Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paresis, Sinusitis, Vaccination site pain, Vertigo, Vomiting
Clinical narrative: was almost paralyzed from the waist down for 6 hours; horrible gastritis; actually could not walk when I did get up the fourth day; I couldn't pick up my head off the pillow, I had a continuos terrible headache; I couldn't get out of bed from extreme exhaustion; vertigo; Vomiting; sinusitis; loss appetite; bone ache; diarrhea explosive; pain at injection site right arm; chills; hypotensive; off-balance; This spontaneous case was reported by a consumer and describes the occurrence of PARESIS (was almost paralyzed from the waist down for 6 hours), SINUSITIS (sinusitis), DECREASED APPETITE (loss appetite), BONE PAIN (bone ache) and DIARRHOEA (diarrhea explosive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00RB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (At that time patient suffered from exhaustion, headache, loss of smell, bone ache and chills.) on 19-Apr-2020. Concurrent medical conditions included Type 1 diabetes mellitus, Bipolar disorder and Thyroid disorder. Concomitant products included METFORMIN, LAMOTRIGINE, LITHIUM and CLONAZEPAM for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BONE PAIN (bone ache), DIARRHOEA (diarrhea explosive), HYPOTENSION (hypotensive), BALANCE DISORDER (off-balance), VACCINATION SITE PAIN (pain at injection site right arm) and CHILLS (chills). On 09-Apr-2021, the patient experienced DECREASED APPETITE (loss appetite). On 10-Apr-2021, the patient experienced SINUSITIS (sinusitis), VERTIGO (vertigo) and VOMITING (Vomiting). On an unknown date, the patient experienced PARESIS (was almost paralyzed from the waist down for 6 hours), GASTRITIS (horrible gastritis), GAIT INABILITY (actually could not walk when I did get up the fourth day), HEADACHE (I couldn't pick up my head off the pillow, I had a continuos terrible headache) and FATIGUE (I couldn't get out of bed from extreme exhaustion). The patient was treated with AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. On 23-Mar-2021, BONE PAIN (bone ache), DIARRHOEA (diarrhea explosive), HYPOTENSION (hypotensive) and BALANCE DISORDER (off-balance) had resolved. On 15-Apr-2021, SINUSITIS (sinusitis), VERTIGO (vertigo) and VOMITING (Vomiting) had resolved. At the time of the report, PARESIS (was almost paralyzed from the waist down for 6 hours), GASTRITIS (horrible gastritis), GAIT INABILITY (actually could not walk when I did get up the fourth day), HEADACHE (I couldn't pick up my head off the pillow, I had a continuos terrible headache) and FATIGUE (I couldn't get out of bed from extreme exhaustion) had resolved and DECREASED APPETITE (loss appetite), VACCINATION SITE PAIN (pain at injection site right arm) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that patient got a terrible reaction to the first shot of the moderna vaccine but no side effects from the second shot. It was reported that the side effects from the shot were more numerous, not all the same and much stronger than the covid 19. However it passed by the end of the fourth day. Patient  believed that reaction to the first shot was due to the fact I had covid 19 for six weeks in April 2020. Treatment information included self administration of ibuprofen, tylenol and pepto bismol.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and New events of was almost paralyzed from the waist down for 6 hours, actually could not walk , had a continuous terrible headache and couldn't get out of bed from extreme exhaustion, horrible gastritis added. Medical history added. Second Dose was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.