chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route and lot number not provided). On an unknown date, 3 days after receiving ZOSTAVAX, the patient developed injections site erythema and swelling. On an unspecified date, the patient recovered from the events. The causal relationship was not reported. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Pt got the flu and the PNEUMOVAX shot on same day 9/17/13 and came back 9/29/13 to show me his hand. The hand was swollen from the shoulder to his fingers, all red, and he says it was very painful. I asked him to see his doctor if it gets any worse.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient called on Tuesday 10-1-13 that she experienced a rash on her arm at first, then spread to her legs and trunk with itching. Told to try BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Skin discolouration, Skin warm
Clinical narrative: Today after imms. L arm swelled up at injection site and was very warm to touch. 12 days after imms were given arm is still discolored and warm to the touch.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Pt complained of rash, dizziness, fever, headache and muscle pain. Went to the Dr and was given Flexeril and Keflex.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: 3 inch oval round, hot, red, rash at injection site 24 hours after injection. She took Benadryl and rash went away after 2 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Pt. got shot vaccine on 9-23 and she called on 9-27 at 12 noon stating that the injection site is now plum size-got worse in 3 days.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: Patient ended up with facial weakness 9/26/2013 was seen by MD 9/27/13 diagnosed with Bell's Palsy.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Cellulitis Left arm (vaccination arm)
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Local swelling, Paraesthesia
Clinical narrative: Pt reported burning after injection. Waited and left store ok. Called back reporting swelling and tingling at L arm. Recommended she go to ED.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling hot, Lacrimation increased, Rhinorrhoea
Clinical narrative: Dizzy, weak, hot in face, runny eyes/nose, seizure like movements. Patient contacted her MD and was advised no treatment necessary. Patient ok now.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure like phenomena
Clinical narrative: Dizzy, weak, hot in face, runny eyes/nose, seizure like movements. Patient contacted her MD and was advised no treatment necessary. Patient ok now.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Patient experienced mild itching near injection site about 20 minutes after administration. Observed patient further - no other symptoms developed. Advised patient to use cold compress and take Benadryl if symptoms continued. I called her after about an hour and she said she was feeling ok. Also contacted her physician.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in Rt arm. Tightness in chest. Inj given in Lt arm.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Patient experience chills and high fever (^105F) about 3 hours after receiving Fluzone HD vaccine. Recovered about 3 hours later. Slept through the night woke up fatigued and fully recovered by Noon. Patient took 1 Tylenol tab for fever, and did not call or go to MD for emergency room. Patient states after reporting incident he had a cold sore on his lip prior to vaccination - did not inform us of this prior to vaccination.
Age: 77.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site swelling, Pain
Clinical narrative: Pain; Swelling in R upper arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 8 patients of unknown age and gender who in August 2013 were vaccinated with VARIVAX 0.5 ml, subcutaneous (Lot # reported as H015222, expiry date 10-AUG-2014). It was reported that the vaccine of VARIVAX were stored in temperature conditions that were not supported by it in house stability data. No adverse effects were reported. This report is linked to 1310USA000667. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, ringing ears, body aches, sinus pressure, trouble breathing.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus headache, Tinnitus
Clinical narrative: Fever, headache, ringing ears, body aches, sinus pressure, trouble breathing.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 1 year old male patient. The patient's medical history included ear infections. The patient had no drug reactions/allergies. On 10-SEP-2013 the patient was vaccinated with MMR II HAS (lot # 0425AE, expiration date 27-FEB-2014) 0.5 ml once for routine vaccination (route was not reported). Concomitant medications were not reported. In September 2013, 10 hrs. after received MMR II the patient experienced 102F fever. The patient's mother, an unspecified nurse practitioner, had been alternating Tylenol and ibuprofen (unspecified) every 4 hours to treat the patient's fever. The outcome of fever was reported as not recovered/not resolved. No lab diagnostic were performed. The relationship between the MMR II and the fever was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Rash macular, Skin warm
Clinical narrative: Patient came to pharmacy today 10/1/13 and showed me a red, flat rash approx 6" long and 3 1/2" wide. It was hot to touch. Injection site was still painful. Pt did go to hospital ER 10/1/13 and saw Dr.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy today 10/1/13 and showed me a red, flat rash approx 6" long and 3 1/2" wide. It was hot to touch. Injection site was still painful. Pt did go to hospital ER 10/1/13 and saw Dr.
Age: 18.0
Sex: M
Vaccine: HPV4, IPV, VARCEL
Symptoms: Erythema, Injection site reaction, Local reaction, Local swelling, Skin warm
Clinical narrative: Local reaction to L upper arm (site of VAR administration). Arm swollen, warm to touch and red with 8x8 cm induration. Ice pack and Ibuprofen given. Youth denies pain and itching.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: 9/23/13-Pt. states as soon as she left her R shoulder became painful and is increasing in pain. 9/28/13 Pt called with complaint but told they are unable to assist. Went to hospital. B/P today 110/70. Still complaining of R shoulder pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Varicella post vaccine
Clinical narrative: Around 5:30 PM on 10/1/2013 pt noticed itchiness, redness, and soreness near site of injection. Appears to be a small outbreak of chicken pox around site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Hypopnoea, Tremor
Clinical narrative: Patient had shallow breathing, started shaking, and she got very cold 2 hours after receiving flu shot.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Skin warm
Clinical narrative: Patient called on 10/11/13 stating she received both PNEUMOVAX and FLUVIRIN day before. She said her arm was swollen, and warm. Told patient she should take BENADRYL and visit local urgent care center. Awaiting future information.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Mobility decreased, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Pt noted arm stiffness/soreness; couldn't raise arm above head x 2 days. Dr told her to apply heat to area which helped somewhat. Also reported nausea, loss of appetite and vomiting x 2. Feels better on 10/1/13 at time of report. Saw doctor for pain meds over weekend.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Pt noted arm stiffness/soreness; couldn't raise arm above head x 2 days. Dr told her to apply heat to area which helped somewhat. Also reported nausea, loss of appetite and vomiting x 2. Feels better on 10/1/13 at time of report. Saw doctor for pain meds over weekend.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Neurological examination, Pain in extremity, Paraesthesia
Clinical narrative: Tingling and pain down left arm and into hand and finger tips. Initial pain with injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: A rash at injection site - 1-2 inches in diameter.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Inj. site swelled hot to touch - as evening came - very fatigue feeling ill. Arm at site swelled double size. By 9 PM couldn't use arm at all - 9/26 sweling and redness moving down arm. Still have inf. and redness.
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Malaise
Clinical narrative: Inj. site swelled hot to touch - as evening came - very fatigue feeling ill. Arm at site swelled double size. By 9 PM couldn't use arm at all - 9/26 sweling and redness moving down arm. Still have inf. and redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Patient came into pharmacy on 9/20/13 and  asked what to do. Her arm was very red, slightly swollen and itchy. Told to try Benadryl and contact MD.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Neck pain
Clinical narrative: Soreness at site of injection (left arm) from neck area to elbow. Patient also had a headache the first night. No redness, just sore and painful.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient had fever, entire arm turned red, hot to touch, and painful. Patient received antibiotic shot and prescription Bactrim to take by mouth.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: Patient had a knot that formed at injection site that itched slightly.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Significant soreness; stiffness of right arm following administration of influenza and pneumococcal in right arm. Treatment: Ice; Analgesic; Manipulate arm gently.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Pain, Rash, Skin warm
Clinical narrative: 48 hrs (approx) after the injection of ZOSTAVAX, patient developed sudden onset of rash which was hot and painful and enlarged in 4 hrs. Patient used cold compress and took BENADRYL. She is still sore and will see physician at 3 PM on 10/01/13 for concern and cellulitis.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site erythema, Injection site pain
Clinical narrative: Patient had tenderness and oozing at injection site the morning after vaccine was given (9/26/13). The patient reported this to the pharmacy on 10-1-13. The area was red and still tender, but not oozing. Pt was instructed to apply NEOSPORIN to area and use cool/warm compresses alternating.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient returned the next day with a raised area on the skin that was red and warm to the touch. She stated it itched. Her doctor recommended BENADRYL.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Almost immediate headache, migraine-like. Patient has history of migraine. Took 2 extra strength TYLENOL. Symptoms subsided after about 20 minutes-40 minutes.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient returned to phcy 2 days and post administration of Zostavax to ask if reaction at site of injection was OK. The red patch was about the size of a silver dollar, it itches, and is warm to the touch but no blistering was observed, she was concerned increased to about 2 inches across and was worried.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: Bruise noted at injection site, approx 1 1/2" x 1". No swelling or redness, no fever. Rash like area below inj site, about 1" x 1". Not itchy or painful. Improved in 24 hours with cortisone cr to area.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus, Rash, Urticaria
Clinical narrative: Severe rash/hives - itchy, red, swollen arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Eosinophil count increased, Lymphocyte count decreased, Lymphocyte count increased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. On 23-AUG-2013, reported as 4 weeks ago, the patient was vaccinated with ZOSTAVAX (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On 23-AUG-2013, reported as 4 weeks ago, the patient had a blood test drawn which showed a change in the patient's lymphocyte and eosinophil counts, lymphocyte count was below range and the eosinophil count was above range. The patient did not sought medical attention and no treatment was given for the adverse events. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site swelling, Local swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her 40's. On 29-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot# reports as J007786, exp 25-SEP-2015), 1 dose in the unknown arm for unknown indications. The patient's relevant medical history includes no allergies to vaccines. Her concomitant medications and past drug history were unknown. On 29-SEP-2013 the patient had edema at the injections site, the site swelled to the size of a silver dollar, some itching and then the whole arm swelled like a balloon. She was treated with Benadryl which did not help the swelling. It was unknown if there was any laboratory data. As of 29-SEP-2013 it was unknown if she would have another PNEUMOVAX23 injection and she continued to have edema at the injection site, itching, and her whole arm was swollen. This pharmacist reports similar events for 4 patients. This was the first of 4 reports. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a health care student concerning a patient of unknown age and gender. It was reported that PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) was exposed to 50 degrees Fahrenheit (F) for 10 days which was not supported. She stated that she was unsure if it was administered to any patients. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 8 patients of unknown age and gender who in September 2013 were vaccinated with VARIVAX 0.5 ml, Subcutaneous (lot # reported as H015222, expiry date 10-AUG-2014). It was reported that the vaccine of VARIVAX were stored in temperature conditions that were not supported by it in house stability data. No adverse effects were reported. This report is linked to 1309USA008246. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from the patient's wife refers to an unknown age male patient. Medical history or current conditions were not reported. On 22-SEP-2012, the patient was vaccinated with ZOSTAVAX (concentration, dose, indication and lot number were not reported). Concomitant therapies were not reported. On an unknown date, the patient had suffered from hives. The outcome of suffering from hives was unknown. Causality was not reported. This is one of two cases reported by the same source (MARRS#1309USA013495). Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test
Clinical narrative: Information has been received from a registered nurse, for VARIVAX, a Pregnancy Registry Product, concerning a female patient of unknown age with none pertinent medical history. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of VARIVAX (lot number G007814) (dose, route not reported) on 14-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient became pregnant. Pregnancy was normal to date. There was no treatment given for adverse event. Pregnancy test was performed. Initial exposure to VARIVAX was at 3 week. The patient's LMP was an approximately 20-AUG-2012 and her EDD was reported as on 27-MAY-2013. The patient sought medical attention, contacted clinic. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival pain, Headache, Injection site reaction, Oral pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old female patient with high blood pressure, atrial fibrillation, erythromycin allergy and rocephin allergy, reporting on herself. The patient's medical history included Myocardial Infarction. On 04-SEP-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route and lot number were not reported) for prevention of shingles. Concomitant therapies included Nexium, losartan potassium (manufacturer unknown), warfarin sodium (manufacturer unknown), atenolol (manufacturer unknown), ramipril (unspecified) and Tranxene. On 11-SEP-2013, the patient experienced headaches and had a rash-like redness at the injection site where she received ZOSTAVAX. The patient also experienced gum and mouth pain. The patient did not seek medical attention. The outcome of headaches, rash-like redness at the injection site, and gum and mouth pain, was not reported. The relationship between the ZOSTAVAX and the events was not reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous report as received from a male consumer refers to his wife of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). The patient's husband report that they had no trouble with the shot but the patient was now in a nursing home with a urinary tract infection. The outcome of urinary tract infection was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse for VARIVAX, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births were not known. The patient might have vaccinated with VARIVAX (lot number, dose, route, injection site and indication were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient was in fact pregnant. The LMP and EDD were not known. Initial exposure to VARIVAX was unknown. The outcome was unknown at the time of report. The patient had went to the office for medical attention. Follow-up information has been received from a registered nurse concerning a 17 year old female patient who had been vaccinated with a dose of VARIVAX and was pregnant. No LMP or gestation date provided. No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 18 years old female patient without Drug Reactions/Allergies The patient's medical history included birth control until 20-SEP-2012, patient had just gotten off unspecified antibiotics. The patient was on unspecified antibiotics once in September 2012 and then in October 2012. The patient's history of previous pregnancies and live births was not know. The patient was vaccinated with the first dose of VARIVAX (Merck) (0.5 ml, subcutaneous, lot # was unknown) on 26-APR-1999. No other co-suspects were reported. There was none concomitant medications. The patient became pregnant with an LMP of 30-SEP-2012 and an EDD of 07-JUL-2013. The patient received the second dose of VARIVAX (Merck) (0.5 ml, subcutaneous, lot # was H006529, expiration date was 09-MAR-2014) on 31-OCT-2012 and was pregnant. No treatment was given for adverse event. The outcome of event was unknown. The patient's urine pregnancy test was positive. The patient sought medical attention via visiting to the nurse. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report has received from 22 years old female patient, for VARIVAX (Merck), a Pregnancy Registry Product, concerning herself with no pertinent medication attention or drug allergy. The patient was vaccinated with a dose of VARIVAX (Merck) on 03-JUN-2012. The patient stated she found out she was pregnant after getting the vaccine. Pregnancy test was performed. The patient sought medical attention by office visit. Follow-up information received. The lot number 0471AE of VARIVAX (Merck) involved, was verified as a valid lot. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 22 years old female consumer with no Pertinent Medical History and no Drug reactions/Allergies reporting on herself. The patient was vaccinated SC with, 0.5 ml VARIVAX (Merck) (lot number not reported) as part of a pregnancy registry on 16-AUG-2012. There were no concomitant medications. The patient reported she was 18 weeks pregnant when got the vaccine. Her last menstrual period (LMP) was 13-APR-2012 and estimated delivery date (EDD) of 18-JAN-13. Initial exposure to VARIVAX (Merck) was at 18 week(s). The patient was exposed to VARIVAX (Merck) during trimester 2. No adverse reaction was reported. No Lab Diagnostics were performed. Additional information has been requested. 30-APR-2013. This is a correction. The onset date for the event of maternal exposure during pregnancy was removed.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 28 years old female consumer, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself, with no medical history and concomitant condition. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated SC. with a dose of, 0.5ml VARIVAX (Merck) (lot# 0428AE, expiration date 27-FEB-2014) on 18-JUL-2012. There were no concomitant medications. The patient was pregnancy before getting the vaccine. The patient said that she might be five or six weeks pregnant. The patient's LMP was approximately on 18-JUN-213 and EDD was on 25-MAR-2013. Initial exposure to VARIVAX (Merck) was approximately 4 week(s). The patient was exposed to a VARIVAX (Merck) during trimester 1. No adverse events reported. No treatment information was reported. The outcome of patient was unknown. The patient had done annual obgyn visits and sought for unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning an 18 year old female patient without drug reactions. The patient's grandmother had heart problems. The patient's history of previous pregnancies and live births was not known. The patient who was pregnant was vaccinated with the second dose of 0.5 ml VARIVAX (Merck) (lot number H006951, expiration date unknown) subcutaneously on 24-SEP-2012. No other co-suspects were reported. There were no concomitant medication. The patient became pregnant with an LMP of 13-AUG-2012 and an EDD of 20-MAY-2013. Initial exposure to VARIVAX (Merck) was at 6 weeks. The patient was exposed to VARIVAX (Merck) during trimester 1. No treatment was given for adverse event. No laboratory diagnostics studies were performed. The patient was sought medical attention via office visit. Follow-up information was received. Patient details were updated. The vaccine was administered by a registered nurse in a public health clinic/hospital and the VARIVAX (Merck) was purchase with public funds. On 24-SEP-2012 the patient was vaccinated with VARIVAX (Merck) (lot # H006951, expiration date not reported) subcutaneously in the right arm. Concomitant vaccines included TDAP, Hepatitis A virus vaccine (unspecified) and MENACTRA given on 24-SEP-2012. Patient had not delivered and has had no prenatal care as of today (at the time of the report). She was suppose to have OD appointment at the time of this report but did not show. Patient was tested for varicella antibodies before vaccination with VZV containing vaccine. There was no local reaction at vaccination site. Follow-up information received. The lot number H006951. Follow up information has been received from the physician and the registered nurse. It was reported that the patient did not showed last appointment and they had not seen her since vaccine given. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Fatigue, Pruritus, Skin warm
Clinical narrative: Patient experienced redness, itching, bruising, area was warmer than surrounding skin and fatigue.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash, Swelling
Clinical narrative: Swelling, pain, rash.
Age: 8.0
Sex: F
Vaccine: RAB
Symptoms: Meningitis, Sepsis
Clinical narrative: Case number PHHY2013US108753 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT from 1997 to 2005. This report refers to an 8-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. She also received HRIG (other manufacturer and batch number: not reported). She experienced meningitis and septicemia, 17 days post vaccination. It was reported that the organism responsible for the events was not isolated. She was hospitalized and was discharged home after improvement. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Blood culture negative, CSF test normal, Meningeal disorder
Clinical narrative: Case number PHHY2013US108767 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 25-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. He also received HRIG (human rabies immunoglobulin, other manufacturer and batch number: not reported) on an unknown date. Twenty one days after vaccination, he experienced meningeal symptoms. He was hospitalized. It was reported that the blood culture was negative and cerebrospinal fluid (CSF) was with no abnormality. He was discharged home after improvement. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency of unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Encephalopathy
Clinical narrative: Case number PHHY2013US108711 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 43-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with RABAVERT (batch number: not reported) on an unknown date. She also received HRIG (human rabies immunoglobulin, other manufacturer and batch number: not reported). On the same day after vaccinations, she experienced acute encephalopathy. It was reported that the neurologist was not able to diagnose or treat the symptoms. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 79.0
Sex: F
Vaccine: RAB
Symptoms: General physical health deterioration, Insomnia, Mental impairment, Mental status changes, Muscular weakness
Clinical narrative: Case number PHHY2013US108799 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT from 1997-2005. This report refers to a 79-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. She also received HRIG (human rabies immunoglobulin, other manufacturer and batch number: not reported) on an unknown date. On an unknown date post vaccination, she developed mental and physical deterioration. It was reported that she had mental changes, myasthenia and insomnia. No conclusive diagnosis was made, but she was with persistence of symptoms. The outcome of the event was reported as condition unchanged. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 3.0
Sex: F
Vaccine: RAB
Symptoms: Grand mal convulsion
Clinical narrative: Case number PHHY2013US108883 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 3-years-old female patient. Her medical history and concomitant medications were not reported. She had a possible contact with a rabid ground hog. She was vaccinated with complete post exposure RABAVERT (batch number: not reported) on an unknown date. She also received HRIG (human rabies immunoglobulin, other manufacturer, batch number: not reported) on an unknown date. The child experienced grand mal seizures 163 days post vaccination. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 5.0
Sex: M
Vaccine: RAB
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US108557 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT from 1997 to 2005. This report refers to a 5-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: not reported) on an unknown date. 120 days after vaccination, he was diagnosed with Guillain-Barre syndrome. The outcome of the event was reported as complete recovery. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 38.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Adverse event
Clinical narrative: Case number PHHY2013US108939 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 38-years-old female patient. Her medical history included depression and concomitant medications were not reported. She was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. She also received tetanus toxoid (manufacturer and batch number: not reported, hence conservatively taken as TETANOL pur INN) on an unknown date. On the same day after vaccination, she experienced possible multiple sclerosis. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency of unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Case number PHHY2013US108690 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 45-years-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of tetanus and diphtheria vaccine (manufacturer and batch number: not reported). She was vaccinated with third dose of pre exposure RABAVERT (batch number: not reported) on an unknown date. Seven days after third dose of RABAVERT (67 days after tetanus and diphtheria vaccine), she experienced acute demyelinating encephalomyelitis (ADEM). The outcome of the event was reported as partial recovery. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Arthritis, Injection site pain, Injection site reaction, Local reaction
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of injection site pain in a female patient of unspecified age who was vaccinated with BOOSTRIX. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown, unknown arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced severe pain and muscle weakness in the arm where BOOSTRIX was administered. It was noted this was a local reaction. The sales representative reported the subject received BOOSTRIX "at the OB-GYN office and most likely only received the BOOSTRIX that day". The subject saw her primary care physician who diagnosed the subject with arthritis and prescribed steroids for treatment. At the time of reporting the injection site pain, arm pain, weak arm muscles and arthritis were unresolved. Follow-up information was received on 30 August 2012 via healthcare professional who reported the 51-year old female subject received a dose of BOOSTRIX in the left arm on 09 January 2012. That same day on 09 January 2012 the subject experienced soreness and weakness below elbow and into hand. The subject notified the healthcare professional that she was examined by her primary care physician and an orthopedic specialist and received x-rays indication possible arthritis. The reporting healthcare professional considered the soreness and weakness below elbow and into hand possibly related to vaccination with BOOSTRIX. At the time of the report the soreness and weakness below elbow and into hand were unresolved, the outcome of the arthritis was not specified.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of injection site pain in a female patient of unspecified age who was vaccinated with BOOSTRIX. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown, unknown arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced severe pain and muscle weakness in the arm where BOOSTRIX was administered. It was noted this was a local reaction. The sales representative reported the subject received BOOSTRIX "at the OB-GYN office and most likely only received the BOOSTRIX that day". The subject saw her primary care physician who diagnosed the subject with arthritis and prescribed steroids for treatment. At the time of reporting the injection site pain, arm pain, weak arm muscles and arthritis were unresolved. Follow-up information was received on 30 August 2012 via healthcare professional who reported the 51-year old female subject received a dose of BOOSTRIX in the left arm on 09 January 2012. That same day on 09 January 2012 the subject experienced soreness and weakness below elbow and into hand. The subject notified the healthcare professional that she was examined by her primary care physician and an orthopedic specialist and received x-rays indication possible arthritis. The reporting healthcare professional considered the soreness and weakness below elbow and into hand possibly related to vaccination with BOOSTRIX. At the time of the report the soreness and weakness below elbow and into hand were unresolved, the outcome of the arthritis was not specified.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Injection site joint pain, Injection site pain, Red blood cell sedimentation rate normal
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of injection site pain in a 46-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included AMBIEN, OCELLA and VALTREX. On 14 March 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). On 14 March 2013, immediately after vaccination with BOOSTRIX, the subject experienced injection site pain ("intense pain at the injection site"). Four to 5 days after the injection, the subject still noted pain at the injection site and pain in the forearm. On 18 March 2013, 4 days after vaccination with BOOSTRIX, the subject experienced injection site movement impairment. This report was associated with a product quality complaint. The subject went on vacation and "was lifting bags and suitcases and the pain was still present." Per the reporter, no redness or swelling was noted. The subject was seen by the physician's office and treated with naproxen and ice. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. The reporter documented 2 other cases with BOOSTRIX. See cases A1021180A and A1021183A for details on the other cases. Follow up was received from Quality Assurance on 2 May 2013. The lot number was reported as AC52B100AA was incorrect. The lot number has been updated to reflect the correct lot number AC52B100CA. Quality Assurance (QA) follow up was received on 23 May 2013. Based on the currently available safety information and the nature of the complaint, it can be concluded that there is no evidence for a safety signal concern for the batch AC52B100CA of BOOSTRIX vaccine and its similar batches. The QC investigation performed on the received samples shows that the complaint samples are confirm to the specification for the description. GlaxoSmithKline Biologicals considers this complaint to be unsubstantiated.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Product quality issue
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of injection site pain in a 46-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included AMBIEN, OCELLA and VALTREX. On 14 March 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). On 14 March 2013, immediately after vaccination with BOOSTRIX, the subject experienced injection site pain ("intense pain at the injection site"). Four to 5 days after the injection, the subject still noted pain at the injection site and pain in the forearm. On 18 March 2013, 4 days after vaccination with BOOSTRIX, the subject experienced injection site movement impairment. This report was associated with a product quality complaint. The subject went on vacation and "was lifting bags and suitcases and the pain was still present." Per the reporter, no redness or swelling was noted. The subject was seen by the physician's office and treated with naproxen and ice. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. The reporter documented 2 other cases with BOOSTRIX. See cases A1021180A and A1021183A for details on the other cases. Follow up was received from Quality Assurance on 2 May 2013. The lot number was reported as AC52B100AA was incorrect. The lot number has been updated to reflect the correct lot number AC52B100CA. Quality Assurance (QA) follow up was received on 23 May 2013. Based on the currently available safety information and the nature of the complaint, it can be concluded that there is no evidence for a safety signal concern for the batch AC52B100CA of BOOSTRIX vaccine and its similar batches. The QC investigation performed on the received samples shows that the complaint samples are confirm to the specification for the description. GlaxoSmithKline Biologicals considers this complaint to be unsubstantiated.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Computerised tomogram, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of arm pain at injection site in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) and unspecified vaccine. A physician or other health care professional has not verified this report. Concurrent medications included Levothyroxine, CYMBALTA, Hormone replacement therapy, Vitamin D3 and Calcium. On 21 April 2013 at 13:00 the subject received unspecified dose of BOOSTRIX (intramuscular, left arm). On 21 April 2013, immediately after vaccination with BOOSTRIX, the subject experienced arm pain at injection site, pain at site during injection and vaccine administered at inappropriate site. Since 21 April 2013 the subject has also experienced arm pain, inability to perform daily activities, unable to lift arm and awake at night. The subject received an intramuscular injection of BOOSTRIX in her upper left arm that was only about an inch from her shoulder. Her previous vaccine injections had always been lower on her arm and the subject thinks that she was injected in more of a joint area that was not very muscular [vaccine administered at inappropriate site]. The injection hurt really bad at the time of administration. Since that time, the pain in her left arm has gotten worse. The pain is limiting the subject from doing a lot of things and she is unable to lift the arm above her head. The pain is happening 24 hours, seven days a week and has also been keeping her awake at night. The subject has tried treating the pain with TYLENOL. At the time of reporting the pain at injection site, pain at site during injection and arm pain were worse; inability to perform daily activities, unable to lift arm and awake at night. The subject also reported experiencing injection site pain that resolved within 24 hours with previous, unspecified vaccination. No other details were provided.