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: 1627188
Sex: F
Age: 73
State: MD

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/24/2021
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: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm) and headache (light headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 0021C21A) for COVID-19 immunization. No medical history reported. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (sore arm) and headache (light headaches). At the time of the report, vaccination site pain (sore arm) and headache (light headaches) resolved. This case linked to MOD-2021-217218 (patient link). Most recent follow-up information incorporated: On Jun 29, 2021: Updated reporter information, added patient details, updated product information, dose-1 batch number and route of administration changed from unknown to intramuscular.

Other Meds:

Current Illness:

ID: 1627189
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) 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. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1627190
Sex: M
Age:
State: NC

Vax Date: 06/08/2021
Onset Date:
Rec V Date: 08/24/2021
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: Test Name: Body temperature; Result Unstructured Data: 100.7

Allergies:

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

Symptoms: Headache; Muscle Ache; Fever; extremely tired sleeping most of the day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Muscle ache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 (High) 100.7. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitants were provided.

Other Meds:

Current Illness:

ID: 1627191
Sex: F
Age: 44
State: IL

Vax Date: 10/01/2020
Onset Date: 02/19/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: chills; fever; muscle ache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa. No Medical History information was reported. In October 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache). On 20-Feb-2021, CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) to be probably related. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1627192
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Soreness of the Arm for 1 day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021. This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness of the Arm for 1 day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of the Arm for 1 day). At the time of the report, PAIN IN EXTREMITY (Soreness of the Arm for 1 day) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No information about concomitant medication was provided. No treatment information was provided. This case was linked to MOD-2021-032991 (Patient Link).

Other Meds:

Current Illness:

ID: 1627193
Sex: F
Age: 39
State: NC

Vax Date: 11/16/2019
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Was pregnant; Rash; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis, Illness and Allergic rhinitis. Concurrent medical conditions included Pollen allergy. Concomitant products included TRIAMCINOLONE ACETONIDE, FLUOCINONIDE (FLUOCINONIDE-E), TACROLIMUS MONOHYDRATE (PROTOPIC), LEVONORGESTREL (MIRENA) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for an unknown indication. On 16-Nov-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by the reporter. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies. She was not sure if it was due to the pollen currently, missed her dupixent dose or moderna covid vaccine. has missed 3 doses in the last 6 months due to "refill issues" with them always having to get authorization from her doctor or some other problem. It was unknown if there were lab data or results available. The reporter doesn't believe the events are related to the vaccine in any way. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received. The causality of the event was updated.

