chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Vaccination error
Clinical narrative: Information has been received from a registered nurse concerning a healthy 11 month old female who on 14-JUL-2009 was vaccinated with ROTATEQ, orally (unknown dose).  Concomitant medications and relevant past drug history are unknown.  The registered nurse reported that the patient was vaccinated accidentally.  It is unknown if the child experienced any adverse effects from this event.  It is unknown if any relevant laboratory testing was performed.  It is unknown if the child will receive any further ROTATEQ vaccination.  Follow-up information was received from the registered nurse indicating that she received a call from a medical assistant at a doctor's office in her county.  The medical assistant was the person that administered the dose in question and then realized her error and called the nurse to see what she should do.  The registered nurse indicated that the patient was an 11 month old male patient (previously reported as female by registered nurse).  No further information is available.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 6 month old patient who on 05-MAR-2009 was vaccinated with the first dose of ROTATEQ (lot number not reported).  On 16-JUL-2009 the patient was vaccinated with the second dose of ROTATEQ (lot number not reported).  There was no adverse effect reported.  Follow-up information has been received from a nurse practitioner who reported that the patient did not have exposure to ROTATEQ nor was there an adverse experience.  It was reported that they were checking on time between vaccines to ensure child could get all three dosages within time frame.  Additional information is not expected.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a nurse concerning a 19 week old male patient who on 07-JUL-2009 was vaccinated orally with the second dose of ROTATEQ (lot number 663264/1485X). In July 2009 the patient possibly developed a rotavirus-like infection. Unspecified medical attention was sought. It was unknown if there were lab studies performed. It was reported that the patient was "fine". The nurse's office was certain that this event was not related to ROTATEQ vaccine. No further information is available.
Age: 0.08
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Crying, Listless
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unknown date was vaccinated with a dose of ROTATEQ. Secondary suspect therapy included ROTATEQ which the patient concomitantly received with PREVNAR. It was reported that the patient had an adverse reaction to the above vaccines. The patient sought unspecified medical attention. The patient's final outcome was not reported. Follow-up information has been received from a consumer concerning her 8 weeks old daughter who in October 2007, was vaccinated with a dose of ROTATEQ (manufacturer unknown). Secondary suspect therapy included PREVNAR and PEDVAXHIB (manufacturer unknown). In October 2007 20 minutes after receiving the shots, the patient cried for 10 hours straight a day for months. The patient's mother called the physician's office and they treated her daughter for some kind of allergy, so the patient's mother had to watch what she ate as for she was nursing. In December 2007, the patient had just started to stop the crying and received "more shots". The patient immediately started crying and never stopped. She would not nurse. The patient's mother called the physician's office who recommended putting the patient on soy formula and MYLICON gas drops. The patient stopped the crying sessions at the end of January 2008. In February 2008, the patient got a "series of shots" and started up again. The patient's mother also stated that it was awful to see her child suffer, cry and then after 10 hours of crying, just see her laying there listless. The patient's mother was afraid her child would never wake-up the next morning, so she would lay on a floor next to her daughter's cribs, checking her to make sure she was breathing every 20 minutes. After that the patient's mother along with the office manager who gives shots and the doctor had a discussion. The physician recommended separating all the vaccines. So from February 2008 the patient has gotten all individual vaccines instead of combos. The patient has individually received the mumps vaccine (manufacturer unknown) and rubella vaccine (manufacturer unknown). The patient's mother stated her daughter has not received MMR and that she refuses to give her child the "chickenpox vaccine". It was also mentioned that the patient's mother wants her child vaccinated but in a controlled setting since she believes that her daughter had a reaction, because "colic babies do not stop being colic when you separate shots". Although her daughter's pediatrician "swears it was not due to a reaction" the patient's mother received information about two components in vaccines that would cause inconsolable crying. The patient's mother wants her child vaccinated with separate vaccines, so she and the doctors know which ones in particular her daughter has a reaction to. It was reported that the patient's pediatrician is going to wait until she goes to school to received MMR, unless she finds individual vaccines available. No further information is available.
Age: 0.85
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 10 month old male patient who on 23-Jul-2009 was vaccinated with the first dose of ROTATEQ (Lot # 663215/0571Y). No adverse symptoms noted. The patient sought medical attention. Follow-up information was received from the registered nurse concerning the 10 months male patient with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions who was vaccinated with ROTATEQ. No concomitant therapies were included. No adverse events were reported. No further information is requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of ROTATEQ at 16 weeks of age. There were no adverse effects reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect dose administered, Regurgitation
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old female patient with unknown drug allergies and a history of respiratory syncytial virus bronchiolitis at 2 months of age who received the first dose of ROTATEQ orally on 09-APR-2009 and the second dose (lot#663842/0068Y ) on 28-MAY-2009. On 27-JUL-2009, the patient was vaccinated with the third dose of ROTATEQ (lot#663842/0068Y ) and vomited after. The patient then was administered the fourth dose. There was no concomitant medication. The patient had sought unspecified medical attention. No laboratory diagnostic study was performed. On 27-JUL-2009, the patient recovered. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Client called 3/29/2010 - Stating she had a reaction to the H1N1 nasal mist - following vaccine develop itching and rash - Complains of intermittent itching and rash from vaccine - treated with BENADRYL- Now on ALLEGRA 180mg daily.
Age: 44.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Client called 3/29/2010 - Stating she had a reaction to the H1N1 nasal mist - following vaccine develop itching and rash - Complains of intermittent itching and rash from vaccine - treated with BENADRYL- Now on ALLEGRA 180mg daily.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Swelling face
Clinical narrative: patient states that she was having shortness of breath and facial swelling
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Urticaria
Clinical narrative: patient states that she was having shortness of breath and facial swelling
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Dyspnoea, Swelling face
Clinical narrative: patient states that she was having shortness of breath and facial swelling
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Erythema, induration, tenderness.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash generalised
Clinical narrative: MOTHER REFERS PATIENT PRESENTED WITH FEVER, SKIN REDNESS, RASH THROUGHOUT THE BODY LASTING 6 DAYS.
Sex: M
Vaccine: RAB
Symptoms: Animal bite, Gastrointestinal infection, Pyrexia
Clinical narrative: Initial physician report received on 01 Apr 2010: This patient received three vaccination of RABIPUR (batch number unknown) for post-exposure rabies prophylaxis due to cat bite on unspecified dates. The patient also received rabies immunoglobulins. On an unknown date, the patient experienced infection of intestine with fever. Outcome of the events was not reported. The physician did not suspect any causal relationship between the event and RABIPUR.
Age: 35.0
Sex: F
Vaccine: MEA
Symptoms: Fatigue, Myalgia, Rash maculo-papular, Rash vesicular
Clinical narrative: MUSCLE ACHES, FATIGUE, POSSIBLE FEVER FOLLOWED BY 1 VESICULAR SPOT ON 4/3 AND FEW MACULO PAPULAR SPOTS ON FACE, TRUNK AND ARMS ON 4/5.
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blood test, Dysphonia, Fatigue, Headache, Laryngoscopy
Clinical narrative: Headache at back of head where tenth cranial nerve is located. Tiredness.Dysphonia diagnosed. Vocal paralysis started right after shot.Three months later I still have the paralysis.
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Thyroid function test, Vocal cord paralysis
Clinical narrative: Headache at back of head where tenth cranial nerve is located. Tiredness.Dysphonia diagnosed. Vocal paralysis started right after shot.Three months later I still have the paralysis.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Pain, tenderness, swelling of arm
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Balance disorder, Computerised tomogram, Confusional state, Convulsion
Clinical narrative: Loss of balance, was unable to stand up.  Had severe nystagmus w/ unequal pupils.  Probable seizure lasted aprox 30 sec. Followed by 10-15 minutes of postictal behavior which included confusion, lack of speech.
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Dysstasia, Full blood count, Nystagmus, Postictal state, Pupils unequal
Clinical narrative: Loss of balance, was unable to stand up.  Had severe nystagmus w/ unequal pupils.  Probable seizure lasted aprox 30 sec. Followed by 10-15 minutes of postictal behavior which included confusion, lack of speech.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Received ROTATEQ on 3-31 came to office on 4-6-10 for diarrhea. Stool studies completed and positive for Rotavirus.
Age: 18.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pruritus, Rash pruritic
Clinical narrative: Patient presenteed with pruritic lesions on both shoulders. 3/15/10 lesions began to appear. Patient stated positive compliance with vaccine site care instructions no history of eczema of severe acne. Dx: vaccinia from vaccination, generalized.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Loss of consciousness, Tonic clonic movements
Clinical narrative: Dizzy, loss of consciousness x 30 seconds seizure - tonic clonic 30-60 sec. - oxygen provided and recovery vital signs monitored.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Patient reports severe flu-like sxs after receipt of ALL vaccinations in the past, most recent being the seasonal influenza vaccine in Nov09. Patient states he develops fever, myalgias and arthralgias and fatigue within 24 hours of receiving vaccines. Goes on quarters for 3 days after every vaccine according to patient. Only sought medical evaluation this year for the 1st time. Due Hep B and Tdap, will draw titers for tetanus Hep B surface antibody to see if immune. Symptoms: Fever(780.6), Generalized pain(780.96), malaise and fatigue NEC(780.79).
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Reaction to previous exposure to any vaccine
Clinical narrative: Patient reports severe flu-like sxs after receipt of ALL vaccinations in the past, most recent being the seasonal influenza vaccine in Nov09. Patient states he develops fever, myalgias and arthralgias and fatigue within 24 hours of receiving vaccines. Goes on quarters for 3 days after every vaccine according to patient. Only sought medical evaluation this year for the 1st time. Due Hep B and Tdap, will draw titers for tetanus Hep B surface antibody to see if immune. Symptoms: Fever(780.6), Generalized pain(780.96), malaise and fatigue NEC(780.79).
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Rhinorrhoea, Vomiting
Clinical narrative: 1/16/10 vomiting, runny nose, coughing, supportive care at home. Albuterol.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt. received vaccines on 11/30/09, then another set of vaccines on 12/14/09. Not enough time between sets of vaccines. Pt. parent reported no adverse reaction.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram, Blister, Migraine with aura, Rash, Visual impairment
Clinical narrative: 1. visual disturbances- unable to see clearly -3 or 4 occurances over 10 day period. Was seen by ophthalmologist and retina specialist and flouracin angiogram done. Diagnosis- ophthalmic migraine. 2. rash- line of 4-5 small blisters center of back and 1 on shoulder.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Had shots on 3/30. Started having redness and swelling on 4/1 to right arm. Visit to Dr. on 4-2-2010.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Red, hot, swollen, tender, hard to touch able to move arm to full capacity- but overall ROM is still very good.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Arthritis, Arthritis reactive, C-reactive protein increased, Condition aggravated
Clinical narrative: Service member currently at hospital for comprehensive evaluation for reactive arthritis that developed initially in Nov 06. Discussed history of symptom development in relation to vaccine receipt. Pt remembers that initial symptoms started in Nov 06 and that he had inflammation in the bilateral knees in Dec 06. History also reveals that pt seemed to flare after receipt of the anthrax #1 and smallpox vaccinations on 5 Apr 07. Pt has severe disease and is currently on enbrel, methotrexate, mobic and vicodin to try to control pain and inflammation. Has permanent joint damage in it wrist in spite of ongoing treatment with immune modulators.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pain, Red blood cell sedimentation rate increased, Rhesus antibodies negative
Clinical narrative: Service member currently at hospital for comprehensive evaluation for reactive arthritis that developed initially in Nov 06. Discussed history of symptom development in relation to vaccine receipt. Pt remembers that initial symptoms started in Nov 06 and that he had inflammation in the bilateral knees in Dec 06. History also reveals that pt seemed to flare after receipt of the anthrax #1 and smallpox vaccinations on 5 Apr 07. Pt has severe disease and is currently on enbrel, methotrexate, mobic and vicodin to try to control pain and inflammation. Has permanent joint damage in it wrist in spite of ongoing treatment with immune modulators.
Age: 29.0
Sex: F
Vaccine: ANTH, FLUN3
Symptoms: Autoantibody positive, Blood glucose increased, Feeling abnormal, Irritability, Sluggishness
Clinical narrative: Service member reporting that she developed Type 1 Diabetes in temporal association to receipt of anthrax vaccination #6 on 15 Sept 09. States she began to experience irritability, sluggishness, thirst and 'not feeling myself' over the next months. She was diagnosed in Feb '10 and has been followed by endocrine by out referral. Service member has learned that others have developed DM 1 and have linked it to receipt of the the anthrax vaccine.
Age: 29.0
Sex: F
Vaccine: ANTH, FLUN3
Symptoms: Thirst, Type 1 diabetes mellitus
Clinical narrative: Service member reporting that she developed Type 1 Diabetes in temporal association to receipt of anthrax vaccination #6 on 15 Sept 09. States she began to experience irritability, sluggishness, thirst and 'not feeling myself' over the next months. She was diagnosed in Feb '10 and has been followed by endocrine by out referral. Service member has learned that others have developed DM 1 and have linked it to receipt of the the anthrax vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, Erythema, pain both thighs.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest X-ray, Fatigue, Full blood count, Malaise, Metabolic function test
Clinical narrative: fatigue, aching, feeling sick, nausea
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Pain, Red blood cell sedimentation rate
Clinical narrative: fatigue, aching, feeling sick, nausea
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: C-reactive protein increased, Full blood count, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: T = 107 degrees; Exergen thermometer; verified axillary = 105 x 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Within 24 hrs. of receiving vaccine pt arm beam sore, swollen & red @ injection site/within 48 hours all symptom intensified with fever 101.1 & swollen axillary lymph nodes RX with ADVIL, given topical cream 4/5/10 all symp. improving by 4/7/10.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Blood test, Computerised tomogram, Gastrointestinal pain, Nausea
Clinical narrative: intestinal discomfort and pain, nausea, that increased episodically over time
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: intestinal discomfort and pain, nausea, that increased episodically over time
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pallor
Clinical narrative: Grew very pale after injection on 2/15/2008. 4/14/2008 grew very pale again without seizure. ? related to pertussis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Hives within 5 minutes of DTaP and IPV shots.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: Evening of inoculation developed significant arm pain at site of injection, fatigue, muscles aches, fever of 100 degrees, lymphadenopathy in groin. Next day had increasing fatigue, persistent fever, chilly. Then improved over 24 hours.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Evening of inoculation developed significant arm pain at site of injection, fatigue, muscles aches, fever of 100 degrees, lymphadenopathy in groin. Next day had increasing fatigue, persistent fever, chilly. Then improved over 24 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypokinesia, Musculoskeletal pain, Neck pain, Skin lesion
Clinical narrative: Information has been received from a physician concerning his 65 year old wife with chloramphenicol allergy who on 10-MAR-2010 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. On 15-MAR-2010 the patient developed red, raised lesions in the distribution of the right arm extending to the right elbow and forearm. The patient also developed pain in the right neck and shoulder which caused difficulty using her right hand. The patient was started on unspecified antiviral medication and NEURONTIN. There were no laboratory diagnostics studies performed. At the time of this report, the pain was slightly improved but the lesions persisted. Difficulty using her right hand was considered to be disabling by the physician. No further information is available.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Breast feeding, Drug exposure during pregnancy, Herpes zoster, Influenza like illness
Clinical narrative: Information has been received from a 29 year old female Pharmacy Technician for ZOSTAVAX (Merck), a Pregnancy Registry product, with drug reaction/allergy to MACROBID and a history of urinary tract infection, chickenpox when she was 1 or 2 years of age. The patient had been nursing her baby since August 2008 and was still nursing at the time of the report. It was reported that the Pharmacy Technician was mixing up a lot of doses of ZOSTAVAX (Merck) for the pharmacists to administered in January 2009 while she was pregnant. Concomitant therapy included unspecified prenatal vitamin. The Pharmacy Technician stated that approximately around 29-JAN-2009 she experienced a fever, aches, flu like symptoms, itchy back, and rash and blisters appeared. The Pharmacy Technician saw her physician on 29-JAN-2010 and he prescribed VALTREX. The patient stated that she did not take the VALTREX because she was pregnant at that time and did not feel comfortable taking VALTREX. The Pharmacy Technician stated that it took about 5 weeks approximately around the beginning of March 2009 before all those symptoms resolved. The Pharmacy Technician stated that she had not mixed up any ZOSTAVAX (Merck) since this had occurred in 2009. The Pharmacy Technician reported that last Monday 22-MAR-2010 she started feeling itchy on the collarbone and neck and by Saturday 27-MAR-2010 she developed shingles type rash. The Pharmacy Technician requested information on how her physician could culture the blister, rash to determine whether the rash was wild type shingles or shingles from exposure to ZOSTAVAX (Merck) since when she experienced the blisters and rash in January 2009 no one had sent it out for analysis to determine the exact cause of the blisters and rash. At the time of the report the patient had not recovered. The patient was scheduled to see the physician on 29-MAR-2010. Fever, aches, flu like symptoms, itchy back, rash and blisters were determined to be an other important medical events for the reporter due to VALTREX prescribed. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a 29 year old female Pharmacy Technician for ZOSTAVAX (Merck), a Pregnancy Registry product, with drug reaction/allergy to MACROBID and a history of urinary tract infection, chickenpox when she was 1 or 2 years of age. The patient had been nursing her baby since August 2008 and was still nursing at the time of the report. It was reported that the Pharmacy Technician was mixing up a lot of doses of ZOSTAVAX (Merck) for the pharmacists to administered in January 2009 while she was pregnant. Concomitant therapy included unspecified prenatal vitamin. The Pharmacy Technician stated that approximately around 29-JAN-2009 she experienced a fever, aches, flu like symptoms, itchy back, and rash and blisters appeared. The Pharmacy Technician saw her physician on 29-JAN-2010 and he prescribed VALTREX. The patient stated that she did not take the VALTREX because she was pregnant at that time and did not feel comfortable taking VALTREX. The Pharmacy Technician stated that it took about 5 weeks approximately around the beginning of March 2009 before all those symptoms resolved. The Pharmacy Technician stated that she had not mixed up any ZOSTAVAX (Merck) since this had occurred in 2009. The Pharmacy Technician reported that last Monday 22-MAR-2010 she started feeling itchy on the collarbone and neck and by Saturday 27-MAR-2010 she developed shingles type rash. The Pharmacy Technician requested information on how her physician could culture the blister, rash to determine whether the rash was wild type shingles or shingles from exposure to ZOSTAVAX (Merck) since when she experienced the blisters and rash in January 2009 no one had sent it out for analysis to determine the exact cause of the blisters and rash. At the time of the report the patient had not recovered. The patient was scheduled to see the physician on 29-MAR-2010. Fever, aches, flu like symptoms, itchy back, rash and blisters were determined to be an other important medical events for the reporter due to VALTREX prescribed. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: RV5
Symptoms: Laboratory test, Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a 15 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (lot # not reported). On an unspecified date the "patient developed rotavirus after getting ROTATEQ" and was hospitalized. Unspecified laboratory test was performed (result not provided). The patient sought unspecified medical attention. The outcome of developed rotavirus was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Broke out in hives all over body. Rash on my arm, fever. Went to ER told me to take BENADRYL. No medication was administered by ER. (Latex bandage was applied to her arm which has the risk for allergic reaction).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus, Vaccination complication
Clinical narrative: Took flu (seasonal) shot & had a reaction of red skin, itching, feeling hot - no swelling or constraints on breathing. (No site reaction).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, erythema, tenderness. Rx: PERIACTIN, PREDNISOLONE.
Age: 41.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dizziness, Hypertension, Tachycardia
Clinical narrative: lightheadedness, tachycardia, hypertension (190/110), transient
Age: 21.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, YF
Symptoms: Abdominal pain, Diarrhoea, Feeling abnormal, Muscle spasms, Nausea
Clinical narrative: Patient states one an half hour after taking the capsule she felt strange. Two hours after consuming the capsule, she started to experience severe abdominal pain and cramping until about 1:00 AM the next morning. She also had nausea, vomiting, and diarrhea.
Age: 21.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, YF
Symptoms: Vomiting
Clinical narrative: Patient states one an half hour after taking the capsule she felt strange. Two hours after consuming the capsule, she started to experience severe abdominal pain and cramping until about 1:00 AM the next morning. She also had nausea, vomiting, and diarrhea.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Gastroenteritis
Clinical narrative: After the patient went to bed on the day of the Tdap vaccination, he developed severe abdominal pain without nausea or vomiting.  Went to the ER the next day (03/23/2010).  Was prescribed a medication (he does not know name), and told he has gastroenteritis.  The problem had resolved by 03/24/2010.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLUX, PNC, RV5
Symptoms: Hypophagia, Irritability, Tremor
Clinical narrative: Increased irritability, tremors of arms, some decreased oral intake, lasted one day, then back to normal, no high fever
Age: 1.31
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Inappropriate schedule of drug administration
Clinical narrative: Contraindication to vaccine.   Vaccine licensed for 2-49 yrs old.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Glossodynia, Nausea, Rash
Clinical narrative: Zoster like rash left buttock, L heel, abdomen, nausea, fatigue, sensitive tongue. Rash and symptoms started one days after getting vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash pruritic, Skin lesion
Clinical narrative: Zoster like rash left buttock, L heel, abdomen, nausea, fatigue, sensitive tongue. Rash and symptoms started one days after getting vaccine.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Fatigue, Hallucination, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, hallucinations, sweats, fatigue
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Miscarriage
Age: 16.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Feeling abnormal, Insomnia, Joint stiffness, Mass, Mobility decreased
Clinical narrative: After the shot, a very sore arm with inability to lift it over 90 degrees to the side.  Increased soreness into next day (04/02/2010). Then about 6:00 PM that evening, noticed a Marble-sized ball of pain around the left clavicle, moveable up and over the clavicle and then it would slip below the clavicle, causing a sharp stabbing type pain and a "raw" feeling as any head movement or shoulder movement would drag the ball over the clavicle.  Difficult sleeping Friday night into Saturday Morning (04/03/2010).  Progressed pain and then stiffness up the left side of the neck to the jaw line.  Finally pain became too much and couldn't lie down w/o pain. Went to Urgent Care.  After eval. with Dr. and full history/exam, determined to be a reaction to the DPT Vacinnation, a swollen/inflamed lymph gland.  Was given two medications, a Vicodin (one pill only) and I believe a Restoril (sleeping pill) since my son was on second day of minimal sleep.  Released from Urgent Care @ 4:00 AM on Easter Sunday (04/04/2010)
Age: 16.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Swelling
Clinical narrative: After the shot, a very sore arm with inability to lift it over 90 degrees to the side.  Increased soreness into next day (04/02/2010). Then about 6:00 PM that evening, noticed a Marble-sized ball of pain around the left clavicle, moveable up and over the clavicle and then it would slip below the clavicle, causing a sharp stabbing type pain and a "raw" feeling as any head movement or shoulder movement would drag the ball over the clavicle.  Difficult sleeping Friday night into Saturday Morning (04/03/2010).  Progressed pain and then stiffness up the left side of the neck to the jaw line.  Finally pain became too much and couldn't lie down w/o pain. Went to Urgent Care.  After eval. with Dr. and full history/exam, determined to be a reaction to the DPT Vacinnation, a swollen/inflamed lymph gland.  Was given two medications, a Vicodin (one pill only) and I believe a Restoril (sleeping pill) since my son was on second day of minimal sleep.  Released from Urgent Care @ 4:00 AM on Easter Sunday (04/04/2010)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pain of skin, Pruritus
Clinical narrative: Patient noticed skin tenderness on right breast. Itching and pain increased in initial affected area but began symptoms on back and armpit. ER visit on 3/28/2010. Diagnosed with Active shingles case and treated with valacyclovir 1 gm bid x10d. Contacted our pharmacy 4/7/2010 to report her adverse event. Report entered 4/7
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: (R) thigh redness, indurated, swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had 2x3 cm patch of redness that was hot to the touch at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4 year old female had vaccines 3/21/10 RA in pain, swollen redness around administered area, hot to touch fussy. Right arm Cellulitis Amoxicillin give.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Irritability
Clinical narrative: 4 year old female had vaccines 3/21/10 RA in pain, swollen redness around administered area, hot to touch fussy. Right arm Cellulitis Amoxicillin give.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Oedema peripheral, Pain, Pain in extremity, Tenderness
Clinical narrative: (L) arm very tender & sore to movement or touch. No redness or swelling. Pt has no fever or any other S o Sx. Pt has routine MD appt tomorrow 3/18/10 and will consult with MD at the visit arm tender since 3/11 w/out worsening on oral antibiotics. 4/7/10 better but still pain & slightly swollen. Seeing improvement.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan
Clinical narrative: (L) arm very tender & sore to movement or touch. No redness or swelling. Pt has no fever or any other S o Sx. Pt has routine MD appt tomorrow 3/18/10 and will consult with MD at the visit arm tender since 3/11 w/out worsening on oral antibiotics. 4/7/10 better but still pain & slightly swollen. Seeing improvement.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Chest X-ray normal, Convulsion, Dyskinesia, Gaze palsy, Laboratory test normal
Clinical narrative: Patient given MMR, Polio, Daptcal, in morning. He then went to daycare where at 12:15pm daycare worker found him jerking in the arms and legs with eyes upward. No incontinence or tongue biting seizure was 2 minutes. Taken to ER by amb. IV started labs and chest x-ray normal. Pt had a 5 minute seizure approximately 3 hrs. after immunizations were administered. At the hospital, blood was drawn and chest X-rays done. No findings.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Culture throat positive, Neck pain, Pyrexia, Vomiting
Clinical narrative: 11 year old with fever of 103 yesterday. Vomiting x 5 yesterday and neck pain since yesterday. Fever and vomiting have resolved but still having neck pain.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, C-reactive protein increased, Diet refusal, Irritability, Lethargy
Clinical narrative: Temp of 105, fussy began the evening of 4/5 awake all night screaming. Refuses solid foods not nursing well, increasing lethargy.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Screaming
Clinical narrative: Temp of 105, fussy began the evening of 4/5 awake all night screaming. Refuses solid foods not nursing well, increasing lethargy.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Blood culture, C-reactive protein, Crying, Culture urine, Full blood count
Clinical narrative: Temp of 105, fussy began the evening of 4/5 awake all night screaming. Refuses solid foods not nursing well, increasing lethargy.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Lethargy, Lumbar puncture, Pyrexia, Somnolence, Unresponsive to stimuli
Clinical narrative: Temp of 105, fussy began the evening of 4/5 awake all night screaming. Refuses solid foods not nursing well, increasing lethargy.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Urine analysis
Clinical narrative: Temp of 105, fussy began the evening of 4/5 awake all night screaming. Refuses solid foods not nursing well, increasing lethargy.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: 1 day after receiving Tetanus Booster, patient developed a quarter size hard lump at site of inj. She described the site a itchy red and hot.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Dyspnoea, Influenza like illness
Clinical narrative: Report received from a consumer regarding her female friend on 30-MAR-2010. The 68 year-old-female (DOB: unknown) received an unspecified flu vaccine (manufacturer unknown), PNEUMOVAX, and ZOSTAVAX on the same day in approximately Dec-2009. Approximately 4 days later, she developed severe joint pain and swelling. Her medical history included lymphoma, and "recent" chemotherapy and radiation therapy before vaccination. The patient subsequently called to report that, in Oct-2009, she received the flu vaccine (manufacturer unknown) and ZOSTAVAX at the same time. Her oncologist advised her it was "OK" to get the vaccine despite reading that ZOSTAVAX was contraindicated in lymphoma patients. A few days after receiving the vaccines, she developed flu-like symptoms-aching, coughing up phlegm, a runny nose, sore throat, etc. Her primary care physician prescribed unspecified antibiotics. She also experienced joint pain, and swelling in her knee, wrist and shoulder. She also experienced joint pain and swelling in her knees, wrist and shoulder, shortness of breath, vomiting, abdominal pain, and chills. She was diagnosed with possible rheumatoid arthritis and was given one Cortisone shot which relieved her symptoms for a few days. She was then diagnosed with possible Lyme disease. At the time of reporting, her physician thought she might have rheumatoid arthritis or recurring lymphoma based on the results of the PET scan (not further specified). The patient had not recovered. No further information is expected. This was originally reported to Merck & Co., Inc. (case # 1003USA01549). This case was considered as serious by the company due to medical significance. The company considered events possible to the suspect drug, flu vaccine. Information derived from this AE report does not change the current safety profile of the product.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Joint swelling, Lymphoma, Oropharyngeal pain, Pain, Positron emission tomogram
Clinical narrative: Report received from a consumer regarding her female friend on 30-MAR-2010. The 68 year-old-female (DOB: unknown) received an unspecified flu vaccine (manufacturer unknown), PNEUMOVAX, and ZOSTAVAX on the same day in approximately Dec-2009. Approximately 4 days later, she developed severe joint pain and swelling. Her medical history included lymphoma, and "recent" chemotherapy and radiation therapy before vaccination. The patient subsequently called to report that, in Oct-2009, she received the flu vaccine (manufacturer unknown) and ZOSTAVAX at the same time. Her oncologist advised her it was "OK" to get the vaccine despite reading that ZOSTAVAX was contraindicated in lymphoma patients. A few days after receiving the vaccines, she developed flu-like symptoms-aching, coughing up phlegm, a runny nose, sore throat, etc. Her primary care physician prescribed unspecified antibiotics. She also experienced joint pain, and swelling in her knee, wrist and shoulder. She also experienced joint pain and swelling in her knees, wrist and shoulder, shortness of breath, vomiting, abdominal pain, and chills. She was diagnosed with possible rheumatoid arthritis and was given one Cortisone shot which relieved her symptoms for a few days. She was then diagnosed with possible Lyme disease. At the time of reporting, her physician thought she might have rheumatoid arthritis or recurring lymphoma based on the results of the PET scan (not further specified). The patient had not recovered. No further information is expected. This was originally reported to Merck & Co., Inc. (case # 1003USA01549). This case was considered as serious by the company due to medical significance. The company considered events possible to the suspect drug, flu vaccine. Information derived from this AE report does not change the current safety profile of the product.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Productive cough, Rheumatoid arthritis, Rhinorrhoea, Vomiting
Clinical narrative: Report received from a consumer regarding her female friend on 30-MAR-2010. The 68 year-old-female (DOB: unknown) received an unspecified flu vaccine (manufacturer unknown), PNEUMOVAX, and ZOSTAVAX on the same day in approximately Dec-2009. Approximately 4 days later, she developed severe joint pain and swelling. Her medical history included lymphoma, and "recent" chemotherapy and radiation therapy before vaccination. The patient subsequently called to report that, in Oct-2009, she received the flu vaccine (manufacturer unknown) and ZOSTAVAX at the same time. Her oncologist advised her it was "OK" to get the vaccine despite reading that ZOSTAVAX was contraindicated in lymphoma patients. A few days after receiving the vaccines, she developed flu-like symptoms-aching, coughing up phlegm, a runny nose, sore throat, etc. Her primary care physician prescribed unspecified antibiotics. She also experienced joint pain, and swelling in her knee, wrist and shoulder. She also experienced joint pain and swelling in her knees, wrist and shoulder, shortness of breath, vomiting, abdominal pain, and chills. She was diagnosed with possible rheumatoid arthritis and was given one Cortisone shot which relieved her symptoms for a few days. She was then diagnosed with possible Lyme disease. At the time of reporting, her physician thought she might have rheumatoid arthritis or recurring lymphoma based on the results of the PET scan (not further specified). The patient had not recovered. No further information is expected. This was originally reported to Merck & Co., Inc. (case # 1003USA01549). This case was considered as serious by the company due to medical significance. The company considered events possible to the suspect drug, flu vaccine. Information derived from this AE report does not change the current safety profile of the product.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Cough, Dyspnoea
Clinical narrative: Report received from a consumer regarding her female friend on 30-MAR-2010. The 68 year-old-female (DOB: unknown) received an unspecified flu vaccine (manufacturer unknown), PNEUMOVAX, and ZOSTAVAX on the same day in approximately Dec-2009. Approximately 4 days later, she developed severe joint pain and swelling. Her medical history included lymphoma, and "recent" chemotherapy and radiation therapy before vaccination. The patient subsequently called to report that, in Oct-2009, she received the flu vaccine (manufacturer unknown) and ZOSTAVAX at the same time. Her oncologist advised her it was "OK" to get the vaccine despite reading that ZOSTAVAX was contraindicated in lymphoma patients. A few days after receiving the vaccines, she developed flu-like symptoms-aching, coughing up phlegm, a runny nose, sore throat, etc. Her primary care physician prescribed unspecified antibiotics. She also experienced joint pain, and swelling in her knee, wrist and shoulder. She also experienced joint pain and swelling in her knees, wrist and shoulder, shortness of breath, vomiting, abdominal pain, and chills. She was diagnosed with possible rheumatoid arthritis and was given one Cortisone shot which relieved her symptoms for a few days. She was then diagnosed with possible Lyme disease. At the time of reporting, her physician thought she might have rheumatoid arthritis or recurring lymphoma based on the results of the PET scan (not further specified). The patient had not recovered. No further information is expected. This was originally reported to Merck & Co., Inc. (case # 1003USA01549). This case was considered as serious by the company due to medical significance. The company considered events possible to the suspect drug, flu vaccine. Information derived from this AE report does not change the current safety profile of the product.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Increased upper airway secretion, Influenza like illness, Joint swelling, Oropharyngeal pain, Pain
Clinical narrative: Report received from a consumer regarding her female friend on 30-MAR-2010. The 68 year-old-female (DOB: unknown) received an unspecified flu vaccine (manufacturer unknown), PNEUMOVAX, and ZOSTAVAX on the same day in approximately Dec-2009. Approximately 4 days later, she developed severe joint pain and swelling. Her medical history included lymphoma, and "recent" chemotherapy and radiation therapy before vaccination. The patient subsequently called to report that, in Oct-2009, she received the flu vaccine (manufacturer unknown) and ZOSTAVAX at the same time. Her oncologist advised her it was "OK" to get the vaccine despite reading that ZOSTAVAX was contraindicated in lymphoma patients. A few days after receiving the vaccines, she developed flu-like symptoms-aching, coughing up phlegm, a runny nose, sore throat, etc. Her primary care physician prescribed unspecified antibiotics. She also experienced joint pain, and swelling in her knee, wrist and shoulder. She also experienced joint pain and swelling in her knees, wrist and shoulder, shortness of breath, vomiting, abdominal pain, and chills. She was diagnosed with possible rheumatoid arthritis and was given one Cortisone shot which relieved her symptoms for a few days. She was then diagnosed with possible Lyme disease. At the time of reporting, her physician thought she might have rheumatoid arthritis or recurring lymphoma based on the results of the PET scan (not further specified). The patient had not recovered. No further information is expected. This was originally reported to Merck & Co., Inc. (case # 1003USA01549). This case was considered as serious by the company due to medical significance. The company considered events possible to the suspect drug, flu vaccine. Information derived from this AE report does not change the current safety profile of the product.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Positron emission tomogram abnormal, Rhinorrhoea, Vomiting
Clinical narrative: Report received from a consumer regarding her female friend on 30-MAR-2010. The 68 year-old-female (DOB: unknown) received an unspecified flu vaccine (manufacturer unknown), PNEUMOVAX, and ZOSTAVAX on the same day in approximately Dec-2009. Approximately 4 days later, she developed severe joint pain and swelling. Her medical history included lymphoma, and "recent" chemotherapy and radiation therapy before vaccination. The patient subsequently called to report that, in Oct-2009, she received the flu vaccine (manufacturer unknown) and ZOSTAVAX at the same time. Her oncologist advised her it was "OK" to get the vaccine despite reading that ZOSTAVAX was contraindicated in lymphoma patients. A few days after receiving the vaccines, she developed flu-like symptoms-aching, coughing up phlegm, a runny nose, sore throat, etc. Her primary care physician prescribed unspecified antibiotics. She also experienced joint pain, and swelling in her knee, wrist and shoulder. She also experienced joint pain and swelling in her knees, wrist and shoulder, shortness of breath, vomiting, abdominal pain, and chills. She was diagnosed with possible rheumatoid arthritis and was given one Cortisone shot which relieved her symptoms for a few days. She was then diagnosed with possible Lyme disease. At the time of reporting, her physician thought she might have rheumatoid arthritis or recurring lymphoma based on the results of the PET scan (not further specified). The patient had not recovered. No further information is expected. This was originally reported to Merck & Co., Inc. (case # 1003USA01549). This case was considered as serious by the company due to medical significance. The company considered events possible to the suspect drug, flu vaccine. Information derived from this AE report does not change the current safety profile of the product.