chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: Temperature began to rise, increased fussiness, less appetite (baby is breastfed).  By morning, temp was almost 104 and mother took her to the doctor.  Where they had sent her to the ER before for a temp of 100.5 this time they told her to go home and give Tylenol and ibuprofen.  They gave an antibiotic shot (cefalexin) and told her to come back the next day for recheck. Gave another antibiotic shot and said blood work was clear except slightly low neutrophils.  Checking for dehydration as baby was barely nursing. Recommended Pedialyte. Baby had stopped nursing altogether by 3/24.  Mom on phone with doc was told to push fluids with syringe as well as continue fever meds.  No recheck on Sunday - appt for 3/25 AM.  Sent to the ER for dehydration. Placed on IV fluids and antibiotics.  Had had a fine red rash that seemed to come and go with fever.  Developed dark red mottled rash by 3/26 (regular room, not ICU).
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Staring, Swelling, Urine output decreased, Viral test negative, Weight decreased
Clinical narrative: Temperature began to rise, increased fussiness, less appetite (baby is breastfed).  By morning, temp was almost 104 and mother took her to the doctor.  Where they had sent her to the ER before for a temp of 100.5 this time they told her to go home and give Tylenol and ibuprofen.  They gave an antibiotic shot (cefalexin) and told her to come back the next day for recheck. Gave another antibiotic shot and said blood work was clear except slightly low neutrophils.  Checking for dehydration as baby was barely nursing. Recommended Pedialyte. Baby had stopped nursing altogether by 3/24.  Mom on phone with doc was told to push fluids with syringe as well as continue fever meds.  No recheck on Sunday - appt for 3/25 AM.  Sent to the ER for dehydration. Placed on IV fluids and antibiotics.  Had had a fine red rash that seemed to come and go with fever.  Developed dark red mottled rash by 3/26 (regular room, not ICU).
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Sluggishness, Swelling face, Vomiting
Clinical narrative: Sluggish, episode of vomiting, side of face puffy.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: 3/19/13 - Tdap administered at same time as depo-medrol shot (different arms). Also completing round of doxycycline mono, 100 mg, for mild respiratory infection. 3/23/13 - Woke up to severe, throbbing pain in shoulder blade, from shoulder to hand on same side of Tdap injection. Some numbness & pins n' needles ensued. Mobility very limited. Prescribed 3 day course of prednisone, 20 mg each, 60 mgs per day. Some initial relief then no effect. Oxycodon, hydrocodon & Advil also taken at prescribed intervals. Some short term relief experienced; not long lasting.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Respiratory tract infection
Clinical narrative: 3/19/13 - Tdap administered at same time as depo-medrol shot (different arms). Also completing round of doxycycline mono, 100 mg, for mild respiratory infection. 3/23/13 - Woke up to severe, throbbing pain in shoulder blade, from shoulder to hand on same side of Tdap injection. Some numbness & pins n' needles ensued. Mobility very limited. Prescribed 3 day course of prednisone, 20 mg each, 60 mgs per day. Some initial relief then no effect. Oxycodon, hydrocodon & Advil also taken at prescribed intervals. Some short term relief experienced; not long lasting.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Headache, Myalgia, Pain in extremity
Clinical narrative: The patient reports having a sore arm which turned into general myalgias which included the quads, gluts and shoulders.  She also reports arthralgias of the wrists and ankles.  Her left wrist is still causing her pain when she lifts heavy objects.  The evening following her vaccination she reported a headache, temperature of 100.8, and a pulse of 100.  Her normal pulse is in the 50s range.  She woke up the next morning with severe ringing in her ears which has lasted for several days.  She reports feeling better at this time and has only residual left wrist pain that started on the day of vaccination.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Tinnitus, Weight bearing difficulty
Clinical narrative: The patient reports having a sore arm which turned into general myalgias which included the quads, gluts and shoulders.  She also reports arthralgias of the wrists and ankles.  Her left wrist is still causing her pain when she lifts heavy objects.  The evening following her vaccination she reported a headache, temperature of 100.8, and a pulse of 100.  Her normal pulse is in the 50s range.  She woke up the next morning with severe ringing in her ears which has lasted for several days.  She reports feeling better at this time and has only residual left wrist pain that started on the day of vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red bumps, fever.
Age: 1.41
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on abdomen and back.  Fever.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Ear pain, Fatigue, Headache, Pain
Clinical narrative: Body Aches, Headache, Ear ache, Chills, Minor fever.  Body aches became so bad that by 8PM I was totally bent over like a 100 year old.  Symptoms gone 24 hours later, but I was exhausted.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Body Aches, Headache, Ear ache, Chills, Minor fever.  Body aches became so bad that by 8PM I was totally bent over like a 100 year old.  Symptoms gone 24 hours later, but I was exhausted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient developed pancake sized welt on arm around injection site.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 25 year old female patient with type 1 diabetes, asthma, rosacea, lactose and gluten intolerance and unspecified reaction to unknown vaccines. The medical history of the patient included eczema. On 08-DEC-2011, the patient was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) with no adverse events. On 23-MAR-2013, the patient was vaccinated with dose 2 of PNEUMOVAX 23 (lot number and expiry date reported as H018608 and 02-JUL-2014 respectively, dose and route unspecified). No concomitant medications were reported. On an unknown date, approximately in March 2013 (reported as recently), the patient was diagnosed with cellulitis at the injection site and was admitted to the hospital. The patient sought medical attention (hospitalized). Name of the hospital was unknown. Before hospitalization, the patient was advised to use heat on the injection site reaction and to take over the counter pain medication as a treatment. The patient had not recovered from cellulitis at the injection site at the time of reporting. The relatedness for the event was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash erythematous, Skin warm, Urticaria
Clinical narrative: Pt experienced red, raised welt, warm to touch, slight red rash, no pain reported, some itching.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 3 days after vaccination patient in pharmacy arm where vaccine given was red, some itching, warm. The red arm was approx 6" in length and 3" wide oval shaped. Patient took BENADRYL and applied ice pack. BENADRYL helped with itching. 4th day area seemed to spread under arm and sore.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Headache, Neck pain, Pain in extremity
Clinical narrative: Pt is experiencing pain in the arm, chest, neck and head. Still having problems month later. Pt advised to seek medical attention.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had reaction at injection site, redness, swelling, hot, large area (4 inches approx).
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Fatigue, Pyrexia, Tenderness
Clinical narrative: 65yo patient presents to clinic for evaluation of a suspected vaccine reaction. The patient received pneumococcal vaccine and two days later developed a fever, and tender red arm. Arthralgias and fatigue were also noted. The patient was given MEDROL dosepak. Patient improved.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood test, Chills, Feeling abnormal, Injection site erythema
Clinical narrative: This spontaneous report was received from a 65-year-old female patient regarding herself with no drug reactions/allergies. Current conditions included fibromyalgia and nocturnal myoclonus. On 13-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot# H021459, expiration date APR-2014) subcutaneously. Concomitant therapies included NEURONTIN, KLONOPIN, CELEXA and aspirin. On 13-FEB-2013, she became "very sick". She stated she had bad chills and weakness and a fever of 101 degrees that went up to 102.7 degrees for 3 days. She was lethargic and had no appetite, and her arm was swollen and red at the injection site. She applied an ice pack to that area and took TYLENOL and drank plenty of fluids. She developed muscle aches. The patient stated she lost 10 pounds approximately on an unknown date in February 2013 (reported as over the course of one week). She also developed cold sores and canker sores on an unknown date in February 2013 for about 5 to 7 days. She had received ZOSTAVAX at a local pharmacy and the pharmacist stated he was sending the batch to the Center of Disease Control (CDC). Pharmacist details were updated. The patient also visited her doctor who tested her stool sample and took blood tests. The patient said that the stool sample came back normal, but the blood tests showed abnormalities. Her blood cell count, hemoglobin and her hematocrit was low. Three weeks later she had another blood test and her red blood count and hematocrit remained low (not resolved) and her hemoglobin became normal (resolved). The outcome of the events had bad chills, developed muscle aches, arm was swollen and red at the injection site, fever of 101 degrees that went up to 102.7 degrees, lot 10 pounds over the course of one week, had no appetite, lethargic, "very sick" and weakness was reported as not recovered/not resolved. The outcome of developed cold sores and canker sores in her mouth was unknown. Causality was not reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lethargy, Pyrexia, Stool analysis normal
Clinical narrative: This spontaneous report was received from a 65-year-old female patient regarding herself with no drug reactions/allergies. Current conditions included fibromyalgia and nocturnal myoclonus. On 13-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot# H021459, expiration date APR-2014) subcutaneously. Concomitant therapies included NEURONTIN, KLONOPIN, CELEXA and aspirin. On 13-FEB-2013, she became "very sick". She stated she had bad chills and weakness and a fever of 101 degrees that went up to 102.7 degrees for 3 days. She was lethargic and had no appetite, and her arm was swollen and red at the injection site. She applied an ice pack to that area and took TYLENOL and drank plenty of fluids. She developed muscle aches. The patient stated she lost 10 pounds approximately on an unknown date in February 2013 (reported as over the course of one week). She also developed cold sores and canker sores on an unknown date in February 2013 for about 5 to 7 days. She had received ZOSTAVAX at a local pharmacy and the pharmacist stated he was sending the batch to the Center of Disease Control (CDC). Pharmacist details were updated. The patient also visited her doctor who tested her stool sample and took blood tests. The patient said that the stool sample came back normal, but the blood tests showed abnormalities. Her blood cell count, hemoglobin and her hematocrit was low. Three weeks later she had another blood test and her red blood count and hematocrit remained low (not resolved) and her hemoglobin became normal (resolved). The outcome of the events had bad chills, developed muscle aches, arm was swollen and red at the injection site, fever of 101 degrees that went up to 102.7 degrees, lot 10 pounds over the course of one week, had no appetite, lethargic, "very sick" and weakness was reported as not recovered/not resolved. The outcome of developed cold sores and canker sores in her mouth was unknown. Causality was not reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphthous stomatitis, Asthenia, Chills, Decreased appetite, Haematocrit decreased
Clinical narrative: This spontaneous report was received from a 65-year-old female patient regarding herself with no drug reactions/allergies. Current conditions included fibromyalgia and nocturnal myoclonus. On 13-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot# H021459, expiration date APR-2014) subcutaneously. Concomitant therapies included NEURONTIN, KLONOPIN, CELEXA and aspirin. On 13-FEB-2013, she became "very sick". She stated she had bad chills and weakness and a fever of 101 degrees that went up to 102.7 degrees for 3 days. She was lethargic and had no appetite, and her arm was swollen and red at the injection site. She applied an ice pack to that area and took TYLENOL and drank plenty of fluids. She developed muscle aches. The patient stated she lost 10 pounds approximately on an unknown date in February 2013 (reported as over the course of one week). She also developed cold sores and canker sores on an unknown date in February 2013 for about 5 to 7 days. She had received ZOSTAVAX at a local pharmacy and the pharmacist stated he was sending the batch to the Center of Disease Control (CDC). Pharmacist details were updated. The patient also visited her doctor who tested her stool sample and took blood tests. The patient said that the stool sample came back normal, but the blood tests showed abnormalities. Her blood cell count, hemoglobin and her hematocrit was low. Three weeks later she had another blood test and her red blood count and hematocrit remained low (not resolved) and her hemoglobin became normal (resolved). The outcome of the events had bad chills, developed muscle aches, arm was swollen and red at the injection site, fever of 101 degrees that went up to 102.7 degrees, lot 10 pounds over the course of one week, had no appetite, lethargic, "very sick" and weakness was reported as not recovered/not resolved. The outcome of developed cold sores and canker sores in her mouth was unknown. Causality was not reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haemoglobin decreased, Injection site erythema, Injection site swelling, Lethargy, Myalgia
Clinical narrative: This spontaneous report was received from a 65-year-old female patient regarding herself with no drug reactions/allergies. Current conditions included fibromyalgia and nocturnal myoclonus. On 13-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot# H021459, expiration date APR-2014) subcutaneously. Concomitant therapies included NEURONTIN, KLONOPIN, CELEXA and aspirin. On 13-FEB-2013, she became "very sick". She stated she had bad chills and weakness and a fever of 101 degrees that went up to 102.7 degrees for 3 days. She was lethargic and had no appetite, and her arm was swollen and red at the injection site. She applied an ice pack to that area and took TYLENOL and drank plenty of fluids. She developed muscle aches. The patient stated she lost 10 pounds approximately on an unknown date in February 2013 (reported as over the course of one week). She also developed cold sores and canker sores on an unknown date in February 2013 for about 5 to 7 days. She had received ZOSTAVAX at a local pharmacy and the pharmacist stated he was sending the batch to the Center of Disease Control (CDC). Pharmacist details were updated. The patient also visited her doctor who tested her stool sample and took blood tests. The patient said that the stool sample came back normal, but the blood tests showed abnormalities. Her blood cell count, hemoglobin and her hematocrit was low. Three weeks later she had another blood test and her red blood count and hematocrit remained low (not resolved) and her hemoglobin became normal (resolved). The outcome of the events had bad chills, developed muscle aches, arm was swollen and red at the injection site, fever of 101 degrees that went up to 102.7 degrees, lot 10 pounds over the course of one week, had no appetite, lethargic, "very sick" and weakness was reported as not recovered/not resolved. The outcome of developed cold sores and canker sores in her mouth was unknown. Causality was not reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Pyrexia, Red blood cell count decreased, Stool analysis normal, Weight decreased
Clinical narrative: This spontaneous report was received from a 65-year-old female patient regarding herself with no drug reactions/allergies. Current conditions included fibromyalgia and nocturnal myoclonus. On 13-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot# H021459, expiration date APR-2014) subcutaneously. Concomitant therapies included NEURONTIN, KLONOPIN, CELEXA and aspirin. On 13-FEB-2013, she became "very sick". She stated she had bad chills and weakness and a fever of 101 degrees that went up to 102.7 degrees for 3 days. She was lethargic and had no appetite, and her arm was swollen and red at the injection site. She applied an ice pack to that area and took TYLENOL and drank plenty of fluids. She developed muscle aches. The patient stated she lost 10 pounds approximately on an unknown date in February 2013 (reported as over the course of one week). She also developed cold sores and canker sores on an unknown date in February 2013 for about 5 to 7 days. She had received ZOSTAVAX at a local pharmacy and the pharmacist stated he was sending the batch to the Center of Disease Control (CDC). Pharmacist details were updated. The patient also visited her doctor who tested her stool sample and took blood tests. The patient said that the stool sample came back normal, but the blood tests showed abnormalities. Her blood cell count, hemoglobin and her hematocrit was low. Three weeks later she had another blood test and her red blood count and hematocrit remained low (not resolved) and her hemoglobin became normal (resolved). The outcome of the events had bad chills, developed muscle aches, arm was swollen and red at the injection site, fever of 101 degrees that went up to 102.7 degrees, lot 10 pounds over the course of one week, had no appetite, lethargic, "very sick" and weakness was reported as not recovered/not resolved. The outcome of developed cold sores and canker sores in her mouth was unknown. Causality was not reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ear infection, Irritability, Ocular hyperaemia, Pyrexia, Rash morbilliform
Clinical narrative: First symptom was fever of 101. Two days later, signs were gooey red eyes, congestion, crankiness, fever, ear infection. 13 days after inoculation, measles rash appeared on neck and back.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Respiratory tract congestion
Clinical narrative: First symptom was fever of 101. Two days later, signs were gooey red eyes, congestion, crankiness, fever, ear infection. 13 days after inoculation, measles rash appeared on neck and back.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Contusion, Erythema, Inflammation, Pyrexia
Clinical narrative: Severe soreness, inflammation, redness, a bump formed, and a large bruise. Fever lasting two days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site pain, Injection site pruritus, Injection site swelling, Paraesthesia
Clinical narrative: Pt felt very itchy and experienced facial swelling. Site of injection is also tender, itchy, swollen. Warm, tingly, itchy feeling all over body. Went to ER.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling face
Clinical narrative: Pt felt very itchy and experienced facial swelling. Site of injection is also tender, itchy, swollen. Warm, tingly, itchy feeling all over body. Went to ER.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Excoriation, Pruritus generalised, Rash, Skin hyperpigmentation
Clinical narrative: Two days after receiving the flu shot the patient developed pruritus on ankles (bilateral). Reaction spread to lower extremities, back and shoulders. Hyperpigmented marks on the abdomen. Excoriated marks noted. Patient has been self medication rash. Methylprednisolone 4mg as directed MG UD, hydroxyzine 25mg q6h MG UD, clobetasol apply sparingly to affected BID.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age. On 12-DEC-2012, 12-JAN-2013 and 21-MAR-2013 the patient was vaccinated with 3 doses of GARDASIL. No adverse effect reported. No other information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a pharmacist via a consumer refers to a patient of an unknown age and number. On an unknown date patient was vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). The pharmacist stated that the patient got sick after getting an injection on an unknown date from the same batch. He was sending the batch to Centre For Disease Control (CDC). The outcome of the event was unknown. Causality was unknown. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Phlebitis, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 4-5 patients seen in hospital obgyn (obstetrician/gynecologist) clinic who were of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patients developed swelling and phlebitis. One of the patient had a reaction severe enough to seek attention in emergency room. It was unknown if the other patients sought medical attention or received treatment. The outcome of phlebitis and swelling was unknown. Follow up information has been received from the pharmacist who called back and reported that the 4 or 5 OB patients were administered PNEUMOVAX 23 (in the thigh after being given an EPIDURAL and after delivery of the baby. He noted that these 4 or 5 OB patients have complained of severe pain in their legs and have not been able to walk after being given PNEUMOVAX 23 (and also have needed to come back to the emergency room for unspecified treatment. Pharmacist also noted that 1 of the unspecified patients needed a cane to walk around. He provided PNEUMOVAX 23 (lot numbers reported as lot H020684 with expiration date: 04/17/2014. "Lot check requested" by the pharmacist. At the time of report, the outcome of patient was unknown. Additional information has been requested. Unable to walk was considered to be disability. This is one of several reports from the same source.
Sex: F
Vaccine: PPV, PPV
Symptoms: Abasia, Pain in extremity, Phlebitis, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 4-5 patients seen in hospital obgyn (obstetrician/gynecologist) clinic who were of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patients developed swelling and phlebitis. One of the patient had a reaction severe enough to seek attention in emergency room. It was unknown if the other patients sought medical attention or received treatment. The outcome of phlebitis and swelling was unknown. Follow up information has been received from the pharmacist who called back and reported that the 4 or 5 OB patients were administered PNEUMOVAX 23 (in the thigh after being given an EPIDURAL and after delivery of the baby. He noted that these 4 or 5 OB patients have complained of severe pain in their legs and have not been able to walk after being given PNEUMOVAX 23 (and also have needed to come back to the emergency room for unspecified treatment. Pharmacist also noted that 1 of the unspecified patients needed a cane to walk around. He provided PNEUMOVAX 23 (lot numbers reported as lot H020684 with expiration date: 04/17/2014. "Lot check requested" by the pharmacist. At the time of report, the outcome of patient was unknown. Additional information has been requested. Unable to walk was considered to be disability. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal pain, Nausea, Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to another staff pharmacist. On 05-MAR-2013 the patient administered a dose of ZOSTAVAX lot # H019038 Exp. 17-JAN-2014 to a 66 year old male patient. In March 2013 (last week) the pharmacist developed burning and tingling pain and also shingles rash on one side of the body after administration of ZOSTAVAX to a patient. The reporting pharmacist refused to provide the demographics of the pharmacist who developed shingles. No adverse effect reported for the patient. The outcome of shingles rash on one side of the body was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Varicella virus test positive, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to another staff pharmacist. On 05-MAR-2013 the patient administered a dose of ZOSTAVAX lot # H019038 Exp. 17-JAN-2014 to a 66 year old male patient. In March 2013 (last week) the pharmacist developed burning and tingling pain and also shingles rash on one side of the body after administration of ZOSTAVAX to a patient. The reporting pharmacist refused to provide the demographics of the pharmacist who developed shingles. No adverse effect reported for the patient. The outcome of shingles rash on one side of the body was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Burning sensation, Herpes zoster, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to another staff pharmacist. On 05-MAR-2013 the patient administered a dose of ZOSTAVAX lot # H019038 Exp. 17-JAN-2014 to a 66 year old male patient. In March 2013 (last week) the pharmacist developed burning and tingling pain and also shingles rash on one side of the body after administration of ZOSTAVAX to a patient. The reporting pharmacist refused to provide the demographics of the pharmacist who developed shingles. No adverse effect reported for the patient. The outcome of shingles rash on one side of the body was unknown. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Pain in extremity, Phlebitis, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 4-5 patients seen in hospital obgyn (obstetrician/gynecologist) clinic who were of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23(lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patients developed swelling and phlebitis. One of the patient had a reaction severe enough to seek attention in emergency room. It was unknown if the other patients sought medical attention or received treatment. The outcome of phlebitis and swelling was unknown. Follow up information has been received from the pharmacist who called back and reported that the 4 or 5 OB patients were administered PNEUMOVAX 23( in the thigh after being given an epidural and after delivery of the baby. He noted that these 4 or 5 OB patients have complained of severe pain in their legs and have not been able to walk after being given PNEUMOVAX 23( and also have needed to come back to the emergency room for unspecified treatment. He provided PNEUMOVAX 23 ( lot reported as H018441 with unspecified expiration date. "Lot check requested" by the pharmacist. At the time of report, the outcome of patient was unknown. Unable to walk was considered to be disability. Additional information has been requested. This is one of the several reports from the same source.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oropharyngeal pain, Thirst, Urticaria, Vomiting
Clinical narrative: Woke with sore throat and thirsty, ate yogurt for breakfast and had emesis immediately. Seemed to be OK after that and tolerated lunch. After lunch, developed hives on face and neck. Took Benadryl at 13:25 PM.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Area became very red, approx 10mm in size. Hard enter core.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dysphagia, Dyspnoea, Eyelid ptosis, Fall
Clinical narrative: Began having swallowing issues, talking issues, weakness, breathing problems, droopy eyelid. The symptoms started out with her feeling tired and weak not long after the shot. By April and may she started having difficulties with swallowing and she started to fall down. I began calling doctors in may and struggled to get appointments with specialists. A pediatric neurologist didn't diagnose anything. It was a neurologist who ordered more testing. He sent her to the facility on July 14, 2010. Patient was diagnosed with Myasthenia Gravis at the age of 14.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Myasthenia gravis, Speech disorder
Clinical narrative: Began having swallowing issues, talking issues, weakness, breathing problems, droopy eyelid. The symptoms started out with her feeling tired and weak not long after the shot. By April and may she started having difficulties with swallowing and she started to fall down. I began calling doctors in may and struggled to get appointments with specialists. A pediatric neurologist didn't diagnose anything. It was a neurologist who ordered more testing. He sent her to the facility on July 14, 2010. Patient was diagnosed with Myasthenia Gravis at the age of 14.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Nodule
Clinical narrative: Knots on extremities. Arms and legs. Denied any itching. Reported to me on 3/14/2013. Benadryl cream applied. Afebrile.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Erythema, Injection site pain, Pruritus, Skin warm, Urticaria
Clinical narrative: Initially back of left arm injection site was sore; redness started on Wednesday 3/27; by Friday 3/29, larger welt developed.  Now hot to touch, sore, itchy, approximately 2 inches in diameter.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Blood immunoglobulin G decreased, Chronic sinusitis, Condition aggravated, Headache
Clinical narrative: Vomiting, all over muscle aches, severe HA, worse than migraine.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Lung infection, Myalgia, Vomiting
Clinical narrative: Vomiting, all over muscle aches, severe HA, worse than migraine.
Age: 72.0
Sex: F
Vaccine: TYP
Symptoms: Headache
Clinical narrative: Mild headaches on and off.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood glucose normal, Dizziness, Syncope
Clinical narrative: Pt received HPV #3. Once she walked to the front felt dizzy & faint. Had pt lie down with feet elevated & gave juice & crackers.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 19-SEP-2011, patient was vaccinated with dose 1 of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 25-SEP-2012, the patient was vaccinated with dose 2 of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 20-MAR-2013, the patient was vaccinated with dose 3 of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a male patient of unknown age. On an unknown date (reported a few years ago), the patient was vaccinated with first dose GARDASIL (lot number, expiry date and route was not reported). On 28-MAR-2013, the patient was vaccinated with second dose GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse symptoms reported. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 54 year old female patient, with drug reactions and allergies reported to amoxicillin, NAPROSYN and TORADOL. On 19-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route of administration were not reported) in the arm. There was no concomitant medication reported. On 20-MAR-2013, the patient experienced a headache and nausea. The patient did not seek medical attention. No treatment was received. The outcome of headache and nausea was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a physician via a representative refers to a 19 year old female patient with chlamydia (four weeks prior, treated with an unspecified antibiotic) and pre-existing genital warts (treated with Aloe Vera). On approximately 11-MAR-2013, about two weeks ago, the patient was vaccinated with the first dose of GARDASIL. It was reported that in approximately 2013 the patient had left upper quadrant pain with nausea and vomiting following vaccination with the first dose of GARDASIL. The patient sought unspecified medical attention by office visit. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Crying, Dizziness, Feeling abnormal, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 13 year old female. The medical history, drug reaction and allergies were reported as none. On 19-MAR-2013, the patient received "her first and last' standard dose of GARDASIL, via intramuscular. On 19-MAR-2013, immediately after vaccination the patient developed headache. This reaction was followed by nausea, vomiting, lightheadedness, severe stomach ache, until she was in tears. The patient also developed fever. The reporter explained that the patient developed these symptoms after being hit in the arm where she had received the vaccine. The patient told that the impact on her arm was the "strangest feeling that she'd ever felt". Therapy with GARDASIL was discontinued. No laboratory test was performed. No treatment was given for the adverse event. The patient sought unspecified medical attention. The outcome of limb discomfort, headache, stomach ache, lightheadedness, nausea, vomiting, limb injury and crying were unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 13 year old female. The medical history, drug reaction and allergies were reported as none. On 19-MAR-2013, the patient received "her first and last' standard dose of GARDASIL, via intramuscular. On 19-MAR-2013, immediately after vaccination the patient developed headache. This reaction was followed by nausea, vomiting, lightheadedness, severe stomach ache, until she was in tears. The patient also developed fever. The reporter explained that the patient developed these symptoms after being hit in the arm where she had received the vaccine. The patient told that the impact on her arm was the "strangest feeling that she'd ever felt". Therapy with GARDASIL was discontinued. No laboratory test was performed. No treatment was given for the adverse event. The patient sought unspecified medical attention. The outcome of limb discomfort, headache, stomach ache, lightheadedness, nausea, vomiting, limb injury and crying were unknown. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, red hands 2 minutes after vaccine given.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Viral diarrhoea
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's medical history included bicuspid aortic valve. Approximately on an unknown date in 2012, the patient was vaccinated with a dose of ROTATEQ (Lot number, expiry date, route and dose were not reported). On 20-MAR-2013, the patient developed viral case of diarrhea which was between the second and third does of ROTATEQ. The patient sought medical attention for the same (called office). The therapy was not discontinued due to the event. The patient had 2 diarrhea like stools and was recovered on 21-MAR-2013. Other family members also developed diarrhea at the same time. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Irritability, Myoclonus, Pyrexia, Somnolence, Vomiting
Clinical narrative: Had the shots Friday morning for the 18-month vaccines and then later in the afternoon child became more irritable and sleepy. Saturday morning had a fever of 102.3, was very crabby, and started having some brief myoclonic jerks that would last maybe up to 10 seconds. No actual seizure. Also had a little bit of vomiting. No diarrhea. No rashes. The patient was seen in the ER, and the decision was made to admit the child for possible seizure activity or a vaccine reaction.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Vomiting
Clinical narrative: At about 9 pm (3/29/13) began to vomit.  Over the next 7 hours had vomited 8 times.  Had NO fever or diarrhea.  3/30/13 had stomach ache, felt dizzy, and felt fatigued. Did not want to get off bed or couch.  4/1/13 Continues to feel tired and fatigued with complaints of stomach still not feeling right-but states it is not an upset stomach feeling. (no one else in home is sick or has been sick with any stomach virus).
Age: 16.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Redness at site that evening. Pt went to facility on 3/26/13 at 21:30 with swelling of (R) arm around site and nausea. Pt given BENADRYL and Ranitidine. Pt discharged 3/26/13 at 22:06.
Age: 0.16
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant concerning an approximately 8 week old male patient with no pertinent medical history. On 12-MAR-2013, the patient was vaccinated with the first dose of Liquid PEDVAXHIB (lot number and expiry date reported as 0419AE and 17-AUG-2014 respectively, dose and route unspecified). No concomitant medications were reported. On 12-MAR-2013, the patient developed an injection site reaction which included swelling, redness and a knot at the injection site. On an unknown date, the patient sought an unspecified medical attention. On an unknown date, the patient had recovered from an injection site reaction which included swelling, redness and a knot at the injection site. The relatedness for an injection site reaction which included swelling, redness and a knot at the injection site was unknown for Liquid PEDVAXHIB. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On an unknown date an unspecified number of patients may have received improperly stored VARIVAX (Merck) (dose, frequency, lot number not provided) and PROQUAD (Merck) (dose, frequency, lot number not provided). The VARIVAX (Merck) and PROQUAD were improperly stared from January of 2012 to present 25-MAR-2013. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 110 patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL, 0.5 ml, via intramuscular, (lot and expiration date were not reported), the doses that had been exposed to light, as far back as September 2012, there was no concomitant medications reported. It was noted that the vaccines were stored at the front of a glass door refrigerator, outside of their boxes, in a room with fluorescent light that is on 24 hours a day. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report was received from a Nurse Practitioner, regarding a female patient "over the age of 65 years" with no pertinent medical history reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number and expiration date not reported)(dose, route or anatomical location not reported). No other co-suspects were reported, no concomitant medications were reported. The Nurse Practitioner reported that on an unknown date (reported as later that day) the patient developed flu-like symptoms. It was reported that within 48 hours the patient felt fine. No treatment information was reported. The reporter did not assess the causality between flu-like symptoms and PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. On 16-APR-2008, the patient was vaccinated with dose 1 of GARDASIL (lot number expiry date and dose unspecified), intramuscularly. On 31-JUL-2008, the patient was vaccinated with dose 2 of GARDASIL (lot number expiry date and dose unspecified), intramuscularly. On 28-MAR-2013 (reported as today), the patient would be administered with dose 3 of GARDASIL (lot number and expiry date unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Oral mucosal blistering
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 2 month old male patient with fatty acid oxidation disorder and no known allergies. On 26-MAR-2013 the patient was vaccinated with the first dose of ROTATEQ (lot number H013164, expiration date 01-MAR-2014) (2mL, oral). No other co-suspects were reported. Concomitant therapy included riboflavin. The Registered Nurse reported that on 26-MAR-2013, within 10 minutes of administering the dose of ROTATEQ, the patient developed a visible blister on the inside of the right lower cheek. The patient was reported as recovering at the time of the report. The reporter stated that no treatment was given for the blister on the inside of the right lower cheek. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician assistant, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported) (dose, not reported, intramuscular route). No other co suspect or concomitant medications were reported. The reporter stated that "within 3 days" after administering ZOSTAVAX on an unspecified date, the patient began to experience "marked redness and swelling" around the injection site. Also it was reported that ZOSTAVAX injection "may have been administered intramuscularly". The patient sought medical attention by visiting to physician assistant's office. At the time of the report the patient's outcome was recovering for the marked redness and swelling" around the injection site. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to 2 unspecified patients (gender and age not reported). It was reported that on an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported) (dose, frequency, route not reported). No other co suspect or concomitant medications were reported. The pharmacist reported that the patients reported similar injection site reactions (red, swollen, warm and painful to the touch area at the injection site) following vaccination with ZOSTAVAX. At the time of the report the patient's conditions were unknown. This case is linked to the case # 1303USA009625. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Body temperature increased, Chills, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient complains of tender, swelling, and erythema at pneumococcal injection site.  Cold pack was applied.  3 hours later site is painful, with redness and swelling of 7 cm.  Patient also has temperature of 99.5, chilling, and aching.  Diphenhydramine is administered.  One hour later, temperature if 100.5, physician examines & notes swelling of vaccination area, and orders cephalexin, acetaminophen, diphenhydramine, and ice.  The following day, the site appearance is stable & patient is dismissed on cephalexin.  Patient presents to our ED on 3/3/13 with worsening symptoms & is admitted with left leg cellulitis & is treated with IV vancomycin x 2 days combined with clindamycin IV x 4 days followed with po clindamycin to continue 7 more days at dismissal.