Other Meds: TRIAMCINOLONE ACETONIDE; FLUOCINONIDE-E; PROTOPIC; MIRENA; ALLEGRA ALLERGY

Current Illness: Pollen allergy

ID: 1627194
Sex: M
Age:
State: CA

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 08/24/2021
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: Didn't sleep all night; felt like chest was going to explode; vaccine may have exacerbated his heart condition; could not lift anything; threw back out from chills/chills; bad body aches/he had severe pain in his whole body for 2 straight days after the 2nd dose of the vaccine.; woozy and lightheaded; really weak; felt like was going to collapse/not feeling good; Terrible back pain/threw out back from chills/lower vertebrae pain; feeling tired; had side effects/bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (vaccine may have exacerbated his heart condition), MOBILITY DECREASED (could not lift anything), VACCINATION COMPLICATION (had side effects/bad reaction), PAIN (bad body aches) and BACK PAIN (Terrible back pain/threw out back from chills/lower vertebrae pain) in a male 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. The patient's past medical history included Heart attack and Stent insertion NOS (3 Stents). Concurrent medical conditions included Hyperthyroidism and Cancer (Cancer on tongue). On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION COMPLICATION (had side effects/bad reaction) and FATIGUE (feeling tired). On 22-May-2021, the patient experienced PAIN (bad body aches), BACK PAIN (Terrible back pain/threw out back from chills/lower vertebrae pain), DIZZINESS (woozy and lightheaded), ASTHENIA (really weak), MALAISE (felt like was going to collapse/not feeling good), CHILLS (threw back out from chills/chills) and MYALGIA (bad body aches/he had severe pain in his whole body for 2 straight days after the 2nd dose of the vaccine.). On an unknown date, the patient experienced CARDIAC DISORDER (vaccine may have exacerbated his heart condition), MOBILITY DECREASED (could not lift anything), INSOMNIA (Didn't sleep all night) and CHEST PAIN (felt like chest was going to explode). The patient was treated with PARACETAMOL (TYLENOL) on 22-May-2021 at a dose of UNK milligram. At the time of the report, CARDIAC DISORDER (vaccine may have exacerbated his heart condition) and MOBILITY DECREASED (could not lift anything) outcome was unknown and VACCINATION COMPLICATION (had side effects/bad reaction), PAIN (bad body aches), BACK PAIN (Terrible back pain/threw out back from chills/lower vertebrae pain), INSOMNIA (Didn't sleep all night), CHEST PAIN (felt like chest was going to explode), DIZZINESS (woozy and lightheaded), ASTHENIA (really weak), MALAISE (felt like was going to collapse/not feeling good), FATIGUE (feeling tired), CHILLS (threw back out from chills/chills) and MYALGIA (bad body aches/he had severe pain in his whole body for 2 straight days after the 2nd dose of the vaccine.) had resolved. Concomitant medications included thyroid pill and beta blocker. Treatmnt information has not provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant FU -Event outcome updated to Resolved. Added medical history Cancer on tongue. On 20-Jul-2021: Significant follow up. Added events vaccine may have exacerbated his heart condition and could not lift anything could not lift anything having outcome unknown. Updated verbatim of events threw back out from chills to threw back out from chills/chills and had side effects to had side effects/ bad reaction both having outcome resolved.

Other Meds:

Current Illness: Cancer (Cancer on tongue); Hyperthyroidism

ID: 1627195
Sex: F
Age: 37
State: IL

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/24/2021
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: Ear infection; Coughing; Unevaluable event; This spontaneous case was reported by a physician and describes the occurrence of EAR INFECTION (Ear infection), COUGH (Coughing) and UNEVALUABLE EVENT (Unevaluable event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis vulgaris. Concurrent medical conditions included Drug allergy (No known drug allergy). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), BROMPHENIRAMINE;PSEUDOEPHEDRINE and AMOXICILLIN TRIHYDRATE (MOXICILLIN) for an unknown indication. In March 2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EAR INFECTION (Ear infection), COUGH (Coughing) and UNEVALUABLE EVENT (Unevaluable event). At the time of the report, EAR INFECTION (Ear infection), COUGH (Coughing) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: ADVIL [IBUPROFEN]; BROMPHENIRAMINE;PSEUDOEPHEDRINE; MOXICILLIN

Current Illness: Drug allergy (No known drug allergy)

ID: 1627196
Sex: U
Age: 66
State: CA

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 08/24/2021
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: tingling sensation; Sleeplessness; Aggravated pain/ pain in my right hip radiating down to the right toe; Severe pain in my right leg; pain in my right leg is excruciating and severely; Shingles/ Blisters have healed now; Pain in right Hip; front muscle of my right thigh was aching severely; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling sensation), INSOMNIA (Sleeplessness), PAIN (Aggravated pain/ pain in my right hip radiating down to the right toe), PAIN IN EXTREMITY (Severe pain in my right leg) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (pain in my right leg is excruciating and severely) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041BB21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient experienced PARAESTHESIA (tingling sensation), INSOMNIA (Sleeplessness), PAIN (Aggravated pain/ pain in my right hip radiating down to the right toe), PAIN IN EXTREMITY (Severe pain in my right leg), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (pain in my right leg is excruciating and severely) and HERPES ZOSTER (Shingles/ Blisters have healed now). an unknown date, the patient experienced ARTHRALGIA (Pain in right Hip) and MYALGIA (front muscle of my right thigh was aching severely). The patient was treated with HYDROCORTISONE for Blisters, at a dose of 1 dosage form; GABAPENTIN (NEURONTIN) for Shingles, at a dose of 1 dosage form; VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 1 dosage form; Bed rest (resting/staying in bed aggravated the pain) for Pain; Physical therapy (it was a case of Sciatica and advised a set of lumbar exercises and walking) for Arthralgia and Physical therapy (it was a case of Sciatica and advised a set of lumbar exercises and walking) for Myalgia. At the time of the report, PARAESTHESIA (tingling sensation), INSOMNIA (Sleeplessness), PAIN (Aggravated pain/ pain in my right hip radiating down to the right toe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (pain in my right leg is excruciating and severely), ARTHRALGIA (Pain in right Hip) and MYALGIA (front muscle of my right thigh was aching severely) outcome was unknown, PAIN IN EXTREMITY (Severe pain in my right leg) had not resolved and HERPES ZOSTER (Shingles/ Blisters have healed now) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient reported over-the-counter anti-allergy medicine for blisters on the back and right leg but it did not work. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received on 03-AUG-2021 and included non-significant information-Patient Demographic added

