VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1161980
Sex: F
Age: 86
State: TN

Vax Date: 02/09/2021
Onset Date: 02/14/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Not sure if the vaccine stirred up the neuropathy in arms; Still getting outbreaks of itching various sites on her body; Redness on the arm and redness proceeded to go down arm; Intense itching at the injection site and it moved down to her forearm; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient reported intense itching at the injection site and it moved down to her forearm . The patient's medical included diabetes. Concomitant medications reported were dulaglutide for diabetes. On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031LZOA) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. on unknown date, Patient reported intense itching at the injection site and it moved down to her forearm and now 2. Treatment details included steroid cream Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events, patient reported intense itching at the injection site and it moved down to her forearm was not reported. Follow-up was obtained on 23 Mar 2021. Patient had history of neuropathy in feet because of diabetes. The patient experienced redness on the arm and redness proceeded to go down arm/erythema and not sure if the vaccine stirred up the neuropathy in arms/neuropathy peripheral. It was medically significant event. Treatment included cortisone 10 over the counter (OTC) medication. The events still getting outbreaks of itching various sites on her body, intense itching at the injection site and it moved down to her forearm, redness on the arm and redness proceeded to go down arm were recovered with the medication on unknown date. The outcome of the event not sure if the vaccine stirred up the neuropathy in arms was unknown. Practitioner said to not get 2nd dose because could be much worse, so she was afraid to get the second dose.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events pruritus, erythema, and vaccination site pruritus, a causal relationship cannot be excluded.The peripheral neuropathy aggravated event is related to the patient's comorbidities.

Other Meds: TRULICITY

Current Illness: Diabetes (She has been taking Trulicity for 6 months for diabetes.)

ID: 1161981
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Bell's palsy; A spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine on an unknown date and experienced Bell's palsy. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On an unspecified date, after first dose of vaccine, the patient experienced Bell's palsy. The event is Bell's palsy was considered as medically significant. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event development of Bell's palsy was not resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1161982
Sex: U
Age:
State: TX

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: injected arm started getting very hot; The shot hurt; Hot fever; Red area around the shot; RA flare gotten worse; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flare gotten worse) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis and Allergic reaction NOS (patient had history of allergic reactions.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injected arm started getting very hot). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RA flare gotten worse) (seriousness criterion medically significant), DIZZINESS (dizzy), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot). At the time of the report, RHEUMATOID ARTHRITIS (RA flare gotten worse), DIZZINESS (dizzy), VACCINATION SITE WARMTH (injected arm started getting very hot), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This case concerns an elderly patient of unknown age with a serious unexpected event of rheumatoid arthritis, and nonserious unexpected dizziness, vaccination site warmth and expected pyrexia, vaccination site pain, vaccination site erythema. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergic reaction NOS (patient had history of allergic reactions.); Rheumatoid arthritis

ID: 1161983
Sex: F
Age: 66
State: PA

Vax Date: 01/26/2021
Onset Date: 02/23/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: I feel tired; Arm is still swollen; Spitted and saw blood; Choking; Coughing; Red arm; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced choking, coughing, spitted blood/hemoptysis, fatigue, arm redness/injection site erythema and swelling of arm/injection site swelling. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were atorvastatin, aspirin, Lipitor, water pills and vitamin D3. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) in the left non-dominant arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient received their second of two planned doses of Mrna-1273 (Lot number: 012M20A) in the left non- dominant arm for prophylaxis of COVID-19 infection. After the second dose, the patient experienced arm redness. On 25 Feb 2021, the patient experienced choking, coughing and spitted out blood, which was experienced on 26 Feb 2021 morning as well. Later, on 26 Feb 2021 the patient developed swollen and reddish arm and fatigue. No such symptoms were experienced after first dose. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, choking, cough, hemoptysis, fatigue, injection site erythema and injection site swelling were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds: ATORVASTATIN; ASPIRIN (E.C.); LIPITOR; VITAMIN D3

Current Illness:

ID: 1161984
Sex: F
Age: 68
State: VA

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Cellulitis; Nausea; Fatigue; Fever; chills; Headache; A spontaneous report was received from a consumer concerning a 68-years-old , female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, fatigue, fever, chills and headache. Sometime after that, the patient was diagnosed with a Cellulitis infection. The patient's medical history was not provided by the reporter. Products known to have been used by patient with in past two weeks included, metformin, levothyroxine and refasten. On 28-JAN-2021 , prior to the onset of the events, the patient received the first of two dose of mRNA-1273 (Lot number: 039K20A) through Intramuscular route for prophylaxis of COVID-19 infection. On an unspecified date, 2 weeks after vaccination patient experienced nausea, fatigue, fever, chills and headache. Sometime after that, the patient was diagnosed with a Cellulitis infection. Treatment included antibiotics. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, nausea, fatigue,fever, chills and headache and cellulitis infection was considered unknown.; Reporter'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.

Other Meds: METFORMIN; SYNTHROID; REFASTIN

Current Illness:

ID: 1161985
Sex: F
Age: 37
State: VT

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 04/02/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: angioedema; blistering on arms; swelling; arms continues to have flaking; arms continues to have blistering; welts on arms; A spontaneous report was received from a Health care professional, concerning a female patient of 37 year age, who received Moderna's COVID-19 vaccine and experienced angioedema, welts on arms, blistering on arms, swelling, arms continues to have flaking, arms continues to have blistering. The patient's medical history includes chronic idiopathic angioedema, paroxysmal atrial fibrillation is noted. Patient has known allergy to benzyl peroxide. Concomitant product use includes cetirizine, famotidine metoprolol, epinephrine were provided by the reporter. On 28 DEC 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. The treatment given were Cetirizine 10mg BID for angioedema, Famotidine 20mg BID for angioedema,2 doses of epinephrine 2 hours apart with no relief for angioedema, triamcinolone for welts and blistering, Benadryl (Diphenhydramine) 25mg-50mg for angioedema noted. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events such as angioedema, welts on arms, blistering on arms, arms continues to have flaking, arms continues to have blistering was considered to be not unknown at the time of this report. The outcome of event swelling considered to be resolved at the time of report.; Reporter'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.

Other Meds: LORATADINE; CETIRIZINE HCL; FAMOTIDINE; METOPROLOL; EPINEPHRINE

Current Illness:

ID: 1161986
Sex: F
Age: 57
State: PA

Vax Date: 01/25/2021
Onset Date: 02/22/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: neuropathy; couldn't walk or coudn't move; felt sick; nauseous; severe throbbing headache; muscle pain; joint pain; A spontaneous report was received from a consumer concerning a 57 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy (medically significant), couldn't walk and couldn't move, felt sick, nauseous, severe throbbing headache, muscle pain, and joint pain. The patient's medical history included brittle diabetes, thyroid issues and neuropathy. Concomitant medications included clonazepam and melatonin. The patient received their first of two planned doses of mRNA-1273 (lot/batch 038K20A) on 25 Jan 2021. On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 22-Feb-2021, post vaccination, the patient felt sick all night which lasted until 25 Feb 2021. The patient described feeling nauseous, had a severe throbbing headache, muscle pain, joint pain, and neuropathy. Patient reported past neuropathy but not like this where patient couldn't walk and couldn't move. Treatment details included 500 mg of paracetamol. The patient received both planned doses of mRNA-1273; therefore action taken with mRNA-1273 in response to the events was not applicable. The events neuropathy, couldn't walk and couldn't move, felt sick, nauseous, severe throbbing headache, muscle pain and joint pain were considered recovered / resolved on 25 Feb 2021.; Reporter'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.

Other Meds: CLONAZEPAM; MELATONIN

Current Illness: Brittle diabetes

ID: 1161987
Sex: F
Age: 72
State: FL

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Convulsions that did not let up, shaking and tremors; severe twitching; Shortened time interval between first and second dose; A spontaneous report was received from a family member concerning a 72-years old, female patient who experienced convulsions that did not let up, shaking and tremors (seizure), twitching (muscle twitching) and shortened time interval between first and second dose (inappropriate schedule of product administration). The patient's relevant medical history included essential tremor. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly on 29-Jan-2021. On 26-Feb-2021, prior to the event onset, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 27-Feb-2021, 25 hours after vaccination, the patient experienced very severe twitching, shaking, tremors and convulsions that did not let up. Reportedly, it lasted 12 hours until she fell asleep and remained ongoing. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, convulsions that did not let up, shaking and tremors and twitching, were not provided. The event, shortened time interval between first and second dose, was resolved on 26 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with an associated convulsions reported. Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Essential tremor (Patient had an underlying tremor condition that was in remission.)

ID: 1161988
Sex: M
Age: 68
State: MA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: doesn't feel tremendous; similar to his other disease, polymyalgia rheumatica; couldn't move; bones and muscles were aching and he couldn't move; fever; nausea; arm was just sore; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was just sore (vaccination site pain), similar to his other disease, polymyalgia rheumatica (polymyalgia rheumatica aggravated), bones bone pain and muscles were aching (myalgia) and he couldn't move (mobility decreased), fever and nausea and couldn't get out of bed (mobility decreased) and doesn't feel tremendous (malaise). The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 10A21A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient's arm was just sore. On 26 Feb 2021 in the middle of the night patient woke up and symptoms he experienced were similar to his other disease, polymyalgia rheumatica. The patient's bones and muscles were aching and he could not move. He had a fever and nausea and could not get out of bed. At the time of reporting, the patient did not feel tremendous, but felt a little better. Treatment for the event included acetaminophen and ibuprofen. Action taken with mRNA-1273 in response to the events was unknown. The events, arm was just sore, bones and muscles were aching, he couldn't move, fever, nausea and couldn't get out of bed were considered resolved on 28 Feb 2021. The event, doesn't feel tremendous, was considered resolving. The outcome of the event, similar to his other disease, polymyalgia rheumatica, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1161989
Sex: M
Age:
State: NJ

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: a potential for cellulitis; Tightness in chest; hard to breathe; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Has egg size lump in shoulder that is hot, red and swollen; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; A spontaneous report was received from an unknown age, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chest discomfort, dyspnea, injection site swelling, injection site pruritus , injection site erythema, injection site pain, and injection site irritation. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26-FEB-2021, before the events onset, the patient received the second of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection. On 02-MAR-2021, the patient experienced tightness in chest, hard to breathe. He also manifested injection site swelling; a potential for cellulitis. He reporting having egg size lump in shoulder that is hot, red, swollen. It is not decreasing in size, has been the same size over the last couple of days. The injection site is itchy, hot, irritable, painful, and extremely swollen. No treatment details or laboratory results were provided for the reported events. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, cellulitis, chest discomfort, dyspnea, injection site swelling, injection site pruritus , injection site erythema, injection site pain, and injection site irritation were not reported.; Reporter'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.

Other Meds:

Current Illness:

ID: 1161990
Sex: M
Age: 70
State: OH

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Some hearing loss; Tinnitus; A spontaneous report was received from Consumer concerning himself, a 71 years old male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced some hearing loss/deafness and tinnitus/tinnitus. The patient's medical history was not provided. Concomitant product included Warfarin. On 1 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 007m20a) by intramuscular route for prophylaxis of COVID-19 infection. On 01 Feb 2021 he had some hearing loss and tinnitus. Patient stated he canceled second Moderna vaccine until he receives more information on his side effect. Patient was concerned about scheduling second Moderna vaccine. Treatment was not reported. Action taken with mRNA-1273 in response to the event was withdrawn. The outcome of the event some hearing loss and tinnitus was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds: WARFARIN

Current Illness:

ID: 1161991
Sex: M
Age: 60
State: MA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Globus; A spontaneous report was received from a Physician concerning a 60 years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced globus/Sensation of foreign body. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) on 17 Feb 2021, approximately one day prior to the onset of the symptoms intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced an instance of globus. On 18 Feb 2021, the patient was taken to the emergency room and treated with dexamethasone via intramuscular route and was discharged from the emergency room. No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcome of the event, globus was recovered on 18 Feb 2021.; Reporter's Comments: Very limited information regarding the symptoms has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1161992
Sex: M
Age: 66
State: AZ

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: the pain level it was a 6 and now it's up to 9; Everything is sore; The arm was sore but that it's hard to tell as everything is sore; A spontaneous report was received from a consumer concerning, a 66 years old, male patient, who received MODERNA'S COVID-19 vaccine (mRNA-1273) and experienced the arm was sore but that it's hard to tell as everything is sore/pain in extremity and everything is sore/myalgia, and the pain level it was a 6 and now it's up to 9/condition aggravated. The patient's medical history was provided as rare autoimmune disease and extreme pain. Concomitant medications reported were prednisone, naproxen, paracetamol, oxycodone for drug use for unknown indication. On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:004M20A/004M204) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the arm was sore but that it's hard to tell as everything is sore, the pain level it was a 6 and now it's up to 9. The patient stopped taking the medication in order to receive the vaccine to avoid the diminishing of the efficacy and wanted to know when can start taking the prednisone again. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, the arm was sore but that it's hard to tell as everything is sore/pain in extremity and everything is sore/myalgia, and the pain level it was a 6 and now it's up to 9, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (Vaccination site pain and myalgia) a causal relationship cannot be excluded. Very limited information regarding the event (condition aggravated) has been provided at this time. Noting underlying autoimmune disease may remain as risk factor. Further information has been requested.

Other Meds: PREDNISONE; NAPROXEN; TYLENOL; OXYCODONE

Current Illness: Autoimmune disorder

ID: 1161993
Sex: F
Age: 62
State: TX

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Passing out sometimes; Very dizzy for two days; Feeling very bad; Hot flashes; Fever; chills; felt like she would fall; A spontaneous report was received from a consumer concerning a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt passing out sometimes/Loss of consciousness, very dizzy for two days/dizziness, felt like she would fall/presyncope, hot flashes/hot flush, feeling very bad/feeling abnormal, chills and fever/pyrexia. Medical history of the patient was not reported. Her concomitant product included rosuvastatin calcium. On 03 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, she developed fever and hot flashes. She took treatment with paracetamol. On an unknown date, she became very dizzy for two days and was feeling very bad. She was passing out sometimes and felt like she would fall. She became dizzy again after two weeks for a couple minutes. The event passing out sometimes was considered to be medically significant. The action taken with mRNA-1273 in response to the events was not known. The outcome of the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds: CRESTOR

Current Illness:

ID: 1161994
Sex: F
Age: 22
State: IL

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Became paralyzed; Every single muscle became tensed; Sore arm; severe reaction/ vaccination adverse reaction; Nauseous; A spontaneous report was received from a consumer concerning herself, a 22-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced every single muscle became tensed, became paralyzed ,sore arm, nauseous and a severe reaction. The patient's medical history was not provided. Concomitant medication use was not provided by reporter. On 02 Mar 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 023A21A) intramuscularly for COVID-19 infection prophylaxis. On 02 Mar 2021, after first dose of the Moderna vaccine, the patient experienced every single muscle became tensed, became paralyzed ,sore arm, nauseous. Treatment details included acetaminophen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, every single muscle became tensed, became paralyzed ,sore arm, nauseous, and a severe reaction was considered unknown at the time of this report.; Reporter'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.

Other Meds:

Current Illness:

ID: 1161995
Sex: F
Age: 66
State: RI

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: weakness; noodle legs; excruciating headache; vomit; extremely nauseous; freezing cold with chills; passed out; weak tingling feeling; loose bowels; low grade temp of 96; sore arm; total, severe exhaustion; A Spontaneous report was received from a consumer concerning herself a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out/loss of consciousness, severe exhaustion/fatigue, sore arm/ pain in extremity, extremely nauseous, weak tingling feeling/Paresthesia , vomiting, freezing cold with chills, loose bowels/diarrhea, low grade temp of 96/body temperature decreased, excruciating headache, weakness/asthenia, noodle legs/muscular weakness. The patient's medical history was not included. Concomitant medications were not listed. On 23 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:023M7) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 23 Feb 2021, She felt total, severe exhaustion until Saturday 27 Feb 2021. She woke up with a sore arm on 24 Feb 2021. On Sunday 28 Feb 2021, she felt extremely nauseous. She had a weak tingling feeling; she started seeing spots and passed out. When she came to, she started to vomit, was freezing cold with chills, then had loose bowels. She had a low-grade temp of 96. She had excruciating headaches. She had weakness; she has noodle legs The event passed out/loss of consciousness was medically significant and serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, severe exhaustion was resolved on 27 Feb 2021, and outcome of event passed out resolved on unknown date. The outcome of the events sore arm, extremely nauseous, weak tingling feeling, vomiting, freezing cold with chills, loose bowels, low grade temp of 96, excruciating headache, weakness, noodle legs were unknown.; Reporter'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.; Sender's Comments: MOD-2021-035997:Same Reporter, Different Patient

Other Meds:

Current Illness:

ID: 1161996
Sex: F
Age: 50
State: TX

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: the nodules have grown 2x bigger since the last time she called; it felt like something twisted in multiple places in my body; she woke up multiple times; a lot more bruises and odd coloration; my whole body inflamed; bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck; make-up covers a great deal of redness on my face; nodule on Rt ankle appears; Right side body & arm tingling; Swelling of hands and feet (angioedema); Full-body Hives; Hot flashes; Burning sensation on her back; A spontaneous report was received from a consumer concerning a 50-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Full-body Hives,Hot flashes,Burning sensation on her back,Swelling of hands and feet (angioedema), Right side body & arm tingling,the nodules have grown 2x bigger since the last time she called,bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck,she woke up multiple times,it felt like something twisted in multiple places in my body,whole body inflamed, have seen a lot of mirroring on my body. and lot more bruises and odd coloration. The patient's medical history, was not provided.No Concomitant medications were reported . On 03 Mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029A21A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 03 Mar 2021 , prior to receiving mRNA-1273, the patient felt Full-body Hives,Hot flashes,Burning sensation on her back,Swelling of hands and feet (angioedema), hands,feet ,legs and arms swelling and on 04 Mar 2021 Right side body & arm tingling. A follow up was done on 12 Mar 2021 and reported events , on 11 Mar 2021 growth on ankle appears and on 12 Mar 2021 whole body inflamed, bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck and on 16 Mar 2021 have seen a lot of mirroring on my body. and lot more bruises and odd coloration and on an unknown date the nodules have grown 2x bigger since the last time she called, and on 18 Jan 2021 she woke up multiple times, felt like something twisted in multiple places in my body and angioedema was medically significant. A second follow up was also done on 19 Mar 2021. Treatment for the events included Corticosteroid injection , Benadryl 300mg , xyzal, montelukast, Zyrtec,Oral prednisone,pepcid AC Epi-pen (not used). Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Full-body Hives,Hot flashes,Burning sensation on her back,Swelling of hands and feet (angioedema), Right side body & arm tingling was not recovered and the outcome of the events the nodules have grown 2x bigger since the last time she called,bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck,she woke up multiple times,it felt like something twisted in multiple places in my body,whole body inflamed,growth on ankle appears,hands,feet ,legs and arms swelling,have seen a lot of mirroring on my body. and lot more bruises and odd coloration was unknown.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded.

Other Meds:

Current Illness:

ID: 1161997
Sex: F
Age: 72
State: FL

Vax Date: 02/12/2021
Onset Date: 02/26/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Hypothermia; Cold sweats; No appetite; Some dizziness; Temperature 94.2; Dull headache; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothermia, cold sweat, appetite lost/decreased appetite, dizziness, temperature body decreased/body temperature decreased and headache The patient's medical history was not provided by the reporter. No concomitant medications were reported. On 12 Feb 2021, about two weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection. On 12 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection. After two weeks on 26 Feb 2021, the patient developed hypothermia in the morning. Then patient experienced a drop in body temperature to 94.2 F. The patient had to change clothes frequently due to cold sweats. The patient also reported that she had headache, dizziness and no appetite. The treatment medication was reported as acetylsalicylic acid for headache. The event hypothermia was considered medically significant. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, hypothermia, dropping body temperature, cold sweats, headache, dizziness and no appetite were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1161998
Sex: F
Age: 75
State: ND

Vax Date: 02/12/2021
Onset Date: 03/14/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Diagnosed with Mild Stroke; Forgetfulness; A spontaneous report was received from a consumer concerning a 48-year-old, female patient, who experienced no movement in her eft arm, all the way to her hand and felt no movement in lip or chin. She experienced numbness on the side of her face and was forgetful and Forgetfulness. The patient's medical history was not provided. Products known to have been used by patient, within two weeks prior to the event, included atorvastatin calcium, acetylsalicylic acid, sodium alginate, sodium bicarbonate, vitamin d and antidepressants. On 12-FEB-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12-MAR-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14-MAR-2021, approximately two days after receiving her vaccine, the patient began experiencing no movement in her left arm, all the way to her hand and felt no movement in lip or chin. She experienced numbness on the side of her face and was forgetful. The patient went to the hospital and was diagnosed with a stroke and felt forgetfulness. On 16-MAR-2021, the patient was discharged from hospital. She was able to use her arm, although her hand was still stiff, and her fingers could move. Treatments for the events was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, cerebrovascular accident and forgetfulness was unknown.; Reporter'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.

Other Meds: LIPITOR; ASPIRIN (E.C.); REFLUXINE ANTACID; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1161999
Sex: F
Age: 82
State: MI

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: extreme fatigue to a point last night she could not go to bed; diarrhea; tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue to a point last night she could not go to bed), DIARRHOEA (diarrhea) and COVID-19 (tested positive for covid-19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme fatigue to a point last night she could not go to bed) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and COVID-19 (tested positive for covid-19) (seriousness criterion hospitalization). At the time of the report, FATIGUE (extreme fatigue to a point last night she could not go to bed), DIARRHOEA (diarrhea) and COVID-19 (tested positive for covid-19) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case concerns an 82 Y/O F hospitalized with serious unexpected events of diarrhea, fatigue, and SARS-CoV-2 test positive. Event onset with unknown latency after first dose mRNA-1273. Treated with bamlanivimab. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 82 Y/O F hospitalized with serious unexpected events of diarrhea, fatigue, and SARS-CoV-2 test positive. Event onset with unknown latency after first dose mRNA-1273. Treated with bamlanivimab. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162000
Sex: M
Age: 68
State: MI

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Chest congestion; Sore arm; Body aches; Fever of 101-102?F; Fatigue; Headache; A spontaneous report was received from consumer, concerning himself, a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 101 to 102 F, chest congestion, body aches, fatigue, headache and sore arm. The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the events, included atorvastatin, enalapril and travoprost. Patient took paracetamol for the symptoms. On 13 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Mar 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the same day post vaccination, the patient started having a fever of 101 to 102F, chest congestion, body aches, fatigue, headache and sore arm. Action taken with mRNA-1273 in response to events were not applicable. All events were resolved over a week.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: ATORVASTATIN; ENALAPRIL; TRAVOPROST

Current Illness:

ID: 1162001
Sex: M
Age: 62
State: TX

Vax Date: 02/14/2021
Onset Date: 03/17/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: 106?F fever; severe shakes; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (106?F fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERPYREXIA (106?F fever) (seriousness criterion medically significant), TREMOR (severe shakes) and FATIGUE (very fatigued). At the time of the report, HYPERPYREXIA (106?F fever), TREMOR (severe shakes) and FATIGUE (very fatigued) outcome was unknown. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162002
Sex: M
Age: 43
State: NY

Vax Date: 02/12/2021
Onset Date: 03/13/2020
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Heart fluttering; more extreme exhaustion; Discomfort; sore arm; Heart fluttering; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CARDIAC FLUTTER (Heart fluttering) and the second episode of CARDIAC FLUTTER (Heart fluttering) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2020, the patient experienced PYREXIA (Fever). On 12-Feb-2021, the patient experienced the first episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), FATIGUE (more extreme exhaustion), DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm). On 13-Mar-2021, the patient experienced the second episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). At the time of the report, last episode of CARDIAC FLUTTER (Heart fluttering) outcome was unknown, FATIGUE (more extreme exhaustion) had resolved, DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm) was resolving and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 103.3 (High) Fever for 103.3 degree. This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and non-serious expected pyrexia. Event onset on Day 2 after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Treatment medications included ibuprofen and acetaminophen.; Sender's Comments: This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and nonserious expected pyrexia. Event onset on Day 2 after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162003
Sex: F
Age: 73
State: AL

Vax Date: 01/25/2021
Onset Date: 02/22/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: corneal ulcer outbreak/two ulcers on her eye; A spontaneous report was received from a consumer concerning a 73-year-old female patient of who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced corneal ulcer outbreak/two ulcers on her eye. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included aciclovir sodium, atenolol, and lisinopril. The patient received the first of two planned doses of mRNA-1273 (batch number: 030L20A) on 25 Jan 2021. On 22 Feb 2021, 3 hours prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 22 Feb 2021, 3 hours after administration of the second dose, the patient had a corneal ulcer outbreak which she explained as two ulcers on her eye. The event corneal ulcer outbreak/two ulcers on her eye was assessed as medically significant. Treatment for the event included, acyclovir, 5 times a day and ganciclovir (zirgan) ointment. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of event, corneal ulcer outbreak/two ulcers on her eye was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: ACYCLOVIR; ATENOLOL; LISINOPRIL

Current Illness:

ID: 1162004
Sex: F
Age: 83
State: NY

Vax Date: 02/24/2021
Onset Date: 02/27/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: pulmonary embolism; shortness of breath; A Spontaneous report was received from physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had pulmonary embolism and shortness of breath. The patient's medical history was not reported, and concomitant medication included Albuterol, Lipitor, Flonase, Synthroid, loratadine, metoprolol and Torsemide. On 24 Feb 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: unknown, Expiration date: not provided) via intramuscular route for prophylaxis of COVID-19 infection. On 27 Feb 2021, after administration of vaccine patient experienced shortness of breath. On an unknown date patient experienced pulmonary embolism and was admitted for three days. She was given Heparin and Coumadin. She was admitted for three days and was sent home with a prescription for Lovenox and Warfarin. Action taken with the mRNA-1273 in response to the events was not provided. The outcome were recovered for events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162005
Sex: M
Age: 67
State: TX

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Peripheral neuropathy extended to whole body; A spontaneous report was received from a consumer concerning a 67-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event peripheral neuropathy extended to whole body/neuropathy peripheral. The patient's medical history included peripheral neuropathy. Concomitant medications included acetylsalicylic acid, losartan and metoprolol. On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly for prophylaxis of COVID-19 infection. The patient is having peripheral neuropathy from last 15 years and it was limited to hands and feet. On an unknown date, after receiving the vaccine it extended to whole body. The patient reported that the condition has been worsened from level 1 to level 3. No treatment details were provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event peripheral neuropathy extended to whole body was not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: ASPIRINE; LOSARTAN; METOPROLOL

Current Illness: Peripheral neuropathy aggravated (It was limited to hands and feet.)

ID: 1162006
Sex: F
Age: 81
State: MI

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: A spontaneous report was received from a consumer concerning an 81 years old, female patient who experienced headache, heart flutter and skip a beat/extra systoles. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 02 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient experienced headache, heart flutter and skip a beat. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events headache, heart flutter and skip a beat were unknown.; Reporter'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.

Other Meds:

Current Illness:

ID: 1162007
Sex: F
Age: 94
State: MI

Vax Date: 02/23/2021
Onset Date: 03/20/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Mechanical fall; Cut her wrist pretty bad and had to get stitches; A spontaneous report was received from a consumer concerning a 94-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mechanical fall/ fall and very bad cut on the wrist /skin lacerations. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 20 Mar 2021, the patient experienced a life threatening and medically significant event of mechanical fall and cut on her wrist which was pretty bad and had to get stitches. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, mechanical fall and cut her wrist pretty bad and had to get stitches was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1162008
Sex: F
Age: 78
State:

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: A Spontaneous report was received from a Consumer concerning a female patient of 77 years who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced positive for COVID-19, diarrhea, decreased appetite. The patient's medical history included heart transplant and was on dialysis prior to the vaccination. No relevant concomitant medications were reported. On 10 Mar 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) on right arm , intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient reports she was tested positive for COVID-19 and was hospitalized with symptoms of diarrhea, loss of appetite. The patient was discharged from the hospital on 19 March 2021 and was still in quarantine at the time of this report. Laboratory details were not provided. Treatment details included Remdesivir. Action taken with mRNA-1273 in response to the events was not reported. On date of this report, the outcome of the events of patient, positive for COVID-19, decreased appetite, diarrhea was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Dialysis; Heart transplant

ID: 1162009
Sex: M
Age: 82
State:

Vax Date: 01/26/2021
Onset Date: 03/13/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: COVID positive with mild infection; Difficulty breathing; Nose bleed; A spontaneous report was received from an 82-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nosebleed, difficulty breathing and COVID positive with mild infection. The patient's medical history included Pulmonary arterial hypertension and Concomitant medication include TREPROSTINIL SODIUM and TADALAFIL. Lab tests provided for COVID-19 tests positive. On 26 Jan 2021, patient received first of two planned dose and on 16 Feb 2021, received second of two planned dose. On 13 Mar 2021, the patient was hospitalized with nosebleed, difficulty breathing and COVID positive with mild infection and the treatment provided was unknown. Action taken with mRNA-1273 in response to the event was not applicable as the patient received both the planned doses prior to the event The outcome of events, nosebleed, difficulty breathing and COVID positive with mild infection was reported unknown; Reporter's Comments: Very limited information regarding these events has been provided at this time. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine

Other Meds: TREPROSTINIL SODIUM; TADALAFIL

Current Illness: Pulmonary arterial hypertension

ID: 1162010
Sex: M
Age: 79
State: WI

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Significant hearing problem in left ear / loss of hearing in left ear; Gets loud ringing in the ear; Amplified sounds after taking first dose; A spontaneous report was received from a consumer concerning himself, 79-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced significant hearing problem in left ear, loss of hearing in left ear/deafness unilateral, gets loud ringing in the ear/tinnitus, amplified sounds after taking the first dose of the moderna vaccine/ ear disorder. The patient's medical history was not provided. Concomitant medications reported included acetylsalicylic acid, simvastatin, vitamin D, multivitamin and levothyroxine for product use for unknown indication. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route for prophylaxis of COVID-19 infection. Patient reports that he was scheduled for a brain scan. On 28 Jan 2021, the patient experienced significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable. The outcome of the event(s), significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine was unknown.; 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.

Other Meds: ACETYLSALICYLIC ACID; SIMVASTATIN; VITAMIN D [VITAMIN D NOS]; MULTIVITAMIN [VITAMINS NOS]; L-THYROXINE [LEVOTHYROXINE]

Current Illness:

ID: 1162011
Sex: F
Age: 60
State: FL

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: A spontaneous report was received from a consumer [United States] concerning 60 years old female patient who received Moderna's COVID-19 (mRNA-1273) and experienced worsening of meniere's disease symptoms/meniere's disease, scratchy throat/oropharyngeal discomfort, sinus pressure/paranasal sinus discomfort, dry cough/cough, phlegm/productive cough, vomiting. The patient's medical history was not reported. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 046A21A) on 18 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection. On 18 Mar 2021 the patient developed a dry cough, scratchy throat, sinus pressure, phlegm, vomiting x1, and worsening of her Meniere's disease symptoms. The medically significant event is meniere's disease. Treatment of the event was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events worsening of meniere's disease symptoms, scratchy throat, sinus pressure, dry cough, phlegm, and vomiting was not reported.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Vomiting is consistent with the product known safety profile.

Other Meds:

Current Illness:

ID: 1162012
Sex: F
Age: 69
State: FL

Vax Date: 02/08/2021
Onset Date: 03/09/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: feel freezing; temperature which read 104 degrees Fahrenheit; feel cold; she felt hot inside; A spontaneous report was received from a consumer, concerning a 69 years adult female patient, who received Moderna COVID-19 Vaccine and experienced feel freezing/ Hypothermia, temperature which read 104 degrees Fahrenheit/ Hyperpyrexia, feel cold/ Chills, she felt hot inside/ Feeling hot. The patient's medical history was not provided. On 08Feb2021, prior to the onset of events, the patient received their first of two planned A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route for prophylaxis of COVID-19 infection. On 9 Mar 2021, the patient experienced the event(s) feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit was unknown. doses of mRNA-1273 (batch number: 031L20A) via unknown route for COVID-19 infection prophylaxis. On 08Mar2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 027A21A) via unknown route for COVID-19 infection prophylaxis. On 09Mar2021, patient began to feel cold then went to the supermarket where she began to feel freezing and left, at home although the heat was on, she still felt cold and resorted to wearing a winter jacket and two blankets still feeling freezing but oddly enough, she felt hot inside so she took her temperature which read 104 degrees Fahrenheit. She then proceeded to drink 1.5 cups of cold sparkling water and gradually these symptoms subsided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The Outcome of the event (Cold,Hyperthermia,Feeling hot, Chills) was considered to be not unknown at the time of this report.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162013
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: A Spontaneous report was received from a consumer concerning a male patient of an unknown age, who received Modern's COVID-19 vaccine (mRNA-1273) and experienced suicidal ideation and severe depression (Major Depression). The patient's medical history is unknown. Concomitant medications is unknown. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date the patient experienced suicidal Ideation and depression after taking the vaccine. The treatment details were unknown. Laboratory details were not provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events suicidal Ideation and depression after taking the vaccine were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162014
Sex: F
Age: 81
State: TN

Vax Date: 01/05/2021
Onset Date: 02/04/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: A spontaneous report was received from a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive 2nd dose within recommended time frame/product dose omission issue and experienced 2 busted blood vessel in left eye/eye hemorrhage, throat burning sensation/throat irritation, nasal irritation/nasal discomfort, breast burning/breast pain and red spots on face and face turned bright red randomly/erythema. The patient's medical history included cataract surgery. Products known to have been used by the patient, within two weeks prior to the event, include Loteprednol etabonate, Bromfenac Sodium, and Gentamicin Sulfate. On 05Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch: 041120A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient did not receive 2nd dose within recommended time frame. On 02 Feb 2021, patient had red spots on face and on 04 Feb 2021, her face turned bright red randomly, throat, nose and breast were burning and on 10 Feb 2021, she had 2 busted blood vessel in left eye. The event 2 busted blood vessel in left eye was considered as medically significant. Treatment medication for the event included Diphenhydramine, unspecified steroid and Cortisone cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event did not receive 2nd dose within recommended time frame was resolved on an unspecified date, throat, nose, breast burning was resolved on 11 Feb 2021, 2 busted blood vessel in left eye was resolved on 15 Feb 2021 and red spots on face and face turned bright red randomly was not resolved at the time of this report. Reporter's Comments: Based on the HCP reporter's assessment the events are assessed as unlikely related to mRNA-1273.The patient had eye surgery and was on medications causing the reported events as side effects.

Other Meds: Lotemax; Prolensa; Gentamicin Sulfate Opthalmic

Current Illness:

ID: 1162015
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Suicidal thoughts; Mood swings; Depression; A spontaneous report was received from a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced suicidal thoughts, mood swings and depression The patient's medical history was not provided. Concomitant medications were not reported. On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown), intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced mood swings, depression, and suicidal thoughts after getting the shot. The patient provided limited information before ending the call Action taken with second dose mRNA-1273 in response to the events was not reported. The outcome of the events, suicidal shots, mood swings, depression and patient got violent were unknown.; Reporter'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.

Other Meds:

Current Illness:

ID: 1162017
Sex: F
Age: 73
State: NC

Vax Date: 02/11/2021
Onset Date: 03/12/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Anaphylactic reaction/Shortness of breath/ Trouble swallowing; Weakness; Sore throat; Night sweats; Elevated blood pressure; Heart rate in 120s; feel lethargic; A spontaneous report was received from a consumer concerning for a 73 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylactic reaction, shortness of breath/ dyspnoea, trouble swallowing/ dysphagia, feel lethargic/lethargy, weakness/asthenia, night sweats and sore throat/ oropharyngeal pain, elevated blood pressure and heart rate in 120s. The patient's medical history was not provided. The concomitant medications on use were also not provided. On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (lot number: 024M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (lot number: 032M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 12 Mar 2021, within 10 minutes of second dose, patient experienced anaphylactic reaction. She experienced flushing and shortness of breath and was given oxygen, benadryl 50 mg and depomedrol intramuscularly by an EMT on site. Patient was taken to the ER for evaluation and discharged on medrol dose pak, tagamet BID and benadryl. As of today 12 days later, patient still has he following side effects: flushing beet red, trouble swallowing feels like throat is closing in, night sweats, feels lethargic, weakness, elevated blood pressure and heart rate in 120s and a sore throat. She has consulted with three HCPs since discharge and all have said to continue on her medications. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The events anaphylactic reaction, shortness of breath, trouble swallowing, feel lethargic, weakness, night sweats and sore throat blood pressure and heart rate in 120s were not recovered at the time of this report.; Reporter'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.

Other Meds:

Current Illness:

ID: 1162018
Sex: F
Age:
State: AZ

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: blood pressure was high; mild stroke; transient global amnesia; sore arm; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/cerebrovascular accident, transient global amnesia, sore arm and high blood pressure. The patient's medical history was unknown. Concomitant product use was not provided by the reporter. On 02 Mar 2021, prior to the onset of event, the patient received their second of two planned dose of mRNA-1273 (Lot number: 010A21A) vaccine in the left arm for prophylaxis of COVID-19 infection. On the same day as the second dose, the patient experienced a sore arm later in the day. On 21 Mar 2021, she had mild stroke. It shocked her because she did not have medical issues that would have lead to a stroke. She did not immediately go to hospital. She followed up with her doctor who then asked her to go to the urgent care or emergency room (ER). She went to the urgent care first and they said she needed to go to the ER because of the symptoms she was having. She then went to the ER. She was there for 6 hours. She asked the nurse if they were going to admit her but nurse said no because she was not having the symptoms at that time. In the ER, she had an MRI, CAT scan, EKG, chest x-ray done and also had blood drawn. The patient had high blood pressure noted while in the ER. The ER doctor said she had transient global amnesia which they said was precursor to the stroke. The event was also considered to be medically significant. Treatment information was not provided. Action taken with the mRNA-1273 in response to the event was not applicable. The outcome of the events, mild stroke, transient global amnesia, sore arm and high blood pressure, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162019
Sex: M
Age: 71
State: TX

Vax Date: 02/25/2021
Onset Date: 03/16/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: E.Coli Infection; Food Poisoning; A spontaneous report was received from a consumer, concerning a 71-year-old male patient who received Modern's COVID-19 vaccine (mRNA-1273) and developed E. coli Infection and food poisoning. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 25 Feb 2021, approximately three weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number:02A21A) in the left arm for prophylaxis of COVID-19 infection. On 16 Mar 2021, the patient was diagnosed with E-coli infection which was considered as serious (medically significant) and food poisoning. Treatment medication included unknown antibiotics for the events. Action taken with mRNA-1273 in response to events were unknown. The outcome of the events E. coli Infection and food poisoning were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1162020
Sex: F
Age: 62
State: PR

Vax Date: 03/16/2021
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: A spontaneous report was received from a consumer concerning a 62-year-old, female patient who felt like a needle in her kidney/renal pain, feve/pyrexiar, fatigue, tiredness/fatigue, chest pain, upset heart/cardiac disorder, headache and inflammation of heart muscle/myocarditis. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, metformin, glimepiride, simvastatin, losartan. On 16 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 001B21A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Mar 2021, 5 minutes later she experienced felt like a needle in her kidney. On 17 Mar 2021, she had fever. On an unknown date in Mar 2021, she had fatigue and tiredness. On 20 Dec 2021, she had chest pain and upset heart. On 21 Mar 2021, she had a headache and fever. On 22 Mar 2021 she had chest pain and went to the doctor and was diagnosed inflammation of the heart muscle. The event inflammation of the heart muscle was assessed medically significant. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The events felt like a needle in her kidney was resolved on 16 Mar 2021. The events fever and headache were resolved on 21 Mar 2021. The outcome of the evens fatigue, tiredness, chest pain, upset heart and inflammation of heart muscle were unknown.; Reporter'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.

Other Meds: LEVOTHYROXINE; METFORMIN; GLIMEPIRIDE; SIMVASTATIN; LOSARTAN

Current Illness:

ID: 1162021
Sex: M
Age:
State: TX

Vax Date: 01/09/2021
Onset Date: 02/06/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Bilateral facial bell's palsy; Guillain Barre syndrome; Weakness in arms and legs; the tingling got worse and he had a lot more weakness in arms and legs; his arm started tingling; Headache/strrong headache; Arm ached; Bit sluggish; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events bilateral facial Bell's palsy/Bell's palsy, bit sluggish, arm ached, Tingling in arms and legs, weakness in arms and legs, Guillain barre syndrome and headache. The patient's medical history was not provided. No relevant concomitant product use was reported. On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient went to the ER. On 06 Feb 2021, the patient experienced bit sluggish, arm ached and head ache. On 12 Feb 2021, the patient developed a strong headache. On 13 Feb 2021, the patient developed tingling in his arms. On 14 Feb 2021, patient had tingling in his feet. On 15 Feb 2021, the tingling got worsened and patient experienced a lot more weakness in arms and legs. On 16 Feb 2021, the patient was diagnosed with Guillen Barre Syndrome. On unknown date ,patient developed bilateral facial Bell's palsy. Laboratory details included CAT scan and lumbar puncture. Treatment received for the events, included IVIG treatment and steroids. Action taken with the with mRNA-1273 in response to the event is not applicable. The outcome of the events bit sluggish and arm ached were resolved . The outcome of the events headache, his arm started tingling, feel also started tingling, weakness in arms and legs, Guillain barre syndrome and bilateral facial Bell's palsy were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1162022
Sex: F
Age: 76
State: NC

Vax Date: 01/21/2021
Onset Date: 02/20/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Oxygen drop; Shingles on her forehead; Heart Racing; Aches/pain; Rash; Sore arm; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Oxygen drop) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HYPOXIA (Oxygen drop) (seriousness criterion hospitalization), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever). The patient was hospitalized on 20-Feb-2021 due to HYPOXIA. At the time of the report, HYPOXIA (Oxygen drop), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. 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.; 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.

Other Meds:

Current Illness:

ID: 1162023
Sex: M
Age: 61
State: PA

Vax Date: 03/03/2021
Onset Date: 03/05/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough. The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue. On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious. On 25 Mar 2021, he coughed up some yellow mucus. Treatment for the events reported included pacemaker and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds: DILTIAZEM; AMIODARONE; TRULICITY; JARDIANCE; REPATHA; HYDROCHLOROTHIAZIDE; POTASSIUM; CITALOPRAM; PANTOPRAZOLE; ELIQUIS; GLIMEPIRIDE; BUSPIRONE

Current Illness:

ID: 1162024
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: stroke-like symptoms, reacting like he "had a stroke" following their vaccine; Feels like a vegetable; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of stroke-like symptoms, reacting like he "had a stroke" following his vaccine and current condition is "like a vegetable" which lead to the hospitalization of the patient. The patient's medical history was not provided. The concomitant medications on use were also not provided. On unknown date, prior to the onset of the events, the patient received their dose of mRNA (Batch/Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection. On unknown date, patient experienced event reacting like he "had a stroke" following their vaccine. Following severe symptoms, patient was subsequently hospitalized and had been transferred twice since. Reporter said their current status is "like a vegetable". The events are medically significant. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event(s) stroke-like symptoms, reacting like he "had a stroke" following their vaccine and current condition is "like a vegetable" were unknown.; Reporter'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.

Other Meds:

Current Illness:

ID: 1162025
Sex: F
Age:
State: OH

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Severe depression; Emotional reaction; Severe anger; A spontaneous report was received from a consumer concerning a 37 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced emotional reaction, severe depression and severe anger. The patient's medical history included hysterectomy. Products known to have been used by the patient, within two weeks prior to the event included ondansetron, pantoprazole, vitamin B complex, probiotics. On 26 Mar 2021, approximately one day prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 019B21A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Mar 2021, the patient experienced severe depression and severe anger, had emotional reaction and no physical reaction. The patient reported that it was not normal for her as she experience this when she has PMS (Premenstrual syndrome) and after taking steroids. However, the patient does not have PMS and did not take any steroids. The patient felt better later. The event severe depression was considered medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events emotional reaction, severe depression and severe anger was resolving.; Reporter'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. Further information has been requested.

Other Meds: ONDANSETRON; PANTOPRAZOLE; VITAMIN B COMPLEX; PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]

Current Illness:

ID: 1162026
Sex: M
Age: 79
State: FL

Vax Date: 03/02/2021
Onset Date: 03/14/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Pneumonia; A spontaneous report was received from a consumer concerning reporter's husband a 79-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed pneumonia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 02 Mar 2021, approximately 13 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 001A21A) via an unknown route for prophylaxis of COVID-19 infection. On 14 Mar 2021 the patient was hospitalized for pneumonia and was discharged on 16 Mar 2021. The reporter stated that her husband has "previously been prone to pneumonia". Treatment information included unspecified antibiotics. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162027
Sex: F
Age: 70
State:

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: very Frantic; episode of psychosis; Delusional; Dizzy; Headache; malaise; big knot there [injection arm]; itched; Could not stand up staright; had 17 or 18 falls in 2 days; slept so much after the vaccination; A spontaneous report was received from a pharmacist concerning a 70-year-old age female patient who received mRNA-1273 vaccine and experienced very frantic/delirium, episode of psychosis/psychotic disorder, Delusions/delusional perception, dizziness, Headache, malaise, knot on injection arm/vaccination site mass, itch/pruritis, could not stand up straight/dysstasia, 17 or 18 falls for 2 days, slept so much/Hypersomnia. The medical history was anaphylactic reaction like iodine. Concomitant medications were not provided by the reporter. On 17 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: 045A21A) via Intramuscular route in the right deltoid for prophylaxis of COVID-19 infection. After the first dose of vaccination, on an unspecified date, the experienced delusional, dizzy, and go through an episode of psychosis and was very frantic and got better and patient never had this before, had headaches and malaise, slept so much, had a big knot in her arm, itched, hard, could not stand up straight, 17 or 18 falls in 2 days. The event delirium worried about was medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event frantic was resolved. The outcome of the events episode of psychosis, delusions, dizziness, headache, malaise, knot on injection arm, itch, could not stand up straight, 17 or 18 falls for 2 days, slept so much were unknown at the time of this report.; Reporter'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.

Other Meds:

Current Illness: Anaphylactic reaction

ID: 1162028
Sex: M
Age:
State:

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Patient started with blood in stool next day after receiving 1st dose; A spontaneous report was received from a consumer concerning a 43-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in stool next day after receiving 1st dose. The patient's medical history as provided by the reporter included hypertension. Concomitant medications reported included blood pressure medication. On 17 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Mar 2021, patient had blood in stool next day after receiving 1st dose. The event was considered medically significant. Lab details were not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, patient started with blood in stool next day after receiving 1st dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1162029
Sex: M
Age: 57
State: VA

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 04/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Did not sleep at all as he kept staring at the clock 2-3 times every hour; Feels bad now which was similar to the time when he had covid; Whole body was moving bad; Chills; Vomiting ( " dry heaves" throwing up but nothing was coming out); Shaking was similar to having convulsions was hard; Very sick this morning; Sore injection site area; Shaking shaking so hard at 2am; A spontaneous report was received from a consumer concerning a 57-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events shaking was similar to having convulsions was hard, very sick this morning, chills, sore injection site area, vomiting (dry heaves throwing up but nothing was coming out), whole body was moving bad, shaking so hard at 2am, did not sleep at all as he kept staring at the clock 2-3 times every hour and feels bad now which was similar to the time when he had Covid-19. The patient's medical history included COVID-19. No relevant concomitant product use was reported. On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 048A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Mar 2021, the patient experienced very sick, chills, injection site sore, vomiting (dry heaves throwing up, but nothing was coming out). On the same day, the patient was shaking so hard at 2 am and the shaking was similar to having convulsions. The patient also reported that, his body was moving bad. The patient went to bathroom and laid back down, but he was unable to sleep and kept staring at the clock 2-3 times every hour. The patient also reported that, he felt bad now and it was similar to the time when he had COVID-19. No treatment details were provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events very sick, chills, injection site sore, vomiting(dry heaves throwing up, but nothing was coming out), shaking so hard at 2 am, shaking was similar to convulsions, whole body was moving bad, did not sleep at al as he kept staring at the clock 2-3 times every hour and feels bad now which was similar to the time when he had COVID-19 were unknown.; Reporter'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. Very limited information regarding these events has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1162030
Sex: M
Age: 76
State: NJ

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 04/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: hard to understand when speaking; hiccups; sore throat; diagnosed with stroke; dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side; feeling cold; A spontaneous report was received from a consumer concerning a 76 year old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced a stroke (Cerebrovascular accident),, dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side/ Dizziness , hard to understand when speaking/ Speech disorder, hiccups, sore throat (Oropharyngeal pain) and feeling cold (Feeling cold). The patient's past medical history not provided. Concomitant product use was not provided by the reporter. On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, the patient experienced feeling cold which lasted for 48 hours. On 08 Mar 2021, the patient started experiencing dizziness, the dizziness continued to get worse until 13 Mar 2021 when it was described as not spinning, but quickly moving from side to side, and patient was taken to the emergency room. On 14 Mar 2021, the patient was diagnosed with a stroke, was extremely hard to understand when speaking, had hiccups and sore throat. The patient had been in the hospital since 14 Mar 2021. The action taken with mRNA-1273 in response to the events was unknown. The outcome of feeling cold was recovered on 09 Mar 2021. The outcome of stroke, hiccups and sore throat, hard to understand when speaking, dizziness was unknown at the time of this report.; 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. Further information has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm