Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| 6VAX-F | DTAP+IPV+HEPB+HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
juvenile dermatomyositis (JDM); swelling of the limbs; mild erythematous macular rash over her cheeks, nose, and arms; difficulty walking; mild cough; rhinorrhea; febrile; tachycardic; diffuse symmetrical, nonpitting edema of the lower extremities; periungual erythema; weakness when attempting to lift her arms and legs; hypoalbuminemia; myositis; soft tissue swelling; malar rash; faint Gottron's papules; Anasarca; nonspecific erythematous maculopapular rash in the malar distribution and over the distal upper extremities; Initial information received on 23-MAR-2026 via other healthcare professional regarding an unsolicited valid serious case issued from a literature article: This case involves 2 years old female patient who experienced juvenile dermatomyositis (JDM) (Dermatomyositis) after receiving diphtheria, tetanus, ac pertussis, hep b, IPV and HIB vaccine, influenza vaccine and pneumococcal vaccine (Latency: Unknown) The patient past medical treatment(s), vaccination(s) and family history not provided. A previously healthy 2-year-old girl, born at 39 weeks gestation, presents to her local hospital because of swelling of the limbs (Peripheral swelling) and 4.5-kg weight gain over 1 week. Edema appeared the day after receiving immunizations, which included diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type B, pneumococcal conjugate, and influenza vaccines (Dose, route, formulation, frequency: Unknown). The patient was previously unimmunized. The swelling was initially attributed to a vaccine reaction; however, as symptoms progressed, the differential became broader. One week after the onset of edema, she developed a mild erythematous macular rash (Rash erythematous) over her cheeks, nose, and arms. She had difficulty walking (Gait disturbance) and trouble lifting her arms. She also developed a mild cough (Cough) and rhinorrhea. She was febrile (pyrexia) to 38 degree Celsius and tachycardic (tachycardia) to 159 bpm with otherwise normal vital signs. Her physical exam was significant for diffuse symmetrical, nonpitting edema of the lower extremities (Non-pitting oedema) with a nonspecific erythematous maculopapular rash in the malar distribution and over the distal upper extremities (Rash maculo-papular). Laboratory studies are significant for hypoalbuminemia (Hypoalbuminaemia) at 2.6 g/dL and elevated liver enzymes with aspartate aminotransferase 251 and alanine aminotransferase 135 U/L. The patient has a positive Mono-spot test, but Epstein-Barr virus antibody panel was negative. N-terminal prohormone of brain natriuretic peptide was mildly elevated to 357 pg/mL, and an echocardiogram was normal. Because of concern for possible nephrotic syndrome, renal ultrasonography was obtained and demonstrates mild right hydronephrosis. The patient was transferred to a tertiary care facility for further evaluation. Urinalysis was positive for nitrites and bacteria but negative for leukocyte esterase. Because of these abnormalities, urine culture was collected and grows more than 100 000 colonies of Escherichia coli. There was no significant proteinuria, ruling out nephrotic syndrome. A respiratory pathogen panel was positive for respiratory syncytial virus (RSV) and rhinovirus enterovirus. The urinary tract infection was treated with cefazolin followed by cephalexin. The patient was given a dose of intravenous albumin and furosemide, leading to an improvement in edema, and was discharged. Following discharge, edema reoccurs within a week. The swelling spreads to the face, abdomen, and lower extremities. She was reluctant to bear weight and has difficulty ambulating. The physical exam again reveals generalized nonpitting edema and an erythematous maculopapular rash over the cheeks, nose, upper arms, and legs. She has blotchy erythema over her metacarpophalangeal (MCP) and proximal interphalangeal joints and has periungual erythema (Erythema) (Figure 1). The patient has significant weakness when attempting to lift her arms and legs (Muscular weakness). She cries and falls back on the bed when attempting to sit up. Labs again reveal hypoalbuminemia and elevated liver enzymes without proteinuria. C-reactive protein was within normal limits. Creatine kinase (CK) was elevated to 1170 U/L. Antinuclear antibody (ANA) was positive with titer 1:320 and speckled. Myositis-specific antibody (MSA) panel was negative. Magnetic resonance imaging (MRI) of the pelvis and lower extremities reveals significant myositis and soft tissue swelling (Figure 2). Physical exam, laboratory studies, and imaging suggest the diagnosis. Diagnosis: The presence of a malar rash (Butterfly rash), faint Gottron's papules (Gottron's papules), periungual erythema, muscle weakness with elevated muscle enzymes, and an MRI demonstrating diffuse myositis are consistent with a diagnosis of juvenile dermatomyositis (JDM). Patient course: The patient received intravenous pulse dose steroids followed by oral steroids, which are being slowly tapered. She also started methotrexate. She showed significant improvement in edema and rash. However, she continued to have significant weakness, so IVIG (Intravenous immunoglobulin) was added every 4 weeks. She also attended physical therapy. She has now gained back full strength and has no functional limitation. Her muscle enzyme levels have normalized, and her liver enzyme levels quickly reduced after initiation of treatment but did not fully normalize until after 7 months of treatment. Anasarca (Generalised oedema) was a rare manifestation of JDM Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Seriousness criteria: Medically significant and hospitalization Action taken: Not applicable for all suspect vaccines Corrective treatment: pulse dose steroids followed by oral steroids, methotrexate and IVIG Outcome: Recovering/Resolving Reporter s causality: Related
Test Name: weight; Test Result: 4.5 kg; Test Name: Body temperature; Result Unstructured Data: Result: 38, Unit: Cel; Test Name: heart rate; Result Unstructured Data: Result: 159, Unit: {beats}/min; Test Name: vital signs; Result Unstructured Data: normal; Test Name: physical exam; Result Unstructured Data: significant for diffuse symmetrical, nonpitting edema of the lower extremities with a nonspecific erythematous maculopapular rash in the malar distribution and over the distal upper extremities.; Test Name: Albumin; Result Unstructured Data: Result: 2.6, Unit: g/dL hypoalbuminemia; Test Name: aspartate aminotransferase; Result Unstructured Data: Result: 251, Unit: U/L; Test Name: alanine aminotransferase; Result Unstructured Data: Result: 135, Unit: U/L; Test Name: Monospot test; Test Result: Negative ; Test Name: Epstein-Barr virus antibody panel; Test Result: Negative ; Test Name: N-terminal prohormone of brain natriuretic peptide; Result Unstructured Data: Result: 357, Unit: pg/mL mildly elevated; Test Name: echocardiogram; Result Unstructured Data: normal; Test Name: renal ultrasonography; Result Unstructured Data: demonstrates mild right hydronephrosis; Test Name: nitrites; Test Result: Positive ; Test Name: bacteria; Test Result: Positive ; Test Name: urine culture; Result Unstructured Data: grows more than 100 000 colonies of Escherichia coli; Test Name: respiratory pathogen panel; Result Unstructured Data: for respiratory syncytial virus (RSV) and rhinovirus enterovirus; Test Name: physical exam; Result Unstructured Data: reveals generalized nonpitting edema and an erythematous maculopapular rash over the cheeks, nose, upper arms, and legs.; Test Name: C-reactive protein; Result Unstructured Data: within normal limits; Test Name: Creatine kinase (CK); Result Unstructured Data: Result: 1170, Unit: U/L elevated; Test Name: Antinuclear antibody (ANA); Result Unstructured Data: with titer 1:320 and speckled; Test Name: Myositis-specific antibody (MSA) panel; Test Result: Negative ; Test Name: Magnetic resonance imaging (MRI) of the pelvis and lower extremities; Result Unstructured Data: reveals significant myositis and soft tissue swelling