Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin mass, Systemic inflammatory response syndrome, Wound drainage
Clinical narrative: shoulder pain; Mild skin rash; paranoia; anxiety; Subcutaneous nodules likely lipoma; SIRS (with transient tachypnoea, tachycardia); Lactic acidosis; cellulitis; Hearing is messed up; huge knots on her face/fore head had big knots/ arms/knots that go and come/ had knots in feet and lower legs; fingers were numb; erythematous area that is tender on left forearm/ She was red; throat got sore; side effects were worse and she has been breaking out ever since; from her spine to her back; When it burst it had a clear drainage; cramping up; almost loosing her eyes because her eyes and ears were irritated; Pain in her left arm/ legs sore; conjunctivitis; Black stool; back / Flank pain; bladder pain; Feeling hot; pruritic; mild headache; felt like body was on fire; feeling tired when working; Nausea; hallucinations; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations), ARTHRALGIA (shoulder pain), RASH (Mild skin rash), PARANOIA (paranoia), ANXIETY (anxiety), LIPOMA (Subcutaneous nodules likely lipoma), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS (with transient tachypnoea, tachycardia)), LACTIC ACIDOSIS (Lactic acidosis) and CELLULITIS (cellulitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypertension, Prediabetes since 04-May-2015, Back pain, Joint pain, Drug allergy (Ibuprofen, reaction- Swells up), Penicillin allergy (reaction- Nausea, vomiting), Drug allergy (Codeine), Sulfonamide allergy and Allergy to antibiotic (Tetracycline).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant), ARTHRALGIA (shoulder pain) (seriousness criterion hospitalization), RASH (Mild skin rash) (seriousness criterion hospitalization), PARANOIA (paranoia) (seriousness criterion hospitalization), ANXIETY (anxiety) (seriousness criterion hospitalization), LIPOMA (Subcutaneous nodules likely lipoma) (seriousness criteria hospitalization and medically significant), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS (with transient tachypnoea, tachycardia)) (seriousness criteria hospitalization and medically significant), LACTIC ACIDOSIS (Lactic acidosis) (seriousness criteria hospitalization and medically significant), CELLULITIS (cellulitis) (seriousness criterion medically significant), HYPOACUSIS (Hearing is messed up), SKIN MASS (huge knots on her face/fore head had big knots/ arms/knots that go and come/ had knots in feet and lower legs), HYPOAESTHESIA (fingers were numb), ERYTHEMA (erythematous area that is tender on left forearm/ She was red), OROPHARYNGEAL PAIN (throat got sore), CONDITION AGGRAVATED (side effects were worse and she has been breaking out ever since; from her spine to her back), WOUND DRAINAGE (When it burst it had a clear drainage), MUSCLE SPASMS (cramping up), EYE IRRITATION (almost loosing her eyes because her eyes and ears were irritated), PAIN IN EXTREMITY (Pain in her left arm/ legs sore), CONJUNCTIVITIS (conjunctivitis), FAECES DISCOLOURED (Black stool), FLANK PAIN (back / Flank pain), BLADDER PAIN (bladder pain), FEELING HOT (Feeling hot), RASH PRURITIC (pruritic), HEADACHE (mild headache), PYREXIA (felt like body was on fire), FATIGUE (feeling tired when working) and NAUSEA (Nausea). The patient was hospitalized from 24-Jul-2021 to 25-Jul-2021 due to ANXIETY, ARTHRALGIA, LACTIC ACIDOSIS, LIPOMA, PARANOIA, RASH and SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; CEPHALEXIN [CEFALEXIN] ongoing since an unknown date at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinations), ARTHRALGIA (shoulder pain), RASH (Mild skin rash), PARANOIA (paranoia), ANXIETY (anxiety), LIPOMA (Subcutaneous nodules likely lipoma), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS (with transient tachypnoea, tachycardia)), LACTIC ACIDOSIS (Lactic acidosis), CELLULITIS (cellulitis), HYPOACUSIS (Hearing is messed up), HYPOAESTHESIA (fingers were numb), ERYTHEMA (erythematous area that is tender on left forearm/ She was red), OROPHARYNGEAL PAIN (throat got sore), CONDITION AGGRAVATED (side effects were worse and she has been breaking out ever since; from her spine to her back), WOUND DRAINAGE (When it burst it had a clear drainage), MUSCLE SPASMS (cramping up), EYE IRRITATION (almost loosing her eyes because her eyes and ears were irritated), CONJUNCTIVITIS (conjunctivitis), FAECES DISCOLOURED (Black stool), FLANK PAIN (back / Flank pain), BLADDER PAIN (bladder pain), FEELING HOT (Feeling hot), DIARRHOEA (Diarrhea), RASH PRURITIC (pruritic), HEADACHE (mild headache), PYREXIA (felt like body was on fire) and NAUSEA (Nausea) outcome was unknown and SKIN MASS (huge knots on her face/fore head had big knots/ arms/knots that go and come/ had knots in feet and lower legs), PAIN IN EXTREMITY (Pain in her left arm/ legs sore) and FATIGUE (feeling tired when working) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that she felt like she was going to have a stroke. Patient heard male voices after vaccine and took Benadryl. Patient had mild skin rash which irritated after rubbing with alcohol.  Company Comment: This case concerns a 72-year-old, female patient with a history of diabetes/pre-diabetes and allergy to multiple drugs (including penicillin) and concomitant treatment with cephalexin, who experienced the unexpected serious (due to important medical event) events of Hallucination and cellulitis, and the unexpected serious events (due to hospitalization) of Arthralgia, Rash, Paranoia, Anxiety, Lipoma, Systemic inflammatory response syndrome and Lactic acidosis. The events occurred at an unknown day after the second dose of mRNA-1273 vaccine. Hospitalization (due to mentioned events) occurred approximately 3 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available The medical history of diabetes/pre-diabetes, allergy to multiple drugs (including penicillin) and concomitant treatment with cephalexin remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-260322 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received contains additional medical history, events, patient demographics and updated narrative.; Sender's Comments: This case concerns a 72-year-old, female patient with a history of diabetes/pre-diabetes and allergy to multiple drugs (including penicillin) and concomitant treatment with cephalexin, who experienced the unexpected serious (due to important medical event) events of Hallucination and cellulitis, and the unexpected serious events (due to hospitalization) of Arthralgia, Rash, Paranoia, Anxiety, Lipoma, Systemic inflammatory response syndrome and Lactic acidosis. The events occurred at an unknown day after the second dose of mRNA-1273 vaccine. Hospitalization (due to mentioned events) occurred approximately 3 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available The medical history of diabetes/pre-diabetes, allergy to multiple drugs (including penicillin) and concomitant treatment with cephalexin remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.