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: 1774690
Sex: M
Age:
State: KY

Vax Date: 03/25/2021
Onset Date: 04/14/2021
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: Severe pain on his left shoulder; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunisation. On 14Apr2021, when the patient woke up, the patient experienced severe pain on his left shoulder blade and worked its way on his breast area. There were no unaddressed medical questions referred or forwarded to medical information. The outcome of the event was unknown. No follow-up attempts are possible; Information related to batch/Lot number could not be requested.

Other Meds:

Current Illness:

ID: 1774691
Sex: F
Age:
State: NC

Vax Date: 02/10/2021
Onset Date: 02/11/2021
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 Nausea; Headache; Fatigue; No appetite; Joint aches; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN9581), dose 2 intramuscular, administered in Deltoid Left on 10Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation (Patient Age at Time of Vaccination: 66 Years). Patient received historical vaccine of dose 1 bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248), dose 1 intramuscular, administered in Deltoid Left on 20Jan2021 13:30 as SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 12Apr2019 to 15Jun2019 Verbatim: Orthoscopic Surgery, influenza from 2019 to 2019, major depression from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine (VENLAFAXINE) taken for major depression from an unspecified start date and ongoing; bupropion (BUPROPION) taken for major depression from an unspecified start date and ongoing; l-methylfolate (L-METHYLFOLATE) taken for major depression from an unspecified start date and ongoing; armodafinil (ARMODAFINIL) taken for major depression from an unspecified start date and ongoing; estradiol (ESTRADIOL) taken for major depression from an unspecified start date and ongoing; losartan (LOSARTAN) taken for major depression from an unspecified start date and ongoing; rosuvastatin calcium (ROSUVASTIN) taken for major depression from an unspecified start date and ongoing. Vaccination facility type was Public Health Clinic. Patient did not receive other vaccine in four weeks of vaccination. Patient did not have relevant family history or tests. On 11Feb2021 09:00 the patient experienced severe nausea, headache, fatigue, no appetite and joint aches. The outcome for the event joint aches was unknown and rest all events was recovered. No Follow-up attempts are needed. No further information is expected.

Other Meds: VENLAFAXINE; BUPROPION; L-METHYLFOLATE; ARMODAFINIL; ESTRADIOL; LOSARTAN; ROSUVASTIN

Current Illness:

ID: 1774692
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date: 04/01/2021
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: sinisistus; low grade fever; cough; body aches; chills; This is a spontaneous report received from a non-contactable consumer or other non-health care professional (patient) via a Regulatory Authority. A female patient with unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; batch no/Lot number: not reported) via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient and her husband had 1st dose of Covid Vaccine on 06Apr2021. On an unspecified date in Apr2021, after 1st dose of Pfizer vaccine patient experienced with Sinusitus and low-grade fever, cough, body aches and chills. Patient was asking the reason for the time lapse in reactions and whether they get the second dose. Outcome of the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774693
Sex: M
Age:
State:

Vax Date:
Onset Date:
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: chills; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: unknown) (age at the time of vaccination was 50 years), via unspecified route on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown) (age at the time of vaccination was 50 years), via an unspecified route of administration, on an unknown date as dose 1, single for COVID-19 immunization. On an unknown date, after receiving the second dose of the Pfizer COVID-19 vaccine. That night, the patient experienced chills, fever, and headache through the night. The patient got gradually better the next day. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774694
Sex: M
Age:
State: WA

Vax Date: 04/10/2021
Onset Date: 04/21/2021
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: I felt a pain in my lower back vertebrae that was only noticeable if I pushed a knuckle into the area; It just feels like inflammation; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW1053) via an unspecified route of administration on 10Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient experienced as, i felt a pain in my lower back vertebrae that was only noticeable if i pushed a knuckle into the area, it just feels like inflammation on 21Apr2021. Reported as, patient received his second dose of BioNTech COVID Vaccine on 10Apr2021. It was now 22Apr2021. Yesterday, he felt a pain in his lower back vertebrae that was only noticeable if he pushed a knuckle into the area. Today, that pain is there without any prodding. The pain was not debilitating, it was just noticeable. It just feels like inflammation, nothing serious. He do not know if this pain was related to the vaccine, but he could not imagine what else could have caused it. He know this pain was minor, and possibly unrelated to the vaccine, but he feel obligated to at least report the condition. The enquiry did not involve a report of exposure during pregnancy. Outcome of the events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774695
Sex: F
Age:
State: VA

Vax Date: 03/24/2021
Onset Date: 04/01/2021
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: Chills; Slight fever; swelling is from a lymph node.; Headache; very tired; felt crappy; her neck was swollen; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 44 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline (SERTRALINE) taken for anxiety, start and stop date were not reported. The patient experienced chills on 15Apr2021 with outcome of recovered, slight fever on 15Apr2021 with outcome of unknown, swelling is from a lymph node. causing lymphadenopathy on 15Apr2021 with outcome of recovering, headache on 15Apr2021 with outcome of unknown, very tired causing fatigue on 15Apr2021 with outcome of unknown, felt crappy on Apr2021 with outcome of unknown and her neck was swollen on Apr2021 with outcome of unknown. The caller is calling about the covid vaccine. The caller had her vaccine last Wednesday at 11:30am. The caller didn't have any side effects the first day. The next morning the caller had chills, slight fever and later in the day she noticed on her right arm, 4-5 inches from where the vaccine was administered, it was swollen quite a bit to the size of a good size tennis ball, it was fluid like, it would bounce and it felt like a pillow on her neck. The caller called her primary care provider and the nurse said to watch it and mark it and if it gets bigger to come see them. The caller wants us to be aware of it. The caller is assuming the swelling is from a lymph node. The caller has nodules on her neck that she gets scanned every year. After the second dose of the vaccine the caller had a headache and was very tired. As soon as the caller had a headache she took some Ibuprofen but the headache lasted for about 2 days, unknown lot and expiration date, the caller finished the bottle and threw it out. The caller had a fever and felt really crappy. That afternoon the next day the caller noticed by her neck was swollen. It took another day or day and a half for it do disintegrate. This bubble was on the same side that she received the vaccine and was 5-4 inches from where she received the vaccine. Caller reporting on the COVID Vaccine. While reporting on the COVID Vaccine caller provided details about a treatment medication due to event that occurred, headache. As soon as the caller had a headache she took some Ibuprofen but the headache lasted for about 2 days, unknown lot and expiration date, the caller finished the bottle and threw it out. No follow-up attempts are needed. No further information is expected.

Other Meds: SERTRALINE

Current Illness:

ID: 1774696
Sex: M
Age:
State: IL

Vax Date: 04/26/2021
Onset Date: 04/26/2021
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: burning; throat kind of burnt after this shot; weak; dizzy; Can't move around; Feels like some kind of allergic reactions; This is a spontaneous report from a contactable consumer (patient). A 18-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), via an unspecified route of administration on 26Apr2021 (at the age of 18-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Apr2021 (on the same day), the patient experienced burning, throat kind of burnt after this shot, weak, dizzy, can't move around, feels like some kind of allergic reactions. It was reported that patient didn't feels the events all day (unspecified). The outcomes of events were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774698
Sex: F
Age: 32
State: OR

Vax Date: 09/17/2021
Onset Date: 09/18/2021
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: Grass

Symptom List: Pharyngeal swelling

Symptoms: Chest tightness, shortness of breath, chest pain for over 2 weeks

Other Meds: None

Current Illness: None

ID: 1774699
Sex: M
Age:
State:

Vax Date:
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Drowsiness; Fever; Restless sleep; Body aches; Chills; Nausea; He felt generally unwell; Woke up with a little headache; This is a spontaneous report from a contactable consumer . A 23-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation the patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date (at age of 23-years-old) as single dose for COVID-19 immunisation. It was reported that patient received the second dose of Pfizer COVID-19 vaccine around 10:30. No effects until about 19:30 when some drowsiness began. Around 21:00 fever started. During the night, he experienced restless sleep (including fever dreams, body aches, and chills) and a little nausea. In the morning the fever was gone but he felt generally unwell. That slowly got better throughout the day. On the second morning, he woke up with a little headache and feels pretty normal now (the afternoon of that day). Event took place after use of product. The Outcome of the all the events was Unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774700
Sex: U
Age:
State: CO

Vax Date:
Onset Date:
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: Elevated bilirubin; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced elevated bilirubin. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248 same reporter/drug/AE, different patients (1st of 3 patients)

Other Meds:

Current Illness:

ID: 1774701
Sex: U
Age:
State: CO

Vax Date:
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: Test Name: Developed elevated bilirubin; Result Unstructured Data: Test Result:Increased

Allergies:

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

Symptoms: Developed elevated bilirubin; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included breast cancer metastatic from an unknown date and unknown if ongoing, gilbert's syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced developed elevated bilirubin on an unspecified date. The patient underwent lab tests and procedures which included blood bilirubin increased: increased on unspecified date. The clinical outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248 same reporter/drug/AE, different patients(2nd of 3 patients)

Other Meds:

Current Illness:

ID: 1774702
Sex: F
Age:
State: MA

Vax Date: 04/21/2021
Onset Date: 04/22/2021
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: 20210422; Test Name: body temperature; Result Unstructured Data: Test Result:100.8; Test Name: SarS-Cov-2 test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Rash, Urticaria

Symptoms: I got the arm sore as little lump or whatever and inability to lift my arm; I got the arm sore as little lump or whatever and inability to lift my arm; it's like rash it's like not rash, all red like a good circle around the Infusion; like very itchy; chills; Headache; fatigue; fever 100.8; but the problem my now is the Injection site I did not feel then my am burn that could have been alcohol; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 21Apr2021 (lot number: EW0170) (age at vaccination 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypertension from 20 years back, auto immune disease, Covid in December and was very ill for about 8 weeks when she was available to get the vaccine. The patient concomitant medications included metoprolol, lisinopril for blood pressure high and Vitamins. The patient had, the problem in the injection site did not feel then my am burn that could have been alcohol, chills, headache, which is reminiscent of actual virus then, had fatigue and in the night had a fever 100.8 on 22Apr2021 and then got the arm sore as little lump or whatever and inability to lift my arm within next day or two which was told have Wednesday, Thursday night, the soreness has been gone like nothing going to be wrong whatever and now like it's one more thing, It's like how it's like rash it's like not rash, all red like a good circle around the Infusion, I do not know it's like very itchy now and it hurts and it's itchy. The patient took Tylenol as this was becoming unbearable like it was Itchy and hurts, do not want to scratch them. The patient lab tests included SarS-Cov-2 test was positive like in December 3 and body temperature was found to be 100.8 on 22Apr2021. The outcome of the events was reported as unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds: METOPROLOL; LISINOPRIL

Current Illness:

ID: 1774703
Sex: F
Age:
State: CA

Vax Date: 01/10/2021
Onset Date: 01/01/2021
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: Test Date: 20210125; Test Name: TSH; Result Unstructured Data: Test Result:0.01; Test Date: 20210204; Test Name: TSH; Result Unstructured Data: Test Result:<0.01; Test Date: 20210212; Test Name: TSH; Result Unstructured Data: Test Result:0.01; Test Date: 20210302; Test Name: TSH; Result Unstructured Data: Test Result:0.19; Test Date: 20210204; Test Name: CT neck; Result Unstructured Data: Test Result:Unknown; Test Name: COVID test PCR; Result Unstructured Data: Test Result:Negative; Test Date: 20210204; Test Name: free T4; Result Unstructured Data: Test Result:5.15; Test Date: 20210212; Test Name: free T4; Result Unstructured Data: Test Result:4.1; Test Date: 20210302; Test Name: free T4; Result Unstructured Data: Test Result:1.9; Test Date: 20210302; Test Name: free T3; Result Unstructured Data: Test Result:2.4

Allergies:

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

Symptoms: mild day pain; Fatigue; Muscle pain; Neck pain; Fever; Dysphagia; lymphan; ottitis; This is a spontaneous report from a contactable Physician who reported that. A 41-years-old female patient received BNT162B2 (Pfizer/BioNTech COVID-19 vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jan2021 (Batch/Lot number was not reported) as DOSE 2 SINGLE for covid-19 immunization (Age at vaccination 41 years). The historical vaccine BNT162B2 dose 1 via an intramuscular route of administration, administered in Arm Left on Dec2020 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was not reported. The concomitant medications were None. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On Jan2021 the patient experienced Mild achy pain, Fever, Fatigue, muscle pain, axillary adenopathy, neck pain, otitis and dysphagia. The patient underwent lab tests and procedures included TSH (25Jan2021) result (0.01), TSH (04Feb2021) result (<0.01), FT4(04Feb2021) result (5.15), CT Neck (04Feb2021) with unknown results, TSH (12Feb2021) result (0.01), FT4(12Feb2021) result (4.1), Thyroid USG (19Feb2021) with unknown results' (02Mar2021) result (0.19), FT4(02Mar2021) result (1.9) and FT3(02Mar2021) result (2.4) and SARS-CoV-2 test both via PCR and Nasal Swab: negative on unspecified date. The event outcome was unknown. No follow up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774704
Sex: F
Age:
State: MO

Vax Date: 04/27/2021
Onset Date: 04/27/2021
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:

Allergies:

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

Symptoms: severe enough to prevent me from sleeping or moving without vomiting; fever; chills; severe joint pain; sore throat; headache; dizziness; nausea; severe enough to prevent me from sleeping or moving without vomiting; This is a spontaneous report from a contactable consumer. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0170, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 10:15 (age at vaccination 32 years) as dose 2, single for covid-19 immunisation. Medical history included covid-19 prior to vaccination. Concomitant medication(s) included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) occasional. The patient had no allergies. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:15 as dose 1, single for covid-19 immunisation. Facility type vaccine other was mass Vaccination Drive. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 21:30 the patient experienced severe enough to prevent me from sleeping or moving without vomiting, fever, chills, severe joint pain, sore throat, headache, dizziness, nausea. Patient received treatment for reported events took Excedrine. The outcome of event was recovering. No follow up attempts are needed. No further information is expected

Other Meds: EXCEDRIN MIGRAINE

Current Illness:

ID: 1774705
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date:
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: chest pain and pressure; flu like symptoms and fatigue; metal taste in mouth; chest pain and pressure; flu like symptoms and fatigue; chills; nausea; taste disruption; This is a spontaneous report from a contactable consumer(patient). A 36-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at the age of 36years) as dose 1, single for COVID-19 immunization. Medical history included allergies to penicillin and also penicillin related drugs, childhood asthma she had sort of severe childhood asthma. Concomitant medications were not reported. The patient experienced chest pain and pressure, flu like symptoms and fatigue, metal taste in mouth, chest pain and pressure, flu like symptoms and fatigue, chills, nausea, taste disruption. It was reported Caller states she was a little bit concerned because she was experiencing chest pain and chest pressure because she had sort of severe childhood asthma. Caller states another hot line she talked to today said that was not a usual side effect. Caller states she did experience a lot of the other symptoms she saw on the website like flu like symptoms, fatigue, chills, nausea, metal taste in mouth, taste disruption were common. Caller states she has an allergy to penicillin and penicillin related drugs and that is in the mix she guesses. Caller wants to know was she a good candidate for the second vaccine. Caller states she was a little bit she has to go pick up her son in a few minutes. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1774706
Sex: U
Age:
State:

Vax Date: 04/20/2021
Onset Date:
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: Body is swelling and its swollen, I am swell up; Forearms are tight; Swollen elbows; Swollen hands; Skin is really gonna burst; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0170, Expiry date: Unknown) via an unspecified route of administration on 20Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date in 2021, the patient experienced body is swelling and its swollen, i am swell up, forearms are tight, swollen elbows, swollen hands, skin is really gonna burst. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774707
Sex: U
Age:
State:

Vax Date: 04/02/2021
Onset Date:
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: My arm has been sore, hurting and now the other arm hurting.; I start itching I still do itch.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 02Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient arm has been sore, hurting and now the other arm hurting and started itching, the patient still does itching. The seriousness of the events was unspecified. The outcome of the event arm has been sore, hurting and now the other arm hurting was unknown while outcome of the event start itching, the patient still do itch was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774708
Sex: U
Age:
State: AK

Vax Date:
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:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Have some inflammation issues going on right now; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting for itself. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunization. Patient medical history included rheumatoid arthritis and Ehlers-Danlos syndrome. Concomitant medications were not reported. It was stated that he was getting his second dose tomorrow and he just find that his first dose well not expecting anything unusual with his second dose. On an unspecified date patient reported that he has some inflammation issues going on right now. His doctor would like to put him on steroids and they were wondering how long after he get his second dose tomorrow. Should they wait for starting the course of steroids. The outcome of then event was unknown. No follow-up attempts are needed; No further is information expected

Other Meds:

Current Illness:

ID: 1774709
Sex: M
Age:
State: DC

Vax Date: 04/19/2021
Onset Date: 04/25/2021
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: Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Diarrhea after first, really painful swollen lymph nodes in both armpits.; Diarrhea after first, really painful swollen lymph nodes in both armpits.; Diarrhea after first, really painful swollen lymph nodes in both armpits.; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received the second dose of bnt162b2 (Solution injection; Batch/Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 19Apr2021 (at the age of 39-years-old) at 10:30 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN9809), via an unspecified route of administration, administered in Arm Left on 29Mar2021 at 10:00 as single dose for covid-19 immunisation. Medical history included headache and depression. Concomitant medications included cimetidine, bupropion, paracetamol and clonazepam. The patient previously took benadryl and experienced drug hypersensitivity. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 25Apr2021, patient experienced diarrhea after first, really painful swollen lymph nodes in both armpits. The patient underwent lab tests and procedures which included ultrasound scan result of which was unknown. Therapeutic measures were taken as a result of the event and was treated with antibiotic. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: CIMETIDINE; BUPROPION; TYLENOL; CLONAZEPAM

Current Illness:

ID: 1774710
Sex: F
Age:
State: NC

Vax Date: 03/15/2021
Onset Date: 03/29/2021
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:

Allergies:

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

Symptoms: felt bad a week after her shot; had a fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Lot number: EL9266) on 18Feb2021 for COVID-19 immunisation. On 29Mar2021 patient experienced had a fever, on an unspecified date felt bad a week after her shot. Caller states his wife and himself got their shots on 15Mar2021. This past Sunday his wife started getting a low-grade fever and they are wondering if that is a side effect even though its 2 weeks later. Caller mentions that his wife had a swollen arm for about 12 hours after the first vaccine. States they had the shot in the afternoon so it might have been the next day, but he cannot recall. States she completely recovered from the swollen arm after about 12 hours. Caller states that he read it takes 2-4 weeks for the vaccine to be effective. Wondering if that is a side effect even though it's 2 weeks later. The outcome of the event fever was not recovered, and outcome of the event felt bad was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774711
Sex: F
Age:
State:

Vax Date: 04/23/2021
Onset Date: 04/24/2021
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: This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 23Apr2021 14:30 as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route, in left arm on 02Apr2021, 03:30 PM as dose 1, single for covid-19 immunisation. Patients medical history was not reported. She had no known allergies. Concomitant medication included ibuprofen taken for unspecified indication, start and stop date not reported, taken in two weeks. Patient did not take any other vaccines in four weeks. On 24Apr2021 12:00 PM patient experienced extremely weak, headaches, nausea, and muscle spasms/ fatigue. The AE resulted in doctor or other healthcare professional office/clinic visit. Patient felt the side effects are not going away as fast as expected. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient did not receive any treatment for the adverse events. The outcome of events was not recovered. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501876 Same reporter/product/event, different patient

Other Meds: IBUPROFEN

Current Illness:

ID: 1774712
Sex: M
Age:
State:

Vax Date: 04/23/2021
Onset Date: 04/24/2021
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: Unevaluable event

Symptoms: This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, left arm, on Apr 23, 2021, at 14:35, single dose, for COVID-19 immunisation. Medical history reported as none. Concomitant medications included ibuprofen. The patient received the first dose of BNT162B2 on Apr 2, 2021, at 14:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. It has been 5 days since patient's second dose. On Apr 24, 2021, at 12:00, patient still felt extremely weak, have headaches, nausea, and muscle spasms/fatigue. The side effects were not going away as fast as expected. It was unknown if patient received the treatment or not. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events: not resolved. No follow-up attempts possible: information about lot/batch number/expiry date cannot be obtained. No further information expected. Sender's comments: Linked report(s): PFIZER INC-2021501866 same reporter/product/event, different patient.

Other Meds: Ibuprofen

Current Illness:

ID: 1774713
Sex: F
Age:
State: CT

Vax Date: 03/25/2021
Onset Date: 03/25/2021
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: Test Date: 20210325; Test Name: fever; Result Unstructured Data: Test Result:100-101

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Injection site soreness; low-grade fever (100-101); headache; fatigue; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:30 (at the age of 62-years-old) at dose 2, single for covid-19 immunization. Medical history included known allergies to CT scan dye. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); calcium citrate; ergocalciferol (VIT D); ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). Patient didn't receive 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 has not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:45 (at the age of 62-years-old) at dose 1, single for covid-19 immunization. The most recent vaccine was administered at Workplace clinic. The patient experienced injection site soreness, low grade fever, headache and fatigue on 25Mar2021. No treatment was given for the events. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240148 Same patient and drug, different event separated in time, similar events

Other Meds: ZYRTEC ALLERGY; CALCIUM CITRATE; VIT D; CENTRUM SILVER +50

Current Illness:

ID: 1774714
Sex: F
Age:
State: GA

Vax Date: 04/30/2021
Onset Date: 05/01/2021
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:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: had body aches; sensitive skin; very tired; felt depressed for the day; wasn't hungry; This is a spontaneous report from a non-contactable consumer (patient). A 32-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 30Apr2021 10:45 as DOSE 2, SINGLE for covid-19 immunization. The medical history included ADHD and depression. Concomitant medication(s) included amfetamine aspar-tate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and lamotrigine (LAMICTAL). The patient previously took first dose of BNT162B2 (lot number: ER8737) in Left Arm, on 31Mar2021 for Covid-19 Immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On May1, 2021, the patient reported that I had body aches, sensitive skin and was very tired. I also felt depressed for the day and wasn't hungry. All of this happened the day after the injection. Patient did not receive any treatment for the event. The outcome of event depression recovered on 01May2021 and other event recovered on an unspecified May2021. No follow-up attempts are possible. No further information is expected.

Other Meds: ADDERALL; LAMICTAL

Current Illness:

ID: 1774715
Sex: M
Age:
State:

Vax Date:
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: This is a spontaneous report from a contactable consumer (patient's mother). A male patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced psoriasis on an unspecified date. Reporter stated she and her son take Stelara every 3 months for psoriasis. The outcome of event: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): PFIZER INC-2021525511 same reporter/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1774716
Sex: M
Age:
State: FL

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

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

Lab Data: Test Date: 2020; Test Name: Covid -19 test; Test Result: Negative ; Comments: Negative for Eight times; before vaccination

Allergies:

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

Symptoms: slept most of the next day; Soreness at the injection site; chills and uncontrollable shivering severe afternoon; very lethargic; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 19Feb2021 11:00 (Lot Number: EL9267) (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. Medical history included chemotherapy from Apr2020 to Jun2020 for diffuse large B-cell Lymphoma, pneumonia from Apr2020 to Aug2020, hospitalized 3 nights for pneumonia (not covid-19 tested negative eight times in 2020). Concomitant medications included meloxicam taken for an unspecified indication from 3 years ago and ongoing; latanoprost taken for an unspecified indication from 1 years ago and ongoing; paracetamol (TYLENOL) taken for an unspecified indication from many years ago and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid on 22Jan2021 11:00 (Lot Number: EL9263) (at the age of 73-years-old) as dose 2, single for covid-19 immunisation and experienced lethargic, no appetite, no bowel movements, soreness at the injection site, chills and uncontrollable shivering, kept awake and slept most of the next day and fever. The patient was very lethargic, chills and uncontrollable shivering severe afternoon on 19Feb2021, day of and day after injection. On 20Feb2021 day after injection, patient had soreness at the injection site and slept most of the next day. The patient did not receive any treatment for the events. Patient was not admitted to hospital due to event. The outcome of the events was recovered on unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: MELOXICAM; LATANOPROST; TYLENOL

Current Illness:

ID: 1774717
Sex: F
Age:
State: CT

Vax Date: 04/25/2021
Onset Date: 04/27/2021
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: Test Date: 202007; Test Name: COVID-19 antibody test; Test Result: Negative ; Test Name: Viral test; Result Unstructured Data: Test Result:Epstein Barr titers

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: After having the first dose the nerve issues began to ramp up again; Severe muscle pain in my legs, mostly on the sides of my shins; Heaviness and pain in my arms; Heaviness and pain in my arms; Numbness in my hands that almost feels like Raynaud's syndrome; Usually run every day and I haven't been able to run, I tried to walk the distance that I normally run and I had trouble with that; Legs down look swollen but that they feel swollen to the touch; Two days after the vaccine, I began experiencing pain in an area that had been plaguing me throughout March 2020-November 2020 (nerve/muscular) under left armpit (I was having these and cardiac issues; Two days after the vaccine, I began experiencing pain in an area that had been plaguing me throughout March 2020-November 2020 (nerve/muscular) under left armpit (I was having these and cardiac issues; Two days after the vaccine, I began experiencing pain in an area that had been plaguing me throughout March 2020-November 2020 (nerve/muscular) under left armpit (I was having these and cardiac issues; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old Non Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731, Expiry date was not reported), via an unspecified route of administration on 25Apr2021 10:00 (at the age of 47-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The Patient Medical history included epstein-barr viraemia from an unknown date and unknown if ongoing Epstein-Barr , cardiac disorder from 2020 and ongoing Cardiac related issues , muscular dystrophy from 2020 to an unknown date , nervous system disorder from an unknown date and unknown if ongoing , nerve compression from an unknown date and unknown if ongoing , echocardiogram from an unknown date and unknown if ongoing , inflammation from an unknown date and unknown if ongoing , autoimmune disorder from an unknown date and unknown if ongoing. Concomitant medication(s) the patient received within 2 weeks of vaccination included ergocalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; amantadine hydrochloride (VIRACON) taken for an unspecified indication, start and stop date were not reported. The Patient was not pregnant at the time of vaccination. The Patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination the patient had not been tested for COVID-19. On 27Apr2021, Two days after the vaccine, she began experiencing pain in an area that had been plaguing me throughout March 2020-November 2020 (nerve/muscular) under left armpit (she was having these and cardiac issues that were deemed post viral last year). In addition to this severe muscle cramps in her legs and numbness in her hands and fingers began to develop at the 2 week post vaccine mark. she was now most concerned about the latter and wonder if it is a known side effect. Will the second dose make it worse. She had a side effect after the first dose of the vaccine. Should she get the second dose. Referred to HCP. "As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Caller is a female consumer who is calling in regards to adverse effects she has experienced since receiving her first dose on the Pfizer COVID 19 vaccine on 25Apr2021. Caller states that prior to receiving the vaccine she had health problems in October and November of 2020. These health problems included nerve entrapment, cardiac issues with an abnormal echo, and inflammation around the heart, and abnormal autoimmune lab work. She reports that prior to receiving the vaccine that these issues were under control and then the day after having the first dose the nerve issues began to ramp up again. She states, she saw my chiropractor and it helped but then the end of last week and this week she have had severe muscle pain in my legs, mostly on he sides of my shins, heaviness and pain in my arms, and numbness in my hands that almost feels like Raynaud's syndrome. she usually run every day and she haven't been able to run, she tried to walk the distance that she normally run and she had trouble with that. Her chiropractor states that on exam her legs down look swollen but that they feel swollen to the touch on 12May2021. He states that it should like an internal nerve problem. She have talked with multiple of her doctors and it seems like no one can give her any answers on if this was caused by the vaccine which she understand since it is so new and no one knows at this point. Which is fair but its frustrating at the same time. She had scheduled to get her second dose on Sunday but she don't know what she should do since she was having these symptoms. she just wanted to know if these symptoms have been reported. What is the effectiveness of the vaccine if she was to push out the timing of her second dose. Caller reported that prior to that, through Mar2020 to Nov202, the caller had a myriad of post viral issues that may or may not have been related to Covid as the virus. Caller reported that whatever virus she had presented long haul issues and reported that her physician tried in Jul2020 but she did not test positive for antibodies for Covid-19 after she got the Covid-19 vaccine, some of her symptoms ramped up again, specifically her muscular and nerve related symptoms. She had some autoimmune blood work done. Caller reported that one of the titers that came back was considered ok by her primary care physician but questionable by her naturopath. Caller reported that she has been seeing a chiropractor who has been working on another issue that the caller previously had and the vaccine seemed to aggravate. Caller reported that her chiropractor informed her that vaccines and viruses can both irritate everything in the body if the body is not firing 1000% on all cylinders inside. Caller stated that she wanted to see if this was a side effect that Pfizer knew about, especially after the first dose of the Covid-19 vaccine. Caller inquired if she should get the second dose of the Covid-19 vaccine as scheduled on Sunday,16May2021, or if she should hold off. Caller reported that she knew that 3 weeks was recommended but that you can go out to 6 weeks for the second dose of the Covid-19 vaccine. Caller reported that she had an autoimmune condition that she did not report online as she was not able to enter the condition into the field. Caller stated that in all fairness to all the doctors, they don't know anything more than she does about it. Caller reported that the Covid-19 vaccine aggravated her pre-existing symptoms. Caller reported that she is now convinced that her symptoms are Covid related. Caller reported that she originally saw the naturopath because she knows that she has a compromised immune system. Caller reported that she gets a lot of things. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on Jul2020, viral test: epstein barr titers on unspecified date. Therapeutic measures were taken as a result of two days after the vaccine, she began experiencing pain in an area that had been plaguing me throughout march 2020-november 2020 (nerve/muscular) under

Other Meds: VITAMIN D; FISH OIL; PROBIOTICS; VIRACON

Current Illness: Cardiac disorder (Cardiac related issues)

ID: 1774718
Sex: M
Age:
State: FL

Vax Date: 02/11/2021
Onset Date:
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: Hearing test; Result Unstructured Data: Test Result:No results; Test Name: blood work; Result Unstructured Data: Test Result:No results; Test Name: Eye exam; Result Unstructured Data: Test Result:No results

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN9581), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing blindness legally blind, ongoing hypersensitivity neuropathy peripheral. The patient's concomitant medications were not reported. The patient previously took klonopin and experienced coma, flu. It was reported that, the patient experienced diarrhoea on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included acoustic stimulation tests: no results on blood test: no results on ophthalmological examination: no results. Therapeutic measures were taken as a result of diarrhoea (diarrhoea). No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Blind (Verbatim: legally blind); Hypersensitivity (Verbatim: hyper sensitive on certain frequencies)

ID: 1774719
Sex: F
Age:
State: VA

Vax Date: 02/23/2021
Onset Date: 02/24/2021
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: Fever; Result Unstructured Data: Test Result:102

Allergies:

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

Symptoms: fever 102; chills; vomiting; diarrhea; abdominal pain; fatigue; nausea; This is a spontaneous report received from a contactable other hcp. A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EI9265) via an intramuscular route of administration in Arm Left on 23Feb2021 08:30 (age at vaccination 62years old) as single dose for covid-19 immunisation. the patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine. Medical history included hypersensitivity from an unknown date and unknown if ongoing Medication: Sulpha, allergy to arthropod bite from an unknown date and unknown if ongoing, thrombocytopenia from an unknown date and unknown if ongoing. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9261) via an intramuscular route of administration in Arm right on 05Feb2021 15.30 PM (age at vaccination 62years old) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced fever 102, chills, vomiting, diarrhoea, abdominal pain, nausea on 24Feb2021, and fatigue on 25Feb2021. The patient underwent lab tests and procedures which included body temperature increased: 102 on unspecified date. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774720
Sex: F
Age:
State: CA

Vax Date: 02/25/2021
Onset Date: 02/26/2021
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: Nausea

Symptoms: Violent diarrhea the following day and contuing; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in right arm on 25Feb2021 (age at vaccination: 72-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EL9265) via unspecified route in right arm on 03Feb2021 1:00 PM (age at vaccination: 72-years) as dose 1, single for covid-19 immunisation. Patient medical history included high blood pressure from an unspecified date and unknown if ongoing. Patient experienced violent diarrhea the following day on 26Feb2021 and is continuing. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Treatment was given as a result of the adverse events, and was still in process. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Device date was reported as 19May2021. The outcome of event was not recovered. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1774721
Sex: F
Age:
State:

Vax Date: 02/10/2021
Onset Date:
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: Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia.; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia.; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; This is a spontaneous report from a non-contactable pharmacist. A 39-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6199), dose 1 intramuscular, administered in Arm Left on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. The patient receive other vaccine previously. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia. Patient consented to receiving second dose after education with RN on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1774722
Sex: F
Age:
State: PA

Vax Date: 04/16/2021
Onset Date: 04/01/2021
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: Test Date: 20210317; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:Normal; Comments: Resolved pneumonic; Test Date: 202103; Test Name: ECHO; Result Unstructured Data: Test Result:Normal; Test Date: 20210325; Test Name: Holter; Result Unstructured Data: Test Result:Normal; Test Date: 20210317; Test Name: Mammogram; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: After the first vaccine patient scalp started to itch significantly; Psoriasis symptoms seemed a little worse; This is a spontaneous report from a contactable consumer. A 53-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0161/Batch number was not reported), dose 1 intramuscular, administered in arm left on 16Apr2021 at 12:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included ongoing psoriasis Onset date (Childhood), hypothyroidism from 2005 and ongoing, antiphospholipid antibodies from an unspecified date in 2012 and ongoing, caesarean section from an unspecified date in 1997 to an unknown date, caesarean section from an unspecified date in 2001 to an unknown date, hysterectomy from an unspecified date in 2012 to an unknown date, hernia repair from an unspecified date in 2012 to an unknown date, covid-19 from an unspecified date in Dec2020 to an unknown date, psoriasis from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) at a dose of 50 ug, daily taken for hypothyroidism from an unspecified start date and ongoing, rivaroxaban (XARELTO) at a dose of 10 mg, daily taken for antiphospholipid antibodies from an unspecified start date and ongoing, pantoprazole (PANTOPRAZOLE) at a dose of 20 mg, daily taken for gastrooesophageal reflux disease from an unspecified start date and ongoing, escitalopram (ESCITALOPRAM) at a dose of 10 mg, daily taken for anxiety from an unspecified start date and ongoing, calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported, vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported, fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported, iron (IRON) taken for an unspecified indication, start and stop date were not reported, calcium citrate, magnesium citrate (MAG CITRATE) taken for an unspecified indication, start and stop date were not reported, multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported and curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced psoriasis symptoms seemed a little worse on an unspecified date in Apr2021 and after the first vaccine patient scalp started to itch significantly on 17Apr2021. The clinical course was as follows: Patient has plaque psoriasis, after 1st dose she noticed that her psoriasis symptoms seemed a little worse. Her plaque psoriasis is only on her scalp. The patient underwent lab tests and procedures which included chest x-ray: normal (Resolved pneumonic), mammogram: normal on 17Mar2021, electrocardiogram ambulatory: normal on 25Mar2021 and echocardiogram: normal on an unspecified date in Mar2021. No treatment was given for the events. The dose number 2 was scheduled on 14May2021. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds: SYNTHROID; XARELTO; PANTOPRAZOLE; ESCITALOPRAM; CALCIUM; SUPER B COMPLEX [VITAMIN B COMPLEX]; FISH OIL; IRON; MAG CITRATE; MULTIVITAMIN [VITAMINS NOS]; TURMERIC CURCUMIN

Current Illness: Hypothyroidism; Lupus anticoagulant; Psoriasis (Onset date: Childhood)

ID: 1774723
Sex: F
Age:
State:

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: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Fever; Chills; This is a spontaneous report from a contactable Other Healthcare Professional. A 92-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 92-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on an unspecified date. The patient experienced fever and chills on 18Mar2021 for 24 hours. It was reported that the MD was aware. Outcome of events were recovered on 19Mar2021. No follow-up attempts are needed. No further information expected.

Other Meds:

Current Illness:

ID: 1774724
Sex: M
Age:
State: TN

Vax Date: 02/11/2021
Onset Date: 02/11/2021
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: Nausea; Cold; soreness at injection; itching at injection site; woke with a sweaty neck; Dizziness; He experienced weakness 1-2 hours after he received the first dose.; Drowsiness; Fever; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Right arm on 11Feb2021 (at the age of 60 year) as dose 1, single for COVID-19 immunisation. Medical history included itching and soreness from allergy shot from 29Jan2021 to 01Feb2021.He gets an allergy shot every 2 weeks. His last allergy shot was on 29Jan2021. He didn't take it for 14 days prior to getting the Covid-19 vaccine. He doesn't know the name of the medication that he gets with the allergy shot. There were no concomitant medications. On 11Feb2021, 1-2 hours after he received the first dose, the patient experienced weakness. He also was drowsy. The dizziness lasted about three hours. When he went to bed he had a fever and nausea. He was cold for a few hours. He felt like he wanted to throw up. He got under the covers and a hour to two later it subsided. He started drinking water to help with the nausea. The fever lasted about two hours. He woke with a sweaty neck. He was cold for 35-40 minutes. No relevant tests were done. The outcome of the events was Drowsiness, pyrexia, nausea, cold was recovered; dizziness was recovered with sequel; sweating was unknown and of other events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1774725
Sex: M
Age:
State: NY

Vax Date: 03/15/2021
Onset Date: 03/30/2021
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: Test Date: 20210503; Test Name: COVID test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: 2 weeks after getting second shot I started getting white spots on hands and face.; 2 weeks after getting second shot I started getting white spots on hands and face.; Vitiligo; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 60-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EN6208; Expiration Date: 30Jun2021), dose 2 via an intramuscular route of administration, administered in arm left on 15Mar2021 at 09:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunisation. Medical history included ongoing high blood pressure and ongoing cholesterol from an unknown date. Historical vaccine included first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EN6201, Expiration Date: 30Jun2021) via an intramuscularly administered in left arm on 22Feb2021 at 09.00 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation and received two doses of chicken pox vaccine, dose 1 on 01Aug2021 and dose 2 on 02Aug2021 (Formulation: injection) in left arm (at the age of 61-year-old) for chicken pox. Concomitant medications included pravastatin 20 mg via oral taken for cholesterol from Feb2021 and ongoing and amlodipine 5mg via oral taken for blood pressure from an unspecified start date and ongoing. The patient was not received other medications within 2 weeks of vaccination. No any other prior vaccinations within 4 Weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced 2 weeks after getting second shot he started getting white spots on hands and face on 05Apr2021 at 08:00 and vitiligo on 30Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 03May2021. The patient received treatment for the adverse events with cream to put on spots/ hands (2x day). The outcome of events reported as not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: PRAVASTATIN; AMLODIPINE

Current Illness: Blood pressure high; Cholesterol

ID: 1774726
Sex: F
Age:
State: MA

Vax Date: 04/14/2021
Onset Date: 05/14/2021
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: Allergy to fruit and milk

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 72, via an unspecified route of administration, in right arm, on Apr 14, 2021, at 17:30, single dose, for COVID-19 immunisation. The patient's medical history included known allergies to fruits and dairy; all from an unknown date and unknown if ongoing. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced palpitations, PAC (premature atrial contraction), PVC (premature ventricular contractions) and atrial trigeminy on May 14, 2021, 12:30 pm. Treatment received as a result of events: Propranolol. The outcome of the events: not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No follow-up attempts possible.

Other Meds:

Current Illness:

ID: 1774727
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
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: Test Name: Covid Test; Result Unstructured Data: Test Result:Nasal Swab; Comments: Covid test type post vaccination: Nasal Swab Covid test result: Negative

Allergies:

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

Symptoms: After the first injection, I noticed that I can barely move my arm. Lots of pain and hard join movement.; After the first injection, I noticed that I can barely move my arm. Lots of pain and hard join movement.; This is a spontaneous report from a contactable consumer or other non hcp. A 55-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not re-ported. On an unknown date, it was reported that after the first injection, he noticed that he can barely move his arm. Lots of pain and hard join movement. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab as Covid test type post vaccination: Nasal Swab Covid test result: Negative on an unknown date. The outcome of all events reported as an unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021634370 similar report from same reporter

Other Meds:

Current Illness:

ID: 1774728
Sex: F
Age:
State: NC

Vax Date: 01/06/2021
Onset Date:
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: low-grade fever; Injection site tenderness; Chills; Feeling unwell; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as in her middle of 20s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 06Jan2021, as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low-grade fever, injection site tenderness, chills, feeling unwell on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774729
Sex: F
Age:
State: IA

Vax Date: 06/04/2021
Onset Date: 06/05/2021
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: Pain in arm; Tiredness; This is a Spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID19 VACCINE, Lot#:Ew0187), via an unspecified route of administration in arm left on 04Jun2021 12:30 at age of 49-year-old as dose 1, single for COVID-19 immunisation. The patient had no known allergies. Prior to vaccination, the patient was diagnosed as COVID-19. The patient was not preganant at time of the vaccination. Other vaccine in four weeks and other medications in two weeks were none. On 05Jun2021, the patient experienced pain in arm,tiredness and swallowed though. The events did not resulted in emergency room visit or physician office visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. In 2021, the outcome of adverse events pain in arm,tiredness and swallowed though was resolved. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774730
Sex: F
Age:
State: VA

Vax Date: 03/01/2021
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:

Allergies:

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

Symptoms: Very bad itching on arms, legs, back, check, stomach.; Bumps that would in same cases stay or others that would come and go. Only one filled with fluid.; Some left scarring.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 49-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, expiration date: not reported) via an unspecified route of administration, administered in left arm on Mar2021 (at the age of 49-years-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, expiration date: not reported) via an unspecified route of administration, administered in left arm on Mar2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunization. Medical history included depression and anxiety start and stop date was unknown. Patient had no known allergies. Concomitant medication(s) included hydroxyzine (HYDROXYZINE), montelukast (MONTELUKAST), fexofenadine hydrochloride (ALLEGRA) and sertraline (SERTRALINE and Montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. I saw the family physician twice and and then they sent me to the allergist. The allergist said it was not hives. It has gone with the exception of my chest still itching from time to time. Prior vaccination, Patient had not covid since tested no covid. On 24Mar2021, patient experienced very bad itching on arms, legs, back, check, stomach, bumps that would in same cases stay or others that would come and go. only one filled with fluid, some Therapeutic measures were taken as a result of very bad itching on arms, legs, back, check, stomach, bumps that would in same cases stay or others that would come and go. only one filled with fluid, some left scarring. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Oral and topical treatments. The outcome of all events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: HYDROXYZINE; MONTELUKAST; ALLEGRA; SERTRALINE; SINGULAIR

Current Illness:

ID: 1774731
Sex: F
Age:
State: HI

Vax Date: 05/20/2021
Onset Date: 05/20/2021
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 Name: urinalysis; Result Unstructured Data: Test Result:blood, white blood cells, trace amounts of protein; Comments: blood and white blood cells on urinalysis with trace amounts of protein.

Allergies:

Symptom List: Pain in extremity

Symptoms: presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein; Persistent Fever for 2 weeks and 5 days after the 2nd dose of the vaccination; Some body aches; headache; throwing up; diarrhea; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 46-years-old non-pregnant 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 20May2021(at 46-years of age) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did don't had COVID prior vaccination and not COVID tested post vaccination. And patient had no Known allergies. On 20May2021 the patient experienced persistent fever for 2 weeks and 5 days after the 2nd dose of the vaccination, some body aches, headache, throwing up (vomiting) and diarrhoea. The patient presented with bloody urine which showed blood and white blood cells on urinalysis with trace amounts of protein on 08Jun2021. Patient visited Doctor or other healthcare professional office/clinic visit. Therapeutic measures include Nitrofurantoin mono mcr 100 mg. The events outcome was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774732
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
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:

Allergies:

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

Symptoms: My mom also received the Pfizer vaccine and had gallstones after as well; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that I'm not sure if this was caused by the vacccine or not, but I got gallstones and had gallbladder removal surgery after. My mom also received the Pfizer vaccine and had gallstones after as well (cholelithiasis) (non-serious) on an unspecified date with outcome of unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1774733
Sex: M
Age:
State: OR

Vax Date: 06/11/2021
Onset Date: 06/01/2021
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: Test Date: 20210618; Test Name: BNP; Result Unstructured Data: Test Result:21 pg/mL; Comments: Norm low: 0 Norm high: 99; Test Date: 20210618; Test Name: CRP; Result Unstructured Data: Test Result:<0.5 mg/dl; Comments: Norm high: 0.5; Test Date: 20210618; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210618; Test Name: ESR; Result Unstructured Data: Test Result:10; Comments: Norm low: 0 Norm high: 15; Test Date: 20210618; Test Name: Troponin l; Result Unstructured Data: Test Result:<3 ng/L; Comments: Norm high: 45

Allergies:

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

Symptoms: Vaccination related malaise; fatigue; local reaction/ sore arm; Fever; local reaction/ sore arm; undiluted second dose of pfizer-biontech covid-19 vaccine; Administered undiluted second dose of Pfizer-BioNTech Covid-19 Vaccine; Paronychia; This is a spontaneous report from a contactable other health care professional. A 14-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191 and expiration date: 30Sep2021) via an intramuscular route of administration in right deltoid on 11Jun2021 at 11:55 AM (age at vaccination 14-year-old) as DOSE 2, 0.3 ml, SINGLE for covid-19 immunisation at physician's office. The patient's medical history included GERD from Dec 2020 to Feb 2021, ongoing paronychia from Jun2021, ongoing obesity from Mar2019, ongoing allergic rhinitis from Jun2016. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0177) on 19May2021 10:55 AM (age at vaccination 14-year-old) at via intramuscular route of administration in left deltoid as DOSE 1, SINGLE for covid-19 immunization. On 11Jun2021, a 14-year-old male patient administered undiluted second dose of Pfizer-Biontech covid-19 vaccine. On 19Jun2021, the patient experienced local reaction/ sore arm, fatigue, fever. On an unknown date, the patient experienced vaccination related malaise and paronychia. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures, which included on 18Jun2021 Brain natriuretic peptide: 21 pg/mL (normal low: 0, normal high: 99), C-reactive protein: less than 0.5 mg/dl (normal high: 0.5), electrocardiogram: normal, ESR (red blood cell sedimentation rate): 10 mm/hr (normal low: 0, normal high: 15), troponin I: less than 3 ng/l (normal high: 45). The NDC number of Pfizer-BioNTech Covid-19 Vaccine: 59267-1000-1. These events local reaction/ sore arm, fatigue, fever were considered non-serious. The outcome of the events local reaction/ sore arm, fatigue, fever was recovered in 2021 and unknown for other events. The physician considers the Pfizer product had a causal effect to the adverse event. Information on Lot/Batch number was available. Additional information has been requested. Follow up (06Jul2021 and 09Jul2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to the HCP letter sent that included: The physician considers the Pfizer product had a causal effect to the adverse event. Added new events local reaction/ sore arm, fatigue, fever, vaccination related malaise and paronychia. Added all lab data. Added all medical history. Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness: Allergic rhinitis; Obesity; Paronychia

ID: 1774734
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/06/2021
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: Test Date: 20210421; Test Name: ALT; Result Unstructured Data: Test Result:11 IU/l; Test Date: 20210421; Test Name: Albumin/Globulin Ratio; Result Unstructured Data: Test Result:1.8; Comments: calc; Test Date: 20210421; Test Name: CYCLIC CITRULLINATED PEPTIDE (CCP) AB (IgG); Result Unstructured Data: Test Result:<16; Comments: <20 units; Test Date: 20210421; Test Name: EPSTEIN BARR VIRUS(EBNA); Result Unstructured Data: Test Result:217.00 IU/ml; Comments: H; Test Date: 20210421; Test Name: SJOGREN'S ANTIBODY (SS-A); Result Unstructured Data: Test Result:<1.0; Comments: AI; Test Date: 20210421; Test Name: SJOGREN'S ANTIBODY (SS-B); Result Unstructured Data: Test Result:<1.0; Comments: AI; Test Date: 20210421; Test Name: ANA SCREEN, IFA; Test Result: Negative ; Test Date: 20210421; Test Name: AST; Result Unstructured Data: Test Result:15 IU/l; Test Date: 20210411; Test Name: Bacteria; Result Unstructured Data: Test Result:None seen; Comments: None seen/HPF; Test Date: 20210421; Test Name: Bacteria; Result Unstructured Data: Test Result:None Seen; Comments: None seen/HPF; Test Date: 20210729; Test Name: Bacteria; Result Unstructured Data: Test Result:None seen; Comments: None seen/HPF; Test Date: 20210421; Test Name: Absolute Basophils; Test Result: 77 uL; Comments: cells/ul; Test Date: 20210421; Test Name: Basophils; Test Result: 1.0 %; Test Date: 20210421; Test Name: Albumin; Result Unstructured Data: Test Result:4.5 g/dl; Test Date: 20210421; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:59 IU/l; Test Date: 20210411; Test Name: Bilirubin; Test Result: Negative ; Test Date: 20210421; Test Name: Bilirubin; Test Result: Negative ; Test Date: 20210729; Test Name: Bilirubin; Test Result: Negative ; Test Date: 20210421; Test Name: Bilirubin, Total; Test Result: 0.4 mg/dl; Test Date: 20210421; Test Name: Calcium; Test Result: 10.2 mg/dl; Test Date: 20210421; Test Name: Chloride; Result Unstructured Data: Test Result:104 mmol/L; Test Date: 20210626; Test Name: Cholesterol Total; Test Result: 274 mg/dl; Test Date: 20210421; Test Name: Creatinine; Test Result: 0.81 mg/dl; Test Date: 20210421; Test Name: Culture; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210411; Test Name: Glucose; Test Result: Negative ; Test Date: 20210421; Test Name: Glucose; Test Result: Negative ; Test Date: 20210729; Test Name: Glucose; Test Result: Negative ; Test Date: 20210421; Test Name: Glucose; Test Result: 78 mg/dl; Test Date: 20210421; Test Name: EPSTEIN BARR VIRUS VCA; Result Unstructured Data: Test Result:36.80; Comments: H; Test Date: 20210421; Test Name: EPSTEIN BARR VIRUS VCA AB (IgM); Result Unstructured Data: Test Result:<36.00 IU/ml; Test Date: 20210411; Test Name: ketones; Test Result: Negative ; Test Date: 20210421; Test Name: ketones; Test Result: Negative ; Test Date: 20210729; Test Name: ketones; Test Result: Negative ; Test Date: 20210421; Test Name: Potassium; Result Unstructured Data: Test Result:3.9 mmol/L; Test Date: 20210421; Test Name: Sodium; Result Unst

Allergies:

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

Symptoms: Epstein Barr Virus (EBNA) AB(IgG) EPSTEIN BARR VIRUS(EBNA): 217.00 H (U/ml), Epstein Barr Virus VCA AB (IgG): EPSTEIN BARR VIRUS VCA: 36.80 H (U/ml); Five days after my first vaccine dose I began a fever running between 99.7 and 100.3 F. I have been running this fever daily since then - now for more than 10 weeks; I feel exhausted; achy; brain fog; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 21Sep2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient) and other healthcare professional. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734) via an unspecified route of administration, administered on the right arm on 01Apr2021 (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. Medical history included dry eyes, high cholesterol, psoriasis, generalized anxiety, migraines, IBS (IBS well controlled since taking Zoloft colonoscopies have been normal neg sibo breath test nml no dietary triggers), Vitamin D Deficiency, hyperlipidemia, bone up calcium magnesium sup. Concomitant medications included sertraline hydrochloride (ZOLOFT); vitamin D NOS; vitamin B NOS; probiotics NOS; calcium; vitamin D2; thiamine (VITAMIN B1 [THIAMINE]); calcium carbonate, colecalciferol (CALCIUM 600 + D) taken for bone up calcium magnesium sup; clonazepam (KLONOPIN). The patient previously took codeine and experienced Allergies: codeine: racing heart; Allergies: Diflucan: rash; xifaxan and Allergies: xyfaxan: Rash; zoloft for IBS. It was reported that five days after her first vaccine dose (06Apr2021) she began a fever running between 99.7 and 100.3 F. She had been running this fever daily since then - now for more than 10 weeks. She felt exhausted, brain fog, achy. She had been to her family doctor, and an infectious disease specialist. Have had a CT scan of chest and abdomen, and dozens of bloods checking everything from viruses like malaria or Lymes disease, to inflammatory markers, UTIs, rheumatoid arthritis, WBC and RBC counts and more. All tests were normal. The events resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received. The event fever was considered serious, medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, PCR Nasal swab: negative. The patient underwent lab tests and procedures which included: Result Date: 29Jul2021 Color: Yellow, Appearance: Cloudy A (Clear), Bilirubin: Negative, Ketones: Negative, Specific Gravity: 1.006 (1.001-1.035), Occult Blood: Negative, pH: 5.5 (5.0-8.0), Protein: Negative, Nitrite: Negative, Leukocyte Esterase: Negative, WBC: None seen (=30.5umol/L), LDL Size: 21.9 (>20.5nm) , LDL-P: 1802 H (<1000nmol/L), LP-IR score: <25(<=45), small LDL-P: 313(<=527nmol/L), HDL-C: 81(>39mg/dL), Triglycerides: 99(0-149mg/dl), Cholesterol, Total: 274 H (100-199mg/dL), LOL-C (NIH calc): 176 H (0-99mg/dL); HIV AG/AB, 4TH GEN: Non-reactive(Non-reactive), Quantiferon(R)-Tb Gold Plus, 1 Tube: Negative, Nil: 0.01(IU/ml), Mitogen-nil: 2.34(IU/ml), TB1-NIL: 0.0(IU/ml), TB2-NIL: 0.0(IU/ml). Result date: 21Apr2021 ANA SCREEN, IFA: Negative, Ferritin: 45 (16-232ng/ml), Cyclic Citrullinated Peptide (CCP) AB (IgG): <16(<20 units), RHEUMATOID FACTOR (IgA): <5(<=6U), RHEUMATOID FACTOR (IgG): <5(<=6U), RHEUMATOID FACTOR (IgY): <5(<=6U), SJOGREN'S ANTIBODY (SS-A): <1.0 (AI), SJOGREN'S ANTIBODY (SS-B): <1.0 (AI); Source: Whole blood, EBV DNA, QN PCR: <200(<200Copies/ml), EBV DNA, QN PCR: <2.30(<2.30 Log cps/ml); EPSTEIN BARR VIRUS(EBNA) AB(IgG) EPSTEIN BARR VIRUS(EBNA): 217.00 H (U/ml), EPSTEIN BARR VIRUS VCA AB (IgM): EPSTEIN BARR VIRUS VCA: <36.00 (U/ml), EPSTEIN BARR VIRUS VCA AB (IgG): EPSTEIN BARR VIRUS VCA: 36.80 H (U/ml); Anti-Streptolysin O: <50(<200IU/ml), Glucose: 78(65-99mg/dL), Urea Nitrogen (BUN): 11(7-25mg/dL), Creatinine: 0.81(0.50-1.10 mg/dl), eGFR Non-Afr. Am: 88(>OR = 60ml/min/1.73m2), eGFR Afr Am: 88(>OR = 102ml/min/1.73m2), BUN/Creatinine Ratio: Not applicable(6-22(calc), Sodium: 140(135-146mmol/L), Potassium: 3.9(3.5-5.3 mmol/L), Chloride: 104(98-110mmol/L), Carbon Dioxide: 28(20-32mmol/L), Calcium: 10.2(6.6-10.2mg/dl), Protein, Total: 7.0(6.1-8.1 g/dl), Albumin: 4.5(3.6-5.1 g/dl), Globulin: 2.5(1.9-3.7 g/dl (calc)), Albumin/Globulin Ratio: 1.8(1.0-2.5(calc)), Bilirubin, Total: 0.4(0.2-1.2 mg/dl), Alkaline Phosphatase: 59(31-125 U/L), AST: 15(10-30 U/L), ALT: 11(6-29 U/L); Bacteria: None seen (None seen/HPF), Culture: NR, Leukocyte Esterase: Negative, Nitrite: Negative, WBC: None seen(<0R=5/HPF), Color: Yellow, Appearance: clear, Bilirubin: Negative, Ketones: Negative, Specific Gravity: 1.005(1.001-1.035), Occult Blood: Negative, pH: 6.5(5.0-8.0), Protein: Negative, RBC: None seen (

Other Meds: ZOLOFT; VITAMIN D NOS; VITAMIN B NOS; PROBIOTICS NOS; CALCIUM; VITAMIN D2; VITAMIN B1 [THIAMINE]; CALCIUM 600 + D; KLONOPIN

Current Illness:

ID: 1774735
Sex: F
Age:
State: NY

Vax Date: 06/18/2021
Onset Date: 06/18/2021
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: Test Date: 20210624; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

Symptom List: Vomiting

Symptoms: Extreme pharyngitis with swelling making it difficult to breathe; Extreme pharyngitis with swelling making it difficult to breathe; Extreme pharyngitis with swelling making it difficult to breathe; 6 days later arm is still swollen with muscle spasms.; 6 days later arm is still swollen with muscle spasms.; Nausea; diarrhea; myalgia; This is a spontaneous report from a contactable Nurse. An 18-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via unspecified route administered in Arm Left on 18Jun2021 (at the age of 18-years-old) as single dose for covid-19 immunisation. Medical history included periodic fever syndrome. Patient had no known drug allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid tested post vaccination. On 18Jun2021 20:00, patient experienced extreme pharyngitis with swelling making it difficult to breathe, 6 days later arm is still swollen with muscle spasms, nausea, diarrhea and myalgia. Therapeutic measures were not taken due to the events. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 24Jun2021. The outcome of all the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774736
Sex: F
Age:
State: GA

Vax Date: 04/28/2021
Onset Date: 04/30/2021
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: Test Date: 20210430; Test Name: blood pressure; Result Unstructured Data: Test Result:Increased

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Increased blood pressure and worsened asthmatic symptoms for 2+ months after; Increased blood pressure and worsened asthmatic symptoms for 2+ months after; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0170, Expiration Date: not reported) via an unspecified route of administration in right arm on 28Apr2021 17:00 as dose 2, single for COVID-19 immunization (at the age of 23-year-old, non-pregnant). Historical vaccine included 1st dose of BNT162B2 (Lot number: EP6955, Expiration Date: not reported) via an unspecified route of administration in left arm on 29Mar2021 17:00 as dose 2, single for COVID-19 immunization (at the age of 23-year-old). Medical history included covid-19 from an unknown date and unknown if ongoing prior vaccination, High blood pressure and asthma from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC); Montelukast and norethindrone acetate all taken for an unspecified indication, start and stop date were not reported. Patient did not received other vaccine in four weeks. The patient experienced increased blood pressure and worsened asthmatic symptoms for 2+ months after on 30Apr2021 12:00. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 30Apr2021. Therapeutic measures were taken as a result of increased blood pressure and worsened asthmatic symptoms for 2+ months after with Increased dosage of existing medications. Covid was not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: BYSTOLIC; MONTELUKAST; NORETHINDRONE ACETATE

Current Illness:

ID: 1774737
Sex: M
Age:
State: PA

Vax Date: 06/26/2021
Onset Date: 06/28/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: he had two diarrhea episodes and the third day one episode so far; This is a spontaneous report from a contactable Physician. A 14-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via intramuscular route of administration in left arm on 26Jun2021 at 14:30 (at the age of 14 years old) as dose 1, single for covid-19 immunisation. Medical history included rare epilepsy, developmental delay, hypotonia. The patient had known allergies to penicillin, pneumococcal vaccine. Concomitant medication included ibuprofen (ADVIL 12 HOUR), 200 mg once time. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Jun2021 at 12:00 second day post vaccination he had two diarrhea episodes and the third day one episode so far. Therapeutic measures were taken as a result of he had two diarrhea episodes and the third day one episode so far with pedialyte and probiotics. The outcome of events was recovering. Follow-up attempts completed. No further information expected.

Other Meds: ADVIL 12 HOUR

Current Illness:

ID: 1774738
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/06/2021
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: Chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), as DOSE 1, SINGLE, then as DOSE 2, SINGLE, both at the age of 31-years-old, via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chest pain on 06Jul2021. There was no treatment received for the event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774739
Sex: F
Age:
State: OH

Vax Date: 07/03/2021
Onset Date: 07/06/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: red itchy rash all over torso; red itchy rash all over torso; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 47-year-old intramuscularly administered in left arm on 03Jul2021 11:15 (Lot Number: EW0196; Expiration Date: Sep2021) as dose 1, single for covid-19 immunisation. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications included ascorbic acid, colecalciferol, nicotinamide, panthenol, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTI VITAMIN); cetirizine hydrochloride (ZYRTEC); calcium; and unspecified birth control pills, all indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jul2021 18:00, the patient experienced red itchy rash all over torso. It was further reported that on day 3 after vaccine, she noticed red itchy rash all over torso. It resembles chicken pox. It's been 6 days of rash and it doesn't appear to be getting any better. The patient has not been tested for covid-19 since vaccination. The patient received treatment for the adverse events which included a prescription for prednisone. The reporter considered the case as non-serious. The adverse events resulted in physician office visit. The outcome of the events was recovered on 22Jul2021. The patient received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) dose 2 at vaccination age of 47-year-old intramuscular in the left arm (reported as left bicep) on 24Jul2021 11:45 (Lot Number: FA7484) as dose 2, single for covid-19 immunisation. Follow-up attempts are completed. No further information is expected.

Other Meds: MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL ; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CALCIUM

Current Illness:

ID: 1774740
Sex: F
Age:
State: VA

Vax Date: 06/25/2021
Onset Date: 07/07/2021
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:

Allergies:

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

Symptoms: Missing menstrual cycle; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration, in the left arm, on 25Jun2021 17:00 (at the age of 48-years-old), as dose number unknown, single for COVID-19 immunisation. The patient has no relevant medical history and concomitant medications were not reported. Patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced missing menstrual cycle on 07Jul2021. Event did not result to either physician office visit nor to emergency room visit. No treatment was given as a result of the event. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am