chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 50 year old female consumer refers to herself. The patient had allergy to penicillin. On 28-OCT-2014 the patient received her ZOSTAVAX (lot#, route not reported, dose: 1 injection, in the arm) at a pharmacy (unspecified name and address) and noticed that the injection was given in an "odd" area of her arm. The ZOSTAVAX injection was given four inches below her armpit, on the upper "flab" of her arm. Concomitant therapies included ZOLOFT, alprazolam, simvastatin(manufacturer unknown) and PRILOSEC. The patient reported that she experienced soreness at the injection site, on 28-OCT-2014, immediately after receiving the ZOSTAVAX vaccine. The next day, on 29-OCT-2014, the injection site of the ZOSTAVAX vaccine was hard, itchy and she also noticed a large welt (3 inches long and 1 inch wide). The patient's arm (at the injection site) also red, painful and hot to the touch. The patient had sought medical attention via calling the pharmacy. Outcome of the events was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a 50 year old female consumer refers to herself. The patient had allergy to penicillin. On 28-OCT-2014 the patient received her ZOSTAVAX (lot#, route not reported, dose: 1 injection, in the arm) at a pharmacy (unspecified name and address) and noticed that the injection was given in an "odd" area of her arm. The ZOSTAVAX injection was given four inches below her armpit, on the upper "flab" of her arm. Concomitant therapies included ZOLOFT, alprazolam, simvastatin(manufacturer unknown) and PRILOSEC. The patient reported that she experienced soreness at the injection site, on 28-OCT-2014, immediately after receiving the ZOSTAVAX vaccine. The next day, on 29-OCT-2014, the injection site of the ZOSTAVAX vaccine was hard, itchy and she also noticed a large welt (3 inches long and 1 inch wide). The patient's arm (at the injection site) also red, painful and hot to the touch. The patient had sought medical attention via calling the pharmacy. Outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two unspecified patients of unknown age and gender. The nurse reported that since 17-OCT-2014, the patients were vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported) that was improperly stored. This was supported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-OCT-2014, the patient was vaccinated with an expired 0.65 ml dose of ZOSTAVAX (lot # J000492 exp 19-JAN-2014) subcutaneously. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No informatino on their medical history, concurrent conditions or concomitant drugs was provided. On 24-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J004267, expiration date: 12-JUL-2014; dose, site and route were not provided. Dose supported. No adverse event was reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient with drug reactions/allergies to: penicillin, cephalosporin, macrolides, ketolides, carbapenem, aztreonam, tacrolimus, sirolimus, pimecrolimus. Patient's medical history included ZOSTAVAX on 19-JUL-2014. The reporting pharmacist stated that 2 patients reported injection site reaction to PNEUMOVAX 23. On 27-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2015; 0.5 ml, intramuscular, anatomical location not reported). On 27-OCT-2014, the patient experienced injection site reactions, swollen arm, hard to touch, aches, pains, fever 101 Fahrenheit (F) and "knot in arm". There was no treatment given for the reported events thus far and the pharmacist suggested ice to the patient which "did nothing". The outcome of hard to touch, aches, pains and injection site reactions was reported as not recovered/not resolved. The outcome of "knot in arm" ("is now gone") and fever 101F ("is now gone") was reported as recovered/resolved (in approximately October 2014, exact dates not reported). The patient sought medical attention by contacting the pharmacy. The relatedness between the therapy with PNEUMOVAX 23 and the reported events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient with drug reactions/allergies to: penicillin, cephalosporin, macrolides, ketolides, carbapenem, aztreonam, tacrolimus, sirolimus, pimecrolimus. Patient's medical history included ZOSTAVAX on 19-JUL-2014. The reporting pharmacist stated that 2 patients reported injection site reaction to PNEUMOVAX 23. On 27-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2015; 0.5 ml, intramuscular, anatomical location not reported). On 27-OCT-2014, the patient experienced injection site reactions, swollen arm, hard to touch, aches, pains, fever 101 Fahrenheit (F) and "knot in arm". There was no treatment given for the reported events thus far and the pharmacist suggested ice to the patient which "did nothing". The outcome of hard to touch, aches, pains and injection site reactions was reported as not recovered/not resolved. The outcome of "knot in arm" ("is now gone") and fever 101F ("is now gone") was reported as recovered/resolved (in approximately October 2014, exact dates not reported). The patient sought medical attention by contacting the pharmacy. The relatedness between the therapy with PNEUMOVAX 23 and the reported events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, dose 3, 0.5 ml, intramuscular. No concomitant medication was reported. On an unknown date the patient received their third dose of GARDASIL a couple of days earlier than the scheduled date. No concomitant medication was reported. No adverse effect was reported. Treatment was not given for the event. No lab diagnostics were performed. The patient did not seek medical attention. There was no intervention to prevent serious criteria. PQC was not involved. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. No demographic information was available. On 23-OCT-2014 the patients were vaccinated with doses of expired PNEUMOVAX 23 lot # J010654, expiration date: 17-OCT-2014, route of administration was not provided. The vaccines were also exposed to temperatures outside of the proper storage range. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, strength, frequency, route and lot # were not reported). Secondary and concomitant therapies were not reported. Nurse reported that the patient was inadvertently administered 2 doses of PROQUAD (Merck) on the same day (date not reported). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a field employee via a physician's assistant refers to a female patient in her 70's. On an unkonwn date when the patient was in her 60's, she was vaccinated with PNEUMOVAX 23 (also reported as unspecified manufacturer). No concomitant medications were reported. On an unknown date the patient experienced pneumonia. The outcome of pneumonia is unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Local swelling, Urticaria
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 25 year old female patient. On 27-OCT-2014, the patient was vaccinated with a first dose of GARDASIL (lot # K009811 exp 19-JUN-2016) (dose and route not reported). The healthcare worker reported that on 27-OCT-2014 in the evening, the patient experienced her finger became swollen in the same arm that she received the injection in. Later that day the patient's hand and the rest of the arm became swollen. The patient decided to go to an ER facility. While in the ER the patient began to break out in hives and was diagnosed with an allergic reaction to the vaccine. The patient was treated with prednisone. The outcome of allergic reaction to the vaccine was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored VAQTA (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a nurse via representative refers to a female patient of unknown age. In October 2006 (unspecified date 8 years ago) the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # was reported as K00454, expiration date unspecified), 1 single shot, intramuscular. No adverse effects were reported with the 1st dose. On an unspecified date in October 2014 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot #, expiration date unspecified). On an unknown date in October 2014 the patient went to the emergency room but was not admitted for cellulitis at the injection site. The outcome of cellulitis at the injection site was reported as recovered/resolved in October 2014. The patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: This spontaneous report as received from a nurse via representative refers to a female patient of unknown age. In October 2006 (unspecified date 8 years ago) the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # was reported as K00454, expiration date unspecified), 1 single shot, intramuscular. No adverse effects were reported with the 1st dose. On an unspecified date in October 2014 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot #, expiration date unspecified). On an unknown date in October 2014 the patient went to the emergency room but was not admitted for cellulitis at the injection site. The outcome of cellulitis at the injection site was reported as recovered/resolved in October 2014. The patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot number and route were not reported) expiration date 25-SEP-2014. Co-suspect and concomitant therapies were not reported. Nurse reported patient was administered expired PNEUMOVAX 23 on 22-OCT-2014. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 64 year old female patient. On 29-OCT-2014, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J007208 exp 20-SEP-2014) (dose, route and lot # not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demographics. Current conditions and medical history was not reproted. On an unknown date, the patient was vaccinated with VARIVAX (Merck), (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Reporting physician stated that many years ago, the patient developed chickenpox sometime after receiving VARIVAX (Merck). Outcome of the event was unknown. Causality assessment was not provided. This case is related to case number 1410USA016139 (same reporter). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number and route were not reported) lot # K009198, expiration date 27-SEP-2015. Co-suspect and concomitant therapies were not reported. Pharmacist reported that on an unknown date, patient experienced a rash around the injection site after receiving ZOSTAVAX. At the time of the report patient's rash recovered 2 days later after injection. Patient did not received treatment or sought medical attention for the adverse event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unknown dates the patients were inadvertently vaccinated with improperly stored VARIVAX (Merck). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 61 year old female patient with diabetes and no drug reactions or allergies. On 27-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# K003595 exp 07-FEB-2015)  subcutaneously. The pharmacist reported that on 29-OCT-2014, the patient developed shingles above the right eye in the scalp. The patient did not receive treatment for the adverse event. There were no lab diagnostics or studies performed. The outcome of shingles above the right eye and on the scalp was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unknown dates the patient were inadvertently vaccinated with improperly stored PROQUAD (Merck) (lot #, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age, reporting on himself. Medical history and concurrent conditions were not reported. Approximately on 17-MAY-2014 (reported as 6 months ago), the patient was vaccinated with the first dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). The patient reported it would be a little longer before till he would financially able to receive the second dose in 2014. No adverse effects were reported. Co-suspect and concomitant therapies were not reported. Additional information is not expected due the lack of demographic information.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unknown dates the patients were inadvertently vaccinated with improperly stored ZOSTAVAX (lot #, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 14 year old patient. On 23-OCT-2014, the patient received a dose of PROQUAD (Merck) (batch/lot#, dose and route were not reported) instead of receiving a dose of M-M-R II and a dose of VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient claims to have had developed cellulitis at needle site requiring ER trip and 10 day treatment of BACTRIM DS.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was inadvertently vaccinated with fourth dose of GARDASIL (lot#, expiration date, dose, route not reported). The healthcare professional was not aware that the patient had already completed the three dose series of GARDASIL. The patient did not seek medical attention. No side effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report as received from a physician via an unspecified field representative on 30-OCT-2014 refers to four different patients of unknown age and gender. The field representative reported to brain from "CTT" that they were informed by a healthcare worker. Four prefilled syringes of RECOMBIVAX HIB injection 5/0.5 microgram/ml (dose, lot # unknown) which were discovered to be leaking from an unspecified location after administration to four different patients on an unknown date. Product quality complaint (PQC) filed. No adverse experiences were reported. All patients were anonymous.  The outcome of event was not provided. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 77 year old male patient refers to himself. The reporter stated that his 70 year old wife was vaccinated with ZOSTAVAX (lot#, dose, frequency and rout unspecified) in January 2007 and in April 2007 he broke out in a mild, flat rash on the right side of his back and shoulder. The patient was seen by a dermatologist in 2007 and it was confirmed as shingles. Treatment was some type of medication, unspecified. The couple state they did not know if the patient had chickenpox as a child. The reporter said that his wife  had a gut feeling it was not shingles.  The outcome of the event was reported as fully recovered on an unspecified date. Additional information is not expected as there was no consent to contact physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report as received from a 67 year old female physician referred to himself with allergies to hay fever and no pertinent medical history. On an unknown date in December 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and lot number not provided). Concomitant therapy included unspecified hormone patch for menopause and multivitamin. On an unknown date the patient experienced shingles approximately in October 2014 "over this past weekend". The patient described the vesicles as "3-4 dermatome distribution; near the left clavicle down the left chest then on the back of the left side of neck coming down lateal to clavicle". The patient prescribed herself VALTREX which she started taking 06-OCT-2014. At the time of reporting, the patient was not recovered from shingles. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient received hepatitis A vaccine when they should have received hepatitis B vaccine.
Age: 20.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: This spontaneous report from a nurse concerns a 21 year old female: CVAE-39-2014. The subject's height, weight and medical history were unknown. The subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 3000741) on 28-JUL-2014 for prophylactic vaccination. Concomitant medications were not reported. On 28-JUL-2014, minutes after receiving the first dose, the subject experienced trouble breathing and tightness in throat. Corrective treatment included Benadryl. Action taken with typhoid vaccine oral ty21a was unknown. At the time of this report, the subject was recovering from trouble breathing and tightness in throat. This report was serious (medically significant).
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Asthenia, Blood electrolytes, Chills, Electrocardiogram
Clinical narrative: Patient's spouse reports that approximately 3 hrs post vaccine patient began feeling tingly and weak with N/V, chills and shivers. Reported to doctor,
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Full blood count, Malaise, Myalgia, Nausea, Paraesthesia
Clinical narrative: Patient's spouse reports that approximately 3 hrs post vaccine patient began feeling tingly and weak with N/V, chills and shivers. Reported to doctor,
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Tremor, Troponin, Vomiting
Clinical narrative: Patient's spouse reports that approximately 3 hrs post vaccine patient began feeling tingly and weak with N/V, chills and shivers. Reported to doctor,
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Chills, Electrocardiogram, Laboratory test, Nausea
Clinical narrative: Patient's spouse reports that approximately 3 hrs post vaccine patient began feeling tingly and weak with N/V, chills and shivers. Reported to doctor,
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Paraesthesia, Vomiting
Clinical narrative: Patient's spouse reports that approximately 3 hrs post vaccine patient began feeling tingly and weak with N/V, chills and shivers. Reported to doctor,
Age: 61.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Arthralgia, Chills, Ear pain, Fatigue, Feeling cold
Clinical narrative: Pt called on 10/20/14 stating that 11 hrs after she received FLUZONE QUAD, she started shivering and shaking which lasted for 4 hrs. She felt extremely tired. She already filled out a report with VAERS.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Renal pain, Tremor
Clinical narrative: Pt called on 10/20/14 stating that 11 hrs after she received FLUZONE QUAD, she started shivering and shaking which lasted for 4 hrs. She felt extremely tired. She already filled out a report with VAERS.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Pt called on 10/20/14 stating that 11 hrs after she received FLUZONE QUAD, she started shivering and shaking which lasted for 4 hrs. She felt extremely tired. She already filled out a report with VAERS.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Arthralgia, Burning sensation, Gait disturbance, Hypoaesthesia, Joint swelling
Clinical narrative: The patient called on 10/24/2014 to report that within 2 hours after her flu injection both her hands, knees and feet were swollen, gray/purple in color and very painful. Stated she had difficulty walking. She reported that the symptoms did not improve, she missed 4 days from work and went to see a doctor on 10/14/2014, had a nerve conduction study on her legs that did not show anything. She continued to have pain, achy and swollen joints, felt very tired and lethargic and returned to the doctor on 10/21/2014 and had a nerve study on her arms which she stated the doctor told her showed abnormal results. She reported that the doctor prescribed Neurontin and that she was still having problems with all extremities but her legs bother her worse than her arms. She has an appointment to see a Neurologist on 11/8/2014. Denies any respiratory problems.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Local swelling, Lymphadenopathy, Mobility decreased, Nerve conduction studies abnormal, Pain in extremity
Clinical narrative: The patient called on 10/24/2014 to report that within 2 hours after her flu injection both her hands, knees and feet were swollen, gray/purple in color and very painful. Stated she had difficulty walking. She reported that the symptoms did not improve, she missed 4 days from work and went to see a doctor on 10/14/2014, had a nerve conduction study on her legs that did not show anything. She continued to have pain, achy and swollen joints, felt very tired and lethargic and returned to the doctor on 10/21/2014 and had a nerve study on her arms which she stated the doctor told her showed abnormal results. She reported that the doctor prescribed Neurontin and that she was still having problems with all extremities but her legs bother her worse than her arms. She has an appointment to see a Neurologist on 11/8/2014. Denies any respiratory problems.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Paraesthesia, Paralysis
Clinical narrative: The patient called on 10/24/2014 to report that within 2 hours after her flu injection both her hands, knees and feet were swollen, gray/purple in color and very painful. Stated she had difficulty walking. She reported that the symptoms did not improve, she missed 4 days from work and went to see a doctor on 10/14/2014, had a nerve conduction study on her legs that did not show anything. She continued to have pain, achy and swollen joints, felt very tired and lethargic and returned to the doctor on 10/21/2014 and had a nerve study on her arms which she stated the doctor told her showed abnormal results. She reported that the doctor prescribed Neurontin and that she was still having problems with all extremities but her legs bother her worse than her arms. She has an appointment to see a Neurologist on 11/8/2014. Denies any respiratory problems.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Arthralgia, Fatigue, Gait disturbance, Impaired work ability, Joint swelling
Clinical narrative: The patient called on 10/24/2014 to report that within 2 hours after her flu injection both her hands, knees and feet were swollen, gray/purple in color and very painful. Stated she had difficulty walking. She reported that the symptoms did not improve, she missed 4 days from work and went to see a doctor on 10/14/2014, had a nerve conduction study on her legs that did not show anything. She continued to have pain, achy and swollen joints, felt very tired and lethargic and returned to the doctor on 10/21/2014 and had a nerve study on her arms which she stated the doctor told her showed abnormal results. She reported that the doctor prescribed Neurontin and that she was still having problems with all extremities but her legs bother her worse than her arms. She has an appointment to see a Neurologist on 11/8/2014. Denies any respiratory problems.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Lethargy, Local swelling, Nerve conduction studies abnormal, Pain in extremity, Skin discolouration
Clinical narrative: The patient called on 10/24/2014 to report that within 2 hours after her flu injection both her hands, knees and feet were swollen, gray/purple in color and very painful. Stated she had difficulty walking. She reported that the symptoms did not improve, she missed 4 days from work and went to see a doctor on 10/14/2014, had a nerve conduction study on her legs that did not show anything. She continued to have pain, achy and swollen joints, felt very tired and lethargic and returned to the doctor on 10/21/2014 and had a nerve study on her arms which she stated the doctor told her showed abnormal results. She reported that the doctor prescribed Neurontin and that she was still having problems with all extremities but her legs bother her worse than her arms. She has an appointment to see a Neurologist on 11/8/2014. Denies any respiratory problems.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dysstasia, Gait disturbance, Pain in extremity, Pollakiuria
Clinical narrative: Less than 12 hrs after vaccination, pt complained of pain in kidneys, pain in legs making walking difficult, urinating every 45 min, chills lasted for 1 1/2 days. Called Dr office, nothing prescribed. Feels fine now.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Renal pain
Clinical narrative: Less than 12 hrs after vaccination, pt complained of pain in kidneys, pain in legs making walking difficult, urinating every 45 min, chills lasted for 1 1/2 days. Called Dr office, nothing prescribed. Feels fine now.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Gait disturbance, Pain in extremity, Pollakiuria, Renal pain
Clinical narrative: Less than 12 hrs after vaccination, pt complained of pain in kidneys, pain in legs making walking difficult, urinating every 45 min, chills lasted for 1 1/2 days. Called Dr office, nothing prescribed. Feels fine now.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Neuralgia, Pain in extremity, Rash papular
Clinical narrative: Patient developed a rash immediately after injection and lasted for 10 days. The rash was only on arm injected and it never itched. The same arm has felt sore whenever moved and still feels sore as of 11/03/14. Patient reports one incident of "nerve pain" tingling sensation in arm that was injected.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient developed a rash immediately after injection and lasted for 10 days. The rash was only on arm injected and it never itched. The same arm has felt sore whenever moved and still feels sore as of 11/03/14. Patient reports one incident of "nerve pain" tingling sensation in arm that was injected.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Patient developed a rash immediately after injection and lasted for 10 days. The rash was only on arm injected and it never itched. The same arm has felt sore whenever moved and still feels sore as of 11/03/14. Patient reports one incident of "nerve pain" tingling sensation in arm that was injected.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives 3-4 hours after flu shot initially noted surrounding flu shot but spread diffusely. Pt presented to ER due to symptoms. No difficulty breathing or facial swelling.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Flushing, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Pain on injection, bleeding, swelling, redness within several hours, heat at injection site swelling increased to size of baseball, injection site aching, hot & red, flushed face 11/2-11/4; took anti-inflammatory on 11/3, redness at injection site and heat continues on 11/4.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain on injection, bleeding, swelling, redness within several hours, heat at injection site swelling increased to size of baseball, injection site aching, hot & red, flushed face 11/2-11/4; took anti-inflammatory on 11/3, redness at injection site and heat continues on 11/4.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Paralysis, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a 55 year old female patient. On an unknown date the patient was vaccinated with dose of ZOSTAVAX (lot #, expiration date, dose and anatomical localization were not reported). On an unknown date the patient experienced rash and developed some kind of paralysis. The patient was hospitalized because of paralysis (unspecified the length of stay in the hospital). The patient recovered from rash and paralysis on an unknown date. The relatedness between adverse event and ZOSTAVAX was not reported. Upon internal review the event of paralysis was considered as medically significant. Additional information is not expected because the reporter did not wish to be contacted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mobility decreased, Pain, Periarthritis, Swelling
Clinical narrative: Initially swelling and redness-difficulty moving arm within 4 hours of vaccine. Pain intensity grew over 2 weeks. Diagnosed with frozen shoulder on 11/3/14.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Amnesia, Anaemia, Apathy, Asthenia, Blood test
Clinical narrative: Child started her first period ever. Every period the last 13 months have been extremely heavy, child has been very sluggish, and no motivation to do anything. Child has had blood work to test for hereditary blood disorders. Child was diagnosed as anemic. Child started having headaches, that turned into a diagnosis of Migraines with Aura. Child has become more exhausted, with little to no energy. Child had an episode, of breathing, but no real response. After ER visit and normal MRI, child was told, likely a seizure. Child had EEG, normal results. Child has loss of appetite. Child is starting to go into depression. Child has short term memory loss, and a hard time concentrating. Child has new symptoms, almost daily.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Convulsion, Decreased appetite, Depression, Disturbance in attention, Electroencephalogram normal
Clinical narrative: Child started her first period ever. Every period the last 13 months have been extremely heavy, child has been very sluggish, and no motivation to do anything. Child has had blood work to test for hereditary blood disorders. Child was diagnosed as anemic. Child started having headaches, that turned into a diagnosis of Migraines with Aura. Child has become more exhausted, with little to no energy. Child had an episode, of breathing, but no real response. After ER visit and normal MRI, child was told, likely a seizure. Child had EEG, normal results. Child has loss of appetite. Child is starting to go into depression. Child has short term memory loss, and a hard time concentrating. Child has new symptoms, almost daily.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Menorrhagia, Migraine with aura, Nuclear magnetic resonance imaging normal
Clinical narrative: Child started her first period ever. Every period the last 13 months have been extremely heavy, child has been very sluggish, and no motivation to do anything. Child has had blood work to test for hereditary blood disorders. Child was diagnosed as anemic. Child started having headaches, that turned into a diagnosis of Migraines with Aura. Child has become more exhausted, with little to no energy. Child had an episode, of breathing, but no real response. After ER visit and normal MRI, child was told, likely a seizure. Child had EEG, normal results. Child has loss of appetite. Child is starting to go into depression. Child has short term memory loss, and a hard time concentrating. Child has new symptoms, almost daily.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Sluggishness
Clinical narrative: Child started her first period ever. Every period the last 13 months have been extremely heavy, child has been very sluggish, and no motivation to do anything. Child has had blood work to test for hereditary blood disorders. Child was diagnosed as anemic. Child started having headaches, that turned into a diagnosis of Migraines with Aura. Child has become more exhausted, with little to no energy. Child had an episode, of breathing, but no real response. After ER visit and normal MRI, child was told, likely a seizure. Child had EEG, normal results. Child has loss of appetite. Child is starting to go into depression. Child has short term memory loss, and a hard time concentrating. Child has new symptoms, almost daily.
Age: 4.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Biopsy kidney abnormal, Eyelid oedema, Fluid retention, Focal segmental glomerulosclerosis, Nephrotic syndrome
Clinical narrative: Patient started to retain water. Her eyes were puffy. On June 16 2014 she was diagnosed with nephrotic syndrome. 4.5 weeks later she has kidney biopsy and we found out she has FSGS.
Age: 4.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Transfusion
Clinical narrative: Patient started to retain water. Her eyes were puffy. On June 16 2014 she was diagnosed with nephrotic syndrome. 4.5 weeks later she has kidney biopsy and we found out she has FSGS.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache and Fever 103.8 and some N/V. Treated with Tylenol came down to 99.8. Headache and Fever again morning of 11/4/2014 t max 103.9. Treated again with Tylenol.
Age: 0.67
Sex: F
Vaccine: FLUC3
Symptoms: Crying, Decreased appetite, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Running nose, low grade fever and fussy.  Crying a lot and is not eating as much.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Lacrimation increased, Scleral disorder, Throat tightness, Wheezing
Clinical narrative: Tightness in throat, wheezing, injected sclera, watery eyes, injection site swelling. Consulted with medical professional. Took Benadryl 50mg and Ibuprofen 600mg complete resolution of throat/chest symptoms at 12 hours and resolution of eye symptoms at 24 hours.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Right arm extremely heavy/achy immediately after administration.  Almost a month later, acute shoulder pain, loss of range of motion (can't move arm back/lift arm).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Tendon rupture
Clinical narrative: Right arm extremely heavy/achy immediately after administration.  Almost a month later, acute shoulder pain, loss of range of motion (can't move arm back/lift arm).
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Insomnia, Myalgia, Pain, Pruritus
Clinical narrative: Couldn't sleep, shoulder muscle sore to touch and movement, red splotches were hot somewhat swollen.  Sunday broke out (large hive type areas - real itchy and red) on right hand between thumb and index finger, between mouth and right ear and between eyebrow and hair line.  Took naproxen sodium and Benadryl.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular, Skin warm, Swelling, Urticaria
Clinical narrative: Couldn't sleep, shoulder muscle sore to touch and movement, red splotches were hot somewhat swollen.  Sunday broke out (large hive type areas - real itchy and red) on right hand between thumb and index finger, between mouth and right ear and between eyebrow and hair line.  Took naproxen sodium and Benadryl.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Ear pain, Headache, Neck pain, Oropharyngeal pain, Swelling
Clinical narrative: Swelling, sore throat, neck pain, ear pain, headache.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pruritus, Skin warm, Swelling
Clinical narrative: Experienced itching at injection site just a short time after receiving immunization.  Over the course of the next day and a half, she developed a red, warm, raised area, oblong in shape and 2-3 inches in size. She will be calling her physician.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Slight swelling and soreness at place of shot...next day...swelling of lymph nodes under left arm down to elbow...last over a week.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Headache, Pyrexia, Temperature regulation disorder
Clinical narrative: Woke up with chills, difficulty regulating body temperature, headache, light-headedness. 100.2 degree fever. Took Tylenol to reduce fever at 8:00 AM. Fever seems to be reducing. Was 99.4 by 9:15 AM.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Hypopnoea, Nasal congestion, Pain
Clinical narrative: Whole body shaking uncontrollably, pulse 113, low grade temp, rapid shallow breathing - hard to catch breath, body aches, vomiting. Then at 4:30 AM: pulse 100, headache, stopped up nose, body aches, shallow breathing. Fever had broken by then and there was no more vomiting.  Headache has continued through 11/04/2014.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory rate increased, Tremor, Vomiting
Clinical narrative: Whole body shaking uncontrollably, pulse 113, low grade temp, rapid shallow breathing - hard to catch breath, body aches, vomiting. Then at 4:30 AM: pulse 100, headache, stopped up nose, body aches, shallow breathing. Fever had broken by then and there was no more vomiting.  Headache has continued through 11/04/2014.
Age: 1.75
Sex: M
Vaccine: FLUX
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives all over body.  On his face, arms, back, legs.
Sex: M
Vaccine: PNC13
Symptoms: Deafness
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A male patient of unspecified age received PREVNAR 13 on unknown date, at single dose. Medical history and concomitant medications were not reported. The patient experienced hearing loss after he was administered with PREVNAR 13. Event outcome was not provided at the time of report.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia, Tremor, Vaccination complication, Viral infection
Clinical narrative: Initial information was received 24 October 2014 from a healthcare professional. A 70 year old female patient was vaccinated intramuscularly on 17 October 2014 with a first dose of INFLUENZA HIGH DOSE, batch U5044BA, site not reported. The patient was not ill at the time of vaccination. It is unknown if the patient had any other vaccinations within 4 weeks of vaccination or was taking any concomitant medications. Pre-existing allergies were reported as "PCN Unknown". The patient called the reporter on 24 October 2014 to say that she had her flu shot on 17 October 2014 and on 18 October 2014 she developed a high temperature of 104, had shakiness and general malaise. She stayed in the hospital for three days and was diagnosed with viral illness vs shot reaction". Laboratory tests were unknown and treatments were not reported. No further details were available at the time of this report. The patient outcome is recovered on an unreported date. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Cerebrovascular accident, Laboratory test, Muscular weakness, Speech disorder
Clinical narrative: Initial report received from a non-healthcare professional on 28 October 2014. A 60-year-old female patient, with a history of seasonal allergies, had received a dose of Influenza vaccine (manufacturer, lot number, route and site of administration not reported) on October 2013. This reporter also reported another event which is captured in case number 2014SA148560. On an unspecified date, within a week post-vaccination, she had a stroke. Right arm and leg weakness was noted. She was found with a residual speech delay. She was hospitalized for 7 days. Stroke work up was done, but no results were provided. It was not reported whether the patient had receive corrective treatment. The events were considered life threatening by the reporter. At the time of the report, the patient was not recovered. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Pain
Clinical narrative: Woke feeling achy- got worse as morning progressed. By 12 or 1pm I felt very achy and was sure I had a temp- I did not have it taken. I took ibuprofen. Aches lessen and by about 6pm I felt as if the temp had passed and I felt good. I slept well last night and woke feeling fine. I am NOT sure this was related to the vaccine but I thought it quite possible. In any event, any signs of fever and all over achiness passed in about a 12 hrs time period.
Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Pt received Gardasil and FluMist and had a vasovagal reaction. Pt went unconscious for a few seconds. Pt was placed in the recovery position and was administered O2. Pt's vital signs were taken every 5 minutes and she was released per responding provider.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Shoulder pain at site of injection traveling down to elbow; ongoing since vaccine was administered; unable to sleep on that side and have limited range of motion with shoulder.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Confusional state, Convulsion, Dyskinesia, Eye movement disorder
Clinical narrative: Approximately 2 mins after patient received the Influenza vaccine, he began to have what appeared to be hiccups; when asked if he was "OK", the patient reported that he didn't feel right and was very diaphoretic and warm; he then began to have what appeared to be a seizure with jerking of upper extremities and his eyes began to roll upward; he seemed to become more alert after a few seconds and then repeated the activity; he had some residual confusion and thought that he was already at the hospital; 911 was called and the patient was taken to the hospital. Oxygen sat was 100% on 5LNC; blood glucose was 153; BP was 109/75 and pt slowly returned to baseline cognition prior to transport.