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: 1188808
Sex: M
Age: 76
State:

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 04/10/2021
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: swelling voice; swelling neck; swelling gland; nausea; Abdominal pain radiating to left side of body; Abdominal pain radiating to left side of body; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Abdominal pain radiating to left side of body) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Abdominal pain radiating to left side of body) (seriousness criterion disability), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain) and NAUSEA (nausea). On 07-Jan-2021, the patient experienced SWELLING (swelling neck) and LYMPHADENOPATHY (swelling gland). On 08-Jan-2021, the patient experienced DYSPHONIA (swelling voice). At the time of the report, PAIN (Abdominal pain radiating to left side of body), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain), DYSPHONIA (swelling voice), SWELLING (swelling neck), LYMPHADENOPATHY (swelling gland) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details include prednisone, Benadryl and oxycontin. Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded

Other Meds:

Current Illness: No adverse event (No medical history reported)

ID: 1188809
Sex: F
Age: 61
State: OH

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 04/10/2021
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: Enlarged lymph nodes; Itching in her scalp and wrist; Hives in neck, forehead and wrist; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in her scalp and wrist), URTICARIA (Hives in neck, forehead and wrist) and LYMPHADENOPATHY (Enlarged lymph nodes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMINS [VITAMINS NOS], RALOXIFENE and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ) for an unknown indication. On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced PRURITUS (Itching in her scalp and wrist) (seriousness criterion medically significant) and URTICARIA (Hives in neck, forehead and wrist) (seriousness criterion medically significant). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itching in her scalp and wrist), URTICARIA (Hives in neck, forehead and wrist) and LYMPHADENOPATHY (Enlarged lymph nodes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment was received.; 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: VITAMIN D [VITAMIN D NOS]; MULTIVITAMINS [VITAMINS NOS]; RALOXIFENE; OLMESARTAN HCTZ

Current Illness:

ID: 1188810
Sex: M
Age: 68
State: FL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 04/10/2021
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: Soreness/aching; Not feeling quite right; Extreme tiredness; Chill; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/aching), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Jan-2021, the patient experienced PAIN (Soreness/aching) (seriousness criterion medically significant), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache). At the time of the report, PAIN (Soreness/aching), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Reporter did not allow further contact; 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: 1188811
Sex: F
Age: 58
State: NY

Vax Date: 01/06/2021
Onset Date: 02/12/2021
Rec V Date: 04/10/2021
Hospital: Y

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: high blood pressure; fever; chills; severe headache; rash all over in the arm where got the vaccine; rash trunk and leg; burned; trouble breathing; throat problem; rapid heartbeat; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure) and TACHYCARDIA (rapid heartbeat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for an unknown indication. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS and Blood pressure (Taking meds to control blood pressure.). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure) (seriousness criterion hospitalization) and TACHYCARDIA (rapid heartbeat) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache), VACCINATION SITE RASH (rash all over in the arm where got the vaccine), RASH (rash trunk and leg), THERMAL BURN (burned), DYSPNOEA (trouble breathing ) and OROPHARYNGEAL DISCOMFORT (throat problem). The patient was hospitalized from 12-Feb-2021 to 18-Feb-2021 due to BLOOD PRESSURE INCREASED and TACHYCARDIA. At the time of the report, BLOOD PRESSURE INCREASED (high blood pressure), TACHYCARDIA (rapid heartbeat), PYREXIA (fever), CHILLS (chills), HEADACHE (severe headache), VACCINATION SITE RASH (rash all over in the arm where got the vaccine), RASH (rash trunk and leg), THERMAL BURN (burned), DYSPNOEA (trouble breathing ) and OROPHARYNGEAL DISCOMFORT (throat problem) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications known to have been used by the patient, within two weeks prior to the event, included thyroid medication and blood pressure medication. Treatment of these events included prednisone and Benadryl.; 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: Blood pressure (Taking meds to control blood pressure.); Thyroid disorder NOS

ID: 1188812
Sex: F
Age: 21
State: NJ

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 04/10/2021
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: serious allergic reaction; breathing was labored; red scratch marks all over her upper body; heart beat was getting very rapid; vision was wonky; right eye was swollen; face was beet red; nauseous; A spontaneous report was received from a consumer's mother who state's a 21 year female experienced a serious allergic reaction(hypersensitivity) to the vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. 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: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03-MAR-2021around 15:00, she received the Moderna COVID-19 vaccine in her left deltoid muscle at Shop Rite Pharmacy. 6 hours later she noticed red scratch marks all over her upper body, her heart beat was getting very rapid, her breathing was labored, her vision was wonky, her right eye was swollen and her face was beat red. 911 was called, upon arrival the EMT administered IV diphenhydramine (Benadryl) 50 mg and at the emergency room they gave her famotidine (Pepcid) and a steroid drip (methylprednisolone). After receiving treatment, the reporter states the patient felt great and was discharged. The doctor prescribed her methylprednisolone. Additionally she states the patient was also nauseous last night which went away around 2:00am. They told her to consult her primary care provider about the second Moderna COVID-19 vaccination Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event, serious allergic reaction is unknown.; Reporter's Comments: This case concerns a 21 Y/O F with serious unexpected events of hypersensitivity, dyspnea, and nonserious unexpected heart rate increased, vision blurred, eye swelling, erythema, scratches and expected nausea. Event onset on Day 1 after first dose mRNA-1273. Treated with diphenhydramine and methylprednisolone. Hypersensitivity resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1188813
Sex: F
Age: 91
State:

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 04/10/2021
Hospital: Y

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: Felt weak; Neuropathy; hot skin all over; skin burning; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak) and NEUROPATHY PERIPHERAL (Neuropathy) in a 91-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 reported medical history). On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Felt weak) (seriousness criterion hospitalization), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Felt weak), NEUROPATHY PERIPHERAL (Neuropathy), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness) had not resolved. Treatment Medication was cortisone cream, cerave, and Citalopram. This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus. Event onset 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.; Sender's Comments: This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus. Event onset 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: 1188814
Sex: U
Age: 63
State: PA

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 04/10/2021
Hospital: Y

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: Chest pain; Dizzy; Spasm; Memory loss; Ringing ears; Off balance; Headache; Sleepy; A spontaneous report was received from a consumer who was also a 63-years-old, patient of unknown gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and who felt dizzy/dizziness, off balance/balance disorder, sleepy/somnolence, memory loss/amnesia, chest pain/non-cardiac chest pain, headache, ears ringing/tinnitus and spasm/muscle spasms. The patient's medical history included reflux, spasm and erosion gastritis. Concomitant product use was not provided by the reporter. On 12 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient had chest pain, dizzy and spasm for which the patient had to take an ambulance to the hospital. No further details regarding hospitalization provided at time of report. The patient also had memory loss, ringing ears, sleepy, off balance and headache. Treatment for the event included pepsid, doxycycline at 100 milligram 2 dose a day and baby aspirin. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. The events were consistent with increased risk of complications associated with history of comorbidities and confounded by age of patient. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1188815
Sex: F
Age: 73
State: FL

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 04/10/2021
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: mild anaphylactic shock; nauseated; about to pass out; bolt of tightness in her chest and across from her shoulder; pain in her chest; shortness of breath; dizzy/lightheadness; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (mild anaphylactic shock) and LOSS OF CONSCIOUSNESS (about to pass out) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 reported ). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (about to pass out) (seriousness criterion medically significant), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness). On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (mild anaphylactic shock) (seriousness criterion medically significant) and NAUSEA (nauseated). On 13-Feb-2021, LOSS OF CONSCIOUSNESS (about to pass out), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (mild anaphylactic shock) and NAUSEA (nauseated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No other relevant medication was reported. No treatment information was reported. This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. 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 a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. 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: 1188816
Sex: F
Age: 41
State: NY

Vax Date: 02/06/2021
Onset Date: 03/06/2021
Rec V Date: 04/10/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips) and ADVERSE REACTION (allergic reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (fever). On 06-Mar-2021, the patient experienced CHILLS (Chills). On 15-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and URTICARIA (Hives). On 20-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest Tightness) (seriousness criterion hospitalization) and LIP SWELLING (Swollen Lips) (seriousness criterion hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (allergic reaction to the vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 20-Mar-2021 due to ADVERSE REACTION, CHEST DISCOMFORT, CHEST PAIN and LIP SWELLING. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips), PAIN (Body Aches), PRURITUS (Itchiness), ERYTHEMA (Redness), URTICARIA (Hives), ADVERSE REACTION (allergic reaction to the vaccine), PYREXIA (fever) and CHILLS (Chills) outcome was unknown. Following the first dose of the vaccine, the patient experienced fever, chills and body aches that lasted for 24-36 hours and then subsided. Following the second dose of the vaccine, the patient initially experienced the similar side effects of fever, chills and body aches that lasted for a similar time frame. Then, on 15 Mar 2021, the patient began to have full body itchiness. No rash was present, but wherever she would itch would turn red and break out into hives. This continued and then on 20 Mar 2021, the patient was taken to the Emergency Room because she experienced tightness in her chest, chest pains and swelling in her lips. There she was treated for an allergic reaction to the vaccine. Some symptoms have improved but all are still present at the time of the report. Treatment details included Pepcid, Claritin D, Mailax, Prednisone, and Benadryl.; 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: SYNTHROID

Current Illness:

ID: 1188817
Sex: F
Age: 54
State: WV

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 04/10/2021
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: hearing loss from right ear; muffled hearing on right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (hearing loss from right ear) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Renal impairment NOS. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DEAFNESS UNILATERAL (hearing loss from right ear) (seriousness criterion medically significant) and PRESBYACUSIS (muffled hearing on right ear). At the time of the report, DEAFNESS UNILATERAL (hearing loss from right ear) and PRESBYACUSIS (muffled hearing on right ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. The patient was evaluated at the urgent care and found a wax plug in her ear. The patient was told it was a coincidence that it started at the same time after getting a shot and is not related to vaccine. Treatment for the events was not reported.; 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: Renal impairment NOS

ID: 1188818
Sex: M
Age: 66
State: TX

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: weakness; inability to rise; frequent urination; lack of taste for food/loss of sense of taste; inability to produce a bowel movement; inability to walk/inability to reach bathroom; blood sugar higher than normal; blood pressure higher than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (inability to walk/inability to reach bathroom), ASTHENIA (weakness), DYSSTASIA (inability to rise), POLLAKIURIA (frequent urination), AGEUSIA (lack of taste for food/loss of sense of taste) and CONSTIPATION (inability to produce a bowel movement) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (10 day hospitalization and administration of oxygen therapy) on 01-Nov-2020. Concurrent medical conditions included Hypertension and Diabetes mellitus. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (inability to walk/inability to reach bathroom) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), DYSSTASIA (inability to rise) (seriousness criterion hospitalization), POLLAKIURIA (frequent urination) (seriousness criterion hospitalization), AGEUSIA (lack of taste for food/loss of sense of taste) (seriousness criterion hospitalization) and CONSTIPATION (inability to produce a bowel movement) (seriousness criterion hospitalization). In March 2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to AGEUSIA, CONSTIPATION, DYSSTASIA, GAIT DISTURBANCE and POLLAKIURIA, and then from 03-Mar-2021 to 06-Mar-2021 due to ASTHENIA. On 06-Mar-2021, GAIT DISTURBANCE (inability to walk/inability to reach bathroom) and CONSTIPATION (inability to produce a bowel movement) had resolved. On 24-Mar-2021, ASTHENIA (weakness), DYSSTASIA (inability to rise) and AGEUSIA (lack of taste for food/loss of sense of taste) had resolved. At the time of the report, POLLAKIURIA (frequent urination), BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment History includes ER visit, hospitalization, IV fluids, IV medications, "injections for blood sugar", EKG, scope to check for blood clots, physical therapy. Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus; Sender's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus

Other Meds:

Current Illness: Diabetes mellitus; Hypertension

ID: 1188819
Sex: F
Age: 61
State: LA

Vax Date: 02/18/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
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: Fever; chills; Hyperexpanded lungs; Inflamed lungs; Pleural Effusion; Trouble breathing; Pain in her chest when taking deep breath; Liver numbers elevated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion), DYSPNOEA (Trouble breathing) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Hypertension and Cholesterol (Takes cholesterol medicine.). On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LUNG HYPERINFLATION (Hyperexpanded lungs) (seriousness criterion medically significant), PNEUMONITIS (Inflamed lungs) (seriousness criterion medically significant), PLEURAL EFFUSION (Pleural Effusion) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing) (seriousness criterion medically significant), NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) (seriousness criterion medically significant) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated). On 18-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 20-Mar-2021, PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) had resolved and DYSPNOEA (Trouble breathing) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: pleural effusion, inflamed and hyperexpanded lungs (abnormal) Pleural effusion, inflamed and hyperexpanded lungs. In March 2021, Liver function test: increased (Inconclusive) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products known to have been used by the patient, within two weeks prior to the event included high blood pressure medication and cholesterol medication. Treatment for the events included acetaminophen. 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: Cholesterol (Takes cholesterol medicine.); Hypertension

ID: 1188820
Sex: F
Age:
State: CA

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 04/10/2021
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: Bled down her leg; Hematoma on lower leg; Creepy; Rash on legs, hands, wrists, fingers; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers). At the time of the report, HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-059458 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of hemorrhage, and nonserious unexpected hematoma, feeling abnormal and expected rash. Event onset with unknown latency after first dose mRNA-1273. Events resolved. 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: 1188821
Sex: M
Age: 43
State: NV

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/10/2021
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: An episode of seizure; Syncope; Unconscious; Dizziness; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (An episode of seizure), SYNCOPE (Syncope) and LOSS OF CONSCIOUSNESS (Unconscious) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SEIZURE (An episode of seizure) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). On 23-Mar-2021, SEIZURE (An episode of seizure) and LOSS OF CONSCIOUSNESS (Unconscious) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: normal (normal) normal. On 23-Mar-2021, Computerised tomogram head: normal (normal) normal. On 23-Mar-2021, Electrocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Patient was taken to the emergency room (ER). Treatment included intravenous fluids.; Sender'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: 1188822
Sex: F
Age:
State: PA

Vax Date: 03/06/2021
Onset Date: 03/09/2021
Rec V Date: 04/10/2021
Hospital: Y

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: Atrial fibrillation; A spontaneous report was received from a consumer concerning a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation. The patient's medical history includes hypertension, cholesterol, and tachycardia. Concomitant product use provided was amiodarone for tachycardia and diltiazem. On 06-MAR-2021, approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:032M20A) via unknown route in an unspecified arm for prophylaxis of COVID-19 infection. Treatment details were not reported. On 09-MAR2-021 patient report she had she had an atrial fibrillation, resulting in hospitalization for 6 days. Action taken with mRNA-1273 in response to the event(s) was unknown. The outcome of the events, atrial fibrillation 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 this event, a causal relationship cannot be excluded.

Other Meds: AMIODARONE

Current Illness: Cholesterol; Hypertension; Tachycardia

ID: 1188823
Sex: F
Age: 61
State: MD

Vax Date: 03/26/2021
Onset Date: 03/29/2021
Rec V Date: 04/10/2021
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: Passed out; Arm is still sore; 102?F fever; This spontaneous case was reported by a health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (COVID-19 in November.) in November 2020. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102?F fever). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102?F fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Concomitant medications was not provided.; 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: 1188824
Sex: M
Age: 82
State: MA

Vax Date: 02/10/2021
Onset Date: 03/05/2021
Rec V Date: 04/10/2021
Hospital: Y

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: fell down the stairs; hit his head; Patient was reported to have low BP; lost his balance, which has been off lately; minor concussion; 47 days since patient received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head) and HYPOTENSION (Patient was reported to have low BP) in an 82-year-old male patient 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 No adverse event (No reported medical history). Concomitant products included HYDROCHLOROTHIAZIDE, PARACETAMOL (TYLENOL), NAPROXEN, DIPHENHYDRAMINE and SIMVASTATIN for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BALANCE DISORDER (lost his balance, which has been off lately) (seriousness criterion hospitalization), FALL (fell down the stairs) (seriousness criterion hospitalization), HEAD INJURY (hit his head) (seriousness criterion hospitalization) and HYPOTENSION (Patient was reported to have low BP) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONCUSSION (minor concussion) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose). The patient was hospitalized for 5 days due to BALANCE DISORDER and CONCUSSION. At the time of the report, BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head), HYPOTENSION (Patient was reported to have low BP) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: low (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. This report also refers to an event PT Product dose omission issue, lot # unknown. There were no AEs specifically associated with this medication error; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. This report also refers to an event PT Product dose omission issue, lot # unknown. There were no AEs specifically associated with this medication error

Other Meds: HYDROCHLOROTHIAZIDE; TYLENOL; NAPROXEN; DIPHENHYDRAMINE; SIMVASTATIN

Current Illness:

ID: 1188825
Sex: F
Age: 56
State: MD

Vax Date: 02/24/2021
Onset Date: 03/24/2021
Rec V Date: 04/10/2021
Hospital: Y

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: Anaphylactic shock after 10-15 minutes of the injection; Rapid heart rate of 166; shaking - mostly left arm and leg; super pale ? lost all her color; voice was off; itching; Rash from the top of the neck, all the way down to her back; teeth were majorly chattering; bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylactic reaction (anaphylactic reaction to sea food 15 years ago so) in 2006. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale ? lost all her color), DYSPHONIA (voice was off), PRURITUS (itching), RASH (Rash from the top of the neck, all the way down to her back), CHILLS (teeth were majorly chattering) and HEADACHE (bad headache). The patient was hospitalized for 1 day due to ANAPHYLACTIC SHOCK. On 24-Mar-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale ? lost all her color), DYSPHONIA (voice was off), RASH (Rash from the top of the neck, all the way down to her back) and CHILLS (teeth were majorly chattering) had resolved. At the time of the report, PRURITUS (itching) outcome was unknown and HEADACHE (bad headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: 166 (High) tachycardia. 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: 1188826
Sex: M
Age: 80
State: FL

Vax Date: 01/30/2021
Onset Date: 03/29/2021
Rec V Date: 04/10/2021
Hospital:

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: Skin cancer; received his 2nd dose today, 29Mar2021; A spontaneous report was received from a consumer concerning an 80-year old male patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin cancer and received his 2nd dose today, 29 Mar 2021. The patient's medical history was not provided. Concomitant medications included atorvastatin, metoprolol for blood pressure and acetylsalicylic acid. On 30 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 006B21A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, after receiving vaccine, the patient was made aware of his skin cancer and had to get the stitches removed and had his surgical appointment o the day his second dose was scheduled. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event Skin cancer was unknown. The event received his 2nd dose today, 29Mar2021 was considered to be reslved on 29 Mar 2021.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # 027L20A with no associated AEs. 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: ATORVASTATIN; METOPROLOL; BABY ASPIRIN

Current Illness:

ID: 1188827
Sex: F
Age: 74
State: IL

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

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: so close to having pneumonia; got sick after the shot; hacking cough; choking; missed the 42 day window; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (so close to having pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event.Concomitant medications were not provided. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (so close to having pneumonia) (seriousness criterion medically significant), MALAISE (got sick after the shot), COUGH (hacking cough), CHOKING (choking) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window). At the time of the report, PNEUMONIA (so close to having pneumonia), ILLNESS (got sick after the shot), COUGH (hacking cough), CHOKING (choking) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window) had not resolved. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender'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. This report also refers to a case of missed dose for mRNA-1273 (Moderna COVID-19 Vaccine) lot # unknown with no associated AEs.

Other Meds:

Current Illness:

ID: 1188828
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 04/10/2021
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: flares with autoimmune condition; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (flares with autoimmune condition) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012AUA and 017BUA) for COVID-19 vaccination. The patient's past medical history included Rheumatoid arthritis. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (flares with autoimmune condition) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (flares with autoimmune condition) outcome was unknown. Concomitant medication not provided. Treatment not provided. Reporter did not allow further contact; Sender'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: 1188829
Sex: F
Age: 55
State: OH

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 04/10/2021
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: dizzy; pukey; deaf in her left ear; water sounds in her ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (deaf in her left ear) in a 55-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 reported medical history). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DEAFNESS (deaf in her left ear) (seriousness criterion medically significant) and TINNITUS (water sounds in her ear). On an unknown date, the patient experienced DIZZINESS (dizzy) and NAUSEA (pukey). At the time of the report, DEAFNESS (deaf in her left ear), TINNITUS (water sounds in her ear), DIZZINESS (dizzy) and NAUSEA (pukey) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: not provided (Inconclusive) Not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-062183 (E2B Linked Report). This case was linked to MOD-2021-062183 (Patient Link).; Sender'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. US-MODERNATX, INC.-MOD-2021-062183:

Other Meds:

Current Illness:

ID: 1188830
Sex: F
Age: 72
State: NV

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 04/10/2021
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: trouble in breathing; congestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble in breathing) and NASAL CONGESTION (congestion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The patient's past medical history included Bronchitis and Shortness of breath (SOB). Concurrent medical conditions included Chronic obstructive pulmonary disease (COPD) and Smoker. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date (reported as few days after vaccination), the patient experienced DYSPNOEA (trouble in breathing) (seriousness criterion medically significant) and NASAL CONGESTION (congestion) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (trouble in breathing) and NASAL CONGESTION (congestion) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The treatment information included inhaler. Reporter did not allow further contact.; 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. However, patient's prior SOB, being a smoker and underlying bronchitis and COPD may have been contributory.

Other Meds:

Current Illness: Chronic obstructive pulmonary disease; Smoker

ID: 1188831
Sex: F
Age: 60
State: AZ

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 04/10/2021
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: none

Symptom List: Injection site pain, Pain

Symptoms: Experience exact symptoms of Covid19 virus as when I had it in Dec/2020. nausea, fever, cough, and body aches. It lasted 24 hours.

Other Meds: metrpolol, cardasartan

Current Illness: none

ID: 1188832
Sex: M
Age: 35
State: CA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 04/10/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Injection site pain, Menorrhagia

Symptoms: 4 hours after the vaccine shot on my left arm, my left eye started twitching. It happened a lot at first, and happened multiple times a day for 10-20 minutes at a time. After a couple weeks it slowed down to the point where it only happens every couple days. This absolutely did not happen before that exact day so I am relatively sure it was caused by the vaccine.

Other Meds: None

Current Illness: None

ID: 1188833
Sex: F
Age: 50
State: TX

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 04/10/2021
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: None

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

Symptoms: Pain Lump/swelling on neck (left side) Lump/swelling on Armpit (left hand) Constant pain

Other Meds: None

Current Illness: None

ID: 1188834
Sex: M
Age: 26
State: UT

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 04/10/2021
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: No

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Flu like symptoms, SEVERE muscle cramps. Loss of feeling in limbs. Headache and nausea. Lightheaded. Chills and shaking.

Other Meds: No

Current Illness: No

ID: 1188835
Sex: F
Age: 24
State: MS

Vax Date: 03/01/2021
Onset Date: 04/07/2021
Rec V Date: 04/10/2021
Hospital: Y

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: currently in hospital (ICU). Fainting, lightheadedness, extreme fatigue, petechiae, extremely low platelet count, possibly kidney damage, nose bleed, weakness,

Other Meds:

Current Illness:

ID: 1188836
Sex: M
Age: 45
State: WA

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 04/10/2021
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: None

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

Symptoms: Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.

Other Meds: Nexium, Hydroxyzine, Zyrtec, men's daily vitamin

Current Illness: None

ID: 1188837
Sex: F
Age: 50
State: FL

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 04/10/2021
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: Nausea

Symptoms: 3b kidney failure; hands were swollen; numb (hands); not eating because she gets kidney pains; lost 10 pounds; essential tremor got much worse; cannot work a 5 day week; This spontaneous case was reported by a health care professional and describes the occurrence of RENAL FAILURE (3b kidney failure) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038k20a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis. Concomitant products included HYDROXYZINE, TOLTERODINE, URO MP, MELOXICAM and CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (3b kidney failure) (seriousness criterion medically significant), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week). At the time of the report, RENAL FAILURE (3b kidney failure), PERIPHERAL SWELLING (hands were swollen), HYPOAESTHESIA (numb (hands)), RENAL PAIN (not eating because she gets kidney pains), WEIGHT DECREASED (lost 10 pounds), TREMOR (essential tremor got much worse) and IMPAIRED WORK ABILITY (cannot work a 5 day week) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the event included hydrochlorothiazide and propranolol. Reporter states has current medical condition autoimmune issues, Interstitial cystitis, essential tremor, spastic pelvic floor, arthritis. Reporter did not allow further contact; 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. The patient's current medical condition of autoimmune issues, interstitial cystitis, essential tremor, spastic pelvic floor, arthritis and product usage of NSAIDS remains confounders.

Other Meds: HYDROXYZINE; TOLTERODINE; URO MP; MELOXICAM; CYCLOBENZAPRIN

Current Illness:

ID: 1188838
Sex: F
Age: 39
State: PR

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 04/10/2021
Hospital:

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

Lab Data:

Allergies: Aspirin, sulfa

Symptom List: Injection site pain

Symptoms: Severe acid reflux

Other Meds: None

Current Illness: None

ID: 1188839
Sex: F
Age: 32
State: TX

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 04/10/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

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

Symptoms: Following morning severe upper arm pain and inability to move it. End up second day migraine, body aches, fever and diarrhea.

Other Meds:

Current Illness:

ID: 1188840
Sex: F
Age: 52
State: CA

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 04/10/2021
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: None

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

Symptoms: Some injection site discomfort in first 12 hours. 24 hours later increasing headache that became severe and lasted for two days. ( I am not prone to headaches, just mild sinus discomfort or slight hangover from alcohol) This headache was much worse. Arm pain increased as time progressed and spread farther in arm and even neck and lasted for 5 days. I felt tired for about 5 days. I had some mild headaches more than normal after the five days and until present. Added note. I don?t get sick often. I worked as a flight attendant for 28 years and exposed to lots of whatever. I don?t get sick with more than a little cough or something but never miss work. I felt pretty bad for 5 days after this vaccine.

Other Meds: Levothyroxin

Current Illness: None

ID: 1188841
Sex: F
Age: 22
State: TX

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 04/10/2021
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: none

Symptom List: Tremor

Symptoms: Moderna COVID- 19 Vaccine EUA 04/09/2021 2300hrs: chills, fatigue, muscle & body aches, headache, dizziness (did not alleviate at all- current time 04/10/2021 0300hrs... all symptoms started within minutes of each other)

Other Meds: fenugreek capsules; biotin capsules

Current Illness: none

ID: 1188842
Sex: F
Age: 74
State: CA

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 04/10/2021
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: Erythema, Pruritus

Symptoms: Blood clot; Fatigue extreme; muscle soreness; loss of appetite; Unable to get out of bed for four days so then they took her to the ER; Lack of circulation on legs due to blood clot produced a wound to develop in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) and FATIGUE (Fatigue extreme) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant), FATIGUE (Fatigue extreme) (seriousness criterion hospitalization), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg). The patient was hospitalized on 22-Mar-2021 due to FATIGUE and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clot), FATIGUE (Fatigue extreme), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1188843
Sex: F
Age: 84
State: TX

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
Hospital: Y

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: She fell after; This spontaneous case was reported by a consumer and describes the occurrence of FALL (She fell after) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FALL (She fell after) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on unspecified dates due to FALL. At the time of the report, FALL (She fell after) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1188844
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/10/2021
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: Signs of early anaphylaxis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician assistant and describes the occurrence of ANAPHYLACTIC REACTION (Signs of early anaphylaxis) in a patient of an unknown age and gender 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Signs of early anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Signs of early anaphylaxis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported treatment information was not provided by reporter Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1188845
Sex: F
Age:
State: TX

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 04/10/2021
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: Allergic reaction; Eyeballs were itching; Lump about the size of an egg at injection site; Whole body was red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant) and EYE PRURITUS (Eyeballs were itching). 29-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Lump about the size of an egg at injection site) and ERYTHEMA (Whole body was red). On 31-Mar-2021, EYE PRURITUS (Eyeballs were itching) had resolved. On 01-Apr-2021, HYPERSENSITIVITY (Allergic reaction) had resolved. At the time of the report, VACCINATION SITE SWELLING (Lump about the size of an egg at injection site) had resolved and ERYTHEMA (Whole body was red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information included patient was seen in emergency room and was given diphenhydramine and a steroid. She was released the same day. 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: 1188846
Sex: M
Age:
State: NY

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
Hospital: Y

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: Positive for Covid 19; Pneumonia; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for Covid 19) and PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced COVID-19 (Positive for Covid 19) (seriousness criterion hospitalization) and PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to 11-Mar-2021 due to COVID-19 and PNEUMONIA. At the time of the report, COVID-19 (Positive for Covid 19) and PNEUMONIA (Pneumonia) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant product use was not provided/unknown. Treatment for events included antibody therapy. Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.

Other Meds:

Current Illness:

ID: 1188847
Sex: M
Age:
State: MA

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
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: Congestion; Respiratory issues; Oxygen breathing is off; Sweats; Coughing; Fever 100 point something; Really tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 76-year-old male 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 Double vessel bypass graft. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea). At the time of the report, PULMONARY CONGESTION (Congestion), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 100 point (Inconclusive) 100 point. In March 2021, Respiratory rate: 92-96-97 (Inconclusive) 92-96-97. Concomitant product use was not provided by the reporter. Treatment information was unknown. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1188848
Sex: M
Age: 65
State: NY

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 04/10/2021
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: Extreme cellulitis in the left leg; swelling; was warm to the touch; severe redness; Pain in his joints; Developed a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Extreme cellulitis in the left leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LTH037A213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, SEVELAMER CARBONATE and FERRIC CITRATE (AURYXIA) for Dialysis, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever). On 20-Mar-2021, the patient experienced CELLULITIS (Extreme cellulitis in the left leg) (seriousness criteria hospitalization and medically significant), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch) and ERYTHEMA (severe redness). At the time of the report, CELLULITIS (Extreme cellulitis in the left leg), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch), ERYTHEMA (severe redness), ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment of the events included, vancomycin 1.25 g IV

Other Meds: INSULIN; LIPITOR; SEVELAMER CARBONATE; AURYXIA

Current Illness: Diabetes

ID: 1188849
Sex: F
Age:
State: AK

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 04/10/2021
Hospital:

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: Bell's Palsy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication included high doses of steroids.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1188850
Sex: M
Age: 69
State: IA

Vax Date: 02/13/2021
Onset Date: 03/15/2021
Rec V Date: 04/10/2021
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: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: loss of hearing right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (loss of hearing right ear) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DEAFNESS (loss of hearing right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (loss of hearing right ear) had not resolved. Additional information: On 15MAR2021 I went to the Emergency room. I then went to see an Ears Nose and Throat Doctor on 17MAR2021. The Doctor put me on Prednisone 60mg daily times one week. I then went to go see the Ears Nose and Throat Doctor again today 01APR2021and he gave me a steroid injection into my right ear.At this point the hearing has not returned to my right ear Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This case was linked to MOD-2021-065921 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1188851
Sex: M
Age: 75
State: CA

Vax Date: 03/10/2021
Onset Date: 03/12/2021
Rec V Date: 04/10/2021
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: Anger; High blood pressure; not being himself; Confused; Agitated; Combative, became aggressive; Crying, yelling, clapping; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGER (Anger), AGGRESSION (Combative, became aggressive) and MENTAL STATUS CHANGES (Crying, yelling, clapping) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 adverse event history.). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), ALLOPURINOL, DOXAZOSIN MESILATE (CARDURA), TELMISARTAN (MICARDIS) and AMLODIPINE. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ANGER (Anger) (seriousness criterion hospitalization), AGGRESSION (Combative, became aggressive) (seriousness criteria medically significant and life threatening), MENTAL STATUS CHANGES (Crying, yelling, clapping) (seriousness criterion medically significant), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated). On an unknown date, the patient experienced HYPERTENSION (High blood pressure). At the time of the report, ANGER (Anger), AGGRESSION (Combative, became aggressive), MENTAL STATUS CHANGES (Crying, yelling, clapping), HYPERTENSION (High blood pressure), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment of these events included Seroquel 400mg once a day. Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds: METFORMIN; LIPITOR; ALLOPURINOL; CARDURA; MICARDIS; AMLODIPINE

Current Illness:

ID: 1188852
Sex: F
Age:
State:

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

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: bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1.75 mg three times a day. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds: ORENITRAM

Current Illness: Pulmonary arterial hypertension

ID: 1188853
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 04/10/2021
Hospital:

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: Choking; arm was really sore; Feels sleepy all the time; retching/gagging; Feels tired/fatigue; Anxiety; Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHOKING (Choking) in a 74-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. Concurrent medical conditions included Pulmonary arterial hypertension since 12-Feb-2021 and Anxiety since 04-Mar-2021. Concomitant products included TREPROSTINIL SODIUM for Primary pulmonary hypertension. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. In February 2021, the patient experienced COUGH (Cough). On 04-Mar-2021, the patient experienced ANXIETY (Anxiety). On an unknown date, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), RETCHING (retching/gagging) and FATIGUE (Feels tired/fatigue). At the time of the report, CHOKING (Choking), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), ANXIETY (Anxiety) and FATIGUE (Feels tired/fatigue) outcome was unknown and COUGH (Cough) and RETCHING (retching/gagging) was resolving.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.

Other Meds: TREPROSTINIL SODIUM

Current Illness: Anxiety; Pulmonary arterial hypertension

ID: 1188854
Sex: F
Age: 59
State: GA

Vax Date: 02/18/2021
Onset Date: 03/18/2021
Rec V Date: 04/10/2021
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: L arm is extremely/absolutely unusable; Can't pick with the arm; Couldn't eat for 2 days; The worse migraine/ several migraine; Incredible inkiness; Intense pain neck and shoulder; Shutting pain in the hand; Doesn't sleeping; Spasm; Pain; Nauseas/ Felt nauseated; Pain in her L arm; Intense pain neck and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (L arm is extremely/absolutely unusable) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can't pick with the arm) in a 59-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 Aaterior cervical discectomy with fusion (Plate in neck). Concurrent medical conditions included Lupus syndrome. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Patient had sore arm afet the first dose. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LIMB INJURY (L arm is extremely/absolutely unusable) (seriousness criterion medically significant), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't pick with the arm) (seriousness criterion medically significant), APPETITE DISORDER (Couldn't eat for 2 days), MIGRAINE (The worse migraine/ several migraine), FEELING ABNORMAL (Incredible inkiness), NECK PAIN (Intense pain neck and shoulder), PAIN IN EXTREMITY (Shutting pain in the hand), INSOMNIA (Doesn't sleeping), NAUSEA (Nauseas/ Felt nauseated), VACCINATION SITE PAIN (Pain in her L arm), ARTHRALGIA (Intense pain neck and shoulder) and MYALGIA (Pain/ little spams). At the time of the report, LIMB INJURY (L arm is extremely/absolutely unusable), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't pick with the arm), APPETITE DISORDER (Couldn't eat for 2 days), MIGRAINE (The worse migraine/ several migraine), FEELING ABNORMAL (Incredible inkiness), NECK PAIN (Intense pain neck and shoulder), PAIN IN EXTREMITY (Shutting pain in the hand), INSOMNIA (Doesn't sleeping), NAUSEA (Nauseas/ Felt nauseated), VACCINATION SITE PAIN (Pain in her L arm), ARTHRALGIA (Intense pain neck and shoulder) and MYALGIA (Pain/ little spams) outcome was unknown. Since the second dose, the patient had been unable to eat because of the nauseas. The notable symptoms started about 8-10 hours later. She have LUPUS (pt thinks that is possible a different impact from covid shot in people with autoimmune disease). The vaccine triggered the worse migraine (several migraine) that She felt nauseated, incredible inkiness and pain in her L arm (couldn't move it, still now). Also the patient had intense pain in the neck and shoulder radiating to the other arm (R arm). The left arm is extremely/absolutely unusable. The elbow and the fingers in same arm, aren't disable to use. She can't pick with the arm, The patient stated never before experienced something like that. Several times,daily she had electrical pulse in her completely left arm, with little life in the right arm. Also had the same in her left leg (2 only or 3 times since the vaccine). She has a previous surgery). She felt shutting pain in the hand and she doesn't sleep because of the pain and the little spams. No concomitant medications provided. Treatment information includes took Aspirin, Tylenol or Advil and Nyquil. This case was linked to MOD-2021-066881 (Patient Link).; 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, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Lupus syndrome

ID: 1188855
Sex: M
Age: 21
State: TX

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 04/10/2021
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: tunnel vision for a bit which then went away; felt like fainting; tinging in his toes and left arm and fingers.; This spontaneous case was reported by a consumer and describes the occurrence of TUNNEL VISION (tunnel vision for a bit which then went away) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A217) 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 reported medical history). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TUNNEL VISION (tunnel vision for a bit which then went away) (seriousness criterion medically significant), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.). At the time of the report, TUNNEL VISION (tunnel vision for a bit which then went away), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment information were not reported.; Sender'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: 1188856
Sex: F
Age: 79
State: GA

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 04/10/2021
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: Worsening of neuropathy of feet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The patient's past medical history included Hyperlipidemia (Patient had elevated cholesterol), Osteoarthritis spinal (osteoarthritis Of spine), Hypothyroidism, Aortic aneurysm and Migraine. Concomitant products included ROSUVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Worsening of neuropathy of feet) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked. Reporter did not allow further contact; Sender'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: SYNTHROID; IMITREX [SUMATRIPTAN SUCCINATE]; ROSUVASTATIN

Current Illness:

ID: 1188857
Sex: M
Age: 55
State: NJ

Vax Date: 03/16/2021
Onset Date: 03/23/2021
Rec V Date: 04/10/2021
Hospital:

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: experienced blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (experienced blood clot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Factor V Leiden mutation. Concomitant products included RIVAROXABAN (XARELTO) for Factor V Leiden mutation. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced THROMBOSIS (experienced blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (experienced blood clot) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was treated with blood thinner Xarelto (rivaroxaban) on a daily basis for factor V mutation and was treated with the same for blood clot.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded

Other Meds: XARELTO

Current Illness: Factor V Leiden mutation

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm