physician on 5 November 2015 and was diagnosed with C6-7 Neuralgia. The patient required ER or doctor visit. No laboratory investigation was performed. The patient received orally NEURONTIN, OTC medications, heat or ice as a corrective treatment. The outcome of the event was unknown. Follow up information received from non-healthcare professional on 26 January 2016. No new information was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a non-healthcare professional  on 7 December 2015. This case involves 18 patients (age and gender not reported) who were vaccinated with a dose of 0.5 ml FLUZONE QUAD ( batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, 18 patients out of the 20 that were vaccinated experienced unspecified adverse reaction. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the below mentioned study on 04 December 2015. The subject (gender and age were not reported) got deathly sick with the flu from an unspecified date, after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. The subject took the high dose "last year" and got deathly sick with the flu and so the subject would never take it again. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse drug reaction
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in a study on 04 December 2015. The subject (gender and age were not reported) did not like its side effects after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). During a prompted discussion, the subject reported to have taken the high dose vaccine a couple years ago and did not like its side effects. The subject was offered high dose this year but refused it. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the study on 04 December 2015. The subject (gender and age were not reported) experienced an adverse event on an unspecified date, after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. During a prompted discussion the subject experienced an adverse reaction "last year" after the subject received the vaccination. And so the subject did not receive the same vaccine this year. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Trismus
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in a study on 04 December 2015. The male subject (age was not reported), on an unspecified date experienced locking up of jaw, a couple of hours, after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. The subject reported in a prompted discussion with HCP that he did not know what kind of vaccine it was and his jaw started locking up a couple of hours after receiving the vaccine. A nurse suggested him to go to a hospital, however he did not as his wife reminded him that he had been complaining about his jaw since a couple of weeks. The lab data and corrective treatment details were not reported. The event of locking up of jaw was resolved on an unspecified date. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 21 December 2015. This case involves a 69-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI513AA, expiration date: 12 June 2016, dose, dose number, route were not reported) site of administration was reported as "left" on 18 December 2015. The patient's medical history was none reported. Concomitant medicaltion was not reported. On 19 December 2015 (the next morning), one day following the vaccination, the patient experienced redness of 3x2 inches and swelling noted to injection site. The patient denies warmth, stated it was tender to the touch and slightly itchy. Laboratory investigation and correctieve treatment were not reported. The outcome of the event was reported as unknown. List of the document held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Impaired work ability, Pain, Pyrexia, Viral infection
Clinical narrative: Initial unsolicited report received from a nurse on 30 December 2015. This case is a cluster of three cases and linked with 2015SA153209 and 2016SA003166 (same vaccine, different patient). This case involves a 43-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI445AC, expiry date: 30 June 2016) in left deltoid on an unknown date. The patient medical history such as allergic to egg or egg products, allergic to flu vaccine, history of guillain barre symdrome, allergic to thiomersal, allergic to latex reported as no. The patient was not pregnant at the time of  vaccination. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed aches, chills, fever and went home from work as thought she had a virus. It was reported that the patient had not worked the day after but fine within 24 hours of vaccination. Laboratory data and corrective treatment was not reported. The patient was recovering from all the events. It was reported that the patient felt better 14 day later. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 08-Jan-2016. This case involves a 60-year-old female patient who was vaccinated with first dose of FLUZONE TIV (batch number: UI195AA expiry date: 30-Jun-2015, dose and route of administration was not reported) in left deltoid on 21-Oct-2014. Patient had no illness at the time of vaccination, no known allergy and no medical history. Concomitant medications were not reported. On 21-Oct-2014, same day after vaccination, the patient experienced normal soreness at the injection site but, that over the past year the numbness tingling and pain has been increasing and patient was barely able to use her arm. No laboratory investigations were performed. It was reported that the patient denied to take medical treatment and patient was urged to seek immediate medical treatment as this appeared to be an evolving issue that could have other medical cause. At the time of this report the patient was not recovered. Documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Cough, Injection site pain, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer on 12 January 2016. This case involves a 70-year-old male patient who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left deltoid on 13 October 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy (NKA). Patient had no other vaccinations within 4 weeks of vaccinations. On 13 October 2015, same day following the vaccination patient developed all over body aches to his toes and generally feeling weak. On an unspecified date, "Within 4 days" following the vaccinations patient developed a cough and cold. On an unspecified date, following the vaccinations patient still had pain in his right (R) shoulder, arm and his low back into his bilateral thighs, left shoulder and testicular pain. Patient required emergency room (ER)/doctor visit. Laboratory investigation involved magnetic resonance imaging (MRI) of his right shoulder on 13 January 2016. Blood work involved Vitamin D deficiency noted elevated PSA level, Xrays of bilateral shoulders and pelvis, negative for arthritis. Corrective treatment was Nonsteroidal anti-inflammatory drugs (NSAIDs). The outcome of event was not recovered for event had all over body aches to his toes and generally feeling weak, pain is still in his (R) shoulder, left shoulder, pain in arm, low back into his bilateral thighs and outcome was recovered for the events cough/cold (lasted for months) and testicular pain. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Prostatic specific antigen increased
Clinical narrative: Initial unsolicited report received from a consumer on 12 January 2016. This case involves a 70-year-old male patient who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left deltoid on 13 October 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy (NKA). Patient had no other vaccinations within 4 weeks of vaccinations. On 13 October 2015, same day following the vaccination patient developed all over body aches to his toes and generally feeling weak. On an unspecified date, "Within 4 days" following the vaccinations patient developed a cough and cold. On an unspecified date, following the vaccinations patient still had pain in his right (R) shoulder, arm and his low back into his bilateral thighs, left shoulder and testicular pain. Patient required emergency room (ER)/doctor visit. Laboratory investigation involved magnetic resonance imaging (MRI) of his right shoulder on 13 January 2016. Blood work involved Vitamin D deficiency noted elevated PSA level, Xrays of bilateral shoulders and pelvis, negative for arthritis. Corrective treatment was Nonsteroidal anti-inflammatory drugs (NSAIDs). The outcome of event was not recovered for event had all over body aches to his toes and generally feeling weak, pain is still in his (R) shoulder, left shoulder, pain in arm, low back into his bilateral thighs and outcome was recovered for the events cough/cold (lasted for months) and testicular pain. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Testicular pain, Vitamin D decreased, Vitamin D deficiency, X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: Initial unsolicited report received from a consumer on 12 January 2016. This case involves a 70-year-old male patient who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration were not reported) in left deltoid on 13 October 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy (NKA). Patient had no other vaccinations within 4 weeks of vaccinations. On 13 October 2015, same day following the vaccination patient developed all over body aches to his toes and generally feeling weak. On an unspecified date, "Within 4 days" following the vaccinations patient developed a cough and cold. On an unspecified date, following the vaccinations patient still had pain in his right (R) shoulder, arm and his low back into his bilateral thighs, left shoulder and testicular pain. Patient required emergency room (ER)/doctor visit. Laboratory investigation involved magnetic resonance imaging (MRI) of his right shoulder on 13 January 2016. Blood work involved Vitamin D deficiency noted elevated PSA level, Xrays of bilateral shoulders and pelvis, negative for arthritis. Corrective treatment was Nonsteroidal anti-inflammatory drugs (NSAIDs). The outcome of event was not recovered for event had all over body aches to his toes and generally feeling weak, pain is still in his (R) shoulder, left shoulder, pain in arm, low back into his bilateral thighs and outcome was recovered for the events cough/cold (lasted for months) and testicular pain. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule
Clinical narrative: Initial unsolicited report received from a pharmacist on 27-JUL-2016. This case involves a female patient (unknown age) who was vaccinated with a dose of ADACEL (batch number: U5292AA, expiration date: 14-Apr-2018, dose, dose in series were not  reported), intramuscularly in the right arm on 21-Apr-2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed a knot at the injection site. Lab data and corrective treatment were not reported. The outcome for the event was reported as unknown. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 28 July 2016. This case involves an 11-year-old male patient who was vaccinated with dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route of administration were not reported) in the right arm on 26 July 2016. Patient's illness at the time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. It was also reported that patient did not get any other vaccine within 4 weeks of vaccination. Concomitant medications were not reported. On 27 July 2016, one day after vaccination, patient developed a slightly reddened area and swelling "the size of a nickel" on his arm. On 28 July 2016, two days post vaccination, his swelling had increased to the "size of a baseball", and area remains reddened and warm and tender to touch. It was reported that patient required ER/doctor visit. Lab data was reported as none at the time of this report. Corrective treatment was not reported. The outcomes of the events were reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided)(lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Erythema, Influenza like illness, Malaise, Pain
Clinical narrative: A FEW DAYS OF ILLNESS AND THROBBING RED ARM. BETTER NOW.  BLISTERS AND FLU LIKE SXS.  STILL RED ARM AND SWOLLEN.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: A FEW DAYS OF ILLNESS AND THROBBING RED ARM. BETTER NOW.  BLISTERS AND FLU LIKE SXS.  STILL RED ARM AND SWOLLEN.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Bruxism, Confusional state, Crying, Dyskinesia, Eye movement disorder
Clinical narrative: My daughter walked out to the car. I was still in the office. I looked out the window and saw her standing in the rain. I went to unlock my car. She reached her hand out to open the door and fell straight back onto the ground. I immediately ran out the door and the nurse followed me. The doctor was there within seconds. My daughter's eyes were rolling, she was jerking, and her jaws were clenching. She started to come to and the doctor and nurse helped her back inside. My daughter was very confused. She kept crying and saying what's happening. She was unable to feel her hands for a few minutes. She would not respond to any of our questions. She kept trying to fall asleep. She couldn't hold her eyes open. She was breathing very fast and shaking. The nurse and doctor elevated her feet and checked all of her vital signs. They took her blood pressure it was 90 something over 55. When she checked in before the shot it was around 105 over 78 and her pulse was 91. The doctor kept us there until we could determine that her vital signs returned to normal. She almost sent us to the emergency room. We did not leave until around 4:50. During that time they took her blood pressure lying down with her legs elevated. Sitting up with legs elevated. Sitting up with legs dangling and finally after standing and walking around the facility twice. She drank two cups of water and had two lollipops. The doctors were very responsive and quick to help.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Fall, Respiratory rate increased, Somnolence, Tremor
Clinical narrative: My daughter walked out to the car. I was still in the office. I looked out the window and saw her standing in the rain. I went to unlock my car. She reached her hand out to open the door and fell straight back onto the ground. I immediately ran out the door and the nurse followed me. The doctor was there within seconds. My daughter's eyes were rolling, she was jerking, and her jaws were clenching. She started to come to and the doctor and nurse helped her back inside. My daughter was very confused. She kept crying and saying what's happening. She was unable to feel her hands for a few minutes. She would not respond to any of our questions. She kept trying to fall asleep. She couldn't hold her eyes open. She was breathing very fast and shaking. The nurse and doctor elevated her feet and checked all of her vital signs. They took her blood pressure it was 90 something over 55. When she checked in before the shot it was around 105 over 78 and her pulse was 91. The doctor kept us there until we could determine that her vital signs returned to normal. She almost sent us to the emergency room. We did not leave until around 4:50. During that time they took her blood pressure lying down with her legs elevated. Sitting up with legs elevated. Sitting up with legs dangling and finally after standing and walking around the facility twice. She drank two cups of water and had two lollipops. The doctors were very responsive and quick to help.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV9
Symptoms: Bruxism, Crying, Fall, Loss of consciousness
Clinical narrative: My daughter walked out to the car. I was still in the office. I looked out the window and saw her standing in the rain. I went to unlock my car. She reached her hand out to open the door and fell straight back onto the ground. I immediately ran out the door and the nurse followed me. The doctor was there within seconds. My daughter's eyes were rolling, she was jerking, and her jaws were clenching. She started to come to and the doctor and nurse helped her back inside. My daughter was very confused. She kept crying and saying what's happening. She was unable to feel her hands for a few minutes. She would not respond to any of our questions. She kept trying to fall asleep. She couldn't hold her eyes open. She was breathing very fast and shaking. The nurse and doctor elevated her feet and checked all of her vital signs. They took her blood pressure it was 90 something over 55. When she checked in before the shot it was around 105 over 78 and her pulse was 91. The doctor kept us there until we could determine that her vital signs returned to normal. She almost sent us to the emergency room. We did not leave until around 4:50. During that time they took her blood pressure lying down with her legs elevated. Sitting up with legs elevated. Sitting up with legs dangling and finally after standing and walking around the facility twice. She drank two cups of water and had two lollipops. The doctors were very responsive and quick to help.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: The patient developed a large red circular rash above the injection site which is itchy and swollen and tender. On 8/8/2016 when the patient reported it to the pharmacy he also saw his doctor who advised him to take benadryl and monitor  for any changes.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child presented to clinic, accompanied by parent and interpreter, on 8/4/2016 at 0830, two days after vaccine administration with a 90mmx70mm oval shape, raised, warm to touch and reddened area to left deltoid. Bandaids are still in place. Child denies urticaria, pain or fevers. Parent states site of vaccine became increasingly red as the day progressed on day of vaccine. Initially tender to touch. Child has an appointment with pediatrician following this visit today. Parent has not applied any type of medicine or compress to area. Child previously received MMR without VZV combination.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash on both legs.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Muscle twitching and cramping.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant via company representative regarding an adult patient of unknown gender. There was no information about concurrent condition and historical medication. On an unknown date, the adult patient was vaccinated with pediatric dose (0.5 ML) of RECOMBIVAX HB INJ 5/0.5 mcrg/ml (drug administered to patient of inappropriate age). Reporter stated that only 0.5 m. of RECOMBIVAX HB was drawn up into the syringe, rather than the entire contents of the vial. No adverse effects reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the unspecified patients were vaccinated with a dose of improperly stored PROQUAD lot number reported as: M007961; expiration date reported as: 15-AUG-2017 (dose, route of administration, anatomical location were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from the patient's mother referring to a 14 years old male patient. The patient had no pertinent medical history, drug reactions/allergies and concomitant medication. On 25-JUL-2016, the patient was vaccinated the third dose of GARDASIL 9 (lot#, expiration date, dose and route not reported). On 26-JUL-2016 (reported as "this morning"), the patient woke up at 4 am running a fever of 102 degree Fahrenheit and a terrible headache. The patient did not seek medical attention. Unspecified treatment was given to the events. No laboratory test was performed. The outcome of the events was not solved. The causality between GARDASIL 9 and the events was not provided. 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 Medical Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the unspecified patients were vaccinated with a doses of improperly stored VARIVAX lot number reported as: M008173; expiration date reported as: 16-FEB-2018 (dose, route of administration, anatomical location were not reported). No adverse effects were reported. This is one of two 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 licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided)(lot #M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Cough, Erythema, Full blood count normal, Metabolic function test normal
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 25 November 2015. This case involves a 36-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, route and site of administration, dose, dose in series were not reported) on 25 September 2015. The patient's medical history and concomitant medications were reported as none. It was reported that on an unspecified date, the patient had started with centrum specialist energy (batch number, route and site of administration, dose were not reported) therapy. On 2 November 2015 patient's nails gradually started to turn red. It had started with the moon shaped white spot on his nails turning red and then the redness seemed to spread out. On 5 November 2015, the patient had stopped taking Centrum. After few days the patient was gradually getting better. On 26 September 2015, one day following the vaccination, the patient had experienced cold for two days and it got worsened. The symptoms include coughing, weakness and throwing up. The patient required an emergency room/doctor visit. Laboratory data includes: Complete blood count (CBC)-Normal and Metabolic panel test-Normal Other laboratory data was not reported. The patient had received amoxicillin as corrective treatment. The patient was recovered from the event on an unspecified date. List of documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 25 November 2015. This case involves a 36-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, route and site of administration, dose, dose in series were not reported) on 25 September 2015. The patient's medical history and concomitant medications were reported as none. It was reported that on an unspecified date, the patient had started with centrum specialist energy (batch number, route and site of administration, dose were not reported) therapy. On 2 November 2015 patient's nails gradually started to turn red. It had started with the moon shaped white spot on his nails turning red and then the redness seemed to spread out. On 5 November 2015, the patient had stopped taking Centrum. After few days the patient was gradually getting better. On 26 September 2015, one day following the vaccination, the patient had experienced cold for two days and it got worsened. The symptoms include coughing, weakness and throwing up. The patient required an emergency room/doctor visit. Laboratory data includes: Complete blood count (CBC)-Normal and Metabolic panel test-Normal Other laboratory data was not reported. The patient had received amoxicillin as corrective treatment. The patient was recovered from the event on an unspecified date. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07 December 2015. This case involves a 72-years old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI524AA, dose, dose in series and route of administration was not reported) in the left arm on 04 December 2015. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none and denied any other vaccinations within four weeks of vaccinations. The patient's concomitant medications were not reported. On 04 December 2015, thirty minutes following the vaccination, the patient had developed metallic taste. Laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the event (after 1.5 day). List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the study  on 04 December 2015. The subject (gender and age were not reported) felt very bad reaction and had to go to urgent care on an unspecified date, three hours after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). During a prompted discussion the subject reported that, the vaccination of high dose to seniors were giving without telling to them. It was reported three years later, the subject experienced very bad reaction and had to go to urgent care. They did not know if the subject could ever had the flu shot again. They called to the subject and told that they were giving the high dose to all seniors. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in a study on 04 December 2015. The subject (gender and age were not reported) experienced a reaction on an unspecified date, after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. During a prompted discussion it was reported that, the subject had reacted to the HD vaccine for over the past two years. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain
Clinical narrative: Severe neck pain.