VAERS 2021 Database www.vaers.hhs.gov

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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: 1773690
Sex: F
Age:
State: CA

Vax Date: 02/18/2021
Onset Date: 02/20/2021
Rec V Date: 10/09/2021
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: Nausea; This is a spontaneous report from a contactable consumer, the patient. A 54-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 18Feb2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, allergies, blood cholesterol abnormal (factor v cholesterol) and blood pressure abnormal. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), carbamazepine (TEGRETOL), bupropion hydrochloride (WELLBUTRIN) and montelukast sodium (SINGULA) and had received within 2 weeks of vaccination for an unknown indication. On 20Feb2021, the patient experienced nausea. The event did not resulted in doctor/other health care professional office/clinic visit and 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 reported events. The clinical outcome of the event nausea 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: EFFEXOR; TEGRETOL; WELLBUTRIN; SINGULA

Current Illness:

ID: 1773691
Sex: F
Age:
State: FL

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Severe stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9262) via an unspecified route of administration in the right arm on 24Feb2021 at 11:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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. On 24Feb2021 at 15:00, the patient experienced severe stomach cramps within 4 hours of injection and diarrhoea. 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 event severe stomach cramps and diarrhoea was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1773692
Sex: F
Age:
State:

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lymph node tenderness under left armpit; Body aches; Fatigue; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 25Feb2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included irregular heartbeat, occasional high blood pressure, low thyroid and recurring shingles. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALTREX), betablockers and vitamins (unspecified); all from unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also received pethidine hydrochloride (DEMEROL) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 14:30, 24 hours after injection, the patient experienced body aches, fatigue and headache and all subsided by the following morning. On 27Feb2021 at 14:30, 48 hours after injection, the patient experienced same symptoms reoccurred, along with lymph node tenderness under left armpit. Symptoms subsided by the following morning and did not recur. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, fatigue, headache and lymph nodes tenderness was resolved on 28Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds: THYROID; VALTREX

Current Illness:

ID: 1773693
Sex: M
Age:
State:

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 10/09/2021
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: Metallic taste in mouth for ~ 30 minutes after shot; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hodgkin's lymphoma (in remission). The patient had no known allergies. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and rosuvastatin calcium (CRESTOR); all taken for unknown indications from an unknown date and unknown if ongoing. 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 26Feb2021 at 15:15, the patient experienced metallic taste in mouth for approximately 30 minutes after shot. 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 metallic taste in mouth for approximately 30 minutes after shot was resolved on 26Feb2021 at 15:45. No follow-up attempts are possible. No further information is expected.

Other Meds: SERTRALINE; VITAMIN D3; CRESTOR

Current Illness:

ID: 1773694
Sex: F
Age:
State: NH

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 10/09/2021
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: Moderate arm pain occasionally zinging down into fingers; Significant fatigue; This is a spontaneous report from a non-contactable nurse, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN); both 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: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient previously received celecoxib (CELEBREX) from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the patient experienced moderate arm pain occasionally zinging down into fingers and significant fatigue which started the following day and lasted approximately 24 hours. 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 significant fatigue was resolved on 07Feb2021; while that of the event moderate arm pain occasionally zinging down into fingers was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: TYLENOL; IBUPROFEN

Current Illness:

ID: 1773695
Sex: F
Age:
State:

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 10/09/2021
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: arm ache in the arm the vaccine was injected into; shivers for 2 hours about 13 hours after getting injection; This is a spontaneous report from a contactable consumer. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration on 27Feb2021(at the age of 23-years-old) as a single dose for COVID-19 immunisation. The 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. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 28Feb2021 at 01:30, about 13 hours after getting injection, the patient experienced arm ache in the arm the vaccine was injected into and shivers for 2 hours. 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 not 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 arm ache in the arm the vaccine was injected into and shivers was recovered on 28Feb2021 at 15:30. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1773696
Sex: M
Age:
State: IL

Vax Date: 03/01/2021
Onset Date: 03/02/2021
Rec V Date: 10/09/2021
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: Sore arm near the injection site, the morning after the 1st dose; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 01Mar2021 at 02:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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 medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the morning after the first dose, the patient experienced sore arm near the injection site. The events did not result in a visit to the doctors 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 event sore arm near the injection site was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773697
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: Intense myalgia for 8 hours starting about 14 hours after the shot, mild myalgia after that; Very sore arm; This is a spontaneous report from a non-contactable physician, the patient. A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 01Mar2021 at 07:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received benzoin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 01Mar2021 at 12:00, the patient had very sore arm. On 01Mar2021 at 21:00, the patient experienced intense myalgia for 8 hours starting about 14 hours after the shot and mild myalgia after that. No therapeutic measures were taken as a result of the events. The adverse events did not result in a visit to the doctors 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 very sore arm and intense myalgia for 8 hours starting about 14 hours after the shot, mild myalgia after that was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773698
Sex: F
Age:
State: WI

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: headache; some dizziness; chills; joint and muscle pain; joint and muscle pain; feeling unwell; tiredness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that: A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6198) via an unspecified route of administration in left arm on 26Feb2021 10:00 (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history were none. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks prior vaccination. Other medications in two weeks were dietary supplements. The patient had no COVID prior vaccination, no COVID tested post vaccination. On 27Feb2021, the patient experienced tiredness, headache, some dizziness, chills, joint and muscle pain and generally feeling unwell. No treatment was given for the events. The outcome of the events was not recovered at the time of last observation. It was reported that, the patient stated that she got her first shot on 10Mar2021, and she was supposed to get the second dose on 26Mar2021. Her doctor changed the schedule to 31Mar2021 because 26Mar 2021 was less than 21 days. However, she received a phone call yesterday that the schedule for her second dose has changed on 01Apr2021 (more than 21 days). The unaddressed medical questions was referred to Medical Information. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773699
Sex: M
Age:
State: MI

Vax Date: 03/08/2021
Onset Date: 03/10/2021
Rec V Date: 10/09/2021
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: light headed; dizzy; passing gas; upset stomach; loose stool; This is a spontaneous report from a contactable consumer (patient himself). An 89-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6206, expiry date: unknown) via unspecified route of administration in left arm on 08Mar2021 (age at vaccination: 89-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Last night or yesterday he had an upset stomach and a loose stool on 10Mar2021. He took some Pepto Bismol and it went away. But today on 11Mar2021 he was light headed, had an upset stomach and another loose stool. He's passing gas. He took Tylenol about 3 hours ago. Hes dizzy, light headed, had a loose stool, passing more gas than he usually does in a day. He goes back on 29Mar2021 for the second shot. The outcome of events was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773700
Sex: F
Age:
State: GA

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

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

Lab Data: Test Name: X-ray of spine; Result Unstructured Data: Test Result:UNKNOWN

Allergies:

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

Symptoms: Pain in her knee from an old injury; Sore arm; reaction in her joints got really bad a little over a week ago; This is a spontaneous report from Pfizer sponsored program via medical information team. A contactable nurse (patient) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ERV6202; Expiration Date: Jun2021), via intramuscular, administered in arm right on 01Mar2021 at 11:00 AM (age at vaccination was 66 years) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation at pharmacy. Vaccine administered at military facility was reported as No. Medical history included covid-19 from Nov2020; sciatic nerve issue, sciatic nerve issue that she had surgery, old injury. She knows she that her spine has arthritis, her L5, it is getting to point where it is almost bone on bone, a lot of arthritis. No family history was reported. Concomitant medications were not reported. No additional vaccine was administered on same date of Pfizer vaccination. The patient historical vaccine includes received second shot of Shingrix for shingles in last week of Dec2020. It was reported that she received the first dose of the vaccine on March 1. She is having pain in her knee from an old injury and has been prescribed prednisone 20mg. She had a sore arm after receiving the vaccine. She had COVID in Nov2020. Back in Dec she had her second shot of Shingrix. It was reported that Confirms she is a retired RN. She has a question. She had reaction in their joints. She had to go to an orthopedist and she was put on an oral steroid for her knee that is killing her. She does not know if it has upset a sciatic nerve issue that she had surgery for in the past and the surgery took care of her sciatic issue. She was put on the oral steroid yesterday to make it where she could walk since her knee was so painful. She has been told that being put on an oral steroid could work against the vaccine. She is asking if it is safe to take an oral steroid. She is not saying the joint issues they are having is from the vaccine. They already had covid last year. She does not know if the vaccine is the cause of their reaction. It is spring there and they have been going back and forth with pollen and it can be hard on those with arthritis. The reaction in her joints got really bad a little over a week ago, a week and a day ago. She could not stand it anymore so that is why she went to doctor. At the moment it is the same , it got worse as time went on. Again states she has no idea if their joint issues have to do with the vaccine but they have not had this before, states it may be arthritis. Also, her 2nd dose schedule is more than 21 days from the 1st dose. Her 2nd dose schedule will be on 29Mar2021. Furthermore, she had a check-up with Orthopedics after the 1st dose of the Covid-19 vaccine and underwent an X-ray procedure and she said that she took oral steroids. She is asking if she can continue taking steroids that were prescribed to her after she heard from someone that steroids are not advisable after getting the Covid-19 vaccination. The patient underwent lab tests and procedures which included spinal x-ray: unknown on an unknown date. Therapeutic measures were taken as result of knee pain. The outcome of the events was unknown while knee pain was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021307957 same reporter/drug, different patient/event.

Other Meds:

Current Illness:

ID: 1773701
Sex: F
Age:
State: VA

Vax Date: 02/16/2021
Onset Date: 02/19/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data: Test Date: 20210312; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Normal; Test Date: 20210312; Test Name: CBC; Result Unstructured Data: Test Result:Normal; Test Date: 20210312; Test Name: Comprehensive metabolic panel; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Rash, Urticaria

Symptoms: increased in fatigue; muscle weakness; pain in thighs; joint pain in knees and hip; It's difficult for her to walk upstairs, she has to drag her leg up the stairs; This is a spontaneous report from a contactable Nurse (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration on 16Feb2021, (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included autoimmune disorder, ongoing migraine and hypothyroidism. Concomitant medication(s) included thyroid (NATURE THROID); citalopram (CITALOPRAM) and Rimegepant sulfate (NURTEC ODT) taken for migraine, start and stop date were not reported. Patient reported that she has an autoimmune and other health issues which are under control. On 19Feb2021, patient noticed increase in fatigue, muscle weakness, pain in her thigh and joint pain in knees, and also her hip, so joint pain and hip. It's difficult for her to walk upstairs, she has to drag her leg up the stairs and it is still ongoing, it is not getting better. She was supposed to get the second dose but she decided to postpone it, so now she is schedule on 25Mar2021, she postponed because she still having this fatigue, her doctor suggested that she speak with the neurologist but her next appointment is in April, so she wanted to know, her question was, how well she is protected and what are the recommendations on getting the second dose if she should take it or not, and finally she mentioned is she spoke with a some healthcare providers and she mentioned people took the Moderna shot and they require a root canal. Patient just little concerned that it has gone on for 4 weeks, so that is why she had originally called she was trying to figure out the timing of the second, she has been putting off the second vaccination for fear of feeling worse than she do now so. Causality: Nurse stated That's the best conclusion I can draw, I certainly don't have total certainty but I, yeah. On 12Mar2021, the patient underwent lab tests and procedures which included c-reactive protein: normal, full blood count: normal and metabolic function test: normal. No therapeutic measures were taken as a result of the events. The outcome of the events increased in fatigue, it's difficult for her to walk upstairs, she has to drag her leg up the stairs, joint pain in knees and hip was not recovered. The outcome of the events muscle weakness and pain in thighs was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: NATURE THROID; CITALOPRAM; NURTEC ODT

Current Illness: Migraine (Verbatim: Migraine)

ID: 1773702
Sex: F
Age:
State: FL

Vax Date: 03/08/2021
Onset Date: 03/11/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: number, expiry date: unknown) via unspecified route of administration, in left arm on 08Mar2021 12:30 (age at vaccination: 79-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route on 15Feb2021 11:00 AM (Age at vaccination: 79-years) as dose 1, single for covid-19 immunisation. Patients medical history included cholesterol, gout and thyroid from an unspecified date and unknown if ongoing (Caller says she takes a medication for this, no details provided about this medication). Concomitant medications were not reported. She said after she got her vaccine it she was fine with no problems, no soreness or nothing, then the 11th she come down with diarrhea that she has had since then. She said the diarrhea was not severe or anything, but it doesn't seem to want to go away, and she would like to know is that a side effect of the shot. She said that the diarrhea started 11Mar2021, and had been staying the same, it doesn't seem to want to go away. As treatment for AE patient said she just start yesterday taking Kaopectate, which had not really done anything yet. She said she took it yesterday two times for her first dose and today she didn't take it at all, though she will probably take it in a little while. She said she doesn't know if it is going to help or not. She said she took one cap full of the liquid that you put in the plastic cap that comes on top of bottle, you drink that. The outcome of event was not recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773703
Sex: F
Age:
State: IL

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 10/09/2021
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: Test Name: Blood; Result Unstructured Data: Test Result:Unknown results; Test Name: Urine; Result Unstructured Data: Test Result:Unknown results; Test Name: TB test; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Muscle aches/Muscles are sore; headache; Her eyes were itching/Eyes itch around the outside; had a runny nose/Has to keep tissue in nose due to running/Nose is running; a hot flash in her face; she felt that there were needles sticking on her face and stuff; Feels like she has the flu; Feels like she has a cold; Where they shot her in the arm is sore; Legs ache; Back ache; Feeling woozy; Tired and sleepy; Tired and sleepy; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 21Mar2021 at 11:20 am (age at vaccination was 63 years) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing lupus (she had been living with lupus for about 20 years). There was no family medical history relevant to adverse event. The patient's concomitant medications were not reported (the patient did take medication). The patient previously took flu shot (she had never had a vaccine in her life except for the flu shot twice and TB test. She had no bad reactions). The facility where the most recent COVID-19 vaccine was administered was School Gymnasium. The vaccine was not administered at Military facility. There was no history of any previous immunizations with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the 1st dose of the vaccine and experienced side effects that bothered her. On 21Mar2021, about an hour after vaccine was administered, the patient had muscle aches, a headache, her eyes were itching, had a runny nose, a hot flash in her face, she felt that there were needles sticking on her face and stuff and the right side of her face had muscle aches. On 21Mar2021, the patient felt like she had the flu. Her muscles ache, her eyes itch around the outside, nose was running, had to keep tissue in her nose, felt like she had a cold with the runny nose and muscle aches. She stated where they shot her in her arm was also sore. Her muscles were sore, her legs and back were aching. She had not felt like that all year. She also felt woozy. The patient stated that all her mentioned symptoms started about an hour after the vaccine. She was still sleepy, nose was still running, still tired. All other symptoms were still there but a little bit better than they were. She stated that her arm was still sore, it started at the same time as all her other symptoms. She felt it when the lady stuck her. Arm felt a little better than it did yesterday. The patient stated that she shouldn't feel like that. She mentioned she took the flu shot, but she never felt sick like that. She did not want to get shots that make her feel sick. She stated that the shot was too strong, it was a strong shot, that why she had wanted to get the Johnson shot to just have to get one shot and be done with it, she asked what would happen if she does not get the second vaccine, would it still be effective. The patient inquired if she has to get the second shot. She asked if she should take the 2nd shot because she does not want to go through that again. The patient had a doctor visit for her checkup last week where they did the blood and urine and the result was unknown on an unspecified date. The patient underwent lab test which included TB (Tuberculin) test and the result was unknown on an unspecified date. The adverse events did not require a visit to Emergency Room or Physician Office. There was a product complaint. The outcome of the events muscle aches/muscles are sore, her eyes were itching/eyes itch around the outside, where they shot her in the arm is sore, legs ache and back ache was resolving. The outcome of the events had a runny nose/has to keep tissue in nose due to running/nose is running, tired and sleepy was not resolved. The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness: Lupus syndrome (She has been living with Lupus for about 20 years.)

ID: 1773704
Sex: F
Age:
State: NJ

Vax Date: 03/04/2021
Onset Date: 03/17/2021
Rec V Date: 10/09/2021
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: Rash; Swollen lips; Tingle lips; This is a spontaneous report from a contactable consumer reported for herself. A 60-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in arm right on 04Mar2021 at 08:00 (age at vaccination was 60 years) as single dose for COVID-19 immunization. The patient's medical history included drug hypersensitivity to penicillin and NASIDS from an unknown date. The patient have any known allergies. Concomitant medication included biotin and multi vitamin taken for an unspecified indication, start and stop date were not reported in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 at 17:00, after the first dose the patient experienced rash, swollen lips and tingle lips. No treatment was received for the adverse events. On 17Mar2021 at 08:30 patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Arm Right and experienced Severe aches, pain, chills, fatigue and full body rash. The outcome of the events was not recovered. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds: BIOTIN

Current Illness:

ID: 1773705
Sex: F
Age:
State: GA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 10/09/2021
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: Puffy on the left side of face from left eye to lip; Tingly on the left side of face from the left eye down to lip; Hard to talk; Face felt heavy; tingly numbness, when she pokes the left side of her face; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration in Arm Left on 19Mar2021 09:15 (age at vaccination 50 years) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included psoriasis. Patient stated she was diagnosed in Sep2020 but has had for a while. Patient stated she received a Flu shot a while back in Dec2020 but does not have any further information to provide. There was no family medical history relevant to AE. Concomitant medications included risankizumab rzaa (Skyrizi) taken for psoriasis from Nov2020 to an unspecified stop date. Skyrizi was received in Nov2020, Dec2020, and Mar2021. Patient was taking COVID Vaccine because of Covid prevention. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. AE did not require a visit to emergency room or physician office. There was no AE following prior vaccinations. There was no prior vaccinations within 4 weeks. On 19Mar2021, patient just got the Pfizer Covid Vaccine around 9:15am this morning, about an hour ago the left side of her face started to get puffy, she stated it's not really big, it was a little tingly like when you go to a dentist and had that gas and get home and itches and then she stated she's trying to get that feeling back. Patient clarifies she was puffy on the left side of her face from the left eye down to her lip. It had not swollen up anymore it was just about the same. Patient clarifies she can tell she was better since her talking was better, it was like she was really having to move her mouth since it was heavy. She feels like the swelling has gone down a lot. When she says tingly numbness, when she pokes the left side of her face, she cannot really feel her fingernail but on the other side she can feel it. It's not constant but she was aware of it. Patient did not receive the treatment for events. There were no relevant tests. The outcome of events was recovering. No follow-up attempts are possible. No further information was expected.