Other Meds:

Current Illness:

ID: 1627197
Sex: M
Age:
State: VA

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: shingles; Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (shingles) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information and treatment information was provided by reporter. Follow up : Reporter states that the shingles reaction is believed to be from the Pfizer vaccine and not the Moderna. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Co-suspect Pfizer Covid-19 vaccine was added.

Other Meds:

Current Illness:

ID: 1627198
Sex: M
Age: 68
State:

Vax Date: 05/01/2020
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Date: 20210526; Test Name: Covid-19 Antibody Test; Test Result: Negative ; Result Unstructured Data: Negative for antibodies

Allergies:

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

Symptoms: Sores on bottom of feet after wearing shoes with hard soles; Forearm muscles felt extremely tired; This spontaneous case was reported by an other and describes the occurrence of SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia and Lymphocytic lymphoma. The patient's past medical history included Plantar fasciitis. Concurrent medical conditions included Chronic lymphocytic leukaemia, Lymphocytic lymphoma, Joint pain since June 2020, Myalgia since July 2020, Bone pain since July 2020, Diarrhea since July 2020, Welts since 2020, Sleep disorder and Muscle pain. Concomitant products included TRAMADOL for Muscle pain, TRAZODONE for Sleep disorder. In May 2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 280 mg once a day. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired). At the time of the report, SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) had not resolved and MUSCLE FATIGUE (Forearm muscles felt extremely tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 antibody test: negative (Negative) Negative for antibodies. Treatment information was not provided. 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. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.; 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. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.

Other Meds: TRAZODONE; TRAMADOL

Current Illness: Bone pain; Diarrhea; Joint pain; Lymphocytic lymphoma; Muscle pain; Myalgia; Sleep disorder; Welts

ID: 1627199
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Mild reaction to COVID-19 VACCINE; asthma consistently got worse in the springtime; asthma consistently got worse in the springtime despite of being on dupilumab; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Asthma and Illness. Concurrent medical conditions included Drug allergy, Drug allergy and Asthma. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab). The patient was treated with PREDNISONE for Asthma aggravated, at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Very limited information regarding these events has been provided at this time. No further information is expected. Company causality for adverse drug reaction and asthma aggravated is assessed as possible, while company causality for therapeutic response decreased is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: TCR Follow-up information contains non-significant information. Upon TCR follow-up, the initial reporter/patient denied reporting reactions experienced after vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected. Company causality for adverse drug reaction and asthma aggravated is assessed as possible, while company causality for therapeutic response decreased is not applicable.

Other Meds:

Current Illness: Asthma; Drug allergy

ID: 1627200
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: sick; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (sick). At the time of the report, MALAISE (sick) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1627201
Sex: M
Age: 66
State: VA

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 08/24/2021
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: received the second dose after 43 days; punching on arm lasted for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the second dose after 43 days) and LIMB DISCOMFORT (punching on arm lasted for 36 hours) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included Guillain-Barre syndrome and Pacemaker insertion (cardiac). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-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 PRODUCT DOSE OMISSION ISSUE (received the second dose after 43 days) and LIMB DISCOMFORT (punching on arm lasted for 36 hours). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the second dose after 43 days) and LIMB DISCOMFORT (punching on arm lasted for 36 hours) outcome was unknown. This case was linked to MOD-2021-063990 (Patient Link).

Other Meds: ASPIRIN

Current Illness:

ID: 1627202
Sex: F
Age: 59
State: IL

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

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

Lab Data: Test Date: 20210603; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: No Covid-19 antibodies.

Allergies:

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

Symptoms: Hands had been stiffer; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Hands had been stiffer) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet, extended release for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis). In January 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 MUSCULOSKELETAL STIFFNESS (Hands had been stiffer). At the time of the report, MUSCULOSKELETAL STIFFNESS (Hands had been stiffer) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, SARS-CoV-2 antibody test: negative No Covid-19 antibodies. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. No treatment information was provided by the reporter. The patient was not advised of possible need to pause Rinvoq prior to receiving the Covid-19 vaccine doses, therefore, she regularly took the medication. The patient stopped Rinvoq due to the negative Covid-19 antibodies. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Significant FU added- New event added

Other Meds: RINVOQ

Current Illness: Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).

ID: 1627203
Sex: F
Age:
State: IL

Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/24/2021
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: Rheumatoid arthritis flare up; Burning leg; Foot/leg cramps; Swelling of legs; Lower extremities weakness of; Generalized aching; Headache; fever; fatigue; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs) and MUSCULAR WEAKNESS (Lower extremities weakness of) 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. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills) outcome was unknown and MUSCLE SPASMS (Foot/leg cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events; 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

Other Meds: HUMIRA

Current Illness: Rheumatoid arthritis

ID: 1627204
Sex: F
Age: 65
State: OH

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 08/24/2021
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: fever; nausea; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination. Concomitant products included INSULIN for Diabetes mellitus, MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication has been reported.

Other Meds: INSULIN; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1627205
Sex: F
Age: 53
State: CA

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 08/24/2021
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: hot in the injection site; Redness (2 inches ) in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site) in a 53-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 DULOXETINE HYDROCHLORIDE (CYMBALTA) for Antidepressant therapy, CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for Antipsychotic drug level, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METFORMIN for Diabetes, BERBERINE for an unknown indication. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site). At the time of the report, VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site) outcome was unknown. Not Provided No Treatment medication were provided Action taken with the mRNA-1273 Moderna was not applicable

Other Meds: METFORMIN; CYMBALTA; VRAYLAR; LIPITOR; BERBERINE

Current Illness:

ID: 1627206
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 08/24/2021
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: SIde effect to vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (SIde effect to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced ADVERSE REACTION (SIde effect to vaccine). At the time of the report, ADVERSE REACTION (SIde effect to vaccine) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter. The patient received Moderna COVID-19 vaccine and had experienced side effects that lasted more than two months.

Other Meds:

Current Illness:

ID: 1627207
Sex: M
Age: 30
State: FL

Vax Date: 04/10/2021
Onset Date: 04/15/2021
Rec V Date: 08/24/2021
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: Hives all over the body; Progressive Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037BQ1A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and OMEPRAZOLE for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: SYMBICORT; OMEPRAZOLE

Current Illness:

ID: 1627208
Sex: M
Age: 69
State: MI

Vax Date: 03/11/2021
Onset Date: 04/12/2021
Rec V Date: 08/24/2021
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: Pains at the left side of the head/ pain location changes each time; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pains at the left side of the head/ pain location changes each time) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A. and 002B21A) for COVID-19 vaccination. The patient's past medical history included Kidney transplant. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced HEADACHE (Pains at the left side of the head/ pain location changes each time). The patient was treated with PARACETAMOL (TYLENOL) for Head pain, at an unspecified dose and frequency. At the time of the report, HEADACHE (Pains at the left side of the head/ pain location changes each time) outcome was unknown. Not Provided The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1627209
Sex: F
Age: 19
State: CA

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Nausea; headache; temperature; feeling hot; Chills; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), HEADACHE (headache), PYREXIA (temperature) and FEELING HOT (feeling hot) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (temperature) and FEELING HOT (feeling hot). On 17-Apr-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 pills to alleviate symptoms. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), HEADACHE (headache), PYREXIA (temperature) and FEELING HOT (feeling hot) outcome was unknown. Not Provided No concomitant medications are provided .

Other Meds:

Current Illness:

ID: 1627210
Sex: F
Age:
State: IN

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/24/2021
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: hot flashes; and some pain; extreme chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills) 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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills). At the time of the report, HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided No treatment medications provided

Other Meds:

Current Illness:

ID: 1627211
Sex: M
Age: 30
State: IL

Vax Date: 04/14/2021
Onset Date: 06/08/2021
Rec V Date: 08/24/2021
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: Poor Quality drug Administered; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA AC) injection for Crohns disease aggravated. Concurrent medical conditions included Alcohol use (Variety, once a week) since 2012, Tobacco user (one cigarette every 2 weeks) since 2014 and Autistic disorder. Concomitant products included ESTRADIOL and SPIRONOLACTONE for Gender reassignment therapy. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA AC) (Subcutaneous) 40 mg once a week. On 08-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) 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 considered POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) to have an unknown relationship. No treatment information was provided by the reporter.

Other Meds: ESTRADIOL; SPIRONOLACTONE

Current Illness: Alcohol use (Variety, once a week); Autistic disorder; Tobacco user (one cigarette every 2 weeks)

ID: 1627212
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: 17 year old daughter administered a dose of the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided No treatment medications were provided

Other Meds:

Current Illness:

ID: 1627213
Sex: F
Age: 42
State: KY

Vax Date: 04/07/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: it's like holding a lot of heat; painful rashes popped up on both her knees 7 ? 8 that were slightly risen; This spontaneous case was reported by a nurse and describes the occurrence of MILIARIA (it's like holding a lot of heat) and RASH (painful rashes popped up on both her knees 7 ? 8 that were slightly risen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (painful rashes popped up on both her knees 7 ? 8 that were slightly risen). On an unknown date, the patient experienced MILIARIA (it's like holding a lot of heat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MILIARIA (it's like holding a lot of heat) and RASH (painful rashes popped up on both her knees 7 ? 8 that were slightly risen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Steroid shot, Steroid cream are taken as treatment medicines.

Other Meds:

Current Illness:

ID: 1627214
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: backache; lymph node inflammation; arthralgia; headache; pain at the vaccination site; Vaccination site inflammation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation) and ARTHRALGIA (arthralgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation) and VACCINATION SITE PAIN (pain at the vaccination site). On 17-Apr-2021, the patient experienced BACK PAIN (backache), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache). At the time of the report, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1627215
Sex: F
Age:
State: IL

Vax Date: 02/04/2021
Onset Date: 03/17/2021
Rec V Date: 08/24/2021
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: it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.; diagnosed with shingles; Backache; developed a backache that felt like a sore muscle which grew worse until Sunday night; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with shingles), BLISTER (it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.), BACK PAIN (Backache) and MYALGIA (developed a backache that felt like a sore muscle which grew worse until Sunday night) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Varicella zoster vaccine (10 years ago). Past adverse reactions to the above products included No adverse event with Varicella zoster vaccine. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced BACK PAIN (Backache) and MYALGIA (developed a backache that felt like a sore muscle which grew worse until Sunday night). On 21-Mar-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles). On an unknown date, the patient experienced BLISTER (it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency; GABAPENTIN at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (diagnosed with shingles), BLISTER (it felt different and she noticed tracks like shingles from her back to her stomach with blisters forming.), BACK PAIN (Backache) and MYALGIA (developed a backache that felt like a sore muscle which grew worse until Sunday night) had not resolved. Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications were reported. Follow-up received on x date included no new information Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: No new information was reported

Other Meds:

Current Illness:

ID: 1627216
Sex: F
Age: 39
State: CA

Vax Date: 03/17/2021
Onset Date: 04/14/2021
Rec V Date: 08/24/2021
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: The flu; Sore throat; Sputum; Cough; Headache; Fever; Chills; The hots; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum) and COUGH (Cough) in a 39-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. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING HOT (The hots) and CHILLS (Chills). On 15-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough) and HEADACHE (Headache). At the time of the report, FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. Not Provided Concomitant medication list was not provided. No treatment was provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-219010 (Patient Link).

Other Meds:

Current Illness:

ID: 1627217
Sex: F
Age: 76
State: NJ

Vax Date: 03/17/2021
Onset Date: 04/14/2021
Rec V Date: 08/24/2021
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: Burning in eyes; itching eyes; swelling arm; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided No concomitant medication was reported. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1627218
Sex: F
Age: 38
State: CA

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: inability to move arm; lightheadedness; nausea; excruciating pain in arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (inability to move arm), DIZZINESS (lightheadedness), NAUSEA (nausea) and MYALGIA (excruciating pain in arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced LIMB DISCOMFORT (inability to move arm), DIZZINESS (lightheadedness), NAUSEA (nausea) and MYALGIA (excruciating pain in arm). The patient was treated with IBUPROFEN at a dose of 800 mg twice a day. At the time of the report, LIMB DISCOMFORT (inability to move arm), DIZZINESS (lightheadedness), NAUSEA (nausea) and MYALGIA (excruciating pain in arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1627219
Sex: F
Age: 78
State: GA

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 08/24/2021
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: back pain; Pain in neck; flu-like symptoms; pain moves from neck to her arm; Muscle ache; Fatigue; chills; pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm) and MYALGIA (Muscle ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ESTRADIOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), PANTOPRAZOLE, HYOSCYAMINE, PROBIOTICS NOS, VITAMIN E NOS and BACLOFEN for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection). At the time of the report, BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment drugs were reported. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds: ESTRADIOL; TRIAMTERENE AND HYDROCHLOROTHIAZIDE; PANTOPRAZOLE; HYOSCYAMINE; PROBIOTICS NOS; VITAMIN E NOS; BACLOFEN

Current Illness:

ID: 1627220
Sex: M
Age: 29
State: OR

Vax Date: 04/07/2021
Onset Date: 04/14/2021
Rec V Date: 08/24/2021
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: Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep; It was red; He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation; He has pain in his elbow joint where he can't bend it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep), ERYTHEMA (It was red), LIMB DISCOMFORT (He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation) and ARTHRALGIA (He has pain in his elbow joint where he can't bend it) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep), ERYTHEMA (It was red), LIMB DISCOMFORT (He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation) and ARTHRALGIA (He has pain in his elbow joint where he can't bend it). The patient was treated with IBUPROFEN at a dose of 600 mg. At the time of the report, PERIPHERAL SWELLING (Right deltoid swell up more than left deltoid/ It has migrated from the middle of his shoulder to the middle of his bicep), ERYTHEMA (It was red), LIMB DISCOMFORT (He has high pressure in his right arm/ Feels like someone is holding his right arm and cutting circulation) and ARTHRALGIA (He has pain in his elbow joint where he can't bend it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1627221
Sex: F
Age: 81
State: VA

Vax Date: 03/15/2021
Onset Date: 04/14/2021
Rec V Date: 08/24/2021
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: warm arm at the injection site; very sleepy, could not stay awake; Very lethargic; Lump over area of vaccine; swollen arm; Red rash over the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine) and PERIPHERAL SWELLING (swollen arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area). At the time of the report, VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area) outcome was unknown. Concomitant medication were not provided by the reporter. Treatment medication were not provided by the reporter. Action taken with mRNA-1273 in response to the events was Not Applicable

Other Meds:

Current Illness:

ID: 1627222
Sex: F
Age: 49
State: IL

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Date: 20210417; Test Name: Fever; Test Result: Inconclusive; Result Unstructured Data: Fever up to 103?F; Test Date: 20210417; Test Name: Fever; Test Result: Inconclusive; Result Unstructured Data: fever went down to 101.3?F; Test Name: Fever; Test Result: Inconclusive; Result Unstructured Data: fever went down to 102?F.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: vitamin B deficiency; feeling horrible; weak; tired; excruciating pain in left arm, it is sore /painful/ body ache; fever; severe chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache) and PYREXIA (fever) in a 49-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 VITAMIN D NOS for Supplementation therapy, VITAMIN B COMPLEX and VITAMIN B12 NOS for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills) and HEADACHE (headache). On an unknown date, the patient experienced VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Cold, at an unspecified dose and frequency. At the time of the report, VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills), HEADACHE (headache) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Pyrexia: 103 (Inconclusive) Fever up to 103?F and 101.3 (Inconclusive) fever went down to 101.3?F. On an unknown date, Pyrexia: 102 (Inconclusive) fever went down to 102?F.. 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: VITAMIN D NOS; VITAMIN B COMPLEX; VITAMIN B12 NOS

Current Illness:

ID: 1627223
Sex: F
Age: 58
State: OH

Vax Date: 04/08/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: Red blotches; warm to the touch; was swollen; the injection site was itching a lot; headache; injection site had a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included METOPROLOL for an unknown indication. On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot), HEADACHE (headache) and VACCINATION SITE RASH (injection site had a rash). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SINUS [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Headache, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE SWELLING (was swollen), VACCINATION SITE PRURITUS (the injection site was itching a lot), HEADACHE (headache) and VACCINATION SITE RASH (injection site had a rash) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: METOPROLOL

Current Illness:

ID: 1627224
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: small hives that are like mosquito bites; Rash; second dose, she developed a rash on site of injection and on her forearm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm). At the time of the report, URTICARIA (small hives that are like mosquito bites), RASH (Rash) and VACCINATION SITE RASH (second dose, she developed a rash on site of injection and on her forearm) outcome was unknown. No treatment medications provided No concomitant medications provided

Other Meds:

Current Illness:

ID: 1627225
Sex: F
Age: 75
State: CA

Vax Date: 03/23/2021
Onset Date: 04/14/2021
Rec V Date: 08/24/2021
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: symptoms of UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (symptoms of UTI) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and SIMVASTATIN for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URINARY TRACT INFECTION (symptoms of UTI). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (symptoms of UTI) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other treatment for UTII include Cranberry juice, apple cider vinegar and stopped drinking coffee. Patient received second dose of MODERNA COVID-19 vaccine. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 17-Apr-2021 contains significant information including event outcome updated from unknown to recovered and 2nd dose information.

Other Meds: LISINOPRIL HCTZ; SIMVASTATIN

Current Illness:

ID: 1627226
Sex: F
Age: 61
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: pain in arm; hot flashes; swelling on the arm; coughing; cold; chills; headache; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes), PERIPHERAL SWELLING (swelling on the arm), COUGH (coughing) and FEELING COLD (cold) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced COUGH (coughing), FEELING COLD (cold), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes) and PERIPHERAL SWELLING (swelling on the arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), HOT FLUSH (hot flashes), PERIPHERAL SWELLING (swelling on the arm), COUGH (coughing), FEELING COLD (cold), CHILLS (chills) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1627227
Sex: F
Age:
State:

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/24/2021
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: Unable to lift her left arm; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her left arm) and FATIGUE (Extreme fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her left arm) and FATIGUE (Extreme fatigue). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her left arm) and FATIGUE (Extreme fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1627228
Sex: F
Age: 66
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: she is in bed and having difficulty getting up; Headache; pain and swelling in injection site; swelling in injection site; chills; severe muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (she is in bed and having difficulty getting up), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) in a 66-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. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site), CHILLS (chills) and MYALGIA (severe muscle ache). On 17-Apr-2021, the patient experienced BEDRIDDEN (she is in bed and having difficulty getting up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (she is in bed and having difficulty getting up), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site), CHILLS (chills) and MYALGIA (severe muscle ache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided.

Other Meds:

Current Illness:

ID: 1627229
Sex: M
Age:
State: KS

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/24/2021
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: yesterday he felt terrible/felt he was hit with a rubber hose; today he broke out in hives on stomach, back and arms; had pain in his head, eyes, and all over his body; had pain in his head, eyes, and all over his body; had pain in his head, eyes, and all over his body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body). At the time of the report, VACCINATION SITE DYSAESTHESIA (yesterday he felt terrible/felt he was hit with a rubber hose), URTICARIA (today he broke out in hives on stomach, back and arms), HEADACHE (had pain in his head, eyes, and all over his body), EYE PAIN (had pain in his head, eyes, and all over his body) and MYALGIA (had pain in his head, eyes, and all over his body) outcome was unknown. No Concomitant medications were provided No Treatment medications were provided.

Other Meds:

Current Illness:

ID: 1627230
Sex: M
Age: 52
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: Hot flashes; Headache; pain and swelling in injection site; swelling in injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills). On 16-Apr-2021, HOT FLUSH (Hot flashes), HEADACHE (Headache), VACCINATION SITE PAIN (pain and swelling in injection site), VACCINATION SITE SWELLING (swelling in injection site) and CHILLS (chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1627231
Sex: F
Age: 27
State: MS

Vax Date: 04/16/2021
Onset Date:
Rec V Date: 08/24/2021
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: 0.125 mL of a dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included METFORMIN, ATORVASTATIN, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30) and LOSARTAN for an unknown indication. On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .125 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered). At the time of the report, ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No treatment medications were reported

Other Meds: METFORMIN; ATORVASTATIN; HUMULIN 70/30; LOSARTAN

Current Illness:

ID: 1627232
Sex: M
Age: 56
State: CA

Vax Date: 04/09/2021
Onset Date: 04/15/2021
Rec V Date: 08/24/2021
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: intense dull, throbbing pain behind eyes; Light sensitivity; Loss of sleep; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided.

Other Meds:

Current Illness:

ID: 1627233
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: she fell body ache and muscle pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (she fell body ache and muscle pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 16-Apr-2021, the patient experienced MYALGIA (she fell body ache and muscle pain). At the time of the report, MYALGIA (she fell body ache and muscle pain) outcome was unknown. The concomitant medications were not provided. The Treatment information was not 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1627234
Sex: F
Age: 66
State: OH

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 08/24/2021
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: Test Date: 20210415; Test Name: Temperature; Result Unstructured Data: 101.2 Degree Fahrenheit; Test Date: 20210417; Test Name: Temperature; Result Unstructured Data: 99.2 Degree Fahrenheit

Allergies:

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

Symptoms: raised hot spot of 4 inches below the injection site; fatigued; arm was sore; chills; temperature of 101.2 degrees Fahrenheit; Headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site), PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), TRAMADOL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit), HEADACHE (Headache) and MYALGIA (muscle ache). On 17-Apr-2021, the patient experienced VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site) and FATIGUE (fatigued). The patient was treated with NAPROXEN SODIUM (ALEVE) on 17-Apr-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 17-Apr-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (raised hot spot of 4 inches below the injection site), PAIN IN EXTREMITY (arm was sore), CHILLS (chills), PYREXIA (temperature of 101.2 degrees Fahrenheit), HEADACHE (Headache), MYALGIA (muscle ache) and FATIGUE (fatigued) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 101.2 degree fahrenheit (High) 101.2 Degree Fahrenheit. On 17-Apr-2021, Body temperature: 99.2 degree fahrenheit (High) 99.2 Degree Fahrenheit. Other treatment Medication includes Ice pack Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds: FLOVENT; XOPENEX; TRAMADOL; FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE

Current Illness:

ID: 1627235
Sex: F
Age: 66
State: OH

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/24/2021
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: flare up of Complex regional pain syndrome; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (flare up of Complex regional pain syndrome) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Complex regional pain syndrome (flare up of Complex regional pain syndrome (CRPS) of right arm and spread to left arm.). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), TRAMADOL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CONDITION AGGRAVATED (flare up of Complex regional pain syndrome). At the time of the report, CONDITION AGGRAVATED (flare up of Complex regional pain syndrome) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided.

Other Meds: FLOVENT; XOPENEX; TRAMADOL; FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE

Current Illness: Complex regional pain syndrome (flare up of Complex regional pain syndrome (CRPS) of right arm and spread to left arm.)

ID: 1627236
Sex: M
Age: 42
State: WA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/24/2021
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: sweating; bone pain; headache; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), BONE PAIN (bone pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN and METFORMIN for Diabetes. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), BONE PAIN (bone pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweating), BONE PAIN (bone pain), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided.

Other Meds: INSULIN; METFORMIN

Current Illness: Diabetes

ID: 1627237
Sex: M
Age: 69
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/24/2021
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: Minimal coughing; Dizziness; Immediately after receiving the injection, he had nausea; Soreness on the injection site; Swelling on the injection site; Headache; He was very fatigue throughout the remainder of 15Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE PAIN (Soreness on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021). On 16-Apr-2021, COUGH (Minimal coughing), DIZZINESS (Dizziness), NAUSEA (Immediately after receiving the injection, he had nausea), VACCINATION SITE SWELLING (Swelling on the injection site), HEADACHE (Headache) and FATIGUE (He was very fatigue throughout the remainder of 15Apr2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness on the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Treatment information not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am