chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Feeling abnormal, Gaze palsy, Loss of consciousness, Pallor
Clinical narrative: GARDASIL given by RN prior to MD going into see the patient. Mom open exam room door approx 5-10 min after injection stating patient passed out & was shaking. MD & RN went in - pt lying down with feet increased - applied cold compress. Pt stated she felt funny - his eyes rolled back, body shook & head jerked to (L) side - very pale.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: GARDASIL given by RN prior to MD going into see the patient. Mom open exam room door approx 5-10 min after injection stating patient passed out & was shaking. MD & RN went in - pt lying down with feet increased - applied cold compress. Pt stated she felt funny - his eyes rolled back, body shook & head jerked to (L) side - very pale.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Pyrexia
Clinical narrative: Headache - severe & low grade fever within 24 hrs had experienced same symptoms with anthrax #3, but was much worse with anthrax #4 vaccination. Resolved by day 2 post injection.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom states red, swollen right upper arm started 11/17/12 morning. Mom gave BENADRYL which helped. Rt. arm swollen at site of vaccines today 11/19/12.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 3 days after administration client began to scratch site (R) thigh. Site began to swell 11/19/12 am. No treatment . Client also has rash which may have precipitated pruritus 2 secondary to parents changing diaper brand.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site warmth, Oedema peripheral
Clinical narrative: Left upper arm was swollen (mild) warm to touch at injection site. Joint aches.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site induration, Injection site rash, Injection site swelling, Pain
Clinical narrative: Patient described injection site area as hard, raised, swelling 1/2 inch. Area was approximately 6 inches by 4 inches. Patient experienced painful, burning sensation. Patient did go to Urgent Care.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope lasted < 30 seconds . Dt -was fine afterwards BP 100/80.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling at varicella injection site (non tender) on left arm, no fever. Advised warm compresses to area. No other treatment. Advised to call if area becomes painful or fever.
Age: 1.53
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth and tenderness surrounding vaccine inoculation site, associated with pruritus. Resolved after 3 day without intervention. 0.5 x 0.5cm nodule left in place.
Age: 1.53
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Nodule
Clinical narrative: Swelling, redness, warmth and tenderness surrounding vaccine inoculation site, associated with pruritus. Resolved after 3 day without intervention. 0.5 x 0.5cm nodule left in place.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on shoulder, upper back, upper chest about 1 hour after injection. Dexamethasone 4 mg and KENALOG 40mg, BENADRYL 25mg.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Skin burning sensation
Clinical narrative: Patient reported after she left pharmacy, her arm swelled and felt on fire. She contacted Dr. He prescribed Prednisone. She is fine now 5 days of Prednisone.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Itching lower half of face, arms (secondary) redness & itching at injection site. Second day, dr prescribed antihistamine.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: No adverse event
Clinical narrative: No symptoms reported.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local swelling and erythema (R) deltoid. Given BENADRYL IM/cold compress.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: 3 days after the shot I was broken out over my entire body from feet to chest, arms as well.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Vomiting
Clinical narrative: Vomited 2 x, 2 minutes after vaccine was given.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a consumer refers to her 73 years old husband. The patient had no drug reactions or allergies. The patient was vaccinated with ZOSTAVAX (lot number not provided) on 16-SEP-2012. No other co-suspects were reported. Concomitant medications included metformin. After receiving the ZOSTAVAX injection, on 17-SEP-2012 the patient had a red rash round the injection site. His rash was a dark red and sore to the touch. It was description as being similar to a welt. The patient stated that the rash was about three inches wide and four-five inches long. The rash lasted for about one and half weeks. The rash was only on the arm. No treatment was given for adverse event. No diagnostics studies were performed. The outcome of adverse events was recovered. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter of unknown age. "Yesterday" on 20-NOV-2012, the patient was vaccinated with the first dose of ROTATEQ, (lot number, expiration date and route was not reported). Concomitant medications were not reported. The consumer asked how long it would take for the side effects to go away and whether ROTATEQ, contains PCV1 and PCV2. The consumer disconnected the call before able to clarify if her daughter was experiencing side effecting and what were the specific side effects. The outcome of the event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Nuclear magnetic resonance imaging, Pain, Paraesthesia, Rash macular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 years old female patient with no drug allergy. The patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously on 03-OCT-2012. Lot# was reported as H011050, expiry date on 05-SEP-2013. Concomitant medications included LOVAZA and FLONASE. On 13-NOV-2012, the patient had "electrical shock like pain" in her both legs and right arm after receiving ZOSTAVAX. Patient also presented with flat macular rash on her leg bilaterally. According to patient's chart, patient stated that shock sensation came and went, lasting several seconds to a minute and the area where patient felt the electrical shock sensation was painful to touch. Patient reported to physician that if she touched the affected area after shock sensation was gone, the area was painful and the pain would last little longer than electrical shock sensation. Nurse reported that patient did  have history of "electrical zap type of pain" in her chart prior to ZOSTAVAX administration but it never affected more than one spot at a time before. Patient had a daughter with multiple sclerosis and physician ordered magnetic resonance imaging(MRI) to rule out diagnostic of multiple sclerosis. The test result was not provided. Physician believed that flat macular rash on legs were not related to ZOSTAVAX. No treatment was given. The outcome of patient was unknown. The patient sought medical attention via office visit. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 87 years old female patient. The patient was vaccinated with ZOSTAVAX on 27-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 27-NOV-2012 the patient experienced injection site burning immediately afterwards. No treatment information was reported. The pharmacist monitored the patient post vaccination. The patient reported she was feeling better. The pharmacist will also follow up with the patient tomorrow. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 02-OCT-2012, the patient was vaccinated with a dose of M-M-R II. No concomitant medications were reported. On 13-NOV-2012 (reported as 6 weeks later), serological testing for titer against measles was done and the patient was found to have negative titers against measles. The patient sought medical attention for the event. The outcome of the event was unknown. No further information is available. Additional information is not expected.
Age: 38.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial information has been received from a Licensed Practical Nurse concerning an approximately 38 years old male patient with asthma, who on 01-NOV-2012, was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot H012650 exp date 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient developed redness, swelling and warmth at the injection site of the left arm a few hours after administration of PNEUMOVAX 23 on 01-NOV-2012. The patient was evaluated at a local emergency room on an unspecified date, and was treated with an unspecified antibiotics for cellulitis. On 06-NOV-2012, the patient was seen in the office and was recovering. On 15-NOV-2012, the patient was fully recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Culture negative, Injection site cellulitis, Pyrexia, Rash
Clinical narrative: Initial information has been received from a Licensed Practical Nurse concerning an approximately 38 years old male patient with asthma, who on 01-NOV-2012, was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot H012650 exp date 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient developed redness, swelling and warmth at the injection site of the left arm a few hours after administration of PNEUMOVAX 23 on 01-NOV-2012. The patient was evaluated at a local emergency room on an unspecified date, and was treated with an unspecified antibiotics for cellulitis. On 06-NOV-2012, the patient was seen in the office and was recovering. On 15-NOV-2012, the patient was fully recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer. The consumer stated she knows of others that had side effects regarding flu shotsand being vaccinated with shingles vaccinations such as ZOSTAVAX. The call was ended before further information was obtained. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from a health care student refers to a 6 patients of unknown ages and genders. In 2012 the patients were vaccinated intramuscular with PNEUMOVAX 23 (dose and lot # not reported). No concomitant medications were reported. The Pharmacy intern reported that in the past 2 weeks, 6 patients have developed cellulitis at the injection site and fever after receiving PNEUMOVAX 23. The outcome for the patients of cellulitis at injection site and fever after receiving PNEUMOVAX 23 was unknown. The relatedness for all adverse events was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 weeks old patient. The patient was vaccinated with a 2 l dose of live, oral ROTATEQ (lot # not reported) on 26-NOV-2012 at 15 weeks and 2 days of age. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that her priest received ZOSTAVAX vaccination and experienced a severe rash about three years later and was diagnosed with shingles (date unspecified), The patient was under physician's care for treatment. The patient sought unspecified medical attention. At the time of the report the outcome of shingles was unknown. The relatedness for shingles was not provided for ZOSTAVAX. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Influenza, Injection site reaction, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a company representative. The field representative state that the doctor indicated all three female patients were administered PNEUMOVAX23 at an unknown date all three patients developed swollen lymph nodes, flu symptoms and injection site reactions. All fields apply to all three patients. No other co-suspects were reported. No concomitant medications were reported. The outcome of swollen lymph nodes, injection site reactions and flu symptoms is unknown. The relatedness for swollen lymph nodes, injection site reactions and flu symptoms is unknown for PNEUMOVAX23. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Influenza, Injection site reaction, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a company representative. The field representative state that the doctor indicated all three female patients were administered PNEUMOVAX23 at an unknown date all three patients developed swollen lymph nodes, flu symptoms and injection site reactions. All fields apply to all three patients. No other co-suspects were reported. No concomitant medications were reported. The outcome of swollen lump nodes, injection site reactions and flu symptoms is unknown. The relatedness for swollen lump nodes, injection site reactions and flu symptoms is unknown for PNEUMOVAX23. No further information is available.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Influenza, Injection site reaction, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a company representative. The field representative state that the doctor indicated all three female patients were administered PNEUMOVAX 23 at an unknown date all three patients developed swollen lymph nodes, flu symptoms and injection site reactions. All fields apply to all three patients. No other co-suspects were reported. No concomitant medications were reported. The outcome of swollen lymph nodes, injection site reactions and fly symptoms is unknown. The relatedness for swollen lymph nodes, injection site reactions and flu symptoms is unknown for PNEUMOVAX 23. No further information is available.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient with no drug reactions/allergies and no pertinent medical history who on 16-NOV-2012 was vaccinated with a dose of PNEUMOVAX23 subcutaneously (dose not reported) (lot # 672781/1706AA, Exp: 03-OCT-2013). Other suspect therapies included ZOSTAVAX (dose, route and lot # not reported) given on the same time on 16-NOV-2012. Concomitant vaccination included: FLUVIRIN given on the same time. The pharmacist noted that on 18-NOV-2012, the patient developed cellulitis around the injection site of PNEUMOVAX23 that spread to her wrist. The patient was seen at the emergency room and administered an antibiotic. The patient was not admitted to the hospital and did not stay overnight in the emergency room. Present patient status was not recovered. No laboratory diagnostic studies were performed. The relatedness for the events was unknown for PNEUMOVAX23 and ZOSTAVAX. This is one of several cases received from the same source (related MARRS # 1211USA008896). Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of approximately 66 years. The patient's medical history included shingles. On an unspecified date, the patient was previously vaccinated with PNEUMOVAX23 and had experienced edema of the arm. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date,route and dose were unspecified). Concomitant medications were unspecified. On an unknown date, the patient received ZOSTAVAX then broken out in cold sores. The patient sought medical attention and the reporter believes that the patient had been to an unspecified local private physician. As a treatment the patient was given acyclovir 2 days after receiving ZOSTAVAX. The patient was not experiencing any known symptoms and on an unknown date, the patient recovered from the event cold sores. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via office manager regarding approximately a 63 years old male patient. Patient's current conditions included hypertension and GERD (gastric esophageal reflux disease). Patient had no drug reactions or allergies. On 15-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number was reported as H013399 and expiry date was 07-MAR-2014) 0.5 cubic centimeter (cc) once intramuscularly. Dose number was not reported. Concomitant medications included losartan potassium 50 milligrams (mg) and omeprazole 20 mg. Approximately on an unspecified date in November 2012, the patient experienced swelling, tenderness and pain at the site of injection. The physician also stated that the patient had redness at the site, the size of an orange. No diagnostic studies were performed. The patient sought medical attention (consulted office). No treatment was given. The physician also stated that the patient was all better now. The outcome of all the reported events was recovering. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 09-NOV-2012 13:51, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.31
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a a health worker refers to a 13 weeks old patient. The patient was in the office to receive with a first dose of live, oral ROTATEQ (dose and lot number not provided) on 21-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-NOV-2012 17:15, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-NOV-2012 10:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. it was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-NOV-2012 18:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.02
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 days old patient with contraception. The age of the patient was also reported as 5 days. The patient was vaccinated with the first dose of ROTATEQ (lot# unspecified) on 05-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm throbbing and sore. Couldn't sleep or turn over on that arm. Can't lift or use it fully. Very painful!!! Had an X-ray and also cortisone shot.
Age: 55.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Pain in extremity, Sleep disorder, X-ray normal
Clinical narrative: Arm throbbing and sore. Couldn't sleep or turn over on that arm. Can't lift or use it fully. Very painful!!! Had an X-ray and also cortisone shot.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: 10/1/2012: Seen by PCP with c/o sore throat. Strep test: GAS Neg. Treated with Amoxicillin 500mg TID. 10/18/2012: Received FLUZONE Smith and Pasteur, Lot # UH746AC, IM, Rt deltoid. 10/19/2012: Phone call to Primary provider. Complaint of numbness of hands and feet for the last week. Referred for lab work. 10/20/2012: Hospital, Emergency Dept. Evaluation for numbness for one week. CT Scan: Neg. Discharged. Felt better. 10/22/2012: Hospital, Emergency Dept. Back pain. LS films, Abd/Pelvic CT; Neg. Discharged with Lumbago. VICODIN. 10/23/2012: Primary care provider. Follow up back pain. Gabapentin prescribed. MRI ordered. 10/24/2012: Unable to do MRI due to pain. To Hospital ED C/O pain, numbness. Admitted with Guillain-Barre Syndrome. 11/5/12: Discharged to home. Remains out of work.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Computerised tomogram abdomen normal, Computerised tomogram normal, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: 10/1/2012: Seen by PCP with c/o sore throat. Strep test: GAS Neg. Treated with Amoxicillin 500mg TID. 10/18/2012: Received FLUZONE Smith and Pasteur, Lot # UH746AC, IM, Rt deltoid. 10/19/2012: Phone call to Primary provider. Complaint of numbness of hands and feet for the last week. Referred for lab work. 10/20/2012: Hospital, Emergency Dept. Evaluation for numbness for one week. CT Scan: Neg. Discharged. Felt better. 10/22/2012: Hospital, Emergency Dept. Back pain. LS films, Abd/Pelvic CT; Neg. Discharged with Lumbago. VICODIN. 10/23/2012: Primary care provider. Follow up back pain. Gabapentin prescribed. MRI ordered. 10/24/2012: Unable to do MRI due to pain. To Hospital ED C/O pain, numbness. Admitted with Guillain-Barre Syndrome. 11/5/12: Discharged to home. Remains out of work.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Spinal X-ray, Streptococcus test negative
Clinical narrative: 10/1/2012: Seen by PCP with c/o sore throat. Strep test: GAS Neg. Treated with Amoxicillin 500mg TID. 10/18/2012: Received FLUZONE Smith and Pasteur, Lot # UH746AC, IM, Rt deltoid. 10/19/2012: Phone call to Primary provider. Complaint of numbness of hands and feet for the last week. Referred for lab work. 10/20/2012: Hospital, Emergency Dept. Evaluation for numbness for one week. CT Scan: Neg. Discharged. Felt better. 10/22/2012: Hospital, Emergency Dept. Back pain. LS films, Abd/Pelvic CT; Neg. Discharged with Lumbago. VICODIN. 10/23/2012: Primary care provider. Follow up back pain. Gabapentin prescribed. MRI ordered. 10/24/2012: Unable to do MRI due to pain. To Hospital ED C/O pain, numbness. Admitted with Guillain-Barre Syndrome. 11/5/12: Discharged to home. Remains out of work.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Left forearm/thumb rash with mild pain. Seen for evaluation on 11/5/12 by physician and advised to start Valtrex if symptoms worsened.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Cough, Cyanosis, Dyspnoea, Heart rate increased, Intensive care
Clinical narrative: SOB, cough, watery eyes, wheezy, oral cyanosis. Rapid heart rate -> give 0.15 mg epinephrine admitted to ICU.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Lacrimation increased, Wheezing
Clinical narrative: SOB, cough, watery eyes, wheezy, oral cyanosis. Rapid heart rate -> give 0.15 mg epinephrine admitted to ICU.
Age: 0.51
Sex: F
Vaccine: DTPHEP, HIBV, IPV, PPV
Symptoms: Conjunctivitis infective, Crying, Irritability, Swelling face, Urticaria
Clinical narrative: Right half of face swelled and broke out in hives.  The white of the right eye turned solid pink.  Infant was extremely fussy and crying.  Unable to be consoled but only the right half (which was facing away from me initially) broke out.  Hives and the pink eye lasted for just over an hour.  Once she calmed down, I took a few pictures of the remaining hives.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscle spasms, Periarthritis
Clinical narrative: Case number PHEH2012US020843 is an initial spontaneous report received from a consumer on 16 Oct 2012. This case refers to a 69-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on an unspecified date sometime in late Oct 2011 or early Nov 2011. Within few days after vaccination she developed loss of range of motion and muscle spasm in her arm. She stated that she saw a physician and was diagnosed with frozen shoulder and muscle spasms approximately two weeks after vaccination. She also stated that one of the pharmacists in place where she was vaccinated told her the vaccine had preservative in it. The outcome was reported as unknown. No other information was available at the time of this report.
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Immediate post-injection reaction, Injection site streaking, Nausea
Clinical narrative: Case number PHEH2012US021060 is an initial spontaneous report received from a nurse on 15 Oct 2012. This case refers to a female patient of unspecified age. She was vaccinated with FLUVIRIN (batch number: 1204901, expiration date: May 2013) on 13 Oct 2012. She immediately experienced streaking at the injection site and then later in the face and abdomen. Then she experienced shortness of breath and chest pain. She also experienced rash and nausea. She was treated at hospital emergency room with BENADRYL and prednisone. Her symptoms dissipated after treatment. She was not treated in hospital overnight. The causality was not reported. No other information was available.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin disorder
Clinical narrative: Case number PHEH2012US021060 is an initial spontaneous report received from a nurse on 15 Oct 2012. This case refers to a female patient of unspecified age. She was vaccinated with FLUVIRIN (batch number: 1204901, expiration date: May 2013) on 13 Oct 2012. She immediately experienced streaking at the injection site and then later in the face and abdomen. Then she experienced shortness of breath and chest pain. She also experienced rash and nausea. She was treated at hospital emergency room with BENADRYL and prednisone. Her symptoms dissipated after treatment. She was not treated in hospital overnight. The causality was not reported. No other information was available.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Blood count abnormal, Laboratory test
Clinical narrative: Case number PHEH2012US023350, is an initial spontaneous report received from consumer (patient) on 26 Nov 2012. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 123124, expiry date: Jun 2013) on 09 Oct 2012. On 15 Nov 2012, about 10:00 PM, the patient went to the hospital emergency room where it was found that her blood count was 2000 (units not provided). She was immediately admitted to the hospital. She had numerous tests conducted but the results did not point to any other specific reason for this condition (details for the results were not reported). She was discharged from the hospital on 20 Nov 2012. The outcome, seriousness and causality of the event was not reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: Case number PHEH2012US023204 is an initial spontaneous report received from a consumer (she also a nurse) on 21 Nov 2012: this case refers to a 41-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: 20 Jun 2013) at dose of 0.5 ml intramuscularly on an unspecified date. On an unspecified date after vaccination, she experienced fever, chills, body aches, dizziness, pus on back of throat, runny nose, cough, sore throat and over all fever like symptoms. She was treated with ROCEPHIN and DECADRON shots. She also stated that, she was missed a day work, she felt like she couldn't breathe in the middle of the night, had still sick, fever of 103 F and extreme body aches and then she was treated with TAMIFLU. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Oropharyngeal pain, Pain, Pyrexia, Rash pustular
Clinical narrative: Case number PHEH2012US023204 is an initial spontaneous report received from a consumer (she also a nurse) on 21 Nov 2012: this case refers to a 41-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: 20 Jun 2013) at dose of 0.5 ml intramuscularly on an unspecified date. On an unspecified date after vaccination, she experienced fever, chills, body aches, dizziness, pus on back of throat, runny nose, cough, sore throat and over all fever like symptoms. She was treated with ROCEPHIN and DECADRON shots. She also stated that, she was missed a day work, she felt like she couldn't breathe in the middle of the night, had still sick, fever of 103 F and extreme body aches and then she was treated with TAMIFLU. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Case number PHEH2012US023204 is an initial spontaneous report received from a consumer (she also a nurse) on 21 Nov 2012: this case refers to a 41-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: 20 Jun 2013) at dose of 0.5 ml intramuscularly on an unspecified date. On an unspecified date after vaccination, she experienced fever, chills, body aches, dizziness, pus on back of throat, runny nose, cough, sore throat and over all fever like symptoms. She was treated with ROCEPHIN and DECADRON shots. She also stated that, she was missed a day work, she felt like she couldn't breathe in the middle of the night, had still sick, fever of 103 F and extreme body aches and then she was treated with TAMIFLU. The outcome, seriousness and causality of the events were not reported.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive, Polymerase chain reaction, Respiratory disorder
Clinical narrative: A report has been received from a physician concerning a child of unknown gender. No concomitant medication or relevant history was provided. During Nov-2012, the patient received nasal FLUMIST, 0.2 millilitres. The patient was admitted to hospital for acute respiratory illness and was tested for flu and some other organisms. The patient had a positive nasopharyngeal PCR test for flu B. According to the physician, the patient's symptoms were not consistent with flu. The outcome of the events of acute respiratory illness and nasopharyngeal PCR positive for flu B was unknown. The reporting physician assessed the events of acute respiratory illness and nasopharyngeal PCR positive for flu B to be serious due to hospitalization. Follow-up information received by AstraZeneca/MedImmune on 15-Nov-2012 from physician upgraded this case to globally expeditable: event of nasopharyngeal PCR positive for flu B updated to serious and serious event of acute respiratory illness added, reporter information updated, patient's age group added.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 24-year-old pregnant, female patient. It was reported, that patient had spotting and other problems (not specified) prior to vaccination with FLUMIST. Concomitant medications were not reported. FLUMIST was administered on 12-Oct-2012. The patient has already been pregnant when the vaccine was received. Start date of pregnancy, last menstruation date or any other details of the pregnancy was not provided. The reporting nurse assessed the patient on 25-Oct-2012 and her vital signs were stable and she was doing well. Three days after her visit (on 28-Oct-2012), the patient had a miscarriage. At the time of the reporting the outcome of the administration to pregnant female and miscarriage was unknown. According to the reporting health professional, the event of miscarriage was considered to be serious with the seriousness criteria of important medical event. Company physician assessed the event of administration to pregnant female to be serious due to important medical event criteria. Follow-up of insignificant information received by AstraZeneca/MedImmune on 24-Oct-2012 from health professional: LOT number and expiration date added for FLUMIST. Follow-up of insignificant information received by AstraZeneca/MedImmune on 07-Nov-2012 from health professional: reference number added, narrative updated. Follow-up information received by AstraZeneca/MedImmune on 14-Nov-2012 from health professional, upgraded this case to expeditable: New serious event (miscarriage), medical history and second reporter of health professional added. Narrative updated accordingly. Event of administration to pregnant female was upgraded from non-serious to serious (important medical event). Corrected report on 27-Nov-2012: Action taken amended to not applicable, and expiry date of FLUMIST to 03-Dec-2012.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, 5-6 liquid stools daily continuing for three weeks (this occurred after first dose at 2 months as well).
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching and erythema in administered arm.
Age: 27.0
Sex: M
Vaccine: ADEN_4_7, FLUN3, HEPAB, MNQ, TDAP, VARCEL
Symptoms: Grip strength decreased, Paraparesis, Paresis
Clinical narrative: MOTOR PARESIS OF BILATERAL LOWER EXTREMITIES AND BOTH HANDS- LIMITIED HAND GRIP.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia, Sleep disorder
Clinical narrative: Immense pain in Left Shoulder where injection was given, felt as if needle went into the shoulder bone, numbness and tingling to entire left arm. Ibuprofen 800 mg was taken and has been taken intermittently since date of shot. As of 11/29/12, still have pain at injection site, unable to life left arm to change clothes without pain 8-9 out of 10, unable to sleep on left side without pain in shoulder.
Age: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Muscle disorder, VIIth nerve paralysis
Clinical narrative: Bells palsy, muscle uncontrollable on right side of face. For 3 days.
Age: 25.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Fatigue, Paraesthesia oral
Clinical narrative: Within 5 min of immunizaiton, patient began complaining of strange feeling in throat, like it was hard to swallow, and then that her tongue felt enlarged/swollen.  A doctor was summoned and at the same time, patient complained of feeling light-headed and faint.  Patient was reclined and legs elevated.  Doctor examined and noted airway was patent with no signs of respiratory distress.  Pulse ox 100%, B/P 90/48, Pulse 55. (Patient stated she runs 4-5 miles/day and her pulse is usually in the 60's.  Doctor recommended transport to ER by ambulance.  Patient refused.  At 12:10 PM patient called her mother to come pick her up.  Continued to c/o light-headedness.  B/P 110/86.  Stated her throat and tongue were feeling "better".  At 12:30 PM she tried sitting up, took sips of water without difficulty and asked for something with sugar in it.  Stated she had worked all night and came straight from work to appointment.  Very tired and had last eaten at 8:00 AM (only applesauce).  Apple juice given. Tolerated well.  At 12:45, her mother arrived.  Mother stated she would take patient to ER.  At 12:55 PM patient's B/P 110-84, patient still complaining of slight light-headedness, but stated her throat and tongue feel better.  Patient released with her mother.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles around right side of waistline.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site reaction, Mobility decreased, Myalgia, X-ray limb normal
Clinical narrative: Muscle pain which was presumed normal for about a week but pain 8/10 persists to this day 11/29/2012. I cannot lift my arm from the shoulder to elbow without help, the deltoid muscle in the left arm is still extremely painful, I cannot lift anything with my arm or even get dressed, the intensity of the symptoms has been consistent and unchanged since the time of the vaccination, no doctor or PA can tell me anything and do not see anything as there has never been a black and blue mark over the muscle. I have tried Aleve, ibuprofen, Excedrin, Valium, robaxin, and oxycotin have only decreased the pain to a 5/10. As of right now I am still unable to use my arm which I need in order to work.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Noticed a red warm spot at the site if injection the size of a 50 cent piece.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, INDURATION, WARMTH, TENDERNESS AT LOCATION OF VACCINE - R UPPER ARM.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye infection, Nasopharyngitis, Rash
Clinical narrative: Patient claims she developed an infection in her eye and cold symptoms a few days after her flu shot - also a rash both on her scalp and below her eyes, and little bumps on the side of her head.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Erythema, swelling, hot to touch, stiffness, itching and pain at site.  Measures 150mm x 200mm today, but states it was bigger yesterday.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Erythema, swelling, hot to touch, stiffness, itching and pain at site.  Measures 150mm x 200mm today, but states it was bigger yesterday.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Apraxia, Autism, Childhood disintegrative disorder, Coordination abnormal, Hypotonia
Clinical narrative: A very large, red bump appeard on the leg where the vaccine was administered. It lasted like this for 6 months. The night of the vaccine, he was extremely irritable with a slight fever. Three months later, he was diagnosed with Sensory Processing Dysfunction, apraxia which affected his speech and body coordination, low muscle tone and autism with 60% learning delays. Prior to this vaccine, he had no learning delays and no physical delays. He met every newborn and baby milestone.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Learning disorder, Pyrexia
Clinical narrative: A very large, red bump appeard on the leg where the vaccine was administered. It lasted like this for 6 months. The night of the vaccine, he was extremely irritable with a slight fever. Three months later, he was diagnosed with Sensory Processing Dysfunction, apraxia which affected his speech and body coordination, low muscle tone and autism with 60% learning delays. Prior to this vaccine, he had no learning delays and no physical delays. He met every newborn and baby milestone.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Sensory integrative dysfunction, Speech disorder
Clinical narrative: A very large, red bump appeard on the leg where the vaccine was administered. It lasted like this for 6 months. The night of the vaccine, he was extremely irritable with a slight fever. Three months later, he was diagnosed with Sensory Processing Dysfunction, apraxia which affected his speech and body coordination, low muscle tone and autism with 60% learning delays. Prior to this vaccine, he had no learning delays and no physical delays. He met every newborn and baby milestone.
Age: 20.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Grand mal convulsion, Posture abnormal
Clinical narrative: Seizure- tonic clonic movements of entire body and abnormal posturing for 30 seconds.
Age: 1.1
Sex: F
Vaccine: FLUX, HEPA, MEA, PPV, VARCEL
Symptoms: C-reactive protein, Culture throat, Culture urine, Decreased appetite, Feeling hot
Clinical narrative: A rash appeared on neck, back, trunk, thighs, arms, palms and soles- maculopapular and spread to face, cheeks and forehead the next day). Child felt hot to warm for 5 days, getting Tylenol or Motrin for the ame once or twice a day, she was eating less than usual but drinking milk. On the 5th day of illness, she started spiking fevers regularly around the clock going up to 104.9 rectally on Day 6. Fever finally broke on day 9 of illness, the next morning she had a maculopapular rash from head to feet (not on palms and soles). The rash diappeared in 2-3 days. On day 17 of illness she started peeling around the fingernails which spread to the whole hand, after another week, she started peeling on the feet as well.
Age: 1.1
Sex: F
Vaccine: FLUX, HEPA, MEA, PPV, VARCEL
Symptoms: Full blood count, Pyrexia, Rash generalised, Rash maculo-papular, Red blood cell sedimentation rate
Clinical narrative: A rash appeared on neck, back, trunk, thighs, arms, palms and soles- maculopapular and spread to face, cheeks and forehead the next day). Child felt hot to warm for 5 days, getting Tylenol or Motrin for the ame once or twice a day, she was eating less than usual but drinking milk. On the 5th day of illness, she started spiking fevers regularly around the clock going up to 104.9 rectally on Day 6. Fever finally broke on day 9 of illness, the next morning she had a maculopapular rash from head to feet (not on palms and soles). The rash diappeared in 2-3 days. On day 17 of illness she started peeling around the fingernails which spread to the whole hand, after another week, she started peeling on the feet as well.
Age: 1.1
Sex: F
Vaccine: FLUX, HEPA, MEA, PPV, VARCEL
Symptoms: Skin exfoliation, Streptococcus test, Urine analysis
Clinical narrative: A rash appeared on neck, back, trunk, thighs, arms, palms and soles- maculopapular and spread to face, cheeks and forehead the next day). Child felt hot to warm for 5 days, getting Tylenol or Motrin for the ame once or twice a day, she was eating less than usual but drinking milk. On the 5th day of illness, she started spiking fevers regularly around the clock going up to 104.9 rectally on Day 6. Fever finally broke on day 9 of illness, the next morning she had a maculopapular rash from head to feet (not on palms and soles). The rash diappeared in 2-3 days. On day 17 of illness she started peeling around the fingernails which spread to the whole hand, after another week, she started peeling on the feet as well.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Oropharyngeal pain, Urticaria
Clinical narrative: Developed dyspnea, sore throat and hives all over with difficulty swallowing 2 hours after vaccines were given went to ER and treated for anaphylaxis.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Basophil percentage, Eosinophil percentage, Erythema, Lymphocyte percentage, Monocyte percentage increased
Clinical narrative: 11-19-12 1014/AM FLUZONE (not preservative free) administered left deltoid area. That evening, parent reports child had walnut size reddened area. 11-20-12 Reddened area 3 inch diameter - warm to touch. Taking BENADRYL. 11-21-12 Reddened area 3 inch x 4 inch today - warm to touch.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Neutrophil percentage, Skin warm, White blood cell count normal
Clinical narrative: 11-19-12 1014/AM FLUZONE (not preservative free) administered left deltoid area. That evening, parent reports child had walnut size reddened area. 11-20-12 Reddened area 3 inch diameter - warm to touch. Taking BENADRYL. 11-21-12 Reddened area 3 inch x 4 inch today - warm to touch.