chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Local reaction, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal
Clinical narrative: Case number PHHY2014US103401 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 36-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 6-8 hours after vaccination he experienced severe pain localized to the injection site and there was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal complete blood count with erythrocyte sedimentation rate (ESR) was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder MR exam completed 1 week after vaccination and results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes and bursal fluid absent (small amount present) and with intrasubstance deltoid edema. No dominant mass lesion, hematoma, or abscess was present. Subcutaneous fat thickness at the proposed site of injection was measured to be 4.2 mm on oblique coronal T1-weighted sequence. Conservative treatment with short-term non-steroidal antiinflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Bone marrow oedema, Bursa disorder, Full blood count normal, Inflammation, Injection site pain
Clinical narrative: Case number PHHY2014US103401 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 36-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 6-8 hours after vaccination he experienced severe pain localized to the injection site and there was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal complete blood count with erythrocyte sedimentation rate (ESR) was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder MR exam completed 1 week after vaccination and results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes and bursal fluid absent (small amount present) and with intrasubstance deltoid edema. No dominant mass lesion, hematoma, or abscess was present. Subcutaneous fat thickness at the proposed site of injection was measured to be 4.2 mm on oblique coronal T1-weighted sequence. Conservative treatment with short-term non-steroidal antiinflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Muscle oedema, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Soft tissue disorder
Clinical narrative: Case number PHHY2014US103401 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 36-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 6-8 hours after vaccination he experienced severe pain localized to the injection site and there was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal complete blood count with erythrocyte sedimentation rate (ESR) was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder MR exam completed 1 week after vaccination and results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes and bursal fluid absent (small amount present) and with intrasubstance deltoid edema. No dominant mass lesion, hematoma, or abscess was present. Subcutaneous fat thickness at the proposed site of injection was measured to be 4.2 mm on oblique coronal T1-weighted sequence. Conservative treatment with short-term non-steroidal antiinflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body mass index increased, Bone disorder, Bone marrow oedema, Bursal fluid accumulation, Bursitis
Clinical narrative: Case number PHHY2014US103430 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 39-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination he prolonged, increasing left shoulder pain. The event lasted for 2 months. Physical examination was normal. On laboratory assessment, leukopenia was noted as (3-4,700 per microliter) on serial tests for 4 months without defined source, although counts were otherwise normal. Erythrocyte sedimentation rate was normal. BMI was recorded as 25.7 kg/m2. MRI of the shoulder performed at 3 months following vaccination showed focal subcortical bone marrow edema-like signal within the greater tuberosity was observed, without associated obvious cortical destruction. There were periosseous soft tissue inflammatory changes, small subacromial/subdeltoid bursal fluid and intrasubstance deltoid edema. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Coincidental diagnosis included malaria and atrial fibrillation. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Full blood count abnormal, Immediate post-injection reaction, Inflammation, Leukopenia, Musculoskeletal pain
Clinical narrative: Case number PHHY2014US103430 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 39-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination he prolonged, increasing left shoulder pain. The event lasted for 2 months. Physical examination was normal. On laboratory assessment, leukopenia was noted as (3-4,700 per microliter) on serial tests for 4 months without defined source, although counts were otherwise normal. Erythrocyte sedimentation rate was normal. BMI was recorded as 25.7 kg/m2. MRI of the shoulder performed at 3 months following vaccination showed focal subcortical bone marrow edema-like signal within the greater tuberosity was observed, without associated obvious cortical destruction. There were periosseous soft tissue inflammatory changes, small subacromial/subdeltoid bursal fluid and intrasubstance deltoid edema. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Coincidental diagnosis included malaria and atrial fibrillation. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Soft tissue inflammation
Clinical narrative: Case number PHHY2014US103430 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 39-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination he prolonged, increasing left shoulder pain. The event lasted for 2 months. Physical examination was normal. On laboratory assessment, leukopenia was noted as (3-4,700 per microliter) on serial tests for 4 months without defined source, although counts were otherwise normal. Erythrocyte sedimentation rate was normal. BMI was recorded as 25.7 kg/m2. MRI of the shoulder performed at 3 months following vaccination showed focal subcortical bone marrow edema-like signal within the greater tuberosity was observed, without associated obvious cortical destruction. There were periosseous soft tissue inflammatory changes, small subacromial/subdeltoid bursal fluid and intrasubstance deltoid edema. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Coincidental diagnosis included malaria and atrial fibrillation. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Atrial fibrillation, Bone marrow oedema, Leukopenia, Muscle oedema, Musculoskeletal pain
Clinical narrative: Case number PHHY2014US103430 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 39-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination he prolonged, increasing left shoulder pain. The event lasted for 2 months. Physical examination was normal. On laboratory assessment, leukopenia was noted as (3-4,700 per microliter) on serial tests for 4 months without defined source, although counts were otherwise normal. Erythrocyte sedimentation rate was normal. BMI was recorded as 25.7 kg/m2. MRI of the shoulder performed at 3 months following vaccination showed focal subcortical bone marrow edema-like signal within the greater tuberosity was observed, without associated obvious cortical destruction. There were periosseous soft tissue inflammatory changes, small subacromial/subdeltoid bursal fluid and intrasubstance deltoid edema. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Coincidental diagnosis included malaria and atrial fibrillation. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Soft tissue inflammation, White blood cell count decreased
Clinical narrative: Case number PHHY2014US103430 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 39-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination he prolonged, increasing left shoulder pain. The event lasted for 2 months. Physical examination was normal. On laboratory assessment, leukopenia was noted as (3-4,700 per microliter) on serial tests for 4 months without defined source, although counts were otherwise normal. Erythrocyte sedimentation rate was normal. BMI was recorded as 25.7 kg/m2. MRI of the shoulder performed at 3 months following vaccination showed focal subcortical bone marrow edema-like signal within the greater tuberosity was observed, without associated obvious cortical destruction. There were periosseous soft tissue inflammatory changes, small subacromial/subdeltoid bursal fluid and intrasubstance deltoid edema. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Coincidental diagnosis included malaria and atrial fibrillation. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Blood glucose, Electrocardiogram, Electroencephalogram, Metabolic function test, Tonic convulsion
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient with allergic rhinitis, migraines and seizure. On 22-AUG-2014, the patient was vaccinated with GARDASIL lot # J009243, intramuscular. No concomitant therapies were reported. After the therapy, the patient experienced seizure (medically significant), headache after the seizure and muscular weakness of the upper and lower extremities. The outcome of seizure was reported as resolved but the patient continued with the muscular weakness of the upper and lower extremities and a headache. The patient went to the emergency room from the doctor's office. No treatment was reported. No lab diagnostics studies were performed. The patient sought medical attention. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Convulsion, Headache, Muscular weakness
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient with allergic rhinitis, migraines and seizure. On 22-AUG-2014, the patient was vaccinated with GARDASIL lot # J009243, intramuscular. No concomitant therapies were reported. After the therapy, the patient experienced seizure (medically significant), headache after the seizure and muscular weakness of the upper and lower extremities. The outcome of seizure was reported as resolved but the patient continued with the muscular weakness of the upper and lower extremities and a headache. The patient went to the emergency room from the doctor's office. No treatment was reported. No lab diagnostics studies were performed. The patient sought medical attention. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Blood electrolytes normal, Blood glucose normal, Convulsion, Disorientation, Electrocardiogram normal
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient with allergic rhinitis, migraines and seizure. On 22-AUG-2014, the patient was vaccinated with GARDASIL lot # J009243, intramuscular. No concomitant therapies were reported. After the therapy, the patient experienced seizure (medically significant), headache after the seizure and muscular weakness of the upper and lower extremities. The outcome of seizure was reported as resolved but the patient continued with the muscular weakness of the upper and lower extremities and a headache. The patient went to the emergency room from the doctor's office. No treatment was reported. No lab diagnostics studies were performed. The patient sought medical attention. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Electroencephalogram abnormal, Loss of consciousness, Muscular weakness, Somnolence, Tonic convulsion
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient with allergic rhinitis, migraines and seizure. On 22-AUG-2014, the patient was vaccinated with GARDASIL lot # J009243, intramuscular. No concomitant therapies were reported. After the therapy, the patient experienced seizure (medically significant), headache after the seizure and muscular weakness of the upper and lower extremities. The outcome of seizure was reported as resolved but the patient continued with the muscular weakness of the upper and lower extremities and a headache. The patient went to the emergency room from the doctor's office. No treatment was reported. No lab diagnostics studies were performed. The patient sought medical attention. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient with allergic rhinitis, migraines and seizure. On 22-AUG-2014, the patient was vaccinated with GARDASIL lot # J009243, intramuscular. No concomitant therapies were reported. After the therapy, the patient experienced seizure (medically significant), headache after the seizure and muscular weakness of the upper and lower extremities. The outcome of seizure was reported as resolved but the patient continued with the muscular weakness of the upper and lower extremities and a headache. The patient went to the emergency room from the doctor's office. No treatment was reported. No lab diagnostics studies were performed. The patient sought medical attention. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 0.15
Sex: M
Vaccine: DTAPH, HEP, RVX, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: Bells Palsy, currently on steroids for treatment.
Age: 0.15
Sex: M
Vaccine: DTAPH, HEP, RVX, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging abnormal, VIIth nerve paralysis
Clinical narrative: Bells Palsy, currently on steroids for treatment.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy artery, Blindness unilateral, C-reactive protein increased, Optic neuropathy, Red blood cell sedimentation rate increased
Clinical narrative: Loss of vision (L) eye. Superior half of vision (L) eye (L) optic neuropathy. Temporal Artery biopsy, IV steroids.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Laboratory test, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: This spontaneous report was received from a 66 year old female patient, regarding herself. No relevant medical history was reported. Drug reactions or allergies were reported as none. The patient was awaiting heart transplant. On an unknown date in 2014 (also reported as couple weeks before reaction) the patient was vaccinated with ZOSTAVAX. Concomitant medication was reported as none. On 29-JUL-2014 the patient experienced swelling of her lips and tongue (hospitalization) as well as hives throughout her body after taking ZOSTAVAX (hospitalization). The patient was hospitalised overnight. She also reported that she was given anti-viral medications for ten days and prednisolone that did not help her condition. The patient sought medical attention by visiting physician. On an unknown date, unspecified lab work and blood test were performed and the results were not provided. The adverse events did not improve. Outcome of the events were reported as not recovered. Therapy with ZOSTAVAX was not reintroduced. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Per pt later in day on 8/22/14 pt developed pain, redness, swelling at injection site and a fever of 102 degrees F.  Pt reports feeling dizzy, weak and very tired.  Pt reports fever x 2 days.  Seen in office on 3rd day after vaccine still with redness, swelling to arm, reporting fatigue - no fever at time of visit.  Pt treated with Medrol dose pack and Claritin 10mg.
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Per pt later in day on 8/22/14 pt developed pain, redness, swelling at injection site and a fever of 102 degrees F.  Pt reports feeling dizzy, weak and very tired.  Pt reports fever x 2 days.  Seen in office on 3rd day after vaccine still with redness, swelling to arm, reporting fatigue - no fever at time of visit.  Pt treated with Medrol dose pack and Claritin 10mg.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism, Crying, General physical condition abnormal, Haematochezia
Clinical narrative: This spontaneous report as received from a consumer refers to a 13 years old male patient. On an unknown date in 2001 (also reported as when the patient was 15 months old) the patient was vaccinated with M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date approximately in 2001 (also reported as when the patient was 15 months old) the patient experienced blood in stool (hospitalization), stopped breathing (hospitalization and medically significant), had night crying jags (hospitalization) and he stopped talking (hospitalization and medically significant). The consumer stated that on an unknown date the patient recovered from his physical illness (hospitalization). On an unknown date approximately in 2001 the patient began showing signs of autism (hospitalization). The reporter stated that the patient was hospitalized on an unknown date (hospitalization date, amount of time spent in hospital was unspecified). The outcome of he began showing signs of autism was reported as not recovered. The outcome of he had stopped breathing, he had night crying jags, blood in his stool and he stopped talking was reported was unknown. The outcome of physical illness was reported as recovered. The relatedness of the events to the therapy with M-M-R II was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Respiratory arrest
Clinical narrative: This spontaneous report as received from a consumer refers to a 13 years old male patient. On an unknown date in 2001 (also reported as when the patient was 15 months old) the patient was vaccinated with M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date approximately in 2001 (also reported as when the patient was 15 months old) the patient experienced blood in stool (hospitalization), stopped breathing (hospitalization and medically significant), had night crying jags (hospitalization) and he stopped talking (hospitalization and medically significant). The consumer stated that on an unknown date the patient recovered from his physical illness (hospitalization). On an unknown date approximately in 2001 the patient began showing signs of autism (hospitalization). The reporter stated that the patient was hospitalized on an unknown date (hospitalization date, amount of time spent in hospital was unspecified). The outcome of he began showing signs of autism was reported as not recovered. The outcome of he had stopped breathing, he had night crying jags, blood in his stool and he stopped talking was reported was unknown. The outcome of physical illness was reported as recovered. The relatedness of the events to the therapy with M-M-R II was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: REDNESS AT THE SITE OF INJECTION AND PATIENT SAID IT FEELS WARM AND IT WAS PAINFUL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Erythema, Fatigue, Headache
Clinical narrative: Received Shingles vaccine in right arm on 8/16/14. Client woke up in the AM with HA, fatigue, weakness, nausea and right arm swelling and redness. Symptoms continued throughout the day followed by two episodes of vomiting; 8/17/14 pm and 8/18/14 am. Missed work 8/18/14. Symptoms resolved 8/18/14 expect right arm stayed swollen and red through 8/13/14. Client attended a public vaccine clinic for shingles vaccine. Large crowd attend and the wait line was  approximately one hour.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Nausea, Vomiting
Clinical narrative: Received Shingles vaccine in right arm on 8/16/14. Client woke up in the AM with HA, fatigue, weakness, nausea and right arm swelling and redness. Symptoms continued throughout the day followed by two episodes of vomiting; 8/17/14 pm and 8/18/14 am. Missed work 8/18/14. Symptoms resolved 8/18/14 expect right arm stayed swollen and red through 8/13/14. Client attended a public vaccine clinic for shingles vaccine. Large crowd attend and the wait line was  approximately one hour.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has a very large red area around the shot site. It is a little raised and seems to itch. (my daughter had a similar reaction that I didn't record). It is now 4 days later and still there.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal death, Stillbirth
Clinical narrative: My baby died and was stillborn 3 days after vaccination on June 2, 2014.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. On an unknown date, 2 months after receiving the first dose (date unspecified) of VAQTA (dose, route of administration, lot/batch number, expiration date and indication were not reported), the patient was vaccinated with the second dose of VAQTA (dose, route of administration, lot/batch number, expiration date and indication were not reported). No adverse effects reported. Additional information is not expected as no consent for contact was given.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt received vaccine on 7/29. Seen in office on 7/31 Dx with reaction shot. Injection site red and warm to touch. pt put on KEFLEX. Mom saw no improvement, admitted to hospital for IV Abx.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling, Vaccination complication, White blood cell count increased
Clinical narrative: Pt received vaccine on 7/29. Seen in office on 7/31 Dx with reaction shot. Injection site red and warm to touch. pt put on KEFLEX. Mom saw no improvement, admitted to hospital for IV Abx.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS, SWELLING & PAIN AT INJECTION SITE OF RIGHT DELTOID.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Muscle tightness
Clinical narrative: I am experiencing jaw joint tightness along with a headache.  NP at pharmacy said I should report it since she has never heard of jaw pain with the Tdap shot.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tenderness at site started the morning following vaccination, which progressed over the next 2-3 days to localized swelling, erythema, warmth, and increased tenderness.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified patient of unknown age and gender. On 21-AUG-2014 the patient received a dose of improperly stored PROQUAD (Merck) (lot# not reported, dose 0.5 ml, subcutaneously), exposed to 38F for 24 hours. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown demographics. Patient's concurrent condition and relevant medical history was unknown. The nurse practitioner reported that the patient was vaccinated expired dose of PNEUMOVAX 23 (lot number: H013847 with expiry date of 15-MAR-2014) dose 1, 0.5 ml, intramuscular on 22-AUG-2014. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 18 year old male patient. On 05-MAY-2014, the patient was vaccinated by a medical assistant with GARDASIL in the right deltoid (dose, route of administration were not provided) (lot # was illegible, expiration date: 28-SEP-2014) that was out of range temperature. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from other health professional via company representative refers to a patient of unknown age and gender. Patient medical history and other previous drug allergic reactions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose number, route, lot number and expiry date unknown) subcutaneously. On an unknown date later, patient developed full blown shingles. The outcome of full blown shingles was unknown. The reporter did not provide the causality of full blown shingles to ZOSTAVAX. No further information provided. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. On 12-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot#, route unspecified, dose/frequency reported as directed in the prescribing information). Concomitant medications were unspecified. On 12-AUG-2014 the patient fainted after receiving GARDASIL. No treatment was given for the adverse event. The patient had sought medical attention by office visit on an unspecified date. Outcome of the event was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Loss of consciousness, Pallor, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. On 12-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot#, route unspecified, dose/frequency reported as directed in the prescribing information). Concomitant medications were unspecified. On 12-AUG-2014 the patient fainted after receiving GARDASIL. No treatment was given for the adverse event. The patient had sought medical attention by office visit on an unspecified date. Outcome of the event was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Pyrexia
Clinical narrative: Local allergic reaction, patient was evaluated at ER dept. (R) arm vaccine site redness and fever. Redness increased in size 24hr. after immunization given.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner (certified nurse midwife), refers to a 23 year old female patient. No medical history or concurrent conditions were reported. On 05-MAY-2014, the patient was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular injection (strength and lot number not provided). Co-suspect or concomitant therapies were not reported. The patient received the first dose of GARDASIL while she was pregnant with an estimated date of conception on 17-APR-2014, LMP (last menstrual period) reported as 03-APR-2014 and EDD (estimated delivery date) on 08-JAN-2015. No adverse effects were reported. Patient sought medical attention through an office visit. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history and current condition are not reported. It was reported that on 07-JUL-2014 the patient was vaccinated with expired ZOSTAVAX (lot # J001007 and expiry date 24-APR-2014). Other co-suspects and concomitant medication are not reported. Also reported that the ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms are reported. Product quality complaint was not reported. The outcome of the event is unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with an expired dose of M-M-R II (0.5 ml, subcutaneous, lot # H014977, expiration date: 09-AUG-2014). No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a consumer's mother refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with two doses of GARDASIL on the same unspecified day. Concomitant medications were unknown. The outcome of the event was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a consumer's mother refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with two doses of GARDASIL on the same unspecified day. Concomitant medications were unknown. The outcome of the event was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a office manager (also reported as health care worker) refers to a 12 year old male patient. The patient's medical history and current condition are not reported. On 20-AUG-2014 the patient was vaccinated with GARDASIL (lot # K001631 and expiry date 06-NOV-2016), of dose 0.5 ml in the arm (deltoid region) twice within one hour. Other co-suspects and concomitant medication are not reported. On 20-AUG-2014, 1 day after onset of therapy the patient experienced headaches. Overdose was reported. The product quality complaint is not involved. The outcome of headaches is unknown. Causality for the event headaches is unspecified by the reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a office manager (also reported as health care worker) refers to a 12 year old male patient. The patient's medical history and current condition are not reported. On 20-AUG-2014 the patient was vaccinated with GARDASIL (lot # K001631 and expiry date 06-NOV-2016), of dose 0.5 ml in the arm (deltoid region) twice within one hour. Other co-suspects and concomitant medication are not reported. On 20-AUG-2014, 1 day after onset of therapy the patient experienced headaches. Overdose was reported. The product quality complaint is not involved. The outcome of headaches is unknown. Causality for the event headaches is unspecified by the reporter. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 41 year old female patient. On an unknown date in 1999 (reported as about 15 years ago), the patient was vaccinated with M-M-R II, intramuscular. The pharmacist reported that the patient had titers drawn on 01-AUG-2014 for work purposes and the results of the titer showed that she had a low titer to rubeola. She reports that she was administered a dose of M-M-R II, 0.5 ml, intramuscular (lot number J016233, with an expiry date of 19-DEC-2015) on 05-AUG-2014 due to the low titer of rubeola. The outcome of low titers to rubeola was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unknown demographics. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with VARIVAX (merck) (1350 U) (0.5 ml, subcutaneously) that had been exposed to a temperature of -14.3 degree Celsius for 1 hour and 43 minutes. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (merck) was not reported. Product quality issues was not involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt's mother called to report that pt broke out in hives approx. 1 hr after the administration of the vaccines. Pt's mother also stated she would take pt to the ED to be checked out.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: 8/22/14 Rec'd Tdap vaccine. 8/23/14 Patient reports pain, swelling and redness along with firm and tender lump at injection site. 8/25/14 Patient reports symptoms worsened and reports to OHS at hospital center.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 50 year old female patient. On 12-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K000326, expiry : 27-FEB-2015) in the left arm. Nurse reported that patient was seen in office 10 days post vaccination on 21-AUG-2014 and presented to the office with a rash on the left arm where the injection site was and also on the right arm. Physician added that she would not have reported this symptom because the rash looked more like a raised heat rash to her. Patient sought medical attention and was seen in the physician's office. Treatment given included hydrocortisone cream on both areas as needed. Because the patient stated they believed it was vaccine related, the physician's office decided to report it. No PQC was reported. The outcome of rash on the left arm where the injection site was and also in right arm was unknown. Therapy with ZOSTAVAX was not discontinued. Causality by the physician was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEP, HPV4, IPV, MMR, TDAP, VARCEL
Symptoms: Pallor, Staring, Unresponsive to stimuli
Clinical narrative: Patient came in for vaccines. Vaccine given were Hep B, BOOSTRIX, IPV, MMR, varicella and HPV. After vaccines were applied patient started getting pale not responding to questions or voice and had blank stare. Course time was 17 minutes in office. EMS was called and was taken to ER.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site warmth, Oral discomfort, Pruritus
Clinical narrative: On 8/6/14 noted very large hot to touch at injection site. Also tender to touch. Pt. called office on 8/7/14 and came to office to evaluate. Right arm grapefruit size red, hot to touch area, pt also states that 8/6/14 area itched and her lips felt "funny". Took BENADRYL in 8/6/14, today just itchy area. RPH evaluated injection site and pt. advised to use BENADRYL, ibuprofen ad ice - ZOSTAVAX added to allergy/intolerance.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: On 8/6/14 noted very large hot to touch at injection site. Also tender to touch. Pt. called office on 8/7/14 and came to office to evaluate. Right arm grapefruit size red, hot to touch area, pt also states that 8/6/14 area itched and her lips felt "funny". Took BENADRYL in 8/6/14, today just itchy area. RPH evaluated injection site and pt. advised to use BENADRYL, ibuprofen ad ice - ZOSTAVAX added to allergy/intolerance.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injected limb mobility decreased, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm where vaccine received was hard, swollen, hot, and could barely lift arm 1 day after receiving vaccine. Applied a cold compress and took BENADRYL.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Mass
Clinical narrative: Was given Tdap and meningitis and a lump amassed under her skin. Called to inquire which arm and HD did not find it documented anywhere.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin warm, Urticaria
Clinical narrative: The evening after vaccines the leg thigh was swollen and red and warm to touch. The patient developed hives on her chest and abdomen. All symptoms resolved.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Mom called. Child has hives (+) itching (L) deltoid x 1 week after injection.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Patient developed rash head to feet the day after received RABAVERT. Rash is isolated pink macules and papules. Itchy.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient received 2 vaccines - HPV #3 and MENACTRA #2 in (L) deltoid. Arm became sore and sl. red next day. Then 2-2 1/2" area of redness, throbbing and hot to touch. Afeb. By day 3 area still red but not throbbing and improving. Rx'ed with cool compress and ice and ibuprofen.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Pt fainted about 5 mins after getting vaccines. He states that he has done it in the pass when giving blood. He states he has been having freq fainting episodes lately. Pt placed on back in floor with both leg elevated. Pt was able to situp within 30 seconds, bp checked freq and was wnl at all times. Pt stated ok to leave after 5 mins of sitting in chair. BP was 130/76. no s/s of complication at that time. Pt states will us know at next visit that he has a hx of fainting. Instructed to see pcp regarding freq fainting.