chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RAB
Symptoms: Colony stimulating factor therapy, Cough, Fatigue, Leukopenia, Productive cough
Clinical narrative: Initial report received from the consumer (patient) on 15 Jul 2010: This polymedicated patient had medical history of diabetes mellitus and was bitten by a dog at index finger on 08 Oct 2009. The patient was vaccinated with RABIPUR (batch unknown). 1 ml. intramuscular 08 Oct 2009, 11 Oct 2009, 15 Oct 2009, 22 Oct 2009 and 05 Nov 2009. On 16 Nov 2009, the patient was hospitalized because he presented with cough, leucopenia and WBC (white blood cell) decreased at 2.1x10^9/L (reference range and unit was not provided). The patient received treatment with granulocyte colony-stimulating factor and was requested to leave hospital on 26 Nov 2009. From 30 Nov 2009 to 31 Dec 2009, the patient was hospitalized again for cough, expectoration and fatigue. The patient was diagnosed with PTB (pulmonary tuberculosis) during hospitalization. WBC decreased value showed at 1x10^9/L (01 Dec 2009) and 3.8x10^9/L (28 Dec 2009). The patient complained that vaccination lead to his leucopenia and his HCP stated that no evidence revealed that the patient's disease was caused by vaccination, but he did not agree. The outcome of the patient was reported as recovered.
Sex: M
Vaccine: RAB
Symptoms: Pulmonary tuberculosis, White blood cell count decreased
Clinical narrative: Initial report received from the consumer (patient) on 15 Jul 2010: This polymedicated patient had medical history of diabetes mellitus and was bitten by a dog at index finger on 08 Oct 2009. The patient was vaccinated with RABIPUR (batch unknown). 1 ml. intramuscular 08 Oct 2009, 11 Oct 2009, 15 Oct 2009, 22 Oct 2009 and 05 Nov 2009. On 16 Nov 2009, the patient was hospitalized because he presented with cough, leucopenia and WBC (white blood cell) decreased at 2.1x10^9/L (reference range and unit was not provided). The patient received treatment with granulocyte colony-stimulating factor and was requested to leave hospital on 26 Nov 2009. From 30 Nov 2009 to 31 Dec 2009, the patient was hospitalized again for cough, expectoration and fatigue. The patient was diagnosed with PTB (pulmonary tuberculosis) during hospitalization. WBC decreased value showed at 1x10^9/L (01 Dec 2009) and 3.8x10^9/L (28 Dec 2009). The patient complained that vaccination lead to his leucopenia and his HCP stated that no evidence revealed that the patient's disease was caused by vaccination, but he did not agree. The outcome of the patient was reported as recovered.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness, knotted area, pain at injection site - started 7/15/10. Pt came in for visit on 7/16/10 with complaints, gave ATARAX prn, Hydrocortisone 1% topical BID, and Prednisone x 5d. Called patient 7-19-10 and states arm is better, no problems.
Age: 29.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site infection, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Noticed left arm had become red and swollen over 75% of the left upper arm. 7/10:  Treated at urgent care because left arm remained swollen.  Given Keflex 100mg Q 12 improved.
Age: 29.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Noticed left arm had become red and swollen over 75% of the left upper arm. 7/10:  Treated at urgent care because left arm remained swollen.  Given Keflex 100mg Q 12 improved.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Crying, Eyelid oedema, Ocular hyperaemia, Pyrexia, Restlessness
Clinical narrative: Fever began at 12pm and peaked at 3:00pm at 103.7. Redness to sclera of eyes. Swelling to eye lids. Daughter with continual crying and restlessness. 120mg Tylenol administered. Fever relieved 1 hour later. Pt appeared back to normal by 7pm.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: 07/14/2010 MODERATE other. PAIN, SWELLING, REDNESS X 5 DAYS, FEVER 99.5 X 1 DAY.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Computerised tomogram normal, Convulsion, Facial palsy, Fatigue, Gaze palsy
Clinical narrative: Patient at clinic for ADHD evaluation. During the exam patient given KINRIX (DTAP and IPV). That night the patient had no problems with fever. He went off to daycare the next morning and went swimming. Following he had lunch and then was to take a nap. Ten minutes later he sat up and said he didn't feel well and was going to vomit. He was able to walk to the bathroom. He proceeded to vomit, had sagging of his face and became unresponsive although continued to stand. The school nurse was called and 911 response was activated. His eyes rolled up, and when the paramedics put him on a gurney he started with left sided seizure activity. His head turned to the left. He had 5 further episodes of seizure activity and inbetween he sat up and stated he was tired. He was transported to hospital. A CT scan of his head was done which was negative. There was a large local reaction in his left arm measuring 3cm by 3 cm due to the KINRIX. He also has mild hemophilia. Due to the concern of a cerebral bleed his hematologist was contacted and the patient was transported to another hospital. He was given Factor VIII replacement and put on TRILEPTAL for seizures. On 7/17/2010 he had an MRI and an MRA both of which were negative. The patient was discharged to be followed by neurology. No etiology except for the KINRIX could be found for the seizure.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Haemophilia, Injection site reaction, Malaise, Nuclear magnetic resonance imaging normal, Unresponsive to stimuli
Clinical narrative: Patient at clinic for ADHD evaluation. During the exam patient given KINRIX (DTAP and IPV). That night the patient had no problems with fever. He went off to daycare the next morning and went swimming. Following he had lunch and then was to take a nap. Ten minutes later he sat up and said he didn't feel well and was going to vomit. He was able to walk to the bathroom. He proceeded to vomit, had sagging of his face and became unresponsive although continued to stand. The school nurse was called and 911 response was activated. His eyes rolled up, and when the paramedics put him on a gurney he started with left sided seizure activity. His head turned to the left. He had 5 further episodes of seizure activity and inbetween he sat up and stated he was tired. He was transported to hospital. A CT scan of his head was done which was negative. There was a large local reaction in his left arm measuring 3cm by 3 cm due to the KINRIX. He also has mild hemophilia. Due to the concern of a cerebral bleed his hematologist was contacted and the patient was transported to another hospital. He was given Factor VIII replacement and put on TRILEPTAL for seizures. On 7/17/2010 he had an MRI and an MRA both of which were negative. The patient was discharged to be followed by neurology. No etiology except for the KINRIX could be found for the seizure.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Vomiting
Clinical narrative: Patient at clinic for ADHD evaluation. During the exam patient given KINRIX (DTAP and IPV). That night the patient had no problems with fever. He went off to daycare the next morning and went swimming. Following he had lunch and then was to take a nap. Ten minutes later he sat up and said he didn't feel well and was going to vomit. He was able to walk to the bathroom. He proceeded to vomit, had sagging of his face and became unresponsive although continued to stand. The school nurse was called and 911 response was activated. His eyes rolled up, and when the paramedics put him on a gurney he started with left sided seizure activity. His head turned to the left. He had 5 further episodes of seizure activity and inbetween he sat up and stated he was tired. He was transported to hospital. A CT scan of his head was done which was negative. There was a large local reaction in his left arm measuring 3cm by 3 cm due to the KINRIX. He also has mild hemophilia. Due to the concern of a cerebral bleed his hematologist was contacted and the patient was transported to another hospital. He was given Factor VIII replacement and put on TRILEPTAL for seizures. On 7/17/2010 he had an MRI and an MRA both of which were negative. The patient was discharged to be followed by neurology. No etiology except for the KINRIX could be found for the seizure.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash
Clinical narrative: Noticed rash on thigh (L) around 7:0 pm, No c/o discomfort to area (7/15/2010).
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Tenderness
Clinical narrative: Swelling, erythema to injection site (L) thigh fever to 102.3 degrees, Rx'd TYLENOL tenderness all beginning day of admin & gradually improved.
Age: 15.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Vasovagal Syncope Pt did say she had not eaten anything  but a cookie and some sunflower seeds for breakfast and nothing for lunch.
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Rash formed all over body, small red raised bumps.
Age: 59.0
Sex: M
Vaccine: TTOX
Symptoms: Myalgia
Clinical narrative: Muscle achiness since he received shot on 5/13/10 (minor achiness).
Age: 1.48
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Insomnia, Irritability, Pyrexia, Rash generalised
Clinical narrative: 7/19/10 AM mother reports rash on abdomen, spreading to generalized rash during day, fussy, mild fever, clingy. 7/20/10 AM mother reports dots have molded together, rash over body including eyelids, unable to sleep through night. Will go to Pediatrician or ER.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Chest discomfort, Dyspnoea, Rash generalised, Urticaria
Clinical narrative: Full body rash with difficulty breathing. Hives waist to thighs et back pt woke up Sat am d/t tightness in chest.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal distension, Alanine aminotransferase increased, Anaemia, Ascites, Aspartate aminotransferase increased
Clinical narrative: Mother reported that soon after the administration of the immunizations infant began to have fever, increased respiratory rate and some abdominal distention.  Mom started to give Tylenol at that time.  The symptoms worsened and mom brought the infant to the emergency room on 7/18/10 for evaluation and treatment.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin increased, Disseminated intravascular coagulation, Haemoglobin decreased, Hepatomegaly
Clinical narrative: Mother reported that soon after the administration of the immunizations infant began to have fever, increased respiratory rate and some abdominal distention.  Mom started to give Tylenol at that time.  The symptoms worsened and mom brought the infant to the emergency room on 7/18/10 for evaluation and treatment.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Platelet count decreased, Pyrexia, Respiratory rate increased, Serum ferritin increased, Splenomegaly
Clinical narrative: Mother reported that soon after the administration of the immunizations infant began to have fever, increased respiratory rate and some abdominal distention.  Mom started to give Tylenol at that time.  The symptoms worsened and mom brought the infant to the emergency room on 7/18/10 for evaluation and treatment.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Thrombocytopenia, Ultrasound abdomen abnormal, Ultrasound scan normal
Clinical narrative: Mother reported that soon after the administration of the immunizations infant began to have fever, increased respiratory rate and some abdominal distention.  Mom started to give Tylenol at that time.  The symptoms worsened and mom brought the infant to the emergency room on 7/18/10 for evaluation and treatment.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Rash generalised, Streptococcus test negative
Clinical narrative: Rash started on face, is on trunk and back, arms and legs.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pallor, Rash
Clinical narrative: Rash developed from 1/17/10 to 1/19/10 blanching discrete rash starting head working down to face.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash
Clinical narrative: Approx 10-15 minutes after administrating 2 month old vaccines PEDIARIX (Hep B, DTAP, IPV), HIB, PCV-13, ROTAVIRUS child broke out in rash on forehead, face/neck and buttocks. Rash resolved in approx 30 min. No resp. distress.
Age: 27.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse for VARIVAX (Merck), a Pregnancy Registry product concerning a 27 year old female patient who on 14-Dec-2009 was vaccinated with VARIVAX (Merck) (Lot#664664/0730Y). Concomitant vaccination on the same day includes MMR II (MSD), DTaP, RECOMBIVAX (manufacturer Unspecified) and TB test. Unspecified medical attention was sought. It was reported that the patient's LMP was in November 2009 and the estimated date of delivery (EDD) is approximately on 08-AUG-2010. On 18-DEC-2009 the patient performed a home pregnancy test and the result was positive. There was no adverse effect reported. Follow up information has been received from the licensed practical nurse who reported that on unspecified date the patient had an spontaneous abortion (<20 weeks). On 19-JAN-2010 the patient was in clinic and reported that "Spontaneous Onset of Labor never formed". The patient's private gynecologist was giving her week to miscarry or would have to Dilation and Curettage. It was unknown if the products of conceptions were examined or if the fetus was normal. It was unknown if the patient was tested for varicella antibodies before vaccination with VARIVAX (Merck). The number of previous pregnancies, birth defects or stillbirth or miscarries occur in any previous pregnancy were unknown. At the time of the report, the patient's outcome was unknown. Upon internal review spontaneous abortion was considered to be an other important medical event. No further information is expected.
Age: 1.1
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Bladder catheterisation, Pyrexia, Rash morbilliform, Urine analysis
Clinical narrative: Low grade fever, reached 102.5 on this day. Spiked to 104 following evening (7/16) and a measles-like rash started to appear.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dysphonia, Dyspnoea, Urticaria
Clinical narrative: DIFFICULTY BREATHING, HOARSENESS, HIVES
Age: 1.38
Sex: F
Vaccine: UNK
Symptoms: Crying, Erythema, Irritability, Pyrexia, Urticaria
Clinical narrative: Large, red welt between shoulder blades.  Irritable, low-grade fever, crying off and on more than normal.  Lasted for two weeks.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives and shortness of breath. MOC had been taking Insulin and Glyburide for IDDM. Pt breastfed. MOC off meds when pt was around 2 1/2 months of age.
Age: 1.02
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever followed by mild rash after taking the Chickenpox vaccination. Doctor said he has symptoms of rubella virus.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Biopsy muscle abnormal, Blood creatine phosphokinase increased, Central nervous system lesion, Disturbance in social behaviour, Eye movement disorder
Clinical narrative: Patient became progressively more irritable over 24 hours.  He then stopped interacting and had dancing eye movements.  He was brought to the local hospital and underwent a neurologic workup yielding a diagnosis of possible Leigh Disease.  He had a muscle biopsy that showed macrophagic myofasciitis that was attributed to the immunizations.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Irritability, Myofascitis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Patient became progressively more irritable over 24 hours.  He then stopped interacting and had dancing eye movements.  He was brought to the local hospital and underwent a neurologic workup yielding a diagnosis of possible Leigh Disease.  He had a muscle biopsy that showed macrophagic myofasciitis that was attributed to the immunizations.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Childhood disintegrative disorder, Emotional disorder, Hypotonia, Irritability, Posture abnormal
Clinical narrative: Patient became progressively more irritable over 24 hours.  He then stopped interacting and had dancing eye movements.  He was brought to the local hospital and underwent a neurologic workup yielding a diagnosis of possible Leigh Disease.  He had a muscle biopsy that showed macrophagic myofasciitis that was attributed to the immunizations.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Somnolence, Visual impairment
Clinical narrative: Patient became progressively more irritable over 24 hours.  He then stopped interacting and had dancing eye movements.  He was brought to the local hospital and underwent a neurologic workup yielding a diagnosis of possible Leigh Disease.  He had a muscle biopsy that showed macrophagic myofasciitis that was attributed to the immunizations.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Redness, swelling and warm to r deltoid area post 17JUL10 Anthrax injection during SRP. Tenderness of 2/10 on 10 scale. No other shot that date. Swelling today measures 6.5" and remains above the elbow and 3.5" wide. No other complaints.
Age: 12.0
Sex: M
Vaccine: FLU(H1N1), HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: H1N1 vaccine given to this person by mistake.  Vaccine was intended for his sister.  No reported adverse effects as of 7/20/10.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Crying, Disorientation
Clinical narrative: Child became disoriented, described by parent as not knowing where she was, and was hysterically crying. Event lasted about 45 minutes and resolved spontaeously. Child could not explain it afterwards.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Erythema, swelling, induration, tenderness at injection site. High fever (> 102), myalgias.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Erythema, swelling, induration, tenderness at injection site. High fever (> 102), myalgias.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Started with rash all over body on Saturday with severe itching. Saw her physician on Wed. 07/14/2010. Placed on Valtrex and Steroids.
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: Cough, Decreased appetite, Diarrhoea, Eye swelling, Hypersomnia
Clinical narrative: Patient started coughing so bad that she threw up. This happened several times. Loss of appetite. Would only eat 2-3 ounces of bottle compared to 7 oz. Eyes were red and swollen and pouring over with tears. Nose was running constantly with clear snot. Injection site was very red and swollen. Very fussy and screaming. Lethargic and sleeping much more than usual. Diarrhea. Symptoms worsened as night went on and into Sunday. Monday morning (07-19-20) woke up with croup like cough and congestion. Those symptoms lessened as day continued. Went to Doctor on 07-19-10 and doctor stated it was probably viral; however, patient had been perfectly healthy prior to vaccine, was not introduced to any new environments, not in daycare, never had a fever and symptoms were improving within only 2 days.
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Irritability, Lacrimation increased, Lethargy
Clinical narrative: Patient started coughing so bad that she threw up. This happened several times. Loss of appetite. Would only eat 2-3 ounces of bottle compared to 7 oz. Eyes were red and swollen and pouring over with tears. Nose was running constantly with clear snot. Injection site was very red and swollen. Very fussy and screaming. Lethargic and sleeping much more than usual. Diarrhea. Symptoms worsened as night went on and into Sunday. Monday morning (07-19-20) woke up with croup like cough and congestion. Those symptoms lessened as day continued. Went to Doctor on 07-19-10 and doctor stated it was probably viral; however, patient had been perfectly healthy prior to vaccine, was not introduced to any new environments, not in daycare, never had a fever and symptoms were improving within only 2 days.
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: Ocular hyperaemia, Respiratory tract congestion, Rhinorrhoea, Screaming, Viral infection
Clinical narrative: Patient started coughing so bad that she threw up. This happened several times. Loss of appetite. Would only eat 2-3 ounces of bottle compared to 7 oz. Eyes were red and swollen and pouring over with tears. Nose was running constantly with clear snot. Injection site was very red and swollen. Very fussy and screaming. Lethargic and sleeping much more than usual. Diarrhea. Symptoms worsened as night went on and into Sunday. Monday morning (07-19-20) woke up with croup like cough and congestion. Those symptoms lessened as day continued. Went to Doctor on 07-19-10 and doctor stated it was probably viral; however, patient had been perfectly healthy prior to vaccine, was not introduced to any new environments, not in daycare, never had a fever and symptoms were improving within only 2 days.
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Patient started coughing so bad that she threw up. This happened several times. Loss of appetite. Would only eat 2-3 ounces of bottle compared to 7 oz. Eyes were red and swollen and pouring over with tears. Nose was running constantly with clear snot. Injection site was very red and swollen. Very fussy and screaming. Lethargic and sleeping much more than usual. Diarrhea. Symptoms worsened as night went on and into Sunday. Monday morning (07-19-20) woke up with croup like cough and congestion. Those symptoms lessened as day continued. Went to Doctor on 07-19-10 and doctor stated it was probably viral; however, patient had been perfectly healthy prior to vaccine, was not introduced to any new environments, not in daycare, never had a fever and symptoms were improving within only 2 days.
Age: 1.83
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying, Diet refusal, Fatigue, Listless, Pyrexia
Clinical narrative: Tiredness first. High fever by noon. See previous box for rest of symptoms.
Age: 1.83
Sex: M
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: Tiredness first. High fever by noon. See previous box for rest of symptoms.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: Client became pale, dizzy, diaphoretic and vomited.  Did NOT lose consciousness.  Client given juice and crackers after event and kept for thirty minutes.  Client was escorted via W/C by RN and sent home with Mom.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Syncope, Vomiting
Clinical narrative: Client became dizzy, diaphoretic.  Client was escorted to a chair and fainted in the presence of two licensed nursing staff.  No fall or injury.  Cool compresses provided.  Water to drink, which she vomited x 1.  Reports not eating breakfast.  Refused Orange Juice or crackers. Stayed for approximately 20 minutes after event.  Recovered well.  Escorted to PMV by RN and mother.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: MOTHER REPORTS CHILD C/O HEADACHES, BODY ACHES, TEMP ELEVATION TO 102' AND NAUSEA FOR ABOUT 36 HOURS DURATION, WITH DECREASED APPETITE.  GIVEN TYLENOL AND IBUPROFEN AS NEEDED AFTER SYMPTOMS BEGAN.
Age: 21.0
Sex: F
Vaccine: FLU(H1N1), TYP
Symptoms: Dizziness, Fall, Neck pain, Skin laceration, Syncope
Clinical narrative: After receiving her first vaccinations, the patient became light-headed, fainted, fell to the floor and suffered a head laceration. She has since reported chronic neck pain.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin lesion, Varicella virus test
Clinical narrative: Presenting with multiple small, itching, non-draining, red lesions on right distal arm/fingers, and 3-4 on left distal arm, appearing at one hour before evaluation.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Bacterial test, Biopsy artery, Blood glucose decreased, Blood glucose increased, Borrelia test
Clinical narrative: Fever and chills started next day; in a few days escalated to fever, chills, and night sweats. Fever went to 102 on June 30, to ER, and sent home. Fever went to 103.5 on July 1, to ER, admitted to hospital, in hospital for 2 weeks. Fevers and chills also affected blood sugar levels from very low to high.  Follow-up: Pt has been diagnosed with Giant Cell Arteritis. The diagnosis was the result of a temporal artery biopsy performed on July 16, 2010. We are not sure whether either of the vaccines (Pneumonia or Tdap) may have triggered the GCA. Is it possible that the vaccines caused or triggered the GCA?
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Echocardiogram, Fungal test, HIV test, Hepatitis viral test
Clinical narrative: Fever and chills started next day; in a few days escalated to fever, chills, and night sweats. Fever went to 102 on June 30, to ER, and sent home. Fever went to 103.5 on July 1, to ER, admitted to hospital, in hospital for 2 weeks. Fevers and chills also affected blood sugar levels from very low to high.  Follow-up: Pt has been diagnosed with Giant Cell Arteritis. The diagnosis was the result of a temporal artery biopsy performed on July 16, 2010. We are not sure whether either of the vaccines (Pneumonia or Tdap) may have triggered the GCA. Is it possible that the vaccines caused or triggered the GCA?
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Laboratory test, Night sweats, Parasite blood test, Parasitic test, Pyrexia
Clinical narrative: Fever and chills started next day; in a few days escalated to fever, chills, and night sweats. Fever went to 102 on June 30, to ER, and sent home. Fever went to 103.5 on July 1, to ER, admitted to hospital, in hospital for 2 weeks. Fevers and chills also affected blood sugar levels from very low to high.  Follow-up: Pt has been diagnosed with Giant Cell Arteritis. The diagnosis was the result of a temporal artery biopsy performed on July 16, 2010. We are not sure whether either of the vaccines (Pneumonia or Tdap) may have triggered the GCA. Is it possible that the vaccines caused or triggered the GCA?
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Viral test, Whole body scan
Clinical narrative: Fever and chills started next day; in a few days escalated to fever, chills, and night sweats. Fever went to 102 on June 30, to ER, and sent home. Fever went to 103.5 on July 1, to ER, admitted to hospital, in hospital for 2 weeks. Fevers and chills also affected blood sugar levels from very low to high.  Follow-up: Pt has been diagnosed with Giant Cell Arteritis. The diagnosis was the result of a temporal artery biopsy performed on July 16, 2010. We are not sure whether either of the vaccines (Pneumonia or Tdap) may have triggered the GCA. Is it possible that the vaccines caused or triggered the GCA?
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Hyperaesthesia
Clinical narrative: Patient unclear if this is related to vaccine.  A few weeks following vaccine she began to get left abdominal wall/skin sensitivity and pain.  No rash.  Did not report until 7/20/2010 so unfortunately could not treat until then.  Treated with acyclovir 800 one tablet 5 times a day.
Age: 3.0
Sex: U
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) thigh 5cm x 5cm redness and swollen. Mom apply ice and gave ibuprofen. Notice today (7/20/10) felt warm.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Time 11:40 a.m. 7-17-10 while giving pt vaccines she was ok until I pulled out syringe - TDAP vaccine out of (R) arm - pt started to fall foward - fainted, I caught pt with help from Mother, checked pt's BS and it was 61 - pt remained conscious and alert gave pt juice and water, checked BS at 11:55 a.m. - 91 - pt was ok - no dizziness.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Haematuria, Occult blood, Protein urine, Red blood cell count increased, Urine analysis normal
Clinical narrative: Hematuria 12 hours after receiving GARDASIL dose #2 on 7/19/2010 urinalysis prior to vaccine (7/19-no RBC no WBC) urinalysis 7/20 10-12 RBC/HPF and 20-25 WBC/HPF.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urine ketone body, White blood cell count decreased
Clinical narrative: Hematuria 12 hours after receiving GARDASIL dose #2 on 7/19/2010 urinalysis prior to vaccine (7/19-no RBC no WBC) urinalysis 7/20 10-12 RBC/HPF and 20-25 WBC/HPF.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Oedema, Rash papular, Rash vesicular
Clinical narrative: 24 hr after vaccination-local reaction with erythema, edema, tender. 3 days after vaccination-papular and vesicular eruption of submental, neck, chest region.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: 24 hr after vaccination-local reaction with erythema, edema, tender. 3 days after vaccination-papular and vesicular eruption of submental, neck, chest region.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash papular
Clinical narrative: Rash on torso. Blister or papules on foot OTC treatment & refer to primary care  Dr.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Growth retardation, Injection site erythema, Injection site warmth
Clinical narrative: Warmth & redness to injection site 5 1/2cm x 4cm.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Within 2-3 minutes after receiving imm, infant developed hives at the sites where PEDIARIX and PREVNAR. Rt thigh - L- thigh - red and swollen, infant had intense cry, high pitched - given BENADRYL P.O. - symptoms resolved 30 min.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, induration tenderness at the site of injection, lasting 3 days.
Age: 1.59
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema and tenderness of (L) upper arm 24 hrs after receiving DTaP and HIB vaccines.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: HPV4
Symptoms: Asphyxia, Autopsy, Death, Drug exposure via breast milk
Clinical narrative: Information has been received from a physician concerning a 6-8 week old patient whose 25 year old mother on 29-JUL-2009 (conflicting information, also reported as two days post-partum) was vaccinated with her first 0.5 mL dose of GARDASIL (lot# 660391/0063X) in her left deltoid, (it was noted that she was not pregnant when she received the first dose). The patient was breastfeeding. On 31-JUL-2008 the patient's mother was breastfeeding her infant and she fell asleep. Subsequently, the infant died from suffocation and was found in the morning. It was ruled as a smothering injury: "overlay compression asphyxia, mother laid over child". The reporting physician felt that the patient's death was not related to vaccination with GARDASIL. A standard lot check investigation was performed. All in-process quality checks for the lot # 660391/0063X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The mother's experience has been captured in WAES# 0809USA04046. Additional information has been requested. This report was previously sent to the FDA on 30-SEP-2008 (WAES# 0809USA04046) and was previously split to create a baby report.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Intussusception, Lethargy, Vomiting
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Intussusception, Surgery, Ultrasound scan, Vaccine breakthrough infection
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Blood amylase increased, Blood creatinine decreased, Blood urea normal, Carbon dioxide normal
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Cholecystectomy, Cholelithiasis, Computerised tomogram abnormal, Cough, Diarrhoea
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Endoscopic retrograde cholangiopancreatography abnormal, Enema administration, Faecal volume decreased, Flatulence, Gastrointestinal haemorrhage
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Hypophagia, Infantile spitting up, Intussusception, Irritability, Laparoscopic surgery
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Lethargy, Lymphadenopathy, Lymphocyte percentage decreased, Magnetic resonance cholangiopancreatography, Neutrophil percentage increased
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Opisthotonus, Pallor, Pancreatitis, Pancreatitis acute, Post procedural haemorrhage
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: White blood cell count normal, X-ray abnormal
Clinical narrative: 4 month old diagnosed with intussusception - ileocolic, treated surgically. Rotavirus immunization given 1 week prior.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Angiogram, Cerebrovascular accident, Echocardiogram, Hemiparesis, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received from a health care professional on 13 July 2010. A 37-year-old female patient, with a medical history of migraine headaches and seasonal allergies, received on 28 April 2010 at 11:00 AM an intramuscular (IM) injection (dose 1) to the left deltoid of ADACEL, lot number C3247AA, and on 26 April 2010 received a intradermal (ID) test (dose 2) of Tubersol 5 TU, lot number C3062AA. On 29 April 2010 at 8:30 AM, the patient developed life threatening right middle cerebral artery stroke and left hemiparesis and was seen in the emergency room. The patient was admitted to the hospital (date not provided) where she had a magnetic resonance imaging (MRI), angiogram and a transesophageal echocardiogram performed (results of testing not provided). The patient was treated with acetylsalicylic acid (ASA) and supportive care. The right middle cerebral artery stroke and left hemiparesis resulted in permanent disability. The outcome for the events was reported as recovering. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Angiogram, Cerebrovascular accident, Disability, Echocardiogram, Hemiparesis
Clinical narrative: Initial report received from a health care professional on 13 July 2010. A 37-year-old female patient, with a medical history of migraine headaches and seasonal allergies, received on 28 April 2010 at 11:00 AM an intramuscular (IM) injection (dose 1) to the left deltoid of ADACEL, lot number C3247AA, and on 26 April 2010 received a intradermal (ID) test (dose 2) of Tubersol 5 TU, lot number C3062AA. On 29 April 2010 at 8:30 AM, the patient developed life threatening right middle cerebral artery stroke and left hemiparesis and was seen in the emergency room. The patient was admitted to the hospital (date not provided) where she had a magnetic resonance imaging (MRI), angiogram and a transesophageal echocardiogram performed (results of testing not provided). The patient was treated with acetylsalicylic acid (ASA) and supportive care. The right middle cerebral artery stroke and left hemiparesis resulted in permanent disability. The outcome for the events was reported as recovering. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Initial report received from a health care professional on 13 July 2010. A 37-year-old female patient, with a medical history of migraine headaches and seasonal allergies, received on 28 April 2010 at 11:00 AM an intramuscular (IM) injection (dose 1) to the left deltoid of ADACEL, lot number C3247AA, and on 26 April 2010 received a intradermal (ID) test (dose 2) of Tubersol 5 TU, lot number C3062AA. On 29 April 2010 at 8:30 AM, the patient developed life threatening right middle cerebral artery stroke and left hemiparesis and was seen in the emergency room. The patient was admitted to the hospital (date not provided) where she had a magnetic resonance imaging (MRI), angiogram and a transesophageal echocardiogram performed (results of testing not provided). The patient was treated with acetylsalicylic acid (ASA) and supportive care. The right middle cerebral artery stroke and left hemiparesis resulted in permanent disability. The outcome for the events was reported as recovering. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Abdominal pain, Arthralgia, Cerebellar syndrome, Chills, Computerised tomogram head
Clinical narrative: Initial report was received 09 July 2010 from a health care professional. A 29-year-old female patient who had been attacked by a kitten "out of nowhere" on an unspecified date, had received Imogam Rabies-HT, and a first dose injection of IMOVAX Rabies vaccine (lot numbers, dosage, routes, sites and dates of administration not reported) and an unspecified amount of time later, she developed mild aches, pain, chills, shaking, abdominal cramping, nausea, a headache and weakness. She was seen in the emergency room (ER) three times for the symptoms which progressed. The third visit to the ER occurred on 08 July 2010 at which time she was admitted with symptoms of left sided weakness and she "could hardly walk". The patient had no concurrent illness and no pre-existing medical conditions at the time of vaccination. At the time of report, the patient had not recovered, but was improving. No further information was provided. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Computerised tomogram normal, Facial paresis, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: Initial report was received 09 July 2010 from a health care professional. A 29-year-old female patient who had been attacked by a kitten "out of nowhere" on an unspecified date, had received Imogam Rabies-HT, and a first dose injection of IMOVAX Rabies vaccine (lot numbers, dosage, routes, sites and dates of administration not reported) and an unspecified amount of time later, she developed mild aches, pain, chills, shaking, abdominal cramping, nausea, a headache and weakness. She was seen in the emergency room (ER) three times for the symptoms which progressed. The third visit to the ER occurred on 08 July 2010 at which time she was admitted with symptoms of left sided weakness and she "could hardly walk". The patient had no concurrent illness and no pre-existing medical conditions at the time of vaccination. At the time of report, the patient had not recovered, but was improving. No further information was provided. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Injection site pain, Laboratory test normal, Myalgia, Neurological examination abnormal, Paraesthesia
Clinical narrative: Initial report was received 09 July 2010 from a health care professional. A 29-year-old female patient who had been attacked by a kitten "out of nowhere" on an unspecified date, had received Imogam Rabies-HT, and a first dose injection of IMOVAX Rabies vaccine (lot numbers, dosage, routes, sites and dates of administration not reported) and an unspecified amount of time later, she developed mild aches, pain, chills, shaking, abdominal cramping, nausea, a headache and weakness. She was seen in the emergency room (ER) three times for the symptoms which progressed. The third visit to the ER occurred on 08 July 2010 at which time she was admitted with symptoms of left sided weakness and she "could hardly walk". The patient had no concurrent illness and no pre-existing medical conditions at the time of vaccination. At the time of report, the patient had not recovered, but was improving. No further information was provided. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Urinary incontinence
Clinical narrative: Initial report was received 09 July 2010 from a health care professional. A 29-year-old female patient who had been attacked by a kitten "out of nowhere" on an unspecified date, had received Imogam Rabies-HT, and a first dose injection of IMOVAX Rabies vaccine (lot numbers, dosage, routes, sites and dates of administration not reported) and an unspecified amount of time later, she developed mild aches, pain, chills, shaking, abdominal cramping, nausea, a headache and weakness. She was seen in the emergency room (ER) three times for the symptoms which progressed. The third visit to the ER occurred on 08 July 2010 at which time she was admitted with symptoms of left sided weakness and she "could hardly walk". The patient had no concurrent illness and no pre-existing medical conditions at the time of vaccination. At the time of report, the patient had not recovered, but was improving. No further information was provided. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Abdominal pain, Asthenia, Chills, Gait disturbance, Headache
Clinical narrative: Initial report was received 09 July 2010 from a health care professional. A 29-year-old female patient who had been attacked by a kitten "out of nowhere" on an unspecified date, had received Imogam Rabies-HT, and a first dose injection of IMOVAX Rabies vaccine (lot numbers, dosage, routes, sites and dates of administration not reported) and an unspecified amount of time later, she developed mild aches, pain, chills, shaking, abdominal cramping, nausea, a headache and weakness. She was seen in the emergency room (ER) three times for the symptoms which progressed. The third visit to the ER occurred on 08 July 2010 at which time she was admitted with symptoms of left sided weakness and she "could hardly walk". The patient had no concurrent illness and no pre-existing medical conditions at the time of vaccination. At the time of report, the patient had not recovered, but was improving. No further information was provided. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Hemiparesis, Nausea, Pain, Tremor
Clinical narrative: Initial report was received 09 July 2010 from a health care professional. A 29-year-old female patient who had been attacked by a kitten "out of nowhere" on an unspecified date, had received Imogam Rabies-HT, and a first dose injection of IMOVAX Rabies vaccine (lot numbers, dosage, routes, sites and dates of administration not reported) and an unspecified amount of time later, she developed mild aches, pain, chills, shaking, abdominal cramping, nausea, a headache and weakness. She was seen in the emergency room (ER) three times for the symptoms which progressed. The third visit to the ER occurred on 08 July 2010 at which time she was admitted with symptoms of left sided weakness and she "could hardly walk". The patient had no concurrent illness and no pre-existing medical conditions at the time of vaccination. At the time of report, the patient had not recovered, but was improving. No further information was provided. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Abdominal pain, Headache, Muscle tightness
Clinical narrative: Initial report was received 09 July 2010 from a health care professional. A 29-year-old female patient who had been attacked by a kitten "out of nowhere" on an unspecified date, had received Imogam Rabies-HT, and a first dose injection of IMOVAX Rabies vaccine (lot numbers, dosage, routes, sites and dates of administration not reported) and an unspecified amount of time later, she developed mild aches, pain, chills, shaking, abdominal cramping, nausea, a headache and weakness. She was seen in the emergency room (ER) three times for the symptoms which progressed. The third visit to the ER occurred on 08 July 2010 at which time she was admitted with symptoms of left sided weakness and she "could hardly walk". The patient had no concurrent illness and no pre-existing medical conditions at the time of vaccination. At the time of report, the patient had not recovered, but was improving. No further information was provided. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC, HIBV, PNC13
Symptoms: Convulsion, Full blood count normal, Metabolic function test, Pallor, Urine analysis normal
Clinical narrative: HIB was given first in (R) thigh IM, pt. cried, mom present, then PREVNAR was given in LL thigh, IM, patient still crying, when mom picked him up he looked pasty, pale. RN stayed with mom and pt. until calm and color was coming back in face before they left. After leaving pat had a seizure and was taken to ER was checked over and released. Two generalized seizures same day.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC, HIBV, PNC13
Symptoms: Blood test normal, Convulsion, Crying, Pallor
Clinical narrative: HIB was given first in (R) thigh IM, pt. cried, mom present, then PREVNAR was given in LL thigh, IM, patient still crying, when mom picked him up he looked pasty, pale. RN stayed with mom and pt. until calm and color was coming back in face before they left. After leaving pat had a seizure and was taken to ER was checked over and released. Two generalized seizures same day.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid with induration.