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: 1634903
Sex: U
Age:
State: MO

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 08/26/2021
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: INADVERTENTLY RECEIVED THE JANSSEN COVID19 VACCINE AFTER COMPLETION OF MRNA SERIES; This spontaneous report received from a health care professional concerned a 74 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. Concomitant medications included mRNA 1273 for prophylactic vaccination. On 20-AUG-2021, the patient experienced inadvertently received the Janssen Covid19 vaccine after completion of mRNA series. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inadvertently received the Janssen Covid19 vaccine after completion of mRNA series. This report was non-serious.

Other Meds: MRNA 1273

Current Illness:

ID: 1634904
Sex: F
Age:
State: WI

Vax Date:
Onset Date: 08/12/2021
Rec V Date: 08/26/2021
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: DIARRHEA; UNABLE TO WORK; PAIN IN HIPS AND NECKS; WEAK MUSCLES; HURTING IN BOTH SHOULDERS; HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced pain in hips and necks. On 12-AUG-2021, the patient experienced weak muscles. On 12-AUG-2021, the patient experienced hurting in both shoulders. On 12-AUG-2021, the patient experienced headache. On 12-AUG-2021, the patient experienced feeling tired. On 13-AUG-2021, the patient experienced unable to work. On 13-AUG-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diarrhea, and had not recovered from headache, pain in hips and necks, feeling tired, weak muscles, hurting in both shoulders, and unable to work. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634905
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/22/2021
Rec V Date: 08/26/2021
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: COUGH; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced cough. On 22-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634906
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 103

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: SORENESS IS ABOUT A 2 FOR A DAY AFTER; NEEDLE PAIN IS MINOR; FEVER GOT UP TO 103; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced soreness is about a 2 for a day after, needle pain is minor, and fever got up to 103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever got up to 103, and the outcome of needle pain is minor and soreness is about a 2 for a day after was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1634907
Sex: F
Age:
State: NY

Vax Date: 12/22/2020
Onset Date: 12/01/2020
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20201222; Test Name: Tmperature; Test Result: Inconclusive ; Result Unstructured Data: 100.4 ?F

Allergies:

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

Symptoms: Fever of 100.4F; Injection site arm hurts a lot; Chills; Feeling sick; Headache; A spontaneous report was received from a physician, who was a female patient who received Moderna's COVID-19 vaccine and experienced feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot. The patient's medical history included Covid-19 in March 2020. Concomitant medications were not provided. On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the evening of 22 Dec 2020, the patient experienced a fever of 100.4 degrees Fahrenheit. On 23 Dec 2020, the patient called and stated that her injection site arm hurt a lot. She denied redness at the injection site. She stated she was having side effects including feeling sick, chills, and headache and still felt symptomatic. Treatment included paracetamol. Action taken with mRNA-1273 in response to the events feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, was not reported. The events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, were considered not resolved. The reporter assessed the events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot as related to the study drug.; Reporter's Comments: This case concerns a female patient who experienced events of feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot. The events occurred 1 day after the first dose of COVID-19 vaccine administration. Due to possible temporal relationship, the events are considered as related to the vaccine.

Other Meds:

Current Illness:

ID: 1634908
Sex: F
Age: 32
State: OH

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/26/2021
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: Test Date: 202011; Test Name: Glucose Tolerance Test; Result Unstructured Data: normal; Test Date: 20200530; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202007; Test Name: Ultrasound scan; Result Unstructured Data: normal; Test Date: 202009; Test Name: Ultrasound scan; Result Unstructured Data: normal

Allergies:

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

Symptoms: Pregnant and received the Moderna Covid-19 Vaccine today; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna Covid-19 Vaccine today) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (Socially). Concurrent medical conditions included Penicillin allergy and Hashimoto's thyroiditis (Has not been given any treatment) since 2016. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) from 15-Jun-2020 to 23-Jan-2021 for Nausea in pregnancy, PRE NATAL FORMULA from 07-Mar-2020 to an unknown date for Pregnancy. On 23-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Apr-2020 and the estimated date of delivery was 04-Feb-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna Covid-19 Vaccine today). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-third week of the pregnancy. The vaginal delivery occurred, which was reported as Full-term.There was perinatal complications or fetal/infant abnormalities. No abnormalities were noted at 1 month post-partum. On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna Covid-19 Vaccine today) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2020, Pregnancy test: positive (Positive) Positive. In July 2020, Ultrasound scan: normal (normal) normal. In September 2020, Ultrasound scan: normal (normal) normal. In November 2020, Glucose tolerance test: 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. Treatment information was not provided. The patient had one live full term birth. The estimated date of conception was reported as 30-May-2020. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. This case was linked to MOD-2020-001339 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: The patient information, pregnancy information and concomitant product dosage information were updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.

Other Meds: PRE NATAL FORMULA; ZOFRAN [ONDANSETRON]

Current Illness: Hashimoto's thyroiditis (Has not been given any treatment); Penicillin allergy

ID: 1634909
Sex: F
Age: 70
State: PR

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/26/2021
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: Problems with concentration, couldn't concentrate; Trouble finding her words, could't speak properly, experience kind of aphasia symptoms; Mind fogginess, brain fog; Hives; Difficulty remembering names; Difficult to do writing tasks; Heart race; nervousness of getting the vaccine; Swallen in the injection site; Redness in the injection site; A spontaneous report was received from a 70-year-old, female consumer who received Moderna's COVID-19 vaccine and developed problems with concentration, could not speak properly, trouble finding her words, brain fog/ mind fogginess, hives, redness and swelling at the injection site, difficult to do writing tasks, difficulty remembering things, increment in heartbeat, heart racing, nervousness of getting the vaccine. The patient's past medical history, as provided by the reporter, included long lasting, bad side effects following the influenza vaccine. Concomitant medication reported included vitamins. On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Dec 2020, four hours after receiving the vaccine, the patient developed problems with concentration, trouble finding her words, mind fogginess, hives, redness and swelling at the injection site, difficult to do writing tasks, difficulty remembering things, increment heart beat. Treatment for the event included tylenol and ibuprofen. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, developed problems with concentration, trouble finding her words, mind fogginess, hives, redness and swelling at the injection site, increment heartbeat were considered as recovered on 30 Dec 2020. At the time of report outcome of the events difficult to do writing tasks, difficulty remembering things was unknown. The reporter's assessment of causality for the events was not applicable. Additional information received on 31 Dec 2020: Events updated. Follow up received on 23Mar2021, included no new information.; 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: 1634910
Sex: F
Age:
State: TX

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/26/2021
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form at an unspecified frequency. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-Apr-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Causality for event Vaccine exposure during pregnancy is not applicable. It was reported the she was am 23 weeks pregnant. As of 30 Dec 2020, she was 24 weeks pregnant.; Sender's Comments: Causality for event Vaccine exposure during pregnancy is not applicable.

Other Meds:

Current Illness:

ID: 1634911
Sex: F
Age:
State: VT

Vax Date: 12/28/2020
Onset Date: 01/04/2021
Rec V Date: 08/26/2021
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: musculoskeletal pain; itching at injection site; Fever; Nauseating feeling; soreness around injection site; Nerve pain; Delayed allergic reaction; Red itchy wheel; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE for Hypothyroidism. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (musculoskeletal pain), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site). At the time of the report, MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site) 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 for the event included ibuprofen 200mg, acetaminophen 350mg and fexofenadine 60mg. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1634912
Sex: F
Age: 65
State: GA

Vax Date: 01/04/2021
Onset Date: 01/11/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Name: Fever; Result Unstructured Data: 100.2; Comments: Low grade rectal temperature of 100.2 this morning.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: injection site, it is a little hard; injection site, it is a little red; Phlebitis- raised skin that feels hard; low-grade rectal temperature of 100.2/ slight fever; there was some swelling; Soreness; Fever in the area; Arm feels tight when lifts; her nose was running/ runny nose; sneezing a lot; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (her nose was running/ runny nose), SNEEZING (sneezing a lot), VACCINATION SITE INDURATION (injection site, it is a little hard), PYREXIA (low-grade rectal temperature of 100.2/ slight fever) and VACCINATION SITE SWELLING (there was some swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dental implantation on 28-Dec-2020. Concurrent medical conditions included BP raised and Type 2 diabetes mellitus. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure high, AMLODIPINE and CHLORTHALIDONE for Blood pressure increased, CLINDAMYCIN and PREDNISONE for Dental surgery NOS, IBUPROFEN (ADVIL 12 HOUR), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-Jan-2021, the patient experienced RHINORRHOEA (her nose was running/ runny nose) and SNEEZING (sneezing a lot). On 12-Jan-2021, the patient experienced PYREXIA (low-grade rectal temperature of 100.2/ slight fever), VACCINATION SITE SWELLING (there was some swelling), PAIN (Soreness), INJECTION SITE WARMTH (Fever in the area) and MUSCLE TIGHTNESS (Arm feels tight when lifts). On 13-Jan-2021, the patient experienced VACCINATION SITE INDURATION (injection site, it is a little hard), INJECTION SITE ERYTHEMA (injection site, it is a little red) and VACCINATION SITE PHLEBITIS (Phlebitis- raised skin that feels hard). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 12-Jan-2021, RHINORRHOEA (her nose was running/ runny nose) and SNEEZING (sneezing a lot) had resolved. At the time of the report, VACCINATION SITE INDURATION (injection site, it is a little hard), PYREXIA (low-grade rectal temperature of 100.2/ slight fever), VACCINATION SITE SWELLING (there was some swelling), PAIN (Soreness), INJECTION SITE WARMTH (Fever in the area), MUSCLE TIGHTNESS (Arm feels tight when lifts), INJECTION SITE ERYTHEMA (injection site, it is a little red) and VACCINATION SITE PHLEBITIS (Phlebitis- raised skin that feels hard) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.2 100.2. 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 includes steroid (prednisone dose pack) on 28 Dec2020 for dental surgery, but stopped the prednisone 3 days later because she is diagnosed with Type 2 diabetes and it was making her blood sugar high. Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Additional information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CLINDAMYCIN; PREDNISONE; ADVIL 12 HOUR; BENADRYL A; ASPRIN; BYSTOLIC; AMLODIPINE; CHLORTHALIDONE

Current Illness: BP raised; Type 2 diabetes mellitus

ID: 1634913
Sex: F
Age: 78
State: NC

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
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: Arm soreness; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) and HEADACHE (Really bad headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness) and HEADACHE (Really bad headache). At the time of the report, VACCINATION SITE PAIN (Arm soreness) and HEADACHE (Really bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received containsed no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1634914
Sex: F
Age: 38
State: CA

Vax Date: 01/05/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
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: warm to the touch - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide; redness - 2 inches below the injection site; a little hard - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide; sore arm - 2 inches below the injection site; swelling - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide; swollen arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to the touch - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide), VACCINATION SITE ERYTHEMA (redness - 2 inches below the injection site), VACCINATION SITE INDURATION (a little hard - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide) and VACCINATION SITE PAIN (sore arm - 2 inches below the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seafood allergy (Lobster) and Drug allergy (Midol). Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for Birth control, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide), VACCINATION SITE ERYTHEMA (redness - 2 inches below the injection site), VACCINATION SITE INDURATION (a little hard - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide), VACCINATION SITE PAIN (sore arm - 2 inches below the injection site) and VACCINATION SITE SWELLING (swelling - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-Jan-2021, PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide), VACCINATION SITE ERYTHEMA (redness - 2 inches below the injection site), VACCINATION SITE INDURATION (a little hard - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide), VACCINATION SITE PAIN (sore arm - 2 inches below the injection site) and VACCINATION SITE SWELLING (swelling - 2 inches below the injection site - covers an area of 4 inches down my arm and is about 3.5 inches wide) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow up appendedPatient demographics were updated.event outcome was updated.

Other Meds: ALLEGRA; SPRINTEC

Current Illness: Drug allergy (Midol); Seafood allergy (Lobster)

ID: 1634915
Sex: F
Age: 58
State: GA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
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: Has a red circle at injection site; red circle at injection site feels like a bruise; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Has a red circle at injection site), VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTI VITAMIN & MINERAL. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose). On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Has a red circle at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Has a red circle at injection site), VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included unknown antidepressants.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VITAMIN D 2000; MULTI VITAMIN & MINERAL

Current Illness:

ID: 1634916
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: soreness at administration site; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE DISCOMFORT (soreness at administration site) and FATIGUE (Fatigue) 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 historical condition 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 VACCINATION SITE DISCOMFORT (soreness at administration site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE DISCOMFORT (soreness at administration site) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitants or treatment medications were reported.

Other Meds:

Current Illness:

ID: 1634917
Sex: F
Age: 27
State:

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/26/2021
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: Light headed; wheezing; pressure in chest; trouble breathing; soreness in vaccinated arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing) and VACCINATION SITE PAIN (soreness in vaccinated arm) in a 27-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. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache). At the time of the report, DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided. This case was linked to MOD-2021-043718 (Parent-Child Link). See case MOD-2021-043718 for details regarding the child case. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Outcome and reporter causality of events updated.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1634918
Sex: M
Age: 58
State: GA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/26/2021
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: thirsty; feels very dehydrated; dry lips and mouth; dry lips and mouth; This spontaneous case was reported by a consumer and describes the occurrence of in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1634919
Sex: F
Age: 67
State: PA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
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: diarrhea; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1634920
Sex: F
Age: 37
State: NJ

Vax Date: 01/11/2021
Onset Date: 01/18/2021
Rec V Date: 08/26/2021
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: Arm was swollen and itchy/Larger swelling, more itching; Throbbing; Overall weakness of arm; larger swelling, more itching, throbbing; larger swelling, more itching, throbbing; Overall weakness of my arm; larger swelling, more itching, throbbing; Arm was swollen and itchy; FELT LIKE BEE STING; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was swollen and itchy), ARTHROPOD STING (FELT LIKE BEE STING), VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing) and ASTHENIA (Overall weakness of arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was swollen and itchy) and ARTHROPOD STING (FELT LIKE BEE STING). On 19-Jan-2021, the patient experienced SWELLING (larger swelling, more itching, throbbing), PAIN (larger swelling, more itching, throbbing) and MUSCULAR WEAKNESS (Overall weakness of my arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing), ASTHENIA (Overall weakness of arm) and PRURITUS (larger swelling, more itching, throbbing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Jan-2021 at an unspecified dose and frequency; PREDNISONE ongoing from 20-Jan-2021 at a dose of 20 milligram twice a day and AMOXICILLIN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Arm was swollen and itchy), ARTHROPOD STING (FELT LIKE BEE STING), VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing), ASTHENIA (Overall weakness of arm), SWELLING (larger swelling, more itching, throbbing), PRURITUS (larger swelling, more itching, throbbing), PAIN (larger swelling, more itching, throbbing) and MUSCULAR WEAKNESS (Overall weakness of my arm) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1634921
Sex: F
Age: 79
State: PA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/26/2021
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: Red rash on her arm; it is itchy; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on her arm), VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE PAIN (soreness in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in her arm). On 20-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on her arm) and VACCINATION SITE PRURITUS (it is itchy). At the time of the report, RASH ERYTHEMATOUS (Red rash on her arm), VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE PAIN (soreness in her arm) 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 relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1634922
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/11/2021
Rec V Date: 08/26/2021
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: vomiting; loss of appetite; dizziness; arm hurt; arm swollen a little bit; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm swollen a little bit) and VOMITING (vomiting) in a 79-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 reported.). Concomitant products included VITAMIN B12 NOS, ASCORBIC ACID (VITAMIN C ACID) and CALCIUM. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and PERIPHERAL SWELLING (arm swollen a little bit). On 12-Jan-2021, the patient experienced DECREASED APPETITE (loss of appetite) and DIZZINESS (dizziness). On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, DECREASED APPETITE (loss of appetite), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm swollen a little bit) and VOMITING (vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.

Other Meds: VITAMIN B12 NOS; VITAMIN C ACID; CALCIUM

Current Illness:

ID: 1634923
Sex: F
Age: 70
State: FL

Vax Date: 01/06/2021
Onset Date: 01/08/2021
Rec V Date: 08/26/2021
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: a bump in her left arm; it itches very bad; little tender at the injection site; swollen at injection site; Experienced her face really red and whole body was red; flashings; very bad back pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Experienced her face really red and whole body was red), HOT FLUSH (flashings), BACK PAIN (very bad back pain), LIMB MASS (a bump in her left arm) and VACCINATION SITE PRURITUS (it itches very bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rosacea. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced BACK PAIN (very bad back pain). On 09-Jan-2021, the patient experienced ERYTHEMA (Experienced her face really red and whole body was red) and HOT FLUSH (flashings). On 20-Jan-2021, the patient experienced LIMB MASS (a bump in her left arm), VACCINATION SITE PRURITUS (it itches very bad), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 09-Jan-2021, ERYTHEMA (Experienced her face really red and whole body was red) and HOT FLUSH (flashings) had resolved. On 10-Jan-2021, BACK PAIN (very bad back pain) had resolved. At the time of the report, LIMB MASS (a bump in her left arm), VACCINATION SITE PRURITUS (it itches very bad), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE SWELLING (swollen at injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitants or treatment medications were reported.

Other Meds:

Current Illness:

ID: 1634924
Sex: F
Age: 45
State: CA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210113; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 158/94; Test Date: 20210113; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: 78; Test Date: 20210113; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: 99 percent

Allergies:

Symptom List: Unevaluable event

Symptoms: Throat tingling; Palpitations; Mild tachycardia; Facial edema; Oropharyngeal edema; Feeling faint; This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema) and OROPHARYNGEAL OEDEMA (Oropharyngeal edema) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 13-Jan-2021 at 7:54 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021 at 7:59 AM, the patient experienced PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema), OROPHARYNGEAL OEDEMA (Oropharyngeal edema) and DIZZINESS (Feeling faint). At the time of the report, PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema), OROPHARYNGEAL OEDEMA (Oropharyngeal edema) and DIZZINESS (Feeling faint) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 158/94. On 13-Jan-2021, Heart rate: 78. On 13-Jan-2021, Oxygen saturation: 99 percent. 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 concomitants or treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received contained non significant info.

Other Meds:

Current Illness: Hypertension

ID: 1634925
Sex: F
Age: 61
State: LA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/26/2021
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: her left arm was weaker; hurts when she tried to lift it; the soreness comeback; muscle soreness; fatigue; very mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle soreness), FATIGUE (fatigue), HEADACHE (very mild headache), MUSCULAR WEAKNESS (her left arm was weaker) and PAIN IN EXTREMITY (hurts when she tried to lift it) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ERGOCALCIFEROL (CALCIFEROL VIT D) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MYALGIA (muscle soreness), FATIGUE (fatigue) and HEADACHE (very mild headache). On 19-Jan-2021, the patient experienced MUSCULAR WEAKNESS (her left arm was weaker), PAIN IN EXTREMITY (hurts when she tried to lift it) and MYALGIA (the soreness comeback). On 09-Jan-2021, MYALGIA (muscle soreness), FATIGUE (fatigue) and HEADACHE (very mild headache) had resolved. At the time of the report, MUSCULAR WEAKNESS (her left arm was weaker), PAIN IN EXTREMITY (hurts when she tried to lift it) and MYALGIA (the soreness comeback) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ALLEGRA; CALCIFEROL VIT D; BABY ASPIRIN

Current Illness:

ID: 1634926
Sex: F
Age: 70
State: FL

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
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: red still continous; injection site(left arm) turned very red; rash; itchy but not too severely; warm at injection site; little discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. Concomitant products included GABAPENTIN (GABAPENTIN "PCD") and LISINOPRIL for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (little discomfort). On 19-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site). On 20-Jan-2021, the patient experienced ERYTHEMA (red still continous). At the time of the report, DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely), VACCINATION SITE WARMTH (warm at injection site) and ERYTHEMA (red still continous) 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: GABAPENTIN "PCD"; LISINOPRIL

Current Illness: Blood pressure

ID: 1634927
Sex: F
Age: 31
State: TX

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: normal

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Back pain; Not able to sleep; chills; headache; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and BACK PAIN (Back pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2020 and Hysterectomy. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 15-Jan-2021, the patient experienced BACK PAIN (Back pain) and INSOMNIA (Not able to sleep). At the time of the report, CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved, BACK PAIN (Back pain) had not resolved and INSOMNIA (Not able to sleep) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: 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.

Other Meds:

Current Illness:

ID: 1634928
Sex: F
Age: 19
State: TX

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 08/26/2021
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: Pregnant patient received the first dose of moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) for Nausea, VITAMIN B6 and PRE NATAL FORMULA. On 09-Jan-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 28-Sep-2020 and the estimated date of delivery was 05-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourteenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 19-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.

Other Meds: UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN B6; PRE NATAL FORMULA

Current Illness:

ID: 1634929
Sex: F
Age:
State: NY

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 08/26/2021
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: A rash which was itchy, red and swollen at the site of injection; A rash which was itchy, red and swollen at the site of injection; A rash which was itchy, red and swollen at the site of injection; Hand was sore for a couple of days; ITCHING; A rash which was itchy, red and swollen at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Hand was sore for a couple of days), PRURITUS (ITCHING), VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection) and the first episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) in a 54-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 No adverse event (No medical history provided). Concomitant products included FISH OIL and VITAMINS NOS. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Hand was sore for a couple of days) and PRURITUS (ITCHING). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), the first episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) and the second episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection). On an unknown date, the patient experienced VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection). At the time of the report, PAIN IN EXTREMITY (Hand was sore for a couple of days), PRURITUS (ITCHING), VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection) and the last episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment were provided

Other Meds: FISH OIL; VITAMINS NOS

Current Illness:

ID: 1634930
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: numbness in the tongue and lower face; tingling in the tongue and lower face; numbness and tingling in lower face; tingling in lower face; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face). At the time of the report, HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face) 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 information included benadryl. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1634931
Sex: F
Age: 37
State: MD

Vax Date: 12/28/2020
Onset Date: 01/05/2021
Rec V Date: 08/26/2021
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: itchy at injection site; painful at injection site; red knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1634932
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: dark red rash, itchy; dark red rash, itchy; dark red rash, itchy; urticaria develop in 4 staff and 1 client after injections; A spontaneous report was received from a nurse concerning a 52 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site erythema, injection site rash and injection site pruritus. 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 their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events injection site dark red rash that was very itchy. Laboratory details was not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event injection site dark red rash that was very itchy was unknown.; Sender's Comments: MOD-2021-012249:Original Case : MOD-2021-011289 US-MODERNATX, INC.-MOD-2021-012249:same reporter, different patient

Other Meds:

Current Illness:

ID: 1634933
Sex: F
Age: 29
State: CA

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 08/26/2021
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: at injection site little warm; at injection site have a bump; red at injection site; A spontaneous report ( United states) was received from a consumer concerning a 30 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ( vaccination site mass, vaccination site erythema, vaccination site warmth) lists. The patient's medical history was not provided. No relevant concomitant medications were reported. on 14/jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch : 011L20A ) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. Laboratory details not provided. No treatment information is provided action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was not reported.

Other Meds:

Current Illness:

ID: 1634934
Sex: M
Age:
State:

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 08/26/2021
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: reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1634935
Sex: F
Age: 87
State: FL

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/26/2021
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: arm on the injection is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm on the injection is a little sore) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121120A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy. On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm on the injection is a little sore). At the time of the report, VACCINATION SITE PAIN (arm on the injection is a little sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. The treatment medication were Xycal for allergies 1 pill, Albuterol inhaler aerosol for seasonal allergies. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information included reporter details

Other Meds:

Current Illness: Seasonal allergy

ID: 1634936
Sex: M
Age: 68
State: TX

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/26/2021
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: itching turned into more of a slight prickly sensation, almost burning; itching; red rectangle 2 x 3.5 inches; arm was a bit sore; A spontaneous report was received from a Reporter concerning about a 68 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list. The patient's medical history was not provided. No relevant concomitant medications were reported. Patient had Moderna first dose vaccine given to him on 08Jan2021. He developed at the injection site a little bit of a side effect. He would like to discuss this with somebody to see if it's dangerous or something he needs to be concerned about. Upon calling 22Jan2021 1003 EST: Patient confirmed he received the Moderna COVID19 vaccine on 08Jan2021 on left arm as IM injection. His arm was a bit sore. On 15Jan2021 patient states he started with the itching. Later he noticed he had a red rectangle 2 x 3.5 inches. The itching went on for about 2 days and then it subsided. On 18Jan2021, the itching was gone but the red area had increased in size. On 20Jan2021, the itching started again and the red area had increased to about 4.6 x 6 inches. Today 22Jan2021, the red area hasn't increased in size, but the itching turned into more of a slight prickly sensation, almost burning. It's not severe, not something that he can't stand, but it's noticeable. He states he never had a reaction like this before. Lot number of vaccine was not on patient's vaccination card. Consent given for safety to contact patient and his HCP. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.

Other Meds:

Current Illness:

ID: 1634937
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/21/2021
Rec V Date: 08/26/2021
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: Reaction at the injection site; arm was swollen; Itchy/occasional itchiness over her whole body; A little bit nausea; A spontaneous report was received from a non healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea. Medical history was not reported. Concomitant medication was not reported. On 12-Jan-2021, prior to the onset of the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011L20A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection. On 21-Jan-2021, the patient experienced having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea. Laboratory details was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea was not provided. The outcome of the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea was not reported. The reporter did not provide the assessment of the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea to study drug.

Other Meds:

Current Illness:

ID: 1634938
Sex: F
Age:
State: WV

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/26/2021
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: arm is very sore after receiving the shot; A spontaneous report was received from a non healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm is very sore after receiving the shot. Medical history was not reported. Concomitant medication was not reported. On 21-Jan-2021, prior to the onset of the event arm is very sore after receiving the shot, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via intramuscular route in right arm shoulder deltoid condition for prophylaxis of COVID-19 infection. On 21-Jan-2021, the patient experienced arm is very sore after receiving the shot. Laboratory details was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event arm is very sore after receiving the shot was not provided. The outcome of the event arm is very sore after receiving the shot was not recovered. The reporter did not provide the assessment of the event arm is very sore after receiving the shot to study drug.

Other Meds:

Current Illness:

ID: 1634939
Sex: F
Age:
State: TX

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 08/26/2021
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: abdominal cramping; nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of ABDOMINAL PAIN (abdominal cramping) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced ABDOMINAL PAIN (abdominal cramping) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN (abdominal cramping) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1634940
Sex: F
Age: 65
State: NC

Vax Date: 01/08/2021
Onset Date: 01/20/2021
Rec V Date: 08/26/2021
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: An orange, red area on the injection site; Swollen area on the injection site; red area on the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for an unknown indication. On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site). On 22-Jan-2021, VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site) 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.

Other Meds: ANTIHISTAMINE ALLERGY RELIEF

Current Illness:

ID: 1634941
Sex: F
Age: 90
State:

Vax Date: 01/13/2021
Onset Date: 01/22/2021
Rec V Date: 08/26/2021
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: red; soreness; Some swelling; itching; rash on the vaccination site; A spontaneous report was received from a medical assistant concerning a ninety-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed rash on the vaccination site, some swelling, itching, soreness and red. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (BATCH # 041L20A) on 13 Jan 2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection. Reporter called regarding Moderna vaccine. Her patient received the vaccine on 13 Jan 2021, and today (22 Jan 2021), she had developed a rash on the vaccination site, and some swelling and itching and soreness. Reporter is patient's provider and also a CMA (Certified Medical Assistant). Vaccine was given on right arm as intramuscular injection. Second dose was due 11 Feb 2021. Patient continued to have the rash, red and itchiness. Swelling had gone down some. Consent was given for safety to contact the reporter for the patient and her HCP (healthcare provider). No further information was reported. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the events rash on the vaccination site, itching and red was not resolving. The outcome of some swelling was resolving. The outcome of soreness was unknown. The reporter did not provide an assessment for the events, rash on the vaccination site, some swelling, itching, soreness and red.

Other Meds:

Current Illness:

ID: 1634942
Sex: F
Age: 71
State: OR

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 08/26/2021
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: having an itchy rash; Soreness around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-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 VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site). At the time of the report, VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site) 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:

Current Illness:

ID: 1634943
Sex: F
Age: 31
State: NY

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 08/26/2021
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: cyst in shoulder; Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) and DERMAL CYST (cyst in shoulder) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026LZ0A and 010MZOA) for COVID-19 vaccination. Concurrent medical conditions included BRCA1 gene mutation since 07-Apr-2014 and Allergy to antibiotic (to amoxicillin). Concomitant products included METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Shoulder pain. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 PAIN IN EXTREMITY (Arm was a little sore) and DERMAL CYST (cyst in shoulder). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) and DERMAL CYST (cyst in shoulder) outcome was unknown. No concomitant medications were reported. Patient reported she finished 4mg Medrol dose pack few days before second dose of Moderna COVID-19 vaccine which she was taking for shoulder pain due to a cyst that ruptured and she does not think that the cyst occurred due to the Moderna COVID-19 vaccine as it was a few weeks after the shot. This case was linked to MOD-2021-015853 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Patient information was updated, allergy to amoxicillin updated On 01-Jun-2021: patient sent MRI report which is unrelated to the case; Sender's Comments: Although the specific date was not provided. However, based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded.

Other Meds: MEDROL [METHYLPREDNISOLONE ACETATE]

Current Illness: Allergy to antibiotic (to amoxicillin); BRCA1 gene mutation

ID: 1634944
Sex: F
Age: 72
State: NC

Vax Date: 01/13/2021
Onset Date: 01/22/2021
Rec V Date: 08/26/2021
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: Delayed local hypersensitivity reaction; big large goose egg-size, light to medium pink,little bit swollen; big large goose egg-size, light to medium pink,little bit swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction), VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 038K20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Sulfa, Clindamycin), Sunscreen sensitivity, Insect bite allergy and Drug allergy (Clindamycin). Concomitant products included CALCIUM ACETATE (CA P) and VITAMIN D NOS for an unknown indication. On 13-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 12:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen). On an unknown date, the patient experienced VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction). On 26-Jan-2021, VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction), VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information has not been provided. This case was linked to MOD-2021-082652, MOD-2021-082652 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporters Address, Email Id provided.Patient information provided.Concomitant medications(sulfa, clindomycin, some skin product, sunscreens, insect bites) provided. Outcome of the event information provided.Outcome of the Follow up-1:The reported events were resolved on 26-JAN-2021.

Other Meds: CA P; VITAMIN D NOS

Current Illness: Drug allergy (Sulfa, Clindamycin); Drug allergy (Clindamycin); Insect bite allergy; Sunscreen sensitivity

ID: 1634945
Sex: F
Age: 72
State: OH

Vax Date: 02/06/2021
Onset Date: 02/12/2021
Rec V Date: 08/26/2021
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: Big knot (injection site); Rash (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big knot (injection site)) and VACCINATION SITE RASH (Rash (injection site)) in a 72-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 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (Big knot (injection site)) and VACCINATION SITE RASH (Rash (injection site)). At the time of the report, VACCINATION SITE MASS (Big knot (injection site)) and VACCINATION SITE RASH (Rash (injection site)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1634946
Sex: F
Age: 70
State: NJ

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/26/2021
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: she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".; fatigue; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness in her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced TASTE DISORDER (she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness in her arm). At the time of the report, TASTE DISORDER (she experienced a bad taste in her mouth "like she has medicine" and is fatigued. She has soreness experienced a bad taste in her mouth "like she has medicine".), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness in her arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1634947
Sex: F
Age: 22
State: NJ

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/26/2021
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: small lump, like a ball at the injection site; It is red; muscle soreness in the arm of the injection; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (muscle soreness in the arm of the injection), VACCINATION SITE MASS (small lump, like a ball at the injection site) and VACCINATION SITE ERYTHEMA (It is red) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (muscle soreness in the arm of the injection). On 02-Feb-2021, the patient experienced VACCINATION SITE MASS (small lump, like a ball at the injection site) and VACCINATION SITE ERYTHEMA (It is red). At the time of the report, MYALGIA (muscle soreness in the arm of the injection) had resolved and VACCINATION SITE MASS (small lump, like a ball at the injection site) and VACCINATION SITE ERYTHEMA (It is red) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1634948
Sex: F
Age: 26
State: PA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
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: swelling of her arm; Hurting of her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of her arm) and PAIN IN EXTREMITY (Hurting of her arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling of her arm) and PAIN IN EXTREMITY (Hurting of her arm). At the time of the report, PERIPHERAL SWELLING (swelling of her arm) and PAIN IN EXTREMITY (Hurting of her arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. On 03Feb2021, her symptoms are back to what they were and are just as bad as originally.

Other Meds:

Current Illness:

ID: 1634949
Sex: F
Age: 25
State: CA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/26/2021
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: Rash near injection site. Rash size of apple. 2-3inch in Diameter; Soreness from initial injection on day 1; A spontaneous case report from united states from an Other Health Professional on 26-JAN-2021 , which refers to a Female aged 25 Years. On 16JAN2021 the patient received Moderna COVID-19 Vaccine for COVID-19 vaccination. the patient developed Rash near injection site. Rash size of apple. 2-3inch in Diamete, .after receiving first dose of Moderna Vaccine. 1st dose was on 16JAN2021(Batch Number 042L20A) intramuscular route. Symptoms started 2 day later on Monday 18JAN2021. Rash right near injection site. Rash size of an apple. 2-3inch in diameter. Had soreness from initial injection on day 1. The soreness went away on the same day. :. The eventual diagnosis made on was Vaccination site rash . Not taking any medications to treat symptoms. Currently on no medications. Second dose on 13FEb2021. Laboratory details were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of reported events fever was recovering and outcome of Rash near injection site was unknown and soreness of injection site was recovered. The reporter assessment for the event(s) were not provided. Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other Health Professional, Age- 25 Years, Sex- Female, Suspect Drug- Moderna COVID-19 Vaccine, Treatment- Diagnosis\Outcome- Rash near injection site. Rash size of apple. 2-3inch in Diameter - Unknown,Soreness from initial injection on day 1 - Recovered/Resolved.

Other Meds:

Current Illness:

ID: 1634950
Sex: F
Age: 68
State: MI

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/26/2021
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: feel like I was hit by a bus; Back pain; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feel like I was hit by a bus), BACK PAIN (Back pain) and PAIN (hip pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for an unknown indication. Concurrent medical conditions included Arthritis (hip arthritis). Concomitant products included IBUPROFEN for Arthritis. On 19-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 PAIN (feel like I was hit by a bus), BACK PAIN (Back pain) and PAIN (hip pain). At the time of the report, PAIN (feel like I was hit by a bus) and BACK PAIN (Back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information is not provided.

Other Meds: IBUPROFEN

Current Illness:

ID: 1634951
Sex: F
Age: 65
State: PA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/26/2021
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: Painful rash; Red rash; Itchy rash; Achy; Myalgia; Fatigue; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Painful rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), PAIN (Achy) and MYALGIA (Myalgia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included HydroDiuril Blood pressure medication for Hypertension, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (Myalgia), FATIGUE (Fatigue) and HEADACHE (headache). On 20-Jan-2021, the patient experienced RASH (Painful rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash) and PAIN (Achy). At the time of the report, RASH (Painful rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), PAIN (Achy), MYALGIA (Myalgia), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: HydroDiuril Blood pressure medication; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1634952
Sex: F
Age:
State: OH

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/26/2021
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: feeling lightheaded; heart rate has been flactuating; diarrhea; clummy; fatigued; nausea; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (feeling lightheaded), HEART RATE IRREGULAR (heart rate has been flactuating), DIARRHOEA (diarrhea), HYPERHIDROSIS (clummy) and FATIGUE (fatigued) in a female patient of an unknown age 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (feeling lightheaded), HEART RATE IRREGULAR (heart rate has been flactuating), DIARRHOEA (diarrhea), HYPERHIDROSIS (clummy), FATIGUE (fatigued) and NAUSEA (nausea). At the time of the report, DIZZINESS (feeling lightheaded), HEART RATE IRREGULAR (heart rate has been flactuating), DIARRHOEA (diarrhea), HYPERHIDROSIS (clummy), FATIGUE (fatigued) and NAUSEA (nausea) 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. Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am