chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Mother said 3 hrs after vaccines, right deltoid area redden, swollen, hot to touch, when arm is moved child complained of pain no fever reported. Child given Advil 1/2 hr after vaccines per mother.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Fatigue, Somnolence, Tinnitus
Clinical narrative: Knees hurting while walking and running; ringing in ears; excessive tiredness hard to wake up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Gastrointestinal pain, Pyrexia
Clinical narrative: Fever, diarrhea, GI cramping, lack of appetite.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cholecystectomy, Computerised tomogram, Dyspnoea, Dysstasia, Hepatobiliary scan
Clinical narrative: Pain in side that gradually increase till the above cannot stand the led to gallbladder removal 06/19/2013. Severe tonsillitis leads to breathing problems and hospitalization. Still has not recovered 07/14/2013-07/16/2013= hospitalization. Symptoms still persist.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Pain, Tonsillitis
Clinical narrative: Pain in side that gradually increase till the above cannot stand the led to gallbladder removal 06/19/2013. Severe tonsillitis leads to breathing problems and hospitalization. Still has not recovered 07/14/2013-07/16/2013= hospitalization. Symptoms still persist.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Hyperhidrosis, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient became diaphoretic, passed out, and became temporarily unresponsive.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: I NOTICED RED BUMPS COVERING MY DAUGHTERS ARMS AND BACK AT BATH TIME. I GAVE HER 2.5 mL OF BENADRYL AND SHE WENT TO BED. UPON WAKING THE NEXT MORNING THE BUMPS HAD SPREAD TO HER FACE, CHEST, STOMACH, GENITALS, AND LEGS.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Front of arm warm and a little red.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema, Skin warm, Tenderness
Clinical narrative: L arm warmth, erythema, tender and mild edema since 7/4/13. Area is 10x12 cm.
Age: 64.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, YF
Symptoms: Erythema, Pruritus
Clinical narrative: (L) arm turned red and about 1 1/2" across. Itchy. No sx til this AM. Recommended warm compress, hydrocortisone cream for itch. TYLENOL PRN.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC
Symptoms: Apnoeic attack, Bradycardia, C-reactive protein increased, Decreased activity, Full blood count normal
Clinical narrative: Approximately 5 hours post vaccination, infant with decreasing tone and activity. Approximately 8 hours post vaccine (PREVNAR) infant with increased apneic/bradycardic episodes requiring being placed on respiratory support for approximately 20-24 hours after PREVNAR given.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC
Symptoms: Hypotonia, Mechanical ventilation
Clinical narrative: Approximately 5 hours post vaccination, infant with decreasing tone and activity. Approximately 8 hours post vaccine (PREVNAR) infant with increased apneic/bradycardic episodes requiring being placed on respiratory support for approximately 20-24 hours after PREVNAR given.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient states she took a home pregnancy test on 8/18/13 and states it was positive during 8/19/13 office visit.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: Patient states she took a home pregnancy test on 8/18/13 and states it was positive during 8/19/13 office visit.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: My skin broke out in severe skin rash and extremely itchy skin.  Went back to pharmacy and they recommend taking Panadol.  This worked but it requires taking it everyday.  They then recommend taking Claritin 10mg.   This worked and initially every 2 days then reduced to 3 days and now I have to take it at least once a week.   If I stop then the rash and itchy skin returns.
Age: 13.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: REDNESS AND WARMTH AT INJECTION SITE AND ITCHING AT SITE. VITAL SIGNS TAKEN AND CLIENT OBSERVED FEW MINUTES THEN BENADRYL 50 MG GIVEN IM.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Anaemia haemolytic autoimmune, Asthenia, Jaundice, Pallor
Clinical narrative: Jaundice, weak, lack of color.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Autoimmune haemolytic anaemia, Jaundice, Laboratory test abnormal, Pallor
Clinical narrative: Jaundice, weak, lack of color.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Ataxia, Cerebellar ataxia, Computerised tomogram head normal, Dysarthria, Nystagmus
Clinical narrative: Woke up with ataxia, developed nystagmus and vomiting later in the day. Slurred speech. CT done in ER nl. Dx with postinfectious cerebellar ataxia.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Woke up with ataxia, developed nystagmus and vomiting later in the day. Slurred speech. CT done in ER nl. Dx with postinfectious cerebellar ataxia.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash erythematous, Rash generalised
Clinical narrative: Rash of pencil lead sized pink spots that started on his face/neck and spread over his torso and bottom.  Spots were light pink, some slightly raised, and paled when pressed. Also, hard red spot at sight of injection (front of thigh).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest X-ray abnormal, Chest discomfort, Chest pain, Cough
Clinical narrative: Headache, itching and redness began the following day, shortly after experienced severe pain stemming from the injection site, up the back and to the hand, immediate loss of function of left arm (injection arm) and respiratory problems, coughing, congestion, throat irritation and elevated heart rate. 103.5* fever recorded at home and was sent to the emergency room. Was hospitalized from 1/21/2013 - 1/25/2013. Since then as until today is still experiencing some congestion and respiratory problems, severe pain in injected arm, pain and pressure in the chest and throat and loss of mobility and use of injected arm. Physical therapy has had no effect in helping resolve these issues. No medicines have been administered but cortisone steroids were advised but not taken.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Heart rate increased, Injected limb mobility decreased, Injection site pain
Clinical narrative: Headache, itching and redness began the following day, shortly after experienced severe pain stemming from the injection site, up the back and to the hand, immediate loss of function of left arm (injection arm) and respiratory problems, coughing, congestion, throat irritation and elevated heart rate. 103.5* fever recorded at home and was sent to the emergency room. Was hospitalized from 1/21/2013 - 1/25/2013. Since then as until today is still experiencing some congestion and respiratory problems, severe pain in injected arm, pain and pressure in the chest and throat and loss of mobility and use of injected arm. Physical therapy has had no effect in helping resolve these issues. No medicines have been administered but cortisone steroids were advised but not taken.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity, Pruritus, Pyrexia, Respiratory disorder
Clinical narrative: Headache, itching and redness began the following day, shortly after experienced severe pain stemming from the injection site, up the back and to the hand, immediate loss of function of left arm (injection arm) and respiratory problems, coughing, congestion, throat irritation and elevated heart rate. 103.5* fever recorded at home and was sent to the emergency room. Was hospitalized from 1/21/2013 - 1/25/2013. Since then as until today is still experiencing some congestion and respiratory problems, severe pain in injected arm, pain and pressure in the chest and throat and loss of mobility and use of injected arm. Physical therapy has had no effect in helping resolve these issues. No medicines have been administered but cortisone steroids were advised but not taken.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion, Throat irritation, X-ray limb abnormal
Clinical narrative: Headache, itching and redness began the following day, shortly after experienced severe pain stemming from the injection site, up the back and to the hand, immediate loss of function of left arm (injection arm) and respiratory problems, coughing, congestion, throat irritation and elevated heart rate. 103.5* fever recorded at home and was sent to the emergency room. Was hospitalized from 1/21/2013 - 1/25/2013. Since then as until today is still experiencing some congestion and respiratory problems, severe pain in injected arm, pain and pressure in the chest and throat and loss of mobility and use of injected arm. Physical therapy has had no effect in helping resolve these issues. No medicines have been administered but cortisone steroids were advised but not taken.
Age: 21.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Skin warm
Clinical narrative: Blurred vission; dizziness/ light headedness; nausea; paleness; sweating; warm and faint feeling. Patient reported feeling better while laying down, instructed to lay down, fluids refused, pulse and B/P monitored throughout duration, he reported feeling better prior to leaving center.
Age: 21.0
Sex: M
Vaccine: TTOX
Symptoms: Vision blurred
Clinical narrative: Blurred vission; dizziness/ light headedness; nausea; paleness; sweating; warm and faint feeling. Patient reported feeling better while laying down, instructed to lay down, fluids refused, pulse and B/P monitored throughout duration, he reported feeling better prior to leaving center.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Pyrexia
Clinical narrative: Fever (103) and chills.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Big redness, soreness and swelling. Patient contacted MD and was given KEFLEX - antibiotic.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: High fever - 102.0 F, HA, nausea.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Local reaction, Nausea
Clinical narrative: Large local reaction w/ redness and itching. Nausea, vomiting, exhaustion (flu like symptoms).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Vomiting
Clinical narrative: Large local reaction w/ redness and itching. Nausea, vomiting, exhaustion (flu like symptoms).
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Chills, Headache, Pain
Clinical narrative: Pt started feeling aches and body pain, headache and chills a few hours after receiving the HPV and MENACTRA vaccines.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at injection site 8-7-13. Woke up during night with increased pain. In am 8/8 - large area of swelling over (R) deltoid-"hand sized"; warm took ALEVE, applied ice. Swelling was worse in evening, about c/o HA took ibuprofen, continued icing. Woke up 8/9/13 -swelling decreased - oral area 4 inches long. 3 inches wide. Reddish area around injection site 2 inches in diameter. Instructed to continue with cold pack x 20 min of off x 1 hour. Pain med. 1% hydrocortisone BID.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Blood magnesium, Blood phosphorus, Full blood count, Metabolic function test, Throat tightness
Clinical narrative: Felt throat/airway closing.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pruritus, Skin warm, Urticaria
Clinical narrative: 2 inch round, hot, itching, large welt; general malaise.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: Patient felt faint about 5 min's after receiving vaccine for HPV. Pt fell back into mother's arms and was pale. No loss of consciousness. Patient laid down and recovered, then went home.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Pt. contacted us on 8/17/13. has had zoster-like rash on left sid eof body previous - was resolved at time of immuniz. Rash developed in area of inj. on Rt. arm 2 days after inj - resembled previous zoster outbreaks.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Grunting, Lacrimation increased, Salivary hypersecretion, Throat irritation, Wheezing
Clinical narrative: After imms administered, the client c/o itching inside his throat, frequent spitting and foals from eyes noted. Very later wheezing and soft tone grunting present. 911 was called. Client evaluated by EMS staff. Symptoms ceased within minutes without treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a registered pharmacist via company representative refers to a couple of unknown age and gender patients (number unspecified). On an unspecified date the patients started therapy with ZOSTAVAX (lot # unspecified) (formulation, route, dose and frequency unspecified) for vaccination. On an unspecified date, the patients who was taking ZOSTAVAX developed a shingles like rash, not at the injection site. Action taken of therapy with ZOSTAVAX was unknown. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician via company representative refers to an older female patient of unknown age. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date, the patient had positive pap smear. The outcome of positive pap smear was unknown. The physician stated that he wants to do a biopsy on the patient. The patient sought medical attention. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient with no drug reactions/allergies. Patients pertinent medical history was none. On 13-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J001002, expiry date 25-APR-2014, route and dose were not reported). Concomitant therapies included simvastatin. On 15-AUG-2013, the patient developed fever as high as 101.7F and experienced gastrointestinal upset. The patient sought medical attention (contacted pharmacist). The event fever was treated with MOTRIN. The outcome of gastrointestinal upset and fever was reported as not recovered/not resolved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Rash
Clinical narrative: This spontaneous report was received from a 76 year old patient regarding herself. On an unknown date in 2008 (reported as 5 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unknown date in March, the patient noticed a rash on the right side of her stomach which lasted for a month and for few months every so many days the patient felt heat in her face, arms and body which would last for about twenty minutes. The patient stated it happened 8 times last month not at all. The outcome of the events were unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a office manager refers to a 13 year old female patient. There were no pertinent medical history or drug allergies or reactions. On 23-AUG-2012, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot # 0459AE, 13-DEC-2014, route was intramuscular in the left arm). Concomitant medications were none. On 23-AUG-2012, the patient experienced tingling in the left leg for 2 weeks. The patient did not notify the office until 25-OCT-2012. There was no laboratory tests performed. Approximately on 05-SEP-2012, the outcome of tingling in the left leg was reported as recovered. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with a dose of GARDASIL (batch # 667866, Lot # 667866/1437Z expiration date 25-FEB-2013 (dose and route unknown) on 05-AUG-2013. No adverse effect reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a 79 year old male consumer (reporting on himself). The patient did not have a pertinent medical history or drug reaction allergies. In November 2007 the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). There was no concomitant therapy. In August 2012, the patient was diagnosed with shingles and since this same date, the patient had suffered with postherpetic neuralgia (PHN). The patient was prescribed revaccination of the ZOSTAVAX vaccine two months ago by his physician and as a result of receiving literature from the pharmacy, advising him to get revaccinated, even though he was still experiencing PHN, to prevent a second outbreak of shingles. The patient stated his PHN has gotten worse covering an area from the left side of trunk of chest around under his left arm to the middle of his back to the spine. The patient sought medical attention and was prescribed with LYRICA. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient has no pertinent medical history or drug reactions/allergies. The patient received three doses of M-M-R II (0.5 ml, subcutaneous. There were no concomitant medications. On an unknown date the patient had a titer done and was shown to have negative results for Rubella. The outcome was reported as not recovered. The patient sought medical attention by visiting the nurse's office. No treatment was received. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Conduct disorder, Fatigue, Mood altered, Sinusitis
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning to an 18 year old male patient with non drug reaction allergies. On 15-JUL-2013 the patient was vaccinated with GARDASIL (lot # H021608, expiration date 13-AUG-2015) (0.5 ml, intramuscular route). In 2013, after receiving GARDASIL the patient experienced fatigue and mood issues. The patient was to follow-up with office visit, if fatigue and mood issues persisted. Physician was informed by patient's mother on 14-AUG-2013, that patient experienced swelling of face and joint pain, that occurred one day after patient received GARDASIL, on 16-JUL-2013; however, swelling of face and joint pain had resolved. It was also reported that on 15-JUL-2013 the patient was diagnosed with sinusitis and conduct disorder. The patient called the physician and no treatment was given for the adverse events. The outcome of swelling of face and joint pain was reported as recovered and the outcome of fatigue, mood issues, sinusitis and conduct disorder was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Swelling face
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning to an 18 year old male patient with non drug reaction allergies. On 15-JUL-2013 the patient was vaccinated with GARDASIL (lot # H021608, expiration date 13-AUG-2015) (0.5 ml, intramuscular route). In 2013, after receiving GARDASIL the patient experienced fatigue and mood issues. The patient was to follow-up with office visit, if fatigue and mood issues persisted. Physician was informed by patient's mother on 14-AUG-2013, that patient experienced swelling of face and joint pain, that occurred one day after patient received GARDASIL, on 16-JUL-2013; however, swelling of face and joint pain had resolved. It was also reported that on 15-JUL-2013 the patient was diagnosed with sinusitis and conduct disorder. The patient called the physician and no treatment was given for the adverse events. The outcome of swelling of face and joint pain was reported as recovered and the outcome of fatigue, mood issues, sinusitis and conduct disorder was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Arthralgia, Blood test abnormal, Cough, Fatigue
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning to an 18 year old male patient with non drug reaction allergies. On 15-JUL-2013 the patient was vaccinated with GARDASIL (lot # H021608, expiration date 13-AUG-2015) (0.5 ml, intramuscular route). In 2013, after receiving GARDASIL the patient experienced fatigue and mood issues. The patient was to follow-up with office visit, if fatigue and mood issues persisted. Physician was informed by patient's mother on 14-AUG-2013, that patient experienced swelling of face and joint pain, that occurred one day after patient received GARDASIL, on 16-JUL-2013; however, swelling of face and joint pain had resolved. It was also reported that on 15-JUL-2013 the patient was diagnosed with sinusitis and conduct disorder. The patient called the physician and no treatment was given for the adverse events. The outcome of swelling of face and joint pain was reported as recovered and the outcome of fatigue, mood issues, sinusitis and conduct disorder was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Incomplete course of vaccination, Mood swings, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning to an 18 year old male patient with non drug reaction allergies. On 15-JUL-2013 the patient was vaccinated with GARDASIL (lot # H021608, expiration date 13-AUG-2015) (0.5 ml, intramuscular route). In 2013, after receiving GARDASIL the patient experienced fatigue and mood issues. The patient was to follow-up with office visit, if fatigue and mood issues persisted. Physician was informed by patient's mother on 14-AUG-2013, that patient experienced swelling of face and joint pain, that occurred one day after patient received GARDASIL, on 16-JUL-2013; however, swelling of face and joint pain had resolved. It was also reported that on 15-JUL-2013 the patient was diagnosed with sinusitis and conduct disorder. The patient called the physician and no treatment was given for the adverse events. The outcome of swelling of face and joint pain was reported as recovered and the outcome of fatigue, mood issues, sinusitis and conduct disorder was unknown. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash on stomach/chest/arms, non-pruritic, day after 4th dose x3d; no associated symptoms.
Sex: U
Vaccine: HEP, HPV4, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker, concerning an unspecified number of patients. The patients pertinent medical history and drug reactions/allergies were not provided. On an unspecified date, the patients received one dose of RECOMBIVAX HB (dose, route, lot number and expiration date were not provided). Other suspect therapies included a dose of GARDASIL (dose, route, lot number and expiration date were not provided), and a dose of (merck) VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant medications were not provided. The reporter stated that an unspecified number of patients received doses of RECOMBIVAX HB, GARDASIL, and (merck) VARIVAX, that were exposed to unsupported temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a 61 year old female consumer refers to herself. No medical history or drug reactions/allergies were reported. On 25-JUL-2013, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and indication not provided). The patient reported that since 25-JUL-2013 (approximately), her arm was still red from shot. Additional information has been requested.
Sex: U
Vaccine: MMR, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of ROTATEQ (dose, route, lot # and expiration date were not provided) and M-M-R II (dose, route, lot # and expiration date were not provided). The certified medical assistant noted that on an unknown date an unspecified number of patients were administered unsupported ROTATEQ and M-M-R II, after temperature stability was not able to be provided. No adverse effect was reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised, Rash macular, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient with no drug reaction/allergies and no other pertinent medical history. On 29-JUL-2013 the patient was vaccinated with a dose of M-M-R II lot # H015829, expiring 24-AUG-2014, 0.5 ml, subcutaneous. Other suspect therapies administered on the same sate included VARIVAX (Merck) lot # H016911, expiring 10-SEP-2014 (dose and route not provided). Concomitant therapies administered on the same date included KINRIX. On 02-AUG-2013, the patient developed hives noted as red splotches all over his body some that looked like half moons. The patient's mother called physician's office on 05-AUG-2013 for medical attention. The physician instructed the patient's mother to give the patient BENADRYL as needed. No lab diagnostic tests were performed. The outcome of the event was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient with no drug reaction/allergies and no other pertinent medical history. On 29-JUL-2013 the patient was vaccinated with a dose of M-M-R II lot # H015829, expiring 24-AUG-2014, 0.5 ml, subcutaneous. Other suspect therapies administered on the same sate included VARIVAX (Merck) lot # H016911, expiring 10-SEP-2014 (dose and route not provided). Concomitant therapies administered on the same date included KINRIX. On 02-AUG-2013, the patient developed hives noted as red splotches all over his body some that looked like half moons. The patient's mother called physician's office on 05-AUG-2013 for medical attention. The physician instructed the patient's mother to give the patient BENADRYL as needed. No lab diagnostic tests were performed. The outcome of the event was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Myalgia
Clinical narrative: Patient had a sore arm from where injection was given.  Myalgia.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 1248AA, exp. date 01-AUG-2013) (dose and route not reported). It was reported that lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lost of VARIVAX (Merck) exposed to -2.5C for a period of 956.5 hours. The excursion date range from 09-FEB-2012 to 06-MAY-2013. All the stock of the lot number was administered to an unknown number of patients. Last dose administered on 06-MAY-2013. This VARIVAX (Merck) lot number was not supported. The reporter stated that she believed that some of the VARIVAX (Merck) should have had stability information to support some of the excursions. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 670699/0814AA, exp. date 02-JUN-2013) (dose and route not reported). It was reported the lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lot of VARVIAX (Merck) exposed to -12C for a period of 328 hours. The excursion date range from 01-SEP-2011 to 05-JUL-2012. All of the stock (quality unknown) of the lot number were administered to an unknown number of patients. Last dose administered on 05-JUL-2012. The reporter stated that she believed that some of the VARVIAX (Merck) should have had stability information to support some of the excursions. Upon review lot # 670699/0814AA exposed to -12C for a period of 328 hours was supported. Temperature excursion did not affect this lot#. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Computerised tomogram abnormal, Hypersensitivity, Inflammation
Clinical narrative: This spontaneous report as received from a mother of the patient refers to a 18 year old female patient with drug allergy to penicillin (had hands and feet swell) and no medical history. On 19-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route and indication were not provided). Concomitant therapies included ORTHO-NOVUM 7/7/7. Within an hour after the patient received the shot she experienced severe abdominal pain. The patient was taken to the emergency room but was not admitted overnight. The patient did not receive the treatment for AE. Computerized axial tomography (CAT) scan showed lymph node on her appendix was inflamed on an unspecified date in 2013. The hospital believed she experienced an allergic reaction to the vaccine and she was recommended to not get the second or third doses of GARDASIL. On 20-JUN-2013, the patient was recovered from 'allergic reaction to the vaccine" and severe abdominal pain. Outcome of "lymph node on her appendix was inflamed" was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 0306AE, exp. date 06-FEB-2014) (dose and route not reported). It was reported the lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lot of VARIVAX (Merck) exposed to -12C for a period of 160 hours. The excursion date range from2 2-JUN-2012 to 10-AUG-2013. All the stock of the lot number were administered to an unknown number of patients. Last dose administered on 10-AUG-2013. The reporter stated that she believed that some of the VARIVAX (Merck) should have had stability information to support some of the excursions. Upon review, lot # 0306AE exposed to -12C for a period of 160 hours was supported. Temperature excursion did not affect this lot#. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot# H010445, exp. date 23-MAY-2014) (dose and route not reported). It was reported the lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lot of VARIVAX (Merck) exposed to -2.5 degrees C for a period of 650.5 hours. The excursion date range from 30-AUG-2012 to 19-JUN-2013. All the stock except two vials of the lot number were administered to an unknown number of patients. Last dose administered on 19-JUN-2013. This VARIVAX (Merck) lot number was not supported. The reporter stated that she believed that some of the VARIVAX (Merck) should have had stability information to support some of the excursions. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an unspecified number of patients of unknown demographics. It was reported that on an unknown date, unspecified number of unspecified patients may have received doses of GARDASIL (lot number, expiry date, dose and route unspecified) that were exposed to an unsupported temperature excursion of 27 degrees Fahrenheit (F) for 2 hours. Nurse practitioner was unsure if any patients actually received the unsupported doses. No concomitant therapy was reported. No adverse effects was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a now 27 years old female patient. The patient had no pertinent medical history or drug allergy. On an unknown date the patient was vaccinated with a dose of M-M-R II. Lot # and route was unspecified). The reporter was not sure if the patient had one or two doses of M-M-R II. The reporter stated that the patient failed to build immunity to M-M-R II. Lab test included blood titer. The lab test result was not provided. The patient had blood work drawn in physician's office. Outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient completed the primary 3 doses of Hepatitis B vaccination series sometime between 1995 and 1999 (manufacturer unspecified, but RECOMBIVAX HB (Merck) could not be ruled out at the time of the call) and recently had a negative titer for Hepatitis B. No adverse event other than the negative Hepatitis B titer. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient ws vaccinated with a dose of ZOSTAVAX (lot#, dose, frequency and route unspecified). On the unspecified date two days later, the patient "developed shingles" The outcome of shingles was unknown. A VZVIP packet would be faxed when the correct fax number was available. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker at a physician's office refers to a now 19 year old female patient. In approximately 1995 (18 years ago), the patient was vaccinated with hepatitis B (manufacturer unknown), lot#, dose, frequency and route unspecified. On an unspecified date in approximately 1995, after the vaccine was administered, the patient took a lab test which shown the patient had negative titers for hepatitis B antibody. The patient went to physician's office for medical attention. The physician re-administered two doses of RECOMBIVAX HB to the patient for treatment on an unspecified date. The outcome of the event was reported as no recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to two patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ (lot#, dosage, route and indication unknown). On an unknown date both the patients reported blood in their stool after receiving ROTATEQ. It was unknown if the patient had sought medical attention. The outcome of the event and action taken with ROTATEQ were unknown. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Flatulence
Clinical narrative: This spontaneous report as received from the patient's mother refers to her 5 month old daughter with no pertinent medical history and no drug reactions/allergies. On 26-JUN-2013 the patient was vaccinated with the first dose of ROTATEQ (dose, frequency, route and lot# not reported) at her 17 weeks which was outside of the prescribing information. The patient had experienced a lot of gas since receiving the shot on 26-JUN-2013. The patient did not seek medical attention but was given some unspecified gas drops. No lab diagnostics studies were performed. The patient had not recovered. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unspecified age and gender. On an unspecified date, PROQUAD (lot # unspecified, route, dose and location were unspecified), which had been stored in the refrigerator at an unspecified temperature for an unspecified amount of time, was administered to the patient instead of MMR II. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to a patient of unknown age and gender who on 13-AUG-2013, was vaccinated with a expired dose of M-M-R II, 0.5 ml, subcutaneous (lot # 0567AA, expiration date 15-APR-2013). No adverse effect reported. This is one of two reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or drug allergies/reactions were reported. On 12-AUG-2013, the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number 0660AA is an invalid lot number for ZOSTAVAX; exp. date 04-AUG-2012). No adverse effect reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Dysphemia
Clinical narrative: I did not realize this website existed at the time of this scary event and time has elapsed which blurs my memory of specific dates and times. But I do clearly recall that within a day or 2 of her MMR my daughter began stuttering. She had always been quite the articulate child and was speaking in full paragraphs shortly after her 2nd birthday. When this stuttering began I didn't immediately become alarmed the 1st day b/c it was occasional but within a few days the stuttering gradually got worse. It was a very strange event lasting approximately 2 weeks and at its peak my daughter was having significant trouble just getting out a sentence. She realized something was wrong with her too. One night as I was tucking her in and she was saying her prayers she stuttered through them for a bit (the stuttering was severe at that point) and suddenly she burst into tears with a terrified look on her face and asked "what is wrong with me? why can't I talk right?" My heart broke for her and at the same time I was horrified that this would continue. Thankfully, it gradually waned and ended by the end of the 3rd week. That was a terrifying time for us. On a side note: I already had some concerns about the MMR and we had delayed this vaccination.....this was her 1st dose of the MMR. The 1st few days into this reaction I didn't even want to believe that this was happen....I mean how could it? I don't think all vaccines are evil and we do vaccinate, just on a delayed schedule. I felt very blessed by our decision to delay her MMR vaccination....if this was the kind of injury she had once she was older and better developed what would the magnitude of the injury have been had we followed the recommended schedule?
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Blood test, Gait disturbance, Hepatic enzyme increased, Pain in extremity
Clinical narrative: Case number PHHY2013US069319 is an initial spontaneous report received from a consumer (patient's mother) via the Vaccine Adverse Event Reporting System (VAERS reference number: 486209) website on 03 Jul 2013, with a follow up received from the QA department on 13 Aug 2013. This report refers to a 11-year-old male patient. His medical history included viral infection and he had overcome it. He was not taking any medications at the time of vaccination. He was vaccinated with MENVEO (batch number: A11076/M11076) into left arm, ADACEL (other manufacturer, batch number: C4170AA) into right arm and VARIVAX (other manufacturer, batch number: H015559) into right arm on 07 Nov 2012. ON 11 Nov 2013, four days after vaccination, he started to experience pain and swelling in hands and feet. It was reported that swelling started with finger and spread all over body. His mother stated that her son was currently unable to attend the school and barely could walk. He also had elevated liver enzymes (values not reported) on an unspecified date. He visited the emergency room and consulted pediatric rheumatologist who had done a number of blood tests (results not provided). The outcome of the events was reported as not recovered as of 05 Mar 2013. The reporter assessed the case as serious (permanent disability). No causality was provided for the events. Based on the batch review, it was stated that the concerned MENVEO batch number A11076/M11076 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 13 Aug 2013: Updated batch report.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Case number PHHY2013US069319 is an initial spontaneous report received from a consumer (patient's mother) via the Vaccine Adverse Event Reporting System (VAERS reference number: 486209) website on 03 Jul 2013, with a follow up received from the QA department on 13 Aug 2013. This report refers to a 11-year-old male patient. His medical history included viral infection and he had overcome it. He was not taking any medications at the time of vaccination. He was vaccinated with MENVEO (batch number: A11076/M11076) into left arm, ADACEL (other manufacturer, batch number: C4170AA) into right arm and VARIVAX (other manufacturer, batch number: H015559) into right arm on 07 Nov 2012. ON 11 Nov 2013, four days after vaccination, he started to experience pain and swelling in hands and feet. It was reported that swelling started with finger and spread all over body. His mother stated that her son was currently unable to attend the school and barely could walk. He also had elevated liver enzymes (values not reported) on an unspecified date. He visited the emergency room and consulted pediatric rheumatologist who had done a number of blood tests (results not provided). The outcome of the events was reported as not recovered as of 05 Mar 2013. The reporter assessed the case as serious (permanent disability). No causality was provided for the events. Based on the batch review, it was stated that the concerned MENVEO batch number A11076/M11076 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 13 Aug 2013: Updated batch report.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Blood test, Gait disturbance, Hepatic enzyme increased, Oedema peripheral
Clinical narrative: Case number PHHY2013US069319 is an initial spontaneous report received from a consumer (patient's mother) via the Vaccine Adverse Event Reporting System (VAERS reference number: 486209) website on 03 Jul 2013, with a follow up received from the QA department on 13 Aug 2013. This report refers to a 11-year-old male patient. His medical history included viral infection and he had overcome it. He was not taking any medications at the time of vaccination. He was vaccinated with MENVEO (batch number: A11076/M11076) into left arm, ADACEL (other manufacturer, batch number: C4170AA) into right arm and VARIVAX (other manufacturer, batch number: H015559) into right arm on 07 Nov 2012. ON 11 Nov 2013, four days after vaccination, he started to experience pain and swelling in hands and feet. It was reported that swelling started with finger and spread all over body. His mother stated that her son was currently unable to attend the school and barely could walk. He also had elevated liver enzymes (values not reported) on an unspecified date. He visited the emergency room and consulted pediatric rheumatologist who had done a number of blood tests (results not provided). The outcome of the events was reported as not recovered as of 05 Mar 2013. The reporter assessed the case as serious (permanent disability). No causality was provided for the events. Based on the batch review, it was stated that the concerned MENVEO batch number A11076/M11076 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 13 Aug 2013: Updated batch report.