chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to the patients of unknown age and gender. It was reported that 13 doses of GARDASIL (doses, units, patient route of administration, lot number were not reported) were improperly stored and administered to unspecified number of patients since 11-SEP-2014. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 14-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml subcutaneous (lot number and expiration date were not reported) that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus
Clinical narrative: Patient presented to a primary care office for a PNEUMOVAX-23 vaccination. A few minutes after administration, he developed redness and itching of both arms. Physician ordered the administration of SOLU-MEDROL 125 mg IM and BENADRYL 25 mg IM injection. The redness and itching resolved shortly after and he was able to leave the clinic with his wife.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-OCT-2014, the patients were vaccinated with improperly stored RECOMBIVAX HB, 0.5 ml, intramuscular. Co-suspect or concomitant therapies were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist via gabby form the patient assistant program on 10-NOV-2014 refers to a 51 year old male patient. The primary reporter was pharmacist. The pharmacist stated patient spoke with her colleague and reported an adverse event. On 29-OCT-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX vial 9lot # K008881, expiration date: 20-SEP-2015), subcutaneous in the left arm. On 30-OCT-2014, the patient had itchy, swelling, warmth, redness down the left arm, post vaccination with ZOSTAVAX. The patient was treated with over the counter BENADRYL. The patient also contacted his primary health care provider, but no other treatment listed. Pharmacist stated the patient's reaction lasted about 5 days. The outcome of events was reported as recovered/resolved on approximately 03-NOV-2014. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional on 14-NOV-2014 refers to unspecified patients. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) (lot #, expiration date and route unspecified) which had been exposed to temperature excursions that were supported, since the first temperature excursion on 28-OCT-2014. No adverse experiences had been observed or reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 4 patients of unknown demographics. The patients medical history and current conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (LOT# and expiry date not provided), 0.5 ml via intramuscular. On an unknown date the patient experienced improperly stored PNEUMOVAX (4 doses) have been administered to 4 patients and no adverse effects reported. Also reported that the pharmacist called to report the second temperature excursion and reported that improperly stored PNEUMOVAX 23 have been administered since first excursion. Product quality complaint was not involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Between July 2014 and August 2014, the unspecified number of patients were vaccinated with doses of VARIVAX (Merck) (dose, lot number, expiration date were not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Local reaction, Skin papilloma
Clinical narrative: Local reaction- warmth and erythema. Pt not given any tx on clinic 11/16 visit. Pt done c/u with Dr on 11/17/14. Unknown if PCP complete form.
Sex: F
Vaccine: HPV4
Symptoms: Embolism venous
Clinical narrative: Information has been received from the authors of an article, concerning 150 female patients who on an unknown date were vaccinated with a dose of Quadrivalent HPV (manufacturer unknown). Patient's outcomes were not reported. Methods: authors conducted a self-controlled case series analysis of venous thromboembolism (VTE) in six healthcare delivery systems. They identified potential VTEs among vaccinated women using coded inpatient and outpatient diagnoses from 2008 through 2011, and then manually reviewed them to confirm the diagnosis and collect risk factor (e.g., hormonal contraceptive, trauma, pregnancy) data. Study physicians adjudicated ambiguous cases. Observation time for each confirmed case was divided into exposed periods (7, 14, 28, 42, and 60 days following HPV4) and unexposed periods (the remainder of the observation period). They calculated the risk of VTE by dividing the incidence in exposure periods by the incidence in unexposed periods. Results: Authors identified 153 confirmed VTE cases in females 9-26 years of age who were exposed to HPV4 (manufacturer unknown) during the study period. Three VTE cases were identified in the 1-7 day period following HPV4 (manufacturer unknown) and the estimated relative risk in this period was 1.51 (95% confidence interval (Cl): 0.48-4.76). The risk estimate decreased with increasing exposure window length; the relative risk in the 1-60 day period following HPV4 (manufacturer unknown) was 0.95 (95% Cl: 0.55-1.62). In the 1-7 day exposure period the risk of VTE associated with HPV4 (manufacturer unknown) among hormonal contraceptive users was 0.88 (95% Cl: 0.12-6.35) compared to 2.44 (95% Cl: 0.59-10.12) among non-users. Conclusions: Authors did not observe a statistically significant increased risk of VTE in the 60 days following HPV4 (manufacturer unknown) exposure in young women. Statistical power was limited for examining potential effect modification by hormonal contraceptive use. The authors considered that venous thromboembolism was related to Quadrivalent HPV (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This report is linked to MARRS 1410USA007541, same literature report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K003408, expiration date 16-MAR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant concerning an 14 year old patient of unknown gender. Medical history or concurrent conditions were not reported. On 21-AUG-2014, the patient was vaccinated with improperly stored GARDASIL, (Lot number K001500; Expiration date: 16-NOV-2016) (dose, frequency, strength not provided). Co-suspect or concomitant therapies were not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant concerning an 11 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 21-AUG-2014, the patient was vaccinated with improperly stored GARDASIL, (Lot number K001500; Expiration date: 16-NOV-2016) (dose, frequency, strength not provided). Co-suspect or concomitant therapies were not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Local reaction to DTaP / upper Rt arm. 3 x 2.5 cm erythematous, warm induration treated with TYLENOL every 4 hours and Prednisolone daily for 4 days successfully.
Age: 0.2
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 month old female patient. The nurse reported that the patient missed her dose of RECOMBIVAX HB on 14-NOV-2014 since patient was inadvertently administered VAQTA (lot#, dose, route not reported, on 14-NOV-2014) instead of RECOMIVAX HB. RECOMBIVAX HB was not administered. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot# was not reported). Nurse reported the vaccine administered were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to 4 unspecified patients of unknown age and gender. On 11-NOV-2014 the patients were vaccinated with PEDVAXHIB, (lot#, dose, dose# and route unspecified) that were exposed to temperature outside the proper storage range. No adverse effect reported. The outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Injection site pain
Clinical narrative: Painful area left thigh around injection site 4cm in diameter area of erythema treated on 11/5/14 at emergency room with rx AUGMENTIN. Followed up at MD office 11/11/14 with provider and symptoms resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: A few weeks after vaccine pt developed a rash on her shoulders and this week she has one on her stomach.  She believes these to be from the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: A few weeks after vaccine pt developed a rash on her shoulders and this week she has one on her stomach.  She believes these to be from the vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased
Clinical narrative: Initial unsolicited report received on 10 November 2014 from a pharmacist. A 51-year-old female patient had received an intramuscular dose of FLUZONE (Batch number UI198AE) in the left arm on 05 November 2014. She had a history of latex allergy. No illness was identified at time of vaccination. She had received previous doses of FLUZONE in the past. On 05 November 2014, immediately after vaccination, the patient's legs and body felt numb. Her heart rate increased, blood pressure was 205/105. "911" was called, and the patient was transported to the Emergency Room via ambulance. Corrective treatment, complementary investigations, concomitant medications were not reported. The patient recovered from the events on an unspecified date. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Initial unsolicited report received on 10 November 2014 from a pharmacist. A 51-year-old female patient had received an intramuscular dose of FLUZONE (Batch number UI198AE) in the left arm on 05 November 2014. She had a history of latex allergy. No illness was identified at time of vaccination. She had received previous doses of FLUZONE in the past. On 05 November 2014, immediately after vaccination, the patient's legs and body felt numb. Her heart rate increased, blood pressure was 205/105. "911" was called, and the patient was transported to the Emergency Room via ambulance. Corrective treatment, complementary investigations, concomitant medications were not reported. The patient recovered from the events on an unspecified date. Documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Bursa disorder, Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain
Clinical narrative: On 11/18/14 received a phone call from patient who reported intermittent left shoulder discomfort starting one to two days after she received flu shot on 10/30/14. Patient reports increasing (L) shoulder pain past 2 1/2 weeks and some loss of function, ie. difficulty dressing, lifting arm and exercising. Patient had not contacted her physician or had a doctor visit. Nurse instructed patient to call/see MD today (11/18/14) for medical evaluation. Patient stated she would.
Age: 45.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Activities of daily living impaired, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: On 11/18/14 received a phone call from patient who reported intermittent left shoulder discomfort starting one to two days after she received flu shot on 10/30/14. Patient reports increasing (L) shoulder pain past 2 1/2 weeks and some loss of function, ie. difficulty dressing, lifting arm and exercising. Patient had not contacted her physician or had a doctor visit. Nurse instructed patient to call/see MD today (11/18/14) for medical evaluation. Patient stated she would.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Biopsy, Blood test, Chest wall mass, Computerised tomogram, Ear pain
Clinical narrative: Pain in left ear, swelling in left ear with growths in the ear, neck, chest, heart and groin area.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Ear swelling, Mass, Neck mass, Positron emission tomogram
Clinical narrative: Pain in left ear, swelling in left ear with growths in the ear, neck, chest, heart and groin area.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Activities of daily living impaired, Diarrhoea, Hypersensitivity, Pyrexia, Rash erythematous
Clinical narrative: Fever of 102° and a rash all over his body. It is very itchy and some spots are redder than others and also diarrhea. Gave ibuprofen for fever and was sent home from school on 11/18/14 for the rash. Took to the MD on 11/18/14 and she said it was a allergic reaction to the MMR vaccine.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Fever of 102° and a rash all over his body. It is very itchy and some spots are redder than others and also diarrhea. Gave ibuprofen for fever and was sent home from school on 11/18/14 for the rash. Took to the MD on 11/18/14 and she said it was a allergic reaction to the MMR vaccine.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Testicular swelling
Clinical narrative: Large swelling on the arm injection was given. Red, itchy, and painful. About the size of a small fist. Was advised by doctor to take allergy medicine (like Benadryl) as she felt given the description I had given her I was having an allergic reaction. Advised to keep an eye out but felt arm would be back to normal within a day or two.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Itching - severe for 3 days then lighter for each day thereafter - intensifies in the evening.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Hypersensitivity, Induration, Pain, Pharyngeal oedema
Clinical narrative: Swelling large oversized, itchy, red, hard n sore. Friday 11/14/14 ended up in emergency room throat swelling shut.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling large oversized, itchy, red, hard n sore. Friday 11/14/14 ended up in emergency room throat swelling shut.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Pallor, Presyncope
Clinical narrative: Patient receivrd HPV immunization and within 10 minutes became very faint, pale and weak and had near syncopal episode while exiting the waiting room. Was returned back to the patient room, laid down and applied cool compress to face. Was assessed by nurse and Dr. Patient remained supine for about 15 minutes until feeling better. Was able to ambulate out of office without help accomanied by father.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Local swelling, Nausea, Pyrexia
Clinical narrative: Pt received PNEUMOVAX and AFLURIA in the afternoon of 11/14/14. The next day she woke up with a swollen arm, a fever of 102 degrees F, feeling fatigued and nauseated. She contacted her PCP and has been taking regular BENADRYL. Today (11/18/14) her arm is still swollen but she is feeling better, jut tired from the BENADRYL.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Multiple sclerosis relapse, Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history included multiple sclerosis. On an unspecified date in September 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route unspecified). On an unspecified date in 2014, after receiving the vaccine, the patient experienced a flare up of her multiple sclerosis. The patient sought medical attention via contacting pharmacist. The outcome of the event "a flare up of her multiple sclerosis" was unknown. Follow up information has been received from reporting pharmacist on 14-NOV-2014. The patient details updated. The pharmacist reported that the patient, received ZOSTAVAX on 07-JUL-2014 (previously reported as unspecified date of September 2014). She stated that a few days after that the patient called the pharmacy reporting a "big rash" at the injection site. The pharmacist reported that the patient does have multiple sclerosis, but that she was not taking any immunosuppressant around the time of administration of ZOSTAVAX. The pharmacist stated that at some point after administration of the ZOSTAVAX, on an unspecified date, the patient was hospitalized at an unspecified hospital for "a flare up of her multiple sclerosis" (HOSPITALISATION). The pharmacist stated that she did not know what symptoms the patient was experiencing, but that the patient did mention "respiratory problems" to her. It is unspecified how the patient was treated during her hospital stay. She stated that the patient was discharged from the hospital and has recovered at this point. Causality of the reported events was unknown (not provided). No further information provided. The pharmacist stated that she has already filed a Vaccine Adverse Event Reporting System (VAERS) form on the website. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Multiple sclerosis relapse
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history included multiple sclerosis. On an unspecified date in September 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route unspecified). On an unspecified date in 2014, after receiving the vaccine, the patient experienced a flare up of her multiple sclerosis. The patient sought medical attention via contacting pharmacist. The outcome of the event "a flare up of her multiple sclerosis" was unknown. Follow up information has been received from reporting pharmacist on 14-NOV-2014. The patient details updated. The pharmacist reported that the patient, received ZOSTAVAX on 07-JUL-2014 (previously reported as unspecified date of September 2014). She stated that a few days after that the patient called the pharmacy reporting a "big rash" at the injection site. The pharmacist reported that the patient does have multiple sclerosis, but that she was not taking any immunosuppressant around the time of administration of ZOSTAVAX. The pharmacist stated that at some point after administration of the ZOSTAVAX, on an unspecified date, the patient was hospitalized at an unspecified hospital for "a flare up of her multiple sclerosis" (HOSPITALISATION). The pharmacist stated that she did not know what symptoms the patient was experiencing, but that the patient did mention "respiratory problems" to her. It is unspecified how the patient was treated during her hospital stay. She stated that the patient was discharged from the hospital and has recovered at this point. Causality of the reported events was unknown (not provided). No further information provided. The pharmacist stated that she has already filed a Vaccine Adverse Event Reporting System (VAERS) form on the website. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Had red streak on right arm where vaccines were administered. Was given Benadryl to alleviate AE.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram, Fall, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient became dizzy and lightheaded after receiving the immunization.  Patient was sitting in exam room chair when he fell over and became unresponsive.  He quickly regained conciousness.  Vital signs and oxygen saturations were monitored.  Patient reported that he had not eaten since early in the morning when he ate one bowl of cereal.  Juice and crackers offered and patient tolerated them without difficulty.  Patient stable at time of release.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Influenza like illness, Middle insomnia, Pyrexia
Clinical narrative: Fever, chills, flu-like symptoms. Middle of the night (4 AM) woke with rapid heart rate.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, itchy area around site of injection.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored ROTATEQ (lot# and expiration date not provided) (dose not reported), orally by default. No adverse effects were reported. This is one several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Condition aggravated, Immediate post-injection reaction, Postural orthostatic tachycardia syndrome
Clinical narrative: Pt has probable POTS which worsened immediately after receiving flu and HPV #3.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Rash pruritic
Clinical narrative: Patient states he has an itchy rash on both arms and legs that started after receiving the vaccine. He had an appointment with his doctor but canceled because it was getting better with hydrocortisone cream. Patient says it is worse now and the itching keeps him up at night. He says he will follow up with his doctor tomorrow.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV4, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female patient. On 23-OCT-2014, the patient was vaccinated with GARDASIL lot # K004205, expiration date 12-JAN-2017, 0.5 ml, intramuscularly. Concomitant therapies included meningococcal vaccine (unspecified), tuberculin purified protein derivative and 2 unspecified medications, TDAP, reported as KEYDAP and unspecified flu vaccine (Influenza virus vaccine), reported as BLUE vaccine. On 23-OCT-2014, 5 min after being vaccinated with GARDASIL, the patient fainted. The patient was in a sitting position and her head went back as she fainted. The GARDASIL was the last vaccine that was given that day. No other symptoms were reported. The patient did not seek medical attention. No treatment was given. The outcome of fainting was unknown. The relatedness between fainting and GARDASIL was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 76 year old female patient. The patient's current condition reported as allergic reaction to antibiotics (reported as CIPRO). On 04-SEP-2013, the patient was vaccinated with the dose of ZOSTAVAX (route intramuscular, lot/batch #1621628-04397, dose not reported). Lot number 1621628-04397 is an invalid lot number for ZOSTAVAX. Concomitant therapies included lithium, gemfibrozil, tretinoin, DITROPAN, levothyroxine sodium (manufacturer unknown), DEXILANT and LEXAPRO. On unspecified date in October 2014, the patient experienced outbound of shingles on lower thoracic and chest (disability and intervention required). The patient required emergency room visit. The outcome of outbound of shingles was not reported. The relatedness between the event and to ZOSTAVAX was not provided. The event, outbound of shingles, was considered to be medically significant by reporter due to requirement of medically or surgical intervention to prevent of the serious criterion. The event, outbound of shingles, was considered to be disabling and medically significant by reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Breast swelling, Muscular weakness, Oedema peripheral, Pain in extremity
Clinical narrative: Pain in armpit, swelling in the arm pit area with some swelling on side of breast, weakness in arm, pain in arm. Called clinic, told to take Tylenol and Motrin staggered, ice pack for swelling.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was very swollen and warm. Gave Motrin and Tylenol to help with discomfort. Pt does have egg allergies. She is able to eat eggs fine but every year her reaction to this vaccine gets more swollen and red. Injection was also given incorrectly, not in deltoid but about half way down her arm.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Insomnia, Pain
Clinical narrative: Excruciating pain, no range of motion, could not sleep at all, shivering from pain, took Tylenol to no avail, applied ice and heat to no avail.
Age: 17.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Exposure during pregnancy, Pyelonephritis, Ultrasound scan abnormal
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician, refers to an approximately 16 year old female patient. Patient's current condition included pyelonephritis for which she had been treated in the past. On 07-NOV-2014 the patient was vaccinated with GARDASIL dose 3. The patient received her first dose of GARDASIL on 22-FEB-2010 and second dose of GARDASIL on 22-AUG-2013. Other suspect therapies included hepatitis A virus vaccine (unspecified) and influenza virus vaccine (unspecified), administered on 07-NOV-2014. Concomitant medication included unspecified birth control. Patient sought medical attention on 10-NOV-2014, she was hospitalized for pyelonephritis (hospitalization, disability) and was discovered to be pregnant by ultrasound upon admission to hospital. The patient became pregnant with last menstrual period (LMP) of 09-AUG-2014 and estimated delivery date (EDD) of 16-MAY-2015. Initial exposure to GARDASIL was at 13 week(s). Physician stated that the patient was currently disabled and incapacitated because she was receiving unspecified intravenous pain medication and unspecified antibiotic as treatment. The physician agreed to be contacted for further information on the patient's hospitalization. Outcome of the events was not reported. The pregnancy outcome was outcome pending. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: After having the Afluria 2014-15 injection, I had a shingles outbreak on my rear left shoulder near where I have had shingles in the past.  I have now had shingles 4 times and had the shingles vaccine a couple years ago.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm pain.  Which I still have 5 weeks after shot.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Rash started on forehead, spread to face, head, neck, chest and back by late afternoon.  Runny nose began 3 days previously (11/15/2014) and fever from 11/9/2014-11/11/2014.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye swelling, Lip swelling, Nasal congestion, Oral pruritus
Clinical narrative: Coughing, itchy mouth, swollen and tingling lips, swollen eyes, blocked nasal passages. Symptoms improved somewhat about one hour after taking Benadryl. Three doses of Benadryl required.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia oral
Clinical narrative: Coughing, itchy mouth, swollen and tingling lips, swollen eyes, blocked nasal passages. Symptoms improved somewhat about one hour after taking Benadryl. Three doses of Benadryl required.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Rash, Urticaria
Clinical narrative: About an hour after immunization, patient broke out in hives all over her body (redness and tiny bumps) and the following morning woke up with swollen eyes.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAS A RED SWOLLEN WARM SPOT AT SITE OF LOCATION.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Ocular hyperaemia, Pharyngeal oedema, Sensation of foreign body
Clinical narrative: At night, throat felt swollen as if she had a lump in it.  Next morning, also had red, puffy eyes and throat still felt as if it was swelling; was concerned that if it continued, she would have difficulty breathing.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Depressed level of consciousness, Headache, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Initially headache and injection site inflammation, but by 3:00 PM the day after vaccination, I was experiencing muscle ache and chills. By 7:00 I was experiencing muscle weakness, nausea, joint stiffness. By 9:00 PM when I got up from lying down I felt like I might pass out and had to lie down on the floor. This happened again later when I went to use the bathroom. By 8:00 AM things had subsided and I was back to having a headache/neckache with pain at the injection site w/ redness about the size of a tennis ball. The nausea lasted much of that day. By Monday 11/17 I was feeling much better with just injection site sensitivity and redness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Joint stiffness, Muscular weakness, Myalgia
Clinical narrative: Initially headache and injection site inflammation, but by 3:00 PM the day after vaccination, I was experiencing muscle ache and chills. By 7:00 I was experiencing muscle weakness, nausea, joint stiffness. By 9:00 PM when I got up from lying down I felt like I might pass out and had to lie down on the floor. This happened again later when I went to use the bathroom. By 8:00 AM things had subsided and I was back to having a headache/neckache with pain at the injection site w/ redness about the size of a tennis ball. The nausea lasted much of that day. By Monday 11/17 I was feeling much better with just injection site sensitivity and redness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Neck pain
Clinical narrative: Initially headache and injection site inflammation, but by 3:00 PM the day after vaccination, I was experiencing muscle ache and chills. By 7:00 I was experiencing muscle weakness, nausea, joint stiffness. By 9:00 PM when I got up from lying down I felt like I might pass out and had to lie down on the floor. This happened again later when I went to use the bathroom. By 8:00 AM things had subsided and I was back to having a headache/neckache with pain at the injection site w/ redness about the size of a tennis ball. The nausea lasted much of that day. By Monday 11/17 I was feeling much better with just injection site sensitivity and redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, and raised to Rt. thigh injection sites. On 11/19/2014 Dr. ordered antibiotic with office visit.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Headache, Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: My daughter passed out, and while passing out was shaking/trembling, a few seconds after given the HPV Vaccine (Gardasil).  Had terrible headaches afterwards.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort
Clinical narrative: Left shoulder discomfort.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site pain, Injection site swelling, Local reaction, Vomiting
Clinical narrative: Local reaction, pain and swelling in the arm, and episode of vomiting.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Following the flu shot, in the left arm, for the next 48 hours, the upper left quarter was so painful that I could not move my arm or even breath without pain. There were no other symptoms - no temp, no nausea, etc.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Right upper arm with 60 cm area of erythema, mildly induration increased warmth. Got Tdap 11/8/14 came in on 11/17/14 after 4 days of vaccination. Came in today 11/19/14 put her on antibiotics.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient experienced muscle pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients of unknown age and gender. It was reported that 13 doses of ROTATEQ (doses and units were not reported) were improperly stored and administered to unspecified number of patients since 11-SEP-2014. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Local reaction, Local swelling
Clinical narrative: Cellulitis of (L) arm (localized redness/swelling) given KEFLEX 3 x/day for 7 days.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Inappropriate schedule of drug administration, Measles post vaccine, Nasopharyngitis, Pyrexia, Rash generalised
Clinical narrative: My daughter had a rash on her legs that looked like a burn. I treated with cortisone and she awoke in the morning with no rash. Then, as the week went on she developed a cold like symtoms. I had her seen at after hours clinic and they treated her as a Upper Respiratory Infection. She had a high fever that I needed to use motrin and Tylenol to control. Finally fever broke, and the next morning she was covered in a rash head to toe, sores in her mouth. I took her to Urgent Care facility and the doctor asked immediately ifshe had her MMR or had been exposed to Measles. She was diagnosed with the Measles on 11/18/14. He left us to watch for repiratory symtoms and keep her hydrated. And he said it will take 3-5 days to clear up. She is still covered fully today, but this would only be day two.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Stomatitis, Upper respiratory tract infection
Clinical narrative: My daughter had a rash on her legs that looked like a burn. I treated with cortisone and she awoke in the morning with no rash. Then, as the week went on she developed a cold like symtoms. I had her seen at after hours clinic and they treated her as a Upper Respiratory Infection. She had a high fever that I needed to use motrin and Tylenol to control. Finally fever broke, and the next morning she was covered in a rash head to toe, sores in her mouth. I took her to Urgent Care facility and the doctor asked immediately ifshe had her MMR or had been exposed to Measles. She was diagnosed with the Measles on 11/18/14. He left us to watch for repiratory symtoms and keep her hydrated. And he said it will take 3-5 days to clear up. She is still covered fully today, but this would only be day two.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Cough, Injection site rash, Lacrimation increased, Measles post vaccine, Nasopharyngitis
Clinical narrative: My daughter had a rash on her legs that looked like a burn. I treated with cortisone and she awoke in the morning with no rash. Then, as the week went on she developed a cold like symtoms. I had her seen at after hours clinic and they treated her as a Upper Respiratory Infection. She had a high fever that I needed to use motrin and Tylenol to control. Finally fever broke, and the next morning she was covered in a rash head to toe, sores in her mouth. I took her to Urgent Care facility and the doctor asked immediately ifshe had her MMR or had been exposed to Measles. She was diagnosed with the Measles on 11/18/14. He left us to watch for repiratory symtoms and keep her hydrated. And he said it will take 3-5 days to clear up. She is still covered fully today, but this would only be day two.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Ocular hyperaemia, Pyrexia, Rhinorrhoea
Clinical narrative: My daughter had a rash on her legs that looked like a burn. I treated with cortisone and she awoke in the morning with no rash. Then, as the week went on she developed a cold like symtoms. I had her seen at after hours clinic and they treated her as a Upper Respiratory Infection. She had a high fever that I needed to use motrin and Tylenol to control. Finally fever broke, and the next morning she was covered in a rash head to toe, sores in her mouth. I took her to Urgent Care facility and the doctor asked immediately ifshe had her MMR or had been exposed to Measles. She was diagnosed with the Measles on 11/18/14. He left us to watch for repiratory symtoms and keep her hydrated. And he said it will take 3-5 days to clear up. She is still covered fully today, but this would only be day two.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Urticaria starting 4 hours after vaccine administration. Large hives covering all four extremities, chest, and back. Urticaria continued for 7 days. Treated with Benadryl every 4-6 hours 3.5ml.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Injection site rash, Irritability, Rash, Rash erythematous
Clinical narrative: Patient woke up with a rash that started on her legs where the vaccines had been given. The rash spread to her trunk and some on her face. Some of the spots were big and red, looking like hives. The rash did not seem to be itchy. Patient had a temp of 100.3 and was fussy. No difficulties breathing or swallowing. Mom instructed to give a one time dose of Benadryl. Follow-up phone call later that afternoon, patient was feeling better and rash was resolving.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Patient woke up with a rash that started on her legs where the vaccines had been given. The rash spread to her trunk and some on her face. Some of the spots were big and red, looking like hives. The rash did not seem to be itchy. Patient had a temp of 100.3 and was fussy. No difficulties breathing or swallowing. Mom instructed to give a one time dose of Benadryl. Follow-up phone call later that afternoon, patient was feeling better and rash was resolving.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Convulsion, Cyanosis, Laboratory test normal, Loss of consciousness, Respiratory arrest
Clinical narrative: Lost consciousness, turned blue, stopped breathing, 2 seizures, projectile vomit. She was put on oxygen and transported via ambulance to ER for further testing. All testing came out normal.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Vomiting projectile
Clinical narrative: Lost consciousness, turned blue, stopped breathing, 2 seizures, projectile vomit. She was put on oxygen and transported via ambulance to ER for further testing. All testing came out normal.
Age: 10.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Cyanosis, Loss of consciousness, Respiratory arrest
Clinical narrative: Lost consciousness, stopped breathing, turned blue.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Activities of daily living impaired, Diarrhoea, Disorientation, Disturbance in attention
Clinical narrative: Stayed home sick from work (1 day so far). Local deltoid/arm pain, moderate; fatigue/tired, severe; fever, mild (~99.5F); gastrointestinal upset - moderate nausea, mild diarrhea, constant burping; disorientation, mild (could be just the severe fatigue); problems focusing and problems with attention, severe. Time course: arm pain started last night. All other symptoms: as of when I got up ~7:30 AM today to present time(~12:40 PM). Treatment: 4 ibuprofen last night, called in sick to work today 1 day so far, rest/nap/sleep, minimal food, probably another dose of ibuprofen.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Eructation, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Stayed home sick from work (1 day so far). Local deltoid/arm pain, moderate; fatigue/tired, severe; fever, mild (~99.5F); gastrointestinal upset - moderate nausea, mild diarrhea, constant burping; disorientation, mild (could be just the severe fatigue); problems focusing and problems with attention, severe. Time course: arm pain started last night. All other symptoms: as of when I got up ~7:30 AM today to present time(~12:40 PM). Treatment: 4 ibuprofen last night, called in sick to work today 1 day so far, rest/nap/sleep, minimal food, probably another dose of ibuprofen.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Immediate post-injection reaction, Injection site pain, Neck pain
Clinical narrative: Immediate left upper arm pain.  As arm pain worsened she began having left neck and left upper back pain. Seen in ER on 10/25/14. Given Solu Medrol, pain meds, anti inflammatory meds and muscle relaxers.  Has since been treated with Depo Medrol. Physical therapy has been ordered.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Asthenia, Blood pressure decreased, Respiratory rate increased, Tremor
Clinical narrative: Approximately 2 hr. after vaccine given, she experienced sudden onset of weakness, rapid breathing, shakiness, anxiousness. Given IM BENADRYL, combined IV of HS bolus and oxygen. Initially room air ox 81%; rose with O2. BP was decreased; rose with treatment.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site oedema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Initial spontaneous report received on 07 November 2014 from a physician who is the patient's parent. An 8 year old male patient with a history of seasonal allergies and allergy to dogs and cats was vaccinated intramuscularly in October 2013 with INFLUENZA QUADRIVAL, batch and site not reported. At an unspecified time the patient began having symptoms at the injection site of swelling; skin was thick, indurated and hot to touch. He was seen by a physician and was prescribed antibiotics. An x-ray on an unspecified date showed fluid and edema at the injection site. The symptoms progressed and in 2-3 days the swelling was over the elbow. The entire arm became swollen from his shoulder to wrist. The patient was hospitalized on an unspecified date for approximately 4 days. On 06 November 2014, the patient received a half dose of INFLUENZA QUADRIVAL, batch, route and site of administration were not reported and the same symptoms occurred, but not as pronounced. The swelling at the injection site occurred within 2 hours of vaccination. The patient's pediatrician contact information and hospital information for 2013 was provided. The patient received FLUMIST, in 2011 and 2012 without a reaction. The patient outcome is not recovered. Documents held by sender: None.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Local swelling, Skin hypertrophy, X-ray limb abnormal
Clinical narrative: Initial spontaneous report received on 07 November 2014 from a physician who is the patient's parent. An 8 year old male patient with a history of seasonal allergies and allergy to dogs and cats was vaccinated intramuscularly in October 2013 with INFLUENZA QUADRIVAL, batch and site not reported. At an unspecified time the patient began having symptoms at the injection site of swelling; skin was thick, indurated and hot to touch. He was seen by a physician and was prescribed antibiotics. An x-ray on an unspecified date showed fluid and edema at the injection site. The symptoms progressed and in 2-3 days the swelling was over the elbow. The entire arm became swollen from his shoulder to wrist. The patient was hospitalized on an unspecified date for approximately 4 days. On 06 November 2014, the patient received a half dose of INFLUENZA QUADRIVAL, batch, route and site of administration were not reported and the same symptoms occurred, but not as pronounced. The swelling at the injection site occurred within 2 hours of vaccination. The patient's pediatrician contact information and hospital information for 2013 was provided. The patient received FLUMIST, in 2011 and 2012 without a reaction. The patient outcome is not recovered. Documents held by sender: None.