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: 1645852
Sex: F
Age:
State: FL

Vax Date: 07/13/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown; Test Date: 202107; Test Name: Oxygen saturation decreased; Test Result: 84 %

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: First Covid 19 vaccine received on 25Feb2021, Second Covid 19 vaccine received on 13Jul2021; Second dose: developed asthma again; Second dose: oxygen saturation level 84%; Second dose: chest heaviness; Second dose: little cough; Both doses: depression and anxiety; Both doses: depression and anxiety; takes deep breaths and gets dizzy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0181, Expiration date not reported) via an unspecified route of administration in the left arm on 13Jul2021 (at the age of 74-year-old) as single dose for COVID-19 immunisation at pharmacy. The patient medical history included blood cholesterol, blood pressure measurement but they are under control because she takes medicine and thyroid disorder/issue all from an unknown date and unknown if ongoing and bronchitis as a child. She does not have diabetes or heart issues. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198, Expiration date not reported), via an unspecified route of administration into the left arm on 25Feb2021 at around 11:30-12:30 (at the age of 74-year-old) as single dose for COVID immunization and diagnosed with the Covid 19 virus. Concomitant medications were not reported. Adverse events following prior vaccinations were reported as none. On an unspecified date in Jul2021, about 2 weeks after her second dose, she developed asthma again and her oxygen saturation level is about 84 percent. The caller had heard that there might be a third dose and she will never, ever put anything of Pfizer in her body again and she was never, ever had asthma or COPD. She was a pretty healthy person. She was going to the gym 4 times a week before this happened. She was very healthy. She was doing Zumba 4 times a week which is a workout with an hour of continual movement. She was very proactive where cancer is concerned because cancer is prevalent in her family. The cough continued, the cough lingered on, it lasted several weeks and had the heaviness in her chest. She knows when her oxygen level was going down because her face would flush brilliant red. Her face was red, brilliant red so she checked her oxygen level last night and it was 84%. She has a cough while reporting, but it was not nearly as bad as with the first Covid 19 vaccine. She did not have a fever with the Covid 19 vaccine. She had her second Covid 19 vaccine on 13Jul2021 and saw her doctor for regular check up on 15Jul2021 and she was telling him how well she was doing. She was feeling good and was back at her exercise class. Then on 19Jul2021 she had an appointment with her heart doctor, and she was telling him that she was doing good. Then on 22Jul2021, that's when it hit her, she started having symptoms. After the second dose she had the chest heaviness again, a little cough, depression and anxiety. She had depression and anxiety with both vaccines, but she thinks it was because she is so frustrated, she is very upset that she received the vaccines. Last night of the reporting date, when her oxygen level dropped to 84-85 percent, she thought what is going on. She thought about going to the emergency room but what good is that. They will tell her to take deep breaths and then she gets dizzy. She was able to get her oxygen level back up to 93 percent but when she woke up this morning her oxygen level was 91 percent. She has not had any oxygen at all with the second dose. She was wondering if she should have oxygen. The patient underwent lab tests and procedures which included chest x-ray: unknown on an unspecified date and oxygen saturation decreased: 84 % in Jul2021. The outcome of all events was reported as unknown. Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645853
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Name: PTT; Test Result: 28.1 s; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:12.0 IU/l; Test Name: antinuclear antibody test; Test Result: Negative ; Test Name: antiplatelet antibodies (APAs); Test Result: Negative ; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:20.0 IU/l; Test Name: Basophils; Test Result: 1.1 %; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:70.0 IU/l; Test Name: Bilirubin-total; Test Result: 0.26 mg/dl; Test Name: Calcium; Test Result: 9.4 mg/dl; Test Name: Chloride; Result Unstructured Data: Test Result:103 mEq/l; Test Name: Creatinine; Test Result: 0.6 mg/dl; Test Name: Fibrinogen; Test Result: 229 mg/dl; Test Name: Random glucose; Test Result: 142 mg/dl; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:194.00 IU/l; Test Name: Potassium; Result Unstructured Data: Test Result:4.7 mEq/l; Test Name: blood pressure; Result Unstructured Data: Test Result:127/80 mmHg; Test Name: peripheral smear; Result Unstructured Data: Test Result:profound, isolated thrombocytopenia that was; Comments: profound, isolated thrombocytopenia that was consistent with immune thrombocytopenia (ITP) with no schistocytes, blasts, microspherocytes, or agglutination.; Test Name: Sodium; Result Unstructured Data: Test Result:138 mEq/l; Test Name: TSH; Result Unstructured Data: Test Result:1.70 MiU/L; Test Name: BUN; Test Result: 8.00 mg/dl; Test Name: Body temperature; Result Unstructured Data: Test Result:did not have fever; Test Name: temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Name: Carbon dioxide; Result Unstructured Data: Test Result:22.5 mEq/l; Test Name: coagulation studies; Result Unstructured Data: Test Result:normal; Test Name: C-reactive protein; Test Result: 0.37 mg/dl; Test Name: age-appropriate cancer screening; Result Unstructured Data: Test Result:Unknown results; Test Name: differential; Result Unstructured Data: Test Result:within normal limits; Test Name: Eosinophils; Test Result: 2.4 %; Test Name: complete blood count (CBC); Result Unstructured Data: Test Result:within normal limits; Test Name: complete blood count (CBC); Result Unstructured Data: Test Result:revealed a platelet count of 1000/uL; Test Name: Immature granulocytes; Test Result: 0.5 %; Test Name: Hematocrit; Test Result: 45 %; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.9 g/dl; Test Name: Haptoglobin; Test Result: 144 mg/dl; Test Name: Haptoglobin; Test Result: 144 mg/dl; Test Name: heart rate; Result Unstructured Data: Test Result:109; Comments: Unit: bpm; Test Name: Heliobacter pylori breath test; Test Result: Negative ; Test Name: Tests for Helicobacter pylori; Test Result: Negative ; Test Name: Hepatitis A virus antibody, IgM; Test Result: Negative ; Test Name: Hepatitis B virus core antibody, IgM; Test Result: Negative ; Test Name: Hepatitis B virus surface antigen; Test Result: Negative ; Test Name: Hepatitis C virus antibody; Test Result: Negative ;

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Immune thrombocytopenia; petechial rash; fatigue; muscle aches; The case we present, of severe ITP after exposure to the BNT162b2 mRNA COVID-19 vaccine, is an important addition to the safety profile of this novel vaccine. A 39-year-old woman received the second dose of the BNT162b2 mRNA COVID-19 vaccine at a community hospital; 3 days later, she presented to the same institution with a petechial rash. Approximately 12 h after her vaccination, she had experienced fatigue and muscle aches. She did not have fever, cough, runny nose, a change in taste or smell, or any other associated symptoms. Her medical history included polycystic ovary syndrome, for which she took norgestimate- ethinyl estradiol. She had no pertinent family or travel history and no history of use of tobacco or alcohol or of substance abuse. The patient had a complete blood count (CBC) and differential 5 months before, during a routine health examination, which was entirely within normal limits. At that time, she also was tested for COVID-19 antibodies; the results were negative. The patient did not have any illnesses or known COVID-19 exposures before the incident reported here. On presentation, the patient had a heart rate of 109 bpm, blood pressure of 127/80 mm Hg, respiratory rate of 18 breaths/min, and a temperature of 36.6 degree Celsius. Physical examination revealed petechiae on her legs, abdomen, chest, and arms which extended to the base of her neck. A CBC revealed a platelet count of 1000/uL (Table 1). She had an elevated erythrocyte sedimentation rate of 75 mm/h and normal coagulation studies (Table 2). A peripheral smear showed profound, isolated thrombocytopenia that was consistent with immune thrombocytopenia (ITP) with no schistocytes, blasts, microspherocytes, or agglutination. An ultrasound of the spleen was normal. The patient was not tested for COVID-19. Tests for viral hepatitis, HIV, and Helicobacter pylori were negative. An antinuclear antibody test also was negative. The results of investigatory tests are summarized in Table 3. On the day of her admission, the patient received a transfusion of 1 unit of platelets and 1000 mg of i.v. methylprednisolone. Approximately 6 h after initial treatment, her platelet count improved to 16 000/uL. The following day, her platelets decreased to 4000/uL. She was treated with a second platelet transfusion and started on i.v. immunoglobulin (IVIG). On her second and third hospital days, she received 70 mg of IVIG. After discussion among the vaccination clinic, primary care team, and hematologist, the team determined that the most likely cause of the patient's ITP was vaccination. The event was then reported through the Vaccine Adverse Event Reporting System. After 3 days of hospitalization and approximately 6 days after vaccination, the patient was discharged with no major bleeding events. Her platelet count on discharge was 92 000/uL. When the patient followed up with her primary care physician the day after discharge, her platelets had further increased to 243 000/uL. Her recovery was uncomplicated. She tested negative for antiplatelet antibodies (APAs) after her discharge and treatment. This case highlights a potential consequence of the BNT162b2 mRNA COVID-19 vaccine that has implications for monitoring after vaccination. Considerations for other causes of ITP were viral hepatitis, HIV, and H. pylori. Tests for these conditions were negative. The isolated thrombocytopenia on peripheral smear and normal reticulocytes, lactate dehydrogenase, and bilirubin (Table 3) ruled out Evans syndrome. The patient was up to date on age-appropriate cancer screening. She had not received any other vaccinations or new medications, nor had she experienced any illness in the preceding months that may have caused the ITP. Her only medication was norgestimateethinyl estradiol. Given the geography and her lack of travel, she was not tested for tropical illnesses that can cause thrombocytopenia. The main limitation is that the diagnosis of ITP is one of exclusion. The patient was not tested for COVID-19, which can cause ITP. Another limitation is the delay in testing of APAs after her recovery. Causally linking the vaccine and ITP with certainty poses challenges. Because of the lack of medications or conditions that could have caused ITP in our patient, we feel that this outcome was most likely due to the BNT162b2 mRNA COVID-19 vaccine. The established relationship between ITP and COVID-19 and ITP and other immunizations further supports this hypothesis. We feel that this case provides insight into a potential new AE for which monitoring should be performed after vaccination. Further investigations are required to determine the risk and frequency of this association. Table 1. Complete blood count and differential. Variable; Results; Reference range White blood cells (thousands/uL); 3.7; 4.5-10.5 Red blood cells (millions/uL); 4.79; 3.9-5.0 Hemoglobin (g/dL); 14.9; 12.0-15.5 Hematocrit (%); 45; 35-45 MCV (fL); 94.8; 80.0-100.0 MCH (pg); 31.1; 27-34 MCHC (g/dL); 32.8; 31.0-35.0 RDW (%); 12.4; 12.0-16.0 Platelets (thousands/uL); 1; 150-400 Neutrophils%; 40.8; 46-78 Lymphocytes%; 38.8; 20-45 Monocytes%; 16.4; 5.0-13.0 Eosinophils%; 2.4; 0.0-7.0 Basophils%; 1.1; 0.0-2.0 Immature granulocytes%; 0.5; 0.0-1.0 MCH - mean cell hemoglobin; MCHC - mean cell hemoglobin concentration; MCV - mean cell volume; RDW - red cell distribution width. Table 2. Hematology and coagulation studies. Variable; Results; Reference range Reticulocytes (thousand/uL); 103; 44-106 Haptoglobin (mg/dL); 144; 30-200 Fibrinogen (mg/dL); 229; 204-408 Erythrocyte sedimentation rate (mm/h); 75; 0.0-20.0 PT (s); 11.6; 10.3-13.5 INR; 1.0; PTT (s); 28.1; 26.6-38.2 INR - international normalized ratio; PT - prothrombin time; PTT - partial thromboplastin time. Table 3. Chemistry studies. Variable; Results; Reference range Random glucose (mg/dL); 142; 80-200 Sodium (mEq/L); 138; 136-145 Potassium (mEq/L); 4.7; 3.5-5.1 Chloride (mEq/L); 103; 98-107 Carbon dioxide (mEq/L); 22.5; 22.0-29.0 BUN (mg/dL); 8.00; 6.0-20.0 Creatinine (mg/dL); 0.6; 0.5-0.9 Calcium (mg/dL); 9.4; 8.6-10.2 Bilirubin-total (mg/dL); 0.26; 0.00-1.20 Alkaline phosphatase (U/L); 70.0; 35.0-104.0 Aspartate aminotransferase (U/L); 20.0; 0.0-31.0 Alanine aminotransferase (U/L); 12.0; 0.0-32.0 B12 (pg/mL); 319; 211-946 TSH (mIU/L); 1.70; 0.27-4.20 Lactate dehydrogenase (U/L); 194.00; 135.0-214.0 Hepatitis A virus antibody, IgM; Negative Hepatitis B virus core antibody, IgM; Negative Hepatitis B virus surface antigen; Negative Hepatitis C virus antibody; Negative Antinuclear antibody; Negative HIV-1,2 screen; Negative HIV-1 P24 antigen; Negative HIV-1 antibody; Negative HIV-2 antibody; Negative C-reactive protein (mg/dL); 0.37; 0.00-4.99 Heliobacter pylori breath test; Negative BUN - blood urea nitrogen; TSH - thyroid-stimulating hormone.; Sender's Comments: Based on the information currently provided (plausible time association), it cannot be fully excluded that the BNT162b2 might have played a contributory role in triggering the occurrence of Immune thrombocytopenia. 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: 1645854
Sex: U
Age:
State:

