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: 1810455
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No treatment medications were reported. This case was linked to MOD-2021-354610 (Patient Link).

Other Meds:

Current Illness:

ID: 1810456
Sex: U
Age: 35
State: AZ

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/23/2021
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: dose administered past the 30-day use by date was the first or second shot; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1810457
Sex: F
Age: 66
State: AL

Vax Date: 04/16/2021
Onset Date: 05/15/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210516; Test Name: Heart rate; Result Unstructured Data: 50 to 150 beats

Allergies:

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

Symptoms: Heart palpitations and problems with 2nd shot; It felt like somebody was stabbing me in my chest; My beats went from low pressure to high pressure/ beats went from 50 to 150; My big toe and the small ones next to it on my right foot, it feels like somebody stomped on it / they are calling it COVID toe; Arm ached during those 2 weeks; My left arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations and problems with 2nd shot), CHEST PAIN (It felt like somebody was stabbing me in my chest), HEART RATE INCREASED (My beats went from low pressure to high pressure/ beats went from 50 to 150), PAIN IN EXTREMITY (My big toe and the small ones next to it on my right foot, it feels like somebody stomped on it / they are calling it COVID toe) and PAIN IN EXTREMITY (Arm ached during those 2 weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spasms. Concomitant products included TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for Spasms, LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITOR), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), SALBUTAMOL SULFATE (PROAIR DIGIHALER), MORPHINE SULFATE, POTASSIUM CHLORIDE and AMLODIPINE BESILATE (NORVASC) for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced PAIN IN EXTREMITY (Arm ached during those 2 weeks) and VACCINATION SITE SWELLING (My left arm swelled up). On 16-May-2021, the patient experienced PALPITATIONS (Heart palpitations and problems with 2nd shot), CHEST PAIN (It felt like somebody was stabbing me in my chest), HEART RATE INCREASED (My beats went from low pressure to high pressure/ beats went from 50 to 150) and PAIN IN EXTREMITY (My big toe and the small ones next to it on my right foot, it feels like somebody stomped on it / they are calling it COVID toe). On 30-May-2021, PAIN IN EXTREMITY (Arm ached during those 2 weeks) and VACCINATION SITE SWELLING (My left arm swelled up) had resolved. In October 2021, PAIN IN EXTREMITY (My big toe and the small ones next to it on my right foot, it feels like somebody stomped on it / they are calling it COVID toe) had resolved. At the time of the report, PALPITATIONS (Heart palpitations and problems with 2nd shot), CHEST PAIN (It felt like somebody was stabbing me in my chest) and HEART RATE INCREASED (My beats went from low pressure to high pressure/ beats went from 50 to 150) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, Heart rate: 50 to 150 (High) 50 to 150 beats. Patient did not receive any treatment for adverse event. The patient had echocardiogram and 24 hour Holter Monitor were performed but results are unknown. A cause has not been determined at this time. She has a Cardiologist appointment on 11-NOV-2021. She stated that she has never had heart problems before receiving the vaccine

Other Meds: SYNTHROID; LIPITOR; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]; PROAIR DIGIHALER; MORPHINE SULFATE; ZANAFLEX; POTASSIUM CHLORIDE; NORVASC

Current Illness: Spasms

ID: 1810458
Sex: F
Age: 74
State: TN

Vax Date: 02/05/2021
Onset Date: 03/05/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: BODY TEMPERATURE; Result Unstructured Data: 102 degrees farenheight

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: nauseous; joint aches; temperature 102 degrees Farenheight; headache which lasted for several hours; eyes blood shot; face red; Chills/shaking; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous) and ARTHRALGIA (joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills/shaking). On an unknown date, the patient experienced OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), NAUSEA (nauseous), ARTHRALGIA (joint aches), PYREXIA (temperature 102 degrees Farenheight) and HEADACHE (headache which lasted for several hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous), ARTHRALGIA (joint aches) and PYREXIA (temperature 102 degrees Farenheight) outcome was unknown and HEADACHE (headache which lasted for several hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees farenheight (High) 102 degrees farenheight.

Other Meds: ACETAMINOPHEN

Current Illness:

ID: 1810459
Sex: M
Age: 48
State: IA

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: felt lethargic; felt bloated; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated). At the time of the report, LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-355582 (Patient Link).

Other Meds:

Current Illness:

ID: 1810460
Sex: F
Age: 57
State: NJ

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
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: feel a little sick, and horrible.; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball) and NAUSEA (nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Immunocompromised. Concomitant products included TRAMADOL, LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITROL [ATORVASTATIN CALCIUM]), VITAMIN D [VITAMIN D NOS], MIRABEGRON (MYRBETRIQ) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication. On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no treatment medication were reported. patient got the first dose of moderna vaccine on 15March202 with batch number 002b21a and received second dose on 12April2021 with lot number 031a21a both on her left arm. She mention that on the 13April2021 felt tired, and didn't take anything and that symptom went away on the 14April2021.

Other Meds: TRAMADOL; SYNTHROID; LIPITROL [ATORVASTATIN CALCIUM]; VITAMIN D [VITAMIN D NOS]; MYRBETRIQ; ALBUTEROL HFA

Current Illness: Asthma; Immunocompromised

ID: 1810461
Sex: M
Age: 48
State: IA

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: continued to feel lethargic; continued to feel bloated; retaining fluid in his face; retaining fluid in his neck; heart beats fast after second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (continued to feel lethargic), ABDOMINAL DISTENSION (continued to feel bloated), FACE OEDEMA (retaining fluid in his face), LOCALISED OEDEMA (retaining fluid in his neck) and HEART RATE INCREASED (heart beats fast after second vaccine dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced LETHARGY (continued to feel lethargic), ABDOMINAL DISTENSION (continued to feel bloated), FACE OEDEMA (retaining fluid in his face), LOCALISED OEDEMA (retaining fluid in his neck) and HEART RATE INCREASED (heart beats fast after second vaccine dose). At the time of the report, LETHARGY (continued to feel lethargic), ABDOMINAL DISTENSION (continued to feel bloated), FACE OEDEMA (retaining fluid in his face), LOCALISED OEDEMA (retaining fluid in his neck) and HEART RATE INCREASED (heart beats fast after second vaccine dose) outcome was unknown. Concomitant medications were not reported. No treatment information was reported. This case was linked to MOD-2021-355568 (Patient Link).

Other Meds:

Current Illness:

ID: 1810462
Sex: F
Age: 74
State: WI

Vax Date: 09/15/2021
Onset Date: 09/16/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 99 ?F; Test Name: West Nile virus; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Diarrhea; Flu like symptoms; Neck stiffness; Neck pain; Sleepy; Cloggy; Temperature of 99?; Headache; Tired; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain) and SOMNOLENCE (Sleepy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included West Nile viral infection (She already had antibodies). On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99?), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99?), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 ?f (High) 99 ?F. On an unknown date, West Nile virus test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product use was reported. No treatment information was provided.

Other Meds:

Current Illness: West Nile viral infection (She already had antibodies)

ID: 1810463
Sex: M
Age:
State: SD

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: 5 doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1810464
Sex: F
Age: 56
State: TX

Vax Date: 03/10/2021
Onset Date: 10/12/2021
Rec V Date: 10/23/2021
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: sore arm; Migraine type pain; Neck Pain; Shooting pain into her head and down her back; body aches; Shooting pain into her head and down her back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091021A, 040A21A and 02FB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concurrent medical conditions included Diabetes. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back), MYALGIA (body aches) and HEADACHE (Shooting pain into her head and down her back). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD [ACETYLSALICYLIC ACID;CHLORPHENAMINE MALEATE;PHENYLEPHRINE BITARTRATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and HEADACHE (Shooting pain into her head and down her back) had not resolved and MYALGIA (body aches) was resolving. Concomitant medications were not reported. This case was linked to MOD-2021-355604 (Patient Link).

Other Meds:

Current Illness: Diabetes

ID: 1810465
Sex: F
Age: 28
State: OH

Vax Date: 09/10/2021
Onset Date: 10/15/2021
Rec V Date: 10/23/2021
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: Can't use the arm; pain went across the shoulder and then to chest and back; pain went across the shoulder and then to chest and back; Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt; Pain; Overall aching feeling; pain went across the shoulder and then to chest and back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt) and PAIN (Pain) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 040CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back) outcome was unknown. Concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1810466
Sex: F
Age:
State:

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 10/23/2021
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: itch; The booster dose, was not a half dose but a full dose; she got an acute urticaria; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), URTICARIA (she got an acute urticaria) and ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose). On an unknown date, the patient experienced PRURITUS (itch) and URTICARIA (she got an acute urticaria). On 26-Aug-2021, ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose) had resolved. At the time of the report, PRURITUS (itch) and URTICARIA (she got an acute urticaria) outcome was unknown. No concomitant medications were reported. Patient was taking an antihistaminic and a cream for the itch.

Other Meds:

Current Illness:

ID: 1810467
Sex: M
Age: 61
State: CA

Vax Date: 04/23/2021
Onset Date: 05/03/2021
Rec V Date: 10/23/2021
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: 1st dose of vaccine on the 23Apr2021 and 2nd dose on the 03May2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of vaccine on the 23Apr2021 and 2nd dose on the 03May2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of vaccine on the 23Apr2021 and 2nd dose on the 03May2021). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of vaccine on the 23Apr2021 and 2nd dose on the 03May2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment information were provided. This case was linked to MOD-2021-355680 (Patient Link).

Other Meds:

Current Illness:

ID: 1810468
Sex: M
Age: 49
State: OK

Vax Date: 08/18/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: received an expired second dose; second dose >35 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1810469
Sex: F
Age: 53
State: TX

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 10/23/2021
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: She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported. This case was linked to MOD-2021-356679 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred approximately 2 weeks after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report

Other Meds:

Current Illness:

ID: 1810470
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Feel weak; Severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction). At the time of the report, ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided Treatment medications were not provided Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation received on 19 Oct 2021 contains translation of social media post

Other Meds:

Current Illness:

ID: 1810471
Sex: F
Age: 53
State: TX

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 10/23/2021
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: There are 5 blood clots in total; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (There are 5 blood clots in total) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A and 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (There are 5 blood clots in total) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (There are 5 blood clots in total) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-356470 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of thrombosis. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. further information was requested.

Other Meds:

Current Illness:

ID: 1810472
Sex: M
Age:
State: VA

Vax Date: 10/02/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
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: it was just sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it was just sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (it was just sore). At the time of the report, VACCINATION SITE PAIN (it was just sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-352100 (Patient Link).

Other Meds:

Current Illness:

ID: 1810473
Sex: F
Age:
State: FL

Vax Date: 10/12/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
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: unspecified reaction to the first and second shot/wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction; fainted; increasing weakness/very weak; felt sick; received 3rd shot and is not immunocompromised; muscle pain; arm pain pretty same immediate after vaccination; rash; seems to be very hot; not feeling fine; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3rd shot and is not immunocompromised), MYALGIA (muscle pain) and VACCINATION SITE PAIN (arm pain pretty same immediate after vaccination). On 13-Oct-2021, the patient experienced ILLNESS (felt sick). On 14-Oct-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and ASTHENIA (increasing weakness/very weak). In October 2021, the patient experienced FEELING HOT (seems to be very hot), MALAISE (not feeling fine) and RASH (rash). On an unknown date, the patient experienced VACCINATION COMPLICATION (unspecified reaction to the first and second shot/wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction). On 12-Oct-2021, EXTRA DOSE ADMINISTERED (received 3rd shot and is not immunocompromised) had resolved. At the time of the report, SYNCOPE (fainted), ILLNESS (felt sick), ASTHENIA (increasing weakness/very weak), FEELING HOT (seems to be very hot), MALAISE (not feeling fine), VACCINATION COMPLICATION (unspecified reaction to the first and second shot/wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction), MYALGIA (muscle pain) and RASH (rash) outcome was unknown and VACCINATION SITE PAIN (arm pain pretty same immediate after vaccination) had not resolved. No concomitant medications information was reported. No treatment medications were provided. The patients husband reported that his wife had the 3rd Moderna COVID-19 vaccine shot and had a reaction. She felt sick after the shot, by the following day. She had arm pain pretty immediate, the same day. She had increasing weakness and seemed to be very hot, he did not knew if it was fever or not. Early morning on 14 Oct 2021 at 4am his wife got up to get a drink of ginger ale and in the process of taking that out of the fridge she fainted on the floor and she had been very weak all day. There was no such reaction to the first shots. She had muscle pain pretty soon after and that continued and wa still not feeling fine. He had the same side effects as with the first two shots (which he had in February), the same they all had at the moment. When asked if immunocompromised he said he did not know and they assumed the 3rd dose included people over 65 years old as well. The side effects were so much different than the previous doses. She also had a rash, and had that every time she had a bad cold or something like that. This is an spontaneous case concerning a 75 year-old, female patient with unknown clinical history who experienced the unexpected serious event of SYNCOPE and other non-serious events. The event occurs approximately 3 days after the third dose of a COVID-19 vaccine (we do not have information if the first two doses were Spikevax or not). The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow up document received wherein batch number updated.; Sender's Comments: This is an spontaneous case concerning a 75 year-old, female patient with unknown clinical history who experienced the unexpected serious event of SYNCOPE and other non-serious events. The event occurs approximately 3 days after the third dose of a COVID-19 vaccine (we do not have information if the first two doses were Spikevax or not). The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1810474
Sex: F
Age:
State: PA

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210703; Test Name: Blood Pressure; Result Unstructured Data: Test Result:120/70 mmHg; Comments: Blood Pressure: 120/70 Blood Pressure Location: Lt brachial Blood Pressure Position: sitting; Test Date: 20210703; Test Name: Height; Result Unstructured Data: Test Result:5 ft 5 in; Comments: Height: 5 ft 5 in; Test Date: 20210703; Test Name: Body Mass Index BMI; Result Unstructured Data: Test Result:23.2; Comments: Body Mass Index BMI: 23.2; Test Name: fever; Result Unstructured Data: Test Result:99; Comments: fever 99- 101; Test Name: fever; Result Unstructured Data: Test Result:101; Comments: fever 99- 101; Test Date: 20210703; Test Name: Temperature; Result Unstructured Data: Test Result:96.9 Fahrenheit; Comments: Temperature: 96.9 F L Temperature Source: Temporal Artery Scan; Test Date: 20210703; Test Name: Pulse Rate; Result Unstructured Data: Test Result:118; Comments: Pulse Rate: 118 H Pulse Source: Monitor; Test Name: Exam; Result Unstructured Data: Test Result:Normal; Test Date: 20210703; Test Name: 02 Sat b Pulse Oximeter; Test Result: 98 %; Comments: 02 Sat b Pulse Oximeter (%): 98 Oxygen Deliver Method: room air; Test Date: 20210703; Test Name: Weight; Result Unstructured Data: Test Result:139 1b 6 oz; Comments: Weight: 139 1b 6 oz

Allergies:

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

Symptoms: large, swollen, painful lymph nodes in both breasts; large, swollen, painful lymph nodes in both breasts; fever 99- 101 on and off; Lip swelling; sore throat; Fatigue; dizzy; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0164), dose 1 intramuscular, administered in Arm Left on 27Apr2021 10:59 as dose 1, single for covid-19 immunisation (at the age of 32-year-old). Medical history included possible autoimmune issue, heart block, heart pvcs, previous ovarian tumors removed, Allergies to sulfa, penicillin, seasonal allergies, strawberries, arugala, dairy, meat products, spices, Penicillins Allergy (Mild, Unverified 29Sep2020 10:17) Hives, Strawberry Allergy (Mild, Unverified 29Sep2020 10:17) Welts, Silver Allergy (Unknown, Unverified 29Sep2020 10:17) Unknown, Sulfa (Sulfonamide Antibiotics) Allergy (Unknown, Unverified 29Sep2020 10:17) Unknown, Raynauds phenomenon (Acute), Vitamin D deficiency (Acute), PTSD (posttraumatic stress disorder), Mobitz (type) I (Wenckebach's) atrioventricular block, Palpitations, Elevated blood pressure reading, Disordered eating, Chronic posttraumatic stress disorder (PTSD), GERD (gastroesophageal reflux disease), Acne, Asthma (Chronic), Anxiety (Chronic), Surgical History (Reviewed 05May2021 at 16:33 S/P removal of ovarian cyst. Former smoker quit date/quit comments: 2014 tobacco type: cigarettes packs per day: 0.25 from an unknown date and unknown if ongoing, family history of hypertension, depres-sion, diabetes mellitus (Father and Mother). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications includ-ed fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for hypersensitivity from an unspecified start date and ongoing; fish oil (FISH OIL) taken for supplementation therapy from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), montelukast sodium (SINGULAIR) taken for hypersensitivity from an unspecified start date and ongo-ing; glucosamine (GLUCOSAMINE) taken for supplementation therapy, collagen (COLLAGEN) taken for supplementation therapy, vitamin b nos (VITAMIN B NOS) taken for supplementation therapy; albuterol sulfate (ALBUTEROL SULFATE) taken for an unspecified indication, ascorbic acid (ASCORBIC ACID) taken for an unspecified indication, cholecalciferol (CHOLECALCIFEROL) taken for an unspecified indica-tion, cyanocobalamin (CYANOCOBALAMIN) taken for an unspecified indication, diazepam (DIAZEPAM) taken for an unspecified indication, epinephrine (EPINEPHRINE) taken for an unspecified indication, fexofenadine (FEXOFENADINE) taken for an unspecified indication, metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication, omeprazole (OMEPRAZOLE) taken for an unspecified indication, clindamycin;tretinoin (CLINDAMYCIN;TRETINOIN) taken for an unspecified indication from an unspecified start date and ongoing. Pediatric multivitamin 1 TAB.CHEW PO from an unspecified start date and ongoing. On 18May2021 11:00 patient experienced large, swollen, painful lymph nodes in both breasts for 5 weeks plus fever 99- 101 on and off for 3 weeks after the first shot and currently with the second shot (it's been over 2 weeks since my second shot) stomach cramping and pain nausea dizzy spells. HCP stated that we discussed her symptoms in great detail. At this time, her symptoms, aside from the breast tenderness are all improving. Patient and I both reviewed information online, I specifically looked on the CDC website. According to the CDC, 86 percent of anaphylactic reac-tions from the Pfizer Covid vaccine occur within the first 30 minutes after administration. I advised patient that the incidence of anaphylaxis is extremely low. Ultimately, I advised patient that she can receive her second Covid vaccination on 18May but would advise she stay at the vaccination site for 30 minutes to be observed following administration. I also advised she continue her allergy medication and consider taking Pepcid if she develops any side effects and she take her EpiPen with her to the vaccination site. If she needs to use the Epi Pen, she should go immediately to the ER to be observed. She states she does live with family, so she will be with other people after she receives a vaccine. End of the visit, patient seemed comfortable with our discussion and my recommendation. She absolutely wants to receive her second vaccine and plans to move forward with it. Patient presents for a video visit to discuss side effects from her first COVID Pfizer vaccine on 27Apr2021. The day she received her vaccine, patient reports feeling very out of it, fatigued, and dizzy. The symptoms continued into the next day. The third day after receiving her vaccine, she developed ransient swelling on the right lower side of her lip a temperature of 99.9, and a sore throat. Denies shortness of breath or difficulty swallowing, but states her throat felt weird. Denies tongue swelling.On the 6th day after vaccination, she developed swollen lymph nodes in her neck and swollen breasts which continue. Her breasts feel sore like they do prior to menses. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 mmhg on 03Jul2021 Blood Pressure: 120/70 Blood Pressure Location: Lt brachial Blood Pressure Position: sitting, body height: 5 ft 5 in on 03Jul2021 Height: 5 ft 5 in, body mass index: 23.2 on 03Jul2021 Body Mass Index BMI: 23.2, body temperature: 99 on an unspecified date, fever 99- 101, body temperature: 101 on fever 99- 101, body temperature: 96.9 fahrenheit on 03Jul2021 Temperature: 96.9 F L Temperature Source: Temporal Artery Scan, heart rate: 118 on 03Jul2021 Pulse Rate: 118 H Pulse Source: Monitor, laboratory test: normal on an unspecified date, oxygen saturation: 98 percent on 03Jul2021 02 Sat b Pulse Oximeter (percent): 98 Oxygen Deliver Method: room air, weight: 139 1b 6 oz on 03Jul2021 Weight: 139 1b 6 oz. The event required the initiation of new medication/other treatment/procedure. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Unknown if patient received treatment. The outcome of the events lip swelling, sore throat, fatigue, dizzy was recovered and Outcome for other events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: ALLEGRA; FLONASE [FLUTICASONE PROPIONATE]; FISH OIL; VITAMIN D [VITAMIN D NOS]; SINGULAIR; GLUCOSAMINE; COLLAGEN; VITAMIN B NOS; ALBUTEROL SULFATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; DIAZEPAM; EPINEPHRINE; FEXOFENADINE; METOPRO

Current Illness: Allergy (Medical History: Allergies); Anxiety (Medical History: Anxiety); Asthma (Medical History: Asthma); AV block first degree (Medical History: Mobitz (type) I (Wenckebach's) atrioventricular block); GERD (Medical History: GERD); Post-traumatic stress disorder (Medical History: PTSD(post-traumatic stress disorder))

ID: 1810475
Sex: F
Age:
State: PA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 10/23/2021
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: Dose 1: Start Date/Time: [Pfizer] 18Jan2021 09:00 AM/ Dose 2: Start Date/Time: [Pfizer] 4Feb2021 09:00 AM; a lump at the injection site that a magnet will stick to; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 67-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization. Medical history included atrial fibrillation (Afib), high cholesterol (blood cholesterol increased), high blood pressure (hypertension), mitral valve replacement in Mar1999 (taking anticoagulants for mitral valve replacement), Known allergies includes penicillin, vancomyacin, any pain medication. Concomitant medication(s) included warfarin; sotalol; famotidine; amlodipine; cetirizine. No other vaccine administered in four weeks. The patient had not diagnosed with covid prior vaccination. Patient is non-pregnant. The patient previously took vancomycin and experienced drug hypersensitivity. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1685 via an unspecified route of administration, administered in Left Arm on 18Jan2021 09:00 as dose 1, single for COVID-19 immunization. On 04Feb2021 at 04:00 the patient experienced a lump at the injection site that a magnet will stick to. Patient received dose 1: start date/time: [pfizer] 18Jan2021 09:00 am/ dose 2: start date/time: [pfizer] 04Feb2021 09:00 am (Inappropriate schedule of vaccine administered). Post vaccination, patient had not tested with COVID. No treatment received for the reported events. The outcome of reported event (Vaccination site lump) was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: WARFARIN; SOTALOL; FAMOTIDINE; AMLODIPINE; CETIRIZINE

Current Illness:

ID: 1810476
Sex: F
Age:
State: WA

Vax Date: 07/09/2021
Onset Date: 07/09/2021
Rec V Date: 10/23/2021
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: 20210720; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Unevaluable event

Symptoms: Nausea; body aches; heat sensation on chest; mouth blisters; fever; sore throat; headaches/migraines; headaches/migraines; This is a spontaneous report from a contactable other hcp (Nurse) for herself. A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 09Jul2021 (age at vaccination: 44-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, asthma and vitamin D deficiency (recently vitamin D deficiency) all from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa (sulfanilamide) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. She received the vaccine at pharmacy or drug store. On 09Jul2021 the patient experienced nausea, body aches, heat sensation on chest, mouth blisters, fever, sore throat, headaches/migraines (headache, migraine). AE resulted in Doctor or other healthcare professional office/clinic visit. On 20Jul2021, the patient underwent lab tests and procedures which included negative COVID-19 with nasal swab. The patient had not received any other vaccine within 4 weeks. No covid prior vaccination. Therapeutic measures were taken as a result of events which included oxycodone, toradol, muscle relaxer and otc ibuprop. The outcome of events was recovered/resolved with sequel (on an unspecified date in 2021). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

Other Meds: IBUPROFEN

Current Illness:

ID: 1810477
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: vertigo; This is a spontaneous report from a contactable consumer (patient's mother-in-law). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced vertigo. Clinical outcome of the event was reported as unknown. The lot number for BNT162B2 was not provided and will be requested during follow up. Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].

Other Meds:

Current Illness:

ID: 1810478
Sex: F
Age:
State: IL

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 10/23/2021
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: Patient received second dose 8 days, after the first dose.; Sore arm, after second vaccine; White, pale, lips, after second vaccine; fever; headache; This is a spontaneous report from a contactable pharmacist. A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration in left arm on 15Sep2021 (probably in the evening), (at the age of 13-years-old) as dose 2, single for COVID-19 immunization at pharmacy. Medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration in left arm, on 07Sep2021 as dose 1, single for COVID-19 immunization. It was unknown if patient received any vaccine within four weeks prior to the first administration date of the vaccine. The patient received second dose 8 days, after the first dose on 15Sep2021 (Inappropriate schedule of vaccine administered). The patient experienced fever, headache, sore arm, after second vaccine and white, pale, lips, after second vaccine on an unspecified date in 2021. The caller (pharmacist) who administered the Pfizer Biontech COVID19 vaccine two weeks earlier than the recommended scheduled interval to a 13-year-old female patient. Reporter mentioned that the mother of the patient was freaking out and thinks that her daughter will die and heard that the second shot is more intense in terms of side effects. They were told originally to watch side effects for fever and headache if it stays that way. Reporter was asking for recommendations on what should they and what to expect with the event. Reporter added that it was not life threatening, and she was told that the patient treated herself with Tylenol for sore arm because it was reported to her, second hand, she does not know if the patient got relief from the Tylenol. It was unknown if the AE required to visit emergency room or physician office. Outcome of the events was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810479
Sex: F
Age:
State:

Vax Date: 09/15/2021
Onset Date: 09/01/2021
Rec V Date: 10/23/2021
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: fever; chills; muscle aches; scratchy throat; can't taste or smell; can't taste or smell; sinus infection/sinus infection off and on; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 39-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date in 2021 for COVID-immunization for no events reported. The patient experienced fever, chills, muscle aches, scratchy throat, can't taste or smell on Sep2021 and sinus infection/sinus infection off and on an unknown date 2021. Caller reports she had her second Pfizer Covid 19 dose on Wednesday. Wants to know if someone can tell her some of the side effects and how long they last. Has had a sinus infection off and on and on Wednesday was fine when she got the shot, now since then she has had a scratchy throat. She told the pharmacist this and was told to go ahead and get the vaccine and she called her doctor. She has had fever, chills, and muscles aches and saw that they were common, but now she could not taste or smell right. Therapeutic measures were taken as a result of events. The outcome for event fever and chills was recovered on an 16Sep2021 while muscle aches and scratchy throat was unknown and rest was not recovered. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810480
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Sore arm with all 3 doses; This is a spontaneous report from a contactable consumer, the patient from a Pfizer sponsored program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder and cancer. The patient concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced sore arm with all 3 doses. The outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and would be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810481
Sex: F
Age:
State: TX

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 10/23/2021
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: Had severe migraines.; Also body aches all over the body; Allergic reaction in the face; swelling mouth, nose and ears; swelling mouth, nose and ears; swelling mouth, nose and ears; Rapid heartbeats; This is a spontaneous report from a contactable consumer (patient). A 30-years-old non pregnant female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route, administered in Left Arm on 22Aug2021 (Age at vaccination 30 year, non-pregnant) as dose 1, single, and via an unspecified route, administered in Left Arm on 22Aug2021 (Age at vaccination 30 year, non-pregnant) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient did not have known allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and has the patient been tested for COVID-19 Since the vaccination. There were no concomitant medications. On 22Aug2021 the patient experienced had severe migraines, also body aches all over the body, allergic reaction in the face, swelling mouth, nose and ears and rapid heartbeats. The outcome of the events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810482
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: vertigo; dizziness; anxiety; panic attacks; This is a spontaneous report from a contactable consumer (reporter's father) . A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, his main concern right now is his dizziness, vertigo, anxiety, panic attacks and he also mentioned that his Dad who got also the Pfizer-BioNTech Covid19 Vaccine is beginning to have the similar problem. The outcome for the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Lot/batch number is not available. Follow-up attempts have been completed and no further information is expected

Other Meds:

Current Illness:

ID: 1810483
Sex: F
Age:
State: CT

Vax Date: 09/08/2021
Onset Date: 09/17/2021
Rec V Date: 10/23/2021
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: extreme itchiness; hives all over her face; her face turned red, then white and was puffy; her face turned red, then white and was puffy; her face turned red, then white and was puffy; extreme left arm pain; chest pain; foggy headed; extremely tired; This is a spontaneous report received from Pfizer medical information team from a contactable patient. A 67-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3184, expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 08Sep2021 10:30 (at the age of 67-year-old) as Dose 1, Single for covid-19 immunisation. Medical history included Graves Disease from an unknown date to 2005 (she is in remission), chest pain from 2004 to an unknown date due to the heat, dental procedure from May2021 to an unknown date, infection from May2021 and ongoing and eye-sight went from reading and editing scientific journals all her life from Jun2021. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for antihistamine, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for Blood pressure and removed excess weight and water retention. The patient previously took flu vaccine and experienced bad reactions and doxycycline in Jun2021. It was reported that patient was placed an antihistamine from her physician a few days prior to getting the vaccine. It worked, she did not have reaction until it wore off. She clarified that she took Allegra 180mg every 24 hours and she split the pill in half 90mg twice a day by mouth because her blood pressure spiked when she took the full 180mg. No lot or expiration to provide. Allegra UPC 4116741200. It was reported that she gained weight and got some like inflammation. Her normal weight was 167lbs. She did not think it was not from the Covid shot. She thinks it was due to heat and her antihistamines and stuff. She clarified that her weight increased prior to the vaccine. It increased after a dental procedure in May2021 and she had an ongoing infection. She said that her body blows up hen she has any type of invasive procedure. NDC number of Comirnaty was reported as 592671000-02. On an unknown date within 24 hours of her antihistamine wore off, the patient experienced extreme itchiness, hives all over her face, her face turned red, then white and was puffy, at 00:50, extreme left arm pain which was enough to wake her up, it didn't persist though and slight chest pain and foggy headed. She said that she thought she only had chest pain once before in 2004 due to the heat. On 17Sep2021, she had extremely tired and took 2 days off. On Saturday afternoon she went swimming and it took the tiredness away. She rarely experiences tiredness like that. She took a 325mg Aspirin, had a banana, and OJ, and it went away, and she was perfectly fine after that. She said that she thinks she took a Tylenol after that about an hour later. It was reported that patient was fine after the vaccination and then 10 days later crashed, tired again, unusual headache, she states she is not a headachy person, it wasn't alarming like I had to go to the hospital or anything. Just like a weird, front of head mild, on and off lasted two days not alarming. The outcome of all the events was reported as unknown. Follow-up (23Sep2021): This is a follow-up spontaneous report received from a contactable consumer (patient) that reported that: course of narrative Follow-Up (12Oct2021): Follow-up attempts were completed. No further information was expected. Follow-Up (18Oct2021): Follow-up attempts were completed. No further information was expected.

Other Meds: ALLEGRA; HYDROCHLOROTHIAZIDE

Current Illness: Infection

ID: 1810484
Sex: F
Age:
State: NV

Vax Date: 06/06/2021
Onset Date: 06/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: Biopsy; Result Unstructured Data: Test Result:2x2 chunk out of her breast; Comments: her breast dropped in size to AA; Test Date: 20210607; Test Name: Fever of 102 degrees Fahrenheit; Result Unstructured Data: Test Result:102 Fahrenheit; Test Date: 202106; Test Name: Fever was down to 100 degrees Fahrenheit; Result Unstructured Data: Test Result:100 Fahrenheit; Test Name: Mammogram; Result Unstructured Data: Test Result:calcifications; Comments: 15 calcifications there; Test Name: Weight; Result Unstructured Data: Test Result:25lb weight gain in a month; Comments: Caller says she gained another 25lbs on Tamoxifen

Allergies:

Symptom List: Nausea

Symptoms: She had a fever of 102 degrees Fahrenheit; She felt like hell.; Has lost a couple pounds; she had no energy; would sleep 5-6 hours after trips to the store; Felt very weak; Bedridden four weeks after vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) received from Pfizer-sponsored program. A 74-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191, Expiry date: Unknown), via an unspecified route of administration on 06Jun2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunisation. Medical history included breast cancer from Dec1999 and ongoing carcinoma in situ Ductal carcinoma in situ, hysterectomy from an unknown date and unknown if ongoing and had surgery on Dec1999 to Dec1999. Description of complaint: Premarin: Caller said that she took Premarin that caused cancer 21 year back and will they probably take both breasts, she would have both removed. She said she had not had cancer in 21 years, they said they would take one and might need to take the other one if it would develop to cancer. Caller said she did something with the other lady, but she does not know if she did a report about Premarin, she thinks this stuff should be taken off market. Premarin NDC/LOT/EXP: Unknown. Caller said she took Premarin starting in 1985 after an emergency hysterectomy, it was recommended by a doctor because she was going nuts and wanted to kill herself, she never felt like that before she had the hysterectomy. She said she wanted to kill herself, she was rolled up in a ball, and her parents were screaming and having a fit and called the doctor. She said she started taking Premarin and in 3 days she was back to normal. She said she had a 25lb weight gain in a month, and she took Premarin from 1985-1999 without realizing it could cause breast cancer. She said she started getting breast cysts, and a surgeon went in and said something was wrong with her milk duct, it did not look right. She said they called 3 days later and said it came back as carcinoma in situ, but told her she won't have to do anything since her lymph nodes were clear. She said they did a biopsy and took a 2x2 chunk out of her breast, it was big, she was not sure if that was measured in inches or centimeters, she thinks inches, her breast dropped in size to AA, it was a scoop like an ice cream scoop. Premarin dosage unknown. She said she had beautiful thick hair before she took the Premarin. She said she took Tamoxifen for 5 years and did aggressive radiation for a month or two, maybe three months, and then she was off Premarin permanently. She said she was fine off Premarin, she did not take anything, she learned to live with the hot sweats. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from Jun1965 and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: AW0135) via an unspecified route of administration, administered in left arm on 16May2021 for covid-19 immunization. She reported that after her first dose she was ok, her arm was sore for two days then after that it was fine. She says she did no treatment for the soreness she just moved it around and went to. She says she didn't take Aleve. She says after her second dose in June she was bedridden. The patient previously took premarin for hysterectomy and experienced cancer, tamoxifen for chemotherapy and experienced aggressive radiation. On an unspecified date in Jun2021, the patient experienced felt very weak, bedridden four weeks after vaccine, has lost a couple pounds, she had no energy, would sleep 5-6 hours after trips to the store. On 07Jun2021 experienced, she had a fever of 102 degrees Fahrenheit, she felt like hell. The patient did not received any treatment for the events. It was further reported that, caller said that she got her first dose on 16 May 2021, and then her second dose on June 06th at. She said you take them a month or so apart. She provides LOT: AW0135 or AW0185 for her first dose and says that the way it was handwritten the numbers are smoothed together. She provides LOT: EW0191 for her second dose. She felt very weak and was bedridden four weeks after getting the vaccine. Caller said it was more like 9 weeks, she did get out of bed, after two weeks she was able to get up and walk, at around 9 weeks she was able to go to the store, clarified at 3 weeks she was going to store then coming back to bed and would sleep 5-6 hours after trips to the store. She said she still falls asleep if she were to be talking like this on the phone she would have to lay down. She said she talked to a lady who got Moderna who said that she has the same thing happen to her. No further details provided about the lady who took Moderna. She said the first day after she got her second dose she had a fever of 102 degrees Fahrenheit and she felt bad. She said the second day she called her doctor because she still felt bad, her fever was down to 100 degrees Fahrenheit. She said on the third day she was doing better. She says she did not take anything to treat the fever, she did not take Aleve or anything because it would interfere with the shot. Caller said it has gotten a little bit easier, she was finally back on her exercise bike for 40 minutes a day. She says she was and was fat, she has lost a couple pounds, she was not a cripple that was bedridden she had no energy. She says she couldn't go to the gym and couldn't get out of bed after she had the Pfizer shot. She says she can go out for little trips, and if she overexerts herself she goes back to bed for an hour or two. She said she went in a month ago for her annual mammogram, which they told her yesterday they found calcifications and said there were 15 calcifications there, those are microscopic, the radiologist said they were around where had she surgery, which might explain it, and the Clinic had said sometimes you could have calcifications after you are hit in your breast, have surgery, or have aggressive radiation. She said that this may have caused it after 21 years, but what she does not understand was since she has not touched any kind of estrogen. She said her doctor today said wait 6 months to see if it changes and if it did they would take the breast off, and she asked what about the other one, and he said they would recommend that come off too if she could get it in her other breast. She said that the doctor wanted to check it in 6 months and do a second mammogram in six months and an ultrasound and if it has grown they want to take it out, they suggested a total mastectomy. She said that it would be agony to wait 6 months since it won't grow enough to spread and show beyond, it was not an aggressive cancer. Caller said she also had a friend who died after taking Premarin, her cancer came back after she took Premarin again, she was dead in 6 months. She said that that Premarin causes cancer, this also happened to her surgeon's nurse, later clarified to being her surgeon's receptionist and the friend she mentioned that died. She said the receptionist had breast cancer after she took Premarin and then a year later she saw her when she was back to work with her hair grew in and the receptionist said she can not stand the hot flashes, and went back to taking Premarin and was dead within 6 months. Caller says she had her surgery in January 2000, and then her doctor's receptionist was bald then, the receptionist was wearing a headpiece, so she asked her what happened and the receptionist said she was getting chemo treatment. She said she thinks the receptionist had chemo for a year, and then when she came back to see the surgeon the receptionist looked much better, her colour was back and she looked really good. She said the receptionist told her she had gotten symptoms back and they were horrible and she went back on Premarin and it killed her, she heard about her death from her doctor, the month or year she died she does not r

Other Meds: SYNTHROID

Current Illness: Breast cancer (carcinoma in situ Ductal carcinoma in situ)

ID: 1810485
Sex: F
Age:
State: MO

Vax Date: 12/29/2020
Onset Date: 01/22/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210906; Test Name: Pcr; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Injection site pain

Symptoms: I had an abnormally long menses; I was confirmed to be post menopausal; I have autoimmune ovarian failure; This is a spontaneous report from a contactable nurse (patient). A 38-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EJ-1686, Expiry date: not reported), via an unspecified route of administration, administrated in left arm on 29Dec2020 16:00 (at age of 38-years-old) as dose 1, single for COVID-19 immunization in workplace clinic. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Jan2021, the patient experienced I had an abnormally long menses, I was confirmed to be post-menopausal, and I have autoimmune ovarian failure. On 06Sep2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative, Nasal Swab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The reporter stated that after first dose, she had an abnormally long menses, then never had one again. In July, the patient was confirmed to be post menopausal at age 38. The patient was referred to a specialist who said that she had autoimmune ovarian failure. No therapeutic measures were taken in response to the events. The outcome of the events was unknown. Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810486
Sex: M
Age:
State: KY

Vax Date: 05/03/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: Brain fog; Digestive issues; Huge knot on his left arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the first vaccine dose. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the left arm on 03May2021 at 10:00am (Batch/Lot Number: EW0176, at age 41-years-old at vaccination) as a single dose for COVID-19 immunisation at a pharmacy/drug store. Medical history and concomitant medications were not reported. The patient had no prior vaccinations (within 4 weeks) of the BNT162B2 vaccine. On 03May2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date in May2021 (after the first vaccination), the patient experienced a huge knot on his left arm and it has remained the same. It was hard as a rock. The patent has been having a lot of side effects since the vaccine and one is brain fog which began around 18May2021 at the latest after the first dose of the vaccine and was ongoing and continues to get worse. He has an appointment with a neuropsychologist to undergo testing to see what was going on. He has a lot of digestive issues and was undergoing tests. The digestive issues also began around the same time as the brain fog and was ongoing and worst. Treatment for event digestive issues included taking Linzess 150mg once per day by mouth since 24Sep2021. The outcome of events huge knot on his left arm, brain fog and digestive issues was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 Same patient/reporter; different dose/AE

Other Meds:

Current Illness:

ID: 1810487
Sex: M
Age:
State: ID

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/23/2021
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: Chronic cough has worsened; Chronic cough has worsened; Extreme dizziness 4 hours after shot; nausea; vomiting; body aches and pains; headache; fatigue/I tire easily; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received third dose (BOOSTER, SINGLE), of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 301308A and expiry date was not reported), via intramuscularly, administered in Arm Left on 28Sep2021 at 12:00 (age at vaccination: 74-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included nausea, pain, hyperlipidaemia and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included prochlorperazine edisylate (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) taken for nausea from 28Sep2021 to 02Oct2021, via oral route of administration, ibuprofen taken for pain from 28Sep2021 to 02Oct2021, via oral route of administration and atorvastatin taken for hyperlipidaemia, blood cholesterol from 2018 to an unspecified stop date. The patient was not diagnosed with covid prior to covid-19 vaccine. The patient was not tested for covid-19 post vaccination. The patient was not allergic to any medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date: Jun2021), via intramuscularly in left arm, on 03Feb2021 at 13:00 (age at vaccination: 73-years-old), as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date: 30Jun2021), via intramuscularly in left arm, on 22Feb2021 at 12:00 (age at vaccination: 73-years-old), as DOSE 2, SINGLE for COVID-19 immunization. It was reported that, approximately 4 hours after 3rd dose was received, I experienced sudden onset of severe Dizziness, Followed by Nausea and Vomitting those sysmptoms persisted for nearly 7 days, then lessened. 10 days later, I am still experiencing Dizziness, but am able to walk and drive. I tired easily and my chronic cough has worsened. On 28Sep2021 at 17:00 PM, the extreme dizziness, nausea, vomiting, body aches and pains, headache, fatigue/I tired easily and chills. 10 days later, he was still experiencing dizziness, but he was able to walk and drive. On an unspecified date, his chronic cough had worsened. The patient did not receive any treatment for the events. Outcome of the event nausea and vomiting was recovered on an unspecified date in 2021, outcome of the events, dizziness, body aches and pains, headache, fatigue/I tired easily, chills was recovering and outcome of the other events was unknown.

Other Meds: COMPAZINE [PROCHLORPERAZINE EDISYLATE]; IBUPROFEN; ATORVASTATIN

Current Illness:

ID: 1810488
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Tingling and numbness progressing to needing a walker to ambulate; Tingling and numbness progressing to needing a walker to ambulate; Tingling and numbness progressing to needing a walker to ambulate; This is a spontaneous report from a contactable other healthcare professional (hcp). This report was received via a sales representative. A 5-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling and numbness progressing to needing a walker to ambulate. This started 3 weeks after a dose of the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Paraesthesia, hypoaesthesia, gait disturbance and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1810489
Sex: U
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: The patient has had substantial anemia, but it's never been bad enough to require a blood transfusion before; This is a spontaneous report from a contactable pharmacist. An elderly patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included anaemia. The patient concomitant medication was not reported. The patient previously took BNT162B2, dose 1 for COVID-19 immunisation. The patient received a blood transfusion within the past 24 to 48 hours. Patient was scheduled for a booster dose of the Pfizer BioNTech Covid-19 Vaccine on 11Oct2021. The patient has had substantial anemia, but it's never been bad enough to require a blood transfusion before. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event( Anaemia aggravated) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1810490
Sex: F
Age:
State: TN

Vax Date: 09/19/2021
Onset Date: 09/01/2021
Rec V Date: 10/23/2021
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: couldn't get out of bed; not able to function like she normally does, couldn't move; couldn't even control her bladder; can't seem to get back on her feet; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Sep2021 (at the age of 64-years) (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) diagnosed in 2010 or 2011, cancer, severely immunocompromised, severely allergic to latex; patient also had surgery for cancer and chemo which is finally over. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No flu prior to vaccination. In Sep2021, the patient couldn't get out of bed; not able to function like she normally does, couldn't move; couldn't even control her bladder and had to have disposal underwear just to handle things, and can't seem to get back on her feet. Every time she thinks she's getting better, she has a bad air quality day and sets her back, it doesn't put her back in bed per se but it puts her where she's not able to function like she normally does and that really affects her COPD (for clarification). She confirmed all symptoms were disabling, she couldn't even get out of bed. She wanted to know how long the symptoms would last from the Pfizer Covid 19 Vaccine. Outcome of the events was unknown. Relatedness of drug to all reactions/events: Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: COPD (diagnosed in 2010 or 2011)

ID: 1810491
Sex: F
Age:
State: PA

Vax Date: 09/29/2021
Onset Date: 10/07/2021
Rec V Date: 10/23/2021
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: 20211007; Test Name: heart beat; Result Unstructured Data: Test Result:Rapid; Comments: night

Allergies:

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

Symptoms: boil, hurts and big; Rapid heart beat that night; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 29Sep2021 12:00 (Batch/Lot Number: FF2588) at the age of 52 years old, as dose 2, single for covid-19 immunisation. Medical history included known allergies: latex. Concomitant medication(s) included iron taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: FF2587) administered in arm left on 08Sep2021 12:00. No other vaccine in four weeks. No COVID prior vaccination; not COVID tested post vaccination. Events started on 07Oct2021 12:00. The patient experienced rapid heartbeat that night (as reported). Unknown treatment for adverse event. Later (as reported), the patient started feeling a burning sensation on her middle back to later be a boil. She doesn't get boils and it hurts and was big. She was prescribed amoxicillin Events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events were recovering.

Other Meds: IRON

Current Illness:

ID: 1810492
Sex: F
Age:
State: NH

Vax Date: 08/10/2021
Onset Date:
Rec V Date: 10/23/2021
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: swollen lymph node in left arm pit; Hives on face and neck; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 10Aug2021 18:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation in a pharmacy or drug store. Medical history included asthma and known allergies to tree nuts. No covid prior to vaccination. There were no concomitant medications, no other vaccine in four weeks and no other medications in two weeks. On an unspecified date in 2021, the patient experienced swollen lymph node in left arm pit and hives on face and neck for 7 days after first the dose. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment included antibiotics. The patient recovered from the events in 2021. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810493
Sex: M
Age:
State: TN

Vax Date: 07/31/2021
Onset Date: 08/13/2021
Rec V Date: 10/23/2021
Hospital: Y

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: this all hit him really hard/had premature beats; heart rate skip a beat every other beat; had premature beats; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. Medical history included feelings of premature beats around the end of May2021 or first part of Jun2021. It might have started earlier, but he didn't know for sure. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 10Jul2021 as dose 1, single for COVID-19 immunization. It was reported the patient ended up in the hospital and had premature beats (also reported as heart rate skip a beat every other beat). On 13Aug2021, all these events hit him really hard and ended up in the hospital for overnight on 14Aug2021 (presumed). As of 22Sep2021, the premature beats and heart rate skip a beat every other beat were ongoing. The outcome of the events was not recovered at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1810494
Sex: M
Age:
State:

Vax Date: 06/15/2021
Onset Date: 06/01/2021
Rec V Date: 10/23/2021
Hospital: Y

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: 2021; Test Name: Ammonia level; Result Unstructured Data: Test Result:Very high; Comments: Levels of ammonia in liver were very high; Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 202106; Test Name: Scan; Result Unstructured Data: Test Result:Blood clot

Allergies:

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

Symptoms: Slipped on steps/fall; blood clot from pfizer shot or fall/had a clot on hip; Hip hurt; Delirium after surgery/unable to speak /did not even remember; hearing voices; Psoriasis came back all over back; Could not even touch the nose or rub the legs; Levels of ammonia in liver very high; This is solicited report. (manufacturer control number: 21K-163-3935590-00). A contactable consumer (patient) reported that a 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly on 15Jun2021 (vaccination age was 53 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate free (40 mg); subcutaneously from 2021 (Batch/Lot number was not reported) to 2021, at Citrate Free; subcutaneously from 2021 (Batch/Lot number was not reported) to an unspecified date, at Citrate Free, all for Plaque psoriasis. Medical history included smoked and he had quit now, Paranoid schizophrenia, psoriasis from an unknown date and ongoing. The patient's concomitant medications were not reported. On 15Jun2021, patient slipped on the steps and had the Pfizer shot at the same time. And in Jun2021, patient had blood clot in his hip. His hip hurt and it was unbearable. He had hip surgery for blood clot on his hip. After surgery he woke up with delirium in 2021 and was like that for about three weeks. He was unable to speak because of it. He did not even remember that he smoked and he had quit now because he did not remember he smoked. He was put in a nursing home and they drugged him and took him off his Humira. Now his psoriasis had come back all over his back. He was back home now and took one shot and his hands already looked better. When he was in the nursing home, they drugged him and he could not even touch his nose or rub his leg when the physician checked him. He was hearing voices and was sent to the hospital and they got him fixed up. Blood work was done and he put on the right medications. Physician took him off whatever psych medication they had put him on at the nursing home and he was all better. When he was in the nursing home on those psych medication, his levels of ammonia in his liver, were very high. They fixed him up at the hospital when he was sent there, then they sent him back to nursing home and within a week he could not talk anymore. He went back and they gave him the right medication again and checked all his levels. Now he was so much better and was at home. On 30Sep2021, the patient's sister called to report an issue with a Humira shipment they received. The patient's niece was the one present when the issue was encountered. When she opened the box, there was only one pen inside instead of two. Unspecified psych medications were considered as suspect. Seriousness criteria was provided as hospitalized and medical significant. The patient underwent lab tests and procedures which included Levels of ammonia in liver were very high in 2021, blood test: unknown results in 2021, scan: blood clot in Jun2021. The action taken in response to the event(s) for adalimumab was unknown. Treatment was received for blood clot, delirium and psoriasis had come back. The outcome of delirium after surgery, psoriasis came back all over back was not recovered. The outcome for other events was reported as recovering. The reporter's causality for the event(s) of Clot blood and Pain in hip to bnt162b2 was possible; the causality of other events to bnt162b2 was not provided. No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness: Plaque psoriasis

ID: 1810495
Sex: M
Age:
State: MI

Vax Date: 09/02/2021
Onset Date: 09/28/2021
Rec V Date: 10/23/2021
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: 20210511; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210928; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptom List: Pain in extremity

Symptoms: Vaccination Failure (28/Sep/2021, covid test result, Positive); covid test result, Positive; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable Consumer. This 52-year-old male Consumer reported for himself that: A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810) via unspecified route of administration in left arm on 02Sep2021 (at the age of 52-year-old) as dose 2, single for COVID-19 immunization. The patient other medical history: one. Patient don't have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination. Concomitant medication was not reported. The patient received other medications within 2 weeks of vaccination: Blood pressure (Other medications in two weeks: Blood pressure). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: El1283) via unspecified route of administration in left arm on 20Jan2021 as dose 1, single for COVID-19 immunization. On 28Sep2021 the patient experienced Drug ineffective, covid test result, positive and inappropriate schedule of vaccine administered. Patient reported on 01Mar2021 we are not sure, but all tests were negative triggering Lichen Planus triggering the loss of all my hand finger nails and feet fingernails. And all these were in Mar2021.Patient received treatment of steroid shots and outcome was not recovered. Patient underwent lab tests and procedures which included sars-cov-2 (Nasal Swab) test negative on 11May2021, sars-cov-2 (Nasal Swab) test positive on 28Sep2021. Patient received treatment for events. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1810496
Sex: F
Age:
State: CA

Vax Date: 09/07/2021
Onset Date: 09/10/2021
Rec V Date: 10/23/2021
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: 2021; Test Name: EKG; Result Unstructured Data: Test Result:extra heart beat; Test Date: 202101; Test Name: COVID-19; Test Result: Positive

Allergies:

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

Symptoms: small stroke; fluttering heart beat; myocarditis; pericarditis; fluttering heart beat and pounding heart; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Sep2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 (She had COVID in Jan2021) from Jan2021 to an unknown date. There were no concomitant medications. The patient previously received the first dose of BNT162B2, administered in left arm on 07Aug2021, was given (24-hour clock): afternoon (at the age of 74-years-old) for COVID-19 immunisation. The patient experienced a small stroke on 06Oct2021 at 01:00, fluttering heart beat and pounding heart, myocarditis and pericarditis on 10Sep2021. The clinical course was as follows: The patient reported getting her first Pfizer BioNtech covid 19 vaccine on 07Aug2021 and her second dose on 07Sep2021, was unsure if these are the exact dates. Three (3) days after her second dose she began experiencing a fluttering heart beat and pounding heart, this side effect is still occurring and getting worse. Two nights ago, on 06Oct2021 she experienced a small stroke. She was wondering whether myocarditis will go away and pericarditis or is she stuck with a bad heart, is this a long-term side effect? She was healthy before and she is active. She has sought medical care and has an upcoming appointment with a cardiologist. Caller hopes this department can answer her questions. Ever since getting the COVID vaccine she has a fluttering heart beat. It was further reported that the other night, she had a little stroke. Now her son told her she might have myocarditis. Will that go away or is she stuck with a bad heart? She would really like an answer from a Cardiologist, but her appointment isn't for a couple of weeks. She had COVID in Jan2021. She got the vaccine because she was forced to get it. She doesn't remember the exact dates of her vaccine. She thinks one might have been 07Aug2021 and the other 07Sep2021 or something like that. It was a couple days, 3 days later, after the second dose that she experienced the fluttering heart beat. If she had it after the first vaccine, she didn't notice it. She had a stroke on 06Oct2021 at 01:00 AM. She still has a fluttering heart beat, and it has worsened. She got the vaccine in her left arm both times. She asked the lady to give it lower because she read it could help prevent the shoulder issues like Bursitis, but the lady refused. she would listen to her. She knows this fluttering heart beat is due to the shot. The patient underwent lab tests and procedures which included electrocardiogram: extra heart beat on 2021 and SARS-COV-2 test: positive on Jan2021. The events resulted in Physician Office visit. The outcome of small stroke was unknown, while of the rest was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810497
Sex: F
Age:
State: CA

Vax Date: 10/06/2021
Onset Date:
Rec V Date: 10/23/2021
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: severe allergic reaction; face was swollen; tongue hurts; sore throat; difficulty breathing; swelling of face/throat; fast heart beat; rash all over body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) as single dose for immunization. The patient medical history and concomitant medications were not reported. She received the third shot of the Pfizer Covid 19 vaccine last Wednesday, 06Oct2021, the first dose, and she also had her flu shot; however, she experienced a severe allergic reaction. She wanted to know what needs to be done after experiencing this. It was still happening at the time of report. She stated she had been to the emergency room twice; she has spent about 4 hours there last night. She spent about 8 hours there and they have already told her there is nothing she can do. She noted she has been to the ER twice, received an epinephrine injection and was told that was all that could be done for her. Her face was swollen, tongue hurts, sore throat. She stated that she was experiencing almost every side effect on the list she is reading including severe ones. She experienced difficulty breathing, swelling of face/throat, fast heart beat and rash all over body. She explained she looked like a monster. The patient has not recovered from the events. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1810498
Sex: M
Age:
State: MO

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 10/23/2021
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: heart rate; Result Unstructured Data: Test Result:45 to 49; Comments: my heart rate is usually around 45 to 49, hardly ever over 60; Test Date: 202110; Test Name: heart rate; Result Unstructured Data: Test Result:158

Allergies:

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

Symptoms: Atrial Fibrillation; short of breath; chest pain when I tried to breathe; heart rate went to 158; very tired; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 27Sep2021 08:30 (Lot Number: fe3592), at the age of 75-years-old, as dose 3 (booster), single for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, back disorder from an unknown date and unknown if ongoing. No known allergies. The patient previously received first dose of bnt162b2, administered Arm Left, on 15Jan2021 04:30 PM (Batch/Lot No: ek4176), at the age of 75-years-old, for COVID-19 immunization and second dose of bnt162b2 administered Arm Left on 05Feb2021 08:30 AM (Batch/Lot No: ek4176), at the age of 75-years-old for COVID-19 immunization. The patient experienced atrial fibrillation on 05Oct2021 08:00; very tired on 28Sep2021; short of breath and chest pain when he tried to breathe on 02Oct2021; heart rate went to 158 in Oct2021. The clinical course was reported as follows: The day after 3 dose became, patient was very tired. He started to get short of breath about 4 days after dose. Then started having chest pain when he tried to breathe. On Tuesday a week and a day after 3 dose, her heart rate went to 158, he went to ER and was told he has Atrial Fibrillation and went home with prescribed medication. He works out on a regular basis. His heart rate is usually around 45 to 49, hardly ever over 60, two days after ER visit he felt much better and seemed to be back to normal. Not sure if related but was told by his doctor he might need to do something about his slow heartbeat, before this occurred. The events resulted in emergency room/department or urgent care. Treatment received for the adverse events which included an unspecified medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: 45 to 49 (heart rate is usually around 45 to 49, hardly ever over 60) on an unknown date and 158 in Oct2021. Therapeutic measures were taken as a result of atrial fibrillation, very tired, short of breath, chest pain when he tried to breathe and heart rate went to 158. The outcome of the events was recovered in Oct2021.

Other Meds:

Current Illness:

ID: 1810499
Sex: F
Age:
State: OR

Vax Date: 07/15/2021
Onset Date:
Rec V Date: 10/23/2021
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: blind; got her first dose on 15Jul2201 and was supposed to have her second dose on 25Aug2021 but she never made it; The initial case was missing the following minimum criteria: medical information only. Upon receipt of follow-up information on 08Oct2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on 15Jul2021 (Lot Number: FD8448; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunization. Medical history included ongoing lupus from an unknown date. The patient's concomitant medications were not reported. The patient got her first dose on 15Jul2201 and was supposed to have her second dose on 25Aug2021 but she never made it. The patient then applied for a job and she is supposed to get both shots, she wanted to know if she should just go to the same place that she got her first one, or what should she do. During the call the patient was reading information from the card and stated that she needs a flashlight because she is blind. The outcome of the event was unknown.

Other Meds:

Current Illness: Lupus erythematosus systemic

ID: 1810500
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:erratic (jumped up and down)

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Sjogren's reacted; Sjogren's reacted, asthma kicked in; headache; rash; nodule; dizziness; blood pressure erratic (jumped up and down); asthma; nausea; had trouble with the left eye/very blurred; had trouble with the left eye/very painful; This is a spontaneous report from a contactable consumer (patient) reported for self. A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included bilateral hearing loss, having a little bit of trouble hearing, autoimmune disorder, 5 autoimmune diseases, asthma, heart, sjogren's disease all from an unknown date and unknown if ongoing. Concomitant medications included rheumatology drugs. Historical vaccine included NT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization and MMR Immunization and has no immunity. The patient experienced Sjogren's reacted, and asthma kicked in, difficulty hearing, headache, rash, nodule, dizziness, blood pressure erratic (jumped up and down), asthma, had trouble with the left eye/very blurred, had trouble with the left eye/very painful and nausea all on an unspecified date. The seriousness of the events was not reported. It was reported that patient has sjogren's disease and after the vaccine she had trouble with the left eye: very painful and got very blurred after vaccine 2 blurriness lasted for over 7 days. Sjogren's reacted" because of her underlying conditions she needs to get a booster dose because they do not know how long her immunity may last or how much immunity she has due to her condition. The outcome of the events had trouble with the left eye/very painful/very blurred were recovered on an unknown date in 2021 and it was unknown for other events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810501
Sex: F
Age:
State: ND

Vax Date: 02/20/2021
Onset Date: 02/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Test Date: 2021; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown result; Test Date: 2021; Test Name: D Dimer test; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: blood clots and lung clots; blood clots and lung clots; severe pain in the right arm; Numbness; short of breath walking; Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) via an unspecified route of administration in the right arm on 20Feb2021 as single dose for COVID-19 immunization. Medical history included Acid Reflux, allergic to Penicillin's, Sulfa, Wasp and Bee strings. Concomitant medications were unknown. The patient was reporting on having blood clots after receiving the Pfizer-BioNTech COVID-19 Vaccine. She had been on the ER. She had also been prescribed Eliquis. The patient received apixaban (ELIQUIS, tablet, strength: 5 mg, lot number: 1796053, expiration date: Sep2023) oral from Mar2021 at 5 mg twice a day for blood clots. The patient was asking for compensation and was given with the Legal Team's address. She wanted to know statistical information on how often blood clots happen after receiving the vaccine and if this was a common side effect. The patient wanted to know details about the side effects of the Pfizer-BioNTech COVID-19 Vaccine, specifically what was fatigue. The patient had the Pfizer covid BioNtech vaccine last year and developed blood clots. She was put on Eliquis. The doctor then took her off Eliquis saying she didn't need it anymore. When she was off of Eliquis she developed clots again and so she was put on Eliquis again. The patient stated that she worked in a healthcare setting before but she was retired. The patient stated that she had reported it to VAERS. During the call she also said that with Eliquis she had been paying a lot out of pocket, and she had been to the ER a couple times and would like compensation. The patient complained that the help for Eliquis was all based on income, they made too much and would not qualify for it, this was one more hurdle she guesses. The patient stated that she had only gotten the first dose of the Pfizer covid vaccine, and she was instructed to not get it anymore. The blood clot began about 2-4 days on Feb2021 after getting the first dose. Initially she had trouble with her leg, but she never expected a blood clot, she had babied it forever, she was thinking to herself how did she pull a muscle and not know. She had elevated the leg. Finally she was at a (withheld) one day and she picked something up and her lower calf felt like big jello just jumped above into the knee into the upper part of the leg and thigh. It was so painful, and she was in the middle of this at withheld. The patient clarified stating that she needed to back up a bit. It was in the lower calf, she didn't know when but she got severe pain in the right arm, and it went numb for a bit but then it went away into the shoulder, back and neck area it was aching. She was still making excuses telling herself maybe she was sitting in the recliner and her head was getting tilted not thinking that it was a blood clot. The clot jumped from the lower leg into the upper leg, luckily she made it home, and that's when they thought it was a clot and said she has got to go to the ER. She went to ER, the doctor there did a scan, they did scans all over, she was there for 5 hours, and they were about to discharge her home but that's when the finally the report from the scans came and that's when they told her she absolutely had a blood clot. The next day, she was short of breath walking from her bedroom to the chair, and so they went back to the ER and told her she had bilateral clots in the lungs confirming that when she went to ER again it was a pulmonary embolism. She then went for blood work follow up. She told her Primary care and brought all her records and primary Care said to stay on Eliquis. She then went to a doctor that did vein work, Dr (withheld) said that he thought the D Dimer test wasn't spiking any more and since there's no family history of clots and since it's more harmful than a benefit to stay on Eliquis he told her to stop the Eliquis. In 10 days she was back with blood clot and lung clots Feb2021. Now today that vein doctor, sent her to her primary care, the patient stated that she will ask her if she can see a hematologist. Next week she will see the Vein doctor again, because he said he wanted to scan the leg again. She called her insurance because she thought back on the Eliquis since Mar2021, she had all these appointments of this illness, and test. The patient stated that she was seen in a clinic, it all started at a clinic, they were the people that initially saw her, when she went to the ER first. The patient clarified that she had only made ER visits in which she would be at the hospital for 5 hours or so, but she was never admitted to the hospital. She was just at the facility 5 hours each time. Eliquis was started in Mar2021 when she first went to the ER. The covid vaccine was given in the right arm and the Right leg was where she had the problem to start with. She was very healthy, she swam and walked. With this blood thinner she didn't know if being on this forever will change what she can do, she didn't want an injury. The patient had had a lot of blood work and CT scans. Prior to ending the call, caller states that she would like to be reimbursed for medical procedure, tests, appointment, her insurance, and Eliquis. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1810502
Sex: F
Age:
State:

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 10/23/2021
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: chills; burning up with fever; burning up with fever; weak; shaking; life is at stake here; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Feb2021 as single dose for Covid-19 immunization. Medical history included an autoimmune condition and was severely immunocompromised. Concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 on 24Jan2021 as single dose for Covid-19 immunization. The patient received first shot of pfizer covid vaccine on 24Jan and was ok. The patient had second shot on 11Feb2021 and then next day on 12Feb2021 burning up with fever, weak, chills and was shaking for several days. Added she was weak for days. The patient stated she received the flu shot on Sep29 and was told by the pharmacist she should wait at least 7 days after the flu shot before getting the booster. She had an autoimmune condition and was severely immunocompromised. She was bald because of her autoimmune condition. She was concerned about reacting to covid vaccine again. She had lots of underlying medical conditions. The patient was asking how long should she wait after receiving the flu shot before getting booster dose. The patient heard that if get sick after covid vaccine it means it is working. wanting more information. The patient had the 1st vaccine, on the 2nd one, she was sick for 4 days, fever, chills, shaking, weak couldn't even stand up by herself. Her life was at stake here in 2021. She lived alone so, she need to talk to somebody about Pfizer. Outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810503
Sex: M
Age:
State: FL

Vax Date: 09/21/2021
Onset Date: 09/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: Temprature; Result Unstructured Data: Test Result:97 degrees; Test Name: Stress test; Result Unstructured Data: Test Result:he experienced Angina like someone was wringing ou; Comments: he experienced Angina like someone was wringing out a rag in his chest; Test Name: Sonogram; Result Unstructured Data: Test Result:that his kidneys were inflamed.; Comments: that his kidneys were inflamed.

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Petechiae; profusely sweating with no fever; severe headache; fell to the floor; his legs gave out and have been giving him trouble ever since; Angina like someone was wringing out a rag in his chest; kidneys were inflamed; It's hard to get in and out of a car and "the water was pouring our of me like a sprinkler system but I had no fever; back is still swollen; so painful; wasn't able to walk; red dots; kidney swelling; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received the 2nd dose of BNT162B2 (COMIRNATY, lot number: 301308A) via an unspecified route of administration in the left arm on 21Sep2021 in the morning at age of 58 years old as single dose for COVID-19 immunization. Medical history included diagnosed allergies, allergic to chocolate, ongoing rheumatoid arthritis, aneurysm, over active immune system/compromised immune status, allergic to statins, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient reported that his throat closed up and he had to have an Epi pen in his neck. Last occurrence several years ago. Afterwards it made him allergic to chocolate because now his throat closes after eating chocolate. Concomitant medications were unknown. No prior Vaccinations (within 4 weeks). The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FC3184) via an unspecified route of administration in the left arm on 03Aug2021 as single dose for COVID-19 immunization. The patient was asking, how long his side effects will last, and if there was any common ingredient between the Pfizer Covid vaccine and Statin drugs. The patient had his Pfizer vaccine 2 weeks ago. After his second dose, that same night he tried to get off of the sofa when he fell to the floor, his legs gave out on 21Sep2021 and had been giving him trouble ever since. The patient reported "It's hard to get in and out of a car" and "the water was pouring our of me like a sprinkler system but I had no fever". The patient reported that he didn't have any of the regular common side effects. He went on to report that, "My left leg does not want to cooperate with the right, the coordination is off. It's really horrendous what is going on. I don't know if it will affect me for life. My back is still swollen, I don't know what to do, it's so painful you can't even imagine". The patient stated, "The CDC was no help. They called me a week and a half later and said that if I had had a prednisone shot within 24 hours of this interaction it would have counteracted the shot. I don't trust them anymore". The patient was also scheduled for a Stress test on Tuesday because he experienced Angina like someone was wringing out a rag in his chest. He also had a Sonogram on his kidneys and was told that his kidneys were inflamed. The patient went on to report that he went to his dentist, and told her what had happened to him, when she said that her girlfriends mother who was 69 yo, had the same thing happen to her. She took the Pfizer Covid vaccine and that night she went to go to bed and fell to the floor. They rushed her to the hospital and 3 days later she caught covid in the hospital after taking the Pfizer shot. The patient reported that he thought there should have been a lot more testing done on all of the vaccines before they came out, "if I had known this I would have never gotten it. And now they recommend a third, there is no way in hell I would take a third". The patient reported that he heard on the news that the vaccine only provides 2 months of protection. He did have a case with the CDC. He and his doctor contacted the CDC. They have done numerous tests at one point, they believed it may have been kidney swelling, or the muscle in his body, or his nerves. The second dose also triggered angina in his heart. It started the same night, and lasted for about 3 days. He was profusely sweating with no fever for about 3 days as well. He had a severe headache on 21Sep2021. He thought his head was going to burst. He still has a headache every now and then. They have continued, but improved from the first one. He had an aneurysm in the left side of his head so he got really nervous and kept calling. He had the aneurysm before the vaccine. He had no rash. He didn't have any of the common side effects. He didn't have a fever, flu like symptoms, no rash, no swelling, and his arm didn't hurt. He wasn't able to walk for two weeks. He was still going through therapy for the swelling in his back. He wanted to know what was in the shot because the CDC won't tell him. Nobody was giving him answers. He didn't have a prescribing doctor. It was after his COVID vaccine second shot. His right leg had improved some, but his left had not. At first both sides of his legs wouldn't move. They had been working on his legs in therapy. They had the swelling in the right side down. The left side still had swelling. It was like his left leg didn't want to coordinated with his right leg. There was like water pouring out of his body, but his temperature was only 97 degrees. He also had petechiae all over his body on 21Sep2021. That started the next day. They were little red dots. He still has them, but they were fading. He has an over active immune system because he has rheumatoid arthritis. AE(s) did not require a visit to Emergency Room or Physician Office. The patient called the doctor who sent him for tests. The doctor wanted him to go to the ER, but he wouldn't. Outcome of the events Angina like someone was wringing out a rag in his chest, profusely sweating with no fever was recovered on Sep2021, of the events "his legs gave out and have been giving him trouble ever since", "severe headache" was recovering, of the other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1810504
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID; a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID; This is a spontaneous report from a contactable physician from a Pfizer sponsored Program. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Batch/Lot number was not reported) on an unspecified date as dose 1, single and on an unspecified date as dose 2, single both via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporting physician wants to know if it was unusual for a patient having two vaccines to get COVID. The physician wants to know how common it is for a person who has two vaccines to get a COVID infection. The physician reported that they have a patient who received both doses of the Pfizer COVID vaccine and then came down with COVID. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am