Other Meds: SKYRIZI [RISANKIZUMAB RZAA]

Current Illness: Psoriasis (Caller stated she was diagnosed in Sep2020 but has had for awhile)

ID: 1773706
Sex: M
Age:
State: MI

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 10/09/2021
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: feels like a stiff neck; every bone and muscle in his body hurt; every bone and muscle in his body hurt; headaches; shoulder pain/pain under right shoulder blade; severe neck pain on the right side; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 19Mar2021 at 13:00 pm (age at vaccination was 68 years) as dose 2, single for COVID-19 immunization. The patient's medical history included bypass right leg artery in 2018, ongoing AFib (atrial fibrillation) (it took a long time for him to be diagnosed with Afib, that the physician wasn't sure what was going on. It had been at least 5 years since he was diagnosed), coronary artery disease from 2010 and ongoing (his arteries get clogged up and that his arteries were cleaned out every once in a while. He was checked every six months. He was diagnosed with coronary artery disease when he had his first bypass in 2010), 2 bad discs in 2019 and ongoing, 2 rods and cage put in below neck in 2020 and ongoing (he went to the physician for his lower back and after examining his MRI, the physician informed him that his neck had to be addressed first. In 2020 he had surgery for another cage to be put in and the hardware rebuilt just below his neck), shoulder replacement in 2019, back surgery in 2018 and ongoing lower back pain. The patient's father died of lung cancer and his mother died of a heart attack. Concomitant medications included tamsulosin taken for having a hard time urinating from an unspecified start date and ongoing (he had been taking for about a year. He began taking tamsulosin because he was having a hard time urinating and the medication makes you urinate), rosuvastatin taken for high cholesterol from an unspecified start date and ongoing (he had been taking rosuvastatin for years, probably 10 or better. Rosuvastatin lowers cholesterol readings and that his readings have been good but his physician has not taken him off of the medication), metoprolol taken for Afib (atrial fibrillation) from an unspecified start date and ongoing (he has been taking metoprolol for about a year, he had previously been on a different medication that was really bad and that he had been bugging his physician about changing the medication and was finally switched), clopidogrel bisulfate (PLAVIX) taken for plaque from 2010 and ongoing, vitamin C [ascorbic acid] taken to boost immune system from an unspecified start date and ongoing (he had been taking vitamin C for 5 years), colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin D was low from an unspecified start date and ongoing (he began taking the vitamin D supplement about 2 years ago), cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]) taken for an unspecified indication to give him a little more pep from an unspecified start date and ongoing (he had been taking the vitamin B12 for a couple of years), hydrocodone taken for an unspecified indication from an unspecified start date and ongoing (hydrocodone acetaminophen does not fully take the pain off of his lower back but it takes the edge off), acetaminophen taken for an unspecified indication from an unspecified start date and ongoing (he had been taking hydrocodone/acetaminophen for 2 years. He took this medication as needed and that sometimes he did not take it), rivaroxaban (XARELTO) taken for bypass on right leg artery from 2018 and ongoing, hydrocodone bitartrate, paracetamol (NORCO) 5/325 taken for lower back pain (this was the only pain medication he takes. He began taking the Norco when he began having back problems, about 2 years ago. He has had quite a few operations. He had been on stronger pain medications in the past but he just takes the lowest dose of the Norco now) and Adult plus 50 multi vitamin taken as a multivitamin from an unspecified start date and ongoing (he had been taking a multivitamin for a couple of years). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiration date: unknown) injection, administered in right arm on 26Feb2021 (age at vaccination was 68 years) as dose 1, single for COVID-19 immunization and he did not have any problems with the first dose of the COVID-19 vaccine. The patient previously took flu shot in Sep2020 (he has not had any shots since he received his flu shot in Sep2020). The facility where the most recent COVID-19 vaccine was administered was a fire department. The vaccine was not administered at Military Facility. No additional vaccines were administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The had the second dose of the Pfizer COVID 19 vaccine on 19Mar2021. On 19Mar2021, the patient experienced severe neck pain on the right side and pain under right shoulder blade/severe neck and shoulder, every bone and muscle in his body hurt and headaches. On 19Mar2021, about 6-7 hours after he received the second dose of the COVID-19 vaccine, the patient experienced severe neck and shoulder pain. Headaches started when the severe neck pain started. He could feel the pain going up his neck behind his ear and into his head. On 19Mar2021 around 21:00 pm, the patient experienced muscle aches. The pain gets so bad that he had to lay down. The pain would go away a little bit for maybe a half hour or something and then the pain comes right back. The body and muscle aches went away the following day, but that the severe neck and shoulder pain and headaches will not go away. It had been four days and he was still having severe neck pain on the right side and pain under right shoulder blade. On an unspecified date, it felt like a stiff neck and intense especially in the evening. It was very irritating. On 21Mar2021, the patient felt better but the severe pain was still present in his neck and under his right shoulder blade. He could not walk very far due to his back pain. He would walk to his mailbox and could not make it back sometimes due to the pain in his lower back. The neck and shoulder pain was not as in bad in the morning when he wakes up, but as the day progresses it gets worse. The patient wanted to know how long that would last asking and would he have that the rest of his life. He has been experiencing the neck pain, shoulder pain, and headaches for 4 days. The patient was a little concerned as he was going in for back surgery on 14Apr2021 for 2 bad discs and he did not want any problems. He wanted to make sure everything was ok, that he had been waiting to have that surgery for a year and cannot wait any longer. He had talked to other people who reported similar side effects and said the side effects only lasted 2 days. He was still having symptoms 4 days after his second dose of the COVID-19 vaccine on 19Mar2021. He was nervous about it with his upcoming surgery on 14Apr2021. He will be hospitalized for 3 days after the surgery and he was anxious to get the COVID-19 vaccine because he wanted to be protected during his hospital stay post surgery. No relevant tests were done. There was a Product Complaint. The outcome of the event every bone and muscle in his body hurt was resolved on 21Mar2021. The outcome of the event feels like a stiff neck was unknown. The outcome of the other events was not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds: TAMSULOSIN; ROSUVASTATIN; METOPROLOL; PLAVIX; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; VITAMIN B 12 [CYANOCOBALAMIN]; HYDROCODONE; ACETAMINOPHEN; XARELTO; NORCO

Current Illness: AFib; Coronary artery disease; Herniated disc; Low back pain; Neck surgery

ID: 1773707
Sex: M
Age:
State: CA

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210119; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Body chilling; sweating; sore throat; sense of smell slightly lost; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9263), via an unspecified route of administration in left arm on 16Feb2021 09:15 AM (at the age of 36-years-old) as a dose 1, single and patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6201), via an unspecified route of administration in left arm on 16Feb2021 (at the age of 36-years-old) as a dose 2, single for COVID-19 immunization. The patients medical history was not reported. The patients concomitant medications (other medications the patient received within 2 weeks of vaccination) included Cephaalosporin, Amoxicillin. The patient had no allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient was not been tested for COVID-19. Post vaccination, the patient had underwent lab test which includes Nasal Swab (SARS-CoV-2 test) test resulted as negative on 19Jan2021. On unspecified date patient stated that he experienced Body chilling sweating sore throat lasts for two months, and the sense of smell slightly lost. Patient had not received any treatment for the events reported. The outcome of events was not recovered. Location of injection information is available for all vaccines received on the same date.

Other Meds: CEPHALOSPORIN C; AMOXICILLIN

Current Illness:

ID: 1773708
Sex: F
Age:
State: VA

Vax Date: 03/20/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: my nose stuffed up; my bottom lip swelling up; soreness in my arm; weird petroleum jelly kind of taste on my lips; bumps on inside the bottom lip; bumps tongue; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution of injection), dose 1 via an unspecified route of administration on 20Mar2021 11:30 (at the age of 62-years-old) (Lot Number: EP7534) as dose 1, single for covid-19 immunisation. The patient medical history included ongoing blood pressure high, ongoing asthma and anaphylaxis from an unknown date and unknown if ongoing, anaphylaxis to drugs and insects and shell fish from unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) 50 mg two times a day taken for high blood pressure, start and stop date were not reported; amlodipine (AMLODIPINE) 5 mg one time a day taken for high blood pressure. 0n 20Mar2021, patient had the first dose of the Pfizer vaccine and ell fish so we did the extra 30 minutes of observation and during that time the only thing that she noticed was soreness in arm and just weird petroleum jelly kind of taste on lips. Patient goes for lunch and goes out the last evening for a half an hour so and at 11PM, her nose stuffed up and bottom lip swelling up and she took two Benadryl (Treatment) dissolvable 12.5 to equal a total of 25mg so they chewable to children but she could not make it them dissolve faster and stopping allergic reaction quicker. She woke up this morning and half of the lips was normal and other half was still slightly swollen hence worried that, it was not good with the second dose like if she get second dose it might an anaphylactic reaction. Patient was stuffiness like in her nose and then in bottom lip started swelling and it was about 12 hours almost exactly 12 hours later but yes that was where she was with the anaphylaxis. Usually, she get bumps on inside of the bottom lip then on tongue, throat and on nose will start to swell and thats as an urgent situation and shen had an EpiPen and Benadryl so she tried Benadryl first and not had using EpiPen till the time of reporting. Patient got very strange reaction and at 12 hours later, on 21Mar2021 in morning half of her lips was still swollen and she look kind of weird. The patient received treatment of Benadryl for event nasal congestion and lip swelling. The outcome of the events was unknown No follow-up attempts are possible. No further information is expected.

Other Meds: LOSARTAN; AMLODIPINE

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

ID: 1773709
Sex: F
Age:
State: MN

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210313; Test Name: Heart rate; Result Unstructured Data: Test Result:156 beats per minute; Test Date: 20210313; Test Name: Heart rate; Result Unstructured Data: Test Result:100-120 beats per minutes; Comments: at least 3 hours

Allergies:

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

Symptoms: I had trouble swallowing; My heart rate went up to 156 beats per minute at the highest point and stayed between 100-120 beats per minutes for at least 3 hours; I also had trouble getting a deep breath during all of this; This is a spontaneous report from a contactable consumer(patient). A 54-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207) via an unspecified route of administration, administered in right arm on 13Mar2021 04:00 PM as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination 54). The patient's medical history included COVID-19 positive (if covid prior vaccination: Yes) on an unspecified date and the concomitant medication was not reported. No history of allergy was reported. No vaccine was received within 4 weeks prior to the COVID vaccine. No other medications was received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not tested for COVID-19 after vaccination. Within 8 minutes of receiving the shot, on 13Mar2021 the patient experienced that she had trouble swallowing. Her heart rate went up to 156 beats per minute at the highest point and stayed between 100-120 beats per minutes for at least 3 hours. They sent her to the ER to get an EKG and that came back normal. She also had trouble getting a deep breath during all of this. The adverse event resulted in emergency room and received treatment for the event as EKG. On 13Mar2021 the patient had lab test for Heart rate and reported as 156 beats per minute at the highest point and stayed between 100-120 beats per minutes for at least 3 hours, on an unknown date the patient underwent lab test for EKG and reported as normal on Mar2021. Since vaccination the patient was not tested for COVID-19. The outcome of the events was recovered on mar2021 (unspecified day). No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1773710
Sex: F
Age:
State: IL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
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: tightness in chest; mild nausea; This is a spontaneous report from a contactable consumer. This consumer reported for a 17-year-old (17.9years) daughter (patient) (non-pregnant) female patient that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the left arm on 23Mar2021 at 13:00 (at the age of 17-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included known allergies to peanut, tree nut, environmental allergies. Concomitant medications were not reported. On 23Mar2021, 10 hours post vaccination at around 10:00 PM, the patient experienced tightness in chest (pro air albuterol used, no relief) and mild nausea. No other vaccine in four weeks. Other medications within 2 weeks of vaccination immunotherapy, breo elipta, pro air (albuterol). Treatment given was pro air albuterol used, no relief. No covid prior vaccination, no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome was not resolved for both the events. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1773711
Sex: M
Age:
State: PA

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: Injection site pain; Pain all over body; Muscle pain; Slight chills; Not really feeling well; Joint pain; Last night her couldn't sleep; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 04Mar2021 07:40 (at the age 69 years) as SINGLE for covid-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications included olmesartan medoxomil taken for high blood pressure who has been on for more than a year and unspecified vitamins for general health. It was reported that during the day when he had the injection in Mar2021, he got the regular injection site pain and discomfort and that went away after day two. Since yesterday, he started having pain all over his body. He adds that it was really intense last night. He adds he also had muscle pain, slight chills, joint pain, not really feeling well. He goes for quick walks sometimes and he does have reaction to some stuff. He adds that for some of those things he has a pen. He has joint pain if he eats wheat. He normally has some pain but that goes away. This is kind of different and it was really pain all over the body. He was wondering if these are signs of infection. He was asking if he can have this kind of reaction after this, after so long after the injection. Muscle pain was all over. He had chills that did not go away, and kind of trouble sleeping from them. Started last night when he went to sleep. It was just when he woke up that he was really sweaty when he woke up. Not really feeling well started last night. He felt fine now. He was going to get back to his normal routine. Once he gets off of the phone, he was going to go for a walk. States that last night couldn't sleep because his "body felt like a war zone". His main question was if can expect to get a reaction and side effects from the shot so many days later. He thought it would be 1 to 2 days normally after the second vaccination that these occur, but he has them after the first shot. The clinical outcome of the event pain all over body, muscle pain, slight chills, not really feeling well, joint pain, insomnia was unknown and recovered for injection site pain in Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: OLMESARTAN MEDOXOMIL

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

ID: 1773712
Sex: F
Age:
State: CO

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 10/09/2021
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: Also got a cough; I have a cough too; Did have a fever when they gave me the shot; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot number: EN6207 and Expiration date: Not reported), via an unspecified route of administration on 17Mar2021 (age at vaccination 74-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes, cold. There were no concomitant medications. It was reported that she went in with the cold, she had cough too, she did have a fever when they gave me the shot. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021322551 same reporter/SD, different patient/AE

Other Meds:

Current Illness:

ID: 1773713
Sex: F
Age:
State: NJ

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Brain scan; Result Unstructured Data: Test Result:she had a blood clot in the left side of her brain; Comments: brain scan showed she had a blood clot in the left side of her brain; Test Name: Stent placement; Result Unstructured Data: Test Result:2 heart stents placed; Comments: she had 2 heart stents placed after it was discovered she had a heart attack

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: she went from 130 lbs. to 95 lbs; Feeling unwell; 3 hours after getting her COVID-19 Vaccine, and was flat in bed with vertigo; she said the tiredness accompanied her vertigo; stated her dizziness started with her vertigo; stated she always has weakness with her vertigo; Runny nose; Diarrhea; Shakiness; her blood pressure went up and down; Feeling hot and cold; her injection site pain was very painful at the time, but went away. She said the injection site wasn't red or anything; Muscle pain; Chills; Joint pain; Difficulty breathing; She had a fast heart beat a week after getting her COVID-19 Vaccine. Her fast heart beat lasted 4-5 hours and then calmed down.; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in left arm on 05Mar2021 10:15 (at the age of 81-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing vertigo from 2001 (patient said she was around diesel fuel all the time and read where diesel fuel may be associated with vertigo. She said she often wondered if diesel fuel was the cause of her vertigo. She said it had been about a year since her last vertigo episode), asthma from an unknown date and unknown if ongoing (patient had asthma from the time she was 11 months old until she was 21 years old. She was exposed to a neighbour who had whooping cough & then she got whooping cough at 11 months old & from that point forward, she had asthma), COPD from an unknown date and unknown if ongoing had COPD for about 3 years and said she was on oxygen twice a day for her COPD, covid-19 from Dec2020 to an unknown date (On Dec2020 patient was in the hospital. She clarified she had her husband bring her to the Emergency Room on 29Dec2020 because she had bad lower back pain, discharged on 30Dec2020 and said on 31Dec2021 husband brought her back to the Emergency Room for her back pain, diagnosed with COVID-19, patient said she has had no sense of taste or smell since being diagnosed with the COVID-19 Virus in Dec2020) , stroke from an unknown date and unknown if ongoing, heart atack from an unknown date and unknown if ongoing She said she discovered she had a prior heart attack while she was being checked for her vertigo, Patient stated she can't have (unspecified allergic): caffeine, Flomax, sodium, antihistamines (used for allergy relief), Naproxen, Novocain, Reglan and IV Contrast or Iodine. She said if she has dental work, the dentist has to give her oxygen before giving Novocain. There were no concomitant medications. Patient stated she has been on Amoxicillin for years for her COPD and Asthma but did not take Amoxicillin 2 weeks before, during, or after she had her COVID-19 Vaccine. No prior vaccination within four weeks. No additional vaccines administered on same date of the Pfizer suspect. On 05Mar2021, patient stated 3 hours after getting her covid-19 vaccine, and was flat in bed with vertigo, tiredness accompanied her vertigo, feeling unwell, her dizziness started with her vertigo, and weakness start the same day she had her COVID-19 Vaccine She said she never had a headache, but 2-3 days after her COVID-19 Vaccine (on unspecified date in Mar2021) she had: injection site pain, muscle pain, chills, joint pain, difficulty breathing, a fast heartbeat, runny nose, diarrhoea, her blood pressure went up and down, and she was hot and cold. She stated a couple days ago she started to have the shakes. Patient stated injection site pain was very painful at that time but went away. She said the injection site wasn't red or anything. She said she had a fast heart beat a week after getting her COVID-19 Vaccine. She was just sitting in her chair, and she could feel her heart started beating fast, and she thought her heart was going to come out of her body, her fast heartbeat lasted 4-5 hours and then calmed down. She said her diarrhoea went away after a couple days. On an unspecified date, patient lost weight when her husband fell and was sick, and she had to become his caregiver. She said she went from 130 lbs. to 95 lbs. Patient stated the only thing she took was 1 generic Meclizine 25mg. On an unspecified date, the patient underwent lab tests and procedures which included Brain scan: she had a blood clot in the left side of her brain and stent placement: she had two heart stents placed after it was discovered she had a heart attack that she never knew she had. She said she discovered she had a prior heart attack while she was being checked for her vertigo. No emergency room or physician office visit. Outcome of the events runny nose, shakiness and feeling unwell was recovering, outcome of event she went from 130 lbs. to 95 lbs was unknown and outcome of rest of the events was recovered on unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Vertigo (Verbatim: Vertigo)

ID: 1773714
Sex: M
Age:
State: CT

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 10/09/2021
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: arm is all red; swollen from elbow; Arm is all swollen; This is a spontaneous report from a contactable consumer (reported for her brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced arm is all red, swollen from elbow, arm is all swollen. Reporter stated, her brother had a shot yesterday (Further confirmed as 23Mar2021) afternoon and his arm is all swollen and it is all red. she wanted to know Is that a normal side effect or should we be concerned. The outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773715
Sex: F
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: nauseated; feeling sick; I can't taste; I can't taste and smell/can't smell anything now; diarrhea; Sleeping constantly; exhausted; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A female patient of (Age 60; Unit: Unknown) received first dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of Mar2021 the patient experienced nauseated, she can't taste, she can't taste and smell/can't smell anything now, diarrhea, sleeping constantly, exhausted, and on 18Mar2021 she experienced feeling sick. Patient stated she felt great when she went to get the vaccine, and she had no symptoms before. Patient stated she had a one of those black jellybeans she tasted that and salt she can taste but she cannot taste too much more. She can't smell anything. Patient asked were these adverse effects of the vaccine? How long will it last? Does the vaccine give you covid 19? Can she get the second shot? Does she get tested for covid? 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: 1773716
Sex: F
Age:
State: TX

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 10/09/2021
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: potential to not get the second dose; neck to swell around the collarbone area / huge swelling around her collarbone/ swelling her collarbone; lumps; lymph glands were swollen / lymph node swollen on left side/ lymph node is swollen; swollen area is red; allergic reaction; Since I had a reaction with the Pfizer covid-19 vaccine for my first injection, and I get the Johnson and Johnson covid-19 vaccine instead for my second injection?; swelling around her collar bone was reported as worsened; throat swollen on left side; Pain (tender) to lymph node on left side; Pain (tender) to lymph node on left side was reported as worsened / it was painful to touch and tender when she laid on that side or touched it; tenderness in left arm; This is a spontaneous report from a contactable consumer (Patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Age at vaccination: 38 years) as dose 1 single for covid-19 immunisation. Patient took the vaccine as she had a newborn and did not want to get him sick. Relevant medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced tenderness in left arm on 05Mar2021, neck to swell around the collarbone area / huge swelling around her collarbone/ swelling her collarbone, lumps, lymph glands were swollen / lymph node swollen on left side/ lymph node is swollen, swollen area is red, allergic reaction, since she had a reaction with the pfizer covid-19 vaccine for her first injection, and she get the johnson and johnson covid-19 vaccine instead for her second injection? (circumstance or information capable of leading to medication error), swelling around her collar bone was reported as worsened (condition aggravated), throat swollen on left side , pain (tender) to lymph node on left side, pain (tender) to lymph node on left side was reported as worsened / it was painful to touch and tender when she laid on that side or touched it on 07Mar2021, potential to not get the second dose (product dose omission issue on 25Mar2021. Patient was asking Can it cause your neck to swell around the collarbone area and should she even get the second injection because of what she was experiencing with the first? she was scheduled to receive the second one tomorrow (3 weeks after the first) but it not sure if she will get it or not because of what she has been experiencing after the first injection. It was further reported that the consumer reports being fine initially after the Pfizer covid-19 injection, but about 3 days letter, she experienced swelling in the collarbone area and up the left side of the neck to the jaw and even a little bit on the side of her face. The consumer reported being able to see some lumps and thought her lymph glands were swollen but was also concerned she might be experiencing an allergic reaction. The consumer stated the swollen area is red and a little bit tender and can be painful to touch. She was asking Since she had a reaction with the Pfizer covid-19 vaccine for her first injection, and she get the Johnson and Johnson covid-19 vaccine instead for her second injection? Caller stated that she wanted to report what happened to her with the vaccine. was the Pfizer Covid vaccine. Stated that she had the first dose and did not feel anything. Had no effects only tenderness in her left arm on Thursday and then on Sunday there was huge swelling around her collarbone. Stated that she had to go to the doctor like it was lymph node. Stated it was painful to touch and tender when she laid on that side or touched it. Stated that her throat felt swole up on left side. Stated that it went down but the lymph node is swollen. Later clarified that everything was on the left side. Stated she has not taken second dose. Stated that she was due for second dose but has not taken it because she heard the second one was there. Stated that she heard that with the second dose that it was worst. Wanted to know how long to take to go down. Stated the swelling her collarbone has been there for three weeks. Wanted to know if she should take the second dose. Wanted to know if she should she not get the second one until swelling and the lymph nodes go down. Wanted to know if this was considered an adverse reaction. Stated that she was supposed to return for the second dose on 25Mar. Stated that there was no doctor. The outcome of tenderness in left arm was recovered on 06March2021. The outcome of neck to swell around the collarbone area / huge swelling around her collarbone/ swelling her collarbone, lymph glands were swollen / lymph node swollen on left side/ lymph node is swollen, swelling around her collar bone was reported as worsened, Pain (tender) to lymph node on left side , Pain (tender) to lymph node on left side was reported as worsened / it was painful to touch and tender when she laid on that side or touched it was not recovered. The outcome of lumps, swollen area is red, allergic reaction, Since I had a reaction with the Pfizer covid-19 vaccine for my first injection, and I get the Johnson and Johnson covid-19 vaccine instead for my second injection? was unknown. The outcome of throat swollen on left side was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1773717
Sex: F
Age:
State: CT

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: Nasopharyngeal swab; Test Result: Negative

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Malase; Headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 02:15 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. Medical history included glaucoma, migraine both from an unknown date and unknown if ongoing. Concomitant medication included almotriptan (ALMOTRIPTAN), diclofenac (DICLOFENAC) both taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced Allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with covid-19.On 23Mar2021 22:00 patient experienced Arm pain, spread to shoulder, neck, and headache, malase. patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the events was reported as resolving at the time of this report. No follow up attempts are needed. No further information is expected.

Other Meds: ALMOTRIPTAN; DICLOFENAC

Current Illness:

ID: 1773718
Sex: F
Age:
State: SC

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 10/09/2021
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: her arm was killing her; swollen real bad, with a red spot at the injection site and a big knot; felt dizzy; felt nauseated; and had body aches; big knot in; itches; States she had most all the side effects except fever; she had a headache; This is a spontaneous report received from a contactable consumer or other non hcp. A 68-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 21Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 01Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big knot in, itches, states she had most all the side effects except fever on 22Mar2021, her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot on an unspecified date, she had a headache on 21Mar2021, felt dizzy, felt nauseated, and had body aches on 23Mar2021. Clinical course was reported as she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 at 12:20PM in the left arm. She didn't have any side effects except a sore arm. Adds she had the second shot on Monday 21Mar2021 at 1220PM in the left arm. She had most all the side effects except fever. Her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot; she had a headache; felt dizzy; felt nauseated; and had body aches. She is most concerned about the knot which is a red raised place the size of half dollar and it itches. The clinical outcome of the events fever, headache, felt dizzy, felt nauseated was recovered on 23Mar2021, and other event had body aches was recovering and big knot in event was not recovered and other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773719
Sex: M
Age:
State: NY

Vax Date: 03/07/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: gest weekly home draws to check his INR; Result Unstructured Data: Test Result:unknown

Allergies:

Symptom List: Nausea

Symptoms: bruising of right arm, shoulder, and chest; arm pain; the shoulder is yellow and bruising, it is yellow and blue and it is pretty.; she thinks it is getting worse; This is a spontaneous report from a contactable consumer or other non hcp (patients daughter). A 87-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Right on 07Mar2021 at 14:30 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included cancers. Reporter stated her dad is on nothing unusual, he is on a lot of medications because he had different cancers but those are all done now and it was years ago. He is not on steroids or anything, walks with a walker, had hip surgery 4 or 5 years ago, but answers no to medical conditions, arthritis and has arthritis in his should which makes it. So he can not move it much. Concomitant medications included warfarin taken for coagulopathy. On 09Mar2021 patient experienced bruising of right arm, shoulder, and chest, arm pain in Mar2021, shoulder is yellow and bruising, it is yellow and blue and it is pretty in Mar2021, getting worse in Mar2021. The patient underwent lab tests and procedures which included international normalised ratio: unknown. The patient had bruising on his right arm near the injection site on his right shoulder and it was migrating to his chest getting bigger but it was not painful. The reporter was asking if she should be alarmed. The reporter sent a photo to the primary physician and because he was on Warfarin the physician thought that was what causing the bruising. The patient reported that It was still going on. An ice pack was placed on the bruising but reporter thought that she waited too long to do that because it hurt. The reporter concerned about the extent of the bruising and if it could be related to Warfarin. The patient experienced the arm pain after receiving the vaccine and only lasted a few days. The arm pain was on and off, it was also attributed to arthritis big time in his shoulders. The reporter added that she told him to move his arm around. She also told him he was not 20 anymore and that sometimes there was no magic pill. The patient was scheduled to receive the second dose on Sunday and his doctor told her to hold his warfarin a couple days prior to the second dose. Reporter wanted to know if to know if that would be okay. It was reported that bruising started by two days after the shot. It was still going on. And thinks it is getting worse. It looked okay on Sunday but now it is moving more towards his chest and getting bigger. The bruising started on his arm, moved down his shoulder and chest. She was responded that when vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. Outcome of the event she thinks it is getting worse, yellow skin and Bruising of arm was not recovered, arm pain recovered on ??-???-2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: WARFARIN

Current Illness:

ID: 1773720
Sex: F
Age:
State: NJ

Vax Date: 03/06/2021
Onset Date: 03/10/2021
Rec V Date: 10/09/2021
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: rash; redness; hives; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient (age at the time of vaccination was 60yrs) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Verbatim: COPD, depression from an unknown date and unknown if ongoing Verbatim: Depression , anxiety from an unknown date and unknown if ongoing Verbatim: Anxiety , seasonal allergy from an unknown date and unknown if ongoing Verbatim: allergic to ragweed , seasonal allergy from an unknown date and unknown if ongoing Verbatim: pollen in the air , mycotic allergy from an unknown date and unknown if ongoing Verbatim: mold, hypothyroidism from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for depression from 2014 and ongoing; buspirone (BUSPIRONE) taken for anxiety from 2014 and ongoing; methylphenidate hydrochloride (RITALIN) taken for depression from 2018 to an unspecified stop date; trazodone (TRAZODONE) taken for insomnia from 2016 and ongoing; formoterol fumarate, mometasone furoate (DULERA) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity, start and stop date were not reported; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication from Mar2021 to an unspecified stop date. On 10Mar, patient broke out in a rash, and it developed inside and behind her legs, her knees, arms, and stomach. She said there was a lot of redness, and little bumps. She said it felt like hives. Consumer said she already went to the doctor and was told that it could have been a large local delayed reaction to the 1st dose. Then on 22Mar, since the rash was not going away, she was put on Prednisone. She wants to know if the rash is associated with the vaccine, and if it would still be safe for her to receive the second dose of the covid vaccine was scheduled for Saturday, 27Mar2021. On 10Mar2021 the patient experienced rash, redness and hives. Therapeutic measures were taken as a result of the events. The outcome for the event rash was recovering while for others it was unknown. No follow-up attempts are possible. No further information is expected. Follow-up (24Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (Patient) reported that: Patient characteristics: Age at time of onset of reaction/event: 60

Other Meds: SYNTHROID; WELLBUTRIN; BUSPIRONE; RITALIN; TRAZODONE; DULERA; FLONASE ALLERGY RELIEF; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1773721
Sex: M
Age:
State: GA

Vax Date: 03/22/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: Very swollen face and facial lymph nodes; Lower back pain; Swollen face; Difficulty to eat and chew; This is a spontaneous report from a contactable consumer (patient's wife). A 55-years-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 10:30 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also denied for other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Mar2021 12:00, the patient experienced Very swollen face and facial lymph nodes, Lower back pain, Swollen face, and Difficulty to eat and chew. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1773722
Sex: F
Age:
State:

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 10/09/2021
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: broke out in hives; I started feeling really bad ;not feeling well; she was sick; brain fog/like foggy head; headache; sore throat; completely without energy; little bit of sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via unspecified route of administration on 06Mar2021 (at the age of 88-year-old) in dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications not reported. Patient queried for and like to know if it was possible to experience side effects 2 weeks after receiving the vaccine. Reporter stated that her symptoms did not start until last Friday in the afternoon. She reports that for 2-3 days on 19Mar2021 she was sick and experienced brain fog, headache, sore throat, and was completely without energy. She reports that these symptoms got better but then completely broke out in hives on 22Mar2021. She states that she was covered in hives. She reports that she has not done anything different in her life since receiving the vaccine, which was why she was attributing these side effects to the vaccine. She said she already spoke with her doctor who was recommending she wait on receiving the second dose, which was due 27Mar2021. Reporter would like to know how long she can wait before receiving her second dose of the vaccine. Patient went on 06Mar2021, got her first vaccine and she was fine except the little bit of sore arm and it was okay about till the last Friday. Friday on 19Mar2021 she started feeling really bad, like foggy head, sore throat, headache and just basically not feeling well and then that subsided. On Wednesday that was subsided. Monday morning on 22Mar2021 and then she dropped out into bunch of hives so now she was dealing with hives. So she had an appointment with her doctor and she was just wondering that if she should take her second shot because she will due to take it on 27th which was this coming Saturday. She was a kind of leery right now because she so full of hives. It was like crazy. Anyway she just thought she report these side effects. Reporter queried for was it possible to get a reaction 2 weeks later. Almost It was, almost 2 weeks before she got the reaction. she need to know if she need if she can take If that safe to take second vaccine, the second dose. Reporter stated that she was surprise after for almost 2 weeks that she would reaction. Outcome of event little bit of sore arm was unknown and broke out in hives was not recovered and recovered for all events on unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773723
Sex: F
Age:
State: TX

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 10/09/2021
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: itchy rashes all over my body; itchy rashes all over my body; the back of my tongue felt thick and tingled; the back of my tongue felt thick and tingled; difficult to swallow; wheezing; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37 years old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Left Arm on 25Feb2021 (at the age of 37-year-old) as Dose 1, single for covid-19 immunization. Facility type vaccination was reported as Other. The patient was non-pregnant at time of vaccination. The patient's medical history included thyroid and asthma. The patient had no known allergies. The patient had received other medications within two weeks of vaccination. Patient was neither diagnosed for covid prior to vaccination nor tested for Covid post vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On 25Feb2021 (30 minutes after receiving the dose 1 vaccination), the patient experienced itchy rashes all over the body, the back of her tongue felt thick and tingled, it was difficult to swallow, and she was wheezing. At the site of injection was red, warm, itchy and raised. This was lasted in 2 days. These events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed steroid pack and OTC Benadryl for resulted events. The outcome of all the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. Information about lot or batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773724
Sex: F
Age:
State: TX

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot; nauseated; fever; didn't feel like herself/feeling bad; mild headache; her left arm was hurting/sore left arm; arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number/expiry date: unknown) (age at the time of vaccination was 62 years), administered in arm left on 05Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included pulmonary embolism from 2012 and unknown if ongoing. Concomitant medications were not reported. On 05Mar2021, the patient received first dose of Pfizer BioNTech Covid vaccine. On 06Mar2021, patient had sore left arm on second and third day after vaccine. On 12Mar2021, the patient had a little bit of a headache. On 13Mar2021, after receiving vaccine the patient arms and thighs were warm to the touch, felt hot and arm hurt at the injection site. The felt nauseated, arm continued to hurt and a mild headache. This lasted 2-4 days where she did not feel like herself. Caller states that she had a side effect starting later on the first or second day. She states on the 8th day after, her left arm was hurting and very warm and hot to the touch and her thighs were hot and she was feeling nauseated. She states on the 11th day after the vaccine she was still feeling nauseated. She states that she had a headache. She states her arm has been hurting for at least a good 10 days. She states that she does not know if she should get second vaccine because they say that people only get side effects the first and second day. States that she was calling because she was due for second one on Friday but she was afraid. No treatment was received, states she was afraid that it would interact with the vaccine. The outcome of the events warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot was recovered on 14Mar2021, mild headache and nauseated resolved on 17Mar2021, fever resolved on 15Mar2021, didn't feel like herself/feeling bad resolved on 17Mar2021, arm hurt at the injection site, her left arm was hurting/sore left arm not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773725
Sex: M
Age:
State: OH

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 10/09/2021
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: Headache; Red eyes; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 18Mar2021 01:30 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY) taken for asthma, start and stop date were not reported. Patient previously received flu vaccine for immunisation about two months ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced chills. On 19Mar2021, patient experienced headache, red eyes. Clinical course: patient got chills later in the afternoon on 18Mar2021, and that his chills have improved since then. patient then got a headache, and his headache was real bad and keeps getting worse, and his eyes are really red. Reporter stated that on 23Mar2021 was the worse headache patient ever had in his life. Reporter asked if the patient can get second dose. The events were reported as non serious. Therapeutic measures taken as a result of event headache included Tylenol and ibuprofen and also taking over-the-counter Visine for his red eyes. Events did not result in emergency room or physician office visit. The outcome of the event chills was recovering and headache, red eyes were not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: TRELEGY

Current Illness:

ID: 1773726
Sex: F
Age:
State: NV

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 10/09/2021
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: broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727; Expiration Date: 30Jul2021), via an unspecified route of administration in the right shoulder on 18Mar2021 10:00 (age at vaccination: 68 years) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. The patient's medical history included lateral lumbar interbody fusion from 10Feb2021 to an unknown date. The patient had surgery 5 weeks before. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. On 18Ma2021, the patient broke out with a rash around surgical area, ears and head itch/the rash was raised, red, super itchy. The rash was only around her surgical site. The rash was really bumpy and dense. It was mostly around her surgical site on her abdomen. The reporter was thinking that she shouldn't get the second dose because of this. The adverse events did not require a visit to emergency room. The patient has been calling her surgeon. The patient did not have any prior vaccinations in four weeks nor was tested post vaccination. The outcome of the events was not recovered. There was no product quality complaint (PQC) present. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773727
Sex: F
Age:
State: VT

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 10/09/2021
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: it is aching into her shoulder, shoulder blade and in the front; my arm started hurting/aching at injection site,; arm sore; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 15Mar2021 13:15 (Batch/Lot number was not reported: Expiry date: unknown) as dose 1, single for covid-19 immunisation (at the age 71-years-old). The patient medical history and concomitant medications were not reported. The patient doesn't have family history. No relevant tests were conducted. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. On 15Mar2021, the patient experienced headache for a day then it was gone. On 22Mar2021, the patient experienced arm sore then last night it was really painful; and today it is aching into her shoulder, shoulder blade and in the front and she also reported yesterday on 23Mar2021, her arm started hurting/aching at injection site, going up into her shoulder. Reporter said and enquired for information about this and some information says a delayed onset can happen. The outcome of the event headache was recovered; arm sore was not recovered and for the remaining events it was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773728
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: Asthma; This is a spontaneous report from a contactable consumer (patient). A 60-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration, in the left arm on an unspecified date in Mar2021 at 09:00 AM (age at the time of vaccination was 60-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma and diabetes from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient had no allergies to medications, food, or other products. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had received other medications (unspecified) within 2 weeks of vaccination. On 10Mar2021 at 09:15 AM, patient experienced asthma. Therapeutic measures were taken as a result of the event and treatment included albuterol. Reporter considered the event as non-serious. Outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773729
Sex: M
Age:
State: WA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:Unknown; Test Name: cardiac enzyme testing; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: Tightness in chest; Tightness in neck area; Light headed; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. Medical history included musculoskeletal disorder and known allergies with Pineapple or citrus fruits from an unknown date and unknown if ongoing. Concomitant medication(s) included cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and diclofenac (DICLOFENAC) received within 2 weeks of vaccination taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 10:30 the patient experienced tightness in chest and neck area, Lightheaded and blurry vision. The patient underwent lab tests and procedures which included electrocardiogram with unknown and myocardial necrosis marker with unknown results on an unspecified date. Therapeutic measures were taken as a result of all events. The adverse events resulted in emergency room visit. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; DICLOFENAC

Current Illness:

ID: 1773730
Sex: F
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: 20210325; Test Name: temperature; Result Unstructured Data: Test Result:99.3 Fahrenheit; Test Date: 20210325; Test Name: temperature; Result Unstructured Data: Test Result:100.3 Fahrenheit; Test Date: 20210325; Test Name: temperature; Result Unstructured Data: Test Result:goes over 100F Fahrenheit

Allergies:

Symptom List: Pain in extremity

Symptoms: cold chills; fever; feel like I have flu symptoms; arm sore; feeling achy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an un-Age: 71; Unit: Unknown received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 24Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling achy, arm sore on 24Mar2021, patient experienced cold chills on 25Mar2021 15:00, patient experienced fever, and feel like i have flu symptoms on 25Mar2021. Caller stated she was looking on the paperwork she received. She received the first dose of the Pfizer vaccine yesterday. his arm got sore last night and this morning for a while. she was feeling achy. Today at 3pm she had cold chills, some of the stuff there that's on the paperwork. Cold, achy joints. she started with a temperature at 99.3 then 100.3. The paperwork says if a fever goes over 100F or higher call Care/doctors. patient temperature is 100.3 it's already after 6pm here. she just wants to know it went over 100. she took Tylenol early this morning for his arm because it was sore and took ibuprofen. she feels like she have flu symptoms. Most people say it's the 2nd shot that they had reactions. she wasn't going to get the vaccine. Everything was so sketchy, one thing one day and something the next day. she got covid in Oct, even though there was a lot of talk about not taking it. It's similar to how she was feeling now, but twice as worse. The patient underwent lab tests and procedures which included body temperature: 99.3 fahrenheit, body temperature: 100.3 fahrenheit, body temperature: goes over 100f fahrenheit on 25Mar2021. The outcome of events was unknown. No follow-up attempts are possible. No information about lot/batch number cannot requested.

Other Meds:

Current Illness:

ID: 1773731
Sex: F
Age:
State: IN

Vax Date: 03/19/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210324; Test Name: fever; Result Unstructured Data: Test Result:100; Comments: fever that got up to 100 at first then 101 later.; Test Date: 20210324; Test Name: Fever; Result Unstructured Data: Test Result:101; Comments: fever that got up to 100 at first then 101 later.; Test Date: 20210324; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Pending

Allergies:

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

Symptoms: 5 days after receiving vaccine I developed flu-like symptoms.; Minor diarrhea; upset stomach; chills; fever that got up to 100 at first then 101 later.; This is spontaneous report from a contactable other healthcare professional. This 41-year-old female other healthcare professional (patient) reported that: A 41-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown) via unknown route of administration on 19Mar2021 10:30 (at the age of 41 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not have relevant medical history and concomitant medication. The patient did not have allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive any other medications within 2 weeks of vaccination. On 24Mar2021 14:30, the patient experienced 5 days after receiving vaccine patient developed flu-like symptoms, minor diarrhea, upset stomach, chills and fever that got up to 100 at first then 101 later. On 24Mar2021, the lab data included body temperature was fever that got up to 100 at first then 101 later and nasal swab test performed result was pending. Patient visited emergency room due to the events. No treatment was received for events. The patient did not have covid prior vaccination and tested for covid post vaccination. The outcome of the events was not recovered at the time of last observation. No follow-up attempts were needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1773732
Sex: F
Age:
State: KY

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 10/09/2021
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: quite red; knot on her arm started to shrink; it started to itch/ it was itching her/ arm is itching; It was hot to touch; a large knot on her arm; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old female consumer received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6204, Expiry date: 30Jun2021) dose 2, Via an unspecified route of administration, administered in left arm on 12Mar2021 at 10:20 as a single dose for (at the age of 62 year) COVID-19 immunisation. Medical history includes high blood pressure, underactive thyroid, and hypothyroidism from unknown start date and unknown if ongoing. Concomitant medication includes ongoing levothyroxine sodium (EUTHYROX) 112ug one tablet orally every morning for underactive thyroid, hypothyroidism over 20 years ago, Ongoing benazepril (BENAZEPRIL) 20 mg tablet orally started taking over 20 years ago and chlorthalidone (CHLORTHALIDONE) 25 mg tablet, started taking about 12 years both taken for high blood pressure start date and stop dates were not reported. Family Medical History Relevant to AE(s): On her maternal and paternal side, both parents had cancer. Her dad was in his seventies and her mom was in her forties. She does not know if this is relevant to her having a reaction on her arm. She has a thyroid condition and there is history of it on in her family on her paternal side, her dad and his mother have it. On her mother's side, history of geriatric diabetes, her aunt and mother's aunt had it. Before taking chlorthalidone, she originally took another water pill but it gave her leg cramps. Her doctor switched her from chlorthalizine to chlorthalidone. Clarified that the medication that gave her leg cramps was chlorthalizine. She was taking chlorthalizine 25mg once a day orally. She started taking chlorthalizine over 30 years ago for high blood pressure. Initially they treated her high blood pressure with a diuretic, but whenever that stopped working, they prescribed her benazepril. Clarified that the diuretic that stopped working was chlorthalizine. Historical vaccine includes bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6001, Expiry date: 30Jun2021) dose 1, Via an unspecified route of administration, administered in left arm on 12Mar2021 10:00AM as a single dose for (at the age of 62 year) COVID-19 immunisation. Within 24 hours of vaccination on 13Mar2021, the knot developed. A large knot on her arm. The knot was pretty good sized. It was hot to touch and also quite red. It remained unchanged until 17Mar2021. Her arm was hot to touch from 13Mar2021 to 16Mar2021. Then the knot was not hot, it was just warm and began to get smaller. As of today, the knot is still there, and it is probably about the size of a quarter. Whenever the knot on her arm started to shrink, it started to itch. It does not itch all of the time on 18Mar2021. The first day or so it was itching her nonstop. Her arm is itching now, and it made her think of it. Patient did not require to visit Emergency Room and Physician Office for the adverse event. Outcome of the event It was hot to touch was resolved on 16Mar2021 while for other events it was recovering and remained unknown for quite red. No follow-up attempts are possible. No further information is expected.

Other Meds: EUTHYROX; BENAZEPRIL; CHLORTHALIDONE

Current Illness:

ID: 1773733
Sex: F
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 10/09/2021
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: Itchy rashes all over my body; My entire tong felt thick and tingly; My entire tong felt thick and tingly; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; Nausea; Diarrhea; Throw-up once; Sweating; Shivering; Body ached all over; I woke-up feeling warm; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 (at the age of 37-year-old) as DOSE 2, SINGLE DOSE for covid-19 immunisation. Medical history included thyroid and asthma. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination was reported as yes. Patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Feb2021 09:15 (at the age of 37-year-old) as DOSE 1, SINGLE DOSE for covid-19 immunisation and experienced Itchy, Rashes all over my body, The back of my tong felt thick and tingly, Difficult to swallow, Wheezing, the site of injection was red, warm, itchy, and raised. On 18Mar2021 09:45, the patient experienced itchy rashes all over her body, her entire tong felt thick and tingly, the injection site was red, warm, itchy, and raised. That night, she woke up sweating and shivering and her body ached all over. She had diarrhea for two days and throw up once. She was still experiencing body pains, nausea, thick and tingly tong, and itchy rashes all over. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient received treatment for events as she was prescribed steroid pack and OTC Benadryl. The outcome of events diarrhea, vomiting was recovered and rest all other events was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773734
Sex: F
Age:
State: LA

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 10/09/2021
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: I had tremors for 2 hours constant shaking with no fever; joint and bone pain; joint and bone pain; headache; neck ache; diarrhea; no appetite; I felt crappy; my coordination is bad and mental capability is slow; my coordination is bad and mental capability is slow; vision was also blurred; have a stinging in my lung and i'm kind of short of breath; have a stinging in my lung and i'm kind of short of breath; started feeling ill; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 09:00 (at the age of 66 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced uncomfortable and feeling sick. Patient stated "after I got my 1st dose, I had side effects, but they were not as extreme as the 2nd dose. After the 1st dose I mainly had 2 days of being uncomfortable and feeling sick, it was over in 2 days. I took my 2nd dose on Saturday 20Mar2021 AT 9 am and started feeling ill at 2pm, I had tremors for 2 hours constant shaking with no fever, I had joint and bone pain, all my long bones in arms and legs aching, headache, neck ache, diarrhea and no appetite, I felt crappy. This morning I took a shower and found that my coordination was bad and mental capability was slow and vision was also blurred, but I was getting better when moving about, I was better than before." Patient had spoken to her doctor. Patient added "I was concerned with my lungs; I had a stinging in my lung, and I was kind of short of breath". The clinical outcome of the events was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773735
Sex: M
Age:
State: TX

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: left side of my jaw next to my ear was swollen/ballooned up by 1/2 to 3/4 of an inch; pain while opening jaw/uncomfortable when he tries to eat and moves his jaw. After talking and eating, it is painful and uncomfortable; injection site soreness; metallic flavor in mouth; headache; joints, knees, and elbows were hurting; slight flushness; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient) via Medical Information Team. A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9264, NDC number: 59267-1000-2, Expiration date: 31May2021), via an unspecified route of administration in arm left (Left shoulder) on 03Feb2021 at 11:00-11:30 (at the age of 47-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included shin splints (1991-1995 is when this started, that was more because of shoe cushioning wearing out), migraines (started 1992 or 1993 while in the military), sinus infections (he mentioned, he has had migraines and sinus infections before). The patient's concomitant medications included nature's Bounty Probiotic which he had been taking for about 7 or 8 months as it helps his stomach and one a Day Vitamins which he had been taking for years to make sure he was getting the vitamins he needs. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL1283, NDC number: 59267-1000-02, Expiration date: 30Apr2021), via an unspecified route of administration on 13Jan2021 (at the age of 47-years-old) as a dose 1, single for COVID-19 immunisation and the patient experienced pain in the injection site for about a day to a day and a half, had joint pains, had a small headache, had a metallic flavor in his mouth for a day to a day and a half following the vaccine, discomfort and slight flushness but not really a fever and that was about it. AE(s) following prior vaccines were reported as none. Stated that, he was not allergic to anything he knew about as he got his shots as a child and they gave him some in the military with no reactions. Prior vaccinations within 4 weeks were reported as none. It was reported that, after 2 hours of being on hold, the patient received the covid vaccination on 13Jan2021 and the second dose on 03Feb2021, both were Pfizer. Stated that, the patient knew that his co-workers mentioned swelling of the lymph node glands. Stated that, to him, it's been over a month since he got the second shot. This morning all of a sudden, the left side of his jaw next to his ear was swollen. He enquired, could it be a side effect even though it's been a while. Stated that, he took an antihistamine and it has gone down some. It was painful and he had discomfort when he ate. He stated that, to him quite a bit of time has passed and he did not think that, he should be having these symptoms. Today, his left side close to his ear by his jawline was swollen up. He was wondered whether this was normal and enquired if he can still get side effects even after quite a bit of time. Stated that, he did not had a fever. This was the only thing that he had was he was swollen up. He was not allergic to anything. He was about to eat breakfast today, on 22Mar2021, he ballooned up by 1/2 to 3/4 of an inch. He added, when he saw himself in the mirror, he can it out to where he can see the swelling on the left side of his face, it was pretty obvious. Stated that, on 03Feb2021, he went for his second vaccine, his follow up vaccine and with his second vaccine, he experienced most of the symptoms that he had with the first vaccine, but they were a little bit stronger. He verified, both vaccines were in his left shoulder/let arm. This time, the metallic flavor on 03Feb2021, did not last as long. He also experienced a headache. He mentioned that, he has had migraines and sinus infections before, but this was just a strong headache. The headache lasted about a day and a half. Injection site soreness, after the second vaccine, the site soreness completely went away. 20 to 30 minutes after his shot was when it start and it lasted about a day and a half. Stated that, he didn't take any medications. The only thing else he took was one a day Vitamins because sometimes his diet was iffy because sometimes he works a lot, sometimes he didn't. His schedule gets chaotic, so he wanted to make sure that he at least has a baseline and have peace of mind that he was getting what his body needs. So, he would rather take a vitamin and play it on the safe side and nature's bounty Probiotic which he had been taking for about 7 or 8 months to help his stomach. Stated that, with the second shot, he had similar symptoms but just a little bit more intense symptoms than what he experienced with the first vaccine. Stated that, unfortunately he knows that Pfizer was swamped, there were 46 people waiting and it takes so long to get through to people. He understands that, it was a public health crisis and there was a lot going on. Stated that, about left side close to ear by jaw was swollen up started today around 10 am (address) time. Some of the inflammation has gone down but he still noticed swelling. Stated that, he said he was about to eat and as he went to take first bite, the pain hit him and he felt it swell up, pain while opening jaw was almost instant. This threw him off because all he did was get up and shower and make breakfast. He stated that, he had gotten full night sleep and he was working evening shifts, got off work and slept till 8:30 am until he was rested and as he was fixing to eat, he just felt pain while opening jaw and touched his face and felt his face swelling. Stated that, swelling was visibly obvious and he still had it. Stated that, on 22Mar2021, it was uncomfortable when he tried to eat and moves his jaw. After talking and eating, it was painful and uncomfortable. He stated that, it was not really hurting right now and some swelling has gone down so he was not that alarmed. Stated that, he thought he was fine and continued to use an N95 when interacting with the public. Stated that, he took off his mask to start eating and felt swelling today when he went to eat. He checked the mirror and checked some things online to see whether he could get hints to see what was happening. He saw that, people were still experiencing side effects even a month after the second shot, so he decided to find out more information before he started panicking and goes to the emergency room. Stated that, he did not know whether to go to the emergency room or not. He was told that, he can still experience side effects from the shot, even with the time that has passed, but he wanted to call Pfizer for ease of mind to see whether his symptoms should go away or if he needed to be checked out at the emergency room or something. However, he did not want to overwhelm the services that are already drained if it was not necessary. Stated that, the only thing else that happened on the same day of receiving the vaccine was the metallic flavor in his mouth. He compared it to when a person was receiving a CAT scan or something and they gave an injection and the person gets a flavor in their mouth. It was like that. He got home and by the time he got home from his injection, the flavor was in his mouth. He was drinking water and juice and the metallic flavor was still there. He thought this was just normal since COVID makes people lose their sense of taste, so maybe the metallic flavor was a reaction. He stated that, if it was something else, he would expect that he would have other adverse reactions. Stated that, he was reading up on other possibilities and everyone was like, you have a slight fever and other discomforts. Stated that, he did not get all of that all he got was swelling and the pain associated with the swelling. Stated that, he took an antihistamine to try and help with the pain and swelling that he got, and that was what probably helped with getting the swelling down. He clarified that, the antihistamine he took

Other Meds:

Current Illness:

ID: 1773736
Sex: F
Age:
State: WI

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Comments: a reaction MRI contrast

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 47-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration on 11Mar2021 at 16:30 (Batch/Lot Number: EN6207) as DOSE 2, SINGLE (at the age of 47-year-old) for covid-19 immunisation. Medical history included lupus, Mixed connective tissue disease, Auto immune disease, a reaction MRI contrast and Allergy to IV medications from an unknown date and unknown if ongoing. Reporter stated that she was allergic to all IV medications, It's not a certain drug class, the pharmacist told her that it seems like she was just allergic to a additive in the IV medications. Concomitant medications (other products) included prednisone (PREDNISONE) and diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 18Feb2021 at 16:30 (Batch/lot number: EN6200, Expiry Not Written) (at the age of 47-year-old) for covid-19 immunisation and experienced Hives, rash and welts. The patient experienced welts/hives, rash on 11Mar2021, reporter stated that within 30 minutes the patient got the hives, rash, welts, but it lasted about a day and a half, however she had took a lot more prednisone before the second dose. She has also Recovered completely form this. When querying to patient, it was stated this was all creepy and scary on an unspecified date. It was reported that the patient was given a high dose of prednisone to take before both Pfizer Covid vaccine doses because she has a history of allergic reaction. She experienced welts/hives within 10 minutes after each vaccine dose. The patient wants to know if there was any information on the efficacy of the vaccine for individuals who have received the vaccine while taking high dose steroids. The reporter stated that she feels the Pfizer website guidance on receiving the second dose after an allergic reaction was not clear. The physician recommended to take high dose prednisone and Benadryl prior to receiving the vaccine. It was reported that prior to the Second dose, she took a total of about 150mg. Then after receiving the second dose the following day she took 40mg in total, then 20mg the next day, and 20mg again the next day after, and then she was done, she didn't have as bad of a rash. It was reported that physician said its fine for the second dose, and to just pre-medicate again. She took more prednisone this time prior to the second dose, got the second dose, she had a rash again. Her physician was indicating that the efficacy of the vaccine was now maybe lower because she had the Prednisone. The patient does not recall if it was Prednisone tablets or capsules, it was little round circle. Therapeutic measures were taken as a result of welts/hives and rash. The outcome of event reported as recovered on unknown date of Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds: PREDNISONE; BENADRYL

Current Illness:

ID: 1773737
Sex: F
Age:
State: FL

Vax Date: 03/16/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: redness around injection site; for the last 2-3 days she had itching at the COVID-19 Vaccine injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number EN6208, Expiry Date: Unknown) via an unspecified route of administration, administered in arm right on 16Mar2021, administered between 1:30PM-2:00PM (at the age of 41-year-old) as a dose 1, single for COVID-19 immunisation at pharmacy/drug store. The patient's medical history included multiple sclerosis from 2018 and unknown if was ongoing. The patient's concomitant medications were not reported. There were no other products. 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 none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. There were no prior vaccinations (within 4 weeks). On the day before reporting (on 24Mar2021), the patient realized she had redness at the place where she was injected with the COVID-19 Vaccine. She said that she now remembered that for the last 2-3 days, she had itching at the COVID-19 Vaccine injection site, as well. She said she had not done anything to the COVID-19 Vaccine injection site. Reported she had multiple sclerosis, and her doctor told her it was safe for her to get the COVID-19 Vaccine. Reported she had a virtual appointment with her doctor yesterday (24Mar2021) and forgot to mention the injection site itching and redness to her doctor at that time. On the day of reporting, the day was 9 from the first dose. It was like a circle around that area that is red. Reported she did not look for injection site redness since she got her COVID-19 Vaccine. She said she just happened to look in the mirror, and saw the COVID-19 Vaccine injection site was red. She clarified the injection site was itching, and she had not touched the injection site, but looked in the mirror, and saw the injection site was red. She stated that she got her COVID-19 Vaccine in her right arm because she was lefthanded. The patient with Multiple Sclerosis since 2018 who received the first dose of the Pfizer Covid-19 vaccine on 16Mar2021. She has noticed itching for the past 2-3 days and yesterday redness around injection site. Is this normal? Her doctor said it was ok to get the vaccine. Today is day 9 from the first dose. It was like a circle around that area that is red. She asked, what should I do? asked if what she was experiencing was a normal reaction to the COVID-19 Vaccine. She did not visit emergency room or physician room. Relevant tests were none. The outcome of both the events were not resolved. The follow-up attempts were made. Follow-up attempts had been completed and no further information was expected.

Other Meds:

Current Illness:

ID: 1773738
Sex: F
Age:
State: VA

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 10/09/2021
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: specific side effect swelling in the face, eyes and nose; specific side effect swelling in the face, eyes and nose; specific side effect swelling in the face, eyes and nose; itching in her throat; Cough; This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EP7533), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 16:15 (Age at vaccination: 24 years old), as DOSE 1, SINGLE for covid-19 immunisation . Medical history included food allergy, complex regional pain syndrome. Concomitant medication(s) included duloxetine (DULOXETINE) taken for complex regional pain syndrome from an unspecified start date and ongoing. Prior Vaccinations within 4 weeks not any other vaccinations administered. On 25Mar2021, patient stated that she got first dose of the Pfizer Covid vaccine yesterday at 4:15 PM, states she woke up this morning, her face was swollen, her eyelids and in between bridge of nose specifically, states she has had a reaction like this before to environmental allergies, states she was allergic to tree nuts but not any medications. Stated her throat was kind of itchy and had a cough last night that has now resolved. She was breathing fine. The outcome of the event cough was recovered and rest all event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: DULOXETINE

Current Illness: Allergy to nuts; Complex regional pain syndrome (Additional Information for Other Conditions: diagnosed a year and half ago)

ID: 1773739
Sex: F
Age:
State: CT

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210325; Test Name: Fever; Result Unstructured Data: Test Result:101.7; Comments: Up to 101.7

Allergies:

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

Symptoms: Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:30 as (At the age of 49-years) dose 2, single for covid-19 immunisation. Medical history included hypertension, hypothyroidism from an unknown date and unknown if ongoing both Controlled with medication. List of any other medications the patient received within 2 weeks of vaccination include Lisinopril, hydrochlorthiazide, and levothyroxine sodium (SYNTHROID) all was taken for an unspecified indication, start and stop date were not reported. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 AM as (At the age of 49-years) dose 1, single for covid-19 immunisation. The patient experienced flu like symptoms, nausea, fever up to 101.7, achiness, vomiting (vomiting, influenza like illness, nausea, pyrexia, and pain) on 25Mar2021 05:00. Patient received treatment for the adverse event as promethazine 25 mg and ibuprofen 800 mg. The patient underwent lab tests and procedures which included body temperature: 101.7 on 25Mar2021 Up to 101.7. The events were assessed as Non serious by reporter. The outcome of events was not recovered at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: LISINOPRIL; HYDROCHLOROTHIAZIDE; SYNTHROID

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am