chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Decreased appetite, Headache, Immediate post-injection reaction
Clinical narrative: H/A immed after vaccine; "tingling in brain; chills, fever of 102 degrees F after few hrs; sick in bed x 3 days with fever, chills, nausea, anorexia. Swollen, painful inj. site.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea, Paraesthesia, Pyrexia
Clinical narrative: H/A immed after vaccine; "tingling in brain; chills, fever of 102 degrees F after few hrs; sick in bed x 3 days with fever, chills, nausea, anorexia. Swollen, painful inj. site.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt presented to campus health urgent care 10/11/12 at 4:35 pm. Presented with red, raised, rash to arms, back, & chest which started 10/9/12. Rash is somewhat itchy and is improving (per pt) Pt. presented with abnormal  vital signs: oral temp 101.4 degrees, BP 139/69, pulse 131, RR 20, SPO2 97%. Treated with TYLENOL and given instructions to return if symptoms do not improve.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Stiff, painful neck (next day) sore arm (L) extending down body to thigh and back. Sore tingly middle fingers (R) hand. Hurts to get up and to walk.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiff, painful neck (next day) sore arm (L) extending down body to thigh and back. Sore tingly middle fingers (R) hand. Hurts to get up and to walk.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Polymyalgia rheumatica, Tenderness, X-ray normal
Clinical narrative: Stiff, painful neck (next day) sore arm (L) extending down body to thigh and back. Sore tingly middle fingers (R) hand. Hurts to get up and to walk.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope following vaccine administration occurred within seconds after administration.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt. states about 1 hour following vaccine administration her arm became very painful. States whole left arm down to palm hurt. No numbness, swelling or warmth. Pt. directed on 10/10/12 at 9:07 AM to take Ibuprofen 800mg. Pain resolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Speaks of blood in stool 4 d after ROTATEQ.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Insomnia, Pain
Clinical narrative: Within 6 hrs. headache. Headache lasted 1 day and a half. Slightly dizzy. Had trouble sleeping because of being achy. ADVIL helped.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Had a golf size ball redness around vaccine - woke up in the middle of the night around 4am with a massive headache. Headache stayed for 6 hours - had headache next day in the middle of the night again - took ALEVE - for 7 days - never had a reaction before - also redness around vaccine & hot to touch. Used ice packs for 2 days & ALEVE relieved headache & swelling.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Discomfort, Erythema, Injection site discolouration, Injection site erythema
Clinical narrative: On 9/10/2012, this 83 year old female (average build 130lb 64 inch) received her pneumococcal vaccine (Merck 0025AE) and Influenza Split virus (UH713AA) to her right arm. She remembers rubbing the site after and moving arm about. She is right handed. She stated her right arm remained sore all day and was unable to sleep on her right side due to deltoid/arm tenderness. On awakening 9/11/2012 she noticed her vaccine site/right deltoid was red, swollen and tender. She denied any fever, nausea, vomiting, headaches, myalgia/arthralgia (other than right arm), or restriction in ROM of right arm. She had no loss of sensation, numbness or tingling to right arm/hand/fingers. Her grip was normal. This discomfort persisted with increased redness extending down to right elbow as of 9/12/2012 which prompted her to seek medical care. Exam by her PCP and HC 9/12/2012 documented the following: Afebrile (98.2), Right arm with full ROM greater than then left arm (due to prior humeral fracture). She is able to grasp both hands and extend over head but not with arms at full extension, they're bent due to prior left arm injury. She can extend her right arm directly over her head w/o restriction. Right arm Hawkins and Apley scratch test negative, Yergason's test positive to right arm with pain in bicep but strength intact. Mild pain to palpation of anterior and posterior acromioclavicular joint. She has full sensation and ROM to right elbow, wrist and fingers. Sensation and ROM to left elbow, wrist and fingers = to right. Neurologic exam normal. Skin: Reddened skin to right lower upper arm was warm to touch. Arm circumference: right 28cm and left 25 cm. Bruising noted to right deltoid (yellow-brown skin discoloration at 5 cm circular pattern) with pale pink redness about injection sites and bright pink/red skin to lower 1/2 of her upper arm (redness stops at elbow) measured 12cm height by 18cm length encircling 2/3 of arm. No discoloration to posterior portion of lower upper arm. She has a small flat bright red macule to lateral arm in center of reddened skin that has been there for years without change. On 9/14/2012 she advised the swelling and redness to her right upper arm had resolved with 3-day course of steroid but the arm was still tender to deltoid region where bruising was noted on deltoid. She has full ROM and no paresthesia or weakness to the left hand. She advised she did not use any antibiotics. On 9/18/2012 she advised full resolution of the contusion and had no reflare of swelling or any discomfort to her right arm off steroids.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site haematoma, Injection site pain, Laboratory test abnormal, Neurological examination normal, Pain in extremity
Clinical narrative: On 9/10/2012, this 83 year old female (average build 130lb 64 inch) received her pneumococcal vaccine (Merck 0025AE) and Influenza Split virus (UH713AA) to her right arm. She remembers rubbing the site after and moving arm about. She is right handed. She stated her right arm remained sore all day and was unable to sleep on her right side due to deltoid/arm tenderness. On awakening 9/11/2012 she noticed her vaccine site/right deltoid was red, swollen and tender. She denied any fever, nausea, vomiting, headaches, myalgia/arthralgia (other than right arm), or restriction in ROM of right arm. She had no loss of sensation, numbness or tingling to right arm/hand/fingers. Her grip was normal. This discomfort persisted with increased redness extending down to right elbow as of 9/12/2012 which prompted her to seek medical care. Exam by her PCP and HC 9/12/2012 documented the following: Afebrile (98.2), Right arm with full ROM greater than then left arm (due to prior humeral fracture). She is able to grasp both hands and extend over head but not with arms at full extension, they're bent due to prior left arm injury. She can extend her right arm directly over her head w/o restriction. Right arm Hawkins and Apley scratch test negative, Yergason's test positive to right arm with pain in bicep but strength intact. Mild pain to palpation of anterior and posterior acromioclavicular joint. She has full sensation and ROM to right elbow, wrist and fingers. Sensation and ROM to left elbow, wrist and fingers = to right. Neurologic exam normal. Skin: Reddened skin to right lower upper arm was warm to touch. Arm circumference: right 28cm and left 25 cm. Bruising noted to right deltoid (yellow-brown skin discoloration at 5 cm circular pattern) with pale pink redness about injection sites and bright pink/red skin to lower 1/2 of her upper arm (redness stops at elbow) measured 12cm height by 18cm length encircling 2/3 of arm. No discoloration to posterior portion of lower upper arm. She has a small flat bright red macule to lateral arm in center of reddened skin that has been there for years without change. On 9/14/2012 she advised the swelling and redness to her right upper arm had resolved with 3-day course of steroid but the arm was still tender to deltoid region where bruising was noted on deltoid. She has full ROM and no paresthesia or weakness to the left hand. She advised she did not use any antibiotics. On 9/18/2012 she advised full resolution of the contusion and had no reflare of swelling or any discomfort to her right arm off steroids.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin test negative, Skin warm, Vaccination site swelling
Clinical narrative: On 9/10/2012, this 83 year old female (average build 130lb 64 inch) received her pneumococcal vaccine (Merck 0025AE) and Influenza Split virus (UH713AA) to her right arm. She remembers rubbing the site after and moving arm about. She is right handed. She stated her right arm remained sore all day and was unable to sleep on her right side due to deltoid/arm tenderness. On awakening 9/11/2012 she noticed her vaccine site/right deltoid was red, swollen and tender. She denied any fever, nausea, vomiting, headaches, myalgia/arthralgia (other than right arm), or restriction in ROM of right arm. She had no loss of sensation, numbness or tingling to right arm/hand/fingers. Her grip was normal. This discomfort persisted with increased redness extending down to right elbow as of 9/12/2012 which prompted her to seek medical care. Exam by her PCP and HC 9/12/2012 documented the following: Afebrile (98.2), Right arm with full ROM greater than then left arm (due to prior humeral fracture). She is able to grasp both hands and extend over head but not with arms at full extension, they're bent due to prior left arm injury. She can extend her right arm directly over her head w/o restriction. Right arm Hawkins and Apley scratch test negative, Yergason's test positive to right arm with pain in bicep but strength intact. Mild pain to palpation of anterior and posterior acromioclavicular joint. She has full sensation and ROM to right elbow, wrist and fingers. Sensation and ROM to left elbow, wrist and fingers = to right. Neurologic exam normal. Skin: Reddened skin to right lower upper arm was warm to touch. Arm circumference: right 28cm and left 25 cm. Bruising noted to right deltoid (yellow-brown skin discoloration at 5 cm circular pattern) with pale pink redness about injection sites and bright pink/red skin to lower 1/2 of her upper arm (redness stops at elbow) measured 12cm height by 18cm length encircling 2/3 of arm. No discoloration to posterior portion of lower upper arm. She has a small flat bright red macule to lateral arm in center of reddened skin that has been there for years without change. On 9/14/2012 she advised the swelling and redness to her right upper arm had resolved with 3-day course of steroid but the arm was still tender to deltoid region where bruising was noted on deltoid. She has full ROM and no paresthesia or weakness to the left hand. She advised she did not use any antibiotics. On 9/18/2012 she advised full resolution of the contusion and had no reflare of swelling or any discomfort to her right arm off steroids.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Pharyngeal oedema
Clinical narrative: Approx 20 minutes after vaccination, pt's jaws felt numb, arms became tingly & throat began to feel swollen. Per protocol, gave 1 EPIPEN injection in thigh, paramedics came, pt felt better after EPIPEN but symptoms returned soon after. Pt given another EPIPEN and transported via paramedics to hospital.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oral discomfort, Pain, Throat irritation
Clinical narrative: Redness, pain, burning of oral cavity and throat beginning on day after injection of FLUZONE HIGH DOSE.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash vesicular
Clinical narrative: Patient developed a headache and a shingles-like rash on forehead.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Hardness and swelling at injection site (L) deltoid (PNEUMOVAX 23). Went to clinic and rec'd antibiotic.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt complained of itchy hands and neck after receiving a flu shot. She said it started in the evening and still had itchiness the next day. Recommended BENADRYL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Ultrasound scan normal
Clinical narrative: Patient received FLUZONE HD on 10/2/2012. 1 hour after receiving vaccine, patient's arm became red, swollen, and painful. Patient sought treatment from urgent care on 10/4/2012.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Myalgia, Pain in extremity
Clinical narrative: Chills, fever, headache, muscle aches, dizzy, sore arm. Lasted 5 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Chills, fever, headache, muscle aches, dizzy, sore arm. Lasted 5 days.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Contusion, Erythema
Clinical narrative: Erythema 10 x 7 cm. Bruise. No fluctuant area.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient received ZOSTAVAX injection 10/3/12 seen PCP office 10/11/12 for rash right side ABD Dx: Zoster - treated with Famciclovir.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Developed sore throat, low grade fever, congestion/rhinorrhea & cough 48 hrs after visit on 10/8.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Feeling hot, Hyperhidrosis
Clinical narrative: Patient report a feeling of "burning up inside, I was sweating and had no energy".
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Muscle disorder, Pain in extremity
Clinical narrative: A day after the vaccine on 9/8/12 - pain (L) shoulder down (L) arm in certain arm positions only. Saw orthopedic MD 10/5/12 - irritation to muscle below (L) elbow - unknown cause. 10/12/12 - physical therapist said he thought symptoms related to flu vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site cellulitis, Injection site pustule
Clinical narrative: (L) upper arm cellulitis with pustule at site of injection. Treatment with Cephalexin.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, PNC13
Symptoms: Dyspnoea, Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: 9-18-12 6p small rash approx 1 cm, appeared like hives. 9-19-12 evening increased swelling 4x's original. Increased redness, warm to touch. To ER 9-19-12 at 10p. C/o difficulty breathing, leg extremely painful to touch. In ER admin 40mg steroid and ABX 3.5mL KEFLEX. Discharged with dexamethasone 0.5mg/5mL 20mL PO 2 days x4 days. KEFLEX 250mg/5mL 3.05mL q 6 hours x7 days. Reaction located at right thigh, site of PVC 13 administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, PNC13
Symptoms: Urticaria
Clinical narrative: 9-18-12 6p small rash approx 1 cm, appeared like hives. 9-19-12 evening increased swelling 4x's original. Increased redness, warm to touch. To ER 9-19-12 at 10p. C/o difficulty breathing, leg extremely painful to touch. In ER admin 40mg steroid and ABX 3.5mL KEFLEX. Discharged with dexamethasone 0.5mg/5mL 20mL PO 2 days x4 days. KEFLEX 250mg/5mL 3.05mL q 6 hours x7 days. Reaction located at right thigh, site of PVC 13 administration.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 inch red, swollen, hot to the touch bump at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 2 inch red, swollen, hot to the touch bump at injection site.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Severe nausea, vomiting, dizziness - at the time I did not think about it being related to vaccine - only several years later when it always happened in October did someone say it was probably linked to vaccine.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Computerised tomogram head, Dizziness, Nausea, Vertigo
Clinical narrative: Severe balance issues, dizziness, nausea, "spinning" at the time. I did not think about it being related to flu vaccine. However, it happened every October, for several years.
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information was received from a medical assistant regarding a male patient, who vaccinated with ROTATEQ on 01-OCT-2012. The medical assistant reported that the patient was administered an expired dose ROTATEQ (reported lot # 0185AA, expiration 21-SEP-2012). No adverse effects reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse via a company representative concerning a two month old infant who on 25-SEP-2012 received a first dose of ROTATEQ (lot number not provided). Concomitant medications included "multiple vaccines" (not specified) that the infant received that day at the 2 month visit. The baby was reported to be a "little wheezy" when they administered the vaccine. After the infant received the first dose orally, the mother was trying to burp the baby and the baby vomited. The mother of the infant was cleaning up the vomit off of the floor and found a piece of plastic. It was reported that the mother felt that the plastic was in the ROTATEQ but both the physician and the nurse felt that the plastic happened to be on the floor. The infant's condition improved and the nurse was "not aware of any" treatments or medical attention that was received. No additional information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot # not reported). It was reported that the GARDASIL had not been stored at the correct temperature. No adverse event symptoms were reported. It was unspecified whether the patient sought for medical attention. GARDASIL was not discontinued. The outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Condition aggravated, Headache
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 22 years old female patient with mild headache, no pertinent medical history and no drug reactions or allergies, who on 15-AUG-2012, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported) and on 09-OCT-2012, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot number 0754AE, Exp. Date: 17-JAN-2015). No other co-suspects were reported. Concomitant medication included unspecified birth control pills. The registered nurse reported that on 09-OCT-2012, the patient was experiencing a mild headache when she had arrived at the office to receive second dose of GARDASIL the headache began prior to receive the second dose. About an hour after receiving the second dose, the patient's headache worsened so she had to go home and lay down. No treatment was given for the experience. No lab diagnostics studies were performed. The patient recovered from the headache on 10-OCT-2012. The patient sought medical attention by calling to the office. The relatedness for the patient's headache worsened after receiving second dose of GARDASIL was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unknown number of patients of unknown ages who from 27-AUG-2012 to 06-SEP-2012, were vaccinated with a dose of GARDASIL (dose, route and lot number not reported) that was stored at 30F for 264 hours and then 31F for 840 hours. The unknown number of patients were not experiencing any known symptoms. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. 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 registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot number not reported) on 08-OCT-2007, 02-DEC-2007 and 28-DEC-2009. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a 16 years old female patient. The patient was vaccinated with GARDASIL in APR-2012. No other co-suspects were reported. Concomitant medications included unspecified medications for "ADHD" and "Birth control". In APR-2012 the patient experienced pain in arm. No treatment information was reported. The outcome of pain was reported as recovering/resolving. Pain in arm is related to GARDASIL.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old female patient with no pertinent medical history and no drug allergy/reaction. The patient was vaccinated with the first dose of GARDASIL intramuscularly on 10-APR-2010. Lot# was unspecified. There was no concomitant medications. On 10-APR-2010, "on that same day" of vaccination, the patient experienced some pain at the injection site which lasted a couple of days. The present patient status was recovered. The reporter noted that the patient would be administered her second dose of GARDASIL today (09-OCT-2012). No treatment was given for the event. No lab diagnostic study performed. The patient saw the reporting physician in the office to seek medical attention. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Malaise
Clinical narrative: Information received from a company representative who received information from a physician regarding a 16 year old male who on 17Jul2012 was vaccinated with his first dose of GARDASIL injection in his left lower arm in the deltoid region. It was reported that patient received his second dose of MENACTRA (Sanofi Pasteur) at the same time, in his left upper arm in the deltoid region. It was reported the GARDASIL injection was given below the MENACTRA injection. It was reported the patient experienced severe abdominal cramping for two days then recovered. The patient did not have any serious medical intervention; did not seek medical attention and recovered with no permanent adverse effects. It was reported that the patient informed his physician of the abdominal cramping at a later sick visit. The patient did not receive his second injection of GARDASIL due to being sick (symptoms not specified). Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient who was a little over 9 months old. The patient was vaccinated with ROTATEQ for the first time on 06-FEB-2012. Second dose was administered on 30-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was given the third dose of ROTATEQ when the patient was a little over nine months old, on 26-SEP-2012. No adverse effects reported and there was no PQC involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Pain, Syncope
Clinical narrative: This spontaneous report as received from a market research agency researcher refers to a 14 years old female patient. The patient had non pertinent medical history. In 2006 the patient was vaccinated with GARDASIL (lot # not reported). Concomitant medications were reported as none. On an unknown date the patient was fainting from anxiety and had "low" pain. It was unspecified whether the patient sought for medical attention. The adverse event stopped "soon". The outcome was reported as recovered/resolved with sequelae. The reporter considered the adverse event to be non serious. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered, No therapeutic response
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 years old nursing student. The patient was vaccinated with 3 dose of 0.25 ml hepatitis b vaccine (recombinant) (manufacturer unspecified and RECOMBIVAX HB could not be ruled out) (Lot number unspecified) (vaccination site unknown) in 1994 and not seroconverted. No other co-suspects were reported. No concomitant medications were reported. On 20-AUG-2012 the patient received a forth dose of hepatitis b vaccine (manufacturer unknown but RECOMBIVAX HB could not be ruled out). No treatment information was reported. The outcome was unknown. The patient had sought unspecified medical attention. This is one of three reports from the same reporter. All telephone attempt to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 56 year old female patient with hyperlipidemia, basal cell carcinoma and no drug reactions or allergies. On 07-JUN-2012, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneously (lot # 672559/1657AA, expiration date 21-JAN-2013). No other co-suspects were reported. Concomitant medications included: atorvastatin. The patient complained of swollen lips for the last 2 months, since approximately August 2012. The patient was recommended BENADRYL as a treatment for swollen lips. No laboratory tests were performed. The patient was feeling better since the day before (date of report 04-OCT-2012). At the time of the report the patient's outcome was recovering. The patient sought medical attention, called office. The relatedness for swollen lips was not reported for ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 02-OCT-2012, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 666029/1456Y, expiration date 06-AUG-2012) (dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered, No therapeutic response
Clinical narrative: The patients were vaccinated with 3 dose of RECOMBIVAX HB (Lot number unspecified) (vaccination site unknown) on an unknown date and not seroconvert. The nursing students had completed the 3 dose series and it had been greater than 6 months since completion. These nursing students were given additional 1 booster dose of hepatitis B vaccine (manufacture unspecified) and a repeat titer on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome was unknown. This is one of three reports from the same reporter. All telephone attempt to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On 04-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671021/0747AA, expiration date 18-AUG-2012) (dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a physician refers to a 74 years old female patient who with none drug reactions/allergies and none pertinent medical history. On 14-SEP-2012 the patient was vaccinated with ZOSTAVAX (one time injection) for shingles prevention. Concomitant medications included: antiviral (unspecified). On 20-SEP-2012 the patient experienced mild case of shingles, itching on her chin, up her left cheek and to her left ear, sensitivity on the back of her head. The patient had sought medical attention. Unspecific treatment was given to the patient. The lab diagnostics was not performed. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a 62 years old female patient regarding herself. The patient's medical history included asthma. Current conditions included penicillin allergy and sulfa allergy. On 10-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant medications included WELLBUTRIN XL, levocetirizine dihydrochloride, SINGULAIR, escitalopram and formoterol fumarate, DULERA. On 12-SEP-2012, the patient experienced a red circle and it itched a little. Later that developed into a rash around her arm. No laboratory tests were performed and no treatment was given. The outcome of the adverse event was reported as not recovered. The relatedness for the adverse event was unknown for ZOSTAVAX. The patient did not seek medical attention. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant, concerning an 83 year old female patient with lisinopril (manufacturer unknown) allergy. On 22-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot #: 665532/0711Z; Expiration date: 29-APR-2011). Concomitant medications included atenolol, triamterene HCTZ, amlodipine, losartan potassium (manufacturer unknown), aspirin, pyridoxine (Vitamin B6) and cholecalciferol (Vitamin D3). The medical assistant reported that on 07-SEP-2012 (also reported as a couple of weeks later after vaccination), the patient developed shingles (also reported as full blown shingles). The patient sought medical attention by contacting the physician. Valacyclovir, prednisone (manufacturer unknown), LIODERM patch and TYLENOL 3 were given as treatments for the event. At the time of the report, the patient was recovering from shingles. The relatedness of full blown shingles, and shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Episcleritis, Gastrointestinal viral infection, Incorrect route of drug administration, Ophthalmological examination abnormal, Respiratory tract infection viral
Clinical narrative: Information has been received from a female patient (an epidemiologist from the CDC) who reported that she received a dose of ZOSTAVAX (Merck) intramuscularly rather than subcutaneously on the morning of 06-OCT-2011. No adverse event reported. The patient sought no medical attention. Follow up information has been received from the HCP (Ph.D.) who reported on herself received the second dose of ZOSTAVAX (Merck) on an unspecified date (lot # and route not reported). The patient developed respiratory and gastrointestinal (GI) viral infection 1 weeks after receiving ZOSTAVAX (Merck) IM and both events were resolved, and then developed episcleritis 1 weeks after that (so 2 weeks after receiving ZOSTAVAX (Merck)). The patient was trying to resolve episcleritis as of now and was being seen by an ophthalmologist. Follow-up information was received via Vaccine Adverse Event Reporting System (VAERS) form from 61 year old female epidemiologist reporting on herself. Patient was vaccinated at a private doctor's office/hospital. The patient received a flu shot (manufacturer unknown) on her left arm on 04-OCT-2011. On 06-OCT-2011 the patient received first dose of ZOSTAVAX in her left arm muscle in the morning. Lot number of ZOSTAVAX not reported. Patient was well at the time of flu and shingles shots. Vaccine was administered in a private doctor's office/hospital. Patient also stated that an adverse event should be filed as she had a severe episcleritis in her right eye for half a year after her shingles shot. The event had resolved on approximately May 2012 (late spring of 2012). Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an "over 60 years old" female patient. "At a previous unspecified date" the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # not reported) subcutaneously. It was reported that "right after" the vaccination, the patient developed a rash at the injection site. The patient did not seek medical attention. And the patient treated herself with OTC antihistamines. The adverse event improved and the outcome of rash at the injection site was reported as recovered. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information was received from a physician regarding a 58 year old female patient. On 25SEP2012 she developed an injection site reaction following a vaccination with ZOSTAVAX. The injection site reaction was described on 26SEP2012 as red and swollen about 4 to 5 cm in diameter. The injection site reaction was still present 28SEP2012, but was about 1 cm in diameter. No other information was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Infection
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 61 years old female patient. The patient was vaccinated subcutaneously with lot # (672429/1606AA), 0.65 ml dose of ZOSTAVAX on 04-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient called the pharmacy on 06-OCT-2012 and said she had "an infection". The patient was calling it "cellulitis". On an unspecified date the patient went to see her primary care physician. The pharmacist did reach out to the primary care physician and was waiting to hear back from him. No treatment information was reported. The outcome of infection and cellulitis was unknown. The relatedness for cellulitis and infection was not provided for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from two registered pharmacists refers to a 70 years old female patient with fibromyalgia, asthma and allergic reaction to quinolones. The patient's medical history included hypertension. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # reported as 0709AE) IM on 03-OCT-2012. No other co-suspects were reported. Concomitant medications included: MOBIC. On the same date, the patient developed chills, fever, myalgia and pain after receiving PNEUMOVAX 23. The reporter mentioned the patient said she had so much pain she could not lift her arm. No treatment was given for the events. The pharmacist reported that the patient's fever and chills were gone but she still had arm pain. The outcome of myalgia was reported as not recovered/not resolved. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from two registered pharmacists refers to a 70 years old female patient with fibromyalgia, asthma and allergic reaction to quinolones. The patient's medical history included hypertension. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # reported as 0709AE) IM on 03-OCT-2012. No other co-suspects were reported. Concomitant medications included: MOBIC. On the same date, the patient developed chills, fever, myalgia and pain after receiving PNEUMOVAX 23. The reporter mentioned the patient said she had so much pain she could not lift her arm. No treatment was given for the events. The pharmacist reported that the patient's fever and chills were gone but she still had arm pain. The outcome of myalgia was reported as not recovered/not resolved. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Information was received from a female consumer who reported she received the ZOSTAVAX. The penetration of the needle in her arm irritated her skin and started to swell. No additional information was reported at that time. Later in the day the consumer called back. She received ZOSTAVAX and INFLUENZA (unspecified) on 25SEP2012. Later that night, she experienced itching and redness on her ZOSTAVAX shot arm. The redness was the diameter of a tennis ball, slightly raised, and felt like "fire ant bites". The next morning, the injection site was 8 inches long and 4 inches half wide. Half was bright red, half was a paler red and it was warm to the touch. In addition she described itchy prickles on hands and face. She said we could contact her HCP. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Sensory disturbance, Skin irritation, Swelling
Clinical narrative: Information was received from a female consumer who reported she received the ZOSTAVAX. The penetration of the needle in her arm irritated her skin and started to swell. No additional information was reported at that time. Later in the day the consumer called back. She received ZOSTAVAX and INFLUENZA (unspecified) on 25SEP2012. Later that night, she experienced itching and redness on her ZOSTAVAX shot arm. The redness was the diameter of a tennis ball, slightly raised, and felt like "fire ant bites". The next morning, the injection site was 8 inches long and 4 inches half wide. Half was bright red, half was a paler red and it was warm to the touch. In addition she described itchy prickles on hands and face. She said we could contact her HCP. No further information was provided. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female who was vaccinated with, 0.65 ml ZOSTAVAX (reported Lot# H011049; exp. 05-SEP-2013) on 19-SEP-2012. The pharmacist reported that the patient came down with shingles rash. The patient noticed red rash on her left hip on 26-SEP-2012. The pharmacist reported that the rash started dying up without any treatment. Additional information requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia intercostal, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 61 years old female patient with no drug reactions/allergies and no pertinent medical history, who on 02-OCT-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reported that on 03-OCT-2012, the patient developed rash on her triceps area after receiving a dose of ZOSTAVAX. The patient also developed 4 inches of redness at the injection site and muscle pain on her ribs. Ibuprofen was given as a treatment. The outcome of the events was reported as not recovered. The relatedness for rash on her triceps area, muscle pain on her ribs and 4 inches of redness at the injection site was unknown for ZOSTAVAX. No laboratory diagnostic studies were performed. The patient sought medical attention via calling the pharmacist. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female who received 2 doses of ZOSTAVAX. The pharmacist reported the first dose of ZOSTAVAX was administered on 04-DEC-2011 and the second dose of ZOSTAVAX (lot # 0364AE expiration 16-MAR-2013) was administered on 25-SEP-2012. No adverse events reported at this time. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot # H011333, expiration date: 06-SEP-2013) on 19-SEP-2012. On 19-SEP-2012, the patient developed a red, raised area about the size of her palm around the injection site following the vaccination with zoster vaccine liv. The pharmacist mentioned that the patient stated "the area feels tight". No treatment was given. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a patient (demographics not provided) with a history of lymph node removal. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX in December 2011 (dosage not provided). In December 2011, the ZOSTAVAX was given in an arm that had lymph nodes removed. No adverse effect was reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a 69 year old female consumer with allergy to codeine. Concomitant medications included blood pressure medication (unspecified), calcium, vitamins and vitamin D. On Thursday, 27-SEP-2012 the consumer was vaccinated with a dose of ZOSTAVAX in her left arm. A day later on 28-SEP-2012 the consumer had a high fever and a tingling sensation on her stomach. By Monday, 01-OCT-2012 she had red spots on her stomach. The consumer sought medical attention. Her doctor advised her it was a minor case of the "virus that causes the chicken pox." Treatments was not given. No further information was provided. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Induration, Injection site warmth, Local swelling, Pain
Clinical narrative: Left deltoid swelling, redness and hardness at injection site. Febrile.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Left deltoid swelling, redness and hardness at injection site. Febrile.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever started around 10:30 AM on 10/12/2012 and progressed. She was given Infants Advil around 12:00 PM. That helped lower the temp for a little while. At 5:00 PM her temp was 104*F. Her fever then went down to 99.8*F when taken at 11 PM.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Urticaria
Clinical narrative: Hive on the neck and face, swelling around the eyes.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Sudden fever of 102. Vomiting.
Age: 2.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Blood creatinine normal, Blood electrolytes normal, Blood urea normal, Body temperature increased, Convulsion
Clinical narrative: On 10/3 patient had temp 100.6 and started cough for 24 hours then back to normal.  Daughter had first seizure on 10/7, unresponsive for 10 seconds.  No fever and no prior history of seizures, seen in emergency room and sent home with no treatment.  On 10/9 experienced another seizure and was seen in ED, labs normal and EEG normal, sent home with a follow up neuro appt.  10/11 cough worsening, scratchy throat.  10/12 temp 99.9.
Age: 2.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Electroencephalogram normal, Haematocrit normal, Haemoglobin normal, Throat irritation
Clinical narrative: On 10/3 patient had temp 100.6 and started cough for 24 hours then back to normal.  Daughter had first seizure on 10/7, unresponsive for 10 seconds.  No fever and no prior history of seizures, seen in emergency room and sent home with no treatment.  On 10/9 experienced another seizure and was seen in ED, labs normal and EEG normal, sent home with a follow up neuro appt.  10/11 cough worsening, scratchy throat.  10/12 temp 99.9.
Age: 2.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Unresponsive to stimuli
Clinical narrative: On 10/3 patient had temp 100.6 and started cough for 24 hours then back to normal.  Daughter had first seizure on 10/7, unresponsive for 10 seconds.  No fever and no prior history of seizures, seen in emergency room and sent home with no treatment.  On 10/9 experienced another seizure and was seen in ED, labs normal and EEG normal, sent home with a follow up neuro appt.  10/11 cough worsening, scratchy throat.  10/12 temp 99.9.
Age: 2.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion, Cough, Grand mal convulsion, Pyrexia
Clinical narrative: On 10/3 patient had temp 100.6 and started cough for 24 hours then back to normal.  Daughter had first seizure on 10/7, unresponsive for 10 seconds.  No fever and no prior history of seizures, seen in emergency room and sent home with no treatment.  On 10/9 experienced another seizure and was seen in ED, labs normal and EEG normal, sent home with a follow up neuro appt.  10/11 cough worsening, scratchy throat.  10/12 temp 99.9.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm and swollen induration at the injection site.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Vaccine positive rechallenge, X-ray limb normal
Clinical narrative: This is the second year in a row this happened to me.  First incident was exactly the same in October 2010.  Arm of injection site sore, which continued to worsen and resulted in limited rotation of shoulder and searing pain for a year. Went to doctor in 2010 and saw no arthritis or any other reason for frozen shoulder. Gave cortisone shot which did not help.  Pain lessened by fall of 2010 and was almost back to normal until my next flu shot in 2011 where the same thing happened again.  One year of searing shoulder pain and limited rotation/mobility.  I was prompted to research this again as my work recently offered flu shots again this year.  I opted not to get a flu shot this year to test it out a third time and endure another year of pain that no one can figure out/provide relief for.  I'm actually feeling good now, one year post vaccination.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Dizziness, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, tiredness, nausea, hot and cold sweats.