chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Skin reaction
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age (gender not reported). On an unknown date the patient was vaccinated with a shot of ZOSTAVAX (lot #, dose and route not reported). According to the physician, on an unknown date the patient experienced a "skin reaction resembling cellulitis near the injection site" after having received ZOSTAVAX. The patient was treated with an unspecified treatment which was used for treating cellulitis. The patient sought medication attention by seeing the physician. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Drug ineffective, Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 13-AUG-2013, the patient was vaccinated with a dose of M-M-R II (Lot number was reported as H017430, expiry date was 20-SEP-2014, route and dose were not reported) that was exposed to 14 C for 30 hours, which was unsupported by in-house stability data. No adverse effect was reported. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Lethargy
Clinical narrative: This spontaneous report was received from a consumer concerning his 4 week old daughter with no known pertinent medical history or drug reactions/allergies. On 13-AUG-2013, the patient was inadvertently given a dose of ROTATEQ (lot # and dose not provided) oral. The patient was also given concomitantly two unspecified "non-live" vaccines. On 13-AUG-2013, since the administration of ROTATEQ, the consumer's daughter has been lethargic. No laboratory tests were performed. There was not given any treatment for the event. At the time of the report, the outcome of lethargy was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccines administered 8-15-13. Initial discomfort which resolved. On 8-19 noted redness, pain and swelling at site. Diagnosed with cellulitis on 8-21-12 (L arm) and treated with clinda.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (clinical manager/medical assistant) refers to a patient of unknown age and gender. On 14-AUG-2013 the patient was vaccinated with M-M-R II (lot #0517AA, expiration date 08-APR-2013) (dose, route and anatomical location unspecified). No adverse effect reported. The patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Corrective lens user, Crying, Dyspnoea, Headache
Clinical narrative: This spontaneous report was received from a consumer refers to her 17 year old daughter. No medical history was reported. On 02-MAR-2009, the patient was vaccinated with first dose of GARDASIL (lot#, expiry not reported) intramuscularly. Since 03-MAR-2009, the patient experienced several severe reactions to the first dose of GARDASIL, and she had not received any other doses in the series. She had been experiencing severe headaches that are so painful that they made the patient cry. The first headache that the patient experienced began the day after receiving the shot. The headache lasted for at least a week and was so painful that she sought medical attention at an unspecified hospital, but she was not hospitalized. At the hospital, she was treated with a shot of TORADOL. The patient had an allergic reaction to the TORADOL. The patient also had 2 Magnetic resonance imaging (MRI) done: results unknown. This patient also had been experiencing bad body aches and stomach aches several times weekly since having received the shot. Additionally, the patient has had vision problems. Her eyes worsened since getting the shot to where she had to get glasses. Even with glasses, her eyes sometimes have difficulty focusing and her vision sometimes gets blurry. This patient has also been experiencing periodic shortness of breath and fast or irregular heartbeat ever since having GARDASIL. Patient received no treatment for the events. Patient sought medical attention. She has been referred to unspecified heart and stomach specialists. The outcome of bad body aches, headaches, fast or irregular heartbeat, shortness of breath, stomachaches and vision sometimes gets blurry was reported as not recovered. The patient would soon be seeing the reporter's physician as the physician she was seeing had left the office about three weeks ago. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Heart rate irregular, Hypersensitivity, Nuclear magnetic resonance imaging, Pain
Clinical narrative: This spontaneous report was received from a consumer refers to her 17 year old daughter. No medical history was reported. On 02-MAR-2009, the patient was vaccinated with first dose of GARDASIL (lot#, expiry not reported) intramuscularly. Since 03-MAR-2009, the patient experienced several severe reactions to the first dose of GARDASIL, and she had not received any other doses in the series. She had been experiencing severe headaches that are so painful that they made the patient cry. The first headache that the patient experienced began the day after receiving the shot. The headache lasted for at least a week and was so painful that she sought medical attention at an unspecified hospital, but she was not hospitalized. At the hospital, she was treated with a shot of TORADOL. The patient had an allergic reaction to the TORADOL. The patient also had 2 Magnetic resonance imaging (MRI) done: results unknown. This patient also had been experiencing bad body aches and stomach aches several times weekly since having received the shot. Additionally, the patient has had vision problems. Her eyes worsened since getting the shot to where she had to get glasses. Even with glasses, her eyes sometimes have difficulty focusing and her vision sometimes gets blurry. This patient has also been experiencing periodic shortness of breath and fast or irregular heartbeat ever since having GARDASIL. Patient received no treatment for the events. Patient sought medical attention. She has been referred to unspecified heart and stomach specialists. The outcome of bad body aches, headaches, fast or irregular heartbeat, shortness of breath, stomachaches and vision sometimes gets blurry was reported as not recovered. The patient would soon be seeing the reporter's physician as the physician she was seeing had left the office about three weeks ago. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred, Visual impairment
Clinical narrative: This spontaneous report was received from a consumer refers to her 17 year old daughter. No medical history was reported. On 02-MAR-2009, the patient was vaccinated with first dose of GARDASIL (lot#, expiry not reported) intramuscularly. Since 03-MAR-2009, the patient experienced several severe reactions to the first dose of GARDASIL, and she had not received any other doses in the series. She had been experiencing severe headaches that are so painful that they made the patient cry. The first headache that the patient experienced began the day after receiving the shot. The headache lasted for at least a week and was so painful that she sought medical attention at an unspecified hospital, but she was not hospitalized. At the hospital, she was treated with a shot of TORADOL. The patient had an allergic reaction to the TORADOL. The patient also had 2 Magnetic resonance imaging (MRI) done: results unknown. This patient also had been experiencing bad body aches and stomach aches several times weekly since having received the shot. Additionally, the patient has had vision problems. Her eyes worsened since getting the shot to where she had to get glasses. Even with glasses, her eyes sometimes have difficulty focusing and her vision sometimes gets blurry. This patient has also been experiencing periodic shortness of breath and fast or irregular heartbeat ever since having GARDASIL. Patient received no treatment for the events. Patient sought medical attention. She has been referred to unspecified heart and stomach specialists. The outcome of bad body aches, headaches, fast or irregular heartbeat, shortness of breath, stomachaches and vision sometimes gets blurry was reported as not recovered. The patient would soon be seeing the reporter's physician as the physician she was seeing had left the office about three weeks ago. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that on 15-AUG-2013 the patient was vaccinated with a fourth dose of GARDASIL (lot number, dose and strength not reported). The first dose of GARDASIL had been administered on 07-JUN-2011, the second dose of GARDASIL had been administered on 23-AUG-2012 and the third dose of GARDASIL had been administered sometime in June of 2013. No adverse event was reported. There was no other information to report. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dyspnoea, Headache, Heart rate irregular, Pain
Clinical narrative: This spontaneous report was received from a consumer refers to her 20 year old daughter. On 02-MAR-2009, the patient was vaccinated with first dose of GARDASIL (lot#, expiry not reported) intramuscularly. The patient had not received any subsequent doses in the series. Since an unknown date, the patient experienced body aches, headaches, fast or irregular heartbeat, shortness of breath and stomach aches. The patient was experiencing bouts of these adverse reactions about 4-5 times each week. The patient also developed bumps all over her body that were diagnosed as rosacea which began on an unspecified date after receiving GARDASIL and lasted for about a month. The patient had been seeing the certified nurse practitioner. The outcome of body aches, headaches, stomachaches, fast or irregular heartbeat and shortness of breath was reported as not recovered. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rosacea
Clinical narrative: This spontaneous report was received from a consumer refers to her 20 year old daughter. On 02-MAR-2009, the patient was vaccinated with first dose of GARDASIL (lot#, expiry not reported) intramuscularly. The patient had not received any subsequent doses in the series. Since an unknown date, the patient experienced body aches, headaches, fast or irregular heartbeat, shortness of breath and stomach aches. The patient was experiencing bouts of these adverse reactions about 4-5 times each week. The patient also developed bumps all over her body that were diagnosed as rosacea which began on an unspecified date after receiving GARDASIL and lasted for about a month. The patient had been seeing the certified nurse practitioner. The outcome of body aches, headaches, stomachaches, fast or irregular heartbeat and shortness of breath was reported as not recovered. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dyspnoea, Headache, Heart rate increased, Heart rate irregular
Clinical narrative: This spontaneous report was received from a consumer refers to her 17 year old daughter. On 02-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (lot#, expiry not reported) intramuscularly. The patient had not received any subsequent doses in the series. Since an unknown date, the patient experienced body aches, headaches, fast or irregular heartbeat, shortness of breath and stomachaches. The patient was experiencing bouts of these adverse reactions about 4-5 times each week. The patient had been seeing the certified nurse practitioner. The outcome of body aches, headaches, stomachaches, fast or irregular heartbeat and shortness of breath was reported as not recovered. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a consumer refers to her 17 year old daughter. On 02-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (lot#, expiry not reported) intramuscularly. The patient had not received any subsequent doses in the series. Since an unknown date, the patient experienced body aches, headaches, fast or irregular heartbeat, shortness of breath and stomachaches. The patient was experiencing bouts of these adverse reactions about 4-5 times each week. The patient had been seeing the certified nurse practitioner. The outcome of body aches, headaches, stomachaches, fast or irregular heartbeat and shortness of breath was reported as not recovered. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 14 year old male patient with acne and attention deficit/hyperactivity disorder (ADHD and a history of insomnia and no drug reactions or allergies who on 20-JUL-2011, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 669285/0691AA, Exp. Date: 17-AUG-2013) and on 08-AUG-2013, was vaccinated with the second dose of GARDASIL (lot number J002641, Exp. Date: 10-DEC-2015). Concomitant therapies included Sulfacetamide sodium, Clonidine, VENTOLIN HFA, RETIN-A MICRO GEL, and Benzoyl peroxide (+) Clindamycin phosphate. The nurse reported that on 15-AUG-2013, the patient's father called to the office regarding a lump in his son throat. The patient was seen in the office on 16-AUG-2013 and the physician diagnosed the patient with lymph node enlargement. Antibiotics, warm compress and Ibuprofen were given as a treatment for the experience. At the time of the report, the patient had not recovered. The relatedness for lymph node enlargement and GARDASIL was unknown. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 60 year old male patient with no known pertinent medical history. In approximately 29-JUL-2013, within the last two weeks the patient was vaccinated with ZOSTAVAX (lot #, dose and route not provided) injection. In approximately 29-JUL-2013, within the last two weeks, the patient had developed a rash on the side of his face and around his eyes. On an unknown date, the patient visited the nurse practitioner, who said based on his clinical experienced that this was shingles. No laboratory tests were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 60 years old, female, non pregnant consumer reporting on herself, with no pertinent medical history report. On 01-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (1 injection, dose and route not specified). No other suspect therapies or concomitant medications were reported. The patient reported that on 10-AUG-2013 (also reported as two weeks after getting the vaccine) she experienced a "rash like the pictures on the internet" on both legs from the knee down. The outcome for "rash like the pictures on the internet" was unknown at the time of the report. No treatment was given for the above mentioned event. It was reported that the patient did not seek medical attention. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Oral herpes, Rash
Clinical narrative: Fever - blisters in mouth, rash in groin area.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia oral, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a physician refers to a 14 year old male patient. No medical history or drug allergies were reported. On 29-JUL-2013, the patient was vaccinated with a dose of GARDASIL (lot # J003727, expiry: 07-NOV-2015), 0.5 ml, intramuscular. No concomitant medications were reported. On 29-JUL-2013, the patient's mother reported to the physician that the patient experienced numbness and tingling of his entire tongue immediately after receiving GARDASIL. The patient's tongue was getting better. However, there was still numbness and tingling on the tip of the patient's tongue. The outcome of numbness and tingling of his entire tongue was reported as recovering. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia oral, Hypogeusia, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a physician refers to a 14 year old male patient. No medical history or drug allergies were reported. On 29-JUL-2013, the patient was vaccinated with a dose of GARDASIL (lot # J003727, expiry: 07-NOV-2015), 0.5 ml, intramuscular. No concomitant medications were reported. On 29-JUL-2013, the patient's mother reported to the physician that the patient experienced numbness and tingling of his entire tongue immediately after receiving GARDASIL. The patient's tongue was getting better. However, there was still numbness and tingling on the tip of the patient's tongue. The outcome of numbness and tingling of his entire tongue was reported as recovering. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: c/o right upper arm tenderness 2 hrs post inj. R. (entire arm hurt-extending to fingers, c/o h/a 2 d. finger pain resolved.was unable to move R arm initially). Rx. - used cold packs, Vicodin and fentanyl patch and elevated R arm. No finger pain since 8/21 AM. As of 8/22 AM Right arm still hurts from elbow to injection site (10/10 pain scale).
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm 1/2 upper area. Red, swollen, warm.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a female patient of unknown age with sulfa allergy. On 31-JUL-2013, the patient received a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unspecified date after the vaccination, on approximately 01-AUG-2013, the patient developed a knot under the skin and redness at the site of ZOSTAVAX injection. The patient did not receive any treatment for the events and sought medical attention by calling the pharmacist. No laboratory test was performed. At the time of the report, the patient was recovering from the events. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received pneumovax vaccine on 8/20/13 L upper arm 15:57 PM. On 8/21/13, the left arm from the deltoid to the left antecubital area was reddened and warm. The patient complained of soreness. Patient was placed on Keflex 500 mg po every 6 hours starting 8/21 at 13:00 PM.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child was given Menveo at age 10 - should have been age 11.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Reported to clinic on 02/15/13. Had a blistered area on right side of head. Had shingles vaccine on 2-7-13. Rates pain at a 3. Noted it first on 2/11/13 to have one spot on 2/12/13 shaved head and has since developed further blistered areas.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Mother called approx 29 hours after immunization to report: headache - day of vaccination, next morning: dizziness and 1/4 red, swollen circle around a left arm injection site, by afternoon (after school, about 2:30pm): 3" red, swollen circle, by 4pm (1 hour later) 4 1/2" red, swollen circle. Advised mother to take child to physician or urgent care.
Age: 53.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pallor, Swelling
Clinical narrative: Pt presented to provider, noted to have erythema and swelling of left upper extremity at the site of the pneumonia vaccine on 07/30/13. Patient noticed redness/swelling/blanching erythema later the same day she received the vaccine. Was getting better. Denied shortness of breath.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a 4 year old (at time of this report) patient. On 30-APR-2010 the patient was vaccinated with VAQTA (lot number not reported) dose 1, 0.5 ml, intravenous and was vaccinated for the second time (dose 2) on 24-SEP-2010. No adverse effect had been observed or reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L arm swollen, red, hot
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Dermatitis, Injection site rash, Irritability, Rash, Rash papular
Clinical narrative: Mother noticed a rash on both legs, fine papular rash symmetrical over the areas of the vaccination no rash on his body, no fever, he is a bit irritable. Papular acrodermatitis.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Pt received Hepatitis A IM LD on 8/20/13. Pt has hive type reaction 3" by 5" where vaccine was given.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J002777, expiration date 07-JUN-2014) injection, subcutaneous. On an unknown date the patient experienced injection site reaction after receiving ZOSTAVAX that was described to be like a "big welt or target" that itched but was not reported to have been a rash. The pharmacist stated that other patient was vaccinated with vial sharing the lot number (MARRS 1308USA010307). The outcome of injection site reaction and injection site itching was unknown. The causality was unknown. This is one of several reports from the same source (MARRS 1308USA010306. 1308USA006743 and 1308USA010307). Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Chills, Feeling hot, Headache
Clinical narrative: Pt. reported having severe headache, back pain, chills and felt like her body was on fire 8/21 5 PM. Took 2 TYLENOL at 2:30 A 8/22/12. 8/22 Talked with pt. Symptom much improved at 4 PM.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Within 5 min of administration hives appeared on right leg. Along with itching.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Haematoma, Oedema peripheral, Pain
Clinical narrative: Hematoma, swollen arm, pain on a scale of 6-7.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Typhoid pills started 8-12-13. Severe abdominal pain and diarrhea starting with first pill. Seemed to improve 2 days after last pill. Taken every other day x 4 pills - correctly as prescribed.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling and induration at site 5x3.5 cm.
Age: 64.0
Sex: M
Vaccine: TYP
Symptoms: Fatigue, Somnolence
Clinical narrative: Extremely tired after the first typhoid pill. Remained tired over days pill was taken and 2 days after finishing. No nausea or vomiting. "Could have slept 20 hrs each day". Pills taken correctly started 8-15-2013.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Arthropod bite, Injection site erythema, Injection site pallor, Injection site reaction, Oedema
Clinical narrative: Given PNEUMOVAX on 8-21/13. On 8/22 left arm splotchy erythema from top of shoulder to just above elbow and circumferentially around arm. Injection site paler. Scattered bug bites. (+) tenderness and edema. OK ROM but reluctant d/t pain.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Rash macular, Tenderness
Clinical narrative: Given PNEUMOVAX on 8-21/13. On 8/22 left arm splotchy erythema from top of shoulder to just above elbow and circumferentially around arm. Injection site paler. Scattered bug bites. (+) tenderness and edema. OK ROM but reluctant d/t pain.
Age: 1.39
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Rec'd DTaP in office on 8/20/13. S/S began next evening, including erythema, edema, and warmth. Seen 8/22/13 with fever (101.5 Max). Increased fussiness with (L) thigh with purplish discoloration and area approximately 3x6cm of redness, induration and hot to touch. Tx with MOTRIN.
Age: 1.39
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Irritability, Oedema, Pyrexia
Clinical narrative: Rec'd DTaP in office on 8/20/13. S/S began next evening, including erythema, edema, and warmth. Seen 8/22/13 with fever (101.5 Max). Increased fussiness with (L) thigh with purplish discoloration and area approximately 3x6cm of redness, induration and hot to touch. Tx with MOTRIN.
Age: 0.64
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an approximately 52 year old female patient. In approximately August 2011, "two years ago", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The pharmacist reported that in approximately 2011, "two weeks later" vaccination, the patient experienced a mild case of shingles. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a 92 year old male patient. On 19-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration, dose unspecified), subcutaneously. On 26-JUL-2013, the patient experienced developed shingles after receiving ZOSTAVAX. The patient sought medical attention via office visit on an unspecified date. FAMVIR (Unspecified manufacturer, dose and frequency) was prescribed for treatment. At the time of report, the event outcome was reported as recovering/resolving. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test, Antibody test normal
Clinical narrative: The spontaneous report as received from a physician refers to a 74 year old male patient. The patient's medical history included atrial fibrillation, kidney stones, hypothyroidism and benign prostatic hyperplasia. In 2012 (the physician reported may have received sometime last year) the patient was vaccinated with ZOSTAVAX). Lot number, dose, route and frequency were not reported. Concomitant therapies included NORPACE, SYNTHROID and FLOMAX. On 08-FEB-2013 the patient's varicella titer was 1.25 "lgGT" for varicella antibody. The outcome of patient's varicella titers were 1.25 "lgGt" for varicella antibody  was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J002777, expiration date 07-JUN-2014) injection, subcutaneous. On an unknown date the patient experienced injection site reaction after receiving ZOSTAVAX, that was described to be like a "big welt or target" that itched but was not reported to have been a rash. The outcome of injection site and injection site itching was unknown. The causality was unknown. This is one of several reports from the same source (MARRS 1308USA010306, 1308USA006743 and 1308USA010308). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
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 ZOSTAVAX (lot # and expiration date unspecified) injection, subcutaneous route. The pharmacist reported that on an unknown date the patient developed an injection site reaction after receiving ZOSTAVAX, that was described to be like a "big welt or target" that itched but was not reported to had been a rash. The pharmacist stated that three other patients had similar reactions. The outcome of injection site reaction and injection site itching was unknown. The causality was unknown. This is one of several reports from the same source (MARRS 1308USA006743, 1308USA010307 and 1308USA010308). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J001700, expiration date 08-MAY-2014) injection, subcutaneous. On an unknown date the patient experienced injection site reaction after receiving ZOSTAVAX that was described to be like a "big welt or target" that itched but was not reported to have been a rash. The pharmacist stated that three patients experienced similar reactions. The outcome of injection site reaction and injection site itching was unknown. The causality was unknown. This is one of several reports from the same source (MARRS 1308USA010306, 1308USA010307 and 1308USA010308). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from the mother of the patient consumer refers to a currently 6 year old male patient. The patient had no pertinent medical history or allergies. On 2008, when the patient was 2 years old, he was vaccinated with the first dose of VARIVAX (Merck). A week after receiving the shot, the patient developed a rash around the injection site. The patient sought medical attention going to an unspecified physician. The patient was treated with acyclovir (manufacturer unspecified). The patient did not undergo any lab test. It was reported that on an unspecified date the patient recovered from the event. At the time of the report the patient has not yet received the second dose of VARIVAX (Merck) and his mother was unsure if the patient would get the second dose. 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 certificate medical assistance refers to a female patient of unknown age. In 2008 the patient received the first dose of GARDASIL (lot #, expiration unspecified). On 09-AUG-2013 (today) she was in the office to get the second dose. No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. In February 2013, the patient was vaccinated with the first dose of GARDASIL (route and lot # not reported). The nurse reported that second and third doses of GARDASIL were administered too close to one another. The second dose of GARDASIL (route and lot # not reported) was administered on 09-APR-2013 and the third dose of GARDASIL (route and lot # not reported) was administered on 11-JUN-2013. No adverse effect was reported. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.34
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.34
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.99
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.82
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.51
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 1.6
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Kinrex administered to child under the age of 4.
Age: 0.35
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.81
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.34
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 0.43
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to child under the age of 4.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pruritus, Vomiting
Clinical narrative: Nausea, vomiting, headache, itching. Shot given at 1pm now 5pm.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vertigo, Visual impairment
Clinical narrative: Headache, head spinning, can see straight.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Vomiting (3 times), headache, dizziness.
Age: 14.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 14 year old patient (gender unknown). No medical history was reported. On 22-FEB-2013, the 14 year old patient was vaccinated with a 0.5 ml dose of PROQUAD (lot#, expiry not reported) subcutaneously. No concomitant medications were reported. The child is not experiencing any adverse reactions. Follow-up information was received from the reporting medical assistant. On 22-FEB-2013 at 14:30 the male patient received the first dose of PROQUAD (Merck) vaccination in the left arm with valid lot # H015643. Additionally on the same date, he received the second dose of hepatitis A vaccination (other company) intramuscularly in the left arm, the first dose of GARDASIL intramuscularly in the left arm with lot # H009746 and the first dose of a flu vaccine (other company) intramuscularly in the right arm. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with unspecified allergy to MACROBID. On 13-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J001693, exp. date: 08-MAY-2014, 0.65 ml, subcutaneous, site of injection not reported). Concomitant therapies included EVISTA and omeprazole (manufacturer unknown). On 13-AUG-2013 the patient experienced a rash around the injection site, measuring approximately five to six inches, after patient received ZOSTAVAX. The reporter stated the injection site was swollen and warm to the touch. Upon visual inspection the patient's physician diagnosed patient with shingles-due to a shingles like rash on patient's neck. The patient was treated with prednisone (manufacturer unknown) and valacyclovir hydrochloride (it was also reported that the patient did not receive treatment for adverse events). The outcome of all events was not reported. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with unspecified allergy to MACROBID. On 13-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J001693, exp. date: 08-MAY-2014, 0.65 ml, subcutaneous, site of injection not reported). Concomitant therapies included EVISTA and omeprazole (manufacturer unknown). On 13-AUG-2013 the patient experienced a rash around the injection site, measuring approximately five to six inches, after patient received ZOSTAVAX. The reporter stated the injection site was swollen and warm to the touch. Upon visual inspection the patient's physician diagnosed patient with shingles-due to a shingles like rash on patient's neck. The patient was treated with prednisone (manufacturer unknown) and valacyclovir hydrochloride (it was also reported that the patient did not receive treatment for adverse events). The outcome of all events was not reported. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. On 16-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J002641, expiry date 10-DEC-2015) (dosing information and route were not provided). The nurse reported that the patient experienced seizure-like reaction after receiving first dose of GARDASIL on 16-AUG-2013. The nurse stated that she was not directly involved with this patient and did not want to provide any further information. Follow up information was received from a registered nurse. She reported that the patient convulsed for "2-3 seconds" and than "passed out" for a "few seconds" after receiving GARDASIL. The nurse reports that the patient was given a granola bar and water 15 minutes after receiving the GARDASIL since the patient reported that she had not eaten all day. The outcome of seizure-like reaction, convulsed for "2-3 seconds" and "passed out" for a "few seconds" is unknown. No reporter causality provided. Upon internal review, convulsed for "2-3 seconds" and "passed out" for a "few seconds" was considered to be medically significant. No consent to contact the physician. Furthermore the patient's mother called the office after her child's reaction and stated that she has done some research (source unknown) and found out that seizure-like reaction was common after GARDASIL administration and she also found from her research that someone has died from GARDASIL reaction and was concerned (captured in MARRS 1308USA010574). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4
Symptoms: Convulsion, Loss of consciousness, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. On 16-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J002641, expiry date 10-DEC-2015) (dosing information and route were not provided). The nurse reported that the patient experienced seizure-like reaction after receiving first dose of GARDASIL on 16-AUG-2013. The nurse stated that she was not directly involved with this patient and did not want to provide any further information. Follow up information was received from a registered nurse. She reported that the patient convulsed for "2-3 seconds" and than "passed out" for a "few seconds" after receiving GARDASIL. The nurse reports that the patient was given a granola bar and water 15 minutes after receiving the GARDASIL since the patient reported that she had not eaten all day. The outcome of seizure-like reaction, convulsed for "2-3 seconds" and "passed out" for a "few seconds" is unknown. No reporter causality provided. Upon internal review, convulsed for "2-3 seconds" and "passed out" for a "few seconds" was considered to be medically significant. No consent to contact the physician. Furthermore the patient's mother called the office after her child's reaction and stated that she has done some research (source unknown) and found out that seizure-like reaction was common after GARDASIL administration and she also found from her research that someone has died from GARDASIL reaction and was concerned (captured in MARRS 1308USA010574). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 05-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J006109, expiry date 21-MAY-2015) (dose, route, injection site not provided). The VARIVAX (Merck) underwent an unsupported temperature excursion and was administered to the patient on 05-AUG-2013. No adverse effect reported. This is one of several reports reporting from same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: CSF test normal, Chills, Electroencephalogram normal, Flank pain, Hyperhidrosis
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Photopsia, Tonic clonic movements
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Acrochordon, Blood glucose increased, Blood glucose normal, Blood pressure diastolic increased, Blood pressure systolic increased
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blood prolactin increased, CSF cell count normal, Chills, Computerised tomogram abnormal, Computerised tomogram head abnormal
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Confusional state, Convulsion, Cyst, Cystitis, Electroencephalogram normal
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.
Age: 27.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Encephalopathy, Fall, Flank pain, Grand mal convulsion, Hyperhidrosis
Clinical narrative: Patient experienced right flank pain upon waking at 5:00 AM. At 6:00 also began to have chills with diaphoresis which was immediately followed by a flash of "orange" with subsequent tonic/clonic witnessed "seizures' x2 of 6 minutes duration. She was transported to the ER by ambulance for evaluation.