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she put in and I had pain in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL1283) via an unspecified route of administration on 21Jan2021 as single dose for covid-19 immunisation. The patient's medical history included weight abnormal, diabetes mellitus, fibromyalgia and autoimmune disorder. The patient's concomitant medications were not reported. The reporter states she put in and patient had pain in arm on an unspecified date. The outcome of the event was unknown. No further information was reported.

Other Meds:

Current Illness:

ID: 1645855
Sex: M
Age:
State:

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: regular blood test; Result Unstructured Data: Test Result:had no antibodies at all; Comments: before he was vaccinated

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: seeing 2 allergists, one said he has hives; Rash/it was on his back/on his thighs also; very-very itchy/horrible itching; seeing 2 allergists, one said he has dermatitis; developing scabs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of 85-years-old age 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 14Feb2021 (age at vaccination: 85-years-old) as DOSE 2, SINGLE for covid-19 immunisation (reason: everyone was saying take it; vaccination time: given in morning). The patient medical history included pacemaker (had it put in a couple months ago) and he had a disease some time ago (unspecified). Concomitant medications included taking some meds (unspecified). Investigation assessment was none. Patient didn't receive other vaccines within 4 weeks prior to vaccination. No additional vaccines administered on same date of the Pfizer Suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family medical history relevant to adverse event was none. Historical vaccine patient received BNT162B2 (Lot number: EL9268), via an unspecified route of administration on 27Jan2021 as DOSE 1, SINGLE for Covid-19 immunisation (he took the first one, he tolerated with no problem/had no effect) (vaccination time: given in morning). Also flu vaccine for immunization, and every vaccine taken and had never any reaction. Before the vaccine, he didn't have any symptoms at all, and his doctor gave a regular blood test on unspecified date (before he was vaccinated), to tell if there were any antibodies, and he got report back, said he had no antibodies at all, patient thought great, but the doctor said it's not great, if he had antibodies, he would have something to fight this, he was clean. He was healthy. He got a rash with the second in 2021, and was seeing 2 allergists, who had no answer, and it's very-very itchy, and one said he has hives (start date: 2021) and the other says dermatitis (start date: 2021), but he didn't have anything before that, he went to see another allergist who said to take a patch test, but he was not going through it, he was taking some medicine, he just had a pacemaker put in, he was taking ALLEGRA and ZYRTEC and it was giving a little relief, but it's horrible itching and it's very bad, and one can go out of mind, so far, he was mentally sane. He was not allergic to anything, from another doctor statements. Rash was noticed a couple days after the second dose and it got pretty bad, now was improving a bit after use of ALLEGRA and ZYRTEC (as therapeutic measures for rash, rash pruritic, hives and dermatitis), but it's still there, it was on his back, he was developing scabs on unspecified date in 2021, and if he was taking a scab off, which he shouldn't, it returned, so he can't touch his back, it opened it, brought it back, and it's on his thighs also. The outcome of the event developing scabs was unknown; while for rest all events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645856
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I have a hard time sleeping anyway because of my heart condition; I have a hard time sleeping anyway because of my heart condition; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization; disopyramide phosphate (NORPACE CR), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; disopyramide phosphate (NORPACE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced have a hard time sleeping anyway because of my heart condition. The patient stated, I am taking Norpace and Norpace CR, for several years, at the request of my doctor. What I called about 3 days, 4 days ago is, is there any news on Norpace CR which has been discontinued and that is the drug that I take along with the regular Norpace. So what he did was send me 2 Norpace so that I can get up in the middle of the night and take a second one which would be like a continuous release. It is kind of hard because I have a hard time sleeping anyway because of my heart condition. It is highly effective. I just want to get the CR. I do love that drug. It is a life saver. That is the number on the letter but you listen for 10 minutes stories about Pfizer shots, which I have already had. Note: The patient is date of birth/ address was not provided on the phone call. The following information was not confirmed during the call, but retrieved from the system: Reporter phone No. The following information was not provided during the call: Patient gender. The outcome for both events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645857
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Another young man in 30's in same community also reported eye problems after shot; This is a spontaneous report from a non-contactable consumer. A 4-decade-old (in his 30's) male patient received bnt162b2 (Formulation: solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 'another young man in 30's in same community also reported eye problems after shot' on an unknown date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1645858
Sex: F
Age:
State: FL

Vax Date: 07/24/2021
Onset Date: 07/24/2021
Rec V Date: 08/28/2021
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: 20210724; Test Name: Oxygen level; Result Unstructured Data: Test Result:Was not 100%

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Passed out; Stopped breathing/hard to breathe; Turned purple; Felt really tired; Sweating; Could hardly talk; Leg was shaking; Her oxygen was not 100 percent/ oxygen level was low; had an allergic reaction; This is a spontaneous report from a Pfizer sponsored program. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in arm right on 24Jul2021 as (at the age of 36-year-old) DOSE 1, SINGLE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included adalimumab (HUMIRA) taken for rheumatoid arthritis, start and stop date were not reported. 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 Vaccinations within 4 weeks. No AE following prior vaccinations. No Patient's Medical History including any illness at time of vaccination. No Family Medical History Relevant to AE. On 24Jul2021 at 10:40 the patient experienced passed out, stopped breathing/hard to breathe, turned purple, felt really tired, sweating, could hardly talk, leg was shaking, her oxygen was not 100 percent/ oxygen level was low, had an allergic reaction. It was reported that Caller had the first dose of the Pfizer vaccine 24Jul2021. A few minutes later, she stopped breathing, turned purple and passed out. She ended up in the emergency room and is now reporting this. She had an allergic reaction to the Pfizer vaccine. Clarified with the caller the details previously provided. Stated that she ended up in the emergency room. Clarified that she is referring to the Pfizer Covid 19 vaccine. States that this happened Saturday. Today is the day she feels normal again. It was reported that Event Details: Not even 3 minutes after, she stopped breathing and her face turned purple. They gave her an Epi Pen and she passed out and woke up in the ambulance. The ambulance rushed her to the hospital because her oxygen was not 100 percent. She couldn't breathe, so they gave her the Epi pen. She couldn't even make it. She remembers sitting there and she started sweating and couldn't really talk or breathe. Her face turned purple, and her leg was shaking. Stated it was there, right after she got the shot, that they had given her the Epi pen. She last remembers waking up in the ambulance. Does not have a clue how long she was out for. It wasn't too long because her 12-year-old daughter was with her, yelling at her to wake up. She was not admitted to the hospital. It was just to the emergency room. Once she was at the emergency room, they gave her a steroid, Benadryl, IV and oxygen. Later that night, into the next day, she was released. They told her not to get the second one. Treatment: Nothing other than the Epi Pen, the Benadryl, IV, oxygen and steroid that were previously mentioned. It was reported that she is currently taking Humira for rheumatoid arthritis. On the information card, they had asked that. It was reported that She just felt really tired, and it was just hard to breathe. Sunday and yesterday, was better and today she feels like herself. Caller clarified that it had been 2 or 3 weeks since taking the Humira. She had wanted to wait on taking it before getting the vaccine. Tests: just had blood work not that long ago and everything was normal. The patient underwent lab tests and procedures which included oxygen saturation was not 100% on 24Jul2021. The outcome of events stopped breathing/hard to breathe and felt really tired was unknown, and outcome of all other events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: HUMIRA

Current Illness:

ID: 1645859
Sex: F
Age:
State: MI

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210707; Test Name: heart/ Heartbeat; Result Unstructured Data: Test Result:heart was racinng; Comments: she felt like her heart was racing or a fast heartbeat

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer (patient) reported that a 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6208, NDC number and Expiry Date: Unknown), via an unspecified route of administration in the arm left on 07Jul2021 at 14:07 (at the age of 23-year-old), as a dose 1, single for COVID-19 immunisation. The patient had just terrified of COVID the new strain and everything with having had it and she also heard if you have long-haul Covid then supposedly the vaccine can help take some of the symptoms away or make you feel better, but mostly the preventative of getting it again. The patient medical history included that she had COVID on an unspecified date in Oct2020, She started getting joint pain almost like when she had Covid and she had leg tremors during COVID. Concomitant medication included Tetanus Bundle (formulation: Injection; Manufacture and lot Number was Unknown) administered in Left arm, dose 1, single on 22Jul2021, which was received within 4 weeks prior to the first administration date of the suspect vaccine. The patient visited to physician Office last Thursday when she got the Tetanus shot, it was like a physical. It was reported that the patient felt that her heart was racing on the first dose which was given on 07Jul2021, and she felt like her heart was racing or a fast heartbeat when it was given to her. She reported when she got the first one she didn't feel good, it almost felt like a slight version of Covid again, then her heart out of no where started racing and pounding, so she went to the emergency room and it eventually slowed down, but it was really scary honestly. She was just asking if she should take the second one, which was scheduled on 28Jul2021 and what would happen if she doesn't take the second one. Would she be able to get it at a further date. On 07Jul2021, the patient reported that it started immediately after getting the shot, she was kind of nauseous and dizzy, then when she got home ,she still felt kind of weird, not anything to rush about, it wasn't a horrible reaction, she just felt weird. She started getting joint pain almost like when she had Covid, her bones felt tight. She reports a few days later, that next Sunday, that she was just laying in bed and her heart started racing like crazy out of nowhere, it was really scary, and she had leg tremors, she had that during COVID, just uncontrollable shaking. The patient was confirmed that she received the vaccine on 07Jul2021. She confirmed all symptoms began the same day 07Jul2021. The patient stated that she was still having a little bit of joint pain, she guessed it could be from that. Confirmed it's ongoing, it's better than it was when she first got it. Confirms it has improved. She reports she got COVID in October 2020 and she's had the long-haul COVID up until just a few months ago, and now she's starting to feel better. She reported that she was feeling pretty much better now in that sense, long haul Covid symptoms are still slightly there. The patient visited to emergency room for all the reported events and was not hospitalized. The outcome of the events Heart racing, Fast Heartbeat, she didn't feel good, it almost felt like a slight version of Covid again, nauseous, dizzy, Feeling abnormal, Shaking was recovered on an unknown date in Jul2021 and other events of joint pain, her bones felt tight, COVID-19 was recovering.

Other Meds:

Current Illness:

ID: 1645860
Sex: F
Age:
State: MD

Vax Date: 07/27/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: hives; my eyes are swollen; I had a allergic reaction, it caused me to have hives; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185. Expiry Date: Unknown) via an unspecified route of administration, administered in Arm Left on 27Jul2021 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included hypertension (Verbatim: High blood pressure) and diabetes mellitus (Verbatim: Diabetes) from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), metoprolol (METOPROLOL), amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. Reporter stated that she went for unspecified laboratory Test 2 months ago. On Jul2021 the patient experienced hives, my eyes are swollen, i had an allergic reaction, it caused me to have hives (hypersensitivity). When paraphrased, consumer stated she called her doctor already, so she was waiting to hear from someone, but they wanted her to report it. Reporter stated she did not receive any other vaccine prior 4 weeks of vaccination. She stated she have been taking Benadryl. Therapeutic measures were taken as a result of hives, my eyes are swollen (eye swelling), i had a allergic reaction, it caused me to have hives (hypersensitivity). The outcome of the events was unknown on an unspecified date. Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: METFORMIN; METOPROLOL; AMLODIPINE

Current Illness:

ID: 1645861
Sex: F
Age:
State: IL

Vax Date: 04/02/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: When I received my second shot a few days later I started a regular period again; I take my birth control very religiously and have been spotting/ been on my period for almost 3 weeks now which is incredibly unusual; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection(Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 as dose 2, single for covid-19 immunisation .Medical history included oligomenorrhoea, I take birth control continuously so I skip my periods and have not had my period or any spotting for 6 months up , contraception take birth control continuously , migraine. Concomitant medication(s) included amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate; fluconazole, vitamin d. Patient previously took first dose of vaccination in right arm for covid 19 immunization.No other medications the patient received within 2 weeks of vaccination, the patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that take birth control continuously, so skip my periods and have not had my period or any spotting for 6 months up until a week after my first shot. When I received my second shot a few days later started a regular period again. And take my birth control very religiously and have been spotting/ been on my period for almost 3 weeks now which is incredibly unusual. My friend also mentioned the same thing happened to her after receiving the Pfizer vaccine so thought to reach out. On unknown date of Apr2021 the outcome of the event was not Recovered, and no treatment was received. The case has been assessed as non serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384998 same reporter/product/event, different patient

Other Meds: ADDERALL; FLUCONAZOLE; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1645862
Sex: F
Age:
State: WI

Vax Date: 07/10/2021
Onset Date:
Rec V Date: 08/28/2021
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: intense heat from my feet all the way up to my head like just under my skin so hot; it ended up passing; my right ear event lost hearing which restored, my left ear then felt like I had hearing as if there's water in my ear that muffled kind of hearing; had a bit of node in my throat for about 30 seconds to 60 seconds it didn't amount to anything it went away; difficulty swallowing; immediately down into the bone into my wrist and even into the bone of my shoulder blade at point and stiff; really intense overwhelming like a hot flash; it lasted for an hour and a half; constantly warm ever since that big hot flash and I would have spikes in me which I would call flashes the hot type flashes but I never stopped being warm; very just disoriented kind of lightheaded; was so distracted and unable to focus because of the pain in my head also that is accompanied by intense pressure in my head; like a feeling of a fullness from the middle of my chest through my neck all the way up into my head that just felt like a fullness; Blurred vision; Ringing in ears; random sharp pain in weird areas like my just my sternum, my neck, my upper abdomen; neck and shoulders were so achy that I have used the travel pillow to kind of hold my head up because my head was so heavy; had a buckle in my eye that they used to, due to the reconstruction of the retina ; it's inflamed; Headache; lymph nodes on my back of my head were very protruded; Fatigue; arm soreness; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACINE, Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration on 10Jul2021 (Age at vaccination: 48-years-old) as single dose for covid-19 immunization; paracetamol (ACETAMINOPHEN EXTRA STRENGTH), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for an unspecified indication; acetylsalicylic acid (ASPIRIN (E.C.)), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for an unspecified indication; caffeine, paracetamol (EXCEDRIN ASPIRIN FREE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for an unspecified indication; naproxen sodium (ALEVE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for an unspecified indication. Medical history included Polycystic ovarian syndrome. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), metformin (METFORMIN), tablet 3 times per day, hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) tablet 28, one tablet a day, simvastatin (SIMVASTATIN) tablet one time a day at bedtime. It was reported that she just want to report, she already done it the VAERS report system but she wanted to also follow up with the Pfizer and tell you what she experienced and then see she do not know recommendation on what she do next or not do next. she got her first shot on 10Jul2021. The shot was her first dose so and following that she mean she had immediate arm soreness which reminded me of the tetanus shot. she was, she had it at withheld in the area which she was advised to stick around in the area of the store for 15 minutes minimum, she stayed for half an hour actually. she had noticed had a bit of node in her throat for about 30 seconds to 60 seconds it did not amount to anything it went away she had a little difficulty swallowing she was kind of self-assessing, making sure that my airway was okay and just kind of taking note of how I felt and I do not know cause she was trying to swallow on command It was just kind of my mind playing tricks on me but like she said it did not persist so she did not worry about it. My arm was sore, like she said through that day she mean immediately down into the bone into my wrist and even into the bone of her shoulder blade at point and stiff, the typical which did not alarm me much just was what she expected from what she have heard, and have read and seen. she was bit fatigued later that day, that night cause she got it about 4:30, 4 to the 5 central time. I did developed a headache and then about 10:30 that evening or so she developed a really intense overwhelming like a hot flash and she was familiar with hot flashes cause she have had them in the past as a woman of a certain age but she have not had one like that in probably a year and a half and it lasted for an hour and a half. It was just intense heat from her feet all the way up to her head like just under my skin so hot she could not believe how hot she was and it ended up passing and so the next day (unspecified date) were pretty much the arm soreness finally went away by late morning on Monday which would be 12Jul2021. The headache persisted actually worse at times just really very, she could not shake it no matter what she did, no matter whatever over the counter items took it just would not go away and then she just the fatigue persisted, the hot feeling she was constantly warm, then just constantly warm ever since that big hot flash and she would have spikes in me which she would call flashes the hot type flashes but she never stopped being warm, she have not spiked again since then with the flashes of heat, she have never stopped being warm, she have not witnessed fever at all. she had check my temperature and she have not a fever but the more concerning aspect present in themselves are Wednesday the 14Jul2021, Thursday 15Jul2021, and Friday 16Jul2021 which I just all of a sudden, just felt very out of it and unwell. she just did not feel right, very just disoriented kind of lightheaded, a little dizzy and then headache, she still had just compounded to the type of headache I never experienced. she was so distracted and unable to focus because of the pain in her head also that is accompanied by intense pressure in my head just, it almost like the, it like a feeling of a fullness from the middle of my chest through my neck all the way up into my head that just felt like a fullness and she had sinus infection before and it was not even like that it was something that she never felt before, the pressure was radiating my eyes specifically her right eye which she had retinal detachment surgery for 6 years ago (No further clarification). she had blurred vision, ringing in my ears, my right ear event lost hearing which restored, my left ear then felt like she had hearing as if there was water in my ear that muffled kind of hearing and now what left with is as if she have been to the concert or really loud environment where it kind of like a shhhh, kind of ability to hear and within that is a very muted high pitched kind of type of frequency and that not ringing almost like a, just a high pitch noise that is kind of muffled underneath that and had, she had a, her heart was racing intermittently during those 3 days and just an intense pounding in er chest and it did not persist for the entire time but it was just intermittent. Also it hurts my eyes and her left eye she can see normally out of it but my right eye she can tell the vision was not, it was blurrier than it had been you know there some blur in there due to my history and you know the surgery but this has noticeably decreased capability of vision and the pain and the ache persisted. Also I went to the eye doctor and I will tell you about that in a minute. she had some minor digestive issue on (unspecified date), which was she said whatever generally concerned me. she had some minor digestive issues, the lymph nodes on my back of my head were very protruded. she had just random sharp pain in weird areas like her just my sternum, my neck, my upper abdomen those have seized but those were happening. My neck and shoulders were so achy that she have used the travel pillow to kind of hold my head up because my head was so heavy and still dealing with stiffness, soreness

Other Meds: METFORMIN; LO LOESTRIN FE; LOSARTAN HCTZ; SIMVASTATIN

Current Illness:

ID: 1645863
Sex: F
Age:
State: NJ

Vax Date: 01/06/2021
Onset Date: 01/15/2021
Rec V Date: 08/28/2021
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 Name: covid test; Test Result: Negative

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Headache pressure get worse; Headache; Pressure in my head; Ear congestion; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (at the age of 72 years) as single for covid-19 immunisation. Medical history included heart arteries, lactose intolerance from an unknown date and unknown if ongoing (Known allergy- Lactose intolerance). Concomitant medication(s) included ramipril (ALTACE, oral capsule, 1.25 mg), metoprolol tartrate (25 mg), amlodipine besilate (NORVASC, 2.5 MG), ranolazine (RANEXA, 500 mg), lactobacillus acidophilus (ACIDOPHILUS), colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium , clopidogrel bisulfate (PLAVIX, 75 mg), acetylsalicylic acid (ASPIRIN EC, 325 mg), isosorbide mononitrate (ISOSORBIDE MN, 30 mg), famotidine (tablet, 40 mg) and Multi Vitamin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient was not pregnant at the time of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, on unspecified date as single for covid-19 immunisation. On 15Jan2021 the patient after second shot about a week and a half after she developed a headache that would not go away. Pressure in head and ear congestion. Headache pressures get worse when she bends down or look up. Also had been to ENT and she does not know what is going on and scheduled to see a neurologist in September. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. On unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test found to be negative. Patient had been being treated with 5 doses of steroids and nothing seems to help. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected

Other Meds: ALTACE; METOPROLOL TARTRATE; NORVASC; RANEXA; ACIDOPHILUS; VITAMIN D [COLECALCIFEROL]; CALCIUM; PLAVIX; ASPIRIN EC; ISOSORBIDE MN; FAMOTIDINE

Current Illness:

ID: 1645864
Sex: F
Age:
State:

Vax Date: 06/18/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: migraines everyday; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 30-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration on 18Jun2021 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 vaccine on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced migraines everyday. Patient has already sought treatment via HCP. Wondering if others have reported this as well. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645865
Sex: M
Age:
State: TX

Vax Date: 04/15/2021
Onset Date: 05/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210607; Test Name: Nasal swab; Test Result: Negative

Allergies:

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

Symptoms: Allergies have been bad starting about 3 weeks after vaccination.; lips are constantly swelling up; had issues with hives for about 6-8 weeks; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8735) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included food and milk allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 05May2021 at 20:00, 3 weeks after vaccination, the patient experienced allergies, that included new allergies that he never had it before and also an increase on those mild ones that he had before but never caused an issue. The patient lips were constantly swelling up and he had issues with hives for about 6-8 weeks. It had been somewhat manageable. The patient reported that he was using medications and completely changed his diet. He had never had any of these issues before the vaccine. He had heard others having the same issues. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which included treatment with unspecified medications and diet change. Since the vaccination, the patient had been tested for COVID-19. On 07Jun2021, the patient underwent nasal swab and the result was negative for COVID-19. The clinical outcome of the events allergy, lips were constantly swelling up and hives was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1645866
Sex: F
Age:
State: CA

Vax Date: 06/30/2021
Onset Date:
Rec V Date: 08/28/2021
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: 202006; Test Name: covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: fever; body ache; flu-like symptoms; This is a spontaneous report from a contactable other hcp (Nurse Practitioner). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 30Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jun2020 to an unknown date. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient experienced fever, body ache, flu-like symptoms. It was reported that The Caller wants to check what to do with his patient since his patient got tested positive last Jun2020 and got the 1st dose of the vaccine last 30Jun2021. His Patient had a significant reaction like lymph nodes, fever, body ache and flu-like symptoms. His patient worries over the myocarditis and pericarditis side effects. