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: 1562771
Sex: F
Age: 65
State: CA

Vax Date: 02/11/2021
Onset Date:
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: All of last night felt body aches; Arms are sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication. On 11-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 (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore). At the time of the report, PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore) 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.

Other Meds: VITAMINS A & D

Current Illness: Blood pressure; Cholesterol

ID: 1562772
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 03/04/2021
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: Hives on her arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hives on her arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient experienced the event(s) hives on her arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), hives on her arm was unknown.

Other Meds:

Current Illness:

ID: 1562773
Sex: F
Age: 76
State: IL

Vax Date: 02/26/2021
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: Diarrhea that have gotten progressively worse; Felt crappy, in bed all day; Achy; Headache; Redness in arm of injection; Tenderness in arm of injection; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea that have gotten progressively worse, achy/ pain, headache, felt crappy, in bed all day/ malaise, redness in arm of injection/ vaccination site erythema, tenderness in arm of injection/ vaccination site pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Feb 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events diarrhea that have gotten progressively worse, achy, headache, felt crappy, in bed all day, redness in arm of injection, tenderness in arm of injection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, diarrhea that have gotten progressively worse, achy, headache, felt crappy, in bed all day, redness in arm of injection, tenderness in arm of injection was unknown.

Other Meds:

Current Illness:

ID: 1562774
Sex: F
Age: 73
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: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.; low grade headache; nausea; low abdominal discomfort and pain below the stomach; gas; bleed at the time of injection; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.), ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 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 HAEMORRHAGE (bleed at the time of injection). On 03-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas) and NAUSEA (nausea). On an unknown date, the patient experienced CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) and HEADACHE (low grade headache). At the time of the report, CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) had resolved and ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection), NAUSEA (nausea) and HEADACHE (low grade headache) 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. This case was linked to MOD-2021-034833 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant: event outcome updated On 02-May-2021: form with pictures

Other Meds:

Current Illness:

ID: 1562775
Sex: F
Age: 56
State:

Vax Date: 02/02/2021
Onset Date: 02/03/2021
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: Rash on shin and knee; Fever; chills; sore bones; headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included NAPROXEN (NAPROSYN E), ATENOLOL, LEVOTHYROXINE, INDAPAMIDE, PERINDOPRIL ARGININE (COVERSYL PLUS [INDAPAMIDE;PERINDOPRIL ARGININE]) and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced RASH (Rash on shin and knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache), FATIGUE (Fatigue) and RASH (Rash on shin and knee) outcome was unknown. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: NAPROSYN E; ATENOLOL; LEVOTHYROXINE; COVERSYL PLUS [INDAPAMIDE;PERINDOPRIL ARGININE]; NEXIUM 1-2-3

Current Illness: Thyroid disorder

ID: 1562776
Sex: F
Age: 78
State: IL

Vax Date: 02/16/2021
Onset Date: 03/04/2021
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: Rash over her body; very red (rash); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history.). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)). At the time of the report, RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1562777
Sex: F
Age: 29
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
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: Received 2 doses 2 months apart; A spontaneous report was received from a consumer (Nurse) concerning a 29 -year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) received second dose of Moderna COVID-19 vaccine two months apart. The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Mar 2021, the patient received her second of two planned doses of mRNA-1273(Batch Number: Unknown) in left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient received second dose of Moderna COVID-19 vaccine two months apart (Inappropriate schedule of vaccine administered). No treatment information was provided. Action taken with mRNA-1273 in response to the event received second dose of Moderna COVID-19 vaccine two months apart was not applicable. The outcome of the event received second dose of Moderna COVID-19 vaccine two months apart was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1562778
Sex: F
Age:
State: LA

Vax Date: 02/19/2021
Onset Date: 03/03/2021
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: Got a dose 11 days earlier from today; A spontaneous report was received from a healthcare professional, concerning a 70-years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got a dose 11 days earlier from today (inappropriate schedule of product administration). No medical history was reported. The concomitant medication included unspecified psychiatric medications. On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly in left arm. The healthcare professional reported that on 19 Feb 2021, the patient got her first Moderna dose. The patient did not disclose to them and on 03 Mar 2021, got another dose of Moderna vaccine which was second dose to left arm. The healthcare professional reported that the patient got a dose 11 days earlier from today. No treatment information was reported. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome for the event, patient got a dose 11 days earlier from today, was considered as resolved on 03 Mar 2021.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (Lot #: Not Provided) with no associated AEs reported

Other Meds:

Current Illness:

ID: 1562779
Sex: F
Age: 70
State: AL

Vax Date: 02/18/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: "mild cold, flu type feeling"; Redness is spreading; area of the size of her palm that is hard; feels tired; area of the size of her palm that is very red; arm became very sore; "mild cold, flu type feeling"; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard) and FATIGUE (feels tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus-like syndrome, Osteoarthritis, High cholesterol, Fibromyalgia and Drug allergy (codeine). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), DULOXETINE HYDROCHLORIDE (CYMBALTA), METOPROLOL SUCCINATE (TOPROL) and HYDROCHLOROTHIAZIDE for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced NASOPHARYNGITIS ("mild cold, flu type feeling"). On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore). At the time of the report, NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The treatment information was unknown. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: follow up received and contain no new information

Other Meds: LIPITOR; CYMBALTA; TOPROL; HYDROCHLOROTHIAZIDE.

Current Illness: Drug allergy (codeine); Fibromyalgia; High cholesterol; Lupus-like syndrome; Osteoarthritis.

ID: 1562780
Sex: M
Age: 67
State:

Vax Date: 02/11/2021
Onset Date: 02/11/2021
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: wake up every few hours; did not sleep well; really cold; lactic acid feeling; felt pretty sick; felt off in his body; terrible aches in his arms; fever; terrible aches in his shoulders; pain; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling) and MALAISE (felt pretty sick) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Infection. Concomitant products included CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) and METRONIDAZOLE for Infection. On 11-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 11-Feb-2021, the patient experienced SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain). On 12-Feb-2021, SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain) had resolved.

Other Meds: CIPRO [CIPROFLOXACIN]; METRONIDAZOLE

Current Illness:

ID: 1562781
Sex: M
Age:
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: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Slight swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Slight swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The patient's past medical history included Bruise, Abdominal discomfort and Swelling. On 25-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Slight swelling). At the time of the report, VACCINATION SITE SWELLING (Slight swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-034823 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: ADR form with pictures

Other Meds:

Current Illness:

ID: 1562782
Sex: F
Age: 76
State: OH

Vax Date: 03/03/2021
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: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: MOTION SICKNESS; HEADACHES; NAUSEA; VOMITING; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (MOTION SICKNESS), HEADACHE (HEADACHES), NAUSEA (NAUSEA) and VOMITING (VOMITING) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported. ). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOTION SICKNESS (MOTION SICKNESS), HEADACHE (HEADACHES), NAUSEA (NAUSEA) and VOMITING (VOMITING). At the time of the report, MOTION SICKNESS (MOTION SICKNESS), HEADACHE (HEADACHES), NAUSEA (NAUSEA) and VOMITING (VOMITING) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1562783
Sex: F
Age: 70
State: CA

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

Symptoms: tingling in face; swollen right side of face; A spontaneous report was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in face/paraesthesia, swollen right side of face/swelling face. The patient's medical history was not provided. No relevant concomitant medications were reported. 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: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, approximately one hour after the vaccination, patient experienced the event(s) tingling in face/paraesthesia, swollen right side of face/swelling face. Treatment information was provided as Benadryl and generic zyrtec. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), tingling in face/paraesthesia, swollen right side of face/swelling face was unknown.

Other Meds:

Current Illness:

ID: 1562784
Sex: F
Age:
State: NC

Vax Date: 02/24/2021
Onset Date: 03/03/2021
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: Hurts; Swelling; Red patch; Bug bite; Itching; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain, feels like a bump inside/swelling, red patch/rash. The patient's medical history included diabetes mellitus type-2, hip replacement. Concomitant medications reported were Metformin, Spironolactone, Lipitor, Micardis, Amoxicillin for drug use for unknown indication. On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 3 Mar 2021, the patient experienced the events itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain, red patch/rash. On 4 Mar 2021, the patient experienced the event feels like a bump inside/swelling. Treatment details included Cortisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain,feels like a bump inside/swelling, red patch/rash were considered not resolved.

Other Meds: METFORMIN; SPIRONOLACTONE; LIPITOR; MICARDIS; AMOXICILLIN

Current Illness: Diabetes mellitus (Type-2)

ID: 1562785
Sex: F
Age: 23
State: MA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 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: Bad Headache; Chills; Extremely Exhausted; Queasy; A spontaneous report was received from a (Consumer) concerning a- 23 years old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced Extremely Exhausted, Queasy, Bad Headache and Chills. The patient's medical history not included. No relevant concomitant medications were reported. 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:010A21A) intramuscular for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced events extremely exhausted and queasy. On 03 March 2021, the patient experienced events bad headache and exhausted again and had chills. Laboratory details not provided. No treatment details included. Action taken with mRNA-1273 in response to the events was not reported. On 27 Feb 2021, the outcome of the event Queasy was Resolved. At the time of this report, the outcome of the events Extremely Exhausted, Bad Headache and chills was unknown.

Other Meds:

Current Illness:

ID: 1562786
Sex: F
Age: 74
State: AZ

Vax Date: 02/15/2021
Onset Date:
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: Drowsy; Rash Spot; Distorted Vision; Had a bad reaction; Reactions to the vaccine as they were pretty strange; Sore Arm; Red Spots; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction) and VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Suspected COVID-19. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), OMEPRAZOLE and ROPINIROLE HYDROCHLORIDE (ROPIDOPIN) for an unknown indication. On 15-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 SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Drowsy), RASH MACULAR (Rash Spot), METAMORPHOPSIA (Distorted Vision), FEELING ABNORMAL (Had a bad reaction), VACCINATION SITE REACTION (Reactions to the vaccine as they were pretty strange), VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE ERYTHEMA (Red Spots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient mentioned that she had a bad reaction because she had covid before the pandemic, and it was the antibodies that attacked the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New events feeling abnormal, vaccination site reaction were added.

Other Meds: ALLEGRA; OMEPRAZOLE; ROPIDOPIN

Current Illness:

ID: 1562787
Sex: M
Age: 74
State: FL

Vax Date: 02/26/2021
Onset Date:
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: Side effect unknown; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect unknown) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced ADVERSE EVENT (Side effect unknown). At the time of the report, ADVERSE EVENT (Side effect unknown) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No relevant concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: OutcomeTCS document attached

Other Meds:

Current Illness:

ID: 1562788
Sex: F
Age:
State:

Vax Date:
Onset Date:
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:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: vaccination site got a little warm; vaccination site got a little red; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site got a little red, vaccination site got a little warm. The patient's medical history was not provided. relevant concomitant products usage were not reported by the reporter. On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) vaccination site got a little red, vaccination site got a little warm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), vaccination site got a little red, vaccination site got a little warm was unknown.

Other Meds:

Current Illness:

ID: 1562789
Sex: F
Age: 35
State: OH

Vax Date: 01/28/2021
Onset Date:
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:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: rash on arm and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm and shoulder) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on arm and shoulder). At the time of the report, RASH (rash on arm and shoulder) outcome was unknown. This case was linked to MOD-2021-034817 (Patient Link).

Other Meds:

Current Illness:

ID: 1562790
Sex: F
Age: 60
State: IN

Vax Date: 03/02/2021
Onset Date: 03/02/2021
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: Patient did not receive 2nd dose on her HCP's medical advice/recommendation; Fever that was 102; Severe vertigo with spinning right to left and up and down; Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers; Red streaks down her arm; Red streaks are hot; could not move her elbow; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot) and VERTIGO (Severe vertigo with spinning right to left and up and down) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. On 02-Mar-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), HYPOKINESIA (could not move her elbow) and VOMITING (Throwing up). On 02-Mar-2021 at 10:00 PM, the patient experienced PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers). On 03-Mar-2021, the patient experienced VERTIGO (Severe vertigo with spinning right to left and up and down). On an unknown date, the patient experienced OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation) and PYREXIA (Fever that was 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), VERTIGO (Severe vertigo with spinning right to left and up and down), PYREXIA (Fever that was 102) and VOMITING (Throwing up) outcome was unknown and PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers) and HYPOKINESIA (could not move her elbow) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's Health care provider gave her letter stating she could skip 2nd dose as she had severe reaction for the first dose. No concomitant medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up appended

Other Meds:

Current Illness:

ID: 1562791
Sex: F
Age: 88
State: FL

Vax Date: 01/11/2021
Onset Date: 03/04/2021
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: Missed the second dose for 52 days now; A spontaneous report was received from a Pharmacist concerning herself, 88 years- old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and missed the second dose for 52 days now. No patient's medical history was reported. No relevant concomitant medications were reported. On 11 Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. As of 04 March 2021, the patient reported that she missed the second dose for 52 days now. No Laboratory investigations were provided. No Treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event, missed the second dose for 52 days now was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.

Other Meds:

Current Illness:

ID: 1562792
Sex: M
Age: 68
State: TN

Vax Date: 02/24/2021
Onset Date: 03/03/2021
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: Unevaluable event

Symptoms: Rash; itchy; This spontaneous case was reported by an other and describes the occurrence of RASH (Rash) and PRURITUS (itchy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0316(orL)20A) for COVID-19 vaccination. No Medical History information was reported. No concomitant medication of the patient was reported. On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced RASH (Rash) and PRURITUS (itchy). At the time of the report, RASH (Rash) and PRURITUS (itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1562793
Sex: M
Age: 67
State: CA

Vax Date: 02/25/2021
Onset Date: 02/28/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Red and Swollen Entire Left Arm; Red Injection Site; Swollen Injection Site; Reaction Spread to the entire Left Arm; Enlarged Lymph Node in the Left Armpit.; Red and Swollen Entire Left Arm; A spontaneous report was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient experienced the event(s) red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm was unknown.

Other Meds:

Current Illness:

ID: 1562794
Sex: F
Age:
State: NJ

Vax Date: 03/03/2021
Onset Date:
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: had a lot of the general side effects; fast heartbeat; dizziness; fatigue; headache; muscle pain; chills; fever; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever. The patient's medical history was not provided. Concomitant medications reported were Synthroid for drug use for unknown indication. On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever. Treatment details included ASPIRIN. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever was unknown.

Other Meds: SYNTHROID

Current Illness:

ID: 1562795
Sex: F
Age:
State:

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: fever of 100.5?F and Head ache; fever of 100.5?F and Head ache; the arm is sore at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 100.5?f(Pyrexia) , head ache(Headache), the arm is sore at the injection site(Injection site pain). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) fever of 100.5?F and Head ache, the arm is sore at the injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event(s), fever of 100.5?f and head ache, the arm is sore at the injection site was unknown.

Other Meds:

Current Illness:

ID: 1562796
Sex: F
Age: 67
State: PA

Vax Date: 01/25/2021
Onset Date: 03/01/2021
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: Swollen lips; 6 inch whelps on her torso, hip and butt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (6 inch whelps on her torso, hip and butt) and LIP SWELLING (Swollen lips) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient's past medical history included No adverse event (medical history not reported). On 25-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (6 inch whelps on her torso, hip and butt). On an unknown date, the patient experienced LIP SWELLING (Swollen lips). At the time of the report, URTICARIA (6 inch whelps on her torso, hip and butt) and LIP SWELLING (Swollen lips) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) and mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 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: 1562797
Sex: F
Age:
State: OH

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: Nausea, Pain in extremity, Pyrexia

Symptoms: Temperature; Sweats; A Spontaneous report was received from consumer concerning a unspecified age, female patient , Modern's COVID-19 vaccine(mRNA 1273) and experienced temperature and sweats. The patient medical history was not provided by the reporter. Concomitant medications were not provided by the reporter. On unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 , via unknown route and unknown anatomical location for prophylaxis of COVID-19 infection. After receiving the first dose the patient experienced Temperature and sweats. Treatment history was not provided by the reporter. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event temperature and sweats were unknown.

Other Meds:

Current Illness:

ID: 1562798
Sex: F
Age: 70
State: MI

Vax Date: 03/04/2021
Onset Date: 03/04/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: tinny taste in the back of my mouth; rash on my arm; face was pink; A spontaneous report was received from a consumer, concerning a 70 years adult female patient, who received Moderna COVID-19 Vaccine and experienced 1 dose. The patient's medical history was not provided. The concomitant products was not provided. On 04-Mar-2021,prior to the onset of events,the patient received the first dose of mRNA-1273(lot number: 029AD1A) and route of administration is unknown route for COVID-19 infection prophylaxis. The treatment includes that Patient reports putting Benadryl on her arm today 04Mar2021. Action taken with mRNA-1273 in response to the events were not reported. The Outcome of the event (Rash,Dysgeusia,Rosacea) was considered to be not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1562799
Sex: F
Age: 84
State: CA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
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: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: swollen; red; itchy; COVID arm; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen, red, itchy, covid arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 4 Feb 2021, the patient experienced the event(s) swollen, red, itchy, covid arm. Treatment details included None. Action taken with mRNA-1273 in response to the events was not reported. On 11 Feb 2021 the outcome of event(s), swollen, itchy, covid arm was resolved. The outcome of event(s), red was unknown.

Other Meds:

Current Illness:

ID: 1562800
Sex: F
Age: 56
State: AL

Vax Date: 01/16/2021
Onset Date: 01/17/2021
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: Test Date: 20210117; Test Name: Heart rate; Test Result: Inconclusive

Allergies:

Symptom List: Nausea

Symptoms: Severe joint pain; Muscle pain in chest and arms; Really bad leg cramps; Legs feel like sciatic overload; Heart rate went up to between 92-98 beats per; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (Really bad leg cramps), SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per), ARTHRALGIA (Severe joint pain) and MYALGIA (Muscle pain in chest and arms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included Ear infection (Reported data: In the past month I had two Rocephin shots for ear infections. Treatment: Rocephin shots) in January 2021. Previously administered products included for Product used for unknown indication: Flu shot on 16-Dec-2020 and Pneumovax shot on 28-Dec-2020. Concurrent medical conditions included Type II diabetes mellitus. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MUSCLE SPASMS (Really bad leg cramps), SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per) and MYALGIA (Muscle pain in chest and arms). On an unknown date, the patient experienced ARTHRALGIA (Severe joint pain). In February 2021, MUSCLE SPASMS (Really bad leg cramps) had resolved. At the time of the report, SCIATICA (Legs feel like sciatic overload), HEART RATE INCREASED (Heart rate went up to between 92-98 beats per), ARTHRALGIA (Severe joint pain) and MYALGIA (Muscle pain in chest and arms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Heart rate: 92-98 Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment for the events included steroids.

Other Meds:

Current Illness: Type II diabetes mellitus

ID: 1562801
Sex: F
Age: 37
State: NY

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: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Hives; Sore Arm; Sore wrist; red rash on chest; nerve pain - right arm; tremors - right arm; weakness - right arm; burning sensation -right arm; itchiness; Rash near her ncek/rash on left side neck/collar bone; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PAIN IN EXTREMITY (Sore Arm), NEURALGIA (nerve pain - right arm), TREMOR (tremors - right arm) and MUSCULAR WEAKNESS (weakness - right arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Nerve damage. Concurrent medical conditions included Allergy to chemicals (Contrast dye) and Allergy to vaccine (Allergy to Gardasil vaccine). 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 RASH (Rash near her ncek/rash on left side neck/collar bone). On 27-Feb-2021, the patient experienced NEURALGIA (nerve pain - right arm), TREMOR (tremors - right arm), MUSCULAR WEAKNESS (weakness - right arm), BURNING SENSATION (burning sensation -right arm) and PRURITUS (itchiness). On 02-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on chest). On an unknown date, the patient experienced URTICARIA (Hives), PAIN IN EXTREMITY (Sore Arm) and ARTHRALGIA (Sore wrist). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Burning sensation, Rash, Hives and Pruritus, at a dose of 2 x 25 mg tablets; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date for Rash, at an unspecified dose and frequency; ALPRAZOLAM (ATARAX [ALPRAZOLAM]) ongoing since an unknown date for Rash erythematous, at a dose of 25 mg; EPINEPHRINE (EPIPEN) ongoing since an unknown date for Hives, at an unspecified dose and frequency and LORAZEPAM (ATIVAN) ongoing since an unknown date at an unspecified dose and frequency. On 27-Feb-2021, RASH (Rash near her ncek/rash on left side neck/collar bone) had resolved. On 08-Mar-2021, NEURALGIA (nerve pain - right arm), TREMOR (tremors - right arm), MUSCULAR WEAKNESS (weakness - right arm), BURNING SENSATION (burning sensation -right arm) and PRURITUS (itchiness) had resolved. On 23-Mar-2021, RASH ERYTHEMATOUS (red rash on chest) had resolved. At the time of the report, URTICARIA (Hives), PAIN IN EXTREMITY (Sore Arm) and ARTHRALGIA (Sore wrist) 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. The patient reported that following her visit to the neurologist on 12-Mar-2021, she completed antibody testing as ordered by her allergist and was found to have antibodies present. She reported that most of her symptoms had improved by the time she was ready for Dose 2 on 26March2021. However, MD at vaccination site told her she was not able to get the Dose 2 of Moderna vaccine or any mRNA vaccine due to the mild hives that she experienced at Dose 1 as per CDC guidelines. Moreover, patient also contacted CDC to ask f she can get Dose 2 of Moderna and Johnson & Johnson COVID-19 vaccine was recommended but that there was no data on the mixing of vaccinations and it would be at the discretion of the caller and primary care physician. Concomitant medications were not reported Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant follow-up appended

Other Meds:

Current Illness: Allergy to chemicals (Contrast dye); Allergy to vaccine (Allergy to Gardasil vaccine.)

ID: 1562802
Sex: F
Age: 87
State: AZ

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:
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: Dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to the company on 05-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication. On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown. Treatment details were not provided. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.

Other Meds: XANAX

Current Illness:

ID: 1562803
Sex: F
Age: 65
State: OH

Vax Date: 02/17/2021
Onset Date:
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: sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats) 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 17-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 an unknown date, the patient experienced HYPERHIDROSIS (sweats). At the time of the report, HYPERHIDROSIS (sweats) outcome was unknown. The patient reported that she had temperature and sweats following her first dose of vaccine. Concomitant and treatment details were not reported. This case was linked to MOD-2021-034865, MOD-2021-034850 (Patient Link).

Other Meds:

Current Illness:

ID: 1562804
Sex: F
Age: 77
State: SD

Vax Date: 02/08/2021
Onset Date: 02/09/2021
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: Tremor

Symptoms: Pain in the left shoulder going to elbow; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left shoulder going to elbow), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left shoulder going to elbow), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in the left shoulder going to elbow), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1562805
Sex: F
Age: 64
State: MI

Vax Date: 08/11/2021
Onset Date: 08/11/2021
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: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1562806
Sex: M
Age: 17
State: TX

Vax Date: 04/29/2021
Onset Date: 04/29/2021
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: Error: Patient Too Young for Vaccine Administered-

Other Meds:

Current Illness:

ID: 1562807
Sex: M
Age: 51
State: CT

Vax Date: 08/14/2021
Onset Date: 08/14/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1562808
Sex: M
Age:
State: TX

Vax Date: 08/01/2021
Onset Date: 08/15/2021
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: Feel like shut. High fever. Body aches.

Other Meds:

Current Illness:

ID: 1562809
Sex: F
Age: 62
State: PA

Vax Date: 07/21/2021
Onset Date: 07/28/2021
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:

Allergies:

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

Symptoms: Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium

Other Meds:

Current Illness:

ID: 1562810
Sex: M
Age: 60
State: FL

Vax Date: 07/24/2021
Onset Date: 07/30/2021
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: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Fever-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium

Other Meds:

Current Illness:

ID: 1562811
Sex: M
Age: 78
State: LA

Vax Date: 07/26/2021
Onset Date: 08/01/2021
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: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Systemic: pneumonia-Mild, Additional Details: Per pt's wife, pt started feeling bad on 8/1/21 and ran a fever of 102. Pt went to doctor on 8/3/21 and was diagnosised with pneumonia. Pt is asymptomatic per wife and received antibiotics.

Other Meds:

Current Illness:

ID: 1562812
Sex: F
Age: 57
State: OH

Vax Date: 08/02/2021
Onset Date: 08/03/2021
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:

Allergies:

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

Symptoms: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Mild

Other Meds:

Current Illness:

ID: 1562813
Sex: F
Age: 15
State: TX

Vax Date: 08/14/2021
Onset Date: 08/14/2021
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: Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted upon minutes after patient given vaccine. Pt was going by seat to sit down after getting vaccinated and brother was on deck for the vaccine. Before sitting down pt fainted and hit the floor. Patient was unresponsive for a few seconds and then recovered. Pt was complaining about headaches but reported to be okay. Asked pt and father multiple times if they were okay, they said they were fine. Pt sat for observation for 15 minutes and then left the pharmacy, fine.

Other Meds:

Current Illness:

ID: 1562814
Sex: F
Age: 56
State: IL

Vax Date: 06/03/2021
Onset Date: 06/03/2021
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: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-

Other Meds:

Current Illness:

ID: 1562815
Sex: U
Age:
State: IL

Vax Date: 02/10/2021
Onset Date: 02/18/2021
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: her lips were swollen; chills; headache; fatigue; blotching redness on her arm; little bit of itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (her lips were swollen), ERYTHEMA (blotching redness on her arm), PRURITUS (little bit of itching), CHILLS (chills) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (blotching redness on her arm) and PRURITUS (little bit of itching). On an unknown date, the patient experienced LIP SWELLING (her lips were swollen), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Chills, Headache, Fatigue and Temperature elevation, at a dose of 200 mg once. On 21-Feb-2021, ERYTHEMA (blotching redness on her arm) and PRURITUS (little bit of itching) had resolved. At the time of the report, LIP SWELLING (her lips were swollen) outcome was unknown and CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reportedly, 3 weeks after being vaccinated, the patient stated started experiencing chills, headache, fatigue, and little bit of temperature, which resolved following treatment with ibuprofen. The patient questioned herself if this could be a delayed reaction from the vaccine or is this common and wanted to due diligence by reporting this to Moderna. Concomitant medications were not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1562816
Sex: F
Age: 35
State: OH

Vax Date: 08/14/2021
Onset Date: 08/15/2021
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: None

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Body aches, my right arm where I got the injection is feels heavy, swollen feet, sore throat and tiredness.

Other Meds: Dulera

Current Illness: None

ID: 1562817
Sex: M
Age: 42
State: TX

Vax Date: 08/14/2021
Onset Date: 08/14/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium

Other Meds:

Current Illness:

ID: 1562818
Sex: F
Age: 15
State: FL

Vax Date: 08/14/2021
Onset Date: 08/14/2021
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: Error: Wrong Patient (documentation in system)-

Other Meds:

Current Illness:

ID: 1562819
Sex: F
Age: 60
State: FL

Vax Date: 08/14/2021
Onset Date: 08/14/2021
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: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient reported pain and swelling at injection site. Swelling decreased within the hour but she was concerned because it hurt more than first dose. She declined follow up with MD, although RPh recommended follow up since patient was concerned.

Other Meds:

Current Illness:

ID: 1562820
Sex: M
Age: 24
State: IL

Vax Date: 08/14/2021
Onset Date: 08/14/2021
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:

Allergies:

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

Symptoms: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am