chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with high blood pressure and no known allergies. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # H011052; Ex date: 05-SEP-2013). Concomitant therapies included ADACEL and NORVASC. On 23-JUL-2013 the patient experienced a red, inflamed 2x3 inch rash, hot and sensitive to touch at the injection site. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention by contacting the pharmacist. No treatment was given. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed swelling, pruritis and tenderness at site of injection.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Dysphagia, Dyspnoea, Ear discomfort, Injection site erythema
Clinical narrative: This patient received the Pneumovax 23 vaccine via IM injection in the morning on 07Aug2013. At 11:30 am on 07Aug2013 this patient started to experience redness and soreness at the site of injection, by noon symptoms progressed to swelling of throat, and shortness of breath and treated herself with a Ventolin (albuterol) inhaler. Symptoms continued to progress and by 7:30 PM the patients lips were swollen and burning, had blurred vision, dizziness, ear pressure, difficulty swallowing, site of injection had edema the size of softball and acute pain. At 7:45 pm the patient treated herself with 25mg of diphenhydramine, 10 mg of certirizine, 400mg cimetidine, albuterol inhaler and ice packs on injection site. At 8:00pm the swollen lips resolved and intensity of other symptoms improved. Patient contacted her PCP and was told to go to ER if symptoms did not continue to resolve and the Pneumovax 23 injection is not to be repeated due to severe allergic reaction.  Patient continues with resolving symptoms and treatment with diphenhydramine, albuterol, ice and cimetidine therapy.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain, Lip swelling, Oral discomfort, Pain
Clinical narrative: This patient received the Pneumovax 23 vaccine via IM injection in the morning on 07Aug2013. At 11:30 am on 07Aug2013 this patient started to experience redness and soreness at the site of injection, by noon symptoms progressed to swelling of throat, and shortness of breath and treated herself with a Ventolin (albuterol) inhaler. Symptoms continued to progress and by 7:30 PM the patients lips were swollen and burning, had blurred vision, dizziness, ear pressure, difficulty swallowing, site of injection had edema the size of softball and acute pain. At 7:45 pm the patient treated herself with 25mg of diphenhydramine, 10 mg of certirizine, 400mg cimetidine, albuterol inhaler and ice packs on injection site. At 8:00pm the swollen lips resolved and intensity of other symptoms improved. Patient contacted her PCP and was told to go to ER if symptoms did not continue to resolve and the Pneumovax 23 injection is not to be repeated due to severe allergic reaction.  Patient continues with resolving symptoms and treatment with diphenhydramine, albuterol, ice and cimetidine therapy.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pharyngeal oedema, Vision blurred
Clinical narrative: This patient received the Pneumovax 23 vaccine via IM injection in the morning on 07Aug2013. At 11:30 am on 07Aug2013 this patient started to experience redness and soreness at the site of injection, by noon symptoms progressed to swelling of throat, and shortness of breath and treated herself with a Ventolin (albuterol) inhaler. Symptoms continued to progress and by 7:30 PM the patients lips were swollen and burning, had blurred vision, dizziness, ear pressure, difficulty swallowing, site of injection had edema the size of softball and acute pain. At 7:45 pm the patient treated herself with 25mg of diphenhydramine, 10 mg of certirizine, 400mg cimetidine, albuterol inhaler and ice packs on injection site. At 8:00pm the swollen lips resolved and intensity of other symptoms improved. Patient contacted her PCP and was told to go to ER if symptoms did not continue to resolve and the Pneumovax 23 injection is not to be repeated due to severe allergic reaction.  Patient continues with resolving symptoms and treatment with diphenhydramine, albuterol, ice and cimetidine therapy.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Infection
Clinical narrative: This patient received the Pneumovax 23 vaccine via IM injection in the morning on 07Aug2013. At 11:30 am on 07Aug2013 this patient started to experience redness and soreness at the site of injection, by noon symptoms progressed to swelling of throat, and shortness of breath and treated herself with a Ventolin (albuterol) inhaler. Symptoms continued to progress and by 7:30 PM the patients lips were swollen and burning, had blurred vision, dizziness, ear pressure, difficulty swallowing, site of injection had edema the size of softball and acute pain. At 7:45 pm the patient treated herself with 25mg of diphenhydramine, 10 mg of certirizine, 400mg cimetidine, albuterol inhaler and ice packs on injection site. At 8:00pm the swollen lips resolved and intensity of other symptoms improved. Patient contacted her PCP and was told to go to ER if symptoms did not continue to resolve and the Pneumovax 23 injection is not to be repeated due to severe allergic reaction.  Patient continues with resolving symptoms and treatment with diphenhydramine, albuterol, ice and cimetidine therapy.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site warmth
Clinical narrative: Patient came in with red area at injection site of right deltoid. Area warm to touch. Small amount of red streaking to arm. Physician instructed that patient apply warm compress to area.
Age: 15.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MMR
Symptoms: Blister, Measles
Clinical narrative: Measles with a light case of blisters.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site plaque
Clinical narrative: Blotchy erythematous patches coalescing over injection site, forming 12 cm slightly raised erythematous plaque.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Signs of infection, increase erythema around injection site 5cm x 5cm, warm to touch, increasing in site, palpable soft tissue swelling.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Mass
Clinical narrative: Hard, red lump 3" in diameter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased activity, Erythema, Hypophagia, Nodule, Pyrexia
Clinical narrative: Redness, warm to touch, low grade fever - 99.9, decrease intake and activity. Office visit on 8-8-13 noted 4" X 3" nodule, redness and warm to touch area. Prednisone was ordered during visit.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm
Clinical narrative: Redness, warm to touch, low grade fever - 99.9, decrease intake and activity. Office visit on 8-8-13 noted 4" X 3" nodule, redness and warm to touch area. Prednisone was ordered during visit.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Severe headache, nausea, red hot swollen 5" x 6" tender hard area on upper right arm where injection was given.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: Severe headache, nausea, red hot swollen 5" x 6" tender hard area on upper right arm where injection was given.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Oedema peripheral, Pain, Pyrexia, Skin warm
Clinical narrative: Redness of upper extremity below injection site extending to elbow. Very warm very tender, fever, circumferential edema of upper extremity. Pain with touch and movement. Has not improved since onset.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Redness of upper extremity below injection site extending to elbow. Very warm very tender, fever, circumferential edema of upper extremity. Pain with touch and movement. Has not improved since onset.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: L arm large redness, swelling, warmth, pain, requiring return appointment for concerns for infection.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Epistaxis, Headache, Increased upper airway secretion, Increased viscosity of nasal secretion
Clinical narrative: First 2 hours - Scratchy throat; 2 1/3 hours later - massive headache; 3 hours later - body aches; 4 hours later - feverish; 5 hours later - weak; 10 hours later - thick, green, bloody filled, mucus collected in nasal and throat; 13 hours later - unable to think clearly and no appetite; 15 hours later - too weak to move. Treatment:  Plenty of tea, juice, water, 10 hours of rest and no medications.  Please note that I'm still going through this, but it's VERY mild.  It's be two days so far.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Pyrexia, Throat irritation
Clinical narrative: First 2 hours - Scratchy throat; 2 1/3 hours later - massive headache; 3 hours later - body aches; 4 hours later - feverish; 5 hours later - weak; 10 hours later - thick, green, bloody filled, mucus collected in nasal and throat; 13 hours later - unable to think clearly and no appetite; 15 hours later - too weak to move. Treatment:  Plenty of tea, juice, water, 10 hours of rest and no medications.  Please note that I'm still going through this, but it's VERY mild.  It's be two days so far.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to three patients (dates of birth, age and gender unspecified). The nurse reported that the patients received third doses of GARDASIL 0.5 ml intramuscular, (lot# and exp date unspecified) in less than 12 week interval between doses. No adverse effects required. Patients outcomes were unknown. This is one of two reports from the same reporter. MARRS: 1308USA003872. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The pharmacist reported that on an unknown date, after received PNEUMOVAX23, the patient's whole arm swelled. The outcome of the patient's whole arm swelled was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient (date of birth, age and gender unspecified). The nurse reported that the patient received third dose of GARDASIL 0.5ml intramuscular, (lot and exp date unspecified) in less than 12 week interval between doses. No adverse effects reported. First dose administered 17-NOV-2009, second dose administered on 23-MAR-2010 and third dose administered 26-MAY-2010. Patient's outcomes was unknown. This is one of two reports from the same reporter. MARRS: 1308USA002622. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Measles post vaccine, Pyrexia, Rash, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 12 month old male patient with no known drug reaction/allergies and no other pertinent medical history. On 12-JUL-2013 the patient was vaccinated with his one and only M-M-R II, subcutaneous (dose and lot number not provided). There was no concomitant medication. The nurse noted on 20-JUL-2013 that the patient developed a fever, was lethargic, and slept all day. Subsequently, on 22-JUL-2013 at 7AM the patient developed a rash. The rash worsened by 23-JUL-2013 and the patient was seen in the office for medical attention that same day; measles was diagnosed during that office visit. No treatment was given for the adverse event. No lab diagnostic test were performed. The outcome of the event was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye irritation
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 28 year old female pharmacist with no drug reactions or allergies and who on 02-AUG-2013 was reconstituting a dose of ZOSTAVAX (lot number not reported) and the vaccine accidentally splashed in an unspecified eye of hers. The pharmacist was experiencing burning of the unspecified eye that the vaccine splashed in. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. The relatedness for experiencing burning of the unspecified eye that the vaccine splashed in the ZOSTAVAX was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Pregnancy test urine negative
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 15 years old female patient with no drug allergies. The other medical history included eczema. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with dose 2 0.5 ml VARIVAX (Merck) (lot# was reported as HQ4272, expiration date not reported) subcutaneously on 26-OCT-2012. There was no concomitant medications. The patient was pregnant when received dose vaccine. A urine pregnancy test was done during the same office visit and it was negative. However, a serum pregnancy test was done at a later time and the result came back on 12-NOV-2012 and it was positive. The first dose of The VARIVAX (Merck)(lot# and expiration date were unknown) was provided by a different provider on an unspecified date. LMP was on approximately November 2012 and EDD will be approximately in August 2013. The patient was exposed to VARIVAX (Merck) during trimester 1. The patient sought medical attention through office visit and no treatment was given. Additional information has been requested. Lot number HQ4272 is an invalid lot number for VARIVAX.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother refers to her son a male patient of unknown age. In approximately August 2013 (about a year ago) the patient was vaccinated with GARDASIL (route, lot number and expiration date not reported) recommended by physician. There was no concomitant medication reported. The patient's mother reported that her son had missed his third dose of GARDASIL. She stated that her son received dose one and dose two within the prescribed period. No adverse event symptoms have been reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient who in February 2013, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The physician reported that on 31-JUL-2013, the patient developed shingles after receiving ZOSTAVAX. At the time of the report, the patient had not recovered from shingles. The patient sought medical attention by speaking with the physician. The relatedness for shingles and ZOSTAVAX was unknown. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, Eye irritation
Clinical narrative: Information has been received from a 30 year old female pharmacist, for ZOSTAVAX, a Pregnancy Registry product, concerning herself. The patient had no pertinent medical history. The patient had no drug allergies. On 01-AUG-2013, the patient was accidentally exposed to ZOSTAVAX (lot # not reported) (strength not specified). There were no concomitant medications. It was reported that while she was reconstituting ZOSTAVAX, the ZOSTAVAX accidentally splashed in an unspecified eye of hers. The patient reported that she experienced a little bit of burning of the eye after the splash of the ZOSTAVAX but she stated that her eye no longer burned at the time of reporting. At the time of accidental exposure, the patient was pregnant for 10 weeks. Her LMP and EDD was on approximately 23-MAY-2013 and 27-FEB-2014. The patient reported that she did not have a physician at this time and did not seek medical attention. No treatment was given. Lab diagnostics studies performed were reported as none. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified number of children, reported as some children, of unknown age and gender. Information on medical history was not reported. On an unknown date the patients was vaccinated with M-M-R II (lot # not reported) (dose number, dose route, indication not reported). It was reported that on unspecified dates the reporting nurse has seen some children making ouch sounds as she was giving injection of M-M-R II which indicated some pain or stinging from the injection. The reporting nurse could not provide any specific information on the number of patients or other detailed patients information regarding these adverse events. The outcome of sounds which indicated some pain or stinging from the injection was not reported. The reporter did not assessed the relationship between the therapy with M-M-R II and some pain or stinging from the injection. This is one of the reports from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 69 year old male patient. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX. No dosage information, anatomical location or lot number was reported. NO concomitant medication was reported. On an unknown date, three months after receiving the vaccine in his physician's office, the patient experienced shingles. It was unknown if the patient received any treatment for the adverse event. The outcome of shingles is unknown. No additional adverse event information was available. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a pharmacist (R.Ph.) refers to a 63 year old male patient. On 03-JUN-2013 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # J001003, expiry date 25-APR-2014), subcutaneous. There was no concomitant medication. And no pertinent medical history and drug reactions/allergies were reported. On 13-JUN-2013, (10 days after receiving ZOSTAVAX) the patient developed an unspecified rash on his face and the lids of his eyes as well as "localized" pain on his hand and an unspecified side of his face after receiving ZOSTAVAX. The pharmacist reported that the patient was seen by his physician on 14-JUN-2013 and the physician diagnosed the patient with shingles. No lab test was performed. The physician prescribed diclofenac (75 mg twice a day) as well as VALTREX (1 gram three times a day for a week). The outcome of shingles was reported as not recovered. This is one of several reports reporting from same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head injury
Clinical narrative: Patient advised her brother she felt like passing out. Grabbing her brother, leaned sideways, hit the right side of her head on wall and nurse caught her and lowered her to the floor. Had her sit down and gave her a drink.
Age: 4.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MMR
Symptoms: Syncope
Clinical narrative: Fainting.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Erythema and warmth right upper arm.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Erythema and warmth R upper arm.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Gait disturbance, Irritability, Pyrexia, Restlessness, Vomiting
Clinical narrative: 15 mo imm. given in office 8/06/13. Dev. fever 102-104 degrees F (usually runs 101-102 degrees with shots) vomited x 1 on 8/06/13 after O.V. Increased fussiness, restless. Did not walk after vaccines till 08/07/13 after noon. No erythema or edema RT-or-LT thighs on 8/8/13 exam. Tx: continue TYLENOL/MOTRIN alt.
Age: 0.11
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was out dated by 4 days. No adverse event.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, Injection site pain
Clinical narrative: Pt received MenA lyophilized conjugate component with plain sterile diluent instead of the men CYW-135 liquid conjugate component. Pt. had soreness at injection site. She will return for the complete vaccine.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Parents brought pt in 5 days after imms. stating the night imms. rec'd she broke out with a rash. her visit on 8/6/13 pt has hives arms, legs, trunk - parents state the resolve in one area and pop up in another area. Welts are raised, pink-not itchy. Rx-OTC BENADRYL. Other possible causes discussed ie food, clothing, bug bites.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin lesion, Varicella
Clinical narrative: This spontaneous report as received from a health care professional refers to a 60 year old female patient with no drug reactions or allergies. On 04-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J000493, expiration date 14-APR-2014 (route not reported). Concomitant therapies included PROZAC. On 23-JUL-2013, the patient experienced chicken pox rash on thighs, stomach and buttocks, the patient developed about 100 chicken pox lesions. The patient told these symptoms to the doctor by phone, she had not visited the office. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a health care professional refers to a 60 year old female patient with no drug reactions or allergies. On 04-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J000493, expiration date 14-APR-2014 (route not reported). Concomitant therapies included PROZAC. On 23-JUL-2013, the patient experienced chicken pox rash on thighs, stomach and buttocks, the patient developed about 100 chicken pox lesions. The patient told these symptoms to the doctor by phone, she had not visited the office. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Convulsion, Dyspnoea, Laboratory test normal, Loss of consciousness
Clinical narrative: Father reports via telephone call that approximately 5-10 minutes after vaccinations, patient complained of shortness of breath, passed out, then had seizures for 40 seconds.  Patient taken to ER where vital signs were normal.  Dad reports no prior history of seizures.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Convulsion, Dyspnoea, Loss of consciousness
Clinical narrative: Father reports via telephone call that approximately 5-10 minutes after vaccinations, patient complained of shortness of breath, passed out, then had seizures for 40 seconds.  Patient taken to ER where vital signs were normal.  Dad reports no prior history of seizures.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin, Dermatomyositis, Laboratory test, Lethargy, Myalgia
Clinical narrative: Patient developed a vascular rash on hands and elbows, lethargy, aching leg muscles and back muscles as well as edema in her hands bilaterally with hand developing a purple hue. Diagnosed with a rare autoimmune disease Juvenile Dermatomyositis. No cure, hope for a lasting remission, in 1979 3yr survival rate. Seen at hospital, rheumatologist caring for her.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Oedema peripheral, Skin discolouration, Vasculitic rash
Clinical narrative: Patient developed a vascular rash on hands and elbows, lethargy, aching leg muscles and back muscles as well as edema in her hands bilaterally with hand developing a purple hue. Diagnosed with a rare autoimmune disease Juvenile Dermatomyositis. No cure, hope for a lasting remission, in 1979 3yr survival rate. Seen at hospital, rheumatologist caring for her.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 52 year old female patient. Patient has no drug allergies. On 01-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001007, expiry: 24-APR-2014) 0.65 ml, subcutaneously in the arm. On 02-AUG-2013, the patient experienced redness and pain at the injection site on her unspecified arm. On 03-AUG-2103, the patient experienced a pain shooting up into her neck and called to inform the pharmacist. No treatment was given. Patient sought medical attention. The pharmacist called this patient back today (05-AUG-2013) to inquire on her status. The patient stated that she was recovering and no longer has any pain. The pharmacist advised the patient to seek medical attention if she experiences any further difficulties. Additional information  has been requested.
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On unknown dates the patient was vaccinated with the first two doses of ROTATEQ (lot number, dose, route and indication were not reported) and at the time of report the patient was in the office to receive a third dose of ROTARIX (it was also reported as manufacturer unspecified) and patient may be given ROTARIX instead of ROTATEQ for the third dose in rotavirus vaccines series. No adverse effect reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from patient's mother refers to her daughter, who was a female patient of unknown age. On an unknown date the patient was vaccinated with her first dose of GARDASIL (injection, strength, lot#, dose/frequency, route were unspecified). The patient experienced soreness in the arm after the vaccination. It was unspecified whether patient had sought medical attention or not. The outcome of soreness in the arm was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse (R.N.) refers to a 21 year old female patient with hypertension and seizure disorder. The patient's medical history included migraines. The patient had no drug allergies. On 31-JUL-2013 the pregnant patient received her first dose of GARDASIL (lot # not reported) (intramuscular, 0.5 ml, strength not reported). Concomitant therapies included PAMELOR and TOPAMAX. The patient had a positive urine pregnancy test in the physician's office on 31-JUL-2013. No adverse effect was reported. The patient's last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. It was unspecified whether the patient sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy report was received from a licensed practical nurse concerning an approximately 17 year old female patient with no pertinent medical history and no drug reactions or allergies. On 30-JUN-198, the patient was vaccinated with the first dose of, 0.5 milliliter of VARIVAX (Merck) (lot#, expiration date and route not reported). On 27-JUN-2013, the pregnant patient was vaccinated with a booster dose of VARIVAX (Merck) (lot number and expiry date reported as H017705 and 25-SEP-2014 respectively) subcutaneously. Other suspect therapy included the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) administered on 27-JUN-2013. Concomitant therapy included vitamins (unspecified) (reported as unspecified prenatal vitamin). Estimated date of conception of the patient was on 20-JUN-2013. Last menstrual period (LMP) was approximately on 06-JUN-2013 and estimated date of delivery (EDD) was on 13-MAR-2014. The pregnancy outcome was pending. The patient sought medical attention (went to office of the physician for general obstetrics appointment). On an unknown date, unspecified pregnancy test was performed. An unspecified treatment was given to the patient. Outcome of the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis post immunization at site of injection.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and indication not reported). The second dose in the series was administered on an unspecified date approximately 5-6 months after the first dose of GARDASIL. The third dose of GARDASIL was administered on an unspecified date one month after the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a physician refers to a couple of patients. On unknown dates the patients might be vaccinated with PNEUMOVAX23 (also reported as unspecified vaccine) (dose, indication, and route not reported). The physician stated since approximately 1998 (10-15 years ago), he had a couple of patients who might have had allergic reactions to an unspecified vaccine, whether their reaction was caused by a vaccine was unknown and what the reaction was, if present at all, was unclear to the physician. Also, if vaccine was cause of reaction, it was not clear if it was a MERCK product. Adverse effects, if any, were not able to be identified. The physician asked for studies pertaining to PNEUMOVAX23 and allergic reactions and also asked if yeast was an ingredient. No PQC. The outcome of allergic reaction is unknown. Additional information has been requested.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3186AA received on 16 February 2009, lot number C3231AA received on 27 April 2009, lot number C3186AA received on 22 June 2009, and lot number C3496AA received on 24 May 2010. The subject developed a cough on 02 July 2013, approximately 3 years after the last dose, and a paroxysmal cough with a whoop on 10 July 2013. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 13 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 13 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 23 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 202 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 202 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3186AA received on 16 February 2009, lot number C3231AA received on 27 April 2009, lot number C3186AA received on 22 June 2009, and lot number C3496AA received on 24 May 2010. The subject developed a cough on 02 July 2013, approximately 3 years after the last dose, and a paroxysmal cough with a whoop on 10 July 2013. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 13 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 13 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 23 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 202 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 202 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.52
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following vaccinations: PENTACEL (dose 1) lot number C4231AA received on 27 June 2012, PENTACEL (dose 2) lot number C4269AA received on 05 September 2012, and DAPTACEL (dose 3) lot number C4186AA on 01 November 2012. The subject developed a cough on 05 July 2013, approximately 246 days after the last dose, and a paroxysmal cough without a whoop on 12 July 2013. The subject also developed cold like symptoms on 05 July 2013, and posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 17 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 18 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 23 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 204 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 204 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.52
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following vaccinations: PENTACEL (dose 1) lot number C4231AA received on 27 June 2012, PENTACEL (dose 2) lot number C4269AA received on 05 September 2012, and DAPTACEL (dose 3) lot number C4186AA on 01 November 2012. The subject developed a cough on 05 July 2013, approximately 246 days after the last dose, and a paroxysmal cough without a whoop on 12 July 2013. The subject also developed cold like symptoms on 05 July 2013, and posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 17 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 18 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 23 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 204 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 204 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Sex: M
Vaccine: PPV
Symptoms: Death
Clinical narrative: Information has been received from a lawyer concerning a male (age unspecified) who on an unspecified date received a dose of PNEUMOVAX23 (route, dose, site and lot number not reported). Subsequently the patient died. The exact cause and date of death was not reported. It was unknown whether the patient underwent an autopsy. The reporter stated that it is believed that the PNEUMOVAX23 caused the patients death. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; dose 1 on 11 June 2010 (lot not reported), dose 2 on 06 August 2010 (lot not reported), dose 3 on 28 September 2010 (lot not reported), and dose 4 (lot number C3781AA) on 29 July 2011. The subject developed a cough on 30 June 2013, approximately 2 years after the last dose, and a paroxysmal cough without a whoop on 03 July 2013. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 13 July 2013 Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 13 July 2013 for 5 days. At the time of final contact on 25 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. The patient was hospitalized for 3 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 203 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 203 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.31
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; dose 1 on 11 June 2010 (lot not reported), dose 2 on 06 August 2010 (lot not reported), dose 3 on 28 September 2010 (lot not reported), and dose 4 (lot number C3781AA) on 29 July 2011. The subject developed a cough on 30 June 2013, approximately 2 years after the last dose, and a paroxysmal cough without a whoop on 03 July 2013. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 13 July 2013 Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 13 July 2013 for 5 days. At the time of final contact on 25 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. The patient was hospitalized for 3 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 203 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 203 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Human papilloma virus test positive, Rectal cancer
Clinical narrative: This spontaneous report as received from a consumer refers to a her 88 year old mother. The patient's medical history included cervical cancer on an unknown date in 1987. On an unknown date in November 2006, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number, expiry date, route and dose were not reported). On an unknown date in 2007, the patient developed rectal cancer with positive HPV virus. The patient sought medical attention and was hospitalized on an unspecified date. The reporter also mentioned that the patient would be discharged on the day of reporting. The outcome of the events was unknown. Upon internal review, the event rectal cancer was considered to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 58 year old female patient. On 19-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # were not reported). On the same day (time not specified) the patient experienced severe leg cramps in both legs and hips; as well as joint pain to the point that the patient visited a walk-in urgent care facility where the patient was administered a steroid injection (brand, manufacturer, and dose unspecified). Within hours the patient showed immediate improvements. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. In September 2012 the patient received her first dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). In November 2012 the patient received the second dose of the vaccine (lot # not reported) (strength and total daily dose not reported). This patient had yet to receive the third dose of the vaccine and at the time of report it was way past the timing of the dosing schedule in the prescribing information. No side effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature, Decreased appetite, Rash generalised
Clinical narrative: This case was received from a foreign health authority on 01-AUG-2013. This case is not medically confirmed as it was reported by a consumer. An 1 year old female patient (weight: 11.5 kg) with no medical history reported, received an injection of measles, mumps and rubella vaccine (manufacturer unknown, batch number not reported), dose, route and site of administration not reported, on an unreported date. On 18-JUL-2013, the patient experienced rash all over with temperature and lack of appetite. At the time of reporting the patient was recovering. The health authority considered that case serious due to be medically significant.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site rash, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient. On 28-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H021710, expiration date 07-MAR-2014, (dose was not reported), subcutaneous in the right arm. At that same time the patient was also vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported), in the left arm. In July 2013 the patient developed 3 inch rash at the ZOSTAVAX injection site of the right arm and body ache. The patient was not hospitalized and it was not life threatening. The patient was checked by his physician and was placed on over the counter BENADRYL. The reporter stated that the patient was feeling better (at the time of the report). The relatedness between the events and ZOSTAVAX, PNEUMOVAX 23 was not reported. This case is linked with case MARRS# 1308USA000698, considered the same reporter. Additional information has been requested.