chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil percentage, Opisthotonus, Pyrexia, Screaming, Urine analysis normal
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old patient. The patient was vaccinated with ROTATEQ (lot # was unknown) on an unknown date. Other suspect therapies included Hib (manufacturer unknown). Concomitant medications included Hib (manufacturer unknown), PEDIARIX and PREVNAR. On an unknown date the patient developed a "high" fever after receiving ROTATEQ. The patient was hospitalized. During the hospitalization the patient had a "radiograph" and was diagnosed with intussusception. The physician reported that the intussusception spontaneously resolved. Patient current status was recovered. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Pyrexia, Radiography guided aspiration
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old patient. The patient was vaccinated with ROTATEQ (lot # was unknown) on an unknown date. Other suspect therapies included Hib (manufacturer unknown). Concomitant medications included Hib (manufacturer unknown), PEDIARIX and PREVNAR. On an unknown date the patient developed a "high" fever after receiving ROTATEQ. The patient was hospitalized. During the hospitalization the patient had a "radiograph" and was diagnosed with intussusception. The physician reported that the intussusception spontaneously resolved. Patient current status was recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an approximately78 (currently 79) year old female patient of unknown age with renal cancer and drug reaction to add generic name AMBIEN and add generic name ULTRAM. On 23-APR-2012, the patient was vaccinated with a dose of ZOSTAVAX lot # 1270AA. Concomitant medications included BONIVA, calcium (unspecified) (+) vitamin D (unspecified), GLUCOVANCE, JANUVIA, LIPITOR, LUNESTA, LYRICA, NORVASC, PRINIVIL, ZIAC and PREVACID. The medical assistant stated that, the patient had been having shingles like symptoms and mild pain in different parts of her body that comes and goes since she received ZOSTAVAX on approximately April 2012. The medical assistant did not know the date these symptoms started, but mentioned that the patient was first seen in the office on 24-JUL-2012. The medical assistant stated the patient did not have a rash. The patient was put on treatment with VICODIN and also was taking TYLENOL for the pain, but was not getting adequate pain relief. Laboratory and diagnostics were not performed. The outcome of shingles like symptoms and mild pain in different parts of her body that comes and goes were reported as not recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an approximately78 (currently 79) year old female patient of unknown age with renal cancer and drug reaction to add generic name AMBIEN and add generic name ULTRAM. On 23-APR-2012, the patient was vaccinated with a dose of ZOSTAVAX lot # 1270AA. Concomitant medications included BONIVA, calcium (unspecified) (+) vitamin D (unspecified), GLUCOVANCE, JANUVIA, LIPITOR, LUNESTA, LYRICA, NORVASC, PRINIVIL, ZIAC and PREVACID. The medical assistant stated that, the patient had been having shingles like symptoms and mild pain in different parts of her body that comes and goes since she received ZOSTAVAX on approximately April 2012. The medical assistant did not know the date these symptoms started, but mentioned that the patient was first seen in the office on 24-JUL-2012. The medical assistant stated the patient did not have a rash. The patient was put on treatment with VICODIN and also was taking TYLENOL for the pain, but was not getting adequate pain relief. Laboratory and diagnostics were not performed. The outcome of shingles like symptoms and mild pain in different parts of her body that comes and goes were reported as not recovered. Additional information has been requested.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Eye movement disorder, Febrile convulsion, Full blood count, Hypotonia, Lethargy
Clinical narrative: We were getting ready for church and patient went from running around laughing and playing to instantly becoming fussy, sleepy, and feverish. While at church we were paged back to the nursery due to her fever and fussiness. She was very weak and appeared exhausted. We took her home administered the appropriate dosage of Tylenol according to her weight and age at about 9:00 pm and rocked her to sleep. She woke up once at about midnight, my husband calmed her down and she fell back asleep. At about 5:30 AM on 08/23/2012 we woke up to our baby girl patient screaming wildly. I ran into her room and she was laying facedown unmoving. I picked her up and she was gazing off to the left. She was not responding to my voice or my husband's. We were calling her name and rocking her and she was constantly screaming with her eyes rolled back and up to the left side of her head. She never did acknowledge us at any point. She could not move her arms or legs. She was completely helpless and unmoving. We woke our 3 yr. old and 6 yr. old and drove immediately to the ER. When we got there our baby girl was still in this catatonic strange state. The screaming had subsided and was replaced with tiny whimpers. Blood work was done and it all came back normal. The ER doctor and Dr. both agreed the vaccine was to blame for our baby's seizure and fever. The nurses and doctor can and will verify all of this account. We were released at about 12:00 PM on 08/23/2012. Throughout the next 5 days our daughter was listless, fussy, and could not play with her brother and sister. All she wanted was to be held. She ate and drank very little and could not stand or walk on her own for long. By the fifth night, Sunday 08/26/2012, she was returning to her normal happy, joyful, talkative, and playful self. We saw our pediatrician on 08/27/2012 where she rechecked our daughter and gave her a clean bill of health and stated that the reaction was to her vaccine and that she would work around it, and figure something out so she could still get her appropriate shots. Dr. also stated that patient may always have seizures now throughout the remainder of her life with any shot or fever.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Metabolic function test, Postictal state, Pyrexia, Slow response to stimuli
Clinical narrative: We were getting ready for church and patient went from running around laughing and playing to instantly becoming fussy, sleepy, and feverish. While at church we were paged back to the nursery due to her fever and fussiness. She was very weak and appeared exhausted. We took her home administered the appropriate dosage of Tylenol according to her weight and age at about 9:00 pm and rocked her to sleep. She woke up once at about midnight, my husband calmed her down and she fell back asleep. At about 5:30 AM on 08/23/2012 we woke up to our baby girl patient screaming wildly. I ran into her room and she was laying facedown unmoving. I picked her up and she was gazing off to the left. She was not responding to my voice or my husband's. We were calling her name and rocking her and she was constantly screaming with her eyes rolled back and up to the left side of her head. She never did acknowledge us at any point. She could not move her arms or legs. She was completely helpless and unmoving. We woke our 3 yr. old and 6 yr. old and drove immediately to the ER. When we got there our baby girl was still in this catatonic strange state. The screaming had subsided and was replaced with tiny whimpers. Blood work was done and it all came back normal. The ER doctor and Dr. both agreed the vaccine was to blame for our baby's seizure and fever. The nurses and doctor can and will verify all of this account. We were released at about 12:00 PM on 08/23/2012. Throughout the next 5 days our daughter was listless, fussy, and could not play with her brother and sister. All she wanted was to be held. She ate and drank very little and could not stand or walk on her own for long. By the fifth night, Sunday 08/26/2012, she was returning to her normal happy, joyful, talkative, and playful self. We saw our pediatrician on 08/27/2012 where she rechecked our daughter and gave her a clean bill of health and stated that the reaction was to her vaccine and that she would work around it, and figure something out so she could still get her appropriate shots. Dr. also stated that patient may always have seizures now throughout the remainder of her life with any shot or fever.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Abnormal behaviour, Asthenia, Blood test normal, Catatonia, Convulsion
Clinical narrative: We were getting ready for church and patient went from running around laughing and playing to instantly becoming fussy, sleepy, and feverish. While at church we were paged back to the nursery due to her fever and fussiness. She was very weak and appeared exhausted. We took her home administered the appropriate dosage of Tylenol according to her weight and age at about 9:00 pm and rocked her to sleep. She woke up once at about midnight, my husband calmed her down and she fell back asleep. At about 5:30 AM on 08/23/2012 we woke up to our baby girl patient screaming wildly. I ran into her room and she was laying facedown unmoving. I picked her up and she was gazing off to the left. She was not responding to my voice or my husband's. We were calling her name and rocking her and she was constantly screaming with her eyes rolled back and up to the left side of her head. She never did acknowledge us at any point. She could not move her arms or legs. She was completely helpless and unmoving. We woke our 3 yr. old and 6 yr. old and drove immediately to the ER. When we got there our baby girl was still in this catatonic strange state. The screaming had subsided and was replaced with tiny whimpers. Blood work was done and it all came back normal. The ER doctor and Dr. both agreed the vaccine was to blame for our baby's seizure and fever. The nurses and doctor can and will verify all of this account. We were released at about 12:00 PM on 08/23/2012. Throughout the next 5 days our daughter was listless, fussy, and could not play with her brother and sister. All she wanted was to be held. She ate and drank very little and could not stand or walk on her own for long. By the fifth night, Sunday 08/26/2012, she was returning to her normal happy, joyful, talkative, and playful self. We saw our pediatrician on 08/27/2012 where she rechecked our daughter and gave her a clean bill of health and stated that the reaction was to her vaccine and that she would work around it, and figure something out so she could still get her appropriate shots. Dr. also stated that patient may always have seizures now throughout the remainder of her life with any shot or fever.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Crying, Decreased appetite, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: We were getting ready for church and patient went from running around laughing and playing to instantly becoming fussy, sleepy, and feverish. While at church we were paged back to the nursery due to her fever and fussiness. She was very weak and appeared exhausted. We took her home administered the appropriate dosage of Tylenol according to her weight and age at about 9:00 pm and rocked her to sleep. She woke up once at about midnight, my husband calmed her down and she fell back asleep. At about 5:30 AM on 08/23/2012 we woke up to our baby girl patient screaming wildly. I ran into her room and she was laying facedown unmoving. I picked her up and she was gazing off to the left. She was not responding to my voice or my husband's. We were calling her name and rocking her and she was constantly screaming with her eyes rolled back and up to the left side of her head. She never did acknowledge us at any point. She could not move her arms or legs. She was completely helpless and unmoving. We woke our 3 yr. old and 6 yr. old and drove immediately to the ER. When we got there our baby girl was still in this catatonic strange state. The screaming had subsided and was replaced with tiny whimpers. Blood work was done and it all came back normal. The ER doctor and Dr. both agreed the vaccine was to blame for our baby's seizure and fever. The nurses and doctor can and will verify all of this account. We were released at about 12:00 PM on 08/23/2012. Throughout the next 5 days our daughter was listless, fussy, and could not play with her brother and sister. All she wanted was to be held. She ate and drank very little and could not stand or walk on her own for long. By the fifth night, Sunday 08/26/2012, she was returning to her normal happy, joyful, talkative, and playful self. We saw our pediatrician on 08/27/2012 where she rechecked our daughter and gave her a clean bill of health and stated that the reaction was to her vaccine and that she would work around it, and figure something out so she could still get her appropriate shots. Dr. also stated that patient may always have seizures now throughout the remainder of her life with any shot or fever.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Gaze palsy, Irritability, Listless, Mobility decreased, Pyrexia
Clinical narrative: We were getting ready for church and patient went from running around laughing and playing to instantly becoming fussy, sleepy, and feverish. While at church we were paged back to the nursery due to her fever and fussiness. She was very weak and appeared exhausted. We took her home administered the appropriate dosage of Tylenol according to her weight and age at about 9:00 pm and rocked her to sleep. She woke up once at about midnight, my husband calmed her down and she fell back asleep. At about 5:30 AM on 08/23/2012 we woke up to our baby girl patient screaming wildly. I ran into her room and she was laying facedown unmoving. I picked her up and she was gazing off to the left. She was not responding to my voice or my husband's. We were calling her name and rocking her and she was constantly screaming with her eyes rolled back and up to the left side of her head. She never did acknowledge us at any point. She could not move her arms or legs. She was completely helpless and unmoving. We woke our 3 yr. old and 6 yr. old and drove immediately to the ER. When we got there our baby girl was still in this catatonic strange state. The screaming had subsided and was replaced with tiny whimpers. Blood work was done and it all came back normal. The ER doctor and Dr. both agreed the vaccine was to blame for our baby's seizure and fever. The nurses and doctor can and will verify all of this account. We were released at about 12:00 PM on 08/23/2012. Throughout the next 5 days our daughter was listless, fussy, and could not play with her brother and sister. All she wanted was to be held. She ate and drank very little and could not stand or walk on her own for long. By the fifth night, Sunday 08/26/2012, she was returning to her normal happy, joyful, talkative, and playful self. We saw our pediatrician on 08/27/2012 where she rechecked our daughter and gave her a clean bill of health and stated that the reaction was to her vaccine and that she would work around it, and figure something out so she could still get her appropriate shots. Dr. also stated that patient may always have seizures now throughout the remainder of her life with any shot or fever.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Screaming, Somnolence, Unresponsive to stimuli
Clinical narrative: We were getting ready for church and patient went from running around laughing and playing to instantly becoming fussy, sleepy, and feverish. While at church we were paged back to the nursery due to her fever and fussiness. She was very weak and appeared exhausted. We took her home administered the appropriate dosage of Tylenol according to her weight and age at about 9:00 pm and rocked her to sleep. She woke up once at about midnight, my husband calmed her down and she fell back asleep. At about 5:30 AM on 08/23/2012 we woke up to our baby girl patient screaming wildly. I ran into her room and she was laying facedown unmoving. I picked her up and she was gazing off to the left. She was not responding to my voice or my husband's. We were calling her name and rocking her and she was constantly screaming with her eyes rolled back and up to the left side of her head. She never did acknowledge us at any point. She could not move her arms or legs. She was completely helpless and unmoving. We woke our 3 yr. old and 6 yr. old and drove immediately to the ER. When we got there our baby girl was still in this catatonic strange state. The screaming had subsided and was replaced with tiny whimpers. Blood work was done and it all came back normal. The ER doctor and Dr. both agreed the vaccine was to blame for our baby's seizure and fever. The nurses and doctor can and will verify all of this account. We were released at about 12:00 PM on 08/23/2012. Throughout the next 5 days our daughter was listless, fussy, and could not play with her brother and sister. All she wanted was to be held. She ate and drank very little and could not stand or walk on her own for long. By the fifth night, Sunday 08/26/2012, she was returning to her normal happy, joyful, talkative, and playful self. We saw our pediatrician on 08/27/2012 where she rechecked our daughter and gave her a clean bill of health and stated that the reaction was to her vaccine and that she would work around it, and figure something out so she could still get her appropriate shots. Dr. also stated that patient may always have seizures now throughout the remainder of her life with any shot or fever.
Age: 19.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Constipation, Lumbar puncture normal, Muscular weakness, Paraesthesia
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 19 years old male patient with no pertinent medical history and no drug reactions or allergies who on 16-JUL-2012, was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that on 17-AUG-2012, the patient was admitted to the hospital for lower extremity tingling that moved up his right leg and got worse and eventually affected both of his legs. In August 2012 a spinal magnetic resonance imaging (MRI) was performed and Guillain Barre and neurological injury were ruled out. On the same date, a spinal tab was performed and was clear. The patient was released on 20-AUG-2012 and going through physical therapy and walking with a cane. At the time of the report, the patient had not recovered. The relatedness for lower extremity tingling that moved up his right leg and got worse and eventually affected both of the legs was unknown for GARDASIL. Tingling that moved up his right leg and got worse and eventually affected both of the legs was considered to be disabling for the reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging spinal cord normal, Paraesthesia, Walking aid user
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 19 years old male patient with no pertinent medical history and no drug reactions or allergies who on 16-JUL-2012, was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that on 17-AUG-2012, the patient was admitted to the hospital for lower extremity tingling that moved up his right leg and got worse and eventually affected both of his legs. In August 2012 a spinal magnetic resonance imaging (MRI) was performed and Guillain Barre and neurological injury were ruled out. On the same date, a spinal tab was performed and was clear. The patient was released on 20-AUG-2012 and going through physical therapy and walking with a cane. At the time of the report, the patient had not recovered. The relatedness for lower extremity tingling that moved up his right leg and got worse and eventually affected both of the legs was unknown for GARDASIL. Tingling that moved up his right leg and got worse and eventually affected both of the legs was considered to be disabling for the reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Inflammation, Oedema peripheral, Pain
Clinical narrative: Arm became red, swollen and inflamed. The area was itchy, hard and red for 1 week.   Child complained of pain. Half the arm affected.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus
Clinical narrative: Arm became red, swollen and inflamed. The area was itchy, hard and red for 1 week.   Child complained of pain. Half the arm affected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Patient presented to pharmacy day after receiving vaccination with redness/swelling about the size of the palm of a hand 6 inches below vaccination site. Rash was slightly warm to touch. Patient reported it was itchy at first but know felt a bit painful took her to see MD, where temperature and BP was normal. MD said he was not sure 100% that it was cellulitis, but treated empirically with cephalexin just to make sure all bases were covered. Followed up with patient 3 days later --> she is fine & rash is going away.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin warm
Clinical narrative: Patient presented to pharmacy day after receiving vaccination with redness/swelling about the size of the palm of a hand 6 inches below vaccination site. Rash was slightly warm to touch. Patient reported it was itchy at first but know felt a bit painful took her to see MD, where temperature and BP was normal. MD said he was not sure 100% that it was cellulitis, but treated empirically with cephalexin just to make sure all bases were covered. Followed up with patient 3 days later --> she is fine & rash is going away.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness and swelling at injection site - 14 x 5 cm induration. Rx: MEDROL 4 mg. Dose pak.
Age: 48.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: 10 days after vaccines, developed neck soreness behind ears and pt felt swollen nodes.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Ecchymosis, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: 2 days -ecchymosis all over body. Idiopathic thrombocytopenia purpura.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass
Clinical narrative: Tdap was given on 8/20/12 - states that since that time area was red & a large lump, since then currently noting a pea sized lump.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 3 days after vaccination patient got a rash on her leg (8/20/12), patient went to walk-in. Clinic 9/1/12 & MD diagnosed it as shingles.
Sex: M
Vaccine: PNC
Symptoms: Bone marrow transplant
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported that a 12-year-old male patient, had received PREVNAR on unknown date and other vaccines in the past. Relevant medical history and concomitant medication were unknown The patient has now undergone a bone marrow transplant on unknown date. The clinical outcome of the event is unknown.
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Dehydration, Diarrhoea, Gastroenteritis, Platelet count decreased, Pyrexia
Clinical narrative: Child had a set of vaccines on 7/25/12. He awoke the next day with fever, rash, vomiting, diarrhea. He was seen in the ER on 7/29/12 and had a follow up visit with PCP on 7/30/12 and was then admitted to the hospital with acute gastroenteritis, dehydration, fever "likely from a viral syndrome and thrombocytopenia" according to the hospital D/C summary.
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Thrombocytopenia, Viral infection, Vomiting
Clinical narrative: Child had a set of vaccines on 7/25/12. He awoke the next day with fever, rash, vomiting, diarrhea. He was seen in the ER on 7/29/12 and had a follow up visit with PCP on 7/30/12 and was then admitted to the hospital with acute gastroenteritis, dehydration, fever "likely from a viral syndrome and thrombocytopenia" according to the hospital D/C summary.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Bed sharing, Death, Sudden infant death syndrome
Clinical narrative: Baby was found dead in parents bed (she sleeps in parents bed). She was on the side with face down in the memory foam mattress. This happened on 8-28-12. Day after she received her 2 months vaccines on 8-27-12. Most probably a case of SIDS.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspepsia, Headache, Nausea, Syncope, Vomiting
Clinical narrative: Received HPV shot at 11:55 am on 8-30-12 - left office went to lunch - nausea after lunch - vomited at school at 2:10 pm - fainted (out for 1 1/2 - 2 minutes) Now has headache and heartburn. Rechecked at 3:30 in office. No treatment.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Hypersensitivity, Hypoaesthesia, Oedema
Clinical narrative: Mom called on-call nurse (after hours) and reported child having allergic reaction to HPV vaccine that was given in office some 8 hours ago. Sx were edema & numbness (L) side of body (arm, neck, leg) with difficulty swallowing pt sent to ER.
Age: 5.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash on left leg, where varicella and TWINRIX was given.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Kawasaki's disease, Pyrexia, Viral infection
Clinical narrative: Developed fever 24 hours after vaccine which persisted for 5-6 days. Infant seen in office on 8/17 felt to have a viral infection - fever persisted & on 8/19 seen in ER again felt to have a viral infection. 8/21 office visit (see attached form - suspected of Kawasaki syndrome).
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Accelerated hypertension
Clinical narrative: Accelerated hypertension.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Mom to HD on 8/24 patient, localized arm swelling 3.5" by 5.5", warm to touch, c/o localized swelling & pain. Instructed use of intermittent cool pack (provided) use of OTC ibuprofen or TYLENOL after seek pharmacist advise on dosage. Told if worsens to seek medical attention. RN left message on parents phone without return call on 8/27-28. No further contact with parent or child.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Local swelling, Pruritus, Urticaria
Clinical narrative: Patient came in pharmacy to fill KEFLEX 500, 1 cap Q6HRS x7 D written by ER doctor at hospital. Patient said she visited ER last night 9/3/12 because she known it was cellulitis which is what ER diagnosed. Patient said area was not hard, red, etc. She stated it began to get like this Sunday (itching on Sunday red, swollen - hive-like).
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Skin lesion, Tenderness
Clinical narrative: Patient came in pharmacy to fill KEFLEX 500, 1 cap Q6HRS x7 D written by ER doctor at hospital. Patient said she visited ER last night 9/3/12 because she known it was cellulitis which is what ER diagnosed. Patient said area was not hard, red, etc. She stated it began to get like this Sunday (itching on Sunday red, swollen - hive-like).
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient came in pharmacy to fill KEFLEX 500, 1 cap Q6HRS x7 D written by ER doctor at hospital. Patient said she visited ER last night 9/3/12 because she known it was cellulitis which is what ER diagnosed. Patient said area was not hard, red, etc. She stated it began to get like this Sunday (itching on Sunday red, swollen - hive-like).
Age: 14.0
Sex: F
Vaccine: HPV2, VARCEL, HPV2, VARCEL
Symptoms: Fatigue, Influenza like illness, Nausea, Oedema peripheral, Pain
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of body pain in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline), VARIVAX (non-gsk). On 14 May 2012 at 16:30 the subject received 1st dose of CERVARIX (.5 ml, unknown route) and on 14 May 2012 the subject received 2nd dose of VARIVAX (Non-GSK) (details unknown). On 14 May 2012, 1 hour after vaccination with CERVARIX and VARIVAX (Non-GSK), the subject experienced "overall" body pain, swelling arm, flu like symptoms, fatigue and nausea. The physician considered the events were disabling. The events lasted for 3 days. On 17 May 2012, the events were resolved. The subject consulted her healthcare provider. The vaccination course with CERVARIX was discontinued.
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Cough, Salivary hypersecretion
Clinical narrative: Pt administered 1-2 drops, started coughing & salivating. Pt suctioned, lasted approx 5-10 minutes. Baby massaged briefly & then fell asleep. Checked with mom in the afternoon baby doing OK.
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Cough, Immediate post-injection reaction, Salivary hypersecretion
Clinical narrative: Pt administered 1-2 drops, started coughing & salivating. Pt suctioned, lasted approx 5-10 minutes. Baby massaged briefly & then fell asleep. Checked with mom in the afternoon baby doing OK.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Local reaction, Swelling
Clinical narrative: (L) arm with local reaction following varicella vaccination. Redness & swelling with same warmth. Area of redness approx. 5-6 cm. No induration.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Dyskinesia, Fall, Fear, Gaze palsy, Headache
Clinical narrative: Child administered Tdap vaccine. He became pale slumped to right side making a jerking movement with his legs and arms. His eyes rolled slightly back. This event lasted less than 2 seconds. His father and I talked to him. He stated he was scared. He complained of nausea, headache. He ambulated with assist to exam room & assisted up to exam table. He lied down for 15 minutes. BP 90/56 P 100. After 15min. increased 110/68 P 80. He felt normal.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pallor
Clinical narrative: Child administered Tdap vaccine. He became pale slumped to right side making a jerking movement with his legs and arms. His eyes rolled slightly back. This event lasted less than 2 seconds. His father and I talked to him. He stated he was scared. He complained of nausea, headache. He ambulated with assist to exam room & assisted up to exam table. He lied down for 15 minutes. BP 90/56 P 100. After 15min. increased 110/68 P 80. He felt normal.
Age: 65.0
Sex: M
Vaccine: IPV, TDAP, YF
Symptoms: Axillary pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Extreme pain in upper left arm, arm pit, scapula.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site urticaria, Papule
Clinical narrative: Student presented to Health Services on 09/04/2011 with hive 6cm x 7cm at injection site, left deltoid. 3 red nodules noted Lt elbow.  2 red papules noted right elbow.
Age: 0.72
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever x5 days. No treatment.
Age: 1.04
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Aggression, Crying, Developmental delay, Encephalopathy, Hypotonia
Clinical narrative: Cries if he hears loud noises, severe temper tantrums, no self control, throws self on ground, met with his doctor who recommended specialist.  Met with specialist who gave DIAGNOSES: Encephalopathy manifesting central hypotonia and global developmental delay.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness at site, swelling at site, pain at site, headaches, warm to touch at site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness & swelling of the left arm where vaccine was administered.
Age: 46.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red and significantly swollen arm from shoulder to elbow with symptoms lasting 3-4 days.  Patient did not notify provider.  Symptoms resolved without treatment.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Local swelling, Pain, Urticaria
Clinical narrative: Localized swelling and pain- reddened area approx size of a softball with welping at injection site.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Middle insomnia, Myalgia, Pain
Clinical narrative: Muscle and joint pain, when arm is moved, particularly when arm is raised. Sleeps on right side, pain wakes patient during the night.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Nausea, Pyrexia, Retching
Clinical narrative: Patient received Fluzone HD (high dose flu shot). The next day she reported dry heaves, very weak, shaky hands, feverish, and nauseous. Patient could not report to work that day. The next day she said she felt much better. She had never had a bad reaction from a flu shot before, but this was the 1st time receiving the high dose flu shot.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient received Fluzone HD (high dose flu shot). The next day she reported dry heaves, very weak, shaky hands, feverish, and nauseous. Patient could not report to work that day. The next day she said she felt much better. She had never had a bad reaction from a flu shot before, but this was the 1st time receiving the high dose flu shot.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pain, Pyrexia, Syncope
Clinical narrative: FAINTING X 2, SHAKY, CHILLS, FEVER, PAIN, FATIGUE, VOMITING.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: FAINTING X 2, SHAKY, CHILLS, FEVER, PAIN, FATIGUE, VOMITING.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin hypertrophy, Skin lesion
Clinical narrative: Localized skin reaction, red itchy skin. Followed by two additional lesions. Appeared day after vaccine in location of vaccine. 2 weeks later lesions still present, not resolving. Lesions are red indurated. Appears to have thickened skin in area or lesion.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Skin reaction, Vaccination site reaction
Clinical narrative: Localized skin reaction, red itchy skin. Followed by two additional lesions. Appeared day after vaccine in location of vaccine. 2 weeks later lesions still present, not resolving. Lesions are red indurated. Appears to have thickened skin in area or lesion.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Concerns with Nausea, emesis and fatigue. Overall feeling bad.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Round, red, painful 1" diameter reaction at injection site.  Lasted for 24 hours, gone at 36 hours.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Erythema nodosum, Injection site nodule, Injection site pain
Clinical narrative: Patient developed multiple painful nodules over arms, at flu vaccine injection site 3-4 days after receiving Fluzone and maintenance allergy immunotherapy injections.  She was diagnosed with erythema nodosum by clinical presentation and skin biopsy.  She was not prescribed any therapy.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Hypersomnia, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Muscle aches for the next month slept for three days straight unable to wake him not even to eat very groggy flu like symptoms headache muscle aches fever.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: Muscle aches for the next month slept for three days straight unable to wake him not even to eat very groggy flu like symptoms headache muscle aches fever.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dyspnoea, Hyperhidrosis, Nausea, Rash, Syncope
Clinical narrative: According to the nurse present, he was on his way out the door when symptoms started. Had syncope episode with dyspnea and facial rash and c/o tongue itching. Became nauseated with vomiting and sweating. He was given epi pen jr., O2 started, ambulance transported him to hospital where he was observed overnight with no other adverse events.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Tongue pruritus, Vomiting
Clinical narrative: According to the nurse present, he was on his way out the door when symptoms started. Had syncope episode with dyspnea and facial rash and c/o tongue itching. Became nauseated with vomiting and sweating. He was given epi pen jr., O2 started, ambulance transported him to hospital where he was observed overnight with no other adverse events.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV
Symptoms: Arterial wall hypertrophy, Discomfort, Kawasaki's disease, Pyrexia
Clinical narrative: Very high fever of 107 that would not go down with Tylenol or Motrin. Persisted and baby seemed to be very uncomfortable. We rushed to the emergency room after giving another dose of Tylenol. Fever only went down to 105. We went to facility for a week and then were moved to another facility for another week.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Extreme pain in arm of injection, entire arm throbbing, shooting pain in arm, neck and shoulder soreness and stiffness, difficulty using arm, especially when lifting.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Extreme pain in arm of injection, entire arm throbbing, shooting pain in arm, neck and shoulder soreness and stiffness, difficulty using arm, especially when lifting.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Discomfort, Injection site discolouration, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Received Varivax on thursday afternoon. Mom worked that evening. Child showed leg to Mom on Friday. Site was hot to the touch. At the site, it was red and swollen (Approx size ~2 inches). By Sunday, the reddened area had increased to 5 to 6 inches with a hard and raised area immedidately at the injection site. Mom used Tylenol, Benadryl  and warm packs to help relieve the discomfort, redness, and itching. Child was not taken into ER or clinic due to redness was starting to reduce by late Sunday nite. By Tuesday, Sept 4, all redness was gone except for minor discoloration at the injection site (resembles a bruise).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Received Varivax on thursday afternoon. Mom worked that evening. Child showed leg to Mom on Friday. Site was hot to the touch. At the site, it was red and swollen (Approx size ~2 inches). By Sunday, the reddened area had increased to 5 to 6 inches with a hard and raised area immedidately at the injection site. Mom used Tylenol, Benadryl  and warm packs to help relieve the discomfort, redness, and itching. Child was not taken into ER or clinic due to redness was starting to reduce by late Sunday nite. By Tuesday, Sept 4, all redness was gone except for minor discoloration at the injection site (resembles a bruise).
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Syncope
Clinical narrative: Syncope X 2.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest discomfort, Contusion, Cough, Induration, Injection site pain
Clinical narrative: Per phone message on 8/31/12 @ 12:51PM: (Patient says) 24 hrs after the vaccine she had a 102 fever, a funny cough, and her chest felt heavy. Went to bed the entire day. The right arm is warm to touch. hard and bruised. Fever is gone and feels better. Denies itching at the site.  On 9/4/12 @ 9:38AM  Patient says vaccine site is now just tender to touch.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Skin warm, Somnolence
Clinical narrative: Per phone message on 8/31/12 @ 12:51PM: (Patient says) 24 hrs after the vaccine she had a 102 fever, a funny cough, and her chest felt heavy. Went to bed the entire day. The right arm is warm to touch. hard and bruised. Fever is gone and feels better. Denies itching at the site.  On 9/4/12 @ 9:38AM  Patient says vaccine site is now just tender to touch.
Age: 0.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, PPV
Symptoms: Convulsion, Febrile convulsion, Respiratory arrest, Vomiting
Clinical narrative: Convulsions, vomiting, stopped breathing. Febrile seizure.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Very swollen at injection site-Patient states baseball size swelling. Redness, pain and itching at site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Very swollen at injection site-Patient states baseball size swelling. Redness, pain and itching at site.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Hard swelling & heat, 2" diameter circle, at injection site, low-grade fever, malaise.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Mother reports, sob, light headedness, Dizziness, Numbness and tingling of upper extremities, Nausea.
Age: 1.53
Sex: M
Vaccine: DTAP
Symptoms: Discomfort, Injection site swelling, Pruritus, Swelling, Weight bearing difficulty
Clinical narrative: 11/21/11 - Vaccine administered. 11/22/11 - Phone call from parent reporting (+) swelling (+) itching (+) discomfort. Swelling from site of injection to knee, unable to bear weight treated with antihistamine.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyskinesia, Hyperhidrosis
Clinical narrative: Chills, sweating, jerking starting when went to bed that evening and continued for 3 days.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema and redness at injection site.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dizziness, Dyspnoea, Gaze palsy, Insomnia
Clinical narrative: Light-headedness followed by eyes rolling back and passed out.  Later, feelings of weakness, insomnia, breathless during exercise.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Light-headedness followed by eyes rolling back and passed out.  Later, feelings of weakness, insomnia, breathless during exercise.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dehydration, Dyspnoea exertional, Gaze palsy, Loss of consciousness
Clinical narrative: Light-headedness followed by eyes rolling back and passed out.  Later, feelings of weakness, insomnia, breathless during exercise.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Middle insomnia, Nervousness, Pallor
Clinical narrative: Light-headedness followed by eyes rolling back and passed out.  Later, feelings of weakness, insomnia, breathless during exercise.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Difficulty breathing hoarseness cough that caused chest to hurt.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dystonia, Headache, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Tremors, head and neck pain, dystonia.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Tremors, head and neck pain, dystonia.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Sweating, fever, nausea, "cloudy" head, chills, vomiting.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Sweating, fever, nausea, "cloudy" head, chills, vomiting.
Age: 13.0
Sex: M
Vaccine: FLU3, HEP, HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted immediately after received HPV vaccine. Immediately recovered.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature fluctuation, Body temperature increased, Fatigue, Listless, Local swelling
Clinical narrative: About 20 to 25 minutes after shots, wife says patient became tired & listless. So that's about 5:45pm-5:50pm. Went to bed at 7:15pm because tired. He tossed & turned most of night. At 9-9:30am, took his temperature, it was 104 degrees F. Got appointment to urgent care at 2pm (on 9/2/12). Arm (left) very tender and swollen up to neck. Urgent care sent him to emergency where they admitted him to the hospital for 1 night. Temp was 102.4 degrees at urgent care and 100.4 F at hospital. Home now but temp fluctuates. WBC increased.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Poor quality sleep, Tenderness, White blood cell count increased
Clinical narrative: About 20 to 25 minutes after shots, wife says patient became tired & listless. So that's about 5:45pm-5:50pm. Went to bed at 7:15pm because tired. He tossed & turned most of night. At 9-9:30am, took his temperature, it was 104 degrees F. Got appointment to urgent care at 2pm (on 9/2/12). Arm (left) very tender and swollen up to neck. Urgent care sent him to emergency where they admitted him to the hospital for 1 night. Temp was 102.4 degrees at urgent care and 100.4 F at hospital. Home now but temp fluctuates. WBC increased.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient fainted after inj of GARDASIL. Patient became pale, diaphoretic within seconds after admin. Regained consciousness within 60 seconds. No injury. 911 called. No treatment needed.
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a healthcare worker who on 17-AUG-2012 was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL (route unknown) (lot # H009826, expiration date on 11-FEB-2014). On 17-AUG-2012, the patient developed a redness reaction behind the arm and across the chest. The patient was taken to an unspecified hospital for an unspecified amount of time and was given unspecified antibiotics to treat the event. The outcome of the event was unknown. The relatedness for the event was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Oedema peripheral, Pain, Tenderness
Clinical narrative: Pt. received PNEUMOVAX vaccine 8/87/12. Pt. called 8/31/12 stating arm was swollen & red. Condition continued to worsen to severe swelling, redness, pain, tenderness and joint pain. PCP told pt. cold compresses & ibu for treatment.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dehydration, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Starting with nausea, diarrhea, fever, ache, headache, sweating & chills. Dehydrated.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Starting with nausea, diarrhea, fever, ache, headache, sweating & chills. Dehydrated.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.