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
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1563396
Sex: M
Age: 77
State: PA

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: First vaccine, he only had chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (First vaccine, he only had chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 022M20A) for COVID-19 vaccination. The patient's past medical history included Surgery (Cataract surgery). Concurrent medical conditions included Drug allergy (Allergic to Versed Anastacia). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 CHILLS (First vaccine, he only had chills). At the time of the report, CHILLS (First vaccine, he only had chills) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-036258 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-036258:Dose 2

Other Meds:

Current Illness: Drug allergy (Allergic to Versed Anastacia)

ID: 1563397
Sex: M
Age: 24
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: both of his arm are red; shaky; Warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm). At the time of the report, ERYTHEMA (both of his arm are red), NERVOUSNESS (shaky) and VACCINATION SITE WARMTH (Warm) outcome was unknown. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Action taken with mRNA-1273 in response to the events was not reported.

Other Meds:

Current Illness:

ID: 1563398
Sex: F
Age:
State: NC

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: Red Bumps; Itching; Soreness; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain (soreness), injection site erythema (red bumps) and pruritus (itching). On 25 Feb 2021, approximately 9 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) through an unknown route for prophylaxis of COVID-19 infection. On 25 Feb 2021, after vaccination, the patient experienced soreness. On 6 Mar 2021, the patient stated experiencing injection site itchy and had red bumps. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, soreness was resolved on 26 Feb 2021. The outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1563399
Sex: F
Age: 89
State: CA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Legs aching terribly; Difficulty walking; Severe muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Solitary kidney. In February 2021, the patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain). At the time of the report, PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain) outcome was unknown. patient reported adverse events after receiving first dose of Moderna Vaccine. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported. No concomitant medication were reported. Patient also received second dose of Moderna Vaccine on unknown date, and did not experience any side effects. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional details provided regarding second dose of Moderna Vaccine and reporter details updated

Other Meds:

Current Illness: Solitary kidney

ID: 1563400
Sex: F
Age: 47
State: TN

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
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Symptoms: right side up to my ear; TMJ; pain in the joint of my jaw; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (right side up to my ear), PAIN IN JAW (pain in the joint of my jaw) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN JAW (pain in the joint of my jaw). On an unknown date, the patient experienced EAR PAIN (right side up to my ear) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, EAR PAIN (right side up to my ear), PAIN IN JAW (pain in the joint of my jaw) and TEMPOROMANDIBULAR JOINT SYNDROME (TMJ) outcome was unknown. On 16 Feb 2021, the patient experienced the pain in the joint of her jaw. On an unknown date, the patient experienced TMJ, yawning triggers and she can't put her teeth together and had pain on right side up to her ear. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.The outcome of events was unknown No medical history and concomitant medications was provided by the reporter. Patient stated that she tried Ibuprofen, but she said she is limited to how much she can take it, because she has reflux.

Other Meds:

Current Illness:

ID: 1563401
Sex: F
Age:
State: NC

Vax Date: 02/10/2021
Onset Date: 02/15/2021
Rec V Date: 08/15/2021
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Symptoms: Tested positive for Covid twice; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid twice) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure inadequately controlled (patient is on high Blood Pressure medication). Concomitant products included METFORMIN for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid twice). At the time of the report, COVID-19 (Tested positive for Covid twice) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication also included blood pressure medication. No treatment information was provided. Patient provided spouse's Moderna Vaccine lot No. 016M20A who was also vaccinated at the same time as her. Patient reported that her HCP recommended to reschedule her second dose.

Other Meds: METFORMIN

Current Illness:

ID: 1563402
Sex: U
Age:
State: MO

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: Lower than authorized dose volume was administered; Syringe was loose/cracked; A spontaneous report was received from a nurse concerning a patient (age and gender unspecified) who received Moderna's COVID-19 vaccine (mRNA-1273). It was observed that the syringe was loose/cracked and a lower than authorized dose volume was administered. The patient's medical history and concomitant medications were not reported. On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, while vaccine administration to a particular patient the syringe was loose/cracked and a lower than authorized dose volume was administered. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of events, were considered resolved on 05 Mar 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 011A21A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1563403
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: hurt all over; felt terrible; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurt all over), FEELING ABNORMAL (felt terrible) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PAIN (hurt all over), FEELING ABNORMAL (felt terrible) and PYREXIA (Fever). At the time of the report, PAIN (hurt all over), FEELING ABNORMAL (felt terrible) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No medical history was provided by the reporter. No concomitant medications was provided by the reporter Treatment was not included by the reporter.

Other Meds:

Current Illness:

ID: 1563404
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Lethargy; Brain fog; Joint pain; Headache; Muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 70-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 since an unknown date. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, LETHARGY (Lethargy), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Joint pain), HEADACHE (Headache) and MYALGIA (Muscle pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza: Negative. On an unknown date, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1563405
Sex: F
Age:
State: CA

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: SHINGLES; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (SHINGLES) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (SHINGLES). At the time of the report, HERPES ZOSTER (SHINGLES) outcome was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563406
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
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Symptoms: periods of fatigue and weakness, itchiness in the area and some irritation; periods of fatigue and weakness, itchiness in the area and some irritation; periods of fatigue and weakness, itchiness in the area and some irritation; itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination. Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication. Concurrent medical conditions included Hypertension. Concomitant products included ALPRAZOLAM (AZOR [ALPRAZOLAM]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MULTIVITAMINS [VITAMINS NOS] (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patients medical history was not provided by the reporter.

Other Meds: AZOR [ALPRAZOLAM]; LIPITOR

Current Illness: Hypertension

ID: 1563407
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: muscle ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MYALGIA (muscle ache). At the time of the report, MYALGIA (muscle ache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-035118, US-MODERNATX, INC.-MOD-2021-035118 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-035118:Cross link case for Reporter's mother neighbor (unknown gender, no patient identifer) US-MODERNATX, INC.-MOD-2021-035118:Reporter's husband case (male patient)

Other Meds:

Current Illness:

ID: 1563408
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: got a little sick; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MALAISE (got a little sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever) and MALAISE (got a little sick). At the time of the report, PYREXIA (low grade fever) and MALAISE (got a little sick) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-036367 (Patient Link).

Other Meds:

Current Illness:

ID: 1563409
Sex: F
Age: 80
State: IL

Vax Date: 02/10/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: lots of itching; hives all over her body except for her face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (lots of itching) and URTICARIA (hives all over her body except for her face) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (lots of itching) and URTICARIA (hives all over her body except for her face). At the time of the report, PRURITUS (lots of itching) and URTICARIA (hives all over her body except for her face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included 5 day unspecified steroid. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1563410
Sex: M
Age: 57
State: CA

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. No relevant concomitant medications were reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown. On 21 Feb 2021, the patient experienced the event sore arm at the injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, sore arm at the injection site was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1563411
Sex: M
Age: 66
State: NC

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Flush; temperature; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush) and BODY TEMPERATURE INCREASED (temperature) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced FLUSHING (Flush) and BODY TEMPERATURE INCREASED (temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FLUSHING (Flush) and BODY TEMPERATURE INCREASED (temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) High. treatment includes paracetamol (Tylenol). This case was linked to MOD-2021-036290 (Patient Link).

Other Meds:

Current Illness:

ID: 1563412
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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Symptoms: cold/flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (cold/flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (cold/flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (cold/flu like symptoms) outcome 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 information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563413
Sex: M
Age: 74
State:

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: Runny nose; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and RHINORRHOEA (Runny nose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. Concomitant products included CARBIDOPA for Parkinson's disease, CLONAZEPAM, GABAPENTIN, TAMSULOSIN and NORTRIPTYLINE HYDROCHLORIDE (PAMELOR) for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Dizzy). On 07-Mar-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, DIZZINESS (Dizzy) and RHINORRHOEA (Runny nose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. This case was linked to MOD-2021-036713 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Outcome of the events were updated.; 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: CARBIDOPA; CLONAZEPAM; GABAPENTIN; TAMSULOSIN; PAMELOR

Current Illness: Parkinson's disease

ID: 1563414
Sex: F
Age: 56
State: TX

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Flu like symptoms; Blood pressure decreased; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache). The patient was treated with ASCORBIC ACID, CYANOCOBALAMIN, FERRIC PYROPHOSPHATE, FOLIC ACID (SEDEROM) at a dose of 500 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BLOOD PRESSURE DECREASED (Blood pressure decreased), CHILLS (Chills) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) decreased. No concomitant medications reported. Action taken for Moderna COVID-19 Vaccine was not applicable.

Other Meds:

Current Illness:

ID: 1563415
Sex: F
Age: 77
State: TX

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: Had an ache all over; Been feeling a little tired; 100-degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had an ache all over), FATIGUE (Been feeling a little tired) and PYREXIA (100-degree temperature) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Had an ache all over), FATIGUE (Been feeling a little tired) and PYREXIA (100-degree temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (100-degree temperature) had resolved. At the time of the report, PAIN (Had an ache all over) and FATIGUE (Been feeling a little tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Pyrexia: 100 degree (plane angle) 100-degree temperature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1563416
Sex: U
Age: 57
State: NC

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: Hot; Pain at injection site (right); Swelling; Redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021. A spontaneous report was received from a consumer concerning a 57-years-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site (right)/ vaccination site pain, swelling/ vaccination site swelling, redness/ vaccination site erythema, hot/ vaccination site warmth. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Mar 2021, approximately one day prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient experienced the events pain at injection site (right), swelling, redness, hot. Treatment details included Motrin one dose, ice, heat. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, pain at injection site (right), swelling, redness, hot was unknown.

Other Meds:

Current Illness:

ID: 1563417
Sex: F
Age:
State: TX

Vax Date: 01/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
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Symptoms: Lethargy; Constipation; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), CONSTIPATION (Constipation) and FEELING ABNORMAL (brain fog) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-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 24-Feb-2021, the patient experienced LETHARGY (Lethargy), CONSTIPATION (Constipation) and FEELING ABNORMAL (brain fog). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Post vaccination syndrome, at a dose of 2 doses. On 28-Feb-2021, LETHARGY (Lethargy), CONSTIPATION (Constipation) and FEELING ABNORMAL (brain fog) had resolved.

Other Meds:

Current Illness:

ID: 1563418
Sex: F
Age: 72
State: NY

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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Symptoms: Felt "wonky and lightheaded"; Felt weak and lacked energy.; Itchy all over her body.; Cold cold chills then got hot hot hot; hot, itchy, cold all the time, and sick to the stomach.; As "having the flu."; Coughing a lot; Also has a running nose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot) and ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose). At the time of the report, DIZZINESS (Felt "wonky and lightheaded"), ASTHENIA (Felt weak and lacked energy.), PRURITUS (Itchy all over her body.), FEELING OF BODY TEMPERATURE CHANGE (Cold cold chills then got hot hot hot), ABDOMINAL DISCOMFORT (hot, itchy, cold all the time, and sick to the stomach.), INFLUENZA LIKE ILLNESS (As "having the flu."), COUGH (Coughing a lot) and RHINORRHOEA (Also has a running nose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1563419
Sex: F
Age: 31
State: IL

Vax Date: 12/23/2020
Onset Date: 01/20/2021
Rec V Date: 08/15/2021
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Symptoms: Sweating; Chills; Fever; A little tired; Skin inflammation; Joint pain; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Sweating), DERMATITIS (Skin inflammation), CHILLS (Chills), FATIGUE (A little tired) and PYREXIA (Fever) in a 31-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 product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Plaque psoriasis. Concurrent medical conditions included Ankylosing spondylitis (Moderate to severe chronic plaque psoriasis) and Plaque psoriasis. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (A little tired). On 21-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever). In 2021, the patient experienced DERMATITIS (Skin inflammation) and ARTHRALGIA (Joint pain). At the time of the report, HYPERHIDROSIS (Sweating), DERMATITIS (Skin inflammation), CHILLS (Chills), FATIGUE (A little tired), PYREXIA (Fever) and ARTHRALGIA (Joint pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 105 (High) 105. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No corrective treatment was provided.

Other Meds:

Current Illness: Ankylosing spondylitis (Moderate to severe chronic plaque psoriasis); Plaque psoriasis

ID: 1563420
Sex: F
Age: 77
State:

Vax Date: 01/20/2021
Onset Date: 02/21/2021
Rec V Date: 08/15/2021
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Symptoms: Diarrhea; Chills; Fatigue; Slight fever; Sever vomiting; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, diarrhea, fatigue (very tired), pyrexia(slight fever) and vomiting( severe vomiting). On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 21 Feb 2021, 6 days after vaccination, the patient experienced sever vomiting, chills, slight fever, diarrhea and she was feeling very tired. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events was unknown.

Other Meds:

Current Illness:

ID: 1563421
Sex: F
Age: 71
State: MI

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: it feels like a "booster shoot"; the whole arm is useless; feeling very very sore; the pain was all night; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it feels like a "booster shoot"), LIMB DISCOMFORT (the whole arm is useless), PAIN (feeling very very sore), PAIN (the pain was all night) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (it feels like a "booster shoot"), LIMB DISCOMFORT (the whole arm is useless), PAIN (feeling very very sore), PAIN (the pain was all night) and HEADACHE (headache). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (it feels like a "booster shoot"), LIMB DISCOMFORT (the whole arm is useless), PAIN (feeling very very sore) and PAIN (the pain was all night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's medical history included Multiple Sclerosis (MS). Concomitant medications reported were blood pressure medication and MS medications. Treatment details included MOTRIN? (Ibuprofen) and Tylenol. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Non Significant follow up

Other Meds:

Current Illness:

ID: 1563422
Sex: F
Age: 83
State: FL

Vax Date: 02/08/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
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Symptoms: tested positive for covid; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced the event(s) tested positive for covid.. she is feeling good feeling and would like to know if she can take her second shot. Treatment details included Robitussin. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), tested positive for covid was unknown.

Other Meds:

Current Illness:

ID: 1563423
Sex: M
Age: 75
State:

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/15/2021
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Symptoms: terribly itching rash with large, red bumps after first dose; Patient he had a rash developed and after his second dose he also had the rash develop again; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again) and VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose). At the time of the report, VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again) and VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1563424
Sex: F
Age: 64
State: FL

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: tremendous dryness in mouth; thickness in throat; arm hurting; tingling in lips; Frightened; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anxiety (frightened), dry mouth (tremendous dryness in mouth), increased upper airway secretion (thickness in throat), pain in extremity (arm hurting) and paresthesia oral ( tingling in lips). On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient experienced tingling in lips, thickness in throat and arm hurting that went away in about 45min to 1 hour. On an unknown date, the patient experienced the tremendous dryness in mouth and was frightened. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, tingling lips and thickness in the throat was resolved on 4 Mar 2021. The outcome of the other events was unknown.

Other Meds:

Current Illness:

ID: 1563425
Sex: F
Age:
State: OR

Vax Date: 02/26/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: Arm started itching; it was really hard at injection site; it was really hot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm started itching), INJECTION SITE REACTION (it was really hard at injection site) and INJECTION SITE WARMTH (it was really hot at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included Breast cancer (Patient had breast cancer on left side and right side patient also has lymph node after surgery.) Concomitant products included EXEMESTANE for Breast cancer, ATORVASTATIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 26-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 PRURITUS (Arm started itching), INJECTION SITE REACTION (it was really hard at injection site) and INJECTION SITE WARMTH (it was really hot at injection site). Treatment included Tylenol(Acetaminophen) was noted. At the time of the report, PRURITUS (Arm started itching), INJECTION SITE REACTION (it was really hard at injection site) and INJECTION SITE WARMTH (it was really hot at injection site) outcome were unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ATORVASTATIN; EXEMESTANE; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1563426
Sex: M
Age: 53
State: NJ

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Problem with arm, all the way down to the elbow to where they freeze - right arm; Problem with arm, all the way down to the elbow to where they hurt - right arm, arm pain; Problem with muscles all the way down to the elbow to where they freeze - right arm; the whole right arm from shoulder to elbow feels like like a back spasm, as if you have a bad knee and need cortisone shot; arm inflammation; pain; Problem with muscles all the way down to the elbow to where they hurt- right arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Problem with arm, all the way down to the elbow to where they freeze - right arm), PAIN IN EXTREMITY (Problem with arm, all the way down to the elbow to where they hurt - right arm, arm pain), MUSCLE DISCOMFORT (Problem with muscles all the way down to the elbow to where they freeze - right arm), MUSCLE SPASMS (the whole right arm from shoulder to elbow feels like like a back spasm, as if you have a bad knee and need cortisone shot) and INFLAMMATION (arm inflammation) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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 04-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) at an unspecified dose. On an unknown date, the patient experienced LIMB DISCOMFORT (Problem with arm, all the way down to the elbow to where they freeze - right arm), PAIN IN EXTREMITY (Problem with arm, all the way down to the elbow to where they hurt - right arm, arm pain), MUSCLE DISCOMFORT (Problem with muscles all the way down to the elbow to where they freeze - right arm), MUSCLE SPASMS (the whole right arm from shoulder to elbow feels like like a back spasm, as if you have a bad knee and need cortisone shot), INFLAMMATION (arm inflammation), PAIN (pain) and MYALGIA (Problem with muscles all the way down to the elbow to where they hurt- right arm). The patient was treated with Physical therapy for Limb discomfort; Physical therapy for Pain in extremity; Physical therapy for Muscle discomfort; Physical therapy for Muscle spasms; Physical therapy for Inflammation; Physical therapy for Pain and Physical therapy for Myalgia. At the time of the report, LIMB DISCOMFORT (Problem with arm, all the way down to the elbow to where they freeze - right arm), PAIN IN EXTREMITY (Problem with arm, all the way down to the elbow to where they hurt - right arm, arm pain), MUSCLE DISCOMFORT (Problem with muscles all the way down to the elbow to where they freeze - right arm), MUSCLE SPASMS (the whole right arm from shoulder to elbow feels like like a back spasm, as if you have a bad knee and need cortisone shot), INFLAMMATION (arm inflammation), PAIN (pain) and MYALGIA (Problem with muscles all the way down to the elbow to where they hurt- right arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Treatment details, contact details updated and event added

Other Meds:

Current Illness:

ID: 1563427
Sex: M
Age: 61
State:

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: Don't have much energy; Pain in the injection site; Muscle pains on their back; Muscle pains on their legs; Muscle pains on their arms; Headaches; They're tired; Have fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms) and HEADACHE (Headaches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy). At the time of the report, INJECTION SITE PAIN (Pain in the injection site), MYALGIA (Muscle pains on their back), MYALGIA (Muscle pains on their legs), MYALGIA (Muscle pains on their arms), HEADACHE (Headaches), FATIGUE (They're tired), PYREXIA (Have fever) and ASTHENIA (Don't have much energy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1563428
Sex: M
Age:
State:

Vax Date:
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Rec V Date: 08/15/2021
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Symptoms: Heart racing; tooth extraction; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia. Concurrent medical conditions included Chronic lymphocytic leukemia, Heart rate abnormal (reported on 06-Nov-2019 that heart rate was in the 40s on an unknown date), Dizziness (reported on 06-Nov-2019 that he was experiencing some dizziness on an unknown date), Heart rate increased (reported by the patient on 24-Jun-2020; again reported on 30-Jun-2020 that he had been having episodes of the fast heart rate around every 3-4 weeks where it gets up to around 128 to 135 and lasts for about 3-4 minutes; again reported periodic heart rate increased by patient on 14-Jan-2021), Fatigue (reported by the patient on 24-Jun-2020), White blood cell count decreased (reported by the patient on 24-Jun-2020), Glare (reported on 30-Jun-2020) and Difficulty focusing eyes (reported on 30-Jun-2020). Concomitant products included METOPROLOL SUCCINATE, LEVOTHYROXINE SODIUM and ATORVASTATIN CALCIUM for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient experienced PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date for Heart racing and Tooth extraction, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that his heart rate was in the 130s and normally he runs in the 50-60s. He thought his heart racing was due to having large meals. Reporter did not allow further contact

Other Meds: METOPROLOL SUCCINATE; LEVOTHYROXINE SODIUM; ATORVASTATIN CALCIUM

Current Illness: Chronic lymphocytic leukemia

ID: 1563429
Sex: M
Age: 90
State: SC

Vax Date: 02/09/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Vision is blurring/Can't watch television; Can't read; Everything at distance is double vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 492021) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision). At the time of the report, VISION BLURRED (Vision is blurring/Can't watch television), VISUAL IMPAIRMENT (Can't read) and DIPLOPIA (Everything at distance is double vision) outcome was unknown.

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Current Illness:

ID: 1563430
Sex: F
Age: 36
State:

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 08/15/2021
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Symptoms: Muscles twitching; arm felt like bowling ball where injection given; Muscles sore/body aches; Tender [where injection given]; Extremely tired; Severe chills; Shaking uncontrollably; Profuse sweating; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given) and CHILLS (Severe chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (ACE Inhibitors), Hypertension and Depression. Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE for an unknown indication. On 29-Jan-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021 at 3:00 AM, the patient experienced TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating) and CHILLS (Severe chills). On 30-Jan-2021 at 7:00 AM, the patient experienced MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired). On 30-Jan-2021 at 7:00 AM, CHILLS (Severe chills) had resolved. At the time of the report, TREMOR (Shaking uncontrollably), HYPERHIDROSIS (Profuse sweating), MUSCLE TWITCHING (Muscles twitching), INJECTION SITE MASS (arm felt like bowling ball where injection given), MYALGIA (Muscles sore/body aches), INJECTION SITE PAIN (Tender [where injection given]) and FATIGUE (Extremely tired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.

Other Meds: OMEPRAZOLE; AMLODIPINE

Current Illness: Depression; Drug allergy (ACE Inhibitors); Hypertension; Sulfonamide allergy

ID: 1563431
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: missed the second dose window; A spontaneous report was received from a female patient concerning herself who received Modern's COVID-19 vaccine (mRNA-1273) and missed the second dose window. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Jan 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and at an unknown anatomical location for prophylaxis of COVID-19 infection. On an unknown date, the patient missed the second dose appointment and was again scheduled to get the second dose on 08 Mar 2021. Action taken with mRNA-1273 in response to the events was not reported. Outcome and causality are not applicable.; Reporter's Comments: This report refers to a case of missed d second dose for mRNA-1273, with no associated AEs. Causality for this medication error is not applicable

Other Meds:

Current Illness:

ID: 1563432
Sex: F
Age: 67
State: CA

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Bumps; Lump; This spontaneous case was reported by a patient and describes the occurrence of GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LL20A) for an unknown indication. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump). At the time of the report, GINGIVAL DISORDER (Bumps) and SENSATION OF FOREIGN BODY (Lump) outcome was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563433
Sex: F
Age:
State:

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/15/2021
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Symptoms: Waiting to receive second dose of the vaccine as partially vaccinated; A 17 year old received 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old received 1st dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (Waiting to receive second dose of the vaccine as partially vaccinated) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old received 1st dose of the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Waiting to receive second dose of the vaccine as partially vaccinated). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old received 1st dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (Waiting to receive second dose of the vaccine as partially vaccinated) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported No treatment medication was reported In the follow up it was reported that patient was partially vaccinated and not experienced any severe adverse reaction. Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Partial vaccination event reported; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 015M20A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1563434
Sex: M
Age: 56
State: IL

Vax Date: 02/02/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Symptoms: entire left armpit and triceps are tender; swollen; not feeling too well; fatigued; fever of 100.5 degrees F; arm soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.5 degrees F), VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen) and FATIGUE (fatigued) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney cancer. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever of 100.5 degrees F) and VACCINATION SITE PAIN (arm soreness on the injection site). On 04-Mar-2021, the patient experienced TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well). On 04-Mar-2021, PYREXIA (fever of 100.5 degrees F) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness on the injection site), TENDERNESS (entire left armpit and triceps are tender), SWELLING (swollen), FATIGUE (fatigued) and MALAISE (not feeling too well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: fever of 100.5 F.

Other Meds: CRESTOR; LISINOPRIL; EFFEXOR

Current Illness:

ID: 1563435
Sex: F
Age:
State: FL

Vax Date: 03/07/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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Symptoms: sore arm; body ache; fever; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, body ache/myalgia, fever/pyrexia. The patient's medical history was not provided. Concomitant medications reported were Tylenol for drug use for unknown indication. On 7 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 7 Mar 2021, the patient experienced sore arm/pain in extremity, body ache/myalgia, fever/pyrexia. Treatment details included Tylenol. Action taken with mRNA-1273 in response to the events was not reported. on an unknown date the outcome of sore arm/pain in extremity, body ache/myalgia, fever/pyrexia was not reported.

Other Meds: TYLENOL

Current Illness:

ID: 1563436
Sex: F
Age: 73
State: NJ

Vax Date: 02/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Symptoms: Non itchy rash; Weird rubber smell; Chills; Verysore arm; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness), RASH (Non itchy rash) and PAROSMIA (Weird rubber smell) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 03L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness) and PAROSMIA (Weird rubber smell). On 05-Mar-2021, the patient experienced RASH (Non itchy rash). On 03-Mar-2021, PAROSMIA (Weird rubber smell) had resolved. At the time of the report, PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness) and RASH (Non itchy rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication reported

Other Meds: SYNTHROID

Current Illness:

ID: 1563437
Sex: F
Age: 68
State: IN

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/15/2021
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Symptoms: Light headedness; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included Latex allergy (blisters , hives, loss of voice), Fragrance sensitivity (loss of voice , tingling tongue), Allergy to chemicals (loss of voice, heart rate increased, tingling tongue, pain in jaws) and Allergy to vaccine (pneumonia vaccine causes Fever of 103. Chills. Aching. Weakness. Swelling. Not able to get into any clothes. ) on 31-Oct-2018. Concomitant products included AMLODIPINE for Hypertension. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 02-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) HIGH. This case was linked to MOD-2021-173466 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: ADEDD MEDICAL HISTORY AND SECOND DOSE INFORMATIONS

Other Meds: AMLODIPINE

Current Illness: Allergy to chemicals (loss of voice, heart rate increased, tingling tongue, pain in jaws); Fragrance sensitivity (loss of voice , tingling tongue); Latex allergy (blisters , hives, loss of voice)

ID: 1563438
Sex: M
Age: 82
State: NY

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Itchy; Hot to touch; Vaccination site discoloration; Rash; Hurt to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch) in an 82-year-old male 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 (Medical history not reported.). On 26-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 RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch). At the time of the report, RASH (Rash), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Hurt to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1563439
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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Symptoms: Headache; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 5 Mar 2021, the patient experienced the event headache. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event, headache was unknown.

Other Meds:

Current Illness:

ID: 1563440
Sex: F
Age: 74
State: AL

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Symptoms: Not self; Warm to touch at the site of the injection; Mild swelling at the site of the injection; Fatigue; Tiredness; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self. The patient's medical history was not provided. Concomitant medications reported were apixaban, metoprolol for drug use for unknown indication. On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection. On 3 Mar 2021, the patient experienced the events mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self.Consent granted for safety to follow up Treatment details included None. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self was unknown.

Other Meds: ELIQUIS; METOPROLOL

Current Illness:

ID: 1563441
Sex: F
Age:
State: AZ

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 08/15/2021
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Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not provided No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-035984 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter did not remember reporting adverse event for her sister. States that she does not have time to discuss as she was at work at the time of the call. Declined to provide email address or complete ADR form but states "everyone's doing fine".; 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. US-MODERNATX, INC.-MOD-2021-035984:2nd dose case

Other Meds:

Current Illness:

ID: 1563442
Sex: M
Age:
State: CA

Vax Date: 02/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Symptoms: While getting second dose noticed that a blood stream was going down the arm; Not receiving the full dose; A spontaneous report was received from a consumer concerning a 79-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood stream was going down patient's arm /vaccination site haemorrhage, not receiving the full dose/ accidental underdose. The patient's medical history was not provided. Concomitant medications included were ezetimibe, simvastatin and metformin. On 03 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 030L20A) in the left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 026A10A) in the left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, while getting the second dose the patient noticed that a blood stream was going down his arm and was worried that the blood was mixed with the vaccine and not receiving the full dose. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, blood stream was going down patient's arm and not receiving the full dose was resolved on 03 Mar 2021.; Reporter's Comments: This report refers to a case of vaccine underdose for mRNA-1273, lot# 026A10A with associated AE of vaccination site bleeding. 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: ZETIA; ZOCOR; METFORMIN

Current Illness:

ID: 1563443
Sex: F
Age: 79
State: NE

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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Symptoms: Little short of breath; tongue burning "felt like bunch of hot peppers"; Face flushing; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers"), FLUSHING (Face flushing) and DYSPNOEA (Little short of breath) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy multiple, Asthma and Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), LANSOPRAZOLE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 ALKALOID), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers") and FLUSHING (Face flushing). On 03-Mar-2021, the patient experienced DYSPNOEA (Little short of breath). On 02-Mar-2021, TONGUE DISCOMFORT (tongue burning "felt like bunch of hot peppers") and FLUSHING (Face flushing) was resolving. On 03-Mar-2021, DYSPNOEA (Little short of breath) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Hypertension (high-Unknown): (High) high blood pressure. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. patient stated that she received her first dose of Moderna Covid-19 vaccine on 02March2021 on left arm. The patient notes that she has "a lot of allergies and I am also on medicine for a-fib". The patient states that she received her vaccine in her doctor's office where she started experiencing high blood pressure, tongue burning "felt like bunch of hot peppers" face flushing. The patient states that her symptoms are little bit ongoing. The patient also states that on 03March2021 she felt little short of breath and states that my asthma medicine did not help. The patients states that she end up staying at the doctor's office for an hour. The patient is asking if she should get second dose of vaccine. The patient agreed to follow up with safety. No treatment provided

Other Meds: XARELTO; LANSOPRAZOLE; BYSTOLIC; ADVAIR; VITAMIN D3; VITAMIN B12 ALKALOID; ZYRTEC ALLERGY; TYLENOL; VITAMINS NOS

Current Illness: Allergy multiple; Asthma; Atrial fibrillation

ID: 1563444
Sex: U
Age: 65
State: CA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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Symptoms: Vaccine vial which has black particles in it; A spontaneous report from a vaccine administrator/reporter/pharmacist concerning Moderna's COVID-19 vaccine (mRNA-1273) (lot# 036A21A) (PC number: 7154) vial that had black particles and administered 2 doses before noticing the change. No details were provided about the patients. No events were reported. Action taken, outcome and causality are not applicable.; Reporter's Comments: This report refers to a case of poor quality product administered for mRNA-1273, lot # 036A21A with no associated AEs. Causality for this medication error is not applicable

Other Meds:

Current Illness:

ID: 1563445
Sex: M
Age: 70
State: PA

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Allergies:

Symptom List:

Symptoms: Shaking violently; Pain in legs; Effected speech; Feeling off; Extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech), MALAISE (Feeling off) and FATIGUE (Extremely fatigued) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. Concomitant products included ALLOPURINOL (ZYLOPRIM), RABEPRAZOLE, ROSUVASTATIN, APIXABAN (ELIQUIS), LISINOPRIL, METOPROLOL, METFORMIN, HYDROCHLOROTHIAZIDE, MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication. 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 TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech), MALAISE (Feeling off) and FATIGUE (Extremely fatigued). On 03-Mar-2021, TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech) and MALAISE (Feeling off) had resolved. On 04-Mar-2021, FATIGUE (Extremely fatigued) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided. The patient's symptoms lasted an hour and a half but the patient was extremely fatigued for rest of the day. This case was linked to MOD21-046829 (E2B Linked Report).; Sender's Comments: MOD21-046829:patient's wife case

Other Meds: ZYLOPRIM; RABEPRAZOLE; ROSUVASTATIN; ELIQUIS; LISINOPRIL; METOPROLOL; METFORMIN; HYDROCHLOROTHIAZIDE; MULTIVITAMIN [VITAMINS NOS]; PRESERVISION.

Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm