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

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1301773
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ACHY; LEGS WERE LEAD; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced fever. On 04-MAY-2021, the subject experienced achy. On 04-MAY-2021, the subject experienced legs were lead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, achy and legs were lead was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301774
Sex: F
Age:
State: MD

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: TESTED NEGATIVE FOR IGG ANTIBODIES; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tested negative for igg antibodies. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) tested negative for spike specific IgG antibodies at Lab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested negative for igg antibodies was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301775
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ACHES AND PAINS; STRONG CHILLS; NAUSEA; TIREDNESS THAT NIGHT AND WAS TIRED NEXT DAY AS WELL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches and pains, strong chills, nausea, and tiredness that night and was tired next day as well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong chills, nausea, aches and pains and tiredness that night and was tired the next day as well was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301776
Sex: U
Age:
State: TX

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VOMITING; SORE THROAT; DIARRHEA; SORE ARMS; MINOR HEADACHES; This spontaneous report received from a patient concerned an 18 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vomiting. On 06-MAY-2021, the subject experienced sore throat. On 06-MAY-2021, the subject experienced diarrhea. On 06-MAY-2021, the subject experienced sore arms. On 06-MAY-2021, the subject experienced minor headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and the outcome of sore throat, diarrhea, minor headaches and sore arms was not reported. This report was non-serious

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1301777
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/10/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, and the outcome of headache and nausea was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301778
Sex: F
Age: 55
State: WI

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 05/10/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: BODY ACHES; FATIGUE; LOW-GRADE FEVER; RAPID HEART RACING; CHILLS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with ergocalciferol; and experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rapid heart racing. On 31-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.1 F, and Heart rate (NR: not provided) 120 bpm. Treatment medications included: ibuprofen. On 31-MAR-2021 16:00, the subject experienced low-grade fever. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 90 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, rapid heart racing, and fatigue on 01-APR-2021, and chills, and low-grade fever on 31-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301779
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/10/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: RED RASH ALL OVER BODY EXCEPT FACE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, sulfa allergy, and lobster allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced red rash all over body except face. Treatment medications included: menthol/zinc oxide, and triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash all over body except face. This report was non-serious.

Other Meds:

Current Illness: Allergic reaction to antibiotics; High cholesterol; Shellfish allergy

ID: 1301780
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY PAIN; ARM PAIN; TIREDNESS SENSATION; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body pain, arm pain, tiredness sensation, and headache. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, arm pain, tiredness sensation, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301781
Sex: F
Age:
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CHEST TIGHTNESS; MUSCLE SPASM; BODY ACHE; LEG AND ARM WARM TO TOUCH; SORE LEG AND ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no previous cardiac issues and was felt fine before receiving janssen covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced body ache. On 06-MAY-2021, the subject experienced leg and arm warm to touch. On 06-MAY-2021, the subject experienced sore leg and arm. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 - 101.5. On 06-MAY-2021 21:00, the subject experienced chest tightness. On 06-MAY-2021 21:00, the subject experienced muscle spasm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness, muscle spasm, fever, chills, body ache, leg and arm warm to touch and sore leg and arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301782
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/10/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SORE ARM; SLIGHT ANXIETY; HEADACHE; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included clotting disorder, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced sore arm. On MAY-2021, the subject experienced slight anxiety. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, low fever, sore arm and slight anxiety was not reported. This report was non-serious.

Other Meds:

Current Illness: Anxiety; Clotting disorder (Clotting disorder for 18 years)

ID: 1301783
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BOTH ARMS HURT IN THE SHOULDERS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced both arms hurt in the shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of both arms hurt in the shoulders was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301784
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: STOMACH ACHE; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis with rheumatoid factor of multiple site. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced stomach ache, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness and stomach ache was not reported. This report was non-serious.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1301785
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SICK; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced sick. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sick, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301786
Sex: U
Age:
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered to patient of inappropriate age was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301787
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY PAIN; JOINT PAIN; CHILLS; HEADACHE; SLIGHT FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache, slight fever, chills, body pain, joint pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, slight fever, chills, body pain, joint pain and fatigue was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301788
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: WHOLE BODY HURT; CHILLS; FEVER; BAD HEADACHE; PAIN MOVING DOWN ARM AS THE SHOT GIVEN; This spontaneous report received from a patient via a company representative concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain moving down arm as the shot given. On 07-APR-2021, the subject experienced whole body hurt. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced bad headache. On 07-APR-2021 18:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body hurt, pain moving down arm as the shot given, chills, fever, and bad headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301789
Sex: M
Age:
State: HI

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: OLU PATIENT POPULATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced OLU - subject population. On 06-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the OLU - patient population and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301790
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY WENT THROUGH HELL AND BACK ALL NIGHT; UNABLE TO SLEEP ALL NIGHT; BURNING UP/ FEELING HOT; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body went through hell and back all night, unable to sleep all night, burning up/ feeling hot, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, unable to sleep all night, body went through hell and back all night and burning up/ feeling hot was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1301791
Sex: F
Age: 75
State: IL

Vax Date: 01/26/2021
Onset Date: 03/01/2021
Rec V Date: 05/10/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine); Tingling on the left side of their body, especially in the face, toes and fingers; Knee pain; Body aching; Chills; Pain is so bad in arthritis areas/Shooting pain from the knees; By night she is a mess; She couldn't move; Freezing cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Arthritis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Body aching). In March 2021, the patient experienced PAIN (Pain is so bad in arthritis areas/Shooting pain from the knees), FEELING ABNORMAL (By night she is a mess), HYPOKINESIA (She couldn't move), FEELING COLD (Freezing cold) and CHILLS (Chills). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine)) (seriousness criterion hospitalization), PARAESTHESIA (Tingling on the left side of their body, especially in the face, toes and fingers) and ARTHRALGIA (Knee pain). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to HYPOAESTHESIA. At the time of the report, HYPOAESTHESIA (Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine)), PAIN (Pain is so bad in arthritis areas/Shooting pain from the knees), PARAESTHESIA (Tingling on the left side of their body, especially in the face, toes and fingers), FEELING ABNORMAL (By night she is a mess), HYPOKINESIA (She couldn't move), FEELING COLD (Freezing cold), MYALGIA (Body aching), CHILLS (Chills) and ARTHRALGIA (Knee pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Computerised tomogram head: normal (normal) normal. On an unknown date, Computerised tomogram neck: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal. Concomitant medications reported were diabetes medications. Treatment details included acetaminophen and ibuprofen. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Prior medical history of diabetes and arthritis may have been contributory for the occurrence of the events. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included reporter details, laboratory investigations, suspect product details, new adverse events, seriousness criteria and treatment medication details.

Other Meds:

Current Illness: Arthritis; Diabetes

ID: 1301792
Sex: F
Age: 57
State: TX

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/10/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: felt like she couldn't breath; Congestion nasal; a crackling cough; was very sick after receiving the first dose; described as having pain in the arm which had been injected.; sometimes gets lightheaded or dizzy; being very tired a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (felt like she couldn't breath) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Hypertension since an unknown date. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSPNOEA (felt like she couldn't breath) (seriousness criterion medically significant), NASAL CONGESTION (Congestion nasal), COUGH (a crackling cough), ILLNESS (was very sick after receiving the first dose), VACCINATION SITE PAIN (described as having pain in the arm which had been injected.), DIZZINESS (sometimes gets lightheaded or dizzy) and FATIGUE (being very tired a lot). At the time of the report, DYSPNOEA (felt like she couldn't breath), ILLNESS (was very sick after receiving the first dose) and DIZZINESS (sometimes gets lightheaded or dizzy) outcome was unknown, NASAL CONGESTION (Congestion nasal) had not resolved, COUGH (a crackling cough) was resolving and VACCINATION SITE PAIN (described as having pain in the arm which had been injected.) and FATIGUE (being very tired a lot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant drugs included blood pressure medication. Treatment Her local pharmacist suggested her to take Mucinex DM for the symptom. She started taking the suggested Mucinex DM therapy three nights ago. 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: Hypertension

ID: 1301793
Sex: M
Age: 64
State: VA

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 05/10/2021
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Symptoms: Felt sore all over; Mild temperature of 100.4 F; Delirious; Soreness of arm; Talking out of his head; Shaking; Was very cold; Got real hot; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Reports that the patient had done regeneron infusion on 02 Feb 2021). On 27-Apr-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold) and FEELING HOT (Got real hot). On 27-Apr-2021 at 11:00 PM, the patient experienced PYREXIA (Mild temperature of 100.4 F). On 28-Apr-2021, the patient experienced MYALGIA (Felt sore all over). At the time of the report, DELIRIUM (Delirious), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold), FEELING HOT (Got real hot), PYREXIA (Mild temperature of 100.4 F) and MYALGIA (Felt sore all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 100.4 Mild temperature of 100.4 F was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included the use of acetaminophen.; 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.

Other Meds:

Current Illness:

ID: 1301794
Sex: F
Age: 44
State: PA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 05/10/2021
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Symptoms: little bumps all over her face and body which are like measles; swollen eyes; watery eyes; Runny nose; Sneezing; Congestion on her chest; Dry eye socket; dry eye socket with crust on eyelashes; Headache; allergic reaction for a week/allergic reactions keep coming back; Ear feels full; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy. Concomitant products included LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced EAR DISCOMFORT (Ear feels full). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back). On an unknown date, the patient experienced PULMONARY CONGESTION (Congestion on her chest) (seriousness criterion medically significant), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (Congestion on her chest), HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), EAR DISCOMFORT (Ear feels full), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache) had not resolved. Treatments provided were 25mg diphenhydramine, 16mg Hydrocortisone cream, Metoprolol steroid, and Doxycycline for 7 days given by her HCP. Action taken with mRNA in respect to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events. This case was linked to MOD-2021-095202 (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 the events. However, the patient's past medical history of food allergies remains a risk factor for these events.

Other Meds: VICTOZA; LANTUS; EFFEXOR; LOSARTAN

Current Illness: Food allergy

ID: 1301795
Sex: F
Age: 44
State: PA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 05/10/2021
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Symptoms: congestion on her chest; having allergic reaction for a week.allergic reactions keep coming back; little bumps all over her face and body which are like measles after the vaccine; swollen eyes; watery eyes; runny nose; sneezing; ear feels full; dry eye socket with crust on eyelashes; Crust on eyelashes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Food allergy since an unknown date. Concomitant products included LIRAGLUTIDE, INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PULMONARY CONGESTION (congestion on her chest) (seriousness criterion medically significant), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (congestion on her chest), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment medications Provided were 25 mg Benadryl. 16 mg hydrocortisone cream. metoprolol steroid, and Doxycycline for 7 days given by her HCP. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-095089 (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 the events, a causal relationship cannot be excluded.

Other Meds: LIRAGLUTIDE; LANTUS; EFFEXOR; LOSARTAN

Current Illness: Food allergy

ID: 1301796
Sex: M
Age: 65
State:

Vax Date: 01/10/2018
Onset Date: 03/30/2021
Rec V Date: 05/10/2021
Hospital: Y

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Symptoms: His oxygen dropped to 88%; Bronchitis, upper bronchitis infection; Meory issues, words wouldn't go together; Sleep apnea, snoring a lot; COPD; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) in a 68-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. Co-suspect product included non-company product AMANTADINE for an unknown indication. The patient's past medical history included Dyskinesia. Concurrent medical conditions included Parkinson's disease. Concomitant products included RASAGILINE MESYLATE, PARACETAMOL (TYLENOL), CARBIDOPA, LEVODOPA (SINEMET), MIRABEGRON (MYRBETRIQ) and DESMOPRESSIN for an unknown indication. On 10-Jan-2018, the patient started AMANTADINE (unknown route) 68.5 mg once a day. On 17-Jan-2018, AMANTADINE (unknown route) dosage was changed to 137 mg once a day. On 26-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) (seriousness criterion hospitalization). On an unknown date, the patient experienced BRONCHITIS (Bronchitis, upper bronchitis infection), DISORGANISED SPEECH (Meory issues, words wouldn't go together), SLEEP APNOEA SYNDROME (Sleep apnea, snoring a lot) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). The patient was hospitalized from 30-Mar-2021 to 04-Apr-2021 due to OXYGEN SATURATION DECREASED. At the time of the report, OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) and BRONCHITIS (Bronchitis, upper bronchitis infection) had resolved and DISORGANISED SPEECH (Meory issues, words wouldn't go together), SLEEP APNOEA SYNDROME (Sleep apnea, snoring a lot) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: Negative. On 24-Dec-2020, X-ray: (Inconclusive) Chest x-ray continued. On 31-Dec-2020, SARS-CoV-2 test: Negative. On 30-Mar-2021, SARS-CoV-2 test: Negative. On 30-Mar-2021, X-ray: Result not provided. On an unknown date, Oxygen saturation: 98%. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medication also includes RYTARY (CARBIDOPA; LEVODOPA) Capsule, 95 mg. The patient was treated each time with unspecified steroids and antibiotics.The infection would seem to resolve then came right back. On a subsequent unspecified date, the patient visited a pulmonologist and was put on a different round of unspecified steroids, nebulizers and antibiotics and finally the bronchitis infection resolved 100%. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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: RASAGILINE MESYLATE; TYLENOL; SINEMET; MYRBETRIQ; DESMOPRESSIN

Current Illness: Parkinson's disease

Date Died: 04/23/2021

ID: 1301797
Sex: F
Age: 62
State: PA

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 05/10/2021
Hospital: Y

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Symptoms: Renal failure; Liver failure; Unresponsive; Died; Stomach pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive), DEATH (Died), RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) in a 62-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 Primary biliary cirrhosis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced DEATH (Died) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criterion hospitalization) and HEPATIC FAILURE (Liver failure) (seriousness criterion hospitalization). On 23-Apr-2021, RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) had resolved and NAUSEA (Nausea) outcome was unknown. The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. The concomitant medication included liver medications, as reported by the reporter. On 07Apr2021 around 1230pm, the patient experienced stomach pain and nausea which the family attributed to her liver medications. The patient went to sleep later that evening. The next day, 08Apr2021, the patient was found to be sleeping around 8am but was unresponsive around 1:30pm. She was taken by ambulance to the local hospital. The patient was eventually placed on life support and passed on 23Apr2021. No other treatment medication were reported. Company comment: Very limited information regarding this events has been provided at this time. However, 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. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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. Further information has been requested.; Reported Cause(s) of Death: unkown cause of death

Other Meds:

Current Illness: Primary biliary cirrhosis

ID: 1301798
Sex: F
Age: 61
State: IL

Vax Date: 03/08/2021
Onset Date: 12/01/2020
Rec V Date: 05/10/2021
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Symptoms: This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) in a 61-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. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for an unknown indication, AZITHROMYCIN (Z-PAK) for an unknown indication and OXYBUTYNIN for an unknown indication. The patient's past medical history included Back pain in 2018. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe). In 2013, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form every two weeks. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free, UNK., PROMETHAZINE (PHENERGAN [PROMETHAZINE]) (Subcutaneous) at an unspecified dose, AZITHROMYCIN (Z-PAK) (unknown route) at an unspecified dose and OXYBUTYNIN (unknown route) at an unspecified dose. In December 2020, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare) (seriousness criterion medically significant). On 04-Mar-2021, the patient experienced NASAL CONGESTION (Stuffy nose) and HYPERSENSITIVITY (Allergy symptoms). In March 2021, the patient experienced ARTHRITIS (Arthritis) and PERIPHERAL SWELLING (One leg swollen). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Had rash near eye / rash that looked like red bites / left leg and right arm rash), ADVERSE DRUG REACTION (Reaction to Humira with COVID vaccine with Humira), DRUG INTERACTION (Reaction to Humira with COVID vaccine with Humira), FEELING HOT (Got real hot after taking Phenergan), FEELING ABNORMAL (Feeling bad), INFLAMMATION (Inflammation), NASOPHARYNGITIS (Cold), MUSCLE SPASMS (Knee cramping), MUSCULOSKELETAL DISCOMFORT (Disk in back bothering/bother/woke up with upper back was bothering and cause discomfort), INTERVERTEBRAL DISC DISORDER (Discopathy), NECK PAIN, FUNGAL SKIN INFECTION (Yeast infection under breast and abdomen), LEFT EYE SWELLING, UNEVALUABLE EVENT, PRURITUS (Itching on arms and legs), DIARRHOEA (Diarrhea), INJECTION SITE PRURITUS (Arm itched real bad after COVID vaccine) and NAUSEA (Nauseous). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare), FEELING ABNORMAL (Feeling bad), MUSCLE SPASMS (Knee cramping), HYPERSENSITIVITY (Allergy symptoms) and PERIPHERAL SWELLING (One leg swollen) had not resolved, RASH ERYTHEMATOUS (Had rash near eye / rash that looked like red bites / left leg and right arm rash) and INJECTION SITE PRURITUS (Arm itched real bad after COVID vaccine) had resolved, ADVERSE DRUG REACTION (Reaction to Humira with COVID vaccine with Humira), DRUG INTERACTION (Reaction to Humira with COVID vaccine with Humira), FEELING HOT (Got real hot after taking Phenergan), NASAL CONGESTION (Stuffy nose), FUNGAL SKIN INFECTION (Yeast infection under breast and abdomen), UNEVALUABLE EVENT (unevaluable event), DIARRHOEA (Diarrhea) and NAUSEA (Nauseous) was resolving and INFLAMMATION (Inflammation), ARTHRITIS (Arthritis), NASOPHARYNGITIS (Cold), MUSCULOSKELETAL DISCOMFORT (Disk in back bothering/bother/woke up with upper back was bothering and cause discomfort), INTERVERTEBRAL DISC DISORDER (Discopathy), NECK PAIN (Neck pain), EYE SWELLING (Left eye swelling) and PRURITUS (Itching on arms and legs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, X-ray: arthritis (abnormal) Arthritis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INJECTION SITE PRURITUS (Arm itched real bad after COVID vaccine) to be possibly related and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare), RASH ERYTHEMATOUS (Had rash near eye / rash that looked like red bites / left leg and right arm rash), DRUG INTERACTION (Reaction to Humira with COVID vaccine with Humira), FEELING HOT (Got real hot after taking Phenergan), FEELING ABNORMAL (Feeling bad), INFLAMMATION (Inflammation), NASAL CONGESTION (Stuffy nose), ARTHRITIS (Arthritis), NASOPHARYNGITIS (Cold), MUSCLE SPASMS (Knee cramping), HYPERSENSITIVITY (Allergy symptoms), PERIPHERAL SWELLING (One leg swollen), MUSCULOSKELETAL DISCOMFORT (Disk in back bothering/bother/woke up with upper back was bothering and cause discomfort), INTERVERTEBRAL DISC DISORDER (Discopathy), NECK PAIN (Neck pain), FUNGAL SKIN INFECTION (Yeast infection under breast and abdomen), EYE SWELLING (Left eye swelling), UNEVALUABLE EVENT, PRURITUS (Itching on arms and legs), DIARRHEA and NAUSEA to have a relationship that was not reported, ADVERSE DRUG REACTION (Reaction to Humira with COVID vaccine with Humira) to be not applicable. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. On an unknown date, the patient received her first dose of the COVID-19 Vaccine/Placebo manufactured by Moderna. On an unknown date, the patient received her second dose of the COVID-19 vaccine, manufactured by Moderna. Promethazine (PHENERGAN), azithromycin (Z-PAK), Oxybutynin, and adalimumab (HUMIRA) were also considered suspect. Concomitant drugs were not reported. The patient was treated with hydrocodone, prednisone, tramadol and loperamide (IMODIUM). On an unknown date, the pain scale was 8. On an unknown date, the patient underwent a vitamin D test to check for gout and a uric acid test (results not provided). This case concerns a 61-year-old female with a serious unexpected event of rheumatoid arthritis flare up, and multiple nonserious unexpected events including hypersensitivity, arthritis, rash erythematous, drug interaction, and inflammation. Latency unknown after mRNA-1273. She received both first and second doses. 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. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded.; Sender's Comments: This case concerns a 61-year-old female with a serious unexpected event of rheumatoid arthritis flare up, and multiple nonserious unexpected events including hypersensitivity, arthritis, rash erythematous, drug interaction, and inflammation. Latency unknown after mRNA-1273. She received both first and second doses. 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: Moderna COVID-19 Vaccine; HUMIRA

Current Illness: Rheumatoid arthritis (Moderate to severe)

ID: 1301799
Sex: F
Age: 54
State: NH

Vax Date: 04/30/2021
Onset Date: 05/07/2021
Rec V Date: 05/10/2021
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Allergies: None

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Symptoms: Rash developed on injection site arm below actual injection area, 7 days post injection. Started as quarter sized area with raised burning/itchy bumps, red and warm to the touch. Coverage area slowly grew throughout the day and became swollen. Day 2 area of rash was a good portion of outer bicep area, accompanied with fever, chills and aches. Fever, chills and aches subsided in 24 hours. Red, itchy, swollen rash continued to spread so that on day 3 it covered most of upper arm, wrapping all the way around. Today is day 4 and swelling is subsiding but redness & itch are still present and it still slowly spreading a little. May contact my pcp today

Other Meds: Chlorthalidone Metoprolol Tartrate Potassium Vitamin D3 & E Multivitamin Magnesium Glucosamine Ashwagandha

Current Illness: None

ID: 1301800
Sex: F
Age: 64
State: NJ

Vax Date: 05/08/2021
Onset Date: 05/09/2021
Rec V Date: 05/10/2021
Hospital: Y

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Allergies: Penicillin

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Symptoms: STEMI that occurred 24 hours after vaccination. Suspect coincidental but temporally related.

Other Meds: I don?t have a full list of the patient?s medications available at this time. Also, the case is complicated because she is currently receiving chemotherapy for lung cancer. She is apparently on aspirin, a statin, and multiple medications fo

Current Illness: Currently receiving chemotherapy for lung cancer (likely stage 4).

ID: 1301803
Sex: F
Age: 36
State: AZ

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 05/10/2021
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Allergies: Sulphur, preservative used to make ranch dressing, kiwi fruit

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Symptoms: Almost instantaneous ovary pains, blood clots passing vaginally, abnormal vaginal bleeding for two weeks

Other Meds: Type 1 diabetic- humalog, lantus, levothyroxine, acylovir, Estraylla, vitamin c, vitamin a, probiotic

Current Illness: Hsv2, hypothyroidism, juvenile type 1 diabetic

ID: 1301804
Sex: M
Age: 86
State: IL

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 05/10/2021
Hospital: Y

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Symptoms: fluid overload; fatigue; Swollen lymph nodes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUID OVERLOAD (fluid overload) in an 86-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. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia. Concurrent medical conditions included Allergic reaction to drug, Chronic lymphocytic leukemia, Blood pressure high, Swollen lymph nodes, Swelling, Fatigue, Allergy to chemicals and Fruit allergy (Cantaloupes). Concomitant products included ATENOLOL for Blood pressure high, COENZYME Q10 [UBIDECARENONE], TURMERIC [CURCUMA LONGA RHIZOME], SELENIUM, VITAMIN D3, VITAMIN B COMPLEX, CALCIUM and FISH OIL for Supplementation therapy. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 03-Apr-2021, the patient experienced FLUID OVERLOAD (fluid overload) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to FLUID OVERLOAD. At the time of the report, FLUID OVERLOAD (fluid overload) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: 182 pounds 182 Pounds. On an unknown date, Weight: 194 pounds 194 Pounds. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The reporter stated, the patient had been taking Imbruvica for the treatment of chronic lymphocytic leukemia for almost one month, but he complained that the drug had not helped to reduce the swelling, which might be caused by swollen lymph nodes. The swelling started before he started to take Imbruvica. The patient also said that the Imbruvica had not helped with his fatigue. He emphasized that he had no side effects from Imbruvica. On 03-Apr-2021, the patient was hospitalized for fluid overload, and 4.9 liters of fluid was removed from his body. He was discharged on 05-Apr-2021 to go home with a prescription of furosemide, to be taken orally daily, for the treatment of fluid overload. When he was admitted to the hospital, he weighed 194 pounds. When he was discharged from the hospital, he weighed 182 pounds. 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 chronic lymphocytic leukemia is a cofounder; 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 chronic lymphocytic leukemia is a cofounder

Other Meds: ATENOLOL; COENZYME Q10 [UBIDECARENONE]; TURMERIC [CURCUMA LONGA RHIZOME]; SELENIUM; VITAMIN D3; VITAMIN B COMPLEX; CALCIUM; FISH OIL

Current Illness: Allergic reaction to drug; Allergy to chemicals; Blood pressure high; Chronic lymphocytic leukemia; Fatigue; Fruit allergy (Cantaloupes); Swelling; Swollen lymph nodes

ID: 1301805
Sex: F
Age: 59
State: IA

Vax Date: 02/07/2021
Onset Date: 02/10/2021
Rec V Date: 05/10/2021
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Allergies: Seasonal allergies

Symptom List:

Symptoms: Chronic cough lasting over 12 weeks

Other Meds: Losartan/HCTZ. 50/12.5 mg Estradial transdermal .1 mg, 81mg aspirin, lotridine10mg nature made vitamin D

Current Illness:

ID: 1301806
Sex: F
Age: 52
State: NY

Vax Date: 05/03/2021
Onset Date: 05/04/2021
Rec V Date: 05/10/2021
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Allergies: Almonds

Symptom List:

Symptoms: Starting from midnight, i experienced fever and body aches. In am i had extreme dizziness and vomited. I also experienced extreme weakness. Fever continued past following midnight. Stomach upset was noted. Following day i still experienced extreme fatigue and weakness.

Other Meds: Levothyroxine 50mcg

Current Illness: N/a

ID: 1301807
Sex: F
Age: 36
State: OH

Vax Date: 05/08/2021
Onset Date: 05/09/2021
Rec V Date: 05/10/2021
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Allergies: Allergic to penicillin.

Symptom List:

Symptoms: Soreness at injection site, swollen lymph node under armpit near injection site, fever of 100.2, headache, fatigue, loss of appetite, muscle soreness.

Other Meds: Omeprazole, Claritin, Flonase, Women?s Multivitamin, Vitamin D supplement.

Current Illness: Common cold approx. which resolved 1 week prior to vaccination.

ID: 1301808
Sex: F
Age: 43
State: AZ

Vax Date: 04/09/2021
Onset Date: 04/22/2021
Rec V Date: 05/10/2021
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Allergies: None

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Symptoms: immediately after dose arm was sore as expected. This subsided within several days. No additional issues were noted until day 13 post dose when I suddenly felt an onset of a raised, warm, reddened area that was very sore and achy. Being a nurse I recognized this as cellulitis. I managed on my own as it was the weekend and I could only go to an ER which seemed unnecessary or the urgent care, which I knew would be busy. It subsided within two or three days

Other Meds: None

Current Illness: None

ID: 1301809
Sex: F
Age: 46
State: IN

Vax Date: 05/06/2021
Onset Date: 05/08/2021
Rec V Date: 05/10/2021
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Allergies: none

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Symptoms: After two days, my arm began to swell, itch, turned red and felt hot to the touch.

Other Meds: none

Current Illness: none

ID: 1301810
Sex: M
Age: 49
State: CA

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

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Lab Data:

Allergies: No

Symptom List:

Symptoms: Dizziness

Other Meds: No

Current Illness: No

ID: 1301811
Sex: F
Age: 79
State: NC

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 05/10/2021
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Symptom List:

Symptoms: Error: Booster Given Too Early

Other Meds:

Current Illness:

ID: 1301812
Sex: F
Age: 21
State: GA

Vax Date: 05/08/2021
Onset Date: 05/09/2021
Rec V Date: 05/10/2021
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Allergies: Kiwis and sun sensitivity

Symptom List:

Symptoms: Sudden rash and red welts all over body and worsening on arms, spreading across face and legs.

Other Meds: Nexplanon

Current Illness: UTI - medicated with sulfamethoxazole-trimethoprim 800-160 mg tablet

ID: 1301813
Sex: M
Age: 34
State: VA

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 05/10/2021
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Symptoms: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Tachycardia-Mild

Other Meds:

Current Illness:

ID: 1301814
Sex: F
Age: 44
State: PA

Vax Date: 03/11/2021
Onset Date: 03/16/2021
Rec V Date: 05/10/2021
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Allergies: None know.

Symptom List:

Symptoms: 3/12/21 fatigue, brain fog, chills for about 12 hours as expected 3/16-3/21 extreme fatigue 3/21-3/22 stomach upset, dizziness, severe anxiety and panic 3/27/21 ER visit due to anxiety and panic; prescribed Ativan with no tests run 3/23- present Severe anxiety and panic, depression, heart burn, diahhrea, dizziness, headaches, weight loss of 20 lbs (unintentional), lack of appetite, insomnia, fatigue On 4/16/21 I had my thyroid levels checked. TSH in a October 2020 was 1.42. On 4/16/21 it was 0.21. Ultrasound of thyroid on 4/30/21 showed normal thyroid but 3 measurable calcium deposits on the side of the thyroid that are now being monitored. I have been unable to work on-site in school due to the anxiety and panic. I?ve tried 2 different anxiety meds but unable to take due to side effects.

Other Meds: LoLoEstrin (birth control), monteklaust, synthroid, pravastatin, multivitamin, nasacort

Current Illness: None

ID: 1301815
Sex: M
Age: 36
State: KY

Vax Date: 05/09/2021
Onset Date: 05/09/2021
Rec V Date: 05/10/2021
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Symptoms: Error: Improper Storage (temperature)

Other Meds:

Current Illness:

ID: 1301816
Sex: F
Age: 37
State: WA

Vax Date: 05/09/2021
Onset Date: 05/09/2021
Rec V Date: 05/10/2021
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Symptoms: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: BP 112/70 HR 65 bpm

Other Meds:

Current Illness:

ID: 1301817
Sex: F
Age: 24
State: CA

Vax Date: 05/09/2021
Onset Date: 05/09/2021
Rec V Date: 05/10/2021
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Symptoms: Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium

Other Meds:

Current Illness:

ID: 1301818
Sex: M
Age: 47
State: TX

Vax Date: 03/19/2021
Onset Date: 05/07/2021
Rec V Date: 05/10/2021
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Allergies: None

Symptom List:

Symptoms: Extreme pain left shoulder, burning and radiant feeling. It lasted for 2 days. I went to urgent care facility, got X-rays and ekg, results were normal. Pain was onset by a common cold, sore throat and aphonia.

Other Meds: Ibuprofen

Current Illness: None

ID: 1301819
Sex: F
Age: 65
State: IL

Vax Date: 01/02/2021
Onset Date: 01/03/2021
Rec V Date: 05/10/2021
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Symptoms: Rheumatoid arthritis; Lack of drug effect; Nodule on extremity; Early morning stiffness; Tiredness; Headache; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Nodule in January 2019, Smoker (Non Tobacco smoking) and Abstains from alcohol. Concurrent medical conditions included Sulfonamide allergy (The sulfa drug allergy was rash), Peanut allergy (The peanut allergy was rash) and Drug allergy (The ACE Inhibitors allergy was chest tightness). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Stiffness and Rheumatoid arthritis. In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 40 mg. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 40 mg. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 30-Jan-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). In February 2021, the patient experienced NODULE (Nodule on extremity) and MUSCULOSKELETAL STIFFNESS (Early morning stiffness). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Lack of drug effect). On 05-Jan-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 31-Jan-2021, HEADACHE (Headache) had resolved. On 01-Feb-2021, FATIGUE (Tiredness) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) outcome was unknown, NODULE (Nodule on extremity) and MUSCULOSKELETAL STIFFNESS (Early morning stiffness) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Pain in arm), FATIGUE (Tiredness) and HEADACHE (Headache) to be probably related and NODULE (Nodule on extremity) and MUSCULOSKELETAL STIFFNESS (Early morning stiffness) to be not related. No further causality assessments were provided for RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with prednisone and paracetamol. Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Very limited information regarding this events has been provided at this time. However, this patient's age, gender, and medical history (nodule) remains a confounders. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, this patient's age, gender, and medical history (nodule) remains a confounders. Further information has been requested.

Other Meds: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Drug allergy (The ACE Inhibitors allergy was chest tightness); Peanut allergy (The peanut allergy was rash); Sulfonamide allergy (The sulfa drug allergy was rash)

ID: 1301820
Sex: M
Age: 59
State: NC

Vax Date: 03/06/2021
Onset Date: 03/10/2021
Rec V Date: 05/10/2021
Hospital: Y

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Symptom List:

Symptoms: nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code; pain was plank like kidney stones pain; throwing up black vomit; running a small fever; nod on the side where he got the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code) and FLANK PAIN (pain was plank like kidney stones pain) in a 59-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 was provided. Concomitant products included SIMVASTATIN (ZOCOR), VALSARTAN and METFORMIN for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code) (seriousness criterion hospitalization), FLANK PAIN (pain was plank like kidney stones pain) (seriousness criterion hospitalization) and VACCINATION SITE INDURATION (nod on the side where he got the injection). On 16-Mar-2021, the patient experienced PYREXIA (running a small fever). On an unknown date, the patient experienced VOMITING (throwing up black vomit). The patient was hospitalized on 16-Mar-2021 due to FLANK PAIN and PAIN. At the time of the report, PAIN (nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code), FLANK PAIN (pain was plank like kidney stones pain), VACCINATION SITE INDURATION (nod on the side where he got the injection), VOMITING (throwing up black vomit) and PYREXIA (running a small fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: (High) blood glucose was high. In 2021, Blood pressure measurement: (High) spike in blood pressure. In 2021, Norepinephrine increased: (High) spike in his norepinephrine level. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: ZOCOR; VALSARTAN; METFORMIN

Current Illness:

ID: 1301821
Sex: M
Age: 57
State: NY

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

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Symptom List:

Symptoms: Could be a minor brain injury; Left side of the body got paralyzed on his leg and whole arm; Some pain in the right arm; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) and BRAIN INJURY (Could be a minor brain injury) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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 HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) (seriousness criterion hospitalization), BRAIN INJURY (Could be a minor brain injury) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (Some pain in the right arm). The patient was hospitalized on 02-Apr-2021 due to HEMIPLEGIA, and then on 02-Apr-2021 due to BRAIN INJURY. At the time of the report, HEMIPLEGIA (Left side of the body got paralyzed on his leg and whole arm) and BRAIN INJURY (Could be a minor brain injury) outcome was unknown and VACCINATION SITE PAIN (Some pain in the right arm) 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. No concomitant medication provided. Treatment information mentioned post hospitalization rehab and physical therapy. Due to the paralysis, patient mentioned walking using a cane. Treatment medications included Aspirin 81mg one per day, Atorvastatin 80mg one per day, Lisinopril 10mg, Amlodipine 10mg, Hydralazine 25mg. He mentioned was thinking of cancelling the second dose. Company Comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events hemiplegia and vaccination site pain, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety profile. There is not enough information to assess the event of brain injury as it was not specified.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events hemiplegia and vaccination site pain, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety profile. There is not enough information to assess the event of brain injury as it was not specified.

Other Meds:

Current Illness:

ID: 1301822
Sex: F
Age: 71
State: PA

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 05/10/2021
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Symptoms: Has a little cold; Bones started to hurt; Very weak; Injection arm soreness; Very tired/Feels a little tired; Fever of 108F/105F; Headache; Body aching; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever of 108F/105F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. Concomitant products included DOXEPIN for Sleep disorder NOS, OLOPATADINE, ONDANSETRON, LOSARTAN POTASSIUM, TRAMADOL, MONTELUKAST SODIUM, MOMETASONE FUROATE, HYDROCHLOROTHIAZIDE, CHOLESTEROL, PANTOPRAZOLE, METFORMIN, ALENDRONATE SODIUM, METOPROLOL, OXYBUTYNIN, LORAZEPAM, CYANOCOBALAMIN and CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE VITAMIN D3) for an unknown indication. On 30-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HYPERPYREXIA (Fever of 108F/105F) (seriousness criterion medically significant). 30-Apr-2021, the patient experienced PAIN (Body aching) and HEADACHE (Headache). On 01-May-2021, the patient experienced BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN IN EXTREMITY (Injection arm soreness) and FATIGUE (Very tired/Feels a little tired). On 02-May-2021, the patient experienced NASOPHARYNGITIS (Has a little cold). At the time of the report, HYPERPYREXIA (Fever of 108F/105F), NASOPHARYNGITIS (Has a little cold), BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN (Body aching), PAIN IN EXTREMITY (Injection arm soreness), HEADACHE (Headache) and FATIGUE (Very tired/Feels a little tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included benzonate. The patient applied cold compress and took diphenhydramine medication as treatment. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Based on the additional information received, additional events (including a serious event), concomitant medications and treatment information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: OLOPATADINE; ONDANSETRON; LOSARTAN POTASSIUM; TRAMADOL; MONTELUKAST SODIUM; MOMETASONE FUROATE; HYDROCHLOROTHIAZIDE; CHOLESTEROL; PANTOPRAZOLE; DOXEPIN; METFORMIN; ALENDRONATE SODIUM; METOPROLOL; OXYBUTYNIN; LORAZEPAM; CYANOCOBALAMIN; CALCI

Current Illness: Asthma

ID: 1301823
Sex: F
Age:
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Vax Date: 02/26/2021
Onset Date: 04/07/2021
Rec V Date: 05/10/2021
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Symptoms: 20% hearing loss; Ringing in the ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (20% hearing loss) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A. and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced DEAFNESS (20% hearing loss) (seriousness criterion medically significant) and TINNITUS (Ringing in the ear). At the time of the report, DEAFNESS (20% hearing loss) and TINNITUS (Ringing in the ear) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication included Prednisone. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1301824
Sex: M
Age: 70
State: UT

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 05/10/2021
Hospital: Y

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Lab Data:

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Symptoms: Diagnosed with Achalasia; He also lost about 40 pound; Chills; Fever; Throwing up Has trouble keeping food and water down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A 2(Z)1A and 041L(C)20D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gastroesophageal reflux disease in 2020. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (He also lost about 40 pound), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up Has trouble keeping food and water down). At the time of the report, OESOPHAGEAL ACHALASIA (Diagnosed with Achalasia), ABNORMAL LOSS OF WEIGHT (He also lost about 40 pound), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up Has trouble keeping food and water down) outcome was unknown. Concomitant product use was not reported. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The causality assessment was not provided. Patient called on 03MAY2021 to report that on 20JAN2021 he received his 1st dose of the Moderna vaccine and 23FEB2021 he received his 2nd dose. After the 2nd dose he experienced chills, fever and had been throwing up. He said he had been having trouble keeping food and water down and it has gotten worse. He also lost 40 pounds. Patient saw a gastroenterologist and had tests done April, 2021. The specialist said patient's esophagus is not functioning well and diagnosed him with Achalasia. Patient is scheduled for further consultation and potential surgery in August 2021 with a Specialist. Patient also stated he had GERDS Reflux about a year ago (2020).; 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.

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Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm