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: 1692237
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: cpk; Result Unstructured Data: Test Result:317 IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:13 ng/ml; Test Name: Body mass index; Result Unstructured Data: Test Result:24.2; Comments: kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: cytomegalovirus (CMV) antibodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities, qualitatively; Comments: showed no structural abnormalities, qualitatively low normal left ventricular systolic function (LVSF), and no pericardial effusion; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:56; Test Name: EKG findings; Result Unstructured Data: Test Result:Abnormal T waves, ST-segment depression; Comments: Abnormal T waves, ST-segment depression; Test Name: electrocardiogram; Result Unstructured Data: Test Result:demonstrated normal sinus rhythm with ST-segment; Comments: demonstrated normal sinus rhythm with ST-segment depressions in V1 and V2; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: Epstein-Barr virus (EBV) titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:0.2 ug/ml; Comments: 0.2; Test Name: laboratories; Result Unstructured Data: Test Result:were unremarkable aside from elevated creatine; Comments: were unremarkable aside from elevated creatine phosphokinase-MB (CPK-MB) level of 13 ng/mL and troponin level of 3.34 ng/mL; Test Name: Parvovirus B19 antibodies; Test Result: Negative ; Test Name: pericardial effusion; Result Unstructured Data: Test Result:No; Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Positive ; Test Name: SARS-CoV-2 spike IgM; Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: troponin level; Result Unstructured Data: Test Result:3.34 ng/ml; Comments: Initial; Test Name: troponin level; Result Unstructured Data: Test Result:4.85 ng/ml; Comments: peak; Test Name: troponin level; Result Unstructured Data: Test Result:3.15 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:7.2

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: perimyocarditis/presented to the emergency department (ED) with retrosternal pressure-like chest pain; This is a literature report. The full publication has been requested. This author reported similar events for eight patients. This is the first of eight reports. A 17-year-old (also reported as 17.6-year-old) male with a past medical history of vitiligo presented to the emergency department (ED) with retrosternal pressure-like chest pain. He denied shortness of breath, fever, vomiting, rhinorrhea, abdominal pain, or diarrhea. The patient tested positive for SARS-CoV-2 10 months before. He received the second dose of the BNT162b2 vaccine 4 days before presentation. Chest X-ray was negative, and electrocardiogram (ECG) demonstrated normal sinus rhythm with ST-segment depressions in V1 and V2. There were no ST-segment elevations or PR-segment depressions. Initial laboratories were unremarkable aside from elevated creatine phosphokinase-MB (CPK-MB) level of 13 ng/mL and troponin level of 3.34 ng/mL. The peak troponin was 4.85 ng/mL. The patient was transferred to our hospital. Transthoracic echocardiogram (TTE) showed no structural abnormalities, qualitatively low normal left ventricular systolic function (LVSF), and no pericardial effusion. Patient was managed with ibuprofen with no recurrence of pain. Patient had a negative respiratory pathogen panel (RPP), adenovirus plasma PCR, cytomegalovirus (CMV) antibodies, enterovirus plasma PCR, Epstein-Barr virus (EBV) titers, and Parvovirus B19 antibodies. SARS-CoV-2 nucleocapsid immunoglobulin G (IgG) was positive. Demographic and clinical characteristics: Body mass index (kg/m2) 24.2. Past medical history (PMH) Vitiligo. History of prior COVID-19 infection: Yes. BNT162b2 vaccine dose 2. Days between vaccine and symptom onset 4. Length of stay (hours) 48. Laboratories: White blood cell count (Ref: 5-10) 7.2; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 4.85; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 3.15; CKMB (Ref:0-3.5ng/mL) 13; CPK (Ref: 33-145 IU/L) 317; D-dimer (Ref: 0.27-0.41 ug/mL) 0.2 . COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 spike IgM Negative; SARS-CoV-2 nucleocapsid IgG Positive; EKG findings Abnormal T waves, ST-segment depression. Imaging Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 56; Pericardial effusion present No; Cardiac MRI performed No;IVIG (intravenous immunoglobulin) No; Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs) Yes. DISCUSSION Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. No follow-up attempts are needed, information about batch number cannot be obtained.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101137122 Same article/ drug/ event and Different patient.;US-PFIZER INC-202101137432 Same article/drug/event; different patient;US-PFIZER INC-202101137891 Same article/drug/event; different patient;US-PFIZER INC-202101138007 Same article/drug/event; different patient;US-PFIZER INC-202101137593 Same article/drug/event; different patient;US-PFIZER INC-202101136924 Same article/ drug/ event and Different patient.;US-PFIZER INC-202101138774 Same article/drug/event; different patient

Other Meds:

Current Illness:

ID: 1692238
Sex: M
Age:
State: FL

Vax Date: 03/13/2021
Onset Date: 03/23/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: antibody; Test Result: Negative ; Comments: Blood test

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: PA had biopsy of blister on chest, histology = Bullus Pemphigoid; skin blisters; This is a spontaneous report from a contactable physician (patient). A 75-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13Mar2021 at 12:00 (Lot Number: EN6206) at the age of 74-year-old as single dose for COVID-19 immunization. Medical history included hypertension benign. Covid prior vaccination was none. The patient performed Covid tested post vaccination. Known allergy included sulfa. The patient didn't received other vaccine whit in four weeks. Concomitant medications included apixaban (ELIQUIS), valsartan, metoprolol, colecalciferol (D3), ubidecarenone (COQ10 [UBIDECARENONE]) and ch 14.18. On 23Mar2021 at 13:30, the patient experienced skin blisters (two or three after first dose) then 10 to total leg blisters after second dose. Treated by (name), referred to Dermatology center in (name) had biopsy of blister on chest, histology = Bullus Pemphigoid. On 17Aug2021, the patient performed Covid test post vaccination. The type was blood test, the name was antibody and the result was negative. Treatment was received. The outcome of events was recovering.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Pemphigoid and BNT162B2 vaccine cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: ELIQUIS; VALSARTAN; METOPROLOL; D3; COQ10 [UBIDECARENONE]; CH 14.18

Current Illness:

ID: 1692239
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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: Sister-in-law and nephew have all gotten covid 19 after being fully vaccinated.; Her Sister-in-law and nephew have all gotten covid 19 after being fully vaccinated; This is a spontaneous report from a Pfizer sponsored program via Medical Information team. A contactable consumer reported that a female patient (reporter's sister-in law) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Not Reported), Dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter's sister in law gotten covid 19 after being fully vaccinated on an unspecified date. She had problems and just got out of the hospital. The outcome of event was unknown. No follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692240
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: ultrasound lower ab; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Glomerulonephritis (inflammation of filters in kidneys); Blood in urine; fatigue; edema; swollen left eyelid; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER/BIONTECH) via an unspecified route of administration on the left arm in Feb2021 at 01:45 PM (Lot Number: EN6201) as single dose for COVID-19 immunizaiton. Medical history included inflammation, immunity, profound deafness and have familial hypertension. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. The patient was a Congenital Rubella Baby w/lifetime immunity. The patient didn't received other vaccine in four weeks. Concomitant medications included amitriptyline, atenolol and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), all taken for Congenital Rubella Baby w/lifetime immunity. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Jan2021 at 01:30 PM (Lot Number: EL9261) as single dose for COVID-19 immunizaiton. In Apr2021, the patient experienced glomerulonephritis (inflammation of filters in kidneys), blood in urine, fatigue, edema and had swollen left eyelid. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included 2 antibiotics, neither worked; ultrasound lower ab. The outcome of events was not recovered.

Other Meds: AMITRIPTYLINE; ATENOLOL; LISINOPRIL HCTZ

Current Illness:

ID: 1692241
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Lack of drug effect; Lack of drug effect; lot of damage to elbows and was in a lot of pain; Pain in elbow; This is a solicited report (Mfr. Control No.: 21K-163-4053360-00). This female consumer (patient) reported for herself. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via unknown route on 20Feb2021 (Batch/Lot number was not reported), dose 2 intramuscular in 2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for an unspecified indication. Medical history was none. The patient's concomitant medications were not reported. The patient experienced Lack of drug effect, Humira was not helping elbows and lot of damage to elbows and was in a lot of pain, pain in elbow on unknown dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of lot of damage to elbows and was in a lot of pain, Humira was not helping elbows and lot of damage to elbows and was in a lot of pain was not provided. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the events elbow injury, arthralgia and other reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1692242
Sex: F
Age:
State: IL

Vax Date: 02/26/2021
Onset Date: 03/01/2021
Rec V Date: 09/11/2021
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: Test Date: 2021; Test Name: Body height; Result Unstructured Data: Test Result:height had shrunken as she used to be sixty five i; Comments: height had shrunken as she used to be sixty five inches tall; Test Date: 202107; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:congestive heart failure; Test Date: 202103; Test Name: Weight; Result Unstructured Data: Test Result:lost 10 lbs lbs; Comments: weight loss, lost 10 lbs; She gained 3 lbs in a week which in turn made her feel a lot better. Weight loss was improved and she weighed 101 lbs

Allergies:

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

Symptoms: swelling in both legs and feet; congestive heart failure; Crohn's flare up/Crohn's acting up; height shrunk; Dizziness; eye sight was not focusing together with Humira 40mg; This is a solicited report based on the information received by Pfizer. (MFR Control No. # 21K-163-3995267-00). A contactable physician and consumer reported that an 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, expiry date: 26Feb2021) via intramuscular on 26Feb2021 (at the age of 83-year-old) as dose 2, single for COVID-19 vaccination; Adalimumab (HUMIRA, Solution for injection in pre-filled pen, lot number: 1141161) from 2019 and ongoing at 40 mg via Subcutaneous for moderate to severe rheumatoid arthritis and celecoxib via an unknow route on an unknown date at an unknown dose and frequency for osteoarthritis. The patient medical history included thyroid, diuretic, supplement, overactive bladder, small intestine, general pain, arthritis, all were ongoing, congestive heart failure from 2017, non-smoker, abstains from alcohol, low iron levels. The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included levothyroxine for thyroid, furosemide for diuretic, potassium chloride for unknown indication, cobamamide (VITAMIN B12) for supplement, oxybutynin for overactive bladder, budesonide for small intestine, acetaminophen for general pain and arthritis. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: BM9809, expiration date: Jun2021) via intramuscular on 05Feb2021 (at the age of 83-year-old) as dose 1, single for COVID-19 vaccination. On unknown date in 2021, the patient experienced height shrunk and dizziness and the patient experienced eye sight was not focusing together with Humira 40mg. In Mar2021, the patient experienced Crohn's flare up/Crohn's acting up. In Jul2021, the patient experienced congestive heart failure. On 01Jul2021, the patient experienced swelling in both legs and feet. Pfizer covid-19 vaccine and Celecoxib were also considered suspect. The patient went to the emergency room and diagnosed with congestive heart failure and she believed this was related to Humira. In 2021, her eye sight had worsened and was advised to get new glasses. In Mar2021, her Crohn's disease flared up really bad after Covid 19 vaccine and felt extreme fatigue and loose stools, diarrhea. Her Crohn's had been acting up. She took Pepto Bismol and an over the counter anti diarrheal to help with her symptoms. She was concerned about weight loss, lost 10 lbs due to excessive diarrhea and was very upset. She gained 3 lbs in a week which in turn made her feel a lot better. Weight loss was improved and she weighed 101 lbs. In Jun2021, she had weight loss, her appetite went down, and felt very tired. In Jul2021, due to swelling in both legs and feet she went to emergency room and had electrocardiogram which had shown she had congestive heart failure. She was not hospitalized and had taken furosemide, wore compression stockings and had been advised to walk around. On unknown date in 2021, Her height had shrunken as she used to be sixty five inches tall. Outcome of the events of Crohn's disease, Body height decreased was unknown and other events was not recovered. The causality of the events of cardiac failure congestive, peripheral swelling, vision blurred, body height decreased, dizziness and Crohn's disease with respect to the suspect bnt162b2 was not related as per reporter (Drug/Vaccine). The causality of the events of cardiac failure congestive, peripheral swelling, vision blurred, body height decreased, dizziness with respect to the co-suspect Humira was not assessable per reporter and no reasonable possibility as per manufacturer; and for the event of Crohn's disease was no reasonable possibility per reporter and no reasonable possibility as per manufacturer. The causality of the events of peripheral swelling, vision blurred, body height decreased, dizziness and Crohn's disease with respect to the co-suspect celecoxib was not related as per reporter and for the event of cardiac failure congestive was Probable as per reporter. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Congestive heart failure, Crohn's disease, body height decreased, dizziness, peripheral swelling and vision blurred cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: LEVOTHYROXINE; FUROSEMIDE; POTASSIUM CHLORIDE; VITAMIN B12 [COBAMAMIDE]; OXYBUTYNIN; BUDESONIDE; ACETAMINOPHEN; CELECOXIB; HUMIRA

Current Illness: Arthritis; Diuretic therapy; Overactive bladder; Pain; Small intestine infection; Supplementation therapy; Thyroid disorder

ID: 1692243
Sex: F
Age:
State: MI

Vax Date: 08/28/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210830; Test Name: drop in Blood Pressure; Result Unstructured Data: Test Result:Drop; Comments: drop in Blood Pressure; Test Date: 20210830; Test Name: pulse; Result Unstructured Data: Test Result:increase; Comments: increase in pulse

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: nausea; Chest pain; dizziness; drop in Blood Pressure; increase in pulse; palpitations/heart racing; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number FF2588 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 28Aug2021 16:00 (vaccination at the age of 46 years) as dose 1, single for covid-19 immunisation. Medical history included Anxiety, depression, allergies, asthma, pericarditis, Chronic Systolic Heart Failure, mixed connective tissue disease (MCTD) all from an unknown date and unknown if ongoing. The patient previously took erythromycin and experienced drug hypersensitivity. The concomitant therapy was reported as yes. On 30Aug2021 15:00, the patient experienced nausea, chest pain, dizziness, drop in blood pressure, increase in pulse, palpitations, heart racing. The patient underwent lab tests and procedures which included drop in blood pressure: drop on 30Aug2021, pulse: increase on 30Aug2021 increase in pulse. The patient had physician office visit for adverse event. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692244
Sex: M
Age:
State: OH

Vax Date: 08/23/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FC3181, Expiry date: not reported), via an unspecified route of administration in right arm on 23Aug2021 09:30 (at age of 73-years-old) as dose 1, single for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. There was no family medical history relevant to adverse event. There were no concomitant medications. The patient previously took shingles vaccine (it was stated that the shingles vaccine was a live virus and it gave the caller varicella zoster infection) in 2014. The patient had not received any other vaccine within 4 weeks (patient hasn't had any vaccines for more than two years). Received the shingles vaccine in 2014, putting out the shingles shot and pulled the shingles vaccine off the market because knew it was bad. The caller stated he had a reaction similar to that one now. Caller cannot provide NDC/lot/expiration. States that was in year 2014. Caller stated the shingles vaccine was a live virus and it gave the caller varicella zoster infection. On 23Aug2021, the patient had a real bad headache. On 24Aug2021, the patient had at the end of the evening, the day after receiving the first dose vaccine, had pens and needles all over body, here, there, and everywhere. On an unspecified date in Aug2021, the patient experienced shingles. Caller stated that the patient received the first dose bnt162b2 covid vaccine a week ago on the day of reporting. Within an hour of receiving the first dose bnt162b2 covid vaccine, the caller had a real bad headache. The headache lasted for half a day. The caller suspected that would have come and little things would go on. At the end of the evening, the day after receiving the first dose vaccine, had pens and needles all over body, here, there, and everywhere. The next day the caller thought he was good to go. The pens and needles all over body had increased every day since. The caller contacted an infectious disease doctor and the doctor was trying some things. The doctor wondered if the first dose bnt162b2 covid vaccine had woke up the shingles virus in the caller's system. The caller was being treated with Valtrex and that was no good yet. Now, the caller tried an antihistamine, just took the antihistamine on the day of reporting and will see what happens. The caller stated because his issue had increased, he was obviously not a good candidate for another dose bnt162b2 covid vaccine with the reaction the caller was having. The caller stated he did not hear any bad things until he told people what was going on, the problems. Valtrex (lot number: not provided, expiry date: Dec2021): Caller took 500 mg twice a day and did not take the medication until 4 days after had pens and needles all over body. Caller states he received first dose Pfizer Covid 19 Vaccine and had a real bad headache and pens and needles all over body. Caller was taking Valtrex and states the Valtrex is doing no good yet. Valtrex was 500mg and the caller took the medication twice a day. Caller stated did not start taking this medication until 4 days after pens and needles all over body occurred. The caller stated that he needs the medication, caller was trying his best to get over this stuff. The events were assessed as medically significant. Relevant tests done were none. Therapeutic measures were taken as a result of the events. The outcome of the event had a real bad headache was recovered in Aug2021 and outcome of the event at the end of the evening, the day after receiving the first dose vaccine, had pens and needles all over body, here, there, and everywhere was not recovered while outcome of the event shingles was unknown.

Other Meds:

Current Illness:

ID: 1692245
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: not feeling good; Diarrhea; Feels sore; shortness of breath; he isn't feeling well; This is a spontaneous report from a Pfizer sponsored program Support. A contactable male consumer (patient) reported that. A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported) dose 1 via an unspecified route of administration on unspecified date in Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Aug2021 the patient experienced shortness of breath, diarrhea and feels sore. On 30Aug2021 the patient experienced not feeling good. On an unspecified date in Aug2021 patient experienced he isn't feeling well. Consumer was supposed to take his 2nd dose of the Pfizer COVID 19 vaccine today and he is not feeling good. States he is asking for advice on when to take the 2nd dose. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up. Follow-up activities closed. Batch /lot number not available.

Other Meds:

Current Illness:

ID: 1692246
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 08/22/2021
Rec V Date: 09/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210822; Test Name: COVID; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: I have COVID; I have COVID; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer Program. A 85-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medications included tofacitinib citrate (XELJANZ XR - 11mg tablet) taken for an unspecified indication, start and stop date were not reported. The patient stated I have covid on 22Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: XELJANZ XR

Current Illness:

ID: 1692247
Sex: F
Age:
State:

Vax Date: 08/07/2021
Onset Date: 08/09/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Uterine bleeding; This is a spontaneous report from a contactable consumer (Patient) A 37-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 07Aug2021 (at the age of 37-year-ol) (Batch/Lot Number: FA7485) as single dose, dose 2 via an unspecified route of administration, administered in arm left on 28Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications in two weeks included Levothyroxine 0.75 mcg. The patient was not pregnant. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced uterine bleeding (medically significant) on 09Aug2021 with outcome of not recovered. The course of events was as follows: Uterine bleeding started after receiving the 1st dose of the vaccine on 07Aug2021. Bleeding started on 09Aug2021 and lasted until 24Aug2021. Uterine bleeding started few hours after receiving second dose on 28Aug2021. No treatment received. COVID was not tested post vaccination. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692248
Sex: M
Age:
State: FL

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
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: 20210831; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: a little bit of high blood pressure; Test Name: Covid; Test Result: Positive

Allergies:

Symptom List: Rash, Urticaria

Symptoms: a little bit of a fever; a little bit of high blood pressure; tried to go to the bathroom, collapsed on the floor; Third dose: 30Aug2021; Third dose: 30Aug2021; not very hungry; he was cold all afternoon, he was cold at dinner, and then went to bed because he was so cold at 18:00; This is a spontaneous report from a contactable consumer (patient). A 88-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date), via intramuscular route of administration, administered in right arm (muscle of the right arm) on 30Aug2021 at 12:30 hours as dose 3, single (at the age of 88-years-old) for COVID-19 immunisation. The patient's medical history included ongoing cholesterol (when he was diagnosed, it had been some while), ongoing blood pressure (when he was diagnosed, it had been some while) and COVID-19 (was in the hospital for 8 days and he can do anything to keep from going back he was going to do, due to which patient had the vaccine and stated that if the doctor says to take another booster shot, he was going to take another booster shot) from an unknown date to unknown date. The patient's concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date), via an unspecified route of administration, on an unspecified date as dose 1, single (at the age of 87-years-old) for COVID-19 immunisation and had no reaction and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date), via an unspecified route of administration, on an unspecified date (back in Dec2020 or early Jan2021) as dose 2, single (at the age of 87-years-old) both for COVID-19 immunisation and after second dose patient had legs were like rubber, he couldn't walk, couldn't get to the bathroom. Patient had no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). On 30Aug2021, patient was cold all afternoon, not very hungry, he was cold at dinner, and then went to bed because he was so cold at 18:00 hours, and he slept all night and then on 31Aug2021, morning when he tried to go to the bathroom, he collapsed on the floor. At the place he lives, they had doctors and nurses there and the nurses got him up and then they sent two more nurses there later and they diagnosed him with a little bit of a fever and a little bit of high blood pressure, not enough to worry about, and she said it would all be gone by tomorrow. Patient would say he was a lot better as he goes along, he was not going to get up out of bed today (31Aug2021), but he was feeling a lot better, he was not cold anymore. Patient had no emergency room and physician Office visit for all the events. No relevant tests were performed. Patient stated that maybe he had a reaction to antibodies. The patient underwent lab tests and procedures which included SARS-COV-2 test and result was positive on an unspecified date. The outcome of all the events was recovered on 31Aug2021 except extra dose administered and off label use. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness: Blood cholesterol abnormal (Verbatim: cholesterol); Blood pressure abnormal (Verbatim: blood pressure)

ID: 1692249
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: Trypanosoma cruzi IgG; Test Result: Negative ; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:61.5 ng/ml; Test Name: Leptospira immunoglobulin M; Test Result: Negative ; Test Name: BMI; Result Unstructured Data: Test Result:25.1; Comments: kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: CMV IgG; Test Result: Negative ; Test Name: CMV IgM; Result Unstructured Data: Test Result:borderline-positive; Test Name: TTE; Result Unstructured Data: Test Result:showed no structural abnormalities and qualitative; Comments: showed no structural abnormalities and qualitatively normal LVSF.; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:55; Test Name: Left ventricular ejection fraction on MRI; Result Unstructured Data: Test Result:60; Test Name: EKG findings; Result Unstructured Data: Test Result:Abnormal T waves, ST-segment depression; Comments: Abnormal T waves, ST-segment depression; Test Name: electrocardiogram; Result Unstructured Data: Test Result:diffuse ST elevation; Comments: ECG showed diffuse ST elevation and PR-segment depression (demonstrating sinus rhythm with normal axis and intervals. Diffuse PR depressions and horizontal ST-segment elevations are illustrated); Test Name: enterovirus PCR; Test Result: Negative ; Test Name: EBV antibody panel; Result Unstructured Data: Test Result:consistent with past infection; Comments: consistent with past infection; Test Name: d-dimer; Result Unstructured Data: Test Result:0.2 ug/ml; Test Name: human immunodeficiency virus (HIV) antigen/antibody; Test Result: Negative ; Test Name: human immunodeficiency virus (HIV) antigen/antibody; Test Result: Negative ; Test Name: Lyme antibody titers; Test Result: Negative ; Test Name: cardiac MRI; Result Unstructured Data: Test Result:consistent with acute Myocarditis; Comments: Cardiac MRI findings were consistent with acute myocarditis, showing late gadolinium enhancement pattern and myocardial edema, normal biventricular size and function, and pericardial thickening.; Test Name: Mycoplasma IgM; Test Result: Positive ; Test Name: pericardial effusion; Result Unstructured Data: Test Result:No; Test Name: adenovirus PCR; Test Result: Negative ; Test Name: nasopharyngeal PCR; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 spike IgM; Test Result: Negative ; Test Name: Toxocara canis IgG; Test Result: Negative ; Test Name: troponin-I; Result Unstructured Data: Test Result:4.82 ng/ml; Comments: elevated; Test Name: troponin-I; Result Unstructured Data: Test Result:5.56 ng/ml; Comments: peak; Test Name: troponin-I; Result Unstructured Data: Test Result:0.72 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:4.3

Allergies:

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

Symptoms: perimyocarditis/presented to the ED with left-sided chest pain and intermittent palpitations for approximately 1 day; This is a literature report. The full publication has been requested. This author reported similar events for eight patients. This is the second of eight reports. A 16-year-old (also reported as 16.7-year-old) male with no past medical history presented to the ED with left-sided chest pain and intermittent palpitations for approximately 1 day. He denied fever, shortness of breath, or recent illness. There was no history of SARS-CoV-2 infection. Patient had received the second dose of BNT162b2 vaccine 3 days prior to presentation. His troponin-I was elevated at 4.82 ng/mL, and ECG showed diffuse ST elevation and PR-segment depression (demonstrating sinus rhythm with normal axis and intervals. Diffuse PR depressions and horizontal ST-segment elevations are illustrated). The patient was managed with ibuprofen with resolution of pain. TTE showed no structural abnormalities and qualitatively normal LVSF. Cardiac MRI findings were consistent with acute myocarditis, showing late gadolinium enhancement pattern and myocardial edema, normal biventricular size and function, and pericardial thickening. Further workup showed negative SARS-CoV-2 nucleocapsid IgG, negative human immunodeficiency virus (HIV) antigen/antibody, adenovirus PCR, enterovirus PCR, Lyme antibody titers, Leptospira immunoglobulin M (IgM), Trypanosoma cruziIgG, and Toxocara canis IgG. EBV antibody panel was consistent with past infection. CMV IgM was borderline-positive, but IgG was negative. RPP was negative. Mycoplasma IgM was positive; however, nasopharyngeal PCR was negative. The decision was made to treat with doxycycline for Mycoplasma infection, although the IgM was suspected to be a false-positive. The patient was discharged home on doxycycline, ibuprofen, and lansoprazole. Demographic and clinical characteristics: Body mass index (kg/m2) 25.1. Past medical history (PMH) No. History of prior COVID-19 infection No. BNT162b2 vaccine dose # 2. Days between vaccine and symptom onset 3. Length of stay (hours) 71. Laboratories: White blood cell count (Ref: 5-10) 4.3; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 5.56; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.72; CKMB (Ref:0-3.5ng/mL) 61.5; d-dimer (Ref: 0.27-0.41 mmg/mL) 0.2. COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 spike IgM Negative; SARS-CoV-2 nucleocapsid IgG Positive EKG findings Abnormal PR depression, diffuse ST-segment elevation. Imagine Chest radiograph (cardiopulmonary findings) Negative. Left ventricular ejection fraction on ECHO 55. Pericardial effusion present No. Cardiac MRI performed Yes. Left ventricular ejection fraction on MRI 60. Myocardial edema on MRI Yes. Late gadolinium enhancement on MRI Yes. Treatment/intervention: IVIG (intravenous immunoglobulin) No; Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs) Yes. DISCUSSION Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. No follow-up attempts are needed, information about batch number cannot be obtained; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101133568 Same article/ drug/ event and Different patient.

Other Meds:

Current Illness:

ID: 1692250
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: Trypanosoma cruzi antibodies; Test Result: Negative ; Test Name: cpk; Result Unstructured Data: Test Result:523 IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:Unknown results ng/ml; Test Name: BMI; Result Unstructured Data: Test Result:39.7; Comments: kg/m2; Test Name: telemetry; Result Unstructured Data: Test Result:had a single 4 beat episode of monomorphic ventric; Comments: had a single 4 beat episode of monomorphic ventricular tachycardia; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: CMV anti bodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:no significant valvular dysfunction; Comments: no significant valvular dysfunction, qualitatively normal biventricular systolic function, and no significant pericardial effusion; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed normal biventricular function; Comments: showed normal biventricular function; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:58; Test Name: Left ventricular ejection fraction on MRI; Result Unstructured Data: Test Result:61; Test Name: ECG; Result Unstructured Data: Test Result:demonstrated normal sinus rhythm with no other abn; Comments: demonstrated normal sinus rhythm with no other abnormalities.; Test Name: ECG; Result Unstructured Data: Test Result:demonstrated sinus rhythm; Comments: demonstrated sinus rhythm with occasional premature ventricular contractions (PVCs), diffuse ST-segment elevations, and no PR depression; Test Name: enterovirus PCR; Test Result: Negative ; Test Name: EBV titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:Unknown results ug/ml; Test Name: human immunodeficiency virus (HIV) antigen/antibody; Test Result: Negative ; Test Name: HIV antigen/ antibody.; Test Result: Negative ; Test Name: Leptospira immunoglobulin M; Test Result: Negative ; Test Name: Lyme antibodies; Test Result: Negative ; Test Name: Myocardial edema on MRI; Result Unstructured Data: Test Result:Yes; Test Name: cardiac MRI; Result Unstructured Data: Test Result:Yes; Comments: late gadolinium enhancement pattern and edema consistent with acute myocarditis; Test Name: cardiac MRI; Result Unstructured Data: Test Result:showed a late gadolinium enhancement pattern and e; Comments: showed a late gadolinium enhancement pattern and edema consistent with acute myocarditis; Test Name: Mycoplasma IgM; Test Result: Negative ; Test Name: Parvovirus B19 PCR; Test Result: Negative ; Test Name: pericardial effusion; Result Unstructured Data: Test Result:No; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Positive ; Test Name: SARS-CoV-2 spike IgM; Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: Troponin; Result Unstructured Data: Test Result:0.45 ng/ml; Comments: first presentation; Test Name: Troponin; Result Un

Allergies:

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

Symptoms: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine.; This is a literature report The full publication has been requested. This author reported similar events for eight patients. This is the third of eight reports. A 17-year-old male with a history of mild perimyocarditis in 2014, presented to the ED with 1 day of retrosternal pressure. In the ED, his troponin was 0.45 ng/mL, and the ECG demonstrated normal sinus rhythm with no other abnormalities. TTE showed normal biventricular function. Patient had received his first BNT162b2 vaccine 14 days earlier. He was discharged with a 2-week course of ibuprofen with complete resolution of symptoms. He had no history of SARS-CoV-2 infection. Patient re-presented to the ED with retrosternal chest pressure 19 days after his first presentation. He received the second BNT162b2 dose 4 days before. Troponin-I level at his second presentation was 34.5 ng/mL. ECG demonstrated sinus rhythm with occasional premature ventricular contractions (PVCs), diffuse ST-segment elevations, and no PR depression. He was treated with 1 dose of intravenous immunoglobulin (IVIG). On telemetry, he had a single 4 beat episode of monomorphic ventricular tachycardia. TTE showed no significant valvular dysfunction, qualitatively normal biventricular systolic function, and no significant pericardial effusion. Cardiac MRI showed a late gadolinium enhancement pattern and edema consistent with acute myocarditis. The patient was found to be SARS-CoV-2 nucleocapsid IgG-positive and SARS-CoV-2 PCR-negative. Extensive infectious workup was negative, including adenovirus plasma PCR, CMV anti bodies, enterovirus plasma PCR, EBV titers, Leptospira antibodies, Lyme antibodies, Mycoplasma IgM, Parvovirus B19 PCR, Trypanosoma cruzi antibodies, and HIV antigen/antibody. Body mass index (kg/m2) 39.7, History of prior COVID-19 infection: No, Length of stay (hours) 95, Laboratories included: White blood cell count (Ref: 5-10) 10.4, Peak troponin-I (Ref: 0.00-0.08 ng/mL) 34.50, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.72, CKMB (Ref:0-3.5ng/mL) N/A, CPK (Ref: 33-145 IU/L) 523, d-dimer (Ref: 0.27-0.41 mmg/mL) N/A. COVID-19 testing: SARS-CoV-2 PCR Negative, SARS-CoV-2 spike IgM Negative, SARS-CoV-2 nucleocapsid IgG Positive. EKG: EKG findings Abnormal PR depression, diffuse ST-segment elevation. Imaging: Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 58, Pericardial effusion present No, Cardiac MRI performed Yes, Left ventricular ejection fraction on MRI 61, Myocardial edema on MRI (yes/no) Yes, Late gadolinium enhancement on MRI (yes/no) Yes, Treatment/intervention included: IVIG (intravenous immunoglobulin) and Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs). Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101133568 Same article/ drug/ event and Different patient.

Other Meds:

Current Illness: Myopericarditis

ID: 1692251
Sex: M
Age:
State:

Vax Date: 03/23/2021
Onset Date: 08/29/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210829; Test Name: Bivax; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Breakthrough Covid infection. Positive covid test on Sunday 29Aug.; Breakthrough Covid infection. Positive covid test on Sunday 29Aug.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248), dose 2 intramuscular, administered in left arm on 23Mar2021 as DOSE 2, SINGLE (at the age of 42-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248), dose 1 intramuscular, administered in left arm on 02Mar2021 as DOSE 1, SINGLE (at the age of 42-years-old) for COVID-19 immunisation. On 29Aug2021 at 13:00 hours, the patient experienced breakthrough COVID infection. positive COVID test on Sunday 29Aug. The patient's symptoms were fever, chest congestion, runny nose, tiredness, and loose stools. The patient underwent lab tests and procedures which included Bivax: positive on 29Aug2021 Nasal Swab. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested positive for COVID-19. The patient has not recovered from the event.

Other Meds:

Current Illness:

ID: 1692252
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: cpk; Result Unstructured Data: Test Result:312 IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:Unknown ng/ml; Test Name: Leptospira immunoglobulin M; Test Result: Negative ; Test Name: BMI; Result Unstructured Data: Test Result:16.8; Comments: 16.8 kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: Chest radiograph (cardiopulmonary findings); Result Unstructured Data: Test Result:normal; Test Name: CMV antibodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:patent foramen ovale; Comments: showed patent foramen ovale, mild mitral valve prolapse with mild-to-moderate mitral regurgitation, mild aortic root dilation (unchanged), and qualitatively low normal LVSF; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:57; Test Name: Left ventricular ejection fraction on MRI; Result Unstructured Data: Test Result:61; Test Name: electrocardiogram; Result Unstructured Data: Test Result:normal Sinus rhythm; Comments: normal sinus rhythm with no other changes; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: EBV titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:less than 0.19 ug/ml; Test Name: Hemodynamic test; Result Unstructured Data: Test Result:remained hemodynamically stable; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:significant for focal edema at the basal inferolat; Comments: significant for focal edema at the basal inferolateral segments, normal biventricular size and global systolic function, and stable aortic root dilation. The patient had 12- and 8- beat runs of irregular polymorphic ventricular tachycardia (Figure 1B). Myocardial edema, left ventricular ejection fraction 61, late gadolinium enhancement; Test Name: Parvovirus B19 PCR; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 spike IgM; Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: sinus rhythm; Result Unstructured Data: Test Result:normal; Test Name: Troponin; Result Unstructured Data: Test Result:7.2 ng/ml; Test Name: Troponin; Result Unstructured Data: Test Result:11.8 ng/ml; Test Name: Discharge troponin-I; Result Unstructured Data: Test Result:0.28 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:11.80 ng/ml; Test Name: White blood cell count; Result Unstructured Data: Test Result:6.6

Allergies:

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

Symptoms: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine; This is a literature report. This author reported similar events for eight patients. This is the fourth of eight reports. The authors describe clinical characteristics of 8 adolescents who presented over the course of 36 days to (Hospital) with perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine. A 15-year-old male with Marfan syndrome and aortic root dilation presented to the ED with sudden onset of retrosternal chest pain, fatigue, and abdominal pain for 1 day. He denied fever, shortness of breath, or recent illness. The patient had a history of SARS-CoV-2 infection in January 2021 with mild symptoms. He had received the first dose of the BNT162b2 vaccine 3 days prior to admission. In the ED, his troponin was 7.2 ng/ mL and ECG demonstrated normal sinus rhythm with no other changes. Chest X-ray was normal. The peak troponin level was 11.8 ng/mL. Pain resolved while he was still in ED. The patient was asymptomatic at the time of admission. TTE showed patent foramen ovale, mild mitral valve prolapses with mild-to-moderate mitral regurgitation, mild aortic root dilation (unchanged), and qualitatively low normal LVSF. Cardiac MRI (magnetic resonance imaging) was significant for focal edema at the basal inferolateral segments, normal biventricular size and global systolic function, and stable aortic root dilation. The patient had 12- and 8-beat runs of irregular polymorphic ventricular tachycardia. The runs occurred within 1 minute of each other, and the patient was asymptomatic at the time. He remained hemodynamically stable. Infectious workup was negative, including adenovirus plasma PCR, CMV antibodies, enterovirus plasma PCR, EBV titers, Leptospira IgM, Parvovirus B19 PCR, and RPP (Respiratory viral panel). Body mass index (kg/m2) 16.8, Past medical history (PMH) Marfan syndrome, History of prior COVID-19 infection: Yes, Days between vaccine and symptom onset 2, Length of stay (hours) 71, Laboratories: White blood cell count (Ref: 5-10) 6.6, Peak troponin-I (Ref: 0.00-0.08 ng/mL) 11.80, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.28, CKMB (creatine kinase myocardial band, Ref:0-3.5ng/mL) N/A, CPK (creatine phosphokinase Ref: 33-145 IU/L) 312, d-dimer (Ref: 0.27-0.41 mmg/mL) less than 0.19, COVID-19 testing: SARS-CoV-2 PCR Negative, SARS-CoV-2 spike IgM Negative, SARS-CoV-2 nucleocapsid IgG Negative, EKG (electrocardiogram): EKG findings Normal sinus Rhythm, Imaging: Chest radiograph (cardiopulmonary findings) Negative, Left ventricular ejection fraction on ECHO (echocardiogram) 57, Pericardial effusion present No, Cardiac MRI performed Yes, Left ventricular ejection fraction on MRI 61, Myocardial edema on MRI (yes/no) Yes, Late gadolinium enhancement on MRI (yes/no) Yes, treatment: no intravenous immunoglobulin; nonsteroidal anti-inflammatory drugs. Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101133568 Same article/drug/event; different patient

Other Meds:

Current Illness:

ID: 1692253
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: cpk; Result Unstructured Data: Test Result:unknown IU/l; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:Unknown ng/ml; Test Name: BMI; Result Unstructured Data: Test Result:30.8; Comments: 30.8 kg/m2; Test Name: Chest radiograph (cardiopulmonary findings); Result Unstructured Data: Test Result:Negative (Normal); Test Name: CMV antibodies; Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities and qualitative; Comments: showed no structural abnormalities and qualitatively normal LVSF; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:60; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Diffuse ST-segment elevation; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: EBV titers; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:0.52 ug/ml; Test Name: Parvovirus B19 antibodies; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 spike IgM; Test Result: Positive ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: Discharge troponin-I; Result Unstructured Data: Test Result:0.81 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:2.42 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:1.92 ng/ml; Test Name: White blood cell count; Result Unstructured Data: Test Result:10

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine.; This is a literature report. This author reported similar events for eight patients. This is the fifth of eight reports. The authors describe clinical characteristics of 8 adolescents who presented over the course of 36 days to (Hospital) with perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine. A 16-year-old male with no past medical history presented to the ED with intermittent retrosternal chest pressure over 2 days. He denied fever, shortness of breath, or recent illness. He had received his second dose of the BNT162b2 vaccine 1 day before symptom onset. Post-vaccination symptoms included mild body aches and headache. Family history was positive for vitiligo in the patient's mother. Troponin-I was elevated at 1.92 ng/mL, and the peak level obtained was 2.42 ng/mL. ECG demonstrated ST-segment elevation. Chest X-ray was negative. TTE showed no structural abnormalities and qualitatively normal LVSF. He had no recurrence of chest pain while admitted. Patient recovered with no medical intervention. Infectious workup was negative, including RPP, adenovirus plasma PCR, CMV antibodies, enterovirus plasma PCR, EBV titers, and Parvovirus B19 antibodies. Additional workup showed SARS-CoV-2 nucleocapsid IgG-negative. Body mass index (kg/m2) 30.8, Past medical history (PMH) No PMH, History of prior COVID-19 infection No, Days between vaccine and symptom onset 1, Length of stay (hours) 34, Laboratories: White blood cell count (Ref: 5-10) 10, Peak troponin-I (Ref: 0.00-0.08 ng/mL) 2.42, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 0.81, CKMB (creatine kinase myocardial band, Ref:0-3.5ng/mL) N/A, CPK (creatine phosphokinase, Ref: 33-145 IU/L) N/A, d-dimer (Ref: 0.27-0.41 mmg/mL) 0.52, COVID-19 testing: SARS-CoV-2 PCR Negative, SARS-CoV-2 spike IgM Positive, SARS-CoV-2 nucleocapsid IgG Negative, EKG electrocardiogram; findings Diffuse ST-segment elevation, Imaging: Chest radiograph (cardiopulmonary findings) Negative, Left ventricular ejection fraction on ECHO echocardiogram; 60, Pericardial effusion present No, Cardiac MRI (magnetic resonance imaging) not performed, Left ventricular ejection fraction on MRI, Myocardial edema on MRI (yes/no), Late gadolinium enhancement on MRI (yes/no), Treatment: No IVIG (intravenous immunoglobulin), No Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs). Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101133568 Same article/drug/event; different patient

Other Meds:

Current Illness:

ID: 1692254
Sex: M
Age:
State: CT

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: low blood pressure; Result Unstructured Data: Test Result:Low

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: sweats; feels like death is going to take him over; low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 7-decade-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration in Mar2021 as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity (allergy to strain of mushroom and penicillin in the vaccine in which he is highly allergic). The patient's concomitant medications were not reported. On an unknown date in Mar2021, the patient feels like death is going to take him over and low blood pressure. On an unknown date, the patient had sweats. It was reported that 5 minutes after receiving the vaccine, the patient had low blood pressure and sweats. The patient states today he feels like death is going to take him over. The patient also wants to know if any other person has been affected like this regarding the symptoms he has had. The patient stated it has been 6 months since the first vaccine dose and his doctor told him not to take the second dose, so caller wants to know if anyone has been affected like. It was reported that the patient had previously talked to someone there who told him there is a strain of mushroom and penicillin in the vaccine in which he is highly allergic. The outcome of all the events was reported as unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692255
Sex: M
Age:
State: CT

Vax Date: 04/22/2021
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210901; Test Name: Positive Covid test; Test Result: Positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Positive Covid test on 01Sep2021; Positive Covid test on 01Sep2021; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A 39-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8735, via intramuscular route of administration on 22Apr2021 (at the age of 39-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included Benign heart murmur. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication within two weeks of vaccination, start and stop date were not reported. The patient previously took Demerol and experienced known allergy. On 01Sep2021, the patient experienced positive covid test. No seriousness criteria were reported. No treatment received for AE. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Sep2021. No other vaccine received in four weeks. No covid prior vaccination, it was unknown if covid tested post vaccination. The outcomes of event was recovering

Other Meds: VALACYCLOVIR [VALACICLOVIR]

Current Illness:

ID: 1692256
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: adenovirus plasma PCR; Test Result: Negative ; Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:19.9 ng/ml; Test Name: blood culture; Test Result: Negative ; Test Name: BMI; Result Unstructured Data: Test Result:29.5; Comments: 29.5 kg/m2; Test Name: temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: fever; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities and qualitative; Comments: showed no structural abnormalities and qualitatively normal LVSF.; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:62; Test Name: electrocardiogram; Result Unstructured Data: Test Result:normal Sinus rhythm; Comments: demonstrated normal sinus rhythm, with no significant ST-segment changes; Test Name: enterovirus plasma PCR; Test Result: Negative ; Test Name: d-dimer; Result Unstructured Data: Test Result:0.53 ug/ml; Test Name: gastrointestinal panel; Test Result: Negative ; Test Name: physical examination; Result Unstructured Data: Test Result:diffuse reproducible chest wall tenderness; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: troponin; Result Unstructured Data: Test Result:5.10 ng/ml; Comments: elevated; Test Name: troponin; Result Unstructured Data: Test Result:1.30 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:5.9

Allergies:

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

Symptoms: perimyocarditis/3 days of sharp, intermittent, retrosternal pain, with associated fever (38 degree C), headache, loose bowel movement, and cough; This is a literature report. This author reported similar events for eight patients. This is the sixth of eight reports. A 15-year-old (also reported as 15.8-year-old) male with obesity, insulin resistance, and dyslipidemia presented to outside hospital ED with 3 days of sharp, intermittent, retrosternal pain, with associated fever (38 degree C), headache, loose bowel movement, and cough. Patient denied any trauma or recent viral illnesses. No prior history of SARS-CoV-2 infection. He had received the second dose of the BNT162b2 vaccine 2 days prior to symptom onset. On physical examination, there was diffuse reproducible chest wall tenderness. Laboratories unremarkable aside from elevated peak troponin-I of 5.1 ng/mL and Creatine Kinase Myocardial Band of 19.9 ng/mL. ECG demonstrated normal sinus rhythm, with no significant ST-segment changes. Chest X-ray was normal. TTE showed no structural abnormalities and qualitatively normal LVSF. He recovered with no medical intervention. Infectious workup was negative but limited to RPP, adenovirus plasma PCR, enterovirus plasma PCR, SARS-CoV-2 nucleocapsid IgG, blood culture, and gastrointestinal panel. Demographic and clinical characteristics: Body mass index (kg/m2) 29.5. Past medical history (PMH) Insulin resistance dyslipidemia. History of prior COVID-19 infection No. BNT162b2 vaccine dose #2. Days between vaccine and symptom onset 2. Length of stay (hours) 37. Laboratories: White blood cell count (Ref: 5-10) 5.9; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 5.10; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 1.30; CKMB (Ref:0-3.5ng/mL) 19.9; D-dimer (Ref: 0.27-0.41 mmg/mL) 0.53. COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 nucleocapsid IgG Negative EKG findings Normal sinus rhythm. Imaging Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 62; Pericardial effusion present No; Cardiac MRI performed No. DISCUSSION Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. No follow-up attempts are needed, information about batch number cannot be obtained.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101133568 Same article/drug/event; different patient

Other Meds:

Current Illness:

ID: 1692257
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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: Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:44.5 ng/ml; Test Name: IgG; Result Unstructured Data: Test Result:positive for mycoplasma; Test Name: IgM; Result Unstructured Data: Test Result:Positive for Mycoplasma; Test Name: BMI; Result Unstructured Data: Test Result:17.3; Comments: 17.3 kg/m2; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities, qualitatively; Comments: showed no structural abnormalities, qualitatively normal LVSF, and no significant pericardial effusion.; Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:60; Test Name: EKG; Result Unstructured Data: Test Result:Intraventricular conduction delay, transient; Comments: Intraventricular conduction delay, transient ST-segment depression; Test Name: electrocardiogram; Result Unstructured Data: Test Result:Intraventricular conduction delay; Comments: Intraventricular conduction delay, transient ST-segment depression; Test Name: 24-hour Holter; Result Unstructured Data: Test Result:showed 13 multiform PVCs, including 1 couplet; Test Name: d-dimer; Result Unstructured Data: Test Result:0.11 ug/ml; Test Name: nasopharyngeal PCR for Mycoplasma; Test Result: Negative ; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: troponin-I; Result Unstructured Data: Test Result:22.05 ng/ml; Comments: peak; Test Name: troponin-I; Result Unstructured Data: Test Result:11.56 ng/ml; Comments: Discharge; Test Name: White blood cell count; Result Unstructured Data: Test Result:8.9

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: perimyocarditis/self-resolving chest pain/intermittent, non-radiating, retrosternal pain; This is a literature report. This author reported similar events for eight patients. This is the seventh of eight reports. A 15-year-old (also reported as 15.2-year-old) male with no past medical history presented with a 2-day history of intermittent, non-radiating, retrosternal pain. He denied recent fever, shortness of breath, or recent illness. No history of SARS-CoV-2 infection. Three days prior to presentation, the patient received his second BNT162b2 vaccine. Upon further interviewing, he reported 2 episodes of self-resolving chest pain 3 days after the first dose of the BNT162b2 vaccine of unclear significance given he did not seek medical care. Chest X-ray was normal. Initial laboratories were unremarkable aside from elevated CPK-MB level of 44.5 ng/mL with a peak troponin level of 22.05 ng/mL. ECG showed intraventricular conduction delay with transient ST-segment depression. TTE showed no structural abnormalities, qualitatively normal LVSF, and no significant pericardial effusion. A 24-hour Holter showed 13 multiform PVCs, including 1 couplet. Patient was managed with ibuprofen with resolution of pain on day 3 of admission. RPP was negative, and Mycoplasma IgG and IgM were positive; however, nasopharyngeal PCR for Mycoplasma was negative. The decision was made to treat with azithromycin for Mycoplasma infection. Patient reported chest pain after first vaccine although he did not seek medical care. Demographic and clinical characteristics: Body mass index (kg/m2) 17.3. No Past medical history (PMH). History of prior COVID-19 infection No. BNT162b2 vaccine dose #2. Days between vaccine and symptom onset 3. Length of stay (hours) 65. Laboratories: White blood cell count (Ref: 5-10) 8.9; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 22.05; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 11.56; CKMB (Ref:0-3.5ng/mL) 44.5; d-dimer (Ref: 0.27-0.41 mmg/mL) 0.11. COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 nucleocapsid IgG Negative EKG findings Intraventricular conduction delay, transient ST-segment depression. Imaging Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 60; Pericardial effusion present No. Treatment/intervention: IVIG (intravenous immunoglobulin) No; Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs) Yes. DISCUSSION Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. No follow-up attempts are needed, information about batch number cannot be obtained.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101133568 Same article/drug/event; different patient

Other Meds:

Current Illness:

ID: 1692258
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: creatine phosphokinase-MB; Result Unstructured Data: Test Result:33.9 ng/ml; Test Name: Chest radiograph (cardiopulmonary findings); Test Result: Negative ; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Test Result:showed no structural abnormalities; Comments: showed no structural abnormalities, qualitatively low normal left ventricular systolic function (LVSF); Test Name: Left ventricular ejection fraction on ECHO; Result Unstructured Data: Test Result:61; Test Name: ECG; Result Unstructured Data: Test Result:demonstrated mild diffuse ST-segment elevation; Test Name: EKG findings; Result Unstructured Data: Test Result:Mild diffuse ST-segment elevation; Test Name: d-dimer; Result Unstructured Data: Test Result:unknown ug/ml; Test Name: RPP; Test Result: Negative ; Test Name: SARS-CoV-2 nucleocapsid immunoglobulin G (IgG); Test Result: Negative ; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: Discharge troponin-I; Result Unstructured Data: Test Result:2.86 ng/ml; Test Name: peak troponin-I; Result Unstructured Data: Test Result:5.09 ng/ml; Comments: elevated

Allergies:

Symptom List: Unevaluable event

Symptoms: perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine.; This is a literature report. This is the eighth of eight reports. The authors describe clinical characteristics of 8 adolescents who presented over the course of 36 days to (Hospital) with perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine. A 17-year-old male with no past medical history presented to the ED with 3 days of sharp, retrosternal pain. He denied fever, shortness of breath, or recent illness. There was no history of SARSCoV-2 infection. Patient had received the second dose of the BNT162b2 vaccine 1 day prior to symptom onset. His troponin-I was elevated with a peak of 5.09 ng/mL. ECG demonstrated mild diffuse ST-segment elevation. TTE showed no structural abnormalities and qualitatively normal LVSF. The patient was managed with ibuprofen with resolution of pain. Infectious workup was negative but limited to RPP and SARS-CoV-2 nucleocapsid IgG. Past medical history (PMH) No PMH, History of prior COVID-19 infection No, Days between vaccine and symptom onset 1, Length of stay (hours) 34, Laboratories: Peak troponin-I (Ref: 0.00-0.08 ng/mL) 5.09, Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 2.86, CKMB (creatine kinase myocardial band, Ref:0-3.5ng/mL) 33.9, COVID-19 testing: SARS-CoV-2 PCR Negative, EKG electrocardiogram; findings Mild diffuse ST-segment elevation, Imaging: Chest radiograph (cardiopulmonary findings) Negative, Left ventricular ejection fraction on ECHO echocardiogram; 61, Pericardial effusion present No, Cardiac MRI (magnetic resonance imaging) performed No, Left ventricular ejection fraction on MRI, Myocardial edema on MRI (yes/no), Late gadolinium enhancement on MRI (yes/no), Treatment/intervention: IVIG (intravenous immunoglobulin) No, Scheduled NSAIDs (nonsteroidal anti-inflammatory drugs) Yes. Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause. Pediatricians should consider myocarditis in the differential diagnosis of patients presenting with chest pain after receiving the BNT162b2 vaccine and be aware of the clinical implications and the need to report this potential adverse event. Currently, the association between perimyocarditis and the BNT162b2 vaccine is unproven but recent reports suggest there may be causality. This case series raises additional questions regarding appropriate recommendations for COVID-19 vaccination in adolescents with a prior history of perimyocarditis, of SARS CoV-2 infection (clinically or by serology), and of multisystem inflammatory syndrome associated with SARS-CoV-2 (MISC). It also poses the issue of whether patients who experience perimyocarditis post-BNT162b2 vaccine should receive booster SARS-CoV-2 vaccines in the future. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101133568 Same article/ drug/ event and Different patient.;US-PFIZER INC-202101133568 Same article/drug/event; different patient

Other Meds:

Current Illness:

ID: 1692259
Sex: F
Age:
State: TX

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
Hospital: Y

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: 202108; Test Name: Blood sugar; Result Unstructured Data: Test Result:High; Test Date: 202108; Test Name: Blood sugar; Result Unstructured Data: Test Result:over 300; Test Date: 202108; Test Name: Temperature; Result Unstructured Data: Test Result:101.8; Test Date: 202108; Test Name: Heart things; Result Unstructured Data: Test Result:Good; Comments: Was told all her scans were good.; Test Date: 202108; Test Name: CAT Scan; Result Unstructured Data: Test Result:Good; Comments: Was told all her scans were good.; Test Date: 202108; Test Name: CT Scan; Result Unstructured Data: Test Result:Good; Comments: Was told all her scans were good.; Test Date: 202108; Test Name: Brain test; Result Unstructured Data: Test Result:unknown results; Test Date: 202108; Test Name: pancreas enzymes; Result Unstructured Data: Test Result:Elevated; Test Date: 20210901; Test Name: pancreas enzymes; Result Unstructured Data: Test Result:Fine; Test Date: 202108; Test Name: Brain Scan; Result Unstructured Data: Test Result:Unknown results; Comments: It was not the stomach flu or pancreatitis

Allergies:

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

Symptoms: severe stomach pain; vomiting; diarrhea; dehydration; pancreas enzymes were elevated; blood sugar was high; pancreatitis; seizure; Eyes water for 18 days like a cold; Passed out four times in one day; Unsteadiness, hard to walk; feeling really weird; Sking was burning; she was freezing; Took her temperature and she was 101.8; get into diabetic ketoacidosis before she could be admitted; Pancreatic levels were up; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer (patient) reported for herself that she received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus from Jan2020 and ongoing, ovarian tumour removed in Jan2020, hysterectomy in Jan2020, Ovarian cancer from an unspecified onset and unknown ongoing, Ovarian neoplasm surgery done in unknown date 2020. concomitant medications were not reported. In Aug2021, 06 days after the vaccination, the patient experienced severe stomach pain, vomiting, diarrhoea, and eventually dehydration, Violently ill, Unsteadiness, hard to walk, Dizziness, Elevated pancreatic enzymes, Eyes watered, Blood sugar was over 300. Patient tried Zofran. Took two bottles of Imodium. Drank two bottles of Pepto over the 20 days. She is scared. She was so dehydrated the hospital was preparing her room for her to have a seizure. It was bad. Did brain scans and tests. Would not listen to her that it was not the stomach flu or pancreatitis. Last time her diarrhoea was water and vomit were bile, It was hard for her to walk, she was scared to walk. She was dizzy. Her Eyes water for 18 days like a cold. She Passed out four times in one day. Caller was admitted to this hospital after her COVID-19 Vaccine first dose for pancreatitis. Wants to know where did it come from? She was admitted, given pain meds, fluids, potassium, and insulin. Was also given blood clot medicine. Did scans. Stayed for 1.5 days, almost 2 days. The ER doctor said she could go home, but to come back if it seems worse. Next day she wasn't feeling well. While driving, she was feeling weird. Skin was burning, but she was freezing. Took her temperature and she was 101.8. She never has a fever. She was miserable. As she was leaving from her CT scan, she passed out. Caller went home. Couple days later, she felt worse. Passed out 4 times at her house. Called the doctor and went to a different hospital on 24Aug2021. She was admitted for the same thing. Pancreatic levels were up. She had no vitamins in her at all. Thought she was going to have a seizure she was so dehydrated. Brain scans were done because she passed out at the doors of the ER. Hospital was afraid why she is passing out. Hospital did all kinds of heart things. She was kept there for two days and started getting better. On pain meds and IVs but doesn't know what else. Was sent home and got better. She Was supposed to get second COVID-19 Vaccine. Doctors kept advising her to get the second shot. She had three weeks of hell. She can't be the only person who has experienced this. Maybe there's something in the vaccine she's allergic to. She is hurting and scared of what's coming. It was so violent when it woke her up at 4AM. She was told her pancreas enzymes were elevated and her blood sugar was high. Caller says the doctors "didn't believe it was from the covid shot". Caller was scheduled to receive her second dose on Friday and waited to receive the second dose on 31Aug2021 at 4:30pm. The patient lab data includes Blood glucose in Aug2021 which showed high value, another reading in same month showed over 300. Body temperature in Aug2021 with a 101.8 centigrade reading, Cardiac function test in Aug2021 Was told all her scans were good, Computerised tomogram in Aug2021 Was told all her scans were good, Brain test in Aug2021 with unspecified results. Pancreatic enzymes with unknown results in Aug2021, Brain Scan in Aug2021 with unknown results. On 01Sep2021 pancreatic enzyme test was found to be fine. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness: Diabetes (not being able to take her diabetes medication during this time)

ID: 1692260
Sex: F
Age:
State: IL

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Name: Tests being done; Result Unstructured Data: Test Result:everything was okay

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: not being able to walk or talk; Could not walk without assistance; horrible slurred speech; rubber legs; dizziness; Not able to talk; passed out; double vision; shakiness of extremities; spasms/Having these things states are spasms where all of a sudden arm would jerk all around, head forward and backward; spasms/Having these things states are spasms where all of a sudden arm would jerk all around, head forward and backward; dehydrated; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER2613, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 24Mar2021 (vaccination at the age of 61 years) as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 14Apr2021 at 14:00 hours as dose 2, single both for COVID-19 immunisation. Patient had no medical history. There were no concomitant medications received by the patient. Patient had no prior to vaccinations (within 4 weeks). Patient had no family medical history and stated that nobody had any side effects. Patient stated that she had extreme side effects that have become no better over time and reaction happened multiple times.. On Mar2021, patient was dehydrated due to which on 25Mar2021, had double vision, it began at the beginning and the first night, patient had shakiness of the extremities. On 25Mar2021, patient got up to go to washroom and passed out in the hallway and patient ended up in the emergency room. Patient spent like 4 days at the hospital. Patient does not know why she passed out and stated that she never passed out in her life. On 25Mar2021 to 28Mar2021, patient had first hospitalization, as patient passed out and double vision. Patient stated that going into the 26Mar2021, shakiness of the extremities was extremely bad. Patient stated that the double vision cleared up now, takes 2 days before it clears up, it comes and goes. Patient stated that when she had an episode the double vision occurs. On 26Mar2021, patient had speech horrible where no one could understand speech, could not walk without assistance, stated that had rubber legs, dizziness, not being able to walk or talk and shakiness of the extremities and patient stated that all these events occur each time when patient had an episode, and these were persisting. On 09Apr2021, patient had these things, had spasms where all of a sudden arm would jerk all around, head forward and backward, had three episodes of this that occurred on 09Apr2021, 10Apr2021 and 11Apr2021 and it was continuing and persisting. The spams were horrible. Patient would be sitting somewhere and all of a sudden, the spasms would just go. Patient was at the doctor's office for her husband, not for herself and the spasm started, just spasming out. On 09Apr2021 to 11Apr2021, patient had second hospitalization. On 21Apr2021 to 22Apr2021, patient had third hospitalization. On 10May2021 to 13May2021, patient had fourth hospitalization. Patient stated that fifth time, she went to the emergency room but discharged from the emergency room, this occurred on 08Aug2021. Patient was sent home, but multiple tests were done in the emergency room. Patient was hospitalized 4 times since Mar2021. Patient stated that she had 15 episodes but stayed home the other times the episodes occurred. Patient stated that stayed home and worked out the problems at home. Since going to emergency room and tests being done, after the test everything was okay. Patient decided to stay home. Patient's husband walked the patient to the washroom and told the patient to stay in her chair and not go anywhere. Patient asked if anyone else has reported these symptoms. Each of the other times hospitalized it was for shakiness, double vision, not being able to walk or talk. Patient clarified that the reaction that happened multiple times includes, dizziness, not being able to walk or talk. Patient stated that she calls these reactions episodes. Patient had been followed up with cardiologist, neurologist, family doctor and even a psychiatrist and received no answers. Patient asked that if other patients experienced any of these same symptoms. The outcome of passed out, double vision, dehydrated and not being able to walk or talk was unknown, not recovered for rest of the events. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692261
Sex: F
Age:
State:

Vax Date: 08/10/2021
Onset Date: 08/13/2021
Rec V Date: 09/11/2021
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: shortness of breath/difficulty breathing; panic attacks; rash on arms and legs; This is a spontaneous report from a contactable nurse, from a Pfizer-sponsored program. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 10Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the reporter was reporting a female patient had first dose of Pfizer Covid 19 vaccine on 10Aug2021 and then developed rash on arms and legs three days later. The nurse who is the vaccine provider explained that the patient also experienced shortness of breath/difficulty breathing but it was attributed to her baseline panic attacks and not the vaccine. Nurse further explained that the patient's HCP advised her not to get the second dose of the vaccine. Vaccine provider would like to know if her patient would be able to get the second dose given the side effects previously experienced. Nurse would like to know if there is an exemption form that can be provided for medical clearance. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692262
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: blood clots; non-stop vaginal bleeding for 23 days straight; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 41-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on an unspecified date single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical dose included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number and expiration date was not reported) first dose via an unspecified route of administration on an unspecified date single for covid-19 immunization. On an unspecified date the patient experienced non-stop vaginal bleeding for 23 days straight and blood clots. The outcome of the events was unknown. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1692263
Sex: U
Age:
State: TX

Vax Date: 01/19/2021
Onset Date: 03/10/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Atrial fibrillation; Daily itching; Flaky skin; This is a spontaneous report received from a contactable consumer (patient) based on information received by Pfizer. (Manufacturer Control Number 20210823000368). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced atrial fibrillation (caused hospitalization) on 10Mar2021 with outcome of unknown, daily itching (non-serious) on 2021 with outcome of recovering, flaky skin (non-serious) on 2021 with outcome of recovering. Therapeutic measures were taken as a result of the events and included treatment with cardioversion and long-term use of medications (for atrial fibrillation), Dupixent (for daily itching and flaky skin). The lot number for bnt162b2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1692264
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: COVID-19; Test Result: Positive ; Comments: 2 days after receiving his second dose of COVID vaccine

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: COVID-19; COVID-19; This is a spontaneous solicited report from a contactable healthcare professional and a consumer (patient) based on the information received by Pfizer (Manufactuter control number 20210339257) and via PPSPHNO02327 SP Services Theracon (no farther information specified). A 75-year-old male patient received two single doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both on unspecified dates in 2021, for COVID-19 immunization. Co-suspect drug included macitentan (OPSUMIT; 10 mg tablet) oral, from 2017, 10 mg, 1x/day, for an unspecified indication. Medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient teste positive for COVID-19. The event required hospitalization from 04Mar2021 to 19Mar2021. The patient recovered from COVID-19 on an unspecified date in 2021. Clinical course was reported as follows. On an unspecified date, the patient experienced flu. On follow up it was reported patient was diagnosed with COVID-19, 2 days after receiving his second dose of COVID vaccine. He was admitted into the hospital on 04Mar2021. The dose of macitatan was not changed. The reporter considered the causality between Macitentan and COVID-19 not related. Company causality between macitetan and COVID-19 was not related. Additional information was received from the health care professional and patient on 11Aug2021. The following information was updated and incorporated into the case narrative: Patient demography. reporter details, event flu was updated to COVID-19, cosuspect and suspect dose details and narrative information was updated. Company Remarks (sender's comments): V2 Follow up pertained to patient demography, event of flu was updated to COVID-19), co-suspect and suspect dose details and reporter details. This report concerned an 8 decade old male patient who had COVID-19 infection while on macitentan. Considering the current COVID-19 pandemic and given the novel status of this disease and limited understanding of COVID-19 pathogenesis, the causality for the event was considered as not related to macitentan. The company will continue to monitor and the potential relationship between maitentan treatment and COVID-19 cases. Protocol relatedness was also reported unknown both for reporter and for company. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.

Other Meds: OPSUMIT

Current Illness:

ID: 1692265
Sex: M
Age:
State: PA

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 09/11/2021
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: ANA positive; Test Result: Positive ; Test Date: 2021; Test Name: Sodium; Result Unstructured Data: Test Result:Low; Comments: sodium was slightly low; Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Comments: Nothing was real revealing.; Test Date: 2021; Test Name: COVID test; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: weight; Result Unstructured Data: Test Result:lost 20 and is now 200 lbs

Allergies:

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

Symptoms: thought maybe he had Lyme disease; Almost passed out a couple of times; Felt a little fever-ish, flu-like at first; he lost weight/he lost 20 lbs; He states it turns out he did have a minor sinus infection; his total body just felt so horrible, like he was dying; lightheadedness/he was so dizzy; sodium was slightly low; felt a little fever-ish, flu-like at first; allergies; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Apr2021 at 10:00 (Batch/Lot Number: ER8735) (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. Medical history included neuropathy in his feet and in his legs as well, autoimmune disease and carpal tunnel syndrome. Concomitant medications included fish oil and colecalciferol, menaquinone-7, phytomenadione, retinol palmitate, tocopherol, tocotrienols nos (VITAMIN D COMPLEX); both taken for an unspecified indication, start and stop date were not reported. The caller stated he had a reaction to the Pfizer COVID-19 vaccine. The caller stated he has been going through living hell since it started. He had his first injection at the end of Apr (22Apr2021) and his second one at the beginning of May (13May2021). He stated his condition has worsened and has been escalating. He has seen multiple doctors and it's all coming back to the vaccine. He stated he is about ready to jump off of a bridge. He stated unfortunately he is in a really bad way, and he is not getting any better, he is getting worse. He is out of work and he really needed help as to what to do. He stated they tried giving him 5mg Prednisone and it was making him even worse, it's just horrible. The patient mentioned his symptoms started relatively mild, he felt-flu-ish, like he had the flu in 2021. He mentioned he lost 20lbs and is now 200lbs. They thought maybe he had Lyme disease, he was tested multiple times for that. He then thought he had maybe he had really bad sinus allergies, like a sinus infection. He stated it turned out he did have a minor sinus infection and was given antibiotics, but he is still not getting better. It was like from the reaction he had with the vaccine and taking an antibiotic, it threw his body into worse shape, like a super wharf. He clarified it was like his total body just felt so horrible, like he was dying. He had no appetite, he lost in appetite back in Jun-ish. He went to the hospital last Thursday (date unspecified) because he was so lightheaded when he walked. He was pushing his mower across the lawn and it hit him and he had to lay down for hours. He has a border collie dog and he tried to let his border collie out for a walk, but he was so dizzy, he had to lay down. He mentioned he almost passed out a couple of times that day. He mentioned he has been checked out multiple times. He has been seen by a Cardiologist and his heart is fine. His family physician has seen him at least 2 or 3 times. He had a COVID test while he was the hospital. Patient clarified he was not hospitalized. He went to the Emergency room at 10:00 and was there until about 21:00 (date unspecified). They did all kinds of bloodwork and nothing was real revealing. His sodium was slightly low, but this doesn't account for any of his symptoms. The doctors were at a loss. He stated he felt a little fever-ish, flu-like at first, like it wasn't anything. He kept thinking maybe it was allergies and then as it got worse, he thought maybe it was Lyme disease. Caller clarifies he had three tests done for Lyme disease. He just was not feeling himself. He clarifies it was within a day or two of getting the vaccine, he felt this way, but he honestly didn't remember if these symptoms began after the first or second dose. When attempting to clarify if he was currently suicidal since he made the statement he is about ready to jump off a bridge, the caller responds that he is not. He states he would be lying if he said it hasn't entered in his mind, but he would not hurt himself. He has a wife, a dog, loved ones and he doesn't want to leave this planet. He stated he is in a very bad way, and he believed it was life-threatening. The patient reported that he received his second dose of vaccine on 13May2021. He stated when he was tested back in early 2021 or latter 2020, he was ANA positive. The events resulted in Emergency Room and Physician Office visit. Outcome of events was unknown.

Other Meds: FISH OIL; VITAMIN D COMPLEX

Current Illness:

ID: 1692266
Sex: F
Age:
State: CT

Vax Date: 04/22/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210830; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Adverse event: Tested positive for COVID 30Aug2021

Allergies:

Symptom List: Nausea

Symptoms: Tested positive for Covid 30Aug2021; Tested positive for Covid 30Aug2021; This is a spontaneous report from a contactable consumer. This consumer reported that a Non-pregnant 36-Year-Old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021 at the age of 35-Year-Old (Lot number: ER8735) as single dose for COVID-19 immunisation. No COVID prior vaccination. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced tested positive for COVID 30Aug2021. Adverse event start date was 31Aug2021. It was Unknown If patient COVID tested post vaccination. No treatment for AE. The outcome of the event was Recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1692267
Sex: F
Age:
State:

Vax Date: 03/25/2021
Onset Date: 05/09/2021
Rec V Date: 09/11/2021
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: Appendicitis attack; Appendix ruptured; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunisation. The patient reported the appendicitis attack on 09May2021 where her appendix ruptured. This was being reported as she noticed that there were SAEs in similar nature with the vaccine on the CDC website and she did not attribute it to the vaccine but wanted to report, event took place after use of product. The clinical outcome of the events were unknown. Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].; Sender's Comments: Based on the available information the reported events appendicitis and appendicitis perforated may not be related to suspect product BNT162B2.

Other Meds:

Current Illness:

ID: 1692268
Sex: F
Age:
State: FL

Vax Date: 04/05/2021
Onset Date: 07/09/2021
Rec V Date: 09/11/2021
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: 20210709; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: Breakthrough case/covid test result = Positive; Breakthrough case/covid test result = Positive; This is a spontaneous report from a contactable consumer (Patient). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: En6206 and Expiry date was not reported), via unspecified route of administration on 15Mar2021 (at the age of 37-years-old) in Arm Left as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8730 and Expiry date was not reported), via unspecified route of administration on 05Apr2021 (at the age of 37-years-old) in Arm Left as dose 2, single for COVID-19 immunization. The Patient Medical history included none from an unknown date and unknown if ongoing other medical history: None. The patient concomitant medications was not reported. The Patient had no known allergies. The patient had received other vaccine in 4 weeks. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had tested for COVID-19 post vaccination. On 09Jul2021 08:00, the patient experienced breakthrough case/COVID-19 test result positive. The Patient did not received treatment. Patient visited emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jul2021 Nasal Swab. The outcome for the events was recovered in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692269
Sex: F
Age:
State: CT

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: weight; Result Unstructured Data: Test Result:33 lbs; Comments: lost 33 lbs to date.

Allergies:

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

Symptoms: Lost 33 lbs to date; Lost appetite; noted hair loss; This is a spontaneous report from a contactable consumer via Pfizer colleague. An elderly non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on 2021 (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. Medical history included COVID-19. The patient previously received 1st dose of BNT162B2 in 2021 (lot number and expiration date were unknown) and experienced runny nose, sore throat, cough, fever, headache. The patient's concomitant medications were not reported. After second dose, patient lost appetite, noted hair loss, and had lost 33 lbs to date, all on an unspecified date. The patient underwent lab tests and procedures which included weight: lost 33 lbs to date on an unknown date. The outcome of the events was unknown. Treatment received was unknown. The events were resulted in Doctor or other healthcare professional office/clinic visit. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692270
Sex: M
Age:
State: PA

Vax Date: 05/13/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: ANA positive; Result Unstructured Data: Test Result:Unknown results; Test Name: Sodium; Result Unstructured Data: Test Result:slightly lo; Test Name: blood work; Result Unstructured Data: Test Result:Nothing was revealing; Test Name: Lyme disease test; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Tremor

Symptoms: Lyme disease; Felt a little feverish, flu-like; Sinus infection; his total body just felt so horrible, like he was dying; No appetite, he lost in appetite; Lost weight; Lightheadedness/Dizzy; almost passed out a couple of times; sodium was slightly low; 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: EU10150), via an unspecified route of administration, administered in right arm on 13May2021 09:00 (at 60 years old) as dose 2, single for COVID-19 immunization. Medical history included neuropathy, and carpal tunnel syndrome, both from an unknown date. Concomitant medications included fish oil; and colecalciferol, menaquinone-7, phytomenadione, retinol palmitate, tocopherol, tocotrienols nos (VITAMIN D COMPLEX); both taken for an unspecified indication. The patient previously received the dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Apr2021, for COVID-19 immunization. On an unspecified date in 2021, the patient mentioned his symptoms started relatively mild, he felt-flu-ish, like he had the flu. He believed he had the second dose 13May2021 and the first dose on 23Apr2021, he confirmed he was 60 years old then. The patient thought maybe he had Lyme disease; he was tested multiple times for that (unknown result). He then thought he had maybe he had really bad sinus allergies, like a sinus infection. It turned out he did have a minor sinus infection and was given antibiotics, but he was still not getting better. It was like from the reaction he had with the vaccine and taking an antibiotic, it threw his body into worse shape, like a super wharf. It was like his total body just felt so horrible, like he was dying. He had no appetite, he lost in appetite back in June (unsure). He took the antibiotics, and he also lost weight. He went to the hospital last Thursday because he was so lightheaded when he walked. He was pushing his mower across the lawn and it hit him, and he had to lay down for hours. He mentioned his wife was out of town. He has a dog and he tried to let his dog out for a walk, but he was so dizzy, he had to lay down. He almost passed out a couple of times that day. He has been seen by a Cardiologist and his heart is fine. His family physician has seen him at least 2 or 3 times. He had a COVID test while he was the hospital. He was not hospitalized. He went to the Emergency room at 10:00 and was there until about 21:00. They did all kinds of bloodwork and nothing was real revealing. His sodium was slightly low, but this doesn't account for any of his symptoms. The doctors were at a loss. They said they could do an MRI at about 16:00 or 17:00, as he was still in the Emergency Room. He agreed to get the MRI, but then they shifted staff. He has been in contact with a Neurologist, and she thought maybe he had Long Haulers but it's not really adding up to that. The doctor doesn't think it was Long Haulers from his impression of their visit. His symptoms seem more connected with the vaccine. He stated he felt a little fever-ish, flu-like at first, like it wasn't anything. He kept thinking maybe it was allergies and then as it got worse, he thought maybe it was Lyme disease. He had three tests done for Lyme disease. He just was not feeling himself. He clarifies it was within a day or two of getting the vaccine, he felt this way, but he honestly doesn't remember if these symptoms began after the first or second dose. The events required visit to Emergency Room and Physician Office. He states he is in a very bad way, and he believed it was life-threatening (unspecified, pending clarification). The outcome of the events was unknown.

Other Meds: FISH OIL; VITAMIN D COMPLEX

Current Illness:

ID: 1692271
Sex: F
Age:
State:

Vax Date: 05/26/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: nervous; experienced numbness in their shoulder, neck and jaw; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 26May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nervous, and numbness in their shoulder, neck and jaw. It took 5 hours to go away. The seriousness of the events was non-serious. The outcome of the events was recovered. Information about lot/ batch number can be requested.

Other Meds:

Current Illness:

ID: 1692272
Sex: F
Age:
State: MI

Vax Date: 02/15/2021
Onset Date: 08/15/2021
Rec V Date: 09/11/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: got sick with COVID virus; got sick with COVID virus; This is a spontaneous report from a contactable consumer reporting for herself. A 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 14:00 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 08:00 (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as dose 1, 0.3 ml single for (at the age of 86 years old) covid-19 immunization at clinic. Medical history included breast cancer from an unknown date and unknown if ongoing (treated for breast cancer since 6 years ago: mastectomy 6 years ago and then cancer reoccurred two years ago in 2019 and she started IBRANCE). Concomitant medication included palbociclib (IBRANCE) taken for breast cancer from 2019 and ongoing. Patient did not receive other vaccine within 4 weeks of COVID vaccine. No Adverse events (AE) following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer Suspect. Family Medical History Relevant to AE(s) was none. The patient experienced got sick with covid virus on 15Aug2021. Event reported as, she got sick with COVID virus two weeks ago on 15Aug2021 (Drug ineffective) and her 14 days was completed. She feels she was fully recovered. She knew other people who got it and it was not that bad. Relevant Tests was none. The patient did not visit Emergency Room or Physician Office due to adverse events. Outcome of the events was recovered on 27Aug2021. Investigation results included: the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EL9261 was investigated. The investigation included reviewing manufacturing and packaging batch records, release test results, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6201 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further information is expected.

Other Meds: IBRANCE

Current Illness:

ID: 1692273
Sex: M
Age:
State: AZ

Vax Date: 08/28/2021
Onset Date: 08/30/2021
Rec V Date: 09/11/2021
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: test; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: pains around left chest area; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Aug2021 at 14:30 (at the age of 38-year-old) (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior to vaccinations received within 4 weeks. No AE(s) following prior vaccinations. Family Medical History Relevant to AE(s) the only thing that he can say was probably blood pressure for his parents. The patient medical history and concomitant medications were none. Patient was calling to report a side effect from the vaccine he took five days ago. Caller clarified vaccine as COVID19 Vaccine. The side effect he felt was pains around left chest area. He doesn't know if it had anything to do with it. He took the shot in his left arm. He had shot and pain in left chest area. It was intense. He first felt it two days after he took the shot and thought it would pass away. It started to get intense. He went to the pharmacy where he got it and they said it could be side effect and for him to go to the emergency room. The Emergency room ran test and gave him Aspirin and some kind of medication that he doesn't know. The next day he felt more better. The shot was given in his left arm. Aspirin: they gave it in the Emergency Room. It was one tablet. He doesn't have the product to provide strength and lot number. He was not currently taking Aspirin and was not on any current medications. Investigations: they did test in the Emergency Room. No further details provided. Event was resulted in emergency room visit. Therapeutic measures were taken for pains around left chest area. The outcome of the event was resolving. Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692274
Sex: M
Age:
State:

Vax Date: 08/31/2021
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
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: 20210901; Test Name: Fever; Result Unstructured Data: Test Result:101.7

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: he has fever that keeps going up right now is 101.7 (unknown units); This is a spontaneous report from a contactable consumer. A male patient of age 12 (units: unknown ) received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he has fever that keeps going up right now is 101.7 (unknown units) on 01Sep2021. The patient underwent lab tests and procedures which included body temperature: 101.7(unknown units) on 01Sep2021. The outcome of the event was not recovered. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692275
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210510; Test Name: ED workup and cardiology consult; Result Unstructured Data: Test Result:no findings

Allergies:

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

Symptoms: chest pain; Received her first dose of Comirnaty on 22Apr2021. The patient found out she is 20 weeks and 5 days pregnant as of today; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Apr2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's last period was 10Apr2021. The patient received her first dose of vaccine at first week of pregnancy. The mother was due to deliver on 10Feb2022. On 10May2021 patient went to the emergency department (ED) complaining of chest pain. While in the ER they worked her up and consulted with cardiology but there were no significant findings and it was inconclusive whether the chest pain was caused by vaccine. At the time of reporting the patient's chest pain persisted. The reporter stated that the patient told the her that she was not pregnant when she received vaccine and the she found out she was 20 weeks and 5 days pregnant on the day of reporting, so she must have been pregnant but just did not know it. The patient consulted primary care physician (PCP) who advised patient to wait on getting her second dose of the vaccine. The patient was now seeking advice from the clinic since she was pregnant and was asking if she should receive the 2nd dose. The outcome of chest pain was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692276
Sex: F
Age:
State:

Vax Date: 08/10/2021
Onset Date:
Rec V Date: 09/11/2021
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: it kind of itched a little for a week after the second dose; arm got a little sore or a weak feeling; arm got a little sore or a weak feeling; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 10Aug2021 at the age of 45-years-oldas DOSE 2, SINGLE for Covid-19 immunization. Medical history included covid-19 from May2021 to an unknown date She caught covid in May2021 , blood pressure abnormal from an unknown date and unknown if ongoing. She got her first vaccination on 20Jul2021 and second one was 10Aug2021.Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for hypertension from May2021 and ongoing; amlodipine besylate; hydrochlorothiazide taken for blood pressure abnormal from an unspecified start date to 17Aug2021. She is going through some health issues for the past month. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has been tested for Covid-19 Since the vaccination and caught covid in May2021. On an unspecified date, probably a week later after the second dose the patient got a red bump that appeared, it kind of itched a little for a week after the second dose. Then the arm got a little sore or a weak feeling. It was a little red bump as if she just got it. Nothing appeared when she first got it. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds: BYSTOLIC; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1692277
Sex: F
Age:
State: MN

Vax Date: 08/12/2021
Onset Date: 08/22/2021
Rec V Date: 09/11/2021
Hospital: Y

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: Pain in extremity

Symptoms: afib; So sore/I ached all over but felt better; I could hardly get out of bed; sweating; cold; sick to my stomach; had a splitting headache; so tired; chills; fever; joint pain; nauseated; awful diarrhea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 12Aug2021, as dose 1, single for COVID-19 immunisation. The patient medical history included angioedema for 6 or 7 years from BP medications. The patient concomitant medications were not reported. The patient after woke up in the morning experienced sore/ached all over but felt better, could hardly get out of bed, sweating, cold, sick to stomach, splitting headache, so tired, chills, fever, joint pain, nauseated and awful diarrhea on 22Aug2021. This lasted for 2 days then it started to feel better on Sunday/Monday. Then on Monday night, it ached all over but felt better. On Tuesday, went to the ER because of feeling worse while wokeup and they told that afib on 25Aug2021 but they didn't think it was from the shot and was hospitalized for a week. The patient did not had afib before. The outcome of the event afib was unknown and the other events were recovered on an unknown date of Aug2021. The patient second dose was on 02Sep2021. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1692278
Sex: U
Age:
State: TN

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

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

Lab Data: Test Date: 2021; Test Name: covid; Result Unstructured Data: Test Result:Positive

Allergies:

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

Symptoms: Tests positive for covid approximately 7 months following full vaccination; Tests positive for covid approximately 7 months following full vaccination; Cough; Fever; Chills; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single; received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tests positive for covid approximately 7 months following full vaccination and had cough, fever and chills. It was reported that patient was currently quarantined. The patient underwent lab tests and procedures which included sars-cov-2 test (covid) and showed results Positive on an unknown date in 2021. At the time of this report, the outcome of events was unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1692279
Sex: M
Age:
State:

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: possibly blood in my stool; redness; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient went to the bathroom past 2 times and reported redness and possibly blood in his stool. Patient received the vaccine at 1 and around 4pm next day he went to the bathroom and it happened again. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, patient was asked to consult with doctor/healthcare provider. There is information on Diarrhea but not about "bloody stools" under: 6 ADVERSE REACTIONS. Outcome of the events were unknown.

Other Meds:

Current Illness:

ID: 1692280
Sex: F
Age:
State: IL

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rectal bleeding; Anal incontinence; Vaccination site pain; This is a non-interventional solicited report based on information received by Pfizer from Regulatory Authority (Mfr Control no.: 21K-163-4053241-00) from contactable physician and a non-contactable consumer reported for a 65-Year-Old female patient. A 65-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly on 11May2021 as dose 2, single (age at vaccination: 65 years) for COVID-19 immunisation; adalimumab (HUMIRA Solution for injection Lot number was not reported) via subcutaneously from an unspecified date to an unspecified date for colitis ulcerative. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly on 16Apr2021 as dose 1, single for COVID-19 immunisation. On an unspecified date 2021, the patient experienced anal incontinence, rectal bleeding, vaccination site pain. It was reported that the patient had leakage and bleeding out the rectum and pain in the arm after covid vaccine with humira. It was unknown if patient was enrolled in a covid-19 vaccine trial. The clinical outcome of the events was not resolved. Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of leakage and bleeding out the rectum unknown onset, leakage and bleeding out the rectum unknown onset and pain in the arm after covid vaccine with humira (adalimumab) was no reasonable possibility. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) (TOZINAMERAN), UNKNOWN, UNKNOWN Daily Dose: The reporters causality for the events anal incontinence, rectal bleeding, vaccination site pain was not related. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available in the case , the association between reported Event rectal bleeding is unrelated to the suspect drug. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: HUMIRA

Current Illness:

ID: 1692281
Sex: U
Age:
State: TN

Vax Date: 04/20/2021
Onset Date: 08/27/2021
Rec V Date: 09/11/2021
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: 20210827; Test Name: Fever; Result Unstructured Data: Test Result:101 degree; Test Date: 20210901; Test Name: rapid covid test; Result Unstructured Data: Test Result:positive

Allergies:

Symptom List: Vomiting

Symptoms: Patient had a rapid covid test on 01Sep2021, results were positive; Patient had a rapid covid test on 01Sep2021, results were positive; worst headache; 101 degree fever; heavy chest; lethargic; achy; extreme fatigue; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer reported that: A 47-years-old patient of an unspecified gender received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161) dose 2 via an unspecified route of administration on 20Apr2021 at the age of 47 years old as dose 2, single, dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced worst headache, 101 degree fever, heavy chest, lethargic, achy and extreme fatigue. The patient underwent lab tests and procedures which included body temperature: 101 degree on 27Aug2021 and had a rapid covid-19 test results as positive on 01Sep2021. The outcome of the all events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1692282
Sex: M
Age:
State:

Vax Date: 05/26/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: myocarditis; nervous; experienced numbness in their shoulder, neck and jaw; This is a spontaneous report from a contactable consumer (Patient's wife) reporting for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis (medically significant), nervous, experienced numbness in their shoulder, neck and jaw on an unknown date in 2021. Caller stated that she and her husband got their first dose in 26May2021. Both of them are kind of nervous and has experienced numbness in their shoulder, neck and jaw. It took 5 hours to go away. Her husband had developed a heart issue. They were told by their Doctor that it was not normal and it advised not to take the vaccine yet. It has been 99 days since they got their first dose. Caller stated that she lost two friends from COVID and her husband has myocarditis which he didn't have before getting the vaccine. Caller stated that she was just afraid to get the second shot with all of this misinformation circulating out there. The outcome for all events was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1692283
Sex: M
Age:
State: IA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
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: sore arm; crying uncontrollably; rage/ wanted to throw something through the wall; episode of depression; blissfulness; high energy as if he could run a marathon; emotional bouts; dizziness; orthostatic changes from laying in bed to sitting up; pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control; sounds like a neuro reaction; can't stand up; This is a spontaneous report from a contactable Physician. This Physician (Patient's father) reported. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection), Lot number was unknown, via unspecified route of administration on 01Sep2021 15:00 as dose 2, single for covid-19 immunization. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, for Covid-19 immunization and experienced only a sore and no other side effects. The patient medical history and concomitant medications were not reported. On 02Sep2021 the patient experienced Sore arm, dizziness, orthostatic changes from laying in bed to sitting up, pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control, sounds like a neuro reaction, can't stand up, crying uncontrollably, rage/ wanted to throw something through the wall, episode of depression, blissfulness, high energy as if he could run a marathon, emotional bouts. On an unspecified date in 2021, the events emotional bouts, high energy as if he could run a marathon, blissfulness, episode of depression, rage/ wanted to throw something through the wall, crying uncontrollably were recovered. At the time of reporting, the outcome of the events can't stand up, sounds like a neuro reaction, dizziness and sore arm were unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during fol-low-up.

Other Meds:

Current Illness:

ID: 1692284
Sex: U
Age:
State: VA

Vax Date: 04/29/2021
Onset Date: 08/31/2021
Rec V Date: 09/11/2021
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: Test Date: 20210831; Test Name: fever; Result Unstructured Data: Test Result:100.2; Comments: low grade fever; Test Date: 20210902; Test Name: fever; Result Unstructured Data: Test Result:temp is now normal; Comments: temp is now normal; Test Date: 2021; Test Name: COVID; Result Unstructured Data: Test Result:positive; Comments: Tested positive for COVID

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Tested positive for COVID after two doses of Pfizer vaccine; Tested positive for COVID after two doses of Pfizer vaccine; difficulty breathing; cough; The highest my fever got was 100.2.; tightness in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient) providing investigation results. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8737) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8733) via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient tested positive for covid after two doses of Pfizer vaccine and difficulty breathing and on unspecified date in 2021, patient experienced tightness in my chest that went on for a long time and on 31Aug2021, patient experienced cough and the highest fever was 100.2. The patient underwent lab tests and procedures which included fever: 100.2 on Tuesday 31Aug2021 and temp normal on Thursday 02Sep2021 and tested positive for COVID on unspecified date in 2021. Therapeutic measures were taken as a result of tightness in my chest, cough, the highest my fever got was 100.2 and difficulty breathing. Patient staying at home and treating symptoms per doctor's instructions and isolating for 10 days from first noted symptoms. Have not gone to the hospital and doctor recommended not going to the hospital unless patient have difficulty breathing. Patient was very happy that patient was vaccinated and very happy it's Pfizer's. As patient thought all along. The reason for patient got the vaccine is not to keep from getting Covid but dying from it. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1692285
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/29/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210829; Test Name: COVID-19; Test Result: Positive

Allergies:

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

Symptoms: His wife (me) had tested positive; His wife (me) had tested positive; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of unknown age received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug Friday as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 01Sep2021 his COVID PCR test came back positive which was taken on Monday 30Aug2021. His wife had tested positive on Sun 29Aug. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on Sunday 29Aug2021. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101148635 different patient, same drug and event

Other Meds:

Current Illness:

ID: 1692286
Sex: F
Age:
State: VA

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 09/11/2021
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: allergic reaction to the 1st dose; Hives; This is a spontaneous report from a contactable consumer (parent). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 10Aug2021 (Lot Number: EW0181) (at the age of 15-years-old) as dose 1, single for covid-19 immunisation. Medical history was none and there were no concomitant medications. The patient had an allergic reaction to the 1st dose of the vaccine and had hives on 10Aug2021, same day of her dose. The patient did not receive the treatment for the events. The reporter was just wondering as their pediatrician said not to get the 2nd dose. The outcome of the events was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am