VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1170601
Sex: F
Age: 29
State: TN

Vax Date: 04/01/2021
Onset Date: 04/03/2021
Rec V Date: 04/06/2021
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: Allergic to Sudafed and Compazine. Seasonal allergies (grass, pollen).

Symptom List: Dysphagia, Epiglottitis

Symptoms: 2 days after vaccine patient began to heavily menstraute. Patient has extremely irregular and light periods that she takes medication for. She went almost 80 days without a period before she had one approximately 2 weeks before the vaccine. PMS symptoms started the day after the vaccine, including tender breasts. Patient also had a fever, chills, congestion, and a headache. Patient experienced severe cramping, nausea, and extremely heavy bleeding.

Other Meds: Lamictal, progestin as needed to trigger periods

Current Illness: None

ID: 1170602
Sex: F
Age: 25
State:

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 04/06/2021
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: None

Symptom List: Anxiety, Dyspnoea

Symptoms: Chills, body aches, took ibuprofen to manage. Almost fainted. Nausea.

Other Meds: Birth control pills, lexapro 15 mg, welbutrin

Current Illness: None

ID: 1170603
Sex: M
Age: 77
State: OH

Vax Date: 02/18/2021
Onset Date: 03/13/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: diarrhea commencing 03/13/2021 and ongoing this date 04/06/2021

Other Meds: metoprolol, lisinopril,ASA

Current Illness:

ID: 1170604
Sex: F
Age: 57
State: TN

Vax Date: 03/09/2021
Onset Date: 03/11/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Shingles on head area only.

Other Meds: None

Current Illness:

ID: 1170605
Sex: F
Age: 32
State:

Vax Date: 03/13/2021
Onset Date: 03/15/2021
Rec V Date: 04/06/2021
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: My arm has been sore for 3 weeks , can?t lift my arm past my shoulder without pain. Constantly feel a full ache.

Other Meds:

Current Illness:

ID: 1170606
Sex: F
Age: 41
State: MA

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 04/06/2021
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: Penicillin: rash; clindamycin; clarithromycin: stomach pain CELERY & Celeriac, Dill: ANAPHYLAXIS& environmental allergy Grain intolerance (severe): migraine, stomach pain, acne, gastrointestinal irritation

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

Symptoms: 5:08pm - vaccine administered Approx. 5:20pm - 50 mg of Benadryl taken for itchy throat, need to clear throat, and difficulty swallowing Approx. 5:40pm - symptoms worsened: 1 adult EpiPen administered and 911 called At hospital: antihistamine, Pepcid, and saline administered vis IV drip (unsure of dosage or time).

Other Meds: Taken at 6:30AM: SRONYX 28 DAY TABLET; Cetirizine Hydrochloride 10 mg (Zyrtec): x1 per day; MUCINEX 1200mg: x1 per day; OMEPRAZOLE 20 mg: x1 per day; Multi-Vitamin: Rainbow Light Women One; Herbal Supplements (NOT taken on 4.5.21 prior to

Current Illness: Migraines

ID: 1170607
Sex: M
Age: 73
State: GA

Vax Date: 03/04/2021
Onset Date: 03/07/2021
Rec V Date: 04/06/2021
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: sulfur drugs

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: tightness in chest develops when exercising.

Other Meds: metoprolol, doxazosin, levothyroxine. red yeast rice

Current Illness: none

ID: 1170608
Sex: M
Age: 24
State: OH

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Pharyngeal swelling

Symptoms: Patient received 1st dose of Moderna Covid-19 vaccine on 09Jan21. Patient was unable to receive second dose of Moderna vaccine and was given dose of Janssen covid-19 vaccine on 18Jan21. Normal vaccine side effects observed.

Other Meds: None

Current Illness: None

ID: 1170609
Sex: M
Age: 43
State: PA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: sulfa medication, methylprednisone, latex

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: extreme fatigue that went away after 48 hours I now have a hearing problem that I did not have prior to the vacceine , I am not sure if it is a eustacean tube disorder but everything sounds muffled and it is like when you need to get your ear to pop but it wont. This has been going on for 5 days now and I plan to see a doctor to see if anything can be done, I am hoping that this is not a permanant issue. I have read of other people having hearing loss from the vacceines from all 3 manufacturers

Other Meds: NONE

Current Illness: NONE

ID: 1170610
Sex: M
Age: 30
State: CA

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 04/06/2021
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: none

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Convulsion- eyes rolled back, involuntary contraction of muscles, unresponsive, lasted 10 seconds other symptoms: chills, nausea, sweating

Other Meds: none

Current Illness: none

ID: 1170611
Sex: M
Age: 34
State: FL

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: No

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

Symptoms: Fever - 39 C and headache

Other Meds: No

Current Illness: No

ID: 1170612
Sex: M
Age: 39
State: TX

Vax Date: 04/01/2021
Onset Date: 04/06/2021
Rec V Date: 04/06/2021
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: Hives under and around both arms. Some hives on insides of legs. Very itchy.

Other Meds:

Current Illness:

ID: 1170613
Sex: F
Age: 37
State: CA

Vax Date: 03/25/2021
Onset Date: 04/01/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: none

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

Symptoms: 2 inch diameter firm lump under skin persisting for about 5 days, started about a week after shot.

Other Meds: Tart Cherry Supplement Biotin Skin and Nails supplement

Current Illness: none

ID: 1170717
Sex: M
Age: 21
State: AK

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 04/06/2021
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: None

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

Symptoms: Low-grade fever, headache, loss of appetite, fatigue, dizziness, moderate pain at the site of injection. Symptoms began approximately 12h after inoculation.

Other Meds: None

Current Illness:

ID: 1170718
Sex: M
Age: 32
State: CA

Vax Date: 04/04/2021
Onset Date: 04/04/2021
Rec V Date: 04/06/2021
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: Penicillin, Depakote

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

Symptoms: Mild fever, swollen lymph nodes, headache/confusion, joint pain, general fatigue, soreness.

Other Meds: Robaxin, clonazepam

Current Illness: None

ID: 1170719
Sex: M
Age: 59
State: IN

Vax Date: 03/26/2021
Onset Date: 04/06/2021
Rec V Date: 04/06/2021
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: hard grains

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

Symptoms: Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patient to Doctor office for treatment. Antibiotics treatment for sore throat to no effect. 2nd dose started and to date same effect. Patient is in pain.

Other Meds: many

Current Illness: none

ID: 1170720
Sex: F
Age: 42
State: CA

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 04/06/2021
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: None

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

Symptoms: Sore arm developed about 3-5 hours after injection and resolved around 40-48 hours. Soreness/stiffness was significant enough during about first 24 hours after onset to inhibit common daily acitivities like putting on clothes, wiping with toilet paper, raising arm straight out or above head, but later could be accomplished with slower, careful stretching movements. About 12 hours after injection (around 2-3 AM), possible low fever (? actual temperature was not taken) or at least a subjective feeling of being too hot/unable to properly regulate body temperature began, with some sweating, that interrupted sleep for about 4-5 hours. I was stiff and sore the next day which might have been also related to poor sleep (and not being able to tolerate lying on my left side as I often do).

Other Meds: None

Current Illness: None

ID: 1170721
Sex: F
Age: 63
State: CA

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: Shell fish

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Red Eye. Seeping discharges, itchy

Other Meds: None

Current Illness: None

ID: 1170722
Sex: F
Age: 42
State: VA

Vax Date: 03/30/2021
Onset Date: 04/02/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: Medicine allergies that I am aware of (main reaction: very swollen eyes): Tylenol, Aspirin, Advil, Vicodin.

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Since the shot on 3/30, it was a bit itchy starting on a Friday 4/2 then some redness over the weekend and by Sunday overnight, I woke up with large red lesion around the injection site. It has firmness but not painful.

Other Meds: Claritin allergy medicine, Yasmine birth control pill

Current Illness: None

ID: 1170724
Sex: F
Age: 57
State: AZ

Vax Date: 03/22/2021
Onset Date: 04/05/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: Penicillin, Sulfa, over reaction to Prednisone

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

Symptoms: Huge rectangular itchy redness on right arm around injection site. Warmness on the inside of the rectangle. Sore arm overall. Not feeling wonderful and may seek professional help.

Other Meds: DDAVP 0.1 mg every 12 hrs, Viviscal, Atorvastatin 40 mg 3x/wk, Keto trim

Current Illness: None

ID: 1170725
Sex: F
Age: 42
State: CA

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 04/06/2021
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: None

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

Symptoms: Almost identical to first dose - sore arm and interrupted sleep first night due to feeling too hot (not sure if actual fever). Sore arm developed about 4-6 hours after injection and resolved around 40-48 hours. Soreness/stiffness was significant enough during about first 24-36 hours after onset to inhibit common daily acitivities, and injection area was quite tender to touch. About 12 hours after injection (around 2 AM), possible low fever (? actual temperature was not taken) or at least a subjective feeling of being too hot/unable to properly regulate body temperature began, with some sweating, plus minor headache and nausea, that interrupted sleep for about 5 hours. The following day had bothersome muscle stiffness/aches, although this might have been caused by poor sleep without usual movements. This resolved within about 24 hours.

Other Meds: None

Current Illness: None

ID: 1170726
Sex: F
Age: 48
State: CT

Vax Date: 04/02/2021
Onset Date: 04/06/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies: Mushrooms

Symptom List: Unevaluable event

Symptoms: Woke up the last 3 nights with a horrible nosebleed. I am not one to get nosebleeds. So rare unless trauma to nose.

Other Meds: Doluxatine 60 mg

Current Illness: None

ID: 1170727
Sex: F
Age: 38
State: IN

Vax Date: 04/03/2021
Onset Date: 04/04/2021
Rec V Date: 04/06/2021
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: Chills. Severe arm pain, fatigue, headache, nausea.

Other Meds:

Current Illness:

ID: 1170728
Sex: M
Age: 59
State: NY

Vax Date: 03/27/2021
Onset Date: 04/05/2021
Rec V Date: 04/06/2021
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: Non

Symptom List: Injection site pain, Pain

Symptoms: Itchiness and redness developed at injection site nine days after receiving dose.

Other Meds:

Current Illness: None

ID: 1170738
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/06/2021
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: SEVERE FATIGUE; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2020, Laboratory data included: (NR: not provided) Negative. On 12-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on MAR-2021, and was recovering from severe fatigue. This report was non-serious.

Other Meds:

Current Illness: Blood pressure high

ID: 1170739
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/06/2021
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: SOME SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced some side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210350170. Version created to amend previously reported information on 25-MAR-2021. Upon review the following information was amended: Batch sentence in narrative corrected.

Other Meds:

Current Illness:

ID: 1170740
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 04/06/2021
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: SWOLLEN ARM ABOUT 10 INCHES DOWN FROM INJECTION SITE; CHILLS; FEVER 101.5; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination on Left Arm. No concomitant medications were reported. On 25-MAR-2021, the subject experienced swollen arm about 10 inches down from injection site. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever 101.5. Laboratory data included: Body temperature (NR: not provided) 101.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever 101.5, and swollen arm about 10 inches down from injection site. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious

Other Meds:

Current Illness:

ID: 1170742
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 03/20/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: NUMBNESS ON THE LEFT ARM; SWEATING; LEFT ARM PAIN (THAT HAS GOTTEN WORSE); RASH AND BUMPS WITH ACCOMPANIED ITCHING ON THE CHEST AREA AND BACK OF BOTH THIGHS; INJECTION SITE HAS RASHES INSIDE THE CIRCLE AROUND IT; FEELING OF WARMTH (FEVERISH WARM); NAUSEA; INJECTION SITE HAD RED CIRCLE AROUND IT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1809031, and expiry: UNKNOWN) dose was not reported, administered on left arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 20-MAR-2021 03:00, the subject experienced numbness on the left arm. On 20-MAR-2021 03:00, the subject experienced sweating. On 20-MAR-2021 03:00, the subject experienced left arm pain (that has gotten worse). On 20-MAR-2021 03:00, the subject experienced rash and bumps with accompanied itching on the chest area and back of both thighs. On 20-MAR-2021 03:00, the subject experienced injection site has rashes inside the circle around it. On 20-MAR-2021 03:00, the subject experienced feeling of warmth (feverish warm). On 20-MAR-2021 03:00, the subject experienced nausea. On 20-MAR-2021 03:00, the subject experienced injection site had red circle around it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, was recovering from left arm pain (that has gotten worse), rash and bumps with accompanied itching on the chest area and back of both thighs, and injection site had red circle around it, had not recovered from numbness on the left arm, and injection site has rashes inside the circle around it, and the outcome of sweating and feeling of warmth (feverish warm) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Other Meds:

Current Illness:

ID: 1170743
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/06/2021
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: FEELING SLEEPY; BODY ACHES; HEADACHE; TEMPERATURE OF 101.8 F; SKIN HURTING; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 166 pounds, and height was not reported. The patient's past medical history included covid-19 and concurrent conditions included penicillin allergy, non alcoholic, and non smoker and other pre-existing medical conditions included patient had no drug abuse or no illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin hurting. On MAR-2021, the subject experienced temperature of 101.8 f. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 25-MAR-2021, the subject experienced feeling sleepy. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin hurting, and had not recovered from feeling sleepy, headache, body aches, and temperature of 101.8 f. This report was non-serious. Version created to amend previously reported information on 25-Mar-2021. Upon review, the following information was amended: Narrative inconsistency corrected.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Penicillin allergy

ID: 1170744
Sex: F
Age:
State: AK

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 04/06/2021
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: RESTLESS LEGS; FEELING WEIRD; SUPER EMOTIONAL AND CRIED VERY EASILY; ACHING PAIN IN LEGS; FEELING TIRED; THROBBING; TINGLING OF BODY AND TINGLING IN LEGS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced throbbing. On 23-MAR-2021, the subject experienced tingling of body and tingling in legs. On 23-MAR-2021, the subject experienced aching pain in legs. On 23-MAR-2021, the subject experienced feeling tired. On 24-MAR-2021, the subject experienced restless legs. On 24-MAR-2021, the subject experienced feeling weird. On 24-MAR-2021, the subject experienced super emotional and cried very easily. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing, tingling of body and tingling in legs, restless legs, feeling weird, super emotional and cried very easily, aching pain in legs, and feeling tired on 30-MAR-2021. This report was non-serious. Additional information received from patient on 30-MAR-2021 The following information was updated and incorporated into the case narrative: Outcome of the events updated.

Other Meds:

Current Illness: Asthma

ID: 1170745
Sex: M
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 04/06/2021
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: SORE ARM; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from nausea, and had not recovered from sore arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1170746
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/06/2021
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: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included on 06/mar/2021, patient got exposed to another person with covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) COVID-19 Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1170747
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 04/06/2021
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: FLUTTER LIKE PRESSURE; MUSCLE SPASM AND FLUTTER SPASM; PAIN IN THE CENTER OF CHEST; FLU-LIKE SYMPTOMS (CHILLS, FEVER); PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hole in heart, hypertensive, chronic migraine, and murmurs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included paracetamol. On 23-MAR-2021, the subject experienced pain in left arm. On 24-MAR-2021, the subject experienced flu-like symptoms (chills, fever). On 25-MAR-2021, the subject experienced flutter like pressure. On 25-MAR-2021, the subject experienced muscle spasm and flutter spasm. On 25-MAR-2021, the subject experienced pain in the center of chest. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Negative negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasm and flutter spasm, flu-like symptoms (chills, fever), pain in the center of chest, and pain in left arm, and the outcome of flutter like pressure was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Other Meds: TYLENOL

Current Illness: Cardiac disorder; Chronic migraine; Heart murmur; Hypertensive

ID: 1170748
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 04/06/2021
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: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: : MAC not required as per standard procedure as case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1170749
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: JOINT PAIN; SHIVER; FEVER; HEADACHE; BODY ACHE; INJECTION SEEMED TO BE ADMINISTERED TOO HIGH UP ON THE SHOULDER; RUNNY NOSE; FELT PRESSURE ON LEFT ARM; DEEP ARM ACHE/ARM SORENESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was not reported and height was 160 centimeters. The patient's past medical history included fever, and body ache, and concurrent conditions included codeine allergy, high blood pressure, vitilago, obesity, seasonal allergy, non smoker, non alcohol, and allergic reaction to flu vaccine, and other pre-existing medical conditions included the patient had no illness at the time of vaccination, acute illness 30 days prior to vaccination or history of hospitalization in last 30 days. the patient had family history of any disease (relevant to vaccination) or allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included garcinia mangostana for daily superfruit taken to control allergies, and valsartan for high blood pressure. On 23-MAR-2021, the subject experienced body ache. On 23-MAR-2021, the subject experienced injection seemed to be administered too high up on the shoulder. On 23-MAR-2021, the subject experienced runny nose. On 23-MAR-2021, the subject experienced felt pressure on left arm. On 23-MAR-2021, the subject experienced deep arm ache/arm soreness. On 23-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 97.8 F, 101.8 F. On 23-MAR-2021 04:00, the subject experienced fever. On 23-MAR-2021 04:30, the subject experienced shiver. On 24-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.6. On an unspecified date, the subject experienced joint pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98.5-99.3. The patient recovered from body ache, joint pain, fever, and headache, had not recovered from felt pressure on left arm, deep arm ache/arm soreness, shiver, and runny nose, and the outcome of injection seemed to be administered too high up on the shoulder was not reported. This report was non-serious.. Version created to amend previously reported information on 23/Mar/2021. Upon review the following information was amended: Labeling of event (felt pressure on left arm) updated to unlabeled from labeled. Version created to amend previously reported information on 31-Mar-2021: Reporter name and outcome of the event updated, concurrent condition, patient details, concomitant medication, past vaccine and new event added.

Other Meds: VALSARTAN; PURE MANGOSTEIN

Current Illness: Abstains from alcohol; Blood pressure high (taking prescription medication to control); Drug allergy; Non-smoker; Obesity; Seasonal allergy; Vitiligo

ID: 1170750
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 04/06/2021
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: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer via a company representative concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 23-MAR-2021, the subject tested positive for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Other Meds:

Current Illness:

ID: 1170752
Sex: F
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 04/06/2021
Hospital: Y

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: Fell down the stairs; Drowsy; very painful sore arm and hurting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell down the stairs) and SOMNOLENCE (Drowsy) 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. The patient's past medical history included No adverse event (No medical history 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 FALL (Fell down the stairs) (seriousness criterion hospitalization), SOMNOLENCE (Drowsy) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (very painful sore arm and hurting). At the time of the report, FALL (Fell down the stairs), SOMNOLENCE (Drowsy) and VACCINATION SITE PAIN (very painful sore arm and hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Follow-up received on 30 Mar 2021 included added serious events of fell down the stairs and drowsy. Very limited information regarding this event/s has been provided at this time. Further information has been requested. This case was linked to MOD-2021-032445 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant Follow up appended; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1170753
Sex: F
Age: 81
State: OH

Vax Date: 01/26/2021
Onset Date: 01/29/2021
Rec V Date: 04/06/2021
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: Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) 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 medications provided. No treatment was 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. Further information has been requested.; 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1170754
Sex: F
Age: 74
State: FL

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 04/06/2021
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: all of a sudden my face felt really tight/Looked into the mirror and it was swollen; face very flushed; throat started to close; feel tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen), FLUSHING (face very flushed), THROAT TIGHTNESS (throat started to close) and FATIGUE (feel tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included LEVOTHYROXINE and VALSARTAN for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen) (seriousness criterion medically significant), FLUSHING (face very flushed) (seriousness criterion medically significant), THROAT TIGHTNESS (throat started to close) (seriousness criterion medically significant) and FATIGUE (feel tired) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen), FLUSHING (face very flushed), THROAT TIGHTNESS (throat started to close) and FATIGUE (feel tired) 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.; Sender's Comments: This case concerns a 74 Y/O F with a serious unexpected event of facial swelling along with throat tightness, flushing and fatigue. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on 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: LEVOTHYROXINE; VALSARTAN

Current Illness:

ID: 1170755
Sex: M
Age: 69
State: TX

Vax Date: 01/19/2021
Onset Date: 02/20/2021
Rec V Date: 04/06/2021
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: Arrhythmia; Supraventricular Tachycardia; Severe cramping; Trouble equalising pressure in ears; sinking spells; Sore arm; Headache; Lethargy; Elevated Temperature; This spontaneous case was reported by a non-health professional and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arrhythmia. Concomitant products included METOPROLOL, SIMVASTATIN, OLMESARTAN and WARFARIN for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced LETHARGY (Lethargy), BODY TEMPERATURE INCREASED (Elevated Temperature), PRESYNCOPE (sinking spells), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). On 21-Feb-2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia), MUSCLE SPASMS (Severe cramping) and BAROTITIS MEDIA (Trouble equalising pressure in ears). On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant). On 22-Feb-2021, LETHARGY (Lethargy), BODY TEMPERATURE INCREASED (Elevated Temperature), SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia), MUSCLE SPASMS (Severe cramping), BAROTITIS MEDIA (Trouble equalising pressure in ears), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, ARRHYTHMIA (Arrhythmia) outcome was unknown and PRESYNCOPE (sinking spells) had resolved. 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. However, the patient's past medical history of Arrhythmia may remain as a risk factor for this event, Further information is requested.; 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. However, the patient's past medical history of Arrhythmia may remain as a risk factor for this event, Further information is requested.

Other Meds: METOPROLOL; SIMVASTATIN; OLMESARTAN; WARFARIN

Current Illness:

ID: 1170756
Sex: F
Age: 33
State: FL

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 04/06/2021
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: Cough; Nasal congestion; cold symptoms; Chest congestion; Postnasal drip; Sore throat; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Chest congestion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Inflammation. Concomitant products included MESALAZINE (LIALDA) for Inflammation NOS. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm was sore). On 07-Mar-2021, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms). On 06-Mar-2021, PAIN IN EXTREMITY (Arm was sore) was resolving. At the time of the report, PULMONARY CONGESTION (Chest congestion), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No laboratory data was provided. Treatment included pseudoephedrine, guaifenesin daily, nyquil and oxymetazoline at night.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LIALDA

Current Illness: Inflammation

ID: 1170757
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 04/06/2021
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: Mild stroke; Sore arm; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/ transient ischaemic attack and sore arm/pain in extremity. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Batch Number: unknown) via unspecified route for prophylaxis of COVID-19 infection. On an unspecified date, after the vaccination, the patient experienced sore arm and mild stroke. Treatment information for the events was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, mild stroke and sore arm, was unknown at the time of this report.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities

Other Meds:

Current Illness:

ID: 1170758
Sex: F
Age: 51
State:

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 04/06/2021
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: Developed kindey infection following Moderna COVID 19 vaccine; Pain in legs; A spontaneous report was received from a pharmacist concerning a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced kidney infection(kidney infection) following Moderna COVID 19 vaccine, and pain in legs/ pain in extremity. The patient's medical history, was not provided by the reporter. No concomitant product use was not provided by the reporter. On 27 Feb 2021, approximately same day prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, prior to receiving mRNA-1273, the patient developed kidney infection following Moderna COVID 19 vaccine with seriousness criteria as medically significant and pain in legs. Treatment for the events included antibiotic medication. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed kidney infection following Moderna COVID 19 vaccine, pain in legs were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1170759
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 03/20/2021
Rec V Date: 04/06/2021
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: Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No adverse event reported.). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route). On 20-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1170760
Sex: M
Age: 79
State: OR

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 04/06/2021
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: Pneumonia; Feeling weird; Stomach problems; Sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ulcers aphthous oral and Hernia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling weird), ABDOMINAL DISCOMFORT (Stomach problems) and SINUS DISORDER (Sinus problems). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), FEELING ABNORMAL (Feeling weird) and SINUS DISORDER (Sinus problems) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach problems) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1170761
Sex: F
Age: 30
State: CA

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 04/06/2021
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: Left side of body weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (Left side of body weakness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Learning disability and Seizure. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEMIPARESIS (Left side of body weakness) (seriousness criterion medically significant). At the time of the report, HEMIPARESIS (Left side of body weakness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded

Other Meds:

Current Illness: Learning disability; Seizure

ID: 1170762
Sex: F
Age: 70
State: FL

Vax Date: 03/02/2021
Onset Date: 03/26/2021
Rec V Date: 04/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax; got really run down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumonia. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) (seriousness criterion medically significant) and FATIGUE (got really run down). At the time of the report, PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) had not resolved and FATIGUE (got really run down) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Chest X-ray: abnormal (abnormal) Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax. On 26-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based in the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based in the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1170763
Sex: F
Age: 25
State: AL

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 04/06/2021
Hospital: Y

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: Pulmonary embolism; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 21-Mar-2021 to 24-Mar-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information included was blood thinner. 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.; 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: 1170764
Sex: F
Age:
State: GA

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 04/06/2021
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: hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeling the same symptoms as she did when she had covid; taste not the same; headache; Fatigue; mucsle aches; slight nausea; problem with a lymph node in that arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (hit her head and blacked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (also treated with 5 days of Remdesivir) in January 2021 and Lumpectomy. Concomitant products included NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS], ZINC, APIXABAN (ELIQUIS), CARVEDILOL, ATORVASTATIN and LETROZOLE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (hit her head and blacked out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm). At the time of the report, LOSS OF CONSCIOUSNESS (hit her head and blacked out), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: sensitive (Inconclusive) Sensitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included was acetaminophen for headache. The patient was hospitalized with coivd in January and had 5 days of Remdesivir. The patient also had problem with a lymph node in that arm. She had a Lumpectomy. They took at a lymph node in the left side of that armpit to see if it had spread. It was sensitive when she had a breast exam and was sent to get a mammogram. Got the breast exam last week in February. Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.

Other Meds: VITAMIN-B COMPLEX; VITAMIN-C; VITAMIN D [VITAMIN D NOS]; ZINC; ELIQUIS; CARVEDILOL; ATORVASTATIN; LETROZOLE

Current Illness:

ID: 1170765
Sex: M
Age: 78
State: MD

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 04/06/2021
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: Bell Palsy; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell Palsy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell Palsy) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment drugs included, valacyclovir and Prednisone. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm