chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Case number PHHY2015US154253, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596280) on 24 Nov 2015. This report refers to a 79 years old female patient. Past medical history and concomitant medication were not reported. The patient vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number, expiry date: not reported) on 18 Sep 2015. On the same day after vaccination, the patient experienced slightly swollen arm, itchy, moved to soft spots in both legs the next two days, slightly swollen arm, swelling and itchiness moved down arm, next 2 days moved to soft spots in legs and buttocks, 4th day woke up with swollen eyes and cheeks and by the evening swelling and itchiness moved to chin. The patient woke up at 2:30 am with hugely swollen chin/throat and tongue and could not swallow or talk. The patient went to the emergency room. The seriousness of the events were reported as non serious. The outcome of the events were reported complete recovery. The causality of the events were not reported. The seriousness assessment of the event pharyngeal oedema, peripheral swelling, dysphagia, aphasia, swollen tongue, eye swelling, swelling face and pruritus was upgraded based on the information available in the source documents.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Angioedema, Urticaria
Clinical narrative: Case number PHHY2015US154412, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 596704) website on 24 Nov 2015. This report refers to a 62 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Sep 2015. On 19 Sep 2015, the patient developed angioedema and urticaria. Patient was taken to an emergency room. Outcome of the events was reported as not recovered (condition unchanged). Events were reported as non-serious. Seriousness assessment of the angioedema was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Swollen tongue
Clinical narrative: Case number PHHY2015US154260, is an initial spontaneous report received from the physician via Vaccine Adverse Event Reporting System (VAERS reference number: 596978) website on 24 Nov 2015. This report refers to an elderly female patient of an unknown age. Medical history and concomitant medications were reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) along with PREVNAR 13 (batch number: not reported, other manufacturer) intramuscular on 17 Dec 2014. On the same day within 8 hours after the vaccination the patient experienced swollen tongue. The patient went home and then returned to the emergency room. The physician does not think that the patient was admitted. The outcome of swelling of tongue was unknown. The event was assessed as non-serious. The physician did not believe that they are related. Seriousness assessment of swollen tongue was upgraded based on information in the source document.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Hypersensitivity, Rhinorrhoea
Clinical narrative: Case number PHHY2015US154356 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 597023) on 24 Nov 2015. This report refers to a 53 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 13 Sep 2015. On the same day after vaccination, the patient had severe allergic symptoms such as sweating and running nose. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the event allergic symptoms were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Ear pain, Fatigue, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US154995, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number 598240) website on 24 NOV 2015. This report refers to a 42 years old female patient. Historical drug included ampicillin. Concurrent conditions included multinodular goiter, hypothyroidism, endometriosis and polycystic ovarian syndrome. Concomitant medications included Synthroid and Tylenol. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 15 SEP 2015. The patient experienced extreme fatigue followed by ear pain in right ear on 22 SEP 2015 in the afternoon. On 26 SEP 2015 the patient presented loss of taste early evening. On 27 SEP 2015 the patient had facial paralysis by PM and was diagnosed as Bell's palsy. The patient went to emergency room due to these events. Treatment medication included Valtrex and prednisone. Outcome of the events was unknown. The case was assessed as non-serious. Seriousness assessment of Bell's palsy was upgraded based on the NVD key event list. Causality assessment was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Diarrhoea, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015US155272 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 598370) on 24 Nov 2015. This report refers to a 66 year old female patient. She had three invasive bowel surgeries in Dec 2014, Mar 2015 and Apr 2015. Her current condition included sarcoidosis diagnosed in 2000 and an unspecified autoimmune disease. Her concomitant medications included prednisone for sarcoidosis, CELEXA, potassium, vitamin D, biotin and Acidophilus. It was reported that she had no active illness at the time of vaccination. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer and batch number: not reported); both vaccines administered on 29 Sep 2015. On the same day after vaccination, she experienced chills, vomiting, fever with a body temperature of 104, weakness and diarrhea. She was very ill. The outcome of the event was reported as complete recovery. The events were reported as non-serious, but the event fever was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US155272 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 598370) on 24 Nov 2015. This report refers to a 66 year old female patient. She had three invasive bowel surgeries in Dec 2014, Mar 2015 and Apr 2015. Her current condition included sarcoidosis diagnosed in 2000 and an unspecified autoimmune disease. Her concomitant medications included prednisone for sarcoidosis, CELEXA, potassium, vitamin D, biotin and Acidophilus. It was reported that she had no active illness at the time of vaccination. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer and batch number: not reported); both vaccines administered on 29 Sep 2015. On the same day after vaccination, she experienced chills, vomiting, fever with a body temperature of 104, weakness and diarrhea. She was very ill. The outcome of the event was reported as complete recovery. The events were reported as non-serious, but the event fever was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Case number PHHY2015US154446 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 598450) on 24 Nov 2015. This report refers to a 39 year old female patient. She had no medical history or current conditions. Her concomitant medications included BEYAZ. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 30 Sep 2015. On the same day her elbows started itching and then hives covered her body very quickly. She had swollen red hives all over. She went to emergency room. No diagnostic tests were done. The events outcome was reported as unknown. The events were reported as non-serious, but the event hives all over was upgraded as medically significant based on information available in the source documents. The causality of the events was not reported.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Eyelid oedema, Pharyngeal oedema, Streptococcus test negative, Swelling face
Clinical narrative: Case number PHHY2015US155097, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 598451) website on 24 Nov 2015. This report refers to a 28-year-old female patient. The patient had no medical history and current illness. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 28 Sep 2015. On 01 Oct 2015, the patient experienced swelling of right side of face, right eye swollen shut, throat swelling and difficulty breathing. The patient underwent Streptococcus test and the result was negative. Final outcome of the events was recovered. Events were reported as non-serious. Seriousness of the events was upgraded based on information available in the source document.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Rhinorrhoea, Sneezing
Clinical narrative: Case number PHHY2014US156880 is an initial spontaneous report received from a consumer on 24 Nov 2014. This report refers to a 72 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with two doses of seasonal influenza vaccine (manufacturer and batch number: not reported) which were of 2014/2015 season on unknown dates. It was reported that the first flu vaccine was administered in the emergency room and the second dose at her physician's office. No adverse events were reported follow the maladministration. She further received a dose of FLUVIRIN (batch number: not reported) intramuscularly form a multi-dose vial on 17 Nov 2014 following which she experienced cough (see related case number: PHEH2014US023663). No further information was available.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Extra dose administered, No adverse event
Clinical narrative: Case number PHHY2014US156880 is an initial spontaneous report received from a consumer on 24 Nov 2014. This report refers to a 72 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with two doses of seasonal influenza vaccine (manufacturer and batch number: not reported) which were of 2014/2015 season on unknown dates. It was reported that the first flu vaccine was administered in the emergency room and the second dose at her physician's office. No adverse events were reported follow the maladministration. She further received a dose of FLUVIRIN (batch number: not reported) intramuscularly form a multi-dose vial on 17 Nov 2014 following which she experienced cough (see related case number: PHEH2014US023663). No further information was available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection was higher than usual and was excruciating going in. Pain did not decrease with time after vaccination, but increased. Severe pain lifting arm developed. Pain disappeared within a few days, but steadily increased again afterward. I am still in pain and have trouble lifting my arm. This is a different location from my previously diagnosed tendonitis and the pain and range of motion changes are presenting differently.
Age: 52.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Nausea / upset stomach.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current condition and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored VAQTA (strength, dose, route and indication not reported) of lot # L018499 and expiry date: 25-FEB-2017. Concomitant medications were not mentioned. The vaccine was stored at 58.5 degree Fahrenheit for a time frame of 24 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse effects have been reported. No additional information was provided. Product Quality Complaint was not filed. Additional information has been requested. This is one of the five reports received from the same reporter.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Injection site with severe erythema and severe edema and pain.  Rx: Ibuprofen 400 MG PO Q6hrs. RX: Benedryl 25 MG PO Q 6hrs. RX: Prelone 15/5 susp. 45mg po day #1 30mg po day #2 22.5mg po day #3 15mg po day #4.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Hyperhidrosis, Tremor
Clinical narrative: Pt was seen by MA and given Pneumovax 13 injection. As patient was checking out at the Desk, she began to feel very flushed, diaphoretic and shaky. Was taken to room via wheelchair accompanied by husband. States
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cyst, Hypersomnia, X-ray normal
Clinical narrative: Slept a lot after vaccination day, noticed a cyst like formation on her hand a few days later. Almost feels so hard its a bone. Doesn't show up on x-ray and doctors nor her orthopedic surgeon don't know exactly what it is.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Arteriogram carotid normal, Blood glucose increased, Computerised tomogram head normal, Confusional state, Disturbance in attention
Clinical narrative: PT said "I feel really confused today". He had difficulty focusing on things. Couldn't remember recipe contents that he had cooked multiple times in the past. Wife noted other subtle changes in his mental status.   1 acute mental status change-sent patient to outside hospital for further evaluation.    While at outside facility had CT scan of the head was normal, CTA of the  carotids which was negative for significant blockage, was found to have  orthostatic hypotension, lisinopril was decreased, metoprolol tartrate dose was  changed from 25 mg daily metoprolol succinate 12.5 mg twice a day.  Developed rash over entire body approximately 36 hours after hospitalization, not sure if related to CT scan contrast for Prevnar or flu vaccine he received.  Saw non-VA PCP was treated with Solu-Medrol followed by a Dosepak. Blood sugars elevated due to this. He followed by non-VA PCP Also notified cardiology hospitalization was scheduled a 48 hour Holter monitor,  Feeling better other than the rash which is improving per patient and family.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Electrocardiogram ambulatory, Laboratory test, Memory impairment, Mental status changes, Orthostatic hypotension
Clinical narrative: PT said "I feel really confused today". He had difficulty focusing on things. Couldn't remember recipe contents that he had cooked multiple times in the past. Wife noted other subtle changes in his mental status.   1 acute mental status change-sent patient to outside hospital for further evaluation.    While at outside facility had CT scan of the head was normal, CTA of the  carotids which was negative for significant blockage, was found to have  orthostatic hypotension, lisinopril was decreased, metoprolol tartrate dose was  changed from 25 mg daily metoprolol succinate 12.5 mg twice a day.  Developed rash over entire body approximately 36 hours after hospitalization, not sure if related to CT scan contrast for Prevnar or flu vaccine he received.  Saw non-VA PCP was treated with Solu-Medrol followed by a Dosepak. Blood sugars elevated due to this. He followed by non-VA PCP Also notified cardiology hospitalization was scheduled a 48 hour Holter monitor,  Feeling better other than the rash which is improving per patient and family.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash generalised
Clinical narrative: PT said "I feel really confused today". He had difficulty focusing on things. Couldn't remember recipe contents that he had cooked multiple times in the past. Wife noted other subtle changes in his mental status.   1 acute mental status change-sent patient to outside hospital for further evaluation.    While at outside facility had CT scan of the head was normal, CTA of the  carotids which was negative for significant blockage, was found to have  orthostatic hypotension, lisinopril was decreased, metoprolol tartrate dose was  changed from 25 mg daily metoprolol succinate 12.5 mg twice a day.  Developed rash over entire body approximately 36 hours after hospitalization, not sure if related to CT scan contrast for Prevnar or flu vaccine he received.  Saw non-VA PCP was treated with Solu-Medrol followed by a Dosepak. Blood sugars elevated due to this. He followed by non-VA PCP Also notified cardiology hospitalization was scheduled a 48 hour Holter monitor,  Feeling better other than the rash which is improving per patient and family.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: "I have a huge red spot where the virus was injected. It is raised and has been sore plus a little itchy".
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Caesarean section, Exposure during pregnancy, Pregnancy test positive, Premature delivery
Clinical narrative: Information has been received from a 35 year old female patient with no drug reactions/allergies and no pertinent medical history for VARIVAX (Merck), a Pregnancy Registry product, who on 22-NOV-2011, was vaccinated with the first dose of VARIVAX (Merck) (route not reported). There was no concomitant medication. The same day, on 22-NOV-2011, a pregnancy test at the doctor's office was negative. The patient ovulated on 26-NOV-2011. A home pregnancy test on 10-DEC-2011 was positive. The patient repeated the home test and it was again negative. The patient telephoned the doctor and would see her on 13-DEC-2011. At the time of the report, the patient outcome was unknown. The last menstrual period was 12-NOV-2011. Estimated delivery date would be 18-AUG-2012. Follow-up information was received from the nurse practitioner on 25-JAN-2016. It was reported that the patient had undergone scheduled C-section (Caesarean section) (medically significant) at 35-36 weeks (premature delivery) of pregnancy and delivered a male infant weighing 3130 grams and 18 3/4 inches in length. The APGAR score was reported as 9/9 at 5 mins. No information was provided regarding the health status of the infant or congenital anomalies. The reason for the patient's scheduled C-section and she reported that the patient had a history of a Myomectomy in 2011 prior to vaccination. The outcome of the events caesarean section and the premature baby was reported as recovered. The relatedness of the events "scheduled C-section" and "premature delivery" with the suspect product VARIVAX (Merck) was unknown. Upon internal review the term "scheduled C-section" and "premature delivery" was considered as medically significant. The case was linked to another case via same parent child link. Additional information is not expected as no further information was not available. Events and narrative updated.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Gait instability. Guillain Barre Syndrome.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a physician via company representative concerning to a female patient of unknown age. No concurrent or historical conditions were reported. On an unspecified date (reported as 7 to 8 years ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided) strength 25/0.5 (units not provided), dose, route, frequency and anatomical, location were unspecified. No concomitant medications were reported. On an unknown date (also reported as 7 to 8 years ago), the patient experienced a local injection site reaction while using PNEUMOVAX 23. At the time of the report the outcome of injection site reaction was unknown. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia, Rash, Viral infection
Clinical narrative: Fever 101-102. Body Aches. Rash.
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Autoimmune disorder, Blood test normal, Borrelia test negative, Burning sensation
Clinical narrative: I had a possible exposure to Rabies as there was a bat in my attic. This happened over Thanksgiving. I received Rabies immunoglobulin and a series of IMOVAX rabies vaccination shots over the course of December. My first shot was December 14, my last shot was December 29. After the immunoglobulin I began experiencing migratory arthralgia and myalgia.  By Christmas I began experiencing severe paresthesias and burning in my arms and legs. My muscles fatigue so easily I can hardly carry my handbag. After visits to Clinics, I finally found a neurologist who feels I have autoimmune related neuropathy secondary to the vaccination. I am on gabapentin, CYMBALTA, and ATIVAN with a very little relief of symptoms. I am devastated.
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Laboratory test normal, Muscle fatigue, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal
Clinical narrative: I had a possible exposure to Rabies as there was a bat in my attic. This happened over Thanksgiving. I received Rabies immunoglobulin and a series of IMOVAX rabies vaccination shots over the course of December. My first shot was December 14, my last shot was December 29. After the immunoglobulin I began experiencing migratory arthralgia and myalgia.  By Christmas I began experiencing severe paresthesias and burning in my arms and legs. My muscles fatigue so easily I can hardly carry my handbag. After visits to Clinics, I finally found a neurologist who feels I have autoimmune related neuropathy secondary to the vaccination. I am on gabapentin, CYMBALTA, and ATIVAN with a very little relief of symptoms. I am devastated.
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Vaccination complication
Clinical narrative: I had a possible exposure to Rabies as there was a bat in my attic. This happened over Thanksgiving. I received Rabies immunoglobulin and a series of IMOVAX rabies vaccination shots over the course of December. My first shot was December 14, my last shot was December 29. After the immunoglobulin I began experiencing migratory arthralgia and myalgia.  By Christmas I began experiencing severe paresthesias and burning in my arms and legs. My muscles fatigue so easily I can hardly carry my handbag. After visits to Clinics, I finally found a neurologist who feels I have autoimmune related neuropathy secondary to the vaccination. I am on gabapentin, CYMBALTA, and ATIVAN with a very little relief of symptoms. I am devastated.
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anxiety, Chest pain, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: I had a possible exposure to Rabies as there was a bat in my attic. This happened over Thanksgiving. I received Rabies immunoglobulin and a series of IMOVAX rabies vaccination shots over the course of December. My first shot was December 14, my last shot was December 29. After the immunoglobulin I began experiencing migratory arthralgia and myalgia.  By Christmas I began experiencing severe paresthesias and burning in my arms and legs. My muscles fatigue so easily I can hardly carry my handbag. After visits to Clinics, I finally found a neurologist who feels I have autoimmune related neuropathy secondary to the vaccination. I am on gabapentin, CYMBALTA, and ATIVAN with a very little relief of symptoms. I am devastated.
Age: 55.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Pain, Paraesthesia
Clinical narrative: I had a possible exposure to Rabies as there was a bat in my attic. This happened over Thanksgiving. I received Rabies immunoglobulin and a series of IMOVAX rabies vaccination shots over the course of December. My first shot was December 14, my last shot was December 29. After the immunoglobulin I began experiencing migratory arthralgia and myalgia.  By Christmas I began experiencing severe paresthesias and burning in my arms and legs. My muscles fatigue so easily I can hardly carry my handbag. After visits to Clinics, I finally found a neurologist who feels I have autoimmune related neuropathy secondary to the vaccination. I am on gabapentin, CYMBALTA, and ATIVAN with a very little relief of symptoms. I am devastated.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous case report was received from a Licensed practical nurse regarding a patient of unknown age and gender. No concurrent conditions and medical history of the patient was reported. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL 9 (lot number and expiration date unspecified) (strength, dosing regimen, frequency). On an unknown date, approximately 3-4 months after the first dose, the patient was again vaccinated with second dose of GARDASIL 9, (inappropriate schedule of vaccine administered). No adverse event was reported. The outcome of the event was unknown. No product quality complaint was reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Neck pain
Clinical narrative: Severe pain upper Left Shoulder that radiates to neck and elbow. Treated with Medrol Dosepak, and Diclofenec Sodium for pain.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Left arm at injection site swollen, red, tender with a large knot in the muscle after injection and persisted for 1-2 weeks after; area still red, not swollen, small 2 cm knot still present.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site paraesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Staff complaints of pain, on left hand, tingling from the injection site down to her fingers, also with numbness to her left hand.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Alanine aminotransferase increased, Anion gap, Arthralgia, Aspartate aminotransferase normal, Back pain
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Basophil count normal, Basophil percentage decreased, Bilirubin conjugated normal, Bilirubin urine, Blood albumin normal
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood bilirubin unconjugated normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood urine absent, Carbon dioxide decreased, Cellulitis, Chills, Chromaturia
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Differential white blood cell count, Dizziness postural, Eosinophil count decreased, Eosinophil percentage decreased, Erythema
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Full blood count, Glomerular filtration rate, Glucose urine absent, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site pain, Lymphocyte count, Lymphocyte count normal, Lymphocyte percentage decreased
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Neutrophil count increased, Neutrophil percentage increased, Nitrite urine absent, Platelet count normal
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Protein total normal, Protein urine absent, Pyrexia, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm, Specific gravity urine normal, Urine ketone body present, Urine leukocyte esterase, Urobilinogen urine
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: White blood cell count increased, pH urine normal
Clinical narrative: Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Nausea, Pyrexia, Throat irritation, Vaccination failure
Clinical narrative: Case number PHHY2015US115608 is an initial spontaneous report received from a consumer on 11 Sep 2015. This report refers to an approximately 56 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in 2014. On an unknown date, after vaccination she experienced flu. The reporter stated that the vaccine did not work. The outcome, seriousness and causality of the events were not reported. The patient was again vaccinated with flu vaccine (manufacturer and batch number: not reported) on 15 Aug 2015 and got flu, scratchy throat, fever and nausea (see case: PHEH2015US017996). Seriousness assessment of the event flu upgraded based on the available information in the source document and event vaccination failure based on the NVx key event list. Follow-up information from consumer received on 30 Oct 2015: New event (vaccination failure), reporter's comment (vaccine did not work), year of vaccination administered, age of the patient were updated.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Skin lesion
Clinical narrative: Husband received Vaccinia vaccination on 20160111.  Wife may have been exposed to vaccination site.  Has 3 lesions consistent wife vaccinia inoculation.  One is very itchy.  (Statement provided by the Doctor).
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Fatigue, headache and body aches, chills. Treated with ibuprofen and fluids.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Paraesthesia oral
Clinical narrative: Tingling of lips, palpitation. Epi-pen shot.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Warm to touch, red at site, hard, pain.
Age: 82.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain
Clinical narrative: Pain in arm where vaccine was administered, and continually ongoing pain up until current date of 01/29/16.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Persistent pain and decreased mobility in shoulder of injection site.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020111, is an initial spontaneous report received from a pharmacist on 07 Oct 2015. This report refers to a 22 year old female patient. Medical history and concomitant medication was not reported. She received AFLURIA (other manufacturer, batch number: unknown) on 10 Sep 2015 and influenza vaccine INN (manufacturer and batch number unknown) on 07 Oct 2015. The patient received 2 doses of flu vaccines within 4 weeks apart from one another. No adverse event was reported. No further information was provided.
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Influenza
Clinical narrative: Case number PHEH2015US003185 is an initial spontaneous report from a consumer (patient) received on 12 Feb 2015. This report refers to an adult female patient. Medical history was not reported. Concomitant medication included LOPRESSOR. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: unknown). On an unknown date, after vaccination, she experienced mild flu that kept her away from lunar new year celebrations. After a week she felt better and went outside. Final outcome of the event was recovered. Seriousness and causality of the event was not reported.
Age: 1.3
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Cold sweat, Hyperhidrosis, Lethargy, Loss of consciousness, Pallor
Clinical narrative: After administration of the vaccine series the pt vomited one time in the office.  5 Minutes After the patient left the office the parents called to inform us that the pt vomited again and "passed out" briefly.  They were instructed to return to the office for exam/stabilization.  Pt returned ~12:15PM and was pale, diaphoretic, and clammy upon initial presentation. VS HR=120, RR=30, T=98.1    Pt was lethargic with eyes closed though he did arouse to painful stimuli. Patient vomited once more and fell asleep in his mothers arms. Respirations remained even and unlabored and color returned from its pallor, vital signs remained stable though he aroused only to painful stimuli.  He was monitored until he woke from his slumber and his condition stabilized/returned to baseline.
Age: 1.3
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Vomiting
Clinical narrative: After administration of the vaccine series the pt vomited one time in the office.  5 Minutes After the patient left the office the parents called to inform us that the pt vomited again and "passed out" briefly.  They were instructed to return to the office for exam/stabilization.  Pt returned ~12:15PM and was pale, diaphoretic, and clammy upon initial presentation. VS HR=120, RR=30, T=98.1    Pt was lethargic with eyes closed though he did arouse to painful stimuli. Patient vomited once more and fell asleep in his mothers arms. Respirations remained even and unlabored and color returned from its pallor, vital signs remained stable though he aroused only to painful stimuli.  He was monitored until he woke from his slumber and his condition stabilized/returned to baseline.
Age: 0.92
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Dtap shot.  Hard red lump formed 2 days after shot at site of injection.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Joint swelling
Clinical narrative: PT PRESENTED AT PHARMACY 2 DAYS POST VACCINATION WITH REDNESS NOT AT INJECTION SITE. LATER PROGRESSED TO SWELLING ON THE INNER BEND OF THE ELBOW. HE REPORTS THAT HIS DOCTOR DIAGNOSED HIM WITH CELLULITIS AND PRESCRIBED DOCXYCYCLINE.
Age: 14.0
Sex: M
Vaccine: FLUX
Symptoms: Ear disorder, Pyrexia, Throat irritation
Clinical narrative: Case number PHEH2015US018002 is an initial spontaneous report from a consumer received on 11 Sep 2015. This report refers to a 14-year-old male patient. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Aug 2015. On an unknown date, after vaccination he experienced scratchy throat, fluid behind ears and mild fever. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Wrong diluent mixed with vaccine. Generic sterile diluent was used to mix vaccine.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Peripheral swelling
Clinical narrative: Patient stated the following night after receiving the immunization her arm was noted reddend and swollen, she stated running a mild fever which she self treated with Aleve, the following day her arm was noted to be swollen approx. 3" around injection site and reddend, she is also has complaints of whole body aches.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient stated the following night after receiving the immunization her arm was noted reddend and swollen, she stated running a mild fever which she self treated with Aleve, the following day her arm was noted to be swollen approx. 3" around injection site and reddend, she is also has complaints of whole body aches.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS, SWELLING, ITCHINESS, SIZE OF REACTION IS 3-3.5 INCHES IN DIAMETER.  HE CALLED HIS PCP AND WAS TOLD TO COME BACK TO THE PHARMACY FOR INSPECTION. HE WILL APPLY ICE AND HYDROCORTISONE CREAM IF THE ICE DOES NOT STOP THE ITCHING REACTION.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain, lasted 2 days. Benadryl was given by her daughter. Pt reported 2wks after the vaccine date. Upon exam on 1/22/16, no redness or swelling. Somewhat uncomfortable when lifting the left arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reactions: swelling, redness, itching.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: REDNESS, SORENESS AT/AROUND SITE.  HARD AND WARM. STILL ABOUT THE SAME SYMPTOMS 10 DAYS LATER.  NO TREATMENT WAS ADMINISTERED.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching and swollen arm for 6 days. Patient was using calamine lotion. Primary care doctor advised using Benadryl.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Anaemia, Menstrual disorder, Oligomenorrhoea, Suicidal ideation
Clinical narrative: From the first vaccine injection to the last everything started going wrong with my daughter's menses. 1st shot, her periods wouldn't stop. 2nd shot, they stopped all together. 3rd shot, they started and didn't end until she was given Provera. Before her shots she had normal menses. Now my daughter is 20 and bleeds everyday. We've tried birth control of all kinds progesterone and estrogen She has been put on antidepressants and is anemic. She has been suicidal and definitely hormonal. We've been to multiple doctors and psychiatrists as well as a stay in a mental hospital. I reported the problems with each shot. The doctor's made light of my comments and I don't even know if they reported them.
Sex: U
Vaccine: HPV9
Symptoms: Local reaction
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of GARDASIL 9 (Lot #, dose and route not reported). Subsequently, on an unknown date, the patient had local to GARDASIL 9 for one week. This is one of three reports from the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Sleep disorder, Tendon pain
Clinical narrative: Muscle/tendon/arm pain for 2 months now can't sleep on left side due to aching pain when putting on clothes/jacket requires backward/upward arm motion.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Activities of daily living impaired, Fatigue, Hypersomnia, Peripheral swelling
Clinical narrative: Sleeping 16 hours daily x 3 day, swelling of both arms. Sleeping sent home due to fatigue sleeping 16 hours - x 2 days.
Age: 31.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abdominal discomfort, Diarrhoea, Ear pain, Injection site pain, Injection site urticaria
Clinical narrative: Upset stomach 2 days after vaccinations, followed by diarrhea. Achiness, mild ear pain, and sore throat. Painful welt at site of injection, unknown which arm received which vaccine. Symptoms have resolved.
Age: 31.0
Sex: F
Vaccine: TYP, YF
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Upset stomach 2 days after vaccinations, followed by diarrhea. Achiness, mild ear pain, and sore throat. Painful welt at site of injection, unknown which arm received which vaccine. Symptoms have resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.