VAERS 2021 Database www.vaers.hhs.gov

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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: 1252435
Sex: M
Age: 46
State: NY

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 04/24/2021
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: N/A

Symptom List: Dysphagia, Epiglottitis

Symptoms: I was vaccinated on 4/18/2021 at 12:10pm. Within 6 hrs, I feel very cold, severe headache, tiredness, body aches and fever till next 48 hours. I took Tylenol and I feel much better on 3rd day morning (Wednesday). However, on Thursday, I feel throat soaring. I took Claritin and throat soreness stopped. On Friday, I feel little gland swelling on right side neck and on Saturday the swelling is bit more prominent. While swallowing food and drinking water, I am feeling awkward in neck.

Other Meds: N/A

Current Illness: N/A

ID: 1252436
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: BODY ACHES; FEVER; HEADACHE; 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103.6 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches and headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252437
Sex: F
Age: 63
State: OR

Vax Date: 04/02/2021
Onset Date: 04/04/2021
Rec V Date: 04/24/2021
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:

Allergies: Keflex

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

Symptoms: Severe headache for two days, notable because I do not get headaches. Followed in two days by extreme light sensitivity that would bring on migraine headaches (my doctor's office called them migraines).

Other Meds: Prednisone, Trazodone, Citalopram, Levothyroxine

Current Illness: None

ID: 1252438
Sex: F
Age: 39
State: MA

Vax Date: 04/14/2021
Onset Date: 04/23/2021
Rec V Date: 04/24/2021
Hospital:

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

Lab Data:

Allergies: food - shellfish, sensitivity to some others such as hazelnuts, some mushrooms norfloxacin (medicine) - mouth ulcers

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: MILD-- > on 23 April, 8-9 days post shot, noticed new redness, swelling, mild itching at injection site plus some tenderness around armpit area in same arm . currently on 24 April it is continuing but reness and swelling seems to have started going down (arm sorenes/heaviness was noted for 2 days alter shot, but had resolved after 3 days)

Other Meds: omeprazole vitamin D vitamin B complex allergra or cetirizine taken for seasonal allergies, bt was stopped 2 days before vaccine (last dose taken at 10pm on 11 april 2021) and not taken since

Current Illness: -- > seasonal allergies - laed to post-nasal drips cartch throat with irritaion cough (mild), sinuus discomfort -- > when Allegra or cetrizine are taken these theese symptoms in check

ID: 1252439
Sex: M
Age: 34
State: CA

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

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

Lab Data:

Allergies: NO

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

Symptoms: aBOUT 10 MINUTES FOLLOWING THE vaccine, the patient lost consciousness and passed out, his hands were clammy and he was pale. He needed to lay down with his legs elevated for about 20 minutes before improving. Shorlty after passing out, he also vomitted. His vitals were always stable and he never had trouble breathing. He later reported that he always passes out after blood draws.

Other Meds: NONE

Current Illness: NO

ID: 1252440
Sex: F
Age: 36
State: NE

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 04/24/2021
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: Achy, fatigue, general unwell feeling

Other Meds: Clomid

Current Illness:

ID: 1252441
Sex: M
Age: 64
State: NJ

Vax Date: 04/11/2021
Onset Date: 04/12/2021
Rec V Date: 04/24/2021
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: Injectable pencilin

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: 1- Mild cough became severe associated with shortness of breath starting from second day. Since the symptoms were progressively worsening, on doctors advice took one course of Z Pack (Azythromycin) starting from Wednesday04/14. 2- Still having mild cough. 3- Having dry upper respiratory passages leading to choking sporadically (once or twice on some days day). 4- Vision getting poor noticeable with watery eyes, started to feel 3 to 4 days after getting first doze COVID19 vaccination. Consulted an eye specialist on 04/24, who believes the vision issue is due to cataract getting progressively worse. As far as I know, cataract does not gets worse over period of 3 to 4 days, so there is likely hood of some adverse effect of the COVID vaccination.

Other Meds: 1Tablet -Norvasc 5mg/ day 2- Tablet Losartan 50 mg /day 3-Tablet Crestor 5mg 4 time/week 4-Asprin 81 Mg 3times/week 5-Multi Vitamin One tablet /day

Current Illness: Mild cough 3 days started before vaccination

ID: 1252442
Sex: U
Age:
State: TX

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: CHILLS; SWEATS; MILD FEVER; HOT/COLD; ACHES/ BODY ACHES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced mild fever. On 12-MAR-2021, the subject experienced hot/cold. On 12-MAR-2021, the subject experienced aches/ body aches. On an unspecified date, the subject experienced chills, and sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sweats, mild fever, hot/cold and aches/ body aches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252443
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced urinary tract infection. On 12-MAR-2021, the subject experienced vaginal bleeding (bright red, only when urinating). On 12-MAR-2021, the subject experienced slight headache. On 12-MAR-2021 13:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from vaginal bleeding (bright red, only when urinating), slight headache, and urinary tract infection. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1252444
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: FEEL LIKE GOT HIT BY A TRUCK; SWEATS; ON AND OFF CHILLS; RIDICULOUS HEADACHE; This spontaneous report received from a health care professional concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no co-morbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced feel like got hit by a truck. On MAR-2021, the subject experienced sweats. On MAR-2021, the subject experienced on and off chills. On MAR-2021, the subject experienced ridiculous headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like got hit by a truck, on and off chills, sweats and ridiculous headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252445
Sex: M
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 04/24/2021
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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: This spontaneous report received from a patient 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252446
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: BODY ACHE; FEELING LIKE HANDS ARE TIGHT; FEELING TIRED; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, osteopenia, fibromyalgia, hypothyroid, insomnia, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. The patient experienced drug allergy when treated with gramicidin/neomycin sulfate/polymyxin b sulfate, and bacitracin/polymyxin b sulfate. 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 12-MAR-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body ache. On 13-MAR-2021, the subject experienced feeling like hands are tight. On 13-MAR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, and feeling tired, and had not recovered from feeling like hands are tight. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Wine/ 2 per year); Arthritis; Fibromyalgia; Hypothyroidism; Insomnia; Non-smoker; Osteopenia

ID: 1252447
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: SLEEPY; ACHY; CHILLS; LIGHT HEADEDNESS; TIRED; DIZZY WHEN STANDING; COLD; 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 past medical history included hysterectomy, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage at the time of reporting. The patient experienced drug allergy when treated with fluconazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:53 on right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced light headedness. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced dizzy when standing. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chills. On an unspecified date, the subject experienced sleepy, and achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy when standing, had not recovered from light headedness, tired, chills, and cold, and the outcome of sleepy and achy 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: Abstains from alcohol; Non-smoker

ID: 1252448
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/24/2021
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: PATIENT FELT LIKE HE IS ON DEATH BED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient felt like he is on death bed. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient felt like he is on death bed was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1252449
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/24/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: CHILLS; HORRIBLE HEADACHE; RIGHT ARM IS SORE; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, attention deficit disorder, non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced horrible headache. On 11-MAR-2021, the subject experienced right arm is sore. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever, horrible headache, and right arm is sore. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Attention deficit disorder (On medications); Non-smoker; Seasonal allergy (uses inhalers)

ID: 1252450
Sex: M
Age:
State: ND

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: ACHINESS; VERY SLIGHT FEVER; This spontaneous report received from a patient 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced achiness. On MAR-2021, the subject experienced very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very slight fever on MAR-2021, and the outcome of achiness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252451
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/24/2021
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: AWFUL METALLIC TASTE IN MOUTH; CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported, administered on 08-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced awful metallic taste in mouth, chills, fever, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The patient recovered from fever, and the outcome of chills, muscle aches and awful metallic taste in mouth was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252452
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and headache, and had not recovered from fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252453
Sex: F
Age:
State: HI

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia, penicillin allergy, and allergy to sulphates. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 12-MAR-2021, and had not recovered from chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252454
Sex: F
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 04/24/2021
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: SORE/ BODY ACHE; NECK ACHE; DIARRHEA; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore/ body ache, neck ache, diarrhea, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore/ body ache, diarrhea, headache, neck ache and low grade fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252455
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: GUMS HURT; BACK ACHE; FALL; CHILLS; FEVER; HEADACHE; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced gums hurt, back ache, and fall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, and fever, and the outcome of gums hurt, back ache and fall was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252456
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 04/24/2021
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: SEVERE HEADACHE; SLIGHT DISCOMFORT AT THE INJECTION SITE; 2-3 RANDOM PATCHES OF SKIN; VIOLENT CHILLS; VERY SLIGHT WAVES OF NAUSEA.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 10-MAR-2021 09:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced slight discomfort at the injection site. On 10-MAR-2021, the subject experienced 2-3 random patches of skin. On 10-MAR-2021, the subject experienced violent chills. On 10-MAR-2021, the subject experienced very slight waves of nausea. On 10-MAR-2021 19:00, the subject experienced severe headache. Treatment medications (dates unspecified) included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from violent chills, was recovering from slight discomfort at the injection site, very slight waves of nausea., and 2-3 random patches of skin, and had not recovered from severe headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252457
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 04/24/2021
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: FEELING WARM; MAJOR SHAKING; CHILLS; 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 14-MAR-2021, the subject experienced feeling warm. On 14-MAR-2021, the subject experienced major shaking. On 14-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, major shaking and feeling warm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252458
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: ITCHINESS IN MOUTH AND TONGUE; NAUSEA; FATIGUE; 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 allergy to shellfish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced itchiness in mouth and tongue. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 13-MAR-2021, and had not recovered from fatigue, and itchiness in mouth and tongue. The reporter causality and nausea, fatigue and itchiness in mouth and tongue was possible. This report was non-serious.

Other Meds:

Current Illness: Shellfish allergy

ID: 1252459
Sex: M
Age:
State: LA

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/24/2021
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: BODY ACHE; CHILLS; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, and high blood pressure, 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, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, once a total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-MAR-2021, was recovering from body ache, and had not recovered from fever, and diarrhea. This report was non-serious.

Other Meds:

Current Illness: Blood pressure high; Chronic obstructive pulmonary disease

ID: 1252460
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 04/24/2021
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: ACHY; 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: Unk) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy on 11-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252461
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body ache and headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252462
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/24/2021
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: CHILLS; TEMPERATURE WAS AT 101.1; This spontaneous report received from a patient via a representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 11-MAR-2021 13:05 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 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 (unit not provided). On 11-MAR-2021 22:45, the subject experienced chills. On 11-MAR-2021 22:45, the subject experienced temperature was at 101.1. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and temperature was at 101.1 was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252463
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain in hands. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced very tired. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced pain in elbow. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAR-2021, was recovering from pain in hands, and pain in elbow, and had not recovered from very tired, muscle aches, and chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252464
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: 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: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen for drug used for unknown indication. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced pain to touch. On 11-MAR-2021, the subject experienced had a knot. On 11-MAR-2021, the subject experienced redness. On 11-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, pain to touch, redness, itching, and had a knot. This report was non-serious.

Other Meds: IBUPROFEN

Current Illness:

ID: 1252465
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: FEVER; NAUSEA; This spontaneous report received from a consumer 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: Unknown, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102, 100.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252466
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: A VERY, VERY MINIMAL SORE AREA IN ARM; This spontaneous report received from a patient via a company representative concerned a 56 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: Unk expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On MAR-2021, the subject experienced a very, very minimal sore area in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a very, very minimal sore area in arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252467
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/24/2021
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: DIARRHEA; BAD HANGOVER; BREATHING RAPIDLY; SHORTNESS OF BREATH; NOT HUNGRY; FEELS FULL; TIREDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced bad hangover. On 11-MAR-2021, the subject experienced breathing rapidly. On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced not hungry. On 11-MAR-2021, the subject experienced feels full. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, tiredness, bad hangover, breathing rapidly, shortness of breath, feels full, and not hungry. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness: Alcohol use (3 drinks a night); Chronic obstructive pulmonary disease; Cigarette smoker (A pack of cigarette every two days)

ID: 1252468
Sex: F
Age:
State: OK

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: NUMBNESS ON THE FACE; TINGLES ON THE FACE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hbp, 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, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 in the right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced numbness on the face. On 12-MAR-2021, the subject experienced tingles on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the face, and tingles on the face. This report was non-serious.

Other Meds:

Current Illness: Blood pressure high

ID: 1252469
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/07/2021
Rec V Date: 04/24/2021
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: Erythema, Pruritus

Symptoms: LEFT SIDED THROAT PAIN; LEFT EAR PAIN; PAIN UNDER LEFT EYE; LEFT SIDED HEADACHE; TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, seasonal allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: Endocrine function test (NR: not provided) within normal limits. On MAR-2021, treatment medications included: naproxen. On 07-MAR-2021, the subject experienced left sided throat pain. On 07-MAR-2021, the subject experienced left ear pain. On 07-MAR-2021, the subject experienced pain under left eye. On 07-MAR-2021, the subject experienced left sided headache. On 07-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left sided headache, and tired, and the outcome of left sided throat pain, left ear pain and pain under left eye was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (A glass of wine 3 times per week.); Non-smoker; Osteoporosis; Seasonal allergy

ID: 1252470
Sex: U
Age:
State: TN

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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 BUMP; BRUISED; INJECTION SITE SWELLING; PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced red bump. On MAR-2021, the subject experienced bruised. On MAR-2021, the subject experienced injection site swelling. On MAR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site swelling, red bump, pain and bruised was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252471
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: SUSPECTED COVID-19 INFECTION; 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: Unknown) dose was not reported, administered on 06-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced suspected covid-19 infection. On 06-MAR-2021 20:30, Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 12-MAR-2021 13:20, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case is associated with PQC number: The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria based on the PQC evaluation/investigation performed.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious..

Other Meds:

Current Illness:

ID: 1252472
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: BLEEDING; HEMATOMA; BUMP AT INJECTION SITE; SWELLING; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced bleeding. On 13-MAR-2021, the subject experienced hematoma. On 13-MAR-2021, the subject experienced bump at injection site. On 13-MAR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding on MAR-2021, was recovering from swelling, had not recovered from bump at injection site, and the outcome of hematoma was not reported. This report was non-serious. Additional information was received on 23-Mar-2021. The following information was updated and incorporated into the case narrative: Patient's sex .; 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: 1252473
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: HEADACHE; UNWELL WITH CHILLS; SHAKING/TREMORS OF HANDS/ARMS; OVERALL ACHES; FELT UNWELL; NIGHT SWEATS (FEVER); TROUBLE SLEEPING AT NIGHT DUE TO THESE SYMPTOMS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 12-MAR-2021, the subject experienced trouble sleeping at night due to these symptoms. On 12-MAR-2021, the subject experienced night sweats (fever). On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021 22:30, the subject experienced shaking/tremors of hands/arms. On 12-MAR-2021 22:30, the subject experienced overall aches. On 12-MAR-2021 22:30, the subject experienced felt unwell. On 12-MAR-2021 22:30, the subject experienced unwell with chills. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/tremors of hands/arms, trouble sleeping at night due to these symptoms, overall aches, felt unwell, night sweats (fever), unwell with chills, fever, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252474
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: ROUGH NIGHTS SLEEP; DRY MOUTH; HEADCOLD; BREATHING ISSUES; SWEATING; FEVER; CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had drug abuse/illicit drug use. not necessarily takes cholesterol pill.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced rough nights sleep. On MAR-2021, the subject experienced dry mouth. On MAR-2021, the subject experienced headcold. On MAR-2021, the subject experienced breathing issues. On MAR-2021, the subject experienced sweating. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 12-MAR-2021, had not recovered from dry mouth, headcold, and breathing issues, and the outcome of rough nights sleep, mild headache and sweating was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1252475
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: FEELING TINGLING IN THIGH; BURNING PAIN; VACCINE DESTROYING BODY; PAIN IN FEET; INJECTION SITE VERY PAINFUL; MUSCLE STIFFNESS AT INJECTION SITE; INFLAMMATION IN THIGHS, BILATERAL FEET, ANKLES AND ARCH OF FEET; 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 past medical history included plantar fasciitis, prp in bilateral feet, and surgery, and concurrent conditions included carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left deltoid arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle stiffness at injection site. On MAR-2021, the subject experienced inflammation in thighs, bilateral feet, ankles and arch of feet. On MAR-2021, the subject experienced burning pain. On MAR-2021, the subject experienced vaccine destroying body. On MAR-2021, the subject experienced pain in feet. On MAR-2021, the subject experienced injection site very painful. On 06-MAR-2021, the subject experienced feeling tingling in thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in feet, feeling tingling in thigh, inflammation in thighs, bilateral feet, ankles and arch of feet, burning pain, vaccine destroying body, muscle stiffness at injection site, and injection site very painful. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Carpal tunnel syndrome

ID: 1252476
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: RED SKIN AREA IN THE SHOT; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced red skin area in the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red skin area in the shot was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252477
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: SWEATY (HOT DURING THE NIGHT); TIRED; POOR SLEEP; BAD HEADACHE; SHOULDER PAIN (LEFT ARM); LITTLE SORENESS AT SITE OF VACCINATION; 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 depression, and anxiety, 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 17:15 for prophylactic vaccination. Concomitant medications included sertraline hydrochloride for anxiety, and depression, and zolpidem tartrate for insomnia. On MAR-2021, the subject experienced shoulder pain (left arm). On MAR-2021, the subject experienced little soreness at site of vaccination. On 12-MAR-2021, the subject experienced poor sleep. On 12-MAR-2021, the subject experienced bad headache. On 13-MAR-2021, the subject experienced sweaty (hot during the night). On 13-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty (hot during the night) on 13-MAR-2021, was recovering from bad headache, had not recovered from tired, and the outcome of poor sleep, shoulder pain (left arm) and little soreness at site of vaccination was not reported. This report was non-serious.

Other Meds: AMBIEN; ZOLOFT

Current Illness: Depression (Routinely takes Zoloft 100mg for treatment)

ID: 1252478
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: CHILLS; FEVER; This spontaneous report received from a patient concerned an 87 year old male. The patient's height, and weight were not reported. The patient's past medical history included copd, and concurrent conditions included streptomycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: 25-MAY-2021) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever. This report was non-serious.

Other Meds:

Current Illness: Drug allergy

ID: 1252479
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: INCREASED HEART RATE; RED EYES; SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included immunodeficient, recurrent infections, chronic inflammation, asthma, cat allergy, dog allergy, and seasonal allergies. The patient experienced drug allergy when treated with azithromycin non-company, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever. On 12-MAR-2021, the subject experienced increased heart rate. On 12-MAR-2021, the subject experienced red eyes. On 12-MAR-2021, the subject experienced severe chills. On 12-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 (not reported), 101.6 (not reported), 102.3-102.5 (not reported), 101.7 (not reported), and Heart rate increased (NR: not provided) over 100 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from red eyes, severe chills, fever, and increased heart rate. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment is not required per standard procedure as the case includes non-serious event.

Other Meds: ADVIL [IBUPROFEN]

Current Illness: Allergic to cats; Allergic to dogs; Asthma; Immunodeficiency; Inflammation; Recurrent infection; Seasonal allergy

ID: 1252480
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/24/2021
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: INJECTION SITE INFECTION; WRONG ADMINISTERED INJECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 4 lung cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site infection, and wrong administered injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site infection and wrong administered injection was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1252481
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/24/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: HEART RACING; DIZZINESS; CHILLS; WEAKNESS; FEVER (102.4 F); 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 10:14 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4 F. On 12-MAR-2021, treatment medications included: paracetamol. On 12-MAR-2021 14:00, the subject experienced heart racing. On 12-MAR-2021 14:00, the subject experienced dizziness. On 12-MAR-2021 14:00, the subject experienced chills. On 12-MAR-2021 14:00, the subject experienced weakness. On 12-MAR-2021 14:00, the subject experienced fever (102.4 f). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (102.4 f), chills, weakness, dizziness, and heart racing. This report was non-serious. This parent/child case is linked to .; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.

Other Meds:

Current Illness:

ID: 1252482
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/24/2021
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: FAST HEARTBEAT; DIZZINESS; TROUBLE SLEEPING; WEAKNESS; 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced trouble sleeping. On MAR-2021, the subject experienced weakness. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fast heartbeat, dizziness, weakness and trouble sleeping was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1252483
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/24/2021
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: DIFFICULTY BREATHING; FEELING DISORIENTED; DIZZY; VERY COLD; CHILLS; NAUSEOUS; 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, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced difficulty breathing. On 13-MAR-2021, the subject experienced feeling disoriented. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced very cold. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling disoriented, dizzy, nauseous, very cold, chills and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1252484
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 04/24/2021
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: MID CHEST COLD VOICE; SCRATCHY THROAT; SINUS ISSUES; 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) 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 14-MAR-2021, the subject experienced mid chest cold voice. On 14-MAR-2021, the subject experienced scratchy throat. On 14-MAR-2021, the subject experienced sinus issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scratchy throat, sinus issues and mid chest cold voice 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:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm