chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.91
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 22 month old patient. Unknown gender. On 30-APR-2013 the patient was vaccinated with VARIVAX (Merck) (dose 5 ml, lot number 670255/0416AA, expiration date 22-APR-2011 (reported as expiration date 16-MAR-2013) subcutaneous for prophylaxis. There were no concomitant medication reported. Nurse reported that the patient received an unexpired dose of VARIVAX (Merck). Nurse stated that she was unsure whether this is the patient's first or second dose. No adverse effects reported. On 30-APR-2013, 1 day after onset of therapy the patient experienced received an expired dose of VARIVAX. The outcome of received an expired dose of VARIVAX is unknown. The reporter considered received an expired dose of VARIVAX to be not related to VARIVAX (Merck). Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX given to 4 month old no symptoms indicated. Pt doing well. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Swollen, red splotchy right arm, hot to touch, and child complained of itchiness and pain. ER physician prescribed antibiotic and motrin- diagnosed cellulitis based on visual inspection. Arm got worse turned purple, more swelling and area affected spread from shoulder to mid forearm. Went back to ER said spreading was expected and FU with Pediatrician. Pediatrician said reaction to Dtap vaccine not cellulitis.  Continuing on antibiotic treatment, Motrin, and added Benadryl in case of allergic reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pain, Pruritus, Rash macular
Clinical narrative: Swollen, red splotchy right arm, hot to touch, and child complained of itchiness and pain. ER physician prescribed antibiotic and motrin- diagnosed cellulitis based on visual inspection. Arm got worse turned purple, more swelling and area affected spread from shoulder to mid forearm. Went back to ER said spreading was expected and FU with Pediatrician. Pediatrician said reaction to Dtap vaccine not cellulitis.  Continuing on antibiotic treatment, Motrin, and added Benadryl in case of allergic reaction.
Age: 0.32
Sex: F
Vaccine: DTAP, IPV, RVX, UNK
Symptoms: Crying, Fluid intake reduced, Insomnia, Screaming, Sleep disorder
Clinical narrative: Intense crying, high-pitched screaming that did not stop for approximately 4 hours. She refused to breastfeed or drink from a bottle for several days. Sleep was severely disturbed for approximately one week. At almost one year later, sleep has still not regulated. Sleep patterns were 4-6 hours at a time. During reaction, patient did not sleep for more than 30 minutes each time, never more than four hours total per night. Current sleep pattern is approximately two hours at a time, ten hours per day/night. Within two weeks of the vaccinations, mother had to eliminate several foods from the diet because of intolerances in the child. Dr. sorry excuse for "treatment" was to let the child cry-it-out and give her rice cereal.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count normal, Injection site cellulitis, Irritability, Pyrexia
Clinical narrative: Fever 101 to 102.5 5/7 -5/8 fussiness cellulitis to left upper thigh.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever 100 to 100.5, fussy.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Disability, Immobile, Joint swelling, Pain
Clinical narrative: Knee swelling then swelling of other joints followed by severe pain & immobility. Hoping disablility will not be permanent but has now been going on for several months.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Developed a fever suddenly and then had a seizure which lasted about 5 minutes and was tonic-clonic.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Neurological symptom
Clinical narrative: PT HAD A DEALYED REACTION. FEVER FOR 7 DAYS AND THEN NEUROLOGICAL SYMPTOMS. Seeing Specialist Physician for treatment.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Nodule
Clinical narrative: STARTED WITH REDNESS TO THE AREA, GAVE BENADRYL LAST NIGHT.  WOKE UP THIS MORNING WITH A KNOT.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called office at ~12:50 stating she was having a reaction to the pneumococcal vaccine, possibly an allergic reaction. She stated the arm where injection was given was swollen and itchy. She denied SOB or chest pain. At that time, she was instructed to take Benadryl and come in if desired. She came to the office this afternoon at about 14:00 with localized swelling around the injection site, approx. 6-7 inches in diameter. The skin is raised and has red edges. The swelling has increased in size since her initial call, but is limited to the injection site only. Patient was given cold compresses to apply to site and a dose of Diphenhydramine 25 mg PO liquid. She was also instructed to take OTC ibuprofen for discomfort. This is her second dose of the pneumococcal vaccine. Her first was in 2006; the manufacturer of that dose is unknown. She was given Pneumovax-23 subcutaneously today; that information is logged into the State Registry of Immunization Transactions and Services. The patient is to follow up with us later today.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Erythema, Myalgia, Oedema peripheral, Palpitations
Clinical narrative: Swelling of arm and sore muscle, red, and hot. Hives, rash, fever in arm heart race dizziness 5/14/13 7:30PM.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Swelling of arm and sore muscle, red, and hot. Hives, rash, fever in arm heart race dizziness 5/14/13 7:30PM.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema(5 x 5cm) and swelling (2 x 2cm) at site;  ice pack applied.  MOC instructed to intermittently apply ice pack on 5-10 minute, off 5-10 minutes. Go to urgent care for dyspnea, or if swelling spreads rapidly.  Call for questions.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, MEN
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/shoulder pain since day post injection.
Age: 5.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Dysarthria, Rash, Rash erythematous
Clinical narrative: Pt mother called and reported softball size rash to (L) leg and red rash to neck and pt is slurring her words. Stated she just noted these s/s today. Was told to take child to ER.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Injection site rash
Clinical narrative: Local injection site rash occurred 1 and 2 days post-injection. Also reported shortness of breath. Nurse advised patient to visit ER. ER doctor prescribed prednisone 40mg daily x 4 days. Provider to follow up.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt was given MENACTRA at office visit. Came in 24 hours later with redness, swelling at site.
Age: 0.26
Sex: M
Vaccine: PNC13
Symptoms: Dry skin, Eczema, Rash generalised
Clinical narrative: Full body rash that turned into dry skin similar to eczema.
Age: 0.76
Sex: F
Vaccine: HIBV
Symptoms: Induration, Injection site necrosis, Rash erythematous
Clinical narrative: Pt has 1cm fatty necrosis noted to (R) thigh. Mom reported to Dr. at this visit pt had an induration with a few small red bumps around site a few days after the injection was given. No treatment or visit was done since vaccination given. No report of reaction til this visit.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: Welts on back, buttocks, (L) neck pain radiated to Rt. side and swollen. (L) arm pain. Saw PCP for follow-up.
Age: 54.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Heat rash, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Pt started to itch on arms, legs, chest while driving home; "red bumps" resembling "heat rash" and "welts" "no bigger than fingernail" on chest; pt took BENADRYL.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Dysphagia, Poor quality sleep, Respiratory disorder, Throat tightness
Clinical narrative: Patient states that his throat closed up, tonsils swollen, hard to swallow and aggravated his respiratory system and joint pain. Restless to sleep.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Tonsillar hypertrophy
Clinical narrative: Patient states that his throat closed up, tonsils swollen, hard to swallow and aggravated his respiratory system and joint pain. Restless to sleep.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: 5/14/13 I received call from client. She had received a tetanus shot on 3/21/13 at our clinic. Reported she has had severe joint pain since tetanus shot was given. Client declined to complete the VAERS form. Stated, "I need to talk to someone else before I answer anymore questions."
Age: 11.0
Sex: U
Vaccine: HPV4, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Pallor, Rash
Clinical narrative: Localized rash located on left deltoid, red whelp at injection site on left arm the patch blanch, little bruise at center. Urticaria local due to left arm shot.
Age: 11.0
Sex: U
Vaccine: HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: Localized rash located on left deltoid, red whelp at injection site on left arm the patch blanch, little bruise at center. Urticaria local due to left arm shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Redness, swelling and itching at injection site. Non-blistering rash on upper chest. Tx: BENADRYL.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Heart rate decreased, Hyperhidrosis, Vomiting
Clinical narrative: Patient arrived with her mother and twin sister to our office about 4:00pm. Patient was given Dtap and Hib on her right thigh and PCV-13 and Hep-A on her left thigh by 4:30. After 2-3 minutes mom said that she was vomiting. Patient was sweating and her heartbeat was going down that's when we call 911. We took her BP 109/59 she was also given epi 1/1000 0.15cc. After that patient was doing ok. She was still transfer to E.R.
Sex: U
Vaccine: HEP, HEPA, HPV4, MMR, RV5, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates during the past year, unspecified patients were administered unspecified doses of various vaccines which might have been exposed to unsupportable warm temperature excursions. The vaccines were as follow: GARDASIL (lot number H012643, expiry date ??-MAR-2015 ; lot number 670050/1229AA, expiry date 12-NOV-2013; lot number 672652/0022AE, expiry date 28-SEP-2014 ;lot number 0459AE, expiry date 13-DEC-2014; lot number H009746, expiry date 11-JAN-2015; lot number H010649, expiry date ??-FEB-2015; lot number H013977, expiry date 19-MAR-2015), RECOMBIVAX HB (lot number H014132, expiry date 08-FEB-2015; lot number 670232/1259AA, expiry date 19-DEC-2013; lot number 670943/1260AA, expiry date 27-MAR-2014; lot number 1740AA, expiry date 07-JUN-2014; lot number reported as 1294AE, expiry date 07-SEP-2014; lot number reported as 0384AA, expiry date 02-NOV-2014; lot number 0385AE, expiry date 08-NOV-2014; lot number H01432, expiry date ??-FEB-2014), VAQTA (lot number H010145, expiry date ??-FEB-2015; lot number 671931/1168AA, expiry date 15-JUN-2014 ; lot number 672274/1442AA, expiry date 06-AUG-2014; lot number reported as 0109AE, expiry date 21-OCT-2014; lot number reported as 05358AE, expiry date 24-JAN-2015; lot number 0273AE, expiry date 06-DEC-2014; lot number H010437, expiry date ??-FEB-2015), ROTATEQ (lot number H012981, expiry date ??-FEB-2014; lot number 671575/1350AAm expiry date 27-MAY-2013; lot number 671982/1693AA, expiry date 29-JUN-2013; lot number 1807AA, expiry date 29-AUG-2013; lot number 0208AE, expiry date 27-SEP-2013; lot number 0576AE, expiry date 25-OCT-2013; lot number H011443, expiry date 15-NOV-2015; lot number H015680, expiry date ??-FEB-2014), M-M-R II (lot number H012572, expiry date ??-JUN-2014; lot number 671320/1121AA, expiry date 12-JUL-2013; lot number 1449AA, expiry date 13-SEP-2013; lot number 1769AA, expiry date 10-NOV-2013; lot number 0233AE, expiry date 26-JAN-2014, lot number 0683AE, expiry date 02-APR-2014; lot number reported as H009781, expiry date 15-MAY-2014; lot number H01032, expiry date 20-MAY-2014) and (merck) VARIVAX (lot number H018449, expiry date ??-OCT-2014; lot number 1059AA, expiry date 05-JUL-2013; lot number reported as 1059AA, expiry date 05-JUL-2013; lot number 1274AA, expiry date 05-AUG-2013; lot number H007702, expiry date 30-MAR-2014; lot number H017705, expiry date 25-SEP-2014). It was unknown at this point if any patient received more than one dose of any of these vaccines. No adverse effect reported. it was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 05-JAN-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot number 670177/0419AA, expiration date: 16-APR-2013) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: This spontaneous report as received from a 65 year old female consumer reporting on herself. In 2008, the patient was vaccinated with a dose of ZOSTAVAX (route and lot# not reported). The consumer reported that she received the vaccine when she was 60 years old and on an unknown date, when she was 65 years old, she experienced shingles. The consumer stated that she had no rash at all and had very back pain. The outcome of shingles was unknown. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Herpes zoster
Clinical narrative: This spontaneous report as received from a 57 year old female consumer with diabetes, severe neuropathy and no drug reactions or allergies reporting on herself. On 30-APR-2013, the consumer was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included "extensive" unspecified drugs. The consumer reported that on 01-MAY-2013, she developed shingles. The consumer reported that she had a headache and diarrhea after being vaccinated. She stated that had 3 active pox, and some that dried. The consumer stated that she started with "v" as treatment for the adverse event. There were no Lab diagnostics or studies performed. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has ben requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site reaction
Clinical narrative: This spontaneous report as received from a 57 year old female consumer with diabetes, severe neuropathy and no drug reactions or allergies reporting on herself. On 30-APR-2013, the consumer was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included "extensive" unspecified drugs. The consumer reported that on 01-MAY-2013, she developed shingles. The consumer reported that she had a headache and diarrhea after being vaccinated. She stated that had 3 active pox, and some that dried. The consumer stated that she started with "v" as treatment for the adverse event. There were no Lab diagnostics or studies performed. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has ben requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her husband. On 30-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The consumer reported that on an unspecified date, the patient experienced headache, diarrhea and an unspecified injection site reaction. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site reaction
Clinical narrative: This spontaneous report as received from a consumer refers to her husband. On 30-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The consumer reported that on an unspecified date, the patient experienced headache, diarrhea and an unspecified injection site reaction. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the third dose of RECOMBIVAX HB (route and lot # not reported) 4 days earlier than the prescribed dosing schedule. No adverse effect was reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse refers to a patient (age and gender not reported) who on 01-MAY-2013 was vaccinated with an expired dose of VARIVAX (Lot No. 0098AA, exp. 12-JAN-2013) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 19 year old female patient. In January 1996 (exact date unspecified) the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route, lot number and expiration date not reported) for varicella immunization. On 30-JUL-2007 the patient was vaccinated with the second dose of VARIVAX (Merck) (dose, route, lot number and expiration date not reported) for varicella immunization. There was no concomitant medication reported. The nurse reported that the patient has joined the military and lab titer was drawn to test immunity on 02-MAY-2013 and the result showed the patient failed to seroconvert for Varicella immunity. Nurse also reported that the physician at the center has ordered for the patient to receive a third dose, not yet administered. The outcome of the events was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: This spontaneous report as received from a 86 year old female consumer reporting on herself. On 15-APR-2013 the patient was vaccinated with ZOSTAVAX (Lot # not provided) 1 time vaccine, subcutaneous (dose not reported). No other co suspects were reported. Concomitant therapies included hydrochlorothiazide, lisinopril+hydrochlorothiazide and levothyroxine sodium. The patient reported that on 29-APR-2013, the patient experienced a rash under her arm on the opposite side the vaccine was given on . The patient reported the rash was on her right elbow to wrist and now on the left arm and stomach. The patient described the rash as itchy, red and welts. The patient did not seek medical attention. Treatment was not given for the events. The outcome of the patient had a rash under her arm on the opposite side and the rash as itchy and welts was unknown. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 69 year old male patient with Angiotensin-converting enzyme (ACE) inhibitors allergy and aspirin allergy. The patient stated no medical history other than surgery to repair aorta. On 01-MAY-2013 the patient was vaccinated with ZOSTAVAX, 1 dose, injection in the right arm (lot number was not reported). Concomitant therapies included acyclovir and AMOX TR-K CLV. On 04-MAY-2013, a few days after the ZOSTAVAX injection patient noticed a blister on the right side of head and a burning sensation. Patient stated he got full blown episodes of shingles. Shingles proceeded down the side of the face and a constant ache, throbbing sensation in his head. Reporter stated that ZOSTAVAX was supposed to prevent shingles and gave him shingles. The patient was treated with gabapentin 100mg prescribed 1 every 8 hours. The patient did not performed any lab diagnostics. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Acne, Burning sensation, Erythema, Headache, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 69 year old male patient with Angiotensin-converting enzyme (ACE) inhibitors allergy and aspirin allergy. The patient stated no medical history other than surgery to repair aorta. On 01-MAY-2013 the patient was vaccinated with ZOSTAVAX, 1 dose, injection in the right arm (lot number was not reported). Concomitant therapies included acyclovir and AMOX TR-K CLV. On 04-MAY-2013, a few days after the ZOSTAVAX injection patient noticed a blister on the right side of head and a burning sensation. Patient stated he got full blown episodes of shingles. Shingles proceeded down the side of the face and a constant ache, throbbing sensation in his head. Reporter stated that ZOSTAVAX was supposed to prevent shingles and gave him shingles. The patient was treated with gabapentin 100mg prescribed 1 every 8 hours. The patient did not performed any lab diagnostics. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 69 year old male patient with Angiotensin-converting enzyme (ACE) inhibitors allergy and aspirin allergy. The patient stated no medical history other than surgery to repair aorta. On 01-MAY-2013 the patient was vaccinated with ZOSTAVAX, 1 dose, injection in the right arm (lot number was not reported). Concomitant therapies included acyclovir and AMOX TR-K CLV. On 04-MAY-2013, a few days after the ZOSTAVAX injection patient noticed a blister on the right side of head and a burning sensation. Patient stated he got full blown episodes of shingles. Shingles proceeded down the side of the face and a constant ache, throbbing sensation in his head. Reporter stated that ZOSTAVAX was supposed to prevent shingles and gave him shingles. The patient was treated with gabapentin 100mg prescribed 1 every 8 hours. The patient did not performed any lab diagnostics. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Headache, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 69 year old male patient with Angiotensin-converting enzyme (ACE) inhibitors allergy and aspirin allergy. The patient stated no medical history other than surgery to repair aorta. On 01-MAY-2013 the patient was vaccinated with ZOSTAVAX, 1 dose, injection in the right arm (lot number was not reported). Concomitant therapies included acyclovir and AMOX TR-K CLV. On 04-MAY-2013, a few days after the ZOSTAVAX injection patient noticed a blister on the right side of head and a burning sensation. Patient stated he got full blown episodes of shingles. Shingles proceeded down the side of the face and a constant ache, throbbing sensation in his head. Reporter stated that ZOSTAVAX was supposed to prevent shingles and gave him shingles. The patient was treated with gabapentin 100mg prescribed 1 every 8 hours. The patient did not performed any lab diagnostics. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of pain above injection point in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. The subject's medical history included endometriosis and infertility. Concurrent medications included Prenatal vitamins. On 6 May 2013 at 14:30 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left deltoid). Her last menstrual period was on an unspecified date and her estimated date of deliver was 20 September 2013. The subject was exposed to BOOSTRIX during the 3rd trimester. On 06 May 2013, at the time of vaccination with BOOSTRIX, the subject experienced sharp pain above injection site, unable to move arm when lifting up or across body, sharp pain up towards rotator cuff pain and vaccine exposure during pregnancy. The subject received BOOSTRIX and experienced sharp pain right above the injection site. The subject stated that the pain was progressively getting worse and her pain level is an eight out of ten. She stated that she is unable to move her arm but when she lifts her arm up or across her body she has the sharp pain up towards the rotator cuff. The healthcare professional considered the events were disabling. At the time of reporting the sharp pain above injection site, unable to move arm when lifting up or across body and sharp pain up towards rotator cuff pain were worse. The immunisation series with BOOSTRIX was discontinued. The pregnancy was ongoing, the outcome was unknown.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of pain above injection point in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. The subject's medical history included endometriosis and infertility. Concurrent medications included Prenatal vitamins. On 6 May 2013 at 14:30 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left deltoid). Her last menstrual period was on an unspecified date and her estimated date of deliver was 20 September 2013. The subject was exposed to BOOSTRIX during the 3rd trimester. On 06 May 2013, at the time of vaccination with BOOSTRIX, the subject experienced sharp pain above injection site, unable to move arm when lifting up or across body, sharp pain up towards rotator cuff pain and vaccine exposure during pregnancy. The subject received BOOSTRIX and experienced sharp pain right above the injection site. The subject stated that the pain was progressively getting worse and her pain level is an eight out of ten. She stated that she is unable to move her arm but when she lifts her arm up or across her body she has the sharp pain up towards the rotator cuff. The healthcare professional considered the events were disabling. At the time of reporting the sharp pain above injection site, unable to move arm when lifting up or across body and sharp pain up towards rotator cuff pain were worse. The immunisation series with BOOSTRIX was discontinued. The pregnancy was ongoing, the outcome was unknown.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt has swelling of anterior thigh, left. Some induration and erythema with heat.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a claims administer, concerning a female who on 30-APR-2013, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). The patient experienced an adverse reaction to ZOSTAVAX (Merck). It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Skin reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history included that the patient had received an unspecified "flu vaccine" each year since the administration of PNEUMOVAX23 and did not have a reaction to the "flu vaccine". On an unknown date in several years ago the patient was vaccinated with PNEUMOVAX23 (lot number, dose and injection site were not reported) intramuscularly as routine. On an unknown date in several years ago the patient experienced bad skin reaction. The action taken was not reported. The outcome of bad skin reaction was reported as recovered on an unspecified date. The adverse event did not reappear after reintroduction. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a 67 year old female patient referred to herself. On an unspecified date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, one injection, strength, lot#, dose/frequency and duration were unspecified). Patient experienced a lingering pain in her arm at the injection site, "ongoing since October 2012". Patient had sought unspecified medication. No lab diagnostics studies were performed and not treatment was given for the event. The outcome was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a secretary, the Healthcare Worker, refers to a patient of unknown age. In 2007, the patient was vaccinated IM with first 0.5 ml dose of GARDASIL (lot# not reported) and received the second dose (IM, 0.5ml, lot# not reported) in July 2012. The patient reported no adverse effects. The patient sought medical attention via office visit. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with allergy to penicillin and no pertinent medical history. On 30-APR-2013 the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # H020683, exp. date: 15-FEB-2014). There was no concomitant medication. Within 24 hours of receiving ZOSTAVAX, on approximately 30-APR-2013, the patient developed an injection site reaction. The area was raised and hot to the touch and radiated past the patient's elbow. No rash reported. Therapies with ibuprofen and BENADRYL were given for the events. No lab diagnostics studies were performed. The pharmacist spoke to the patient yesterday (on 05-MAY-2013) who said that the area was improving. At time of report, the outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Coma
Clinical narrative: This legal report (initial receipt 02-May-2013) concerns a patient, gender and age not specified. On an unspecified date the patient received a flu shot (manufacturer not specified) and PNEUMOVAX. The batch number 1947AA was provided however it was unclear if this was associated with the flu shot or PNEUMOVAX. A few days after the vaccinations the patient went into a coma. No further details were provided about the event. Reporter's comment: The reporter stated that it was not determined which vaccine (flu shot or PNEUMOVAX) was responsible for the event.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse refers to a 32 year old female patient with no pertinent medical history and no drug reactions/allergies. On 03-APR-2013 the patient was vaccinated IM into her left deltoid with a 0.5 ml dose of GARDASIL (lot # H013977, expired on 19-MAR-2015) instead of the intended Tdap vaccine (manufacturer unknown). There was no concomitant medication. The patient pregnant gestation was 32 weeks and 6 days. The last menstrual period (LMP) was on 21-SEP-2012 and estimated date of delivery (EDD) on 28-JUN-2013. The patient did not seek medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a 63 year old female patient. The patient has no pertinent medical history or drug reactions/allergies. On 2011 (reported as 2 years), the patient was vaccinated with dose of ZOSTAVAX, (lot number not provided) subcutaneous. On 24-APR-2013, the patient was diagnosed with the shingles. The patient stated if was on her upper mid section on her right side from chest to upper arm. The outcome of shingles is unknown. The action taken with ZOSTAVAX was not provided. The reporter did not assess the relationship between the event and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certificated medical assistant refers to about 6 patients of unknown ages and genders. The reporter stated that on unspecified dates, since 02-APR-2013, about six patients received a dose of GARDASIL (dose, route application site were unspecified) (lot# H010123; exp date: 16-JAN-2015), and two to three patients received ROTATEQ: MARRS#1305USA002896. The reporter stated that the GARDASIL were exposed to an unsupported temperature excursion. These vaccines were exposed multiple times into the freezing range, the lowest temperature being 23F; the total time frame being 1 month. The number of excursions into the freezing range exceeded 5 times. The exact number of times these entered the freezing range was unspecified. No known adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4, MMR, PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse who stated a unspecified number of "children" were vaccinated with improperly stored vaccines. Nurse stated their data logger were blinking from 2 refrigerators from last May 2012. Multiple excursions, as high as 14C, and low -0.5C. M-M-R II, GARDASIL, PEDVAXHIB, PNEUMOVAX 23, stored inside, (merck) VARIVAX stored in 2 freezers that also went out of range, since last May 2012. Nurse stated she was still researching the freezer temperatures. Nurse stated no adverse events reported at this time. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 70 year old mother. Approximately on 02-MAY-2013 the patient was vaccinated intramuscularly with a dose of ZOSTAVAX (dosage and lot# not reported) at an unspecified physician office. Approximately on 02-MAY-2013, the patient developed a bruise at the injection site which was resolving without requiring medical attention. There was no treatment given for the event. There were no lab diagnostics studies performed. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 01-MAY-2013 the patient was vaccinated with ZOStAVAX lot # J000436, exp. 10-APR-2014, 0.65 ml, subcutaneous for prophylaxis. The patient experienced "bad swelling, warm to touch and redness" of upper arm after the patient received ZOSTAVAX, at the pharmacy. The patient sought medical attention by contacting physician and was treated iwth BENADRYL and ice topically. At the time of reporting, the outcome was unknown. The pharmacist explained adverse event was reported to VAERS. Pharmacist requested lot check for ZOSTAVAX (lot # J000436, exp. 10-APR-2014). This is one of the reports from the same reporter (SR#1-7171986880, SR#1-7176426810 and 1-7176426358 (1305USA009032)). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 01-MAY-2013 the patient was vaccinated with ZOStAVAX lot # J000436, exp. 10-APR-2014, 0.65 ml, subcutaneous for prophylaxis. The patient experienced "bad swelling, warm to touch and redness" of upper arm after the patient received ZOSTAVAX, at the pharmacy. The patient sought medical attention by contacting physician and was treated iwth BENADRYL and ice topically. At the time of reporting, the outcome was unknown. The pharmacist explained adverse event was reported to VAERS. Pharmacist requested lot check for ZOSTAVAX (lot # J000436, exp. 10-APR-2014). This is one of the reports from the same reporter (SR#1-7171986880, SR#1-7176426810 and 1-7176426358 (1305USA009032)). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Incorrect dose administered, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 year old female patient with no medical history and with no drug reactions/allergies. On 07-MAY-2013 the patient was vaccinated with an adult dose of VAQTA (INJ 50/1.0 U/ML, lot # H010269, exp date 03-NOV-2014, dose/frequency, route and duration were unspecified) for prophylaxis. This was her 1st dose of VAQTA. There was no concomitant medications. The day after vaccination (08-MAY-2013), patient developed a headache and later began to vomit. Patient had sought medical attention via calling the office. Treatment of ibuprofen was given for the event. The outcome were unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Tic
Clinical narrative: A spontaneous report was received from a company representative who learned of this information from a physician regarding a male consumer who on 07MAY2013 reportedly suffered symptoms of TIC disorder after the administration of GARDASIL injection on 06MAY2013. Legal issue involved AE sent to legal. The patient's current status was reported as recovering. No further AE information was provided.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 month old patient. On 26-APR-2013 the patient was vaccinated with the first dose of oral ROTATEQ (lot number not provided). No adverse event was reported. No product confusion was discovered. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Myelitis transverse
Clinical narrative: Case number PHEH2013US001365 is an initial spontaneous report received from a physician on 10 Jan 2013, with follow up received from the physician on 12 Mar 2013, with a follow-up received on 14 May 2013: This report refers to an adult female patient (around 30). Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date in 2012, she experienced transverse myelitis. No seriousness criteria was reported. The outcome and causality were not reported. No further information was provided. Upon follow-up, the physician confirmed that the mother (this female patient) experienced the event but not her children. Follow up received from the physician on 12 Mar 2013: No new medical information was updated. Follow-up was received on 14 May 2013: Physician statement was updated.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions/allergies. On 01-MAY-2013 the patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # J000446, expiry date 11-APR-20140. Concomitant therapies included tizanidine hydrochloride, LIPITOR (Generic), FLEXERIL (Generic), acetaminophen, NORCO (Generic), LYRICA, tramadol hydrochloride, AMBIEN, AMITIZA, DEPAKOTE and PRILOSEC. The patient reported to pharmacist that after receiving ZOSTAVAX the injection site became "red at first then on 01-MAY-2013, later that day, the redness extended down her entire left arm, was itching, burning and painful". The pharmacist recommended that the patient visit her unspecified healthcare provider. Before the patient saw her unspecified healthcare provider, she self medicated with BENADRYL. The unspecified healthcare provider stated the patient "had an allergic reaction and should take BENADRYL". There were no laboratory diagnostic studies performed. The patient came in to see the pharmacist "today", 08-May-2013, and the injection site was "just a little red, still itchy but no burning or pain". Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions/allergies. On 01-MAY-2013 the patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # J000446, expiry date 11-APR-20140. Concomitant therapies included tizanidine hydrochloride, LIPITOR (Generic), FLEXERIL (Generic), acetaminophen, NORCO (Generic), LYRICA, tramadol hydrochloride, AMBIEN, AMITIZA, DEPAKOTE and PRILOSEC. The patient reported to pharmacist that after receiving ZOSTAVAX the injection site became "red at first then on 01-MAY-2013, later that day, the redness extended down her entire left arm, was itching, burning and painful". The pharmacist recommended that the patient visit her unspecified healthcare provider. Before the patient saw her unspecified healthcare provider, she self medicated with BENADRYL. The unspecified healthcare provider stated the patient "had an allergic reaction and should take BENADRYL". There were no laboratory diagnostic studies performed. The patient came in to see the pharmacist "today", 08-May-2013, and the injection site was "just a little red, still itchy but no burning or pain". Additional information has been requested.
Sex: M
Vaccine: FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of Bell's palsy in an adult male subject who was vaccinated with Influenza vaccine (unspecified), (manufacturer unspecified). On an unspecified date in 2003 the subject received unspecified dose of Influenza vaccine (unspecified) (unknown). On an unspecified date in 2003, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced Bell's palsy. Approximately 10 years ago in 2003, the subject received influenza vaccination and experienced Bell's palsy; brand name or manufacturer was unknown. The sales representative reported that the healthcare professional wanted to remain anonymous. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. An adult male subject developed Bell's Palsy within 24 hours of being vaccinated with FLUARIX (season was not specified). The physician associated the Bell's Palsy with the FLUARIX vaccine, lot number was not available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. The subject developed Bell's Palsy within 24 hours of being vaccinated with FLUARIX in 2012, for this case please see A1023598A.
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, VIIth nerve paralysis
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of Bell's palsy in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included Bell's palsy 10 years ago. On an unspecified date in 2012 the subject received unspecified dose of FLUARIX (unknown). On an unspecified date in 2012, within 24 hours of vaccination with FLUARIX, the subject experienced Bell's palsy. An adult male subject developed Bell's Palsy within 24 hours of being vaccinated with FLUARIX (season was not specified). The physician associated the Bell's Palsy with the FLUARIX vaccine, lot number was not available. The sales representative reported that the healthcare professional wanted to remain anonymous. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. Approximately 10 years ago, the subject received influenza vaccination and experienced Bell's Palsy; brand name or manufacturer was unknown. For this case please see A1023598B.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia
Clinical narrative: Joint pains. Treated with Prednisone for 7 months.
Age: 1.52
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of the left leg with erythema at the site of the injecton of.
Age: 0.4
Sex: M
Vaccine: PPV
Symptoms: Constipation, Pyrexia
Clinical narrative: Prolonged low grade fever and fever over, constipation.
Age: 9.0
Sex: M
Vaccine: MEN, PPV, TDAP
Symptoms: Agitation, Asthenia, Crying, Emotional distress, Headache
Clinical narrative: Fever, lethargy, extreme headache, nausea, weakness, crying, emotional, agitated.
Age: 9.0
Sex: M
Vaccine: MEN, PPV, TDAP
Symptoms: Lethargy, Nausea, Pyrexia
Clinical narrative: Fever, lethargy, extreme headache, nausea, weakness, crying, emotional, agitated.
Age: 9.0
Sex: F
Vaccine: MEN, PPV, TDAP
Symptoms: Emotional disorder, Headache, Lethargy, Nausea, Oedema peripheral
Clinical narrative: Fever 101-100.8, extreme lethargy, extreme headache, nausea, emotional,  swollen arm.
Age: 9.0
Sex: F
Vaccine: MEN, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 101-100.8, extreme lethargy, extreme headache, nausea, emotional,  swollen arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Headache, Joint stiffness, Myalgia
Clinical narrative: Muscle ache in arm, extreme fatigue, dizziness, fainted next day, headache, joint stiffness. Still continues three days later, but getting better.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Muscle ache in arm, extreme fatigue, dizziness, fainted next day, headache, joint stiffness. Still continues three days later, but getting better.