VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1559114
Sex: F
Age:
State: FL

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: behind ear lymph node soreness that she cannot hear well; behind ear lymph node soreness that she cannot hear well; bad stomach pain; slight headache; soreness L arm of injection; tenderness L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (bad stomach pain), HYPOACUSIS (behind ear lymph node soreness that she cannot hear well), VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection) and LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN D [VITAMIN D NOS], ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), PROGESTERONE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FLECAINIDE for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection) and HEADACHE (slight headache). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (bad stomach pain). On an unknown date, the patient experienced HYPOACUSIS (behind ear lymph node soreness that she cannot hear well) and LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well). At the time of the report, ABDOMINAL PAIN UPPER (bad stomach pain), HYPOACUSIS (behind ear lymph node soreness that she cannot hear well), VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection), LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well) and HEADACHE (slight headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. .

Other Meds: VITAMIN D [VITAMIN D NOS]; VITAMIN C PLUS [ASCORBIC ACID]; PROGESTERONE; PANTOPRAZOLE; BABY ASPIRIN; FLECAINIDE

Current Illness:

ID: 1559115
Sex: U
Age: 65
State: PA

Vax Date: 02/20/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: sneezing a lot; flu-like symptoms; runny nose; feels congested stuffy nose; her head feels congested; cough bringing up phlegm; feels a little tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose) and HEAD DISCOMFORT (her head feels congested) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, ATORVASTATIN and VITAMINS NOS for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired) had resolved. Concomitant products also included Water pills. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Updated event outcome to Resolved and treatment medication taken.

Other Meds: AMLODIPINE; ATORVASTATIN; VITAMINS NOS

Current Illness: Blood pressure high

ID: 1559116
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: 17 year old got the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1559117
Sex: F
Age: 73
State: IL

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Itchy; Pain; Red blotch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red blotch at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-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 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotch at injection site). On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Pain). On 01-Mar-2021, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red blotch at injection site) was resolving. No concomitant medication details was reported. No treatment medication details was reported. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received TCR document Patient declined further follow up and state that she is fine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1559118
Sex: F
Age: 67
State: CT

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swollen/inflammation on hand started12 Feb 2021; headache started 12 Feb 2021; arms left and right so much pain felt like snake bite -11 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (swollen/inflammation on hand started12 Feb 2021), PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021) and HEADACHE (headache started 12 Feb 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021). On 12-Feb-2021, the patient experienced INFLAMMATION (swollen/inflammation on hand started12 Feb 2021) and HEADACHE (headache started 12 Feb 2021). At the time of the report, INFLAMMATION (swollen/inflammation on hand started12 Feb 2021), PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021) and HEADACHE (headache started 12 Feb 2021) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided. No treatment medication were provided.

Other Meds:

Current Illness:

ID: 1559119
Sex: F
Age: 65
State: FL

Vax Date: 01/29/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Weakness on both legs (she was taking small steps when she walked; Almost losing her balance; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked), BALANCE DISORDER (Almost losing her balance) and FATIGUE (Feels tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked), BALANCE DISORDER (Almost losing her balance) and FATIGUE (Feels tired). On 27-Feb-2021, MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked) and BALANCE DISORDER (Almost losing her balance) had resolved. At the time of the report, FATIGUE (Feels tired) outcome was unknown. No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1559120
Sex: M
Age:
State: LA

Vax Date: 02/27/1900
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: hot to touch; pain; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, hot to touch. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Feb 1900, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced the event(s) pain at the injection site (pain scale level 5 -1 being no pain and 10 with, worst pain), hot to touch. No treatments was taken. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), pain, hot to touch was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1559121
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Numbness in upper lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness in upper lip) in a female 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 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 20-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness in upper lip). At the time of the report, HYPOAESTHESIA ORAL (Numbness in upper lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up information was received on 22 Apr 2021, correct adverse event numbness of upper lip updated;

Other Meds:

Current Illness:

ID: 1559122
Sex: F
Age:
State: PA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: front of the tongue is sore; scratchy throat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 28-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (front of the tongue is sore) and OROPHARYNGEAL PAIN (scratchy throat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M204) for COVID-19 vaccination. 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 GLOSSODYNIA (front of the tongue is sore) and OROPHARYNGEAL PAIN (scratchy throat). At the time of the report, GLOSSODYNIA (front of the tongue is sore) and OROPHARYNGEAL PAIN (scratchy throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1559123
Sex: F
Age:
State:

Vax Date: 01/09/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: dermatographism; trouble swallowing; throat closing up; rash all over the body; ear hot and red; Hives; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body) and ERYTHEMA (ear hot and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives). At the time of the report, MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives) outcome was unknown. No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable

Other Meds:

Current Illness:

ID: 1559124
Sex: F
Age: 73
State: OH

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fatty tumor is right where the shot went. Fatty tumor covers the muscle.; Burned like heck when went in; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it burned like heck when it went in the fatty tumor where the shot went in. The patient's medical history included acid reflux, hypothyroidism, high blood pressure and type-2 diabetes. The Patient's Concomitant medications included Omeprazole, Synthroid, Beazepril and Rybelsus. The patient is allergic to Percocet and motrin. On 26-FEB-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:022M20A) in the left arm for prophylaxis of COVID-19 infection. On 26-FEB-2021, The patient experienced the event fatty tumor is right where the shot went. Laboratory details were not provided. Action taken with mRNA-1273 in response to the events was not reported. On unknown date, the outcome of the events fatty tumor is right where the shot went(Inappropriate route of vaccination). is recovered/resolved. The reporter assessed the event fatty tumor is right where the shot went(Inappropriate route of vaccination) related to the study drug is unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 022M20A) with reported event of vaccination site pain.

Other Meds: OMEPRAZOLE; SYNTHROID; BENAZEPRIL; RYBELSUS.

Current Illness:

ID: 1559125
Sex: F
Age:
State: CA

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: feeling very weak; lower back aches which then resulted in her aching everywhere at night; body aches from her head to her toes; feels like it's the flu or as if she was hit by a truck; sinuses are messed up; face feels a bit swollen; tighter lump at the injection site; headaches; injection site very sore; fever of 101; achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes) and INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101). At the time of the report, ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101) outcome was unknown. Concomitant product information was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1559126
Sex: F
Age: 67
State: SC

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 4 inch in diameter/circular red itchy patch at injection site; 4 inch in diameter/circular red itchy patch at injection site; redness at the injection site; sore arm - 18 Feb 2021 , duration "a few days"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"). On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site). On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site). At the time of the report, PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated events outcome to recovered/resolved.

Other Meds:

Current Illness:

ID: 1559127
Sex: F
Age: 68
State: OK

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: temperature was near 100?F; sore arm; chills at night, was very cold, woke up freezing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), CHILLS (chills at night, was very cold, woke up freezing) and PYREXIA (temperature was near 100?F) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 041L20A) for COVID-19 vaccination. Concomitant products included TICAGRELOR (BRILINTA), MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and ROSUVASTATIN for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and CHILLS (chills at night, was very cold, woke up freezing). On 26-Feb-2021, the patient experienced PYREXIA (temperature was near 100?F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm), CHILLS (chills at night, was very cold, woke up freezing) and PYREXIA (temperature was near 100?F) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable This case was linked to MOD-2021-028494 (Patient Link).

Other Meds: BRILINTA; MULTIVITAMIN [VITAMINS NOS]; ASPIRIN 81; LISINOPRIL; ROSUVASTATIN

Current Illness:

ID: 1559128
Sex: M
Age: 77
State: NJ

Vax Date: 02/19/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Could not raise the arm; Is still experiencing pains in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 32L20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment information was reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Events outcome updated.

Other Meds:

Current Illness:

ID: 1559129
Sex: F
Age: 80
State: MI

Vax Date: 02/02/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: shingles 24 days after 1st Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles 24 days after 1st Covid-19 vaccine) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles 24 days after 1st Covid-19 vaccine). At the time of the report, HERPES ZOSTER (shingles 24 days after 1st Covid-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559130
Sex: F
Age: 32
State: TX

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pregnant patient received the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 17-Aug-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifteenth week of the pregnancy. On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) 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 relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559131
Sex: F
Age:
State: MO

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

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

Lab Data: Test Date: 20200815; Test Name: SARS-CoV-2 test; Test Result: Positive

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: unable to walk; Difficulty with speech; Pain in left arm; Injection site red and swollen; Injection site red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk), SPEECH DISORDER (Difficulty with speech), INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen). On 26-Feb-2021, the patient experienced GAIT INABILITY (unable to walk) and SPEECH DISORDER (Difficulty with speech). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (unable to walk), SPEECH DISORDER (Difficulty with speech), INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Follow up received and events added.

Other Meds:

Current Illness:

ID: 1559132
Sex: F
Age: 69
State: OH

Vax Date: 02/09/2021
Onset Date: 02/22/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data: Test Date: 20210223; Test Name: COVID 19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Tested positive for COVID; Aches; Hair hurt; congestion; runny nose; cough; nausea; headache; hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over). On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with BAMLANIVIMAB (intravenous) on 26-Feb-2021 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication were reported Patient said she is scheduled for second dose on 9Mar2021 This case was linked to MOD-2021-033480 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up information received and contains significant information. Outcome of the events were changed from Unknown to Not recovered.

Other Meds:

Current Illness:

ID: 1559133
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a female 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 RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided . No treatment information provided. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1559134
Sex: F
Age:
State: CO

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; sore arm; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (sore arm), HEADACHE (headache) and the second episode of VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced the first episode of VACCINATION SITE PAIN (sore arm). On 26-Feb-2021, the patient experienced HEADACHE (headache) and the second episode of VACCINATION SITE PAIN (sore arm). At the time of the report, HEADACHE (headache) and the last episode of VACCINATION SITE PAIN (sore arm) outcome was unknown. No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable

Other Meds:

Current Illness:

ID: 1559135
Sex: F
Age:
State: MA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data: Test Name: Genetic testing; Result Unstructured Data: Normal; Test Date: 2021; Test Name: Anatomy scan; Result Unstructured Data: Normal

Allergies:

Symptom List: Unevaluable event

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D10A21A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;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. The patient's last menstrual period was on 17-Oct-2020 and the estimated date of delivery was 24-Jul-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighteenth week of the pregnancy. On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound foetal: normal (normal) Normal. On an unknown date, Amniocentesis: normal (normal) Normal. 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. past pregnancy details: Live birth, full term pregnancy on Aug-2018.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1559136
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Difficulty breathing; Weak; Cough; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 28-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1559137
Sex: M
Age: 72
State: PA

Vax Date: 01/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Rash under both arms, back, neck , groin and waste area.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under both arms, back, neck , groin and waste area.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 27-Feb-2021, the patient experienced RASH (Rash under both arms, back, neck , groin and waste area.). At the time of the report, RASH (Rash under both arms, back, neck , groin and waste area.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1559138
Sex: F
Age:
State: MD

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash) in a female 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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE RASH (rash). No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1559139
Sex: M
Age:
State:

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Couple hours with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Couple hours with fatigue) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Couple hours with fatigue). At the time of the report, FATIGUE (Couple hours with fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD21-041006 (Patient Link).

Other Meds:

Current Illness:

ID: 1559140
Sex: F
Age: 66
State: CA

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: bumps have tiny blisters in the center; bumps are itchy; bumps are very bright red; Bumps on neck, torso, legs and back; Little body ache; left arm was a little sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy) and ERYTHEMA (bumps are very bright red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Vitamin D deficiency, Drug allergy and Digestion impaired (trouble digesting pills in stomach). Concomitant products included COLECALCIFEROL (VITAMIN D 3) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was a little sore) and PAIN (Little body ache). On 23-Feb-2021, the patient experienced BLISTER (bumps have tiny blisters in the center), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back). At the time of the report, PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication were reported. patient took Neuro-Immune Stabilizer topical cream as concomitant medication.

Other Meds: VITAMIN D 3

Current Illness: Digestion impaired (trouble digesting pills in stomach); Drug allergy; Vitamin D deficiency

ID: 1559141
Sex: F
Age: 36
State: MD

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: impressive level of sore; deep tissue bruise; extremely uncomfortable; a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore). At the time of the report, PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559142
Sex: F
Age: 77
State: FL

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient have large pink area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Patient have large pink area around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Patient have large pink area around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Patient have large pink area around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1559143
Sex: F
Age: 53
State: ME

Vax Date: 01/19/2021
Onset Date: 01/24/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: She also had hives and itching all over; She also had hives and itching all over; Full body rash with itching including the soles of her feet, palms of her hands, and in her ears; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of RASH (Full body rash with itching including the soles of her feet, palms of her hands, and in her ears), URTICARIA (She also had hives and itching all over) and PRURITUS (She also had hives and itching all over) in a 53-year-old female 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 24-Jan-2021, the patient experienced RASH (Full body rash with itching including the soles of her feet, palms of her hands, and in her ears). On an unknown date, the patient experienced URTICARIA (She also had hives and itching all over) and PRURITUS (She also had hives and itching all over). At the time of the report, RASH (Full body rash with itching including the soles of her feet, palms of her hands, and in her ears), URTICARIA (She also had hives and itching all over) and PRURITUS (She also had hives and itching all over) 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. Treatment medication was reported as Antihistamines. Concomitant product use was not provided by the reporter. This case was linked to MOD21-039588 (Patient Link).

Other Meds:

Current Illness:

ID: 1559144
Sex: M
Age: 82
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Nausea; Vomiting; Looks flush; Face slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), FLUSHING (Looks flush) and SWELLING FACE (Face slightly swollen) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SWELLING FACE (Face slightly swollen). On 26-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and FLUSHING (Looks flush). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), FLUSHING (Looks flush) and SWELLING FACE (Face slightly swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported Treatment information were not provided

Other Meds:

Current Illness:

ID: 1559145
Sex: M
Age:
State: IL

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: large red circular welt that is 2 inches wide and 2.5 inches long,; Welt is warm to touch; Welt is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen). At the time of the report, URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1559146
Sex: F
Age: 66
State: IL

Vax Date: 02/25/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: anxiety was exaggerated; feels anxiety day and night and wakes up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. Concurrent medical conditions included Mental disorder NOS. On 25-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 27-Feb-2021, the patient experienced ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night). At the time of the report, ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night) outcome was unknown. No treatment information was provided. No concomitant medication was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness: Mental disorder NOS

ID: 1559147
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Reaction; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction) and RASH (Rash) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction) and RASH (Rash). At the time of the report, VACCINATION COMPLICATION (Reaction) and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Information about concomitant medication was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1559148
Sex: F
Age: 63
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Eye heaviness; Sore arm; Fever; Heavy arm; Night sweats; Bladder Pressure; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure), ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergy to macrobid), Drug allergy (Allergy to pepcid), Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to minocycline), Drug allergy (Allergy to foxin) and Drug allergy (Allergy to amitiza). Concomitant products included DENOSUMAB (PROLIA) for Bone density abnormal, MULTIVITAMIN [VITAMINS NOS], BIOTIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for an unknown indication. On 15-Feb-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. On 15-Feb-2021, the patient experienced NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure) and LIMB DISCOMFORT (Heavy arm). On an unknown date, the patient experienced ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure), ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm), PYREXIA (Fever) and LIMB DISCOMFORT (Heavy arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked. This case was linked. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Second dose information was added On 21-Jul-2021: Follow up information received on 21-Jul-2021 and included Updated patient demographics, medical history , vaccine facility. Updated events and concomitant medications.; Sender's Comments: MOD21-083869:

Other Meds: PROLIA; MULTIVITAMIN [VITAMINS NOS]; BIOTIN; VITAMIN D [COLECALCIFEROL]; CALCIUM.

Current Illness: Drug allergy (Allergy to pepcid); Drug allergy (Allergy to minocycline); Drug allergy (Allergy to macrobid); Drug allergy (Allergy to foxin); Drug allergy (Allergy to amitiza); Sulfonamide allergy (Allergy to sulfa.)

ID: 1559149
Sex: F
Age: 54
State: GA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; tingling in hand; swelling of face; feeling of shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), PARAESTHESIA (tingling in hand), SWELLING FACE (swelling of face) and DYSPNOEA (feeling of shortness of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0237L20A) for COVID-19 vaccination. Concurrent medical conditions included IgG decreased. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (headache), PARAESTHESIA (tingling in hand), SWELLING FACE (swelling of face) and DYSPNOEA (feeling of shortness of breath). At the time of the report, HEADACHE (headache), PARAESTHESIA (tingling in hand), SWELLING FACE (swelling of face) and DYSPNOEA (feeling of shortness of breath) 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. Treatment medications included, benadryl and injection epi pen. No concomitant medications were provided by reporter.

Other Meds:

Current Illness: IgG decreased

ID: 1559150
Sex: F
Age: 80
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Site of injection is itching; Site of injection has red mark; pain on the site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain on the site of injection), VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-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 VACCINATION SITE PAIN (pain on the site of injection). On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark). On 21-Feb-2021, VACCINATION SITE PAIN (pain on the site of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1559151
Sex: F
Age: 82
State: WI

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: stiffness of the neck; Weakness in the body; Headaches; a little achiness/feel achy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness of the neck), ASTHENIA (Weakness in the body), PAIN (a little achiness/feel achy) and HEADACHE (Headaches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (a little achiness/feel achy). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness of the neck), ASTHENIA (Weakness in the body) and HEADACHE (Headaches). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness of the neck), ASTHENIA (Weakness in the body), PAIN (a little achiness/feel achy) and HEADACHE (Headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1559152
Sex: F
Age: 48
State: NJ

Vax Date: 12/30/2020
Onset Date: 01/28/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: over 100

Allergies:

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

Symptoms: Arthralgia; fever; fatigue; Severe headache; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 29-Jan-2021, ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) over 100. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) to be possibly related. No concomitant medications were reported. This case was linked to MOD-2021-028515 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 and added Event stop date.

Other Meds:

Current Illness:

ID: 1559153
Sex: F
Age: 31
State: TX

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pregnant; Fatigue; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient did not take any treatment. No concomitant medication were reported

Other Meds:

Current Illness:

ID: 1559154
Sex: U
Age: 67
State: NJ

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: itching; Pain at injection site; Heat (left); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat (left)), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Pain at injection site) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination. The patient's past medical history included Heart valve operation (Heart valve repaired.). Concomitant products included WARFARIN SODIUM (WARFIN) for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat (left)) and VACCINATION SITE PAIN (Pain at injection site). On 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. On 23-Feb-2021, VACCINATION SITE WARMTH (Heat (left)) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received included outcome of the event updated to recovered. Corrections made on the initial, treatment medication were added.

Other Meds: WARFIN

Current Illness:

ID: 1559155
Sex: F
Age: 39
State: IN

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

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

Lab Data: Test Name: Body temperature

Allergies:

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

Symptoms: Temperature of up to 102; violently puking; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of up to 102) and VOMITING (violently puking) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature of up to 102) and VOMITING (violently puking). At the time of the report, PYREXIA (Temperature of up to 102) and VOMITING (violently puking) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1559156
Sex: F
Age: 71
State: CA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 001A21A) for COVID-19 vaccination. Concomitant products included ESTROGEN NOS;PROGESTERONE and LEVODOPA for an unknown indication. 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 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 28-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable

Other Meds: ESTROGEN NOS;PROGESTERONE; LEVODOPA

Current Illness:

ID: 1559157
Sex: F
Age: 87
State: AZ

Vax Date: 02/21/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tired all week; covid arm; big red spot on the arm; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired all week), HYPERSENSITIVITY (covid arm), ERYTHEMA (big red spot on the arm) and VACCINATION SITE PRURITUS (itchiness at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm), ERYTHEMA (big red spot on the arm) and VACCINATION SITE PRURITUS (itchiness at the injection site). On an unknown date, the patient experienced FATIGUE (tired all week). At the time of the report, FATIGUE (tired all week), HYPERSENSITIVITY (covid arm), ERYTHEMA (big red spot on the arm) and VACCINATION SITE PRURITUS (itchiness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1559158
Sex: F
Age: 68
State: OH

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Headache; Body ache; Sore throat; Nausea; Coughing; Wheezing; Extremely ill; very tired and Completely wiped out; Scary sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea) and COUGH (Coughing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Back surgery (patient had 2 back surgeries). Concomitant products included OXYCODONE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LEVOTHYROXINE for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick). At the time of the report, HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided by reporter.

Other Meds: OXYCODONE; CLARITIN ALLERGIC; LEVOTHYROXINE

Current Illness:

ID: 1559159
Sex: F
Age:
State: TX

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: concerned may have not received a full dose; syringe connection issues; A spontaneous report was received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and during administration, some drops leaked out of the syringe (device connection issue) and she was concerned that she may have not received a full dose (underdose). The patient's medical history was not reported. No concomitant product use was reported. On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, during administration, the patient noticed some drops leaked out of the syringe and was concerned that she might have not received a full dose and was asking what to do. 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 was recovered on 26 Feb 2021.; Reporter's Comments: This report refers to a case of a female patient of unknown age who experienced non-serious unexpected events of some drops leaked out of the syringe ( syringe issue) and she was concerned that she may have not received a full dose ( Incomplete dose administered) for mRNA-1273 (Lot number: 012A21A) . There were no reported AEs associated with this case of syringe issue and incomplete dose administered

Other Meds:

Current Illness:

ID: 1559160
Sex: F
Age:
State: GA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Warm; swollen from shoulder to elbow; arm got sore again; got severe itching; I had sore arm for day or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I had sore arm for day or so), PAIN IN EXTREMITY (arm got sore again), PRURITUS (got severe itching), INJECTION SITE WARMTH (Warm) and SWELLING (swollen from shoulder to elbow) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN, MIRABEGRON (MYRBETRIQ), CHLORDIAZEPOXIDE, CLIDINIUM BROMIDE (LIBRAX [CHLORDIAZEPOXIDE;CLIDINIUM BROMIDE]) and BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (I had sore arm for day or so). On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm got sore again) and PRURITUS (got severe itching). On 28-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm) and SWELLING (swollen from shoulder to elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (I had sore arm for day or so), PAIN IN EXTREMITY (arm got sore again), PRURITUS (got severe itching), INJECTION SITE WARMTH (Warm) and SWELLING (swollen from shoulder to elbow) outcome was unknown.

Other Meds: SYNTHROID; GABAPENTIN; MYRBETRIQ; LIBRAX [CHLORDIAZEPOXIDE;CLIDINIUM BROMIDE]; BUSPAR

Current Illness:

ID: 1559161
Sex: F
Age:
State: LA

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: shortness of breath; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), CHILLS (Chills) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DYSPNOEA (shortness of breath), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up was received on 02-JUN-2021, and contains updated contact information.

Other Meds:

Current Illness:

ID: 1559162
Sex: M
Age: 72
State: PA

Vax Date: 02/08/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a bad rash that started 2 weeks after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a bad rash that started 2 weeks after receiving the vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for an unknown indication. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced RASH (a bad rash that started 2 weeks after receiving the vaccine). At the time of the report, RASH (a bad rash that started 2 weeks after receiving the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1559163
Sex: F
Age: 65
State: TN

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data: Test Date: 20210307; Test Name: covid-19 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Loss of taste/lost my sense of taste; Loss of smell/lost my sense of smell; My throat felt like something was stuck in it, & couldn't get it up or down, like some kind of drainage.; felt like my airway got smaller; achy; Tiredness/felt tired; Headaches; Nausea; Face feeling hot but no fever; Soreness of arm; Post nasal Drip; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste/lost my sense of taste), ANOSMIA (Loss of smell/lost my sense of smell), FEELING HOT (Face feeling hot but no fever), PAIN IN EXTREMITY (Soreness of arm) and UPPER-AIRWAY COUGH SYNDROME (Post nasal Drip) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (Face feeling hot but no fever), PAIN IN EXTREMITY (Soreness of arm), UPPER-AIRWAY COUGH SYNDROME (Post nasal Drip), DIARRHOEA (Diarrhea), FATIGUE (Tiredness/felt tired), HEADACHE (Headaches) and NAUSEA (Nausea). On 26-Feb-2021, the patient experienced AGEUSIA (Loss of taste/lost my sense of taste), ANOSMIA (Loss of smell/lost my sense of smell), OROPHARYNGEAL DISCOMFORT (My throat felt like something was stuck in it, & couldn't get it up or down, like some kind of drainage.), OBSTRUCTIVE AIRWAYS DISORDER (felt like my airway got smaller) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and ANTIBIOTICS at an unspecified dose and frequency. At the time of the report, AGEUSIA (Loss of taste/lost my sense of taste), ANOSMIA (Loss of smell/lost my sense of smell), FEELING HOT (Face feeling hot but no fever), PAIN IN EXTREMITY (Soreness of arm), UPPER-AIRWAY COUGH SYNDROME (Post nasal Drip), DIARRHOEA (Diarrhea), OROPHARYNGEAL DISCOMFORT (My throat felt like something was stuck in it, & couldn't get it up or down, like some kind of drainage.), OBSTRUCTIVE AIRWAYS DISORDER (felt like my airway got smaller), FATIGUE (Tiredness/felt tired), HEADACHE (Headaches), NAUSEA (Nausea) and MYALGIA (achy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported but patient mentioned that she had prednisone and antibiotics on hand due to her asthma and self-medicated using these as treatment for her adverse events on an unknown start date. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received included: Address, new events and treatments for Dose 1, medical history and Dose 2 information.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness: Asthma

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am