Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: don't remember a thing; Interchange of vaccine products; Revaccination with different Covid 19 vaccine; couldn't stand up; sore neck; couldn't lift her head up; Severe nausea; vomiting; chills; enormous fatigue; high fever of 102 degree; passed out/black out / instant black out for a long time; fainting; dry heaving; very sick; Cold / Body Cold; arm was not working; Body cold and Clammy; unable to move her body/could not move; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out/black out / instant black out for a long time) and SYNCOPE (fainting) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m21a and 051f21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Near death experience (she really was dying in 2016 and had to be hospitalized for a month) in 2016. Previously administered products included for Product used for unknown indication: Flu shot (she really was dying in 2016 and had to be hospitalized for a month) in 2015 and J and J (1st dose batch number- 1805025 and with J and J vaccine patient experienced no reaction.) on 13-Mar-2021. Past adverse reactions to the above products included Lyme disease with Flu shot; and No adverse event with J and J. Concurrent medical conditions included Antiphospholipid syndrome (serious heart autoimmune disorder or a blood autoimmune disorder and Complex) in 2016, Asthma, Allergy to molds, Pollen allergy, Autoimmune disorder (serious heart autoimmune disorder or a blood autoimmune disorder.) in 2016 and Walker user (had to use back in 2016 when she first came down with autoimmune issues) in 2016.   On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced LOSS OF CONSCIOUSNESS (passed out/black out / instant black out for a long time) (seriousness criterion medically significant), SYNCOPE (fainting) (seriousness criterion medically significant), RETCHING (dry heaving), ILLNESS (very sick), FEELING COLD (Cold / Body Cold), LIMB DISCOMFORT (arm was not working), COLD SWEAT (Body cold and Clammy), MOBILITY DECREASED (unable to move her body/could not move), DYSSTASIA (couldn't stand up), NECK PAIN (sore neck), HEAD DISCOMFORT (couldn't lift her head up), NAUSEA (Severe nausea), VOMITING (vomiting), CHILLS (chills), FATIGUE (enormous fatigue) and PYREXIA (high fever of 102 degree). On an unknown date, the patient experienced AMNESIA (don't remember a thing), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different Covid 19 vaccine). At the time of the report, LOSS OF CONSCIOUSNESS (passed out/black out / instant black out for a long time), SYNCOPE (fainting), RETCHING (dry heaving), ILLNESS (very sick), FEELING COLD (Cold / Body Cold), LIMB DISCOMFORT (arm was not working), COLD SWEAT (Body cold and Clammy), MOBILITY DECREASED (unable to move her body/could not move), DYSSTASIA (couldn't stand up), HEAD DISCOMFORT (couldn't lift her head up), NAUSEA (Severe nausea), VOMITING (vomiting), CHILLS (chills), FATIGUE (enormous fatigue) and PYREXIA (high fever of 102 degree) had resolved, AMNESIA (don't remember a thing), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different Covid 19 vaccine) outcome was unknown and NECK PAIN (sore neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree Celsius.         Patient did not had COVID positive test or diagnosis and never had symptoms for COVID.Concomitant medications were not reported.  Patient finally got over that and got normal. Patient though the reaction was severe, though she cheated death. The event in May was probably connected to auto immune issues. About blackout in May patient did not remember things. The last thing patient remember in May was Kneeling on the floor over toilet vomiting. Dry heaving. The patient realized did not had food poisoning in May. Patient had a sore neck. For months and months and months and still actually had it. No treatment information was provided.   This case was linked to MOD-2022-674780, MOD-2022-674732 (Patient Link).   Company comment: This spontaneous case reported by a patient refers to a 74 year old female patient with relevant medical history of Antiphospholipid syndrome , initially vaccinated with Covid 19 vaccine Johnson and Johnson as initial Covid 19 vaccine ( with no reported adverse events )  and a mRNA-1273 vaccine at 1st booster dose . This patient experienced Serious ( Medically significant ) , unexpected events of loss of consciousness and Serious ( Medically significant ) Syncope.  This was accompanied by other non-serious events of nausea , vomiting , retching, chills, fatigue , pyrexia , Illness ,feeling cold ( cold)  , limb discomfort , head discomfort , cold sweat , mobility decreased , dysstasia, amnesia ( transient amnesia )  ,   and neck pain. The events occurred May 2022 around 20 hours post vaccination with the 2nd booster of mRNA-1273 vaccine. This patient reported that after the 2nd Moderna booster dose she experienced a worse reaction 20hrs after the shoot: severe nausea, vomiting, dry heaving, chills, enormous fatigue, high fever of 102°, very sick, passed out, cold, black out, fainting, instant black out for a long time, could not move, body cold and clammy, arm was not working, unable to move her body, couldn't lift her head up, couldn't stand up.  A non-serious  event of Interchange of Vaccine Products and Covid 19 Immunization ( Revaccination with a different Covid 19 vaccine also occurred. Patient reported she also had reactions with her previous vaccination in March also with mRNA-1273 vaccine. The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the events was all resolved except for the event neck pain and events memory loss and interchange of vaccine products and Covid 19 Immunization ( revaccination with different Covid 19 vaccine , outcome was unknown.  The medical history of Antiphospholipid syndrome may be considered as a confounder for the events. Reporter  reported that all of the  events were related to the product.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Additional follow-up received, added product quality complaint number.; Sender's Comments: This spontaneous case reported by a patient refers to a 74 year old female patient with relevant medical history of Antiphospholipid syndrome , initially vaccinated with Covid 19 vaccine Johnson and Johnson as initial Covid 19 vaccine ( with no reported adverse events )  and a mRNA-1273 vaccine at 1st booster dose . This patient experienced Serious ( Medically significant ) , unexpected events of loss of consciousness and Serious ( Medically significant ) Syncope.  This was accompanied by other non-serious events of nausea , vomiting , retching, chills, fatigue , pyrexia , Illness ,feeling cold ( cold)  , limb discomfort , head discomfort , cold sweat , mobility decreased , dysstasia, amnesia ( transient amnesia )  ,   and neck pain. The events occurred May 2022 around 20 hours post vaccination with the 2nd booster of mRNA-1273 vaccine. This patient reported that after the 2nd Moderna booster dose she experienced a worse reaction 20hrs after the shoot: severe nausea, vomiting, dry heaving, chills, enormous fatigue, high fever of 102°, very sick, passed out, cold, black out, fainting, instant black out for a long time, could not move, body cold and clammy, arm was not working, unable to move her body, couldn't lift her head up, couldn't stand up.  A non-serious  event of Interchange of Vaccine Products and Covid 19 Immunization ( Revaccination with a different Covid 19 vaccine also occurred. Patient reported she also had reactions with her previous vaccination in March also with mRNA-1273 vaccine. The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the events was all resolved except for the event neck pain and events memory loss and interchange of vaccine products and Covid 19 Immunization ( revaccination with different Covid 19 vaccine , outcome was unknown.  The medical history of Antiphospholipid syndrome may be considered as a confounder for the events. Reporter  reported that all of the  events were related to the product.  The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.