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: 1811973
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
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: joint pain bilateral arms, hands and hip; swelling of glands under left arm; Left shoulder frozen; This is a spontaneous report from a non-contactable nurse, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021, post injection, the patient experienced joint pain bilateral arms, hands and hip, swelling of glands under left arm and left shoulder frozen and ongoing pain was 8/10 past the 4 week. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events joint pain bilateral arms, hands and hip, swelling of glands under left arm and left shoulder frozen was not resolved at the time of this 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: 1811974
Sex: F
Age:
State: MA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
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: Test Date: 20210414; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: Nasal swab

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Face/cheek swelling.; Cheeks and mouth/teeth felt numb / Teeth felt like after dental anasthetic; Cheeks and mouth/teeth felt tingly; Flushing appearance; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and known allergies to pomegranate. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mepyramine maleate, pamabrom, paracetamol (PAMPRIN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levofloxacin (LEVAQUIN) and experienced drug allergy. On 08Apr2021 at 10:45, the patient experienced face/cheek swelling and no swelling of lips. The swelling and flush appearance/feeling progressed over 3 hours then subsided. Cheeks and mouth/teeth felt numb, tingly and teeth felt like after dental anesthetic. On 14Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events face/cheek swelling, flush appearance and mouth/teeth felt numb, tingly and teeth felt like after dental anesthetic was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: PAMPRIN

Current Illness:

ID: 1811975
Sex: F
Age:
State: OH

Vax Date: 04/07/2021
Onset Date: 04/08/2021
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: 20210412; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Chills; Night sweats; bodyaches; Fatigue; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 07Apr2021 at 16:15(at the age of 59-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 16:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 10:00, the patient experienced chills, night sweats, body aches, fatigue and low grade fever. On 12Apr2021, the patient underwent SARS-CoV-2 test and the result was negative. The patient also underwent unspecified tests on an unknown date. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which include treatment with NSAIDs. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, night sweats, body aches, fatigue and low grade fever were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811976
Sex: F
Age:
State: PA

Vax Date: 04/02/2021
Onset Date: 04/01/2021
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:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: little bit tired; besides just sore site injection and little bit tired; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: ER8734; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm (Anatomical site of administration: patient stated, the upper left arm) on 02Apr2021 (Age at vaccination: 50-year-old) as DOSE 1, SINGLE for COVID-19 immunization at Rite Aid; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication (taken Ibuprofen after but nothing). The patient medical and concomitant medication history were report-ed. It was reported that patient not on any medication. In Apr2021, it was reported that, patient did not have any side effect on the first shot, besides just sore site injection and little bit tired. Patient was little worried that this was like permanent thing that patient have to deal with now. The event was not treated. The outcome of the event was unknown. No follow up attempts are needed. No further information expected.

Other Meds:

Current Illness:

ID: 1811977
Sex: F
Age:
State: IN

Vax Date: 04/13/2021
Onset Date: 04/23/2021
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: Metallic taste; Metallic smell; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Apr2021 at 17:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, prior to the vaccination. The patient did not have any known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6955) via an unspecified route of administration in the right arm on 23Mar2021 at 17:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced metallic taste and metallic smell which was ongoing for 4 days. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event metallic taste and metallic smell was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811978
Sex: F
Age:
State: PA

Vax Date: 04/08/2021
Onset Date: 04/09/2021
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: Right arm injection site became swollen (golf ball size), warm and red, painful.; Right arm injection site became swollen (golf ball size), warm and red, painful.; Right arm injection site became swollen (golf ball size), warm and red, painful.; Right arm injection site became swollen (golf ball size), warm and red, painful.; As of 04/26/2021 still feeling discomfort.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 08Apr2021 at 19:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Sjogren's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included daily multivitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received naproxen sodium (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 09Apr2021 at 18:00, the patient's right arm injection site became swollen (golf ball size), warm and red, painful. As of 26Apr2021 still felt discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm injection site became swollen (golf ball size), warm and red, painful and as of 26Apr2021 still felt discomfort was resolved with sequelae on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811979
Sex: M
Age:
State:

Vax Date: 04/19/2021
Onset Date: 04/25/2021
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: Pain on backside of leg. NOT JOINT but as sciatic nerve leg pain.; Anxiety; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 29Mar2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 11:00, the patient experienced pain on backside of leg. It was not joint but as sciatic nerve leg pain. On 25Apr2021 at 11:00 the patient also experienced anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain on backside of leg; not joint but as sciatic nerve leg pain and anxiety was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1811980
Sex: F
Age:
State: CO

Vax Date: 04/22/2021
Onset Date: 04/23/2021
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:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Vaginal pain on labia, not cramping; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 22Apr2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID); all for an unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 29Mar2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 01:00, the patient experienced vaginal pain on labia, not cramping. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal pain on labia, not cramping was resolved on an unknown date in Apr2021. No follow-up attempts are possible. No further information is expected.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MONTELUKAST; ARMOUR THYROID

Current Illness:

ID: 1811981
Sex: F
Age:
State: CA

Vax Date: 04/21/2021
Onset Date: 04/23/2021
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: 20210318; Test Name: Abbot; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Rash similar to hives started on April 23 and have continued to date. The rash is itchy and hasnt responded to allergy medications.; The rash is itchy and hasnt responded to allergy medications.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 21Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ursodeoxycholic acid (URSODIOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 29Mar2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 18Mar2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 23Apr2021 at 08:00, the patient experienced rash which was similar to hives and had continued to date. The rash was itchy and was not responded to allergy medications. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with allergy medications. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events rash similar to hives and rash was itchy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: URSODIOL

Current Illness:

ID: 1811982
Sex: F
Age:
State: CA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
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: In the evening the day "I" received the vaccine "I" felt itchy all over "my" body; Since then, "my" neck continues to be itchy and "I" have developed a rash; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included abdominal adhesions and related pain, and allergy to avocado. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medication. On 08Apr2021 at 17:00, in the evening of the day of vaccination, the patient had felt itchy all over her body. Since then, her neck continued to be itchy and she developed a rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt itchy all over body; since then, neck continued to be itchy and developed a rash was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811983
Sex: F
Age:
State: MN

Vax Date: 04/19/2021
Onset Date: 04/19/2021
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: Test Date: 20210419; Test Name: Body temperature; Result Unstructured Data: Test Result:101 fever

Allergies:

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

Symptoms: Facial flushing within 15 minutes, went away after 30 minutes.; Facial puffiness within 15 minutes, went away after 30 minutes.; Arm got swollen later in the day; Arm got swollen and very warm later in the day; itchy later in the day; Experienced Fatigue off and on for 6 days after; Experienced brain fog off and on for 6 days after; Experienced 101 fever off and on 6 days after; temporary loss of taste off and on for 6 days after; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, high blood pressure, allergies to diary and sulfa. It was unknown, whether the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received amoxicillin/ clavulanic acid (AUGMENTIN) for an unknown indication on an unknown date and experienced drug allergy. On 19Apr2021 at 13:45 within 15 minutes, the patient experienced facial flushing and puffiness which went away after 30 minutes. Arm got swollen, very warm and itchy later in the day. On the same day, the patient also experienced fatigue, brain fog, 101 fever and temporary loss of taste off and on for 6 days after. On 19Apr2021, the patient underwent lab tests and procedures which included body temperature test and the result was found to be 101 (unspecified units). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events facial flushing, puffiness within 15 minutes were recovered on an unknown date in Apr2021 after 30 minutes, while the events fatigue, brain fog, 101 fever and temporary loss of taste off and on were recovered on an unknown date in Apr2021 after 6 days and the events arm got swollen, very warm and itchy later in the day were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811984
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date: 04/23/2021
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: Painful lymph node; Painful lymph node swelling in collarbone on side of injection site; Also fatigued; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 16Apr2021 at 16:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 23Apr2021 at 12:00 the patient experienced painful lymph node swelling in collarbone on side of injection site, also fatigued. All occurred 1 week after first dose. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful lymph node swelling in collarbone on side of injection site, also fatigued were not resolved at the time of this 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: 1811985
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date: 03/12/2021
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: 20210323; Test Name: COVID test; Test Result: Negative

Allergies:

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

Symptoms: Shaky; Cold; Clammy; Sore neck muscles; Joint pain; Couldnt sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 at 21:30, the patient experienced shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep and all lasted for about 5 hours. On 23Mar2021, the patient underwent COVID-19 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shaky, cold, clammy, sore neck muscles, joint pain and couldn't sleep was resolved on13Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1811986
Sex: M
Age:
State: WA

Vax Date: 04/06/2021
Onset Date: 04/08/2021
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: Skin rash; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 06Apr2021 at 15:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included type ii diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Apr2021, the patient experienced skin rash and itchy from 2 days after the shot for about 10 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event itchy and included treatment with unspecified anti-itchy skin medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events skin rash and itchy was resolved on 18Apr2021, after the duration of 10 days. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811987
Sex: M
Age:
State: NJ

Vax Date: 04/18/2021
Onset Date: 04/22/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Diarrhea; Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer in 2015. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 22Apr2021, the patient experienced diarrhea and severe tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and severe tinnitus was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811988
Sex: F
Age:
State:

Vax Date: 04/05/2021
Onset Date: 04/16/2021
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:

Allergies:

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

Symptoms: Period a week late; Abnormally heavy bleeding; Cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on the left arm on 05Apr2021 at 14:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported for the patient. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications were not reported for the patient. On 16Apr2021, the patient experienced period a week late, abnormally heavy bleeding and cramping. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period a week late, abnormally heavy bleeding and cramping was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1811989
Sex: M
Age:
State: CA

Vax Date: 04/21/2021
Onset Date: 04/21/2021
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: Diarrhea; Pfizer Covid Vaccine Dose and Moderna Covid Vaccine Dose both administered on the same day, 21APR2021.; This is a spontaneous report from a contactable other healthcare professional. A contactable other healthcare professional (Pharmacy technician calling on behalf of the pharmacist) reported for a 38-year-old male patient that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0161, Expiry date: 26May2021) via an unspecified route of administration on 21Apr2021 at 19:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 21Apr2021 at 19:30 (Lot number was not reported, Batch number: 002C21A, Expiry date: 14Oct2021) to 21Apr2021 19:30, at dose 1, single for covid-19 immunisation (NDC# 80777027399). The patient medical history was not reported. Concomitant medications included gabapentin (GABAPENTIN) and pramipexole (PRAMIPEXOLE) taken for unspecified indications, start and stop dates were not reported. On 21Apr2021, the patient experienced diarrhea and Pfizer covid vaccine dose and Moderna covid vaccine dose both administered on the same day, 21Apr2021. No investigation assessment. No treatments. Caller states they had an instance where a patient received a dose of the Pfizer vaccine and Moderna vaccine dose on the same day and enquired if there were any adverse reactions to look for or any steps they need to take. No history of previous immunization with the Pfizer vaccine considered as suspect. States he may have gone to the doctors office because he needed refills for his medication but she was unsure. No ER or physician office visit. Additional vaccines administered on same date of the Pfizer suspect was Moderna Covid Vaccine. No prior vaccinations (within 4 weeks). He did mark he had a reaction to vaccines before, nothing specific, just checked yes. Outcome was resolved on 22Apr2021 for event diarrhea and was unknown for the other event. The action taken in response to the events for covid-19 vaccine mrna (mrna 1273) was not applicable. No follow up attempt are possible. No further Information is expected.

Other Meds: GABAPENTIN; PRAMIPEXOLE

Current Illness:

ID: 1811990
Sex: F
Age:
State: FL

Vax Date: 04/21/2021
Onset Date: 04/24/2021
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: A protuberance around ''my'' left clavicle bone. Can move it up and down the clavicle, feels like a nodule; Not actively painful but a bit of soreness; This is a spontaneous report from a contactable pharmacist, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies (NKA). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in left arm on 31Mar2021 at 08:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 08:00, the patient experienced a protuberance around left clavicle bone, could move it up and down the clavicle, felt like a nodule, not actively painful but a bit of soreness. She noticed when showering Saturday on 24Apr2021 morning and today Monday 26Apr2021 still had it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events a protuberance around left clavicle bone and bit of soreness was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: ATORVASTATIN

Current Illness:

ID: 1811991
Sex: F
Age:
State:

Vax Date: 04/12/2021
Onset Date: 04/13/2021
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: Soreness at injection site; Gastrointestinal discomfort; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 13Apr2021, after vaccination the patient experienced soreness at injection site and gastrointestinal discomfort. The patient feeling much better 36 hours after the shot than before the shot, including resolution of symptoms from a prior COVID-19 infection, shortness of breath, lethargy, and brain fog that had been lingering for months prior to the vaccination. It was unknown if patient received treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. It was unknown if the patient been tested for COVID-19 since the vaccination. The clinical outcome of the events soreness at injection site and gastrointestinal discomfort was resolved on an unknown date of Apr2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811992
Sex: F
Age:
State: PA

Vax Date: 03/31/2021
Onset Date: 04/22/2021
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:

Allergies:

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

Symptoms: Headaches; Swollen under left arm; Hot and cold feeling; Menstrual cycle came back on after going off just before the injection; Pain/ Throbbing pain under my arm; fatigued; I couldn't concentrate; I was moving in slow motion, and tripping over my feet; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) in the left arm on 31Mar2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medications included unspecified multivitamins for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021, the patient experienced headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back on after going off just before the injection. Every evening around 02:00, she also experienced pain, such as headache and throbbing pain under arm, gary fatigued and really could not concentrate and seemed like she was moving in slow motion and tripping over her feet. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back, throbbing pain under arm, gary fatigued, could not concentrate, seemed like she was moving in slow motion and tripping over her feet was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) in the left arm on 28Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811993
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 04/22/2021
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: Warm sensation in right hip / Feels like someone pressing very warm iron to right buttock.; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 22Apr2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, sickle cell disease and iodine allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took codeine phosphate (CODEIN) and sulfur (MANUFACTURER UNKNOWN); both for unknown indication on an unknown date and experienced drug allergy. On 22Apr2021 at 11:30, the patient experienced warm sensation in right hip that began half an hour after vaccination. The sensation was intermittent throughout day, worse at night and felt like someone pressing very warm iron to the right buttock. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event warm sensation in right hip was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811994
Sex: M
Age:
State: TX

Vax Date: 05/01/2021
Onset Date: 05/02/2021
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: Unevaluable event

Symptoms: left side of the chest between the left arm and under the armpit really swollen and it hurts; left side of the chest between the left arm and under the armpit really swollen and it hurts; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male adult patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, administered in left arm on 01May2021 at 04:30 PM (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation at other facility. Medical history included high triglycerides from an unknown date and unknown if ongoing. Concomitant medications were not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. He did not receive any other vaccine in 4 weeks. The patient previously took first dose of BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number was not reported) via unspecified route of administration in arm left on 10Apr2021 at 01:00 PM (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation at other facility. On 02May2021 at 08:30 PM, the patient experienced left side of the chest between the left arm and under the armpit really swollen and it hurts, left side of the chest between the left arm and under the armpit really swollen and it hurts. Still the patient do not know what to do, and asking for visit emergency room. No therapeutic measures were taken as a result of adverse events. Outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot been obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811995
Sex: F
Age:
State: MN

Vax Date: 04/26/2021
Onset Date: 04/27/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Heavy menstrual bleeding, lasting over 6 days. I have Mirena IUD. Sore throat.; Sore throat; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 as a single dose for COVID-19 immunisation. Medical history included embedded intra uterine device (Mirena IUD). The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, the patient experienced heavy menstrual bleeding, lasting over 6 days and also experienced sore throat. Therapeutic measures included treatment with ibuprofen, taken as a result of the events, heavy menstrual bleeding and sore throat. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat and heavy menstrual bleeding were recovering at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811997
Sex: M
Age:
State: ME

Vax Date: 04/29/2021
Onset Date: 05/03/2021
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: Woke up last night sheets wet (sweats)/awakening both symptoms very pronounced; Hoarse voice/awakening both symptoms verypronounced; Hoarse voice (throat irritatation); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 29Apr2021 at 09:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension at times. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sildenafil citrate (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 09:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 02:00, the patient woke up with night sheets wet (sweats) and hoarse voice (throat irritation) and that morning upon awakening both symptoms were very pronounced. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, woke up with night sheets wet (sweats) and hoarse voice (throat irritation) that morning upon awakening both symptoms very pronounced was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: SILDENAFIL CITRATE

Current Illness:

ID: 1811998
Sex: F
Age:
State: MA

Vax Date: 04/30/2021
Onset Date: 05/02/2021
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: Swollen left armpit; tender left armpit; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm left on 30Apr2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and known allergy to yellowjackets (allergy to arthropod bite). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 09Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 07:00, the patient experienced swollen and tender left armpit. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and tender left armpit was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1811999
Sex: F
Age:
State: MD

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Full body rash; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history includes auto-immune disease and hypercoagulation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN) and hydrochloride; all from an unknown date for an unknown indication and unknown if ongoing. On 29Apr2021, the patient experienced full body rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of full body rash which included treatment with diphenhydramine hydrochloride (BENADRYL) and cortisone cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event full body rash was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE; VENLAFAXINE

Current Illness:

ID: 1812000
Sex: F
Age:
State: NY

Vax Date: 04/29/2021
Onset Date: 04/29/2021
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: she came out with a rash in the upper chest, on the collar bone area near neck and and on her back; it was itching; pain in right arm at injection site; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 40-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered in right arm on 29Apr2021 at 11:30 (at the age of 40-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history reported as none. Family medical history was none. The patient's concomitant medications were not reported. She did not receive any prior vaccine (within 4 weeks) and not received any other vaccinations within four weeks prior to the first administration date of the suspect. On 29Apr2021, there was pain in right arm at injection site. She had the first shot of Pfizer Covid-19 vaccine on Thursday morning and yesterday at mid-afternoon on 02May2021, she came out with a rash in the upper chest, on the collar bone area near neck and on her back, it was a small rash at night it was itching. The events did not result in emergency room or physician office. Outcome of the event pain in right arm at injection site was recovered on 30Apr2021, for itching it was unknown and for a small rash in the front near her neck and on the back, it was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812001
Sex: M
Age:
State: CT

Vax Date: 04/19/2021
Onset Date: 04/01/2021
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: RA

Lab Data: Test Date: 202104; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: other 2 tests on Thursday or Friday (same week after second dose) and the results were negative.; Test Date: 20210421; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: he did a test (Tuesday 10:00AM) and it was negative

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: barely walk; had joint pain; headache; pain in his while body (like a horrible flu); no taste or smell; no taste or smell; some cough; he feels very weak, has cold sweat all the time and some cough; still has joint pain and in his bottom part is worse (leg).; he feels very weak, has cold sweat all the time and some cough; he still has sweat, still has pain in his body, weak, no energy; for 2 or 3 weeks not he is not feeling well; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 19Apr2021 at 17:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included allergies and asthma. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. After the second dose on 19Apr2021, the next morning on 20Apr2021, he got up and had a bagel with cream cheese for breakfast with his husband, his husband told him that the cream cheese was sour but he couldnt taste that. He went to work and took a coffee and didnt have taste, it was like water, he had no taste or smell. Next day (on 21Apr2021) he went to the doctor to see what was going on if he had Covid-19 and he did a test (Tuesday 10:00AM) and it was negative (the smell and taste came back on Saturday). Next day on 22Apr2021 (Wednesday) he could barely walk, had joint pain, headache and pain in his while body (like a horrible flu). The pain in his leg started after the first dose, however after the second dose the pain was worse and it had been almost 3 weeks (unknown date in Apr2021). On Saturday and Sunday he felt better but he still had joint pain and in his bottom part is worse (leg) (unknown date in Apr2021). Patient also mentioned that he felt very weak, has cold sweat all the time and some cough (unknown date in Apr2021) (but he immune system problems: asthma and allergies so that could be the reason). Caller received other 2 tests on Thursday or Friday (same week after second dose) and the results were negative. Patient wanted to know what was going on, if the vaccine could have triggered something in his body. He said he had the Pfizer vaccine for coronavirus and he did not remember when he had his first shot but he remembers his second shot. He said he was in the worst pain ever. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Apr2021 at 10:00, sars-cov-2 test: negative on Apr2021 other 2 tests on Thursday or Friday (same week after second dose) and the results were negative. The outcome of joint was not recovered, no taste or smell was recovered on an unknown date in Apr2021 and outcome for all the other events was unknown. No follow-up attempts needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812002
Sex: F
Age:
State: PA

Vax Date: 04/29/2021
Onset Date: 04/29/2021
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: hives worsened; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on 29Apr2021 (at the age of 63-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she received the first dose of the Pfizer covid 19 vaccine 29Apr2021 in the late evening (as reported on Thursday). Caller stated that after the shot she noticed different things going on. Caller reiterated that after the shot things started happening and things started intensifying. Caller stated she has hives on 29Apr2021. She mentioned she started to get the hives right after getting the shot and she let the nurse know when she got it while sitting there. She was given Benadryl, but she still experienced the hives for some reason. She was looked at and was informed she would be fine. However, a couple of days have gone by, and things were progressively worse. Her whole back, back of her neck and face have broken out. It does not look right. She felt the hives, but it was intensifying now. Caller did not have full HCP details to provide. While capturing HCP Details caller mentioned her son was calling and asked for us to hold. Caller stated she did yard work earlier in the week. Caller stated this shot was given by the state. Caller asked who was going to pay for the adverse reactions, as she was unemployed and wanted to know how a person that was unemployed and had side effects how was that handled. Caller asked if she was to go see her doctor. Therapeutic measures were taken as a result of hives with Benadryl. At the time of this report, the outcome of event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812003
Sex: F
Age:
State: CA

Vax Date: 04/28/2021
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: RA

Lab Data: Test Date: 2021; Test Name: Fever; Result Unstructured Data: Test Result:102.5 Centigrade

Allergies:

Symptom List: Nausea

Symptoms: Fever/I am running like 102.5 fever and it's keeps going up; swollen lymph gland; Fatigue; Nausea; Muscle ache; Headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient herself) via a Pfizer sponsored Program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was unknown), via an unspecified route of administration on 28Apr2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was unknown), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, the patient got the 2nd dose yesterday (on 28Apr2021). Stated that, she feels a high fever after she took the 2nd dose. Stated that, she took Tylenol an hour ago. The consumer stated that, she had the second Pfizer shot yesterday and right now she was running like 102.5 fever and it's keeps going up on an unspecified date in 2021 and she didn't know whether that's normal on a point she need to, like whether she had to go hospital or not but she didn't know whether it was normal or not. Stated that, she had been trying to find information but she couldn't find anything. Enquired, was that normal or not. When paraphrased, the consumer stated that, she was trying to understand was that normal or at what point did she had to go to the hospital. Stated that, she was alone, so she did not really had a way to go the hospital. Always been like an ambulance or something. Stated that, she did not know whether that was normal. Stated that, she was just trying to find out. She have had every symptom. Stated that, on an unspecified date in 2021, she had swollen lymph gland, fatigue, nausea, muscle ache, headache, fever you name it. Stated that, she have had everything. So, it was really bad. Stated that, she was informed about the role of Pfizer Drug Safety and Medical Information Department for the concern and was provided with the contact# for Pfizer Medical Information. The consumer later stated that, she would better call them because she just did not know what to do. Stated that, she did not know how high the fever actually gets before she needs to go to the hospital. The consumer stated that, she can't really read Lot number, it looks like EW0176, she thinks so. Stated that, the consumer confirmed it was the Pfizer Covid19 vaccine. As consumer was not sure about the lot number hence it was not captured in the tab. The consumer was unwilling to complete the report. The reporter seriousness for the events was reported as unspecified. Therapeutic measures were taken as a Tylenol an hour for fever. On an unspecified date in 2021, the patient underwent lab tests and procedures which included fever, (body temperature increased), resulted as 102.5 Centigrade. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812004
Sex: F
Age:
State:

Vax Date: 04/20/2021
Onset Date: 04/01/2021
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:

Allergies:

Symptom List: Injection site pain

Symptoms: Flu like symptoms; Heart palpitations; This is a spontaneous report from a Pfizer sponsored program. A contactable other-Health Care Professional and a non-contactable consumer (patient) reported. This case is a spontaneous report received on 23Apr2021, from a consumer via specialty pharmacy. Initial Reporter Also Sent Report to FDA- UNK. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 20Apr2021 (at the age of 60 years old) as dose 1, single for covid-19 immunisation; treprostinil sodium (REMODULIN), via an unspecified route of administration from 15Aug2019 to an unspecified date, at 5.0 mg/ml, daily (UNK, continuing, (Continued)), subcutaneous from an unspecified date (Batch/Lot Number: 2101734; Expiration Date: 30Nov2021) to an unspecified date, at 0.068 micro g/kg, continuing for secondary pulmonary arterial hypertension; macitentan (OPSUMIT), via an unspecified route of administration from 20Apr2021 to an unspecified date, at unspecified dose for an unspecified indication . Medical history included secondary pulmonary arterial hypertension from an unknown date and unknown if ongoing. Concomitant medication included riociguat (ADEMPAS). It was reported that the patient might took a double dose of Opsumit but she was not sure. The patient also reported having flu like symptoms after COVID vaccination on Tuesday (on 20Apr2021) as well as heart palpitations. On an unreported date in Apr 2021, the patient experienced the events of heart palpitations [Palpitations], flu like symptoms after COVID vaccination. The action taken in response to the events for treprostinil sodium was unknown, for macitentan was unknown. The outcome of event palpitations and influenza like illness was unknown at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: ADEMPAS

Current Illness:

ID: 1812005
Sex: F
Age:
State: MI

Vax Date: 04/20/2021
Onset Date: 04/01/2021
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: Lymph nodes under her armpit and neck are swollen; Swollen arm; Muscles being tight it could affect the nerves and be causing her pain; Shoulder is swollen and she could feel it was warmer on the left side; It was warmer on the left side; the next day, were very sore and tight/pain radiated down to her elbow and wrist; the next day, were very sore and tight/pain radiated down to her elbow and wrist; her arm started to get "stiff and sore; intense throbbing pain, from her shoulder through her back; felt very fatigued and tired, and she stayed in bed and slept the whole day; felt very fatigued and tired, and she stayed in bed and slept the whole day; Arm started to get "stiff and sore"/her arm and shoulder on the left, the next day, were very sore and tight/pain radiated down to her elbow and wrist; her left arm, where she received the vaccine, "started to get sore; Pain from her left shoulder drop back down into her back and the back of shoulder scapula; neck stiffness; This is a spontaneous report received from a contactable consumer(patient). A 47-year-old female patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 20Apr2021 at17:05 (Lot number: EW0150) into left arm as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported. On 21Apr2021, the patient had experienced that her arm started to get "stiff and sore" and that is was "throbbing" and she was "exhausted. She stayed in bed for a day, went back to work cleaning houses on Thursday 22Apr2021. She reported that the pain radiates from her left shoulder, around to the scapula on her back, then down to her elbow and wrist, and feels like its "pulling" and she "feels like I need to continue to flex my wrist". Symptoms worsen when she walks, stands, or sits, the only relief she gets is when laying on her back in bed, or in a very specific way on her left side. She reported that symptoms worsened 27Apr2021 and that she's "been in bed since Wednesday" (28Apr2021). On 30Apr2021 the patient had experienced shoulder was swollen and she could feel it was warmer on the left side. On 03May2021, the patient had experienced swollen arm, and the lymph nodes under her armpit and neck are swollen and also experienced with the muscles being tight it could affect the nerves and be causing her pain. Therapeutic measures were taken for the AE and treatment included were Ibuprofen, Acetaminophen, Massage, ice, and heat. The outcome of the events felt very fatigued and tired, and she stayed in bed and slept the whole day was recovered, on unknown date. The outcome of other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812006
Sex: F
Age:
State: MO

Vax Date: 04/21/2021
Onset Date: 04/21/2021
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: She doesn't hear very well; She does have allergies.; She had a couple of red streaks on each leg on the inner part of her knee; hot flash feeling on her face, it felt warm; hot flash feeling on her face, it felt warm; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0162, Expiration date: unknown), via an unspecified route of administration, administered in left arm on 21Apr2021 (at the age of 90 years) as dose 1, single for covid-19 immunization. Medical history included allergic to dye, sulfa drugs and a bunch of other drugs. There were no concomitant medications. On 21Apr2021, patient experienced a warm feeling in her face like a hot flash, that only lasted 4-5 days then after that, nothing. On 24Apr2021, patient had a couple of red streaks on each leg on the inner part of her knee. It was reported that, this is how she reacts with anything with dye in it. They were maybe streaks that were probably 2 inches long and half an inch wide. They went away. They didn't develop until the third day after her shot. Patient asked if she could take Benadryl. It was reported that, the patient doesn't hear very well and had allergies, on an unknown date. It was stated that, she had the first shot, and she asks if she takes the second shot and happens to have breaking out if she can take Benadryl. She does have allergies. As reported clinical course: She called her druggist and they gave her this number. She called her druggist and they gave her this number. They gave her the Covid shot there. She didn't have anybody to help her with this situation. The druggist at tried to explain it to her. She doesn't hear well, but she thought he said some of these ingredients could be related to sulfa drugs. She is not 100% sure. She wanted to verify if she should take the next shot on13May2021. She wanted to know about the ingredients. States she had a paper on it, but wants to know if there is any dye or sulfa drugs in it. Caller states everything was fine and then she noticed a red streak a 1/4" wide on her legs and inside of her knees on both legs. States she also had a hot flash feeling on her face, it felt warm. States she can eat a cherry pie with red dye in it and it would do the same thing, but she didn't eat a cherry pie. States she did not have No big reaction, no swelling and everything. Just that one reaction, and she is just wondering about those 2 ingredients. States she had allergies but she had no fever or bleeding or any of these things listed they could possibly have. Caller states she had no joint pain, she didn't even have a headache, no fever, no nausea or tiredness. Just a warm feeling in her face like a hot flash, that only lasted 4-5 days then after that, nothing and the red streaks on her legs. Patient clarified that the streaks were red then brown. Patient did not take any treatment for events. The events a warm feeling in her face like a hot flash, and had a couple of red streaks on each leg on the inner part of her knee was recovered on 26Apr2021, whereas outcome of rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812007
Sex: F
Age:
State: WA

Vax Date: 04/26/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Internal shaking; Chest pain; Chest pain that made her out of breath; Anxiety; Lack of sleep; Headache; Fatigue; Muscle pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8735, Expiry Date: Unknown) via an unspecified route of administration in right arm (reported as injection to upper right arm) on 26Apr2021 at 08:00 (at the age of 53 years-old) as dose 1, single for COVID-19 immunization. Patient medical history reported as none. The concomitant medications (other products) were not reported. The vaccine was not administered at (Privacy) facility. No Family medical history relevant to adverse events was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. No additional administered vaccines and prior vaccinations (within 4 weeks) reported. Adverse events following prior vaccinations once, it was the flu shot, her arm got the flu, if that, it sounds weird, her arm became feverish, swollen, she became somewhat sick, tired, it was a really nasty reaction to that shot, the injection area. Flu shot, lot, expiry unknown. On Apr2021 patient experienced headache, fatigue, muscle pain, chest pain that made her out of breath, these side effects causing her anxiety and lack of sleep and shivering of internal muscle (it is outside the norm, she is having kind of, she does not know how to describe it, it was like cold and shiver, it is kind of an internal shaking and is still having that) on 26Apr2021. Internal shaking was started the same day as the vaccine, but later that night, it is not going away. Patient first shot symptoms were more noticeable. Patient didn't visited emergency room and physician office. The relevant tests and investigation assessment were not reported. The outcome of internal shaking was not recovered (ongoing) while that of remaining was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812008
Sex: F
Age:
State: FL

Vax Date: 04/29/2021
Onset Date: 05/01/2021
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:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: started coughing and coughing and coughing ever since.; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number:ER8737 and Expiry date was not reported), via an unspecified route of administration on 29Apr2021 at 13:00 (at the age of 39-years-old) in right arm as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: ER2613 and Expiry date was not reported), via an unspecified route of administration on 08Apr2021 in right arm as dose 1, single for COVID-19 immunization. Time the Vaccination was given between 13:00-13:30 both the first and second dose. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. Patient's Medical History including any illness at time of vaccination was none. No Family Medical History Relevant to AE(s). Relevant Tests was none. The patient had not received other products. Caller would like to know if a cough is a common side effect after receiving the second dose of the Pfizer COVID vaccine. Caller states she did an online report and regarding her side effect. Call then is taken over by the patient's mother. Consumer who states her daughter is coughing so bad she cannot talk to the Agent. The caller reports her daughter received the second dose Pfizer Covid Vaccine on 29Apr2021 and had no side effects until a couple days ago, on 01May2021, the patient started coughing and coughing and coughing ever since. Caller states she would be a health care provider since she's a mom. Caller clarified she is a consumer and not an HCP. Caller states her daughter does not have a primary care physician. Caller states her daughter is concerned about the coughing, wants to make sure her daughter is not dying or anything right now. The patient was not visited to emergency room and physician office. The outcome for the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812009
Sex: F
Age:
State: MD

Vax Date: 04/30/2021
Onset Date: 04/30/2021
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: A Pharmacist told her the injection may have been given too low on the arm; Caller experienced side effects (unnamed); Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; Red, Raised, Warm, Burning Spot on Left Arm; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8737), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 13:30 (at the age of 56 years old) as dose 2, single for covid-19 immunisation. Medical history included breast cancer from 2020 to an unknown date Verbatim: Breast Cancer. Additional Information for Other Conditions: Diagnosed 4-5 years ago, ongoing rheumatoid arthritis Verbatim: Rheumatoid arthritis. The Patient Medical continuing: Yes. Concomitant medications included methotrexate sodium (METHOTREXATE [METHOTREXATE SODIUM]) from Feb2021 and ongoing, prednisone (PREDNISONE) and tamoxifen (TAMOXIFEN) taken for breast cancer, aromatase inhibition therapy from Feb2021 to an unspecified stop date. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 as dose 1, single for covid-19 immunisation. It was reported No related to a study or programme, Investigation Assessment, Vaccine Administered at emergency room and Physician Office. On an unspecified date, the patient experienced caller experienced side effects (unnamed), A Pharmacist told her the injection may have been given too low on the arm. On 30Apr2021, the patient experienced red, raised, warm, burning spot on left arm. The outcome of the event Red, Raised, Warm, Burning Spot on Left Arm was not recovered and other was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: METHOTREXATE [METHOTREXATE SODIUM]; PREDNISONE; TAMOXIFEN

Current Illness: Rheumatoid arthritis (Verbatim: Rheumatoid arthritis Patient Medical continuing: Yes)

ID: 1812010
Sex: F
Age:
State: NJ

Vax Date: 04/30/2021
Onset Date: 05/03/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Blood Blister on her cheek on the left side; I felt a little bump in my mouth then when I looked, it was this dark, like their was blood in it.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0165), via an unspecified route of administration, administered in Arm Left on 30Apr2021 (age at the time of vaccination was 47 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03May2021 at 03:00, the patient experienced blood blister on her cheek on the left side and i felt a little bump in my mouth then when i looked, it was this dark, like their was blood in it. It was reported that, the patient received first dose of the vaccine Pfizer covid vaccine on Friday. The patient stated that this morning, at 3am she felt a little bump in her mouth then when she looked, it was this dark, like there was blood in it, a blood blister. She enquired was that something that had been reported as a reaction to the vaccine. She read it could be tied to the rare blood disorder. She asked does she need to go to the ER and if it was a platelet issue. The patient stated that she received her first vaccination on Friday, 30Apr2021. The patient stated that last night, at 03:00a.m. she got a thing in her mouth, a blood blister. She said she have never had any blood blisters before and she had nothing going on with her mouth. She asked if this was a possible side effect and does she need to go to the ER. She enquired was there a possibility of it being the rare blood disorder people were getting. She stated she had no bruises and she wasn't doing anything. She clarified it started today at 03:00a.m, she was finishing up something before she went to bed. She stated it felt like it was getting smaller. She said she wants to know if she should go to the ER to make sure there is no platelet issue or was that something Pfizer heard a lot. Treatment was reported as none. Reporter seriousness for Blood Blister on her cheek on the left side was reported as unspecified. It was reported that this report was not related to a study or programme. Investigation Assessment was reported as no. The outcome of the events was recovering. No follow-up attempts needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812011
Sex: F
Age:
State: MD

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: has had other allergies and has broken out in hives before; she developed hives; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176, Expiry date: not reported), via intramuscular route of administration in right arm on 29Apr2021 15:00 (at age of 51-years-old) as dose 1, single for covid-19 immunization. Medical history included covid-19 from Mar2021 to an unknown date. No patient medical history (including any illness at time of vaccination) was reported. The patient's concomitant medications were not reported. History of all previous immunization with the bnt162b2 vaccine considered as suspect were none. No additional vaccines administered on same date of the bnt162b2 suspect. It was unknown if the patient had received any other vaccine within 4 weeks. The patient was taking bnt162b2 vaccine to protect self and others. On 29Apr2021 at 17:30, the patient experienced she developed hives and had other allergies and has broken out in hives before on an unspecified date. Further reported that patient had a little on her forehead on Friday 30Apr2021. Definitely Saturday everything was gone. Patient has asked that should or shouldn't she get the second shot scheduled for 20May2021. The patient did not require visit to emergency room or physician office due to the adverse events. No relevant tests were performed. The outcome of the event has had other allergies and has broken out in hives before was unknown while the event hives recovered on 01May2021 (at 18:30). No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812012
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 05/2021; Test Name: heart rate; Result Unstructured Data: Test Result: High.

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 27-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on May 1, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On unspecified date, patient experienced 20 to 30 seconds of dizziness. It went away. He also felt lightheaded for 20 to 30 seconds; began having chest heaviness and became sweaty almost immediately after the dizziness, while walking to the observation room. On unspecified date in May 2021, patient experienced high heart rate. Patient inquired if any people reported this issue and how often. He wanted to know if he can take the second dose or not because he experienced increased heart rate after first dose of Pfizer COVID-19 vaccine this weekend on May 1, 2021. Referred to HCP or vaccination provider to determine if he had a severe allergic reaction and if he should receive a second dose of the vaccine. Inquired if there are any general blood tests to check for allergies to the vaccine. The patient underwent lab tests and procedures, which included heart rate results high on unspecified date in May 2021. The outcome of 20-30 seconds dizziness; went away or felt lightheaded as well for 20-30 seconds recovered on unspecified date; and for remaining events unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812013
Sex: F
Age:
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: The rash started on her palms, and migrated to different parts of her body; arm pain; hives and some redness on her belly; hives and some redness on her belly; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch Number: EN6201) via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The reporter stated that his wife is healthy and does not take any other medications. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Patient Medical History including any illness at time of vaccination reported as none. It was reported that both parents have the vaccine and are fine. It was reported that she received her first dose of the Pfizer-BioNTech Covid19 vaccine and developed a rash a week later on 21Apr2021. He reported that her rash showed up out of nowhere and had nothing to do with the arm that she received the vaccine in. The rash started on her palms and migrated to different parts of her body including hives and some redness on her belly and the back of her ear looked swollen and also involved her knees and toes. The rash was short lived and resolved within 24 hours after treating with an antihistamine. It was reported that his wife noticed the rash at 10:00 pm that night. It was reported that she also had arm pain on 16Apr2021 that lasted for 2-3 days. Reporter stated that she is due for her second dose this Thursday and they are asking if she should still receive that dose or not. Patient received treatment with antihistamine for rash. Patient relevant Tests reported as none. The outcome of the event the rash started on her palms and migrated to different parts of her body was recovered on 22Apr2021 and the outcome of event arm pain was on unknown date in Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812014
Sex: M
Age:
State: CT

Vax Date: 04/26/2021
Onset Date: 04/27/2021
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: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:102.7 Units:[degF]; Comments: Fever kept increasing to about 102.7 F

Allergies:

Symptom List: Pain in extremity

Symptoms: Woke up that night with bad chills; Had low grade fever / fever kept increasing to about 102.7 F; Very tired/fatigued; Sweating a lot; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 26Apr2021 at 12:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), desvenlafaxine succinate monohydrate (PRISTIQ) and multivitamin (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 02:00, the patient woke up that night with bad chills. On 27Apr2021, later that morning, the patient had low grade fever and was very tired/fatigued. Around 11:30, he took Motrin, felt better and around 15:30 felt very tired again and fever came back. He slept and fever kept increasing to about 102.7 Fahrenheit at 19:45 and around 20:30 took more Motrin. Fever came down and he was sweating a lot then after that no more fever. On 28Apr2021 (Wednesday), he felt pretty tired but was able to return to work. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (MOTRIN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had low grade fever / fever kept increasing to about 102.7 F and sweating was resolved on 27Apr2021 while bad chills and very tired/fatigued was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: WELLBUTRIN; ADDERALL; PRISTIQ

Current Illness:

ID: 1812015
Sex: F
Age:
State: PA

Vax Date: 04/28/2021
Onset Date:
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:

Allergies:

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

Symptoms: She has been experiencing a sore throat; lost of her voice; a lot of coughing; Throat very irritated; Sometimes feels like she needs a little bit of air; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Apr2021 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced a sore throat, lost of her voice, a lot of coughing, throat very irritated, sometimes felt like she needs a little bit of air. She does not have a fever, no headache, no chills or any other symptoms. She doesn't have flu symptoms, and she doesn't know if it was a coincidence and if it was allergies. She has taken some over the counter medication. She doesn't know what to do. It has been a whole year without anything. She has been in her house. She doesn't know if these were side effects or what happened. She needs to know if this is normal or if this is just a regular cough. She was fine when she went to get the vaccine. She called her doctor and they were on break. Outcome of the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812016
Sex: F
Age:
State: LA

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

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

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: allergic reaction; face and lips swelled up; face turned red; lips swelled up; This is a spontaneous report received from a contactable consumer (patient). An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration at right arm on 22Jan2021 14:00 (at the age of 87-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Upon requesting about lot number, she stated that she just had cataract surgery and she was even having trouble even seeing and patient provided Lot number as either EL8982 or FL8982. Medical history included allergic to sulfa drug and lymphedema in her left arm. Patient further stated that she was allergic to sulfa drugs or any drug that says "if you're allergic to sulfa drugs do not take this. She gave them that information when she got her COVID vaccine, and they said that no sulfa drugs are involved with this vaccine. She didn't know if that it was the polyethylene glycol maybe that she was allergic to and just didn't know it. She has lymphedema in her left arm, so everything has to be done in her right arm. The patient's concomitant medications were not reported. Patient further stated about that no relevant concomitant products, medical conditions and test results, she was taking the same medications that she has been taking for a long time. There was nothing new or different for her. No further details provided. Prior Vaccinations within 4 weeks were reported as none. Relevant family history related to AE's reported as none. The patient experienced allergic reaction, face and lips swelled up, face turned red, lips swelled up on 22Jan2021. Patient stated that she had the Pfizer COVID vaccine injection on 22Jan2021, and she had an allergic reaction to it. Her face and lips swelled up and her face turned red. When she went back to get the second dose, they said that they couldn't give to her because of her having had an allergic reaction to the first dose. She then read where she could possibly get the Johnson and Johnson COVID vaccine. She saw on the news or in the newspaper that she could make an appointment and go to the civic centre where she lives and get the Johnson and Johnson vaccine so she had made an appointment and went there and then they said that they couldn't give it to her, it had to be done in the hospital setting. No hospitals are giving out the Johnson and Johnson vaccine. Her question was if she had the first dose 22Jan2021 how much immunity she has without having the second injection. Patient further stated that the reaction happened within 15 to 20 minutes of receiving the COVID vaccine. She was able to drive home and asked before she left if she could take Benadryl when she got home, and they said yes. When she got back home, she took Benadryl right away and within a short period of time everything got back to normal. Patient did not visit the emergency room visit or physician office visit for the events. Patient received treatment with Benadryl. Outcome of all events was recovered on 22Jan2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1812017
Sex: F
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 04/30/2021
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:

Allergies:

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

Symptoms: Day after 2nd injection, a rash in the chest area that has persisted as of today 5/3/21; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0117) via an unspecified route of administration in the left arm on 28Apr2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 09:00, day after 2nd injection the patient experienced a rash in the chest area that persisted as on the day of reporting on 03May2021. Therapeutic measures were taken as a result of event and included treatment with hydrocortisone (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL) dose. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a rash in the chest area was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812018
Sex: F
Age:
State: CO

Vax Date: 04/22/2021
Onset Date: 04/27/2021
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: was a little tired; arm just started itching and blew"arm just started itching and blew up to a big, red ring/her arm started itching; her arm now has a big red circle around it and it's kind of hot; her arm now has a big red circle around it and it's kind of hot; Pain in arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8735) via an unspecified route of administration, administered in arm left on 22Apr2021 11:00 (at the age of 61-years-old) as dose 2, single for COVID-19 immunization. Medical history included back pain, knee pain and diabetes mellitus. The patient began experiencing back pain years ago; she had been experiencing knee pain for a few years. She was diagnosed with diabetes 10-15 years ago. Concomitant medications included gabapentin (GABAPENTIN); atorvastatin (ATORVASTATIN); bupropion hydrochloride (WELLBUTRIN); trazodone (TRAZODONE); levothyroxine (LEVOTHYROXINE) and metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8737) via an unspecified route of administration, administered in arm left on 01Apr2021 as dose 1, single for COVID-19 immunization. On an unspecified date, the patient was having side effects after a week from receiving her second COVID vaccine; the patient was little tired. On 27Apr2021, the patient's arm just started itching and blew arm just started itching and blew up to a big, red ring/her arm started itching; her arm now has a big red circle around it and it's kind of hot to the touch. She also had pain in arm. Pain in arm was reported as worsened. She was concerned because these symptoms did not happen right away. She added that it just seems strange that 5 days later after the COVID- 19 vaccine her arm would do that. She was still experiencing the itching sometimes; it hurts too much to scratch her arm, so she rubs it and that helps. Big red circle on arm it pretty much stayed the same. The heat and itching in her arm have gotten better but the pain has gotten worse. The outcome of the event the patient was a little tired was unknown. The outcome of the event arm just started itching and blew arm just started itching and blew up to a big, red ring/her arm started itching and her arm now has a big red circle around it and it's kind of hot was recovering. The outcome of the event erythema and pain in arm was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: GABAPENTIN; ATORVASTATIN; WELLBUTRIN; TRAZODONE; LEVOTHYROXINE; METFORMIN

Current Illness: Back pain; Diabetes; Knee pain

ID: 1812019
Sex: F
Age:
State: IL

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: She had a muscle soreness in her left arm and had worsened/Caller is still having muscle and shoulder pain in her left arm where she got the 2nd dose of the vaccine; She had a muscle soreness in her left shoulder and had worsened/Caller is still having muscle and shoulder pain in her left arm where she got the 2nd dose of the vaccine; Her arm is still sore; This is a spontaneous report from contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 60-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0150, Expiration Date- Jul2021) via unspecified route of administration in left arm on 20Apr2021 between 10:00 and 10:30 (as reported) (age at vaccination 60-years-old) as dose 2, single for COVID-19 immunization. Patient medical history included ongoing blood pressure high for about 10 years. The concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8730, Expiration Date- Jul2021) intramuscularly at left arm on 29Mar2021 as dose 1, single for COVID-19 immunization and had for a day and a half, and the muscle pain went away on its own and did not go into her left shoulder. The patient did not receive any other vaccines within four weeks prior to the vaccination. Additional Vaccines Administered on same date of the Pfizer Suspect was reported as none. The patient had muscle soreness in her left arm and muscle soreness in left arm had worsened on 20Apr2021. She was still having muscle and shoulder pain in her left arm where she got the second dose of the vaccine on 20Apr2021. She had a muscle soreness in her left shoulder and muscle soreness in left shoulder had worsened on 20Apr2021. She was still having muscle and shoulder pain in her left arm where she got the second dose of the vaccine and was wondering if that is typical and how long should it typically last on 20Apr2021. She had the second dose of the Pfizer COVID vaccine 2 weeks ago and her arm was still sore and hurting. She said she received the first dose 29Mar2021 and second dose was 20Apr2021. Second shot 2 weeks ago and my arm was still sore and still hurting. She had took some of her pain pills for her left arm and shoulder soreness. She clarified she took some Naproxen that was previously prescribed for arthritis. She said she did not have the Naproxen prescription bottle to provide the Naproxen dose. She had a muscle soreness in her left arm and left shoulder that started the day she got her second COVID-19 Vaccine, and the muscle soreness in her left arm and left shoulder worsened since it started. She her first COVID-19 Vaccine shot she had the same kind of left arm muscle pain for a day and a half, and the muscle pain went away on its own. She said with the first COVID-19 Vaccine the left arm muscle pain did not go into her left shoulder. She had a muscle soreness in her left arm that started the day she got her second COVID-19 vaccine on 20Apr2021, arm was still sore on an unspecified date in 2021. The patient had received the treatment for the events, she had took some of her pain pills for her left arm and shoulder soreness. She clarified she took some Naproxen that was previously prescribed for arthritis. The adverse events did not require to visit emergency room and physician office. The outcome of the event arm is still sore was unknown and the other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Blood pressure high (Verbatim: Blood pressure high)

ID: 1812020
Sex: F
Age:
State: TX

Vax Date: 04/29/2021
Onset Date: 04/30/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: nausea; back pain; body pain; fatigue; chills; neck swelling; more in the back side of the neck, causing her pain.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021 (age at vaccination was 34 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism (Consumer reports she has hypothyroidism) from an unknown date and unknown if ongoing. There were no concomitant medications. Reporter stated that the patient was vaccinated on 29Apr2021, Thursday. On 30Apr2021 at 05:00 PM (reported as Friday), the patient experienced nausea, back pain, body pain, fatigue, chills and neck swelling. The patient reported that the neck swelling was due to the two bumps both sides of neck and palm sized, and one more in the back side of the neck, causing her pain. Consumer called in requesting information about whether she should being vaccinated with second dose after these adverse effects with first dose. Outcome of the events was unknown. No follow-up attempts are possible; Information about Lot/Batch Number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812021
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
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: Shortness of breath; Tired; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced shortness of breath and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event shortness of breath and tired was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812022
Sex: M
Age:
State: AL

Vax Date: 04/28/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: vomiting; coughing; sore throat; This is a spontaneous report from a contactable consumer (wife). A 33-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 28Apr2021 (reported as on Wednesday) (at the age of 33-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was not reported. On an unspecified date in 2021, after vaccination, the patient experienced vomiting, coughing and sore throat. It was reported, Today (at the time of report) after vaccination, the patient was having symptoms of vomiting, coughing and a sore throat. Reporter was asking should the patient go get tested for COVID or are these symptoms from the vaccine. The outcome of the events was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812023
Sex: F
Age:
State: SC

Vax Date: 04/26/2021
Onset Date: 04/26/2021
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: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Extreme pain in bones of right foot; Couldn't walk or move foot; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 15:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and unspecified vitamin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 26Apr2021 at 18:45 (reported as 18:30), 3 hours after the vaccination, only reaction the patient experienced was extreme pain in bones of right foot which lasted 12 hours and gone. It was reported that there was no visible bruising or swelling but no way to alleviate pain and couldn't walk or move foot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme pain in bones of right foot and couldn't walk or move foot was recovered on 27Apr2021 at 06:45. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: BABY ASPIRIN

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am