chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2013US016490 is an initial spontaneous report received from a physician on 01 Aug 2013: This report refers to a male child. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: M12096) intramuscularly on 29 Jul 2013. On 31 Jul 2013, he experienced redness and swelling from the injection site to the elbow. No further information about seriousness, outcome and causality was reported.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2013US017041 is an initial spontaneous report received from a consumer on 08 Aug 2013 with a follow up information received from the physician on 27 Aug 2013. This report refers to a 19-years-old female patient. It was reported that she was healthy. Her medical history included allergies and concomitant medications were not reported. Her vaccination status was up to date and she was previously administered MENACTRA (other manufacturer, batch number: not reported) which was well tolerated. She was vaccinated with MENVEO (batch  number: not reported) at a dose of 0.5 ml intramuscularly in the right arm on 05 Aug 2013. She also concomitantly received GARDASIL (other manufacturer, batch number: not reported) in left arm on 05 Aug 2013. It was reported that on the same day evening, the injection site of her right arm was red, warm to touch and swollen about 2 inches oval shaped. It was reported that it hurt to touch the vaccination site, but she was able to move her arm. The outcome of the event was reported as complete recovery. No further information was provided. Follow up information received from physician on 27 Aug 2013: Physician was added as primary reporter, patient demographics (height and weight), medical history and vaccination history, dose of vaccine and event outcome updated.
Age: 36.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2013US018827 is an initial spontaneous report received from a nurse on 05 Sep 2013. This report refers to a 36-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11082) intramuscularly in the deltoid on 23 Aug 2013. It was reported that on the same date she experienced pain and soreness in the injection site (deltoid/shoulder area). The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2013US020416, is an initial spontaneous report received from a medical assistant on 27 Sep 2013. This case refers to an 11-years-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: not reported), at a dose of 0.5 ml intramuscularly on 04 Sep 2013. Within 48-hours after vaccination, she experienced redness, swelling and warmth to touch at the injection site. The seriousness, outcome and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2013US020421, is an initial spontaneous report received from a medical assistant on 27 Sep 2013. This case refers to an 11-years-old male patient. past medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: not reported), at a dose of 0.5 ml intramuscularly, sometime in Jul 2012. Within 48-hours after vaccination, he experienced redness, swelling and warmth to touch at the injection site. The seriousness, outcome and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: DTAP, FLU3, MNQ
Symptoms: Dizziness
Clinical narrative: Case number PHEH2013US020956 is an initial spontaneous report received from the medical assistant on 04 Oct 2013 with a follow up information received from the medical assistant on 05 Nov 2013. This report refers to a female child patient who was of 11-12 years of age. She had no recent injury, no allergic reactions and allergy to medications. She had a history of lactose intolerance, intestinal disaccharide deficiency and vitiligo. Her current conditions included sore throat, cough, congestion, headache and watery eyes and concomitant medications were not reported. Her vaccination history included administration of varicella virus vaccine (other manufacturer, batch number: not reported), MMR (other manufacturer, batch number: not reported) and HIB-PRP-T (other manufacturer, batch number: not reported) on 08 Nov 2002, DTaP (other manufacturer, batch number: not reported) and PCV13 (other manufacturer, batch number: not reported) on 31 Jan 2003, hepatitis A vaccine (other manufacturer, batch number: not reported), varicella vaccine (other manufacturer, batch number: not reported), DTaP (other manufacturer, batch number: not reported) and MMR (other manufacturer, batch number: not reported) on 23 Mar 2007, hepatitis A vaccine (other manufacturer, batch number: not reported) on 06 Aug 2009, H1N1 flu vaccine (unknown manufacturer, batch number: not reported) in 23 Nov 2009 and seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in 23 Dec 2009. She was vaccinated with 0.5 ml of MENVEO (batch number: A12114, expiry date: 31 Aug 2014) intramuscularly in the right arm on 03 Oct 2013. She also received influenza vaccine (other manufacturer, batch number: UHB99AA, expiry date: 30 Jun 2014) and Tdap (other manufacturer, batch number: U4617AA, expiry date: 22 Oct 2015) on the same date. On an unknown date after vaccination, she experienced lightheadedness and dizziness. Her vital signs were checked and were normal. Physical examination was done and the findings were normal. The events outcome was reported as complete recovery. The seriousness and causality were not reported. No additional information was available. Follow up information received from the medical assistant on 05 Nov 2013: Patient demographics (height and weight), laboratory data, vaccination history, suspect vaccines, site of vaccination, outcome of the event updated.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: Case number PHEH2013US021212 is an initial spontaneous report received from a consume on 09 Oct 2013. This report refers to an 18-year-old female patient. Her medical history included latex allergy. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 08 Oct 2013 at the college in medical facility. On the same day, she had vomited and was nauseated. Her mother stated that her daughter vomited approximately 10 hours after receiving MENVEO. She was still nauseated as of 09 Oct 2013. Final outcome of the events was unknown. No other information was provided.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Case number PHEH2013US023416 is an initial spontaneous report received from a health care professional on 04 Nov 2013. This report refers to a 12-year-old female patient. She was vaccinated with MENVEO, (batch number: M11081) intramuscularly on an unspecified date. On 08 Oct 2013, she experienced redness, swelling and pain at injection site. She also had big red welts on arm, hot to touch with golf ball to orange size. Outcome of the events was unknown. No seriousness and causality was reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Case number PHEH2013US023416 is an initial spontaneous report received from a health care professional on 04 Nov 2013. This report refers to a 12-year-old female patient. She was vaccinated with MENVEO, (batch number: M11081) intramuscularly on an unspecified date. On 08 Oct 2013, she experienced redness, swelling and pain at injection site. She also had big red welts on arm, hot to touch with golf ball to orange size. Outcome of the events was unknown. No seriousness and causality was reported.
Sex: U
Vaccine: MNQ
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2013US024198 is an initial spontaneous report received from a consumer via a claim examiner on 18 Nov 2013: This report refers to a patient of unknown age and gender. She was vaccinated with MENVEO (batch number: A13011 and expiry date: Sep 2014) on 07 Nov 2013 and experienced allergic reaction on an undetermined date. No further information about outcome, seriousness and causality was reported.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Case number PHEH2014US002352 is an initial spontaneous report from the medical assistant received on 31 Jan 2014. This report refers to a 13-year-old male patient. He was vaccinated with MENVEO, (batch number: M13051, expiry date: May 2015) at a dose of 0.5 ml intramuscularly on 20 Jan 2014. On 21 Jan 2014, he experienced 12x12 cm of red welt near the injection site. The outcome of the event reported as not recovered. The events reported as non serious. The causality of the events was not reported.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2014US002948 is an initial spontaneous report received from a nurse on 10 Feb 2014. This report refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of MENVEO, (batch number: A13013, expiry date: Sep 2014) intramuscularly on 07 Feb 2014. On the same day, post vaccination, she experienced swelling, pain, hardness and redness at the injection site. Outcome of the events was reported as condition unchanged at the time of this report. Seriousness and causality of the events was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2014US002953 is an initial spontaneous report received from a nurse on 10 Feb 2014. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml dose of MENVEO (batch number: A13013, expiry date: Sep 2014) intramuscularly on 07 Feb 2014. On the same day, post vaccination, he experienced swelling, pain, hardness and redness at the injection site. Outcome of the events was reported as condition unchanged at the time of this report. Seriousness and causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Loss of consciousness, Somnolence, Urine analysis
Clinical narrative: At approx 1130 am 2/11/15 I passed out at the abuse shelter. Staff unable to wake me. Taken to ER-heart monitored and IV fluids administered. Discharged between 2-3 pm.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Culture, Rash
Clinical narrative: Pt presented to urgent care with c/o rash on left arm as a result of PCV13 given 1/29/15 appointment. Patient evaluated 1/29/15 by Dr. for adverse reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, concerning 2 patients of an unknown age and gender. Medical history and current conditions were not reported. On 27-JAN-2015, the patients were vaccinated with a dose of VARIVAX (Merck) (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous route, that had been improperly stored. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Hep A #2 given IM-RT, Varicella #2 given SQ-back of RT-Mother noted golf ball size-red hard swelling at back of RT on 2-11-15.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling of extremity - moderate.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Differential white blood cell count normal, Full blood count normal, Respiratory distress
Clinical narrative: C/O chest tightness, coughing, wheezing in obvious distress. Taken to ER. Given Epi 0.2mg SQ and SOLUMEDROL 250mg IV, BENADRYL 50mg and Albuterol nebulizer treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: C/O chest tightness, coughing, wheezing in obvious distress. Taken to ER. Given Epi 0.2mg SQ and SOLUMEDROL 250mg IV, BENADRYL 50mg and Albuterol nebulizer treatment.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Itchy papular rash several hours after receiving PREVNAR-13 vaccination. Scattered mildly erythematous papules on the arms and upper chest.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Eye irritation, Hyperhidrosis, Irritability, Muscle twitching
Clinical narrative: This spontaneous report was received from a patient's mother concerning a 2 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. The reporter stated that there was history of other family members having unspecified adverse effects. On 02-FEB-2015 the patient was vaccinated with M-M-R II (1 single shot, route unspecified) (lot number: K009956 with expiry date 14-JUL-2016). Concomitant medications were not reported. On unknown date in February 2015 the patient experienced sore throat, lack of appetite, sweats, irritability, fever of 102.8 Fahrenheit, muscle twitching and keeps rubbing his eye. No treatment was given for the adverse events. The patient sought medical attention by speaking with the physician. The outcome of the events was reported as not recovered/not resolved. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous report was received from a patient's mother concerning a 2 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. The reporter stated that there was history of other family members having unspecified adverse effects. On 02-FEB-2015 the patient was vaccinated with M-M-R II (1 single shot, route unspecified) (lot number: K009956 with expiry date 14-JUL-2016). Concomitant medications were not reported. On unknown date in February 2015 the patient experienced sore throat, lack of appetite, sweats, irritability, fever of 102.8 Fahrenheit, muscle twitching and keeps rubbing his eye. No treatment was given for the adverse events. The patient sought medical attention by speaking with the physician. The outcome of the events was reported as not recovered/not resolved. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. The patient was administered the first dose of RECOMBIVAX HB 02-JUL-1993, the second dose on 04-NOV-1993, the third dose 10-MAY-1995. The patient was inadvertently administered fourth dose of RECOMBIVAX HB on 15-OCT-2014. No adverse effects reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. Additional information is not expected as the reporter did not wish to contact.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US003645, is an initial spontaneous report received form a nurse on 08 Feb 2013, and with a follow up report received on 12 Mar 2013. This report refers to 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M10130), at a dose of 0.5 ml IM into right arm on 08 Feb 2013 at 8:30 am. He received MenCWY liquid conjugate component only, instead of being reconstituted with MenA. No adverse reaction was reported. Follow up report received on 12 Mar 2013. Dose and site of vaccination updated.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report was received on 08 February 2015 from a consumer, who is also the patient. A female patient (date of birth not reported) with a history of asthma had received on an unspecified date a QIV influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, developed the flu. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Chills, Cyanosis, Fatigue, Irritability
Clinical narrative: Tired, Irritable, Clingy, Fever, Shivers, teeth chattering, and lips turned blue in warm bath, Breathing speeds up and slows down.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Respiratory rate decreased, Respiratory rate increased
Clinical narrative: Tired, Irritable, Clingy, Fever, Shivers, teeth chattering, and lips turned blue in warm bath, Breathing speeds up and slows down.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute lymphocytic leukaemia, Chills, Diarrhoea, Hypoxia, Influenza like illness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male "immunocompromised" patient with chronic myeloid leukemia (CML) for 10 years. It was not specified how long the patient has been immunocompromised. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were unspecified). Concomitant therapies included atenolol and nifedipine (reported as "nisedipine"). On approximately 07-FEB-2015 (reported as "4 days ago"), the patient experienced "flu-like symptoms" such as chills, loose stools, hypoxemia, and pericardial friction rub. On 08-FEB-2015, the patient was admitted to hospital due to those symptoms. Since being in the hospital, he had had unspecified labs and diagnostic studies performed and received intravenous acyclovir as well as intravenous doxycycline and acetaminophen for fever/chills (on an unknown date in February 2015). The pharmacist also reported that the patient was going to be undergoing induction therapy on an unspecified date for acute lymphatic leukemia (ALL) which was diagnosed on an unknown date. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. The reporting pharmacist considered the symptoms that the patient developed with being "immunocompromised" including: "flu-like symptoms"/fever/chills, loose stools, hypoxemia and pericardial friction rub to be life-threatening. Upon internal review acute lymphocytic leukemia (ALL) was considered to be medically significant. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Pericardial rub, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male "immunocompromised" patient with chronic myeloid leukemia (CML) for 10 years. It was not specified how long the patient has been immunocompromised. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were unspecified). Concomitant therapies included atenolol and nifedipine (reported as "nisedipine"). On approximately 07-FEB-2015 (reported as "4 days ago"), the patient experienced "flu-like symptoms" such as chills, loose stools, hypoxemia, and pericardial friction rub. On 08-FEB-2015, the patient was admitted to hospital due to those symptoms. Since being in the hospital, he had had unspecified labs and diagnostic studies performed and received intravenous acyclovir as well as intravenous doxycycline and acetaminophen for fever/chills (on an unknown date in February 2015). The pharmacist also reported that the patient was going to be undergoing induction therapy on an unspecified date for acute lymphatic leukemia (ALL) which was diagnosed on an unknown date. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. The reporting pharmacist considered the symptoms that the patient developed with being "immunocompromised" including: "flu-like symptoms"/fever/chills, loose stools, hypoxemia and pericardial friction rub to be life-threatening. Upon internal review acute lymphocytic leukemia (ALL) was considered to be medically significant. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Blood culture, Blood test, Pyrexia, Seizure like phenomena
Clinical narrative: Information has been received from a pharmacist on 10-FEB-2015, concerning a 12 month old male patient with gastric reflux and no known allergies. The patient's medical history included eczema and ear infection. On 04-FEB-2015 the patient was vaccinated with a dose of M-M-R II (lot # K005574, expiration date 17-APR-2016) (dose and route unspecified). Concomitant therapies included omeprazole. On 09-FEB-2015, the patient experienced seizure-like movements and 101F fever and went to an emergency department on 10-FEB-2015 at 12:11. The patient was treated for the seizure-like movements with DILANTIN, phenobarbital, VERSED, and lorazepam, and he was transported to another hospital at 02:24 on 10-FEB-2015, by flight transport to be admitted for further evaluation. The patient underwent blood culture and other unspecified blood tests without results. The pharmacist requested a lot check for the lot of M-M-R II that the patient received. The outcome of events was unknown. The pharmacist considered the event seizure-like movements to be medical significant due to "normally, patients don't get put on a VERSED infusion and then flown to another hospital to be admitted". This is one of several reports from same source. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Seizure
Clinical narrative: Information has been received from both pharmacist and a nurse referring to a 1 year old male patient. The patient's medical history and drug reactions/allergies were not reported. On 10-NOV-2014 the patient was vaccinated with M-M-R II injection (dose, frequency, route and lot# were not unspecified) at unspecified clinic. On 09-FEB-2015, the patient was vaccinated with other suspect vaccines which included PENTACEL (manufacturer unspecified) and PREVNAR 13 (manufacturer unspecified). Then the patient went to the emergency department to seek medical attention for seizure-like activity on the same day. The patient was not admitted to the hospital, but he was discharged to home. The nurse stated that the patient received PENTACEL and PREVNAR 13 before he had the seizure. The nurse did not think M-M-R II caused the patient's seizure for considering he received it 3 months ago. However the patient did receive other vaccines on 09-FEB-2015 and then he had the seizure following them. The outcome of the event was not reported. Upon internal review, seizure was considered to be medically significant. This is one of several reports from same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received BOOSTRIX (batch number 4P724, expiry date 1st October 2015. Previously administered products included dtpa vaccine (dose 1, 2 and 3). On an unknown date, the patient received the 4th dose of BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: RN reports inadvertent administration of BOOSTRIX to a 15 month old as dos 4 in the DTaP series.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Motor dysfunction, Neck pain
Clinical narrative: Client states arm hurt when shot was given and continued to ache and in the following 2 weeks the painful area included her left shoulder and neck and whole left arm. She states the shoulder and neck pain stopped about 2 weeks ago, but the arm pain continues.  Also states it has affected her motor skills in left hand, as her fingers feel tingly and numb.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Client states arm hurt when shot was given and continued to ache and in the following 2 weeks the painful area included her left shoulder and neck and whole left arm. She states the shoulder and neck pain stopped about 2 weeks ago, but the arm pain continues.  Also states it has affected her motor skills in left hand, as her fingers feel tingly and numb.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash morbilliform
Clinical narrative: Patient developed raised red morbiliform rash. Reportedly started on face. By the time of the visit has spread to upper extremities and shoulders. Otherwise well, afebrile.
Age: 30.0
Sex: F
Vaccine: ANTH, MMR, TYP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Unknown, patient is following with OB/GYN at this time, received anthrax vaccination while pregnant, currently 35 weeks at this time.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Rash generalised, Rash papular, Varicella post vaccine
Clinical narrative: Dx with varicella. Visit date for generalized papular vesicular rash to Medical Center was 22 days after vv1. Rash onset unknown. The character of symptoms is not redness and not oozing. Mom picked him up from dad's on 5/13 and the child had the rash.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Heart transplant, Herpes zoster, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Dx with Herpes Zoster in one dose varicella vaccine recipient. Treated with IV acyclovir. Unilateral rash, one dermatome. Rash lasted <4 weeks. Also given topical Bactrim. Heart transplant recipient in September 2013.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site urticaria
Clinical narrative: Per patient redness at site, itching, urticaria, swollen salivary glands, reports fever before 2/2/15 but then it went away.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Rash erythematous, Salivary gland enlargement
Clinical narrative: Per patient redness at site, itching, urticaria, swollen salivary glands, reports fever before 2/2/15 but then it went away.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patiens were orally vaccinated with ROTATEQ (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception, Surgery
Clinical narrative: INTUSSUSCEPTION ILEOCECAL.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Acute disseminated encephalomyelitis, CSF white blood cell count increased, Hemiparesis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Parents noted right sided weakness, he was admitted to the hospital and diagnosed with ADEM.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acupuncture, Erythema, Feeling hot, Injection site joint pain, Local reaction
Clinical narrative: On 12/30/14, client reported resolving local reaction (pain, redness, warmth) but complains of continuing joint pain in particular the left shoulder. She did not want to see a physician. Patient returned on Feb. 6th with the same complaint of joint soreness.  She has been receiving accupuncture treatments for this and still does not want to see a physician.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: On 12/30/14, client reported resolving local reaction (pain, redness, warmth) but complains of continuing joint pain in particular the left shoulder. She did not want to see a physician. Patient returned on Feb. 6th with the same complaint of joint soreness.  She has been receiving accupuncture treatments for this and still does not want to see a physician.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: On 12/30/14, client reported resolving local reaction (pain, redness, warmth) but complains of continuing joint pain in particular the left shoulder. She did not want to see a physician. Patient returned on Feb. 6th with the same complaint of joint soreness.  She has been receiving accupuncture treatments for this and still does not want to see a physician.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tendon pain
Clinical narrative: On 12/30/14, client reported resolving local reaction (pain, redness, warmth) but complains of continuing joint pain in particular the left shoulder. She did not want to see a physician. Patient returned on Feb. 6th with the same complaint of joint soreness.  She has been receiving accupuncture treatments for this and still does not want to see a physician.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 12/30/14, client reported resolving local reaction (pain, redness, warmth) but complains of continuing joint pain in particular the left shoulder. She did not want to see a physician. Patient returned on Feb. 6th with the same complaint of joint soreness.  She has been receiving accupuncture treatments for this and still does not want to see a physician.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Aspartate aminotransferase increased, Blood calcium normal, C-reactive protein normal, Full blood count normal, Injection site pain
Clinical narrative: A few days after getting vaccine, had pain in L arm between shoulder and elbor with arm movement. Not strength deficits, no radiation pain, no numbness. Able to do all activity but has pain with active movement.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test normal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: A few days after getting vaccine, had pain in L arm between shoulder and elbor with arm movement. Not strength deficits, no radiation pain, no numbness. Able to do all activity but has pain with active movement.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Developed significant erythema, pain and discomfort in shoulder exactly where she received immunization several days prior.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: HERPES ZOSTER DIAGNOSIS IN TWO-DOSE VARICELLA VACCINE RECIPIENT. DX ON 8/19. PAINFUL ITCHY RASH ON RIGHT CHEST AND UPPER BACK. SYMPTOMS IMPROVED BY 8/22. NO TREATMENT.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Injection site rash, Measles, Pyrexia, Rash
Clinical narrative: Runny nose, cough, and fever began on 2/7. Rash developed around injection site and on left face on 2/8. On 2/9 patient presented to ER for suspect measles with rash that began on ears and legs and spread to the entire body. Patient was ill with RSV and pneumonia prior to vaccination. Patient continued to had continuously had coryza and cough.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rhinitis, Rhinorrhoea
Clinical narrative: Runny nose, cough, and fever began on 2/7. Rash developed around injection site and on left face on 2/8. On 2/9 patient presented to ER for suspect measles with rash that began on ears and legs and spread to the entire body. Patient was ill with RSV and pneumonia prior to vaccination. Patient continued to had continuously had coryza and cough.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Injection site erythema, Nasal congestion, Pruritus, Urticaria
Clinical narrative: Started coughing, signficant nasal congestion, then 15 minutes later scratching at scalp, hives on arms and chest, redness at site of injection.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Pain
Clinical narrative: Severe body aches all over and dizziness.
Age: 1.01
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Pallor, Rash erythematous, Skin lesion
Clinical narrative: Pt woke with a rash on 2/8/2015 (10 days after recieving vaccine). Did not have any fever, was acting her usual, playful self. Parents brought child in to physician office for evaluation of rash on 2/9/2015. Parents stated that the rash started on child's chin and chest and it spread from there. The rash was observed by physician, stating it was diffuse red, raised, blanching, non-pruritic rash, and the lesions on upper arms have coalesced.  The parents reported the rash had spread a lot from a few scattered spots this morning. Because patient had been to a hospital 2-3 days prior to receiving vaccine and was unsure if she had been exposed to measles, Dr was unable to determine if rash was from the vaccine or if she had contracted a wild virus. Collaboration was done through the infection control nurse at our associated hospital as well as the county health Dept and state Dept of Health regarding the possible PCR testing for measles. Because patient was asymptomatic except for the rash, she did not meet the CDC criteria for PCR testing. IgG and IgM were completed, but showed that child had developing immunity, but it was unable to determine if it was due to vaccination. As of 2/13/2015 around 4PM, parents stated that the rash had nearly faded completely and the child never did develop a fever or cough or other symptom of measles.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Flatulence, Irritability
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 9 week old female patient without drug reaction or allergies. There was no pertinent medical history. On 11-DEC-2014 the patient was vaccinated with her first dose of ROTATEQ (lot# K007244, expiration date 16-MAR-2016, dose not provided) orally as standard 2 month appointment. No concomitant medication was involved. On 12-DEC-2014 the mother of the patient sought medical attention from the nurse's facility by calling the office. The mother stated that her daughter, who was the patient, was gassy and irritable after the administration of ROTATEQ on approximately 11-DEC-2014. No treatment was given for these events. No lab diagnostics study was performed. The outcome of these events was reported as recovered on an unknown date. The relationship between ROTATEQ and these events was unknown. This is one of two reports received from the same reporter. The other report was 1502USA005198. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Papule, Rash vesicular
Clinical narrative: BURNING SENSATION DEVELOPED ON R CHEST AND BACK ON 2/7/15, THEN ERYTHEMATOUS PAPULES AND VESICLES DEVELOPED ON 2/9/15 (HERPES ZOSTER-LIKE RASH).
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: After the vaccination, the patient got up for a moment, then stated that she felt dizzy and had to sit back down.  I went to check on her immediately as I heard her say she was dizzy. By the time I reached the patient, she started to lose consciousness and was unresponsive for about five to ten seconds.  The patient was checked out and cleared by the paramedics.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: It started with some soreness of my arm (similar to a flu shot) and a lump under my skin at site of injection. The bump started to feel warm to the touch & red. The bump became more prominent & swollen as the redness spread to about 2-2.5 inch diameter. It is the end of Day 3 right now since the vaccine was administered and the symptoms are still present but not getting worse.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Vomiting
Clinical narrative: Employee complained that she had vomited shortly after vaccine, and that her arm was very sore at the injection site.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called the immunizations clinic on 02/12/2015 c/o redness and swelling to the area around the injection site 2 days after vaccination. Patient was told that minor swelling, redness, and pain are all possible mild signs and symptoms after receiving that particular vaccination and he was advised to f/u with us today if it got any worse. Patient called back this morning stating that the amount of redness and swelling has increased and he was advised to see his primary care manager for further care. Pt was prescribed a 7 day supply of Keflex.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: INTUSSUSCEPTION.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Mobility decreased, Pain, Pain in extremity
Clinical narrative: SEVERE MUSCULAR ARM PAIN, UNABLE TO LIFT ARM.  NO REDNESS OR SWELLING. ALSO SOME BODYACHES, FATIGUE.
Sex: F
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a consumer (patient's sister) refers to a female patient of unknown age. Concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with M-M-R II injection (dose, route, lot number and frequency not provided). No concomitant therapy was reported. On an unknown date, the patient experienced a seizure (medically significant) after receiving MMR II. Patient sought medical attention and had a office visit on unspecified date. The outcome of seizure was reported as recovered. The causality assessment was not provided by the reporter. Upon internal review convulsion was considered as medically significant. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Muscle spasms, Seizure
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 14 or 15 year old male patient. The patient's medical history included leukemia at 5 years of age. Concurrent conditions were not reported. On 09-FEB-2015 the patient received second dose of GARDASIL (1 single shot, dose and frequency not provided). No concomitant therapy was reported. On 10-FEB-2015, the patient experienced a spasm or seizure (medically significant) which caused him to fall out of his chair. No lab diagnostics studies performed. No adverse events were reported with the first dose of GARDASIL. No treatment was given for the events. Patient did not seek medical attention. The outcome of the events was reported as recovered on 10-FEB-2015. The physician did not provide the causality between the event and the GARDASIL. Product quality complaint was not reported. Upon internal review the convulsion was considered to be medically significant. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLUC3
Symptoms: Arthralgia, Biopsy skin abnormal, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Extreme skin pain due to near total Peripheral neuropathy and vertigo and swollen lymph glands under arms, left arm red and swollen at shot site, Extreme tiredness and joint pain after shot. Possible GBS due to Flu shot.
Age: 50.0
Sex: M
Vaccine: FLUC3
Symptoms: Lymphadenopathy, Neuropathy peripheral, Pain of skin, Vertigo
Clinical narrative: Extreme skin pain due to near total Peripheral neuropathy and vertigo and swollen lymph glands under arms, left arm red and swollen at shot site, Extreme tiredness and joint pain after shot. Possible GBS due to Flu shot.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured, Full blood count normal, Pyrexia
Clinical narrative: 2/13/15 Diarrhea, fever, stools green and foul smelling per mother. Admitted to Hospital for fluids. CBC (WNL).
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Electrocardiogram, Loss of consciousness
Clinical narrative: Syncope - occurrence approximately 10 min after HPV administration. Unresponsive greater than 10 minutes, response to pain stimuli only. Vital signs stable with HR approximately 110; BP 130/80; O2=100%, RR=16, normal pulses, normal skin tone. To ED via EMS.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bronchial hyperreactivity, Chest X-ray abnormal, Computerised tomogram head abnormal, Pregnancy test urine negative, Sinusitis
Clinical narrative: Syncope - occurrence approximately 10 min after HPV administration. Unresponsive greater than 10 minutes, response to pain stimuli only. Vital signs stable with HR approximately 110; BP 130/80; O2=100%, RR=16, normal pulses, normal skin tone. To ED via EMS.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Unresponsive to stimuli, Viral infection
Clinical narrative: Syncope - occurrence approximately 10 min after HPV administration. Unresponsive greater than 10 minutes, response to pain stimuli only. Vital signs stable with HR approximately 110; BP 130/80; O2=100%, RR=16, normal pulses, normal skin tone. To ED via EMS.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Borrelia test negative, Lymphadenopathy, Myalgia
Clinical narrative: Pt c/o swollen glands in neck and under arms, joint and muscle pain all over since flu vaccine.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Ear pain, Fall, Feeling cold, Loss of consciousness
Clinical narrative: Human Resource representative called me 2/11/15 at 3:30P to tell me that patient passed out at work. They thought it was due to vaccines patient received for credentialing on 2/10/2015 - I called him and he said he had felt faint and had fallen to his knees. He was assisted into a chair - he said he was "out" - lost consciousness for a few seconds - he states he had a cold 1 week before but was not sick at time of vaccines - he said he had felt chilled and had right earache before he fainted - states he feels fine now - resting at home at 4:PM 2/11/15. Follow up 2/13/15 - no further complaints.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces, Haematochezia, Mucous stools, Stool analysis
Clinical narrative: Information has been received from a certified medical assistant (also reported as healthcare worker) concerning an approximately 3 month old male patient with no current or historical conditions. On 02-DEC-2014, the patient was vaccinated with the first dose of ROTATEQ (lot#, expiration date and dose not reported). There was no concomitant medication. On 03-DEC-2014, the patient had blood in the stool and the stool was stringy and mucous. The patient had about five more similar episodes of blood in the stool which occurred on specified dates every few weeks after 03-DEC-2014. It was reported that a stool sample was done on an unspecified date, and the results of the stool sample evaluation were still pending at the time of reporting. The patient did not received any treatment for these events. At the time of reporting, the outcome of these events was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Injection site swelling, Tenderness
Clinical narrative: Vital signs: Blood pressure: 105/63, temperature 98.4. Increased redness to bilateral upper legs. Increased swelling to injection sites. Skin intact. Areas tneder to touch. Denies pain.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Injection site bruising, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Received PCV13 on 2/3/15 and developed bruise and rash on right arm below injection site. Area on right arm was itchy, approx. 6cm x 4cm of red raised rash with small bruise noted at injection site. Pt developed rash 2/5/15.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, Electromyogram abnormal, Muscular weakness, Myositis
Clinical narrative: Weakness LE progressing over 2 week. 1/20 LP increased protein 126-/no cells. Dx: neuropathy myositis. Weakness started early in January
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, CSF white blood cell count negative, Electromyogram abnormal, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Weakness LE progressing over 2 week. 1/20 LP increased protein 126-/no cells. Dx: neuropathy myositis. Weakness started early in January
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myositis, Neuropathy peripheral
Clinical narrative: Weakness LE progressing over 2 week. 1/20 LP increased protein 126-/no cells. Dx: neuropathy myositis. Weakness started early in January
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Pt received Tdap and MCV on 2/10/2015 on the left deltoid and yesterday 2/11/15, she started with pain on the injection site but also going down the trunk and the left lower extremity.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: Arm ached immed after adminis - next day A.M. the site was itchy, red. Started next with severe headache, nausea, no appetite - extreme fatigue, muscle aches, joint aches, swollen lymph nodes 2/13/1500. Called with very edematous axilla - unable to put her arm down at her side - unable to sleep on that side - very painful.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Lymphadenopathy, Myalgia, Nausea, Oedema peripheral
Clinical narrative: Arm ached immed after adminis - next day A.M. the site was itchy, red. Started next with severe headache, nausea, no appetite - extreme fatigue, muscle aches, joint aches, swollen lymph nodes 2/13/1500. Called with very edematous axilla - unable to put her arm down at her side - unable to sleep on that side - very painful.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Arm ached immed after adminis - next day A.M. the site was itchy, red. Started next with severe headache, nausea, no appetite - extreme fatigue, muscle aches, joint aches, swollen lymph nodes 2/13/1500. Called with very edematous axilla - unable to put her arm down at her side - unable to sleep on that side - very painful.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pt report left arm pain and weakness after shot -> top of arm then moved to bottom of arm.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Eye movement disorder, Irritability, Respiratory arrest, Skin reaction
Clinical narrative: After vaccines, time frame unknown, patient would fuss, turn red, stop breathing, eyes roll back into head. Stopped breathing for approx. 1 minute then resume breathing.