VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1796530
Sex: M
Age: 69
State: WA

Vax Date: 10/11/2021
Onset Date: 10/12/2021
Rec V Date: 10/19/2021
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: None

Symptom List: Dysphagia, Epiglottitis

Symptoms: Swelling in mouth and gums. Very painful

Other Meds:

Current Illness: None

ID: 1796531
Sex: F
Age: 74
State: TN

Vax Date: 05/25/2021
Onset Date: 05/26/1921
Rec V Date: 10/19/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: EKG (many) 7/28,8/18 9/17 ultrasound 10/01. Angiogram 10/11 Cardioversion (didn?t last)

Allergies: None

Symptom List: Anxiety, Dyspnoea

Symptoms: Atrial fibrillation Heart rate 120-140

Other Meds: Thyroid 60mg Metoprolol 50mg

Current Illness: None

ID: 1796532
Sex: M
Age: 30
State: CA

Vax Date: 10/16/2021
Onset Date: 10/17/2021
Rec V Date: 10/19/2021
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: Body Aches - random spots on the body starts hurt, mostly joint areas AND MUSCLES Chills - my sense of heat was mostly gone. I felt cold under heavy blanket. I took a hot shower, but the highest setting (111*F) felt lukewarm.

Other Meds:

Current Illness:

ID: 1796533
Sex: M
Age: 77
State: FL

Vax Date: 03/09/2021
Onset Date: 04/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: No issues

Allergies: None

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: No issues

Other Meds: Lisinopril 10mg daily

Current Illness: Caught Covid-19 in January 2021. Asymptomatic for one month with subtle breathing issue, disappearing after the month. Had Pfizer 1st dose Feb.17,2021. Pfizer 2nd dose on Mar.09,2021. Believe heart palpitations started shortly after 2nd Pfizer dose. Now diagnosed as PVC?s at an irregular rate. Not sure all this is related, but want to know, bc why some adolescents have heart issues, but not adults !

ID: 1796536
Sex: F
Age: 21
State: GU

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: NONE STATED

Allergies: NONE STATED

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

Symptoms: PATIENT WAS ADMINISTERD PFIZER VACCINE WHEN SHE SHOULD HAVE RECEIVE MODERNA VACCINE. PT IS 15 WEEKS PREGNANT.

Other Meds: NONE STATED

Current Illness: NONE STATED

ID: 1796538
Sex: M
Age: 49
State: MA

Vax Date: 10/14/2021
Onset Date: 10/15/2021
Rec V Date: 10/19/2021
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: none

Allergies: none

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

Symptoms: -High fever (102F+) for 2 days after injection -Dizziness impacting ability to walk for 2 days after injection -Significant facial swelling, left and right side near ears, starting 2 days after injection lasting 1 day -Body aches, lethargy, headaches for 2 days after injection -Significant pain at injection site, and radiating inwards to underarm for 3 days after injection

Other Meds: none

Current Illness: none

ID: 1796539
Sex: M
Age: 21
State:

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/19/2021
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 - RASH

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Pt received first dose Moderna (Lot 038C21A) on 01 SEP 2021 (Left Arm via IM). Pt returned and accidentally given Pfizer as a second shot, instead of Moderna, on 19 OCT 2021. Pt was observed for 30 minutes after the second injection, at which time he did not develop any adverse reactions.

Other Meds: NONE

Current Illness: NONE

ID: 1796870
Sex: M
Age: 44
State:

Vax Date: 04/09/2021
Onset Date: 04/14/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Pt states ER monitored him and informed him to come back if things progressed into being worse.

Allergies: Allergies to Sulfa drugs and penicillin

Symptom List: Pharyngeal swelling

Symptoms: Pt states he started having heart palpitations, leg px and musculoskeletal px. Pt states malaise as well and went to Emergency Room.

Other Meds: None

Current Illness: None

ID: 1796980
Sex: F
Age:
State: PR

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 10/19/2021
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: I have felt an itch mainly in the arm where I was injected; As the times passes I feel it in various parts of the body.; Tingling in the legs; Joint pain; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EW0179, Expiry date: Unknown), via an unspecified route of administration in Arm Left on 04May2021 13:15 as dose 2, single (at the age of 22-years-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in Hospital. The patient's medical history included thyroid disorder and seafood allergy from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID 75 and SYNTHROID 88) taken for an unspecified indication, start and stop date were not reported. The patient previously received past drug BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EW0161, Expiry date: Unknown), via an unspecified route of administration in Arm Left on 13Apr2021 10:15 as dose 1, single for COVID-19 immunisation. On 04May2021 14:00, after a couple of hours, the patient experienced that she had felt an itch mainly in the arm where she was injected, as the times passed, she felt it in various parts of the body, tingling in the legs, joint pain and headache. Therapeutic measures were not taken as a result of adverse events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1797064
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/19/2021
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: Suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. In March 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, between 6 and 8 months after receiving Shingles vaccine and between 7 and 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. For the last week before the date of reporting, the patient had been suffering with the shingles and the patient had very painful shingle for the last 5 days. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.

Other Meds:

Current Illness:

ID: 1797065
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1797068
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: had the shingles\ suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles, got the Shingles shot and had a lot less pain from the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1797069
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: suspected vaccination failure; had the worst case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had this Shingles shot many years before the date of reporting when they first came out and one and a half years later the patient had the worst case of shingles that the patient has ever heard of. The patient stated forget the shot as far as he/she concerned. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.

Other Meds:

Current Illness:

ID: 1797070
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: possible cellulitis on injection arm.; swelling and redness with possible cellulitis on injection arm./ Shoulder to elbow; swelling and redness with possible cellulitis on injection arm.; This case was reported by a physician via sales rep and described the occurrence of cellulitis of arm in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced cellulitis of arm (serious criteria GSK medically significant), extensive swelling of vaccinated limb and erythema of extremities. The patient was treated with medication unknown (Patch) and antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the cellulitis of arm, extensive swelling of vaccinated limb and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the cellulitis of arm, extensive swelling of vaccinated limb and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. A day after administration of Shingrix, the patient had swelling, redness with possible cellulitis on injection arm from shoulder to elbow. The patient sought treatment at local emergency department. The patient was given patch and antibiotics. The symptoms resolved. No additional information known at the time of reporting. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1797090
Sex: F
Age: 1
State: MD

Vax Date: 08/14/2020
Onset Date: 08/14/2020
Rec V Date: 10/19/2021
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: 4 months of age (administered on 29Jul2019 / 16 months of age (administered on 14Aug2020 / 19 months of age (administered on 13Nov2020; 4 months of age (administered on 29Jul2019 / 16 months of age (administered on 14Aug2020 / 19 months of age (administered on 13Nov2020; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 1-year-old female patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 5CK5K, expiry date 17th January 2022) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Infanrix (received 1st dose on 29th May 2019 at 8 weeks of age, batch number and expiration date were unknown) and Infanrix (received 2nd dose on 29th July 2019 at 4 month of age, batch number and expiration date were unknown). On 13th November 2020, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th August 2020, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 14th August 2020, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 13th November 2020, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The nurse reported that patient received 3rd dose of Infanrix at 16 months of age and booster dose at 19 months of age longer than recommended schedule, which led to lengthening of vaccine schedule. The first two doses were administered at a different doctor's office, the second two doses were administered at the reporter's facility. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1797092
Sex: M
Age: 61
State: OR

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 10/19/2021
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: Lightheadedness; Ischemic Stroke with paralysis (on his left side); Ischemic Stroke with paralysis (on his left side); This case was reported by a consumer via call center representative and described the occurrence of ischemic stroke in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 52b24, expiry date unknown) for prophylaxis. Previously administered products included Moderna Covid vaccine (received 6 months prior to Shingrix). On 26th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 26th July 2021, 2 hrs after receiving Shingrix, the patient experienced ischemic stroke (serious criteria GSK medically significant) and left sided paralysis (serious criteria GSK medically significant). On an unknown date, the patient experienced light headedness. On an unknown date, the outcome of the ischemic stroke and left sided paralysis were recovered/resolved and the outcome of the light headedness was not recovered/not resolved. It was unknown if the reporter considered the ischemic stroke, left sided paralysis and light headedness to be related to Shingrix. Additional details were provided as follows: The case was reported by patient himself. The patient received 1st dose of Shingrix in his left deltoid at his local pharmacy and two hours after vaccination, the patient experienced a left-sided ischemic stroke with paralysis. The patient reported that he had made a rapid recovery from the stroke and that the only remaining symptom he still sometimes experienced was lightheadedness. The patient's doctor still wanted him to get the second dose of the Shingrix, but the patient was afraid to do so. The patient reported that he was not certain that the stroke was related to the Shingrix vaccine and that it might had just been coincidental. The patient did not have the expiration date of the Shingrix vaccine he was given. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1797107
Sex: F
Age:
State: KS

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/19/2021
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: CHILLS; BODY ACHE; FATIGUE; HEADACHE; WELTS ON LEFT ARM; SMALL COUGH; RASH ON LEFT ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no known allergies and no history of drug abuse or illicit drug use. 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 07-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced small cough. On OCT-2021, the patient experienced rash on left arm. On OCT-2021, the patient experienced welts on left arm. On 07-OCT-2021, the patient experienced fatigue. On 07-OCT-2021, the patient experienced headache. On 08-OCT-2021, the patient experienced body ache. On 08-OCT-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, small cough, chills, fatigue, headache, and welts on left arm on OCT-2021, and had not recovered from rash on left arm. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Cancer; Non-smoker

ID: 1797108
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 10/19/2021
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: DOUBLE VISION; LEG SWELLING; ABDOMINAL PAIN; BACK OF TONGUE SWOLLEN; BLADDER PAIN GOT WORSE; VISION GETTING WORSE; LITERALLY DYING; PAINFUL LEG; FEELS WEAK; CHEST PAIN GETTING WORSE; MIGRAINES; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known allergies and drug abuse or illicit drug usage. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced migraines. On an unspecified date, the patient experienced chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, vision getting worse, painful leg, feels weak, and literally dying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain getting worse, double vision, leg swelling, abdominal pain, back of tongue swollen, bladder pain got worse, migraines, feels weak, vision getting worse, painful leg, and literally dying. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Diabetes (Borderline diabetes - no medication); Non-smoker

ID: 1797109
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 202110; Test Name: Heart rate; Result Unstructured Data: 102 {beats}/min

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: STOMACH ACHE THAT FELT LIKE CRAMP IN STOMACH; INCREASED HEART RATE; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was 57.7 kilograms, and height was not reported. The patient's concurrent conditions included: secondary pulmonary hypertension. The patient received selexipag (tablet, oral, batch number: 1223186, and batch number: 1223186 expiry: 31-JUL-2022) 800 ug, 2 times every 1 day from 07-SEP-2021 to 07-OCT-2021 for secondary pulmonary hypertension. 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 OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included macitentan for drug used for unknown indication, and sildenafil citrate for drug used for unknown indication. On OCT-2021, the patient experienced increased heart rate. Laboratory data included: Heart rate (NR: not provided) 102 {beats}/min. On an unspecified date, the patient experienced stomach ache that felt like cramp in stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The patient had not recovered from increased heart rate, and the outcome of stomach ache that felt like cramp in stomach was not reported. This report was non-serious.

Other Meds: SILDENAFIL CITRATE; OPSUMIT

Current Illness: Pulmonary hypertension secondary

ID: 1797110
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 10/12/2021
Rec V Date: 10/19/2021
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: BACK PAIN GOTTEN WORSE; WEAKNESS IN RIGHT ARM; NUMBNESS IN RIGHT ARM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 180 pounds, and height was 63 inches. The patient's concurrent conditions included: back pain, non smoker, and non alcoholic, and other pre-existing medical conditions included: The patient does not have any known allergies. The patient does not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21/DEC/2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-OCT-2021, the patient experienced back pain gotten worse. On 12-OCT-2021, the patient experienced weakness in right arm. On 12-OCT-2021, the patient experienced numbness in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in right arm, weakness in right arm, and back pain gotten worse. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Back pain (don't take no medications); Non-smoker

ID: 1797111
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: IMMUNE THROMBOCYTOPENIC PURPURA; This spontaneous report received from a pharmacist concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on JUL-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 an unspecified date after the vaccination, the patient was diagnosed with immune thrombocytopenic purpura (ITP) and patient received the courses of Intravenous immune globulin (IVIG) and steroids. The patient recently started on Eltrombopag. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from immune thrombocytopenic purpura. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20211028342-COVID-19 VACCINE AD26.COV2.S-. This event(s) immune thrombocytopenic purpura is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1797112
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 10/14/2021
Rec V Date: 10/19/2021
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: CAN'T EAT ANYTHING; BODY IS SORE; NAUSEA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021, the patient experienced can't eat anything. On 14-OCT-2021, the patient experienced body is sore. On 14-OCT-2021, the patient experienced nausea. On 14-OCT-2021, the patient experienced vomiting. On 14-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, can't eat anything, body is sore and headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797113
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 10/08/2021
Rec V Date: 10/19/2021
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: EXPIRED DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 and expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028561 and 20211029005.

Other Meds:

Current Illness:

ID: 1797114
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 10/08/2021
Rec V Date: 10/19/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028555.

Other Meds:

Current Illness:

ID: 1797115
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 09/21/2021
Rec V Date: 10/19/2021
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: VERTIGO; GETTING SHORT OF BREATH; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, bad breathing, peanut allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient had an allergy to whatever is in like medication to lower cholesterol and allergy to NSAIDs. The patient stated that she was very healthy, motivated, hands-on, very energetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate for bad breathing, meloxicam for fibromyalgia, tramadol for fibromyalgia, ascorbic acid, cyanocobalamin, magnesium, and paracetamol. On 21-SEP-2021, the patient experienced vertigo. On 21-SEP-2021, the patient experienced getting short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from getting short of breath, and vertigo. This report was non-serious.

Other Meds: MELOXICAM; TRAMADOL; ADVAIR; VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]; MAGNESIUM; TYLENOL

Current Illness: Difficulty breathing; Fibromyalgia; Peanut allergy; Penicillin allergy

ID: 1797116
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797117
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 10/13/2021
Rec V Date: 10/19/2021
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: Test Name: Body temperature; Result Unstructured Data: One degree above normal.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: BODY ACHES; CRAMPING IN LEGS; FEEL HOT; FACIAL FLUSHING; STUFFY NOSE; BAD CHILLS (DREAMING THAT WAS STUCK IN SNOW) / FREEZING AND SHAKING BAD AND UNCONTROLLABLY (FELT LIKE A TRUCK RAN OVER); HEADACHE; POTENTIAL MEDICATION ERROR (ADMINISTRATION OF FIRST DOSE OF MODERNA VACCINE BEFORE JANSSEN VACCINE); This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's past medical history included: Clostridioides difficile, muscle eating infection in right arm, left wrist surgery, dialysis, coma, hit by a car, head injury, and shattered knee, and concurrent conditions included: shingles, kidney failure, non alcohol user, smoker, and Charlie horses, and other pre-existing medical conditions included: The patient had history of drug abuse or illicit drug usage (had a substance abuse problem and has been clean for several years). The patient experienced drug allergy when treated with haloperidol for drug used for unknown indication. 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 13-OCT-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included miRNA 1273 for prophylactic vaccination. On 13-OCT-2021, the patient experienced potential medication error (administration of first dose of Moderna vaccine before Janssen vaccine). On 14-OCT-2021, the patient experienced body aches. On 14-OCT-2021, the patient experienced cramping in legs. On 14-OCT-2021, the patient experienced feel hot. On 14-OCT-2021, the patient experienced facial flushing. On 14-OCT-2021, the patient experienced stuffy nose. On 14-OCT-2021, the patient experienced bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over). On 14-OCT-2021, the patient experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) One degree above normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over), and cramping in legs, had not recovered from body aches, headache, feel hot, facial flushing, and stuffy nose, and the outcome of potential medication error (administration of first dose of moderna vaccine before janssen vaccine) was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Cramps in legs; Kidney failure (kidney failure was on dialysis.); Shingles (Had shingles about a month ago. Have a tiny bit of a rash and a little bit of itching still remaining); Smoker (Vape trying to quit).

ID: 1797118
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 10/08/2021
Rec V Date: 10/19/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028555 and 20211028561.

Other Meds:

Current Illness:

ID: 1797119
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: High

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: RACING HEART (HEART STUFF WAS AWFUL); HIGH BLOOD PRESSURE; PAIN; UNCONTROLLABLE SHAKING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced racing heart (heart stuff was awful), high blood pressure, pain, and uncontrollable shaking. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart (heart stuff was awful), and high blood pressure, and the outcome of pain and uncontrollable shaking was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797120
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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 is a spontaneous, non-serious report received from a patient. A male, of unspecified age (height, and weight not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown) dose, start therapy date not reported, for immunization. No past medical history or concurrent conditions reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications reported. On an unspecified date, patient experienced a little injection site pain. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of a little injection site pain: not reported.

Other Meds:

Current Illness:

ID: 1797121
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 10/17/2021
Rec V Date: 10/19/2021
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: STIFFNESS IN THE NECK; DIZZINESS; SHORTNESS OF BREATH; PAIN IN THE NECK; UNABLE TO ROTATE NECK TO THE RIGHT; SEVERE PAIN IN THE RIGHT SHOULDER AND SHOULDER BLADE; SEVERE HEADACHE; OVERALL WEAKNESS; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient has had no change in lifestyle to account for effects. 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 16-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-OCT-2021, the patient experienced stiffness in the neck. On 17-OCT-2021, the patient experienced dizziness. On 17-OCT-2021, the patient experienced shortness of breath. On 17-OCT-2021, the patient experienced pain in the neck. On 17-OCT-2021, the patient experienced unable to rotate neck to the right. On 17-OCT-2021, the patient experienced severe pain in the right shoulder and shoulder blade. On 17-OCT-2021, the patient experienced severe headache. On 17-OCT-2021, the patient experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in the right shoulder and shoulder blade, stiffness in the neck, severe headache, dizziness, shortness of breath, overall weakness, pain in the neck, and unable to rotate neck to the right. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797122
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Name: Color vision tests; Result Unstructured Data: 20/20

Allergies:

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

Symptoms: VISION IMPAIRED; ANXIETY; STRESS (NORMAL); This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: epstein barr, and other pre-existing medical conditions included: The patient never had COVID but was exposed to COVID twice in the past before received the vaccine. The patient had glasses before. The patient have had underwent through DNA (deoxyribonucleic acid) immunity test and had immunity after the vaccine was reported. The patient was previously treated with guaifenesin for allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced vision impaired, anxiety, and stress (normal). Laboratory data (dates unspecified) included: Color vision tests (NR: not provided) 20/20. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vision impaired, and anxiety, and the outcome of stress (normal) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797123
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: INSOMNIA; MINOR MUSCLE SORENESS FROM THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was mostly in bed by midnight. The patient had 2 monsters drink at 8-9 PM so that might had a little to do with insomnia. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced insomnia, and minor muscle soreness from the injection site. The action taken with covid-19 vaccine was not applicable. The outcome of the insomnia and minor muscle soreness from the injection site was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797124
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/19/2021
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: FATIGUE; NAUSEA; HEADACHE; FEVER; RACING HEART; WEIRD DREAMS; FEEL UNUSUAL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-OCT-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 OCT-2021, the patient experienced feel unusual. On 06-OCT-2021, the patient experienced racing heart. On 06-OCT-2021, the patient experienced weird dreams. On 06-OCT-2021, the patient experienced fatigue. On 06-OCT-2021, the patient experienced nausea. On 06-OCT-2021, the patient experienced headache. On 06-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, weird dreams, fatigue, headache, and fever on 13-OCT-2021, and had not recovered from nausea, and feel unusual. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797125
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: This spontaneous report received from a patient via a company representative concerned an 80 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797126
Sex: M
Age:
State: MO

Vax Date:
Onset Date: 10/13/2021
Rec V Date: 10/19/2021
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: STORAGE OF VACCINE OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE; This spontaneous report received from a health care professional concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient experienced administration of vaccine stored outside of the recommended storage. On an unspecified date, the patient experienced storage of vaccine outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine stored outside of the recommended storage and storage of vaccine outside of the recommended storage conditions was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797127
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: positive; Test Date: 20210805; Test Name: Antibody test; Result Unstructured Data: positive for spike; Test Name: Antibody test; Result Unstructured Data: natural antibodies

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: SLIGHT FEVER; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: generalized neuropathy, and fatigue syndrome, and other pre-existing medical conditions included: patient had no known allergies and no drug abuse or illicit drug user. The patient was in hospital prior to receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 06-APR-2021, the patient experienced slight fever. Treatment medications included: paracetamol. On 05-AUG-2021, Laboratory data included: Antibody test (NR: not provided) positive for spike. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) natural antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever on 06-APR-2021. This report was non-serious.

Other Meds:

Current Illness: Fatigue; Neuropathy peripheral

ID: 1797128
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Body temperature; Result Unstructured Data: 102

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 patient experienced very sick for 12 hours straight, and fever for few hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick for 12 hours straight, and fever few hours. This report was non-serious. This case, from the same reporter is linked to 20211032411.

Other Meds:

Current Illness:

ID: 1797129
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 10/19/2021
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: DEPRESSION; ANXIETY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-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 AUG-2021, the patient experienced flu like symptoms. On an unspecified date, the patient experienced depression, and anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from depression, and anxiety, and the outcome of flu like symptoms was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797130
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 10/19/2021
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: Test Date: 202103; Test Name: Diagnostic ultrasound; Result Unstructured Data: Blood clot was ruled out

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced leg pain. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blood clot was ruled out. The action taken with covid-19 vaccine was not applicable. The outcome of leg pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797131
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/08/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 03/08/2021; Test Name: Body temperature; Result Unstructured Data: Not over 100.

Allergies:

Symptom List: Pain in extremity

Symptoms: This is a spontaneous, non-serious report received from a consumer. A female, of unspecified age (height, weight and concomitant medications not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown), dose not reported, administered on Mar 7, 2021, for immunization. The patient's concurrent conditions included: type 1 diabetic. The batch/lot number requested. On Mar 8, 2021, patient felt nauseous (like flu coming on) and tired. Laboratory data included: Body temperature (NR: not provided/not over 100). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from felt nauseous (like flu coming on) and tired on Mar 10, 2021. This case, from the same reporter linked to 20211031878.

Other Meds:

Current Illness: Type 1 diabetes mellitus

ID: 1797132
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 03/08/2021
Rec V Date: 10/19/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Date: 20210308; Test Name: Body temperature; Result Unstructured Data: Not over 100

Allergies:

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

Symptoms: This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: controlled high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced 12 hours after injection felt nauseous like flu coming on but more intense, quite intense. On 08-MAR-2021, the patient experienced basically wiped out. Laboratory data included: Body temperature (NR: not provided) Not over 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 12 hours after injection felt nauseous like flu coming on but more intense, quite intense, and basically wiped out on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211031835.

Other Meds:

Current Illness: High cholesterol

ID: 1797133
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: This is a spontaneous, non-serious report received from a patient. A patient, of unspecified age and sex (height and weight not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown/not reported) dose, start therapy date not reported, for immunization. No medical history or concurrent conditions reported. The company was unable to perform follow-up to request batch number. No concomitant medications reported. On an unspecified date, patient experienced freezing, sore arm, headache and nausea. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from freezing, sore arm, headache and nausea.

Other Meds:

Current Illness:

ID: 1797134
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: High; Test Name: Oxygen saturation; Result Unstructured Data: Low

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: LOW OXYGEN SATURATION; HEALTH ISSUES; HIGH FEVER; SEVERE FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced low oxygen saturation, health issues, high fever, and severe fatigue. Laboratory data (dates unspecified) included Body temperature (NR not provided) High, and Oxygen saturation (NR not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, severe fatigue, health issues and low oxygen saturation was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797135
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: Patient had family history of Multiple sclerosis and had a higher risk of Guillain Barre. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick from vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211032083.

Other Meds:

Current Illness:

ID: 1797136
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 10/19/2021
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: POTENTIAL MEDICATION ERROR (JASSEN VACCINE RECEIVED AFTER PFIZER VACCINE); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, and other pre-existing medical conditions included: Patient had other underlying health conditions. 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 JUL-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bnt 162 for prophylactic vaccination. On JUL-2021, the patient experienced potential medication error (jassen vaccine received after pfizer vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential medication error (jassen vaccine received after pfizer vaccine) was not reported. This report was non-serious.

Other Meds: PFIZER COVID-19 VACCINE

Current Illness: Diabetic

ID: 1797137
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: SEVERE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects. The action taken with covid-19 vaccine was not applicable. The outcome of severe side effects was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797138
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: THE DRUGS HE WAS GIVEN, THEY POISON HIM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced the drugs he was given, they poison him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drugs he was given, they poison him was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797139
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 10/16/2021
Rec V Date: 10/19/2021
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: RAPID HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-OCT-2021, the patient experienced rapid heart rate. On 16-OCT-2021, the patient experienced dizziness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rapid heart rate, and dizziness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1797140
Sex: F
Age: 77
State: PA

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 10/19/2021
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: Bells palsy; fever blisters; got rash and pruritus all over the trunk; rash and itching all over the trunk; This spontaneous case was reported by a physician and describes the occurrence of BELL'S PALSY (Bells palsy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included METOPROLOL, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), DULOXETINE, FOLIC ACID, VITAMIN A NOS, BALOFLOXACIN, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) and AMLODIPINE for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (rash and itching all over the trunk) and RASH (got rash and pruritus all over the trunk). On 28-Feb-2021, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant) and ORAL HERPES (fever blisters). The patient was treated with PREDNISONE for Adverse event, at a dose of 15 milligram and VALACYCLOVIR [VALACICLOVIR] for Adverse event, at a dose of 1 gram. On 27-Feb-2021, PRURITUS (rash and itching all over the trunk) and RASH (got rash and pruritus all over the trunk) had resolved. At the time of the report, BELL'S PALSY (Bells palsy) and ORAL HERPES (fever blisters) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company comment : This case concerns a 77 year-old female subject, who experienced the unexpected event of BELL?S PALSY The event occurred three days after the first dose of mRNA-1273. The event was considered related to the product per the reporter's physician. The benefit-risk relationship of drug Spikevax mRNA-1273 is not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Upon internal review on 17-Sep-2021, case was unlocked to get company comment from MSAand removed event of facial paralysis , added new event rash; Sender's Comments: This case concerns a 77 year-old female subject, who experienced the unexpected event of BELL?S PALSY The event occurred three days after the first dose of mRNA-1273. The event was considered related to the product per the reporter's physician. The benefit-risk relationship of drug Spikevax mRNA-1273 is not affected by this report

Other Meds: METOPROLOL; LISINOPRIL; ASPIRIN (E.C.); OMEPRAZOLE; VITAMIN D 2000; DULOXETINE; FOLIC ACID; VITAMIN A NOS; BALOFLOXACIN; VITAMIN B 12 [VITAMIN B12 NOS]; AMLODIPINE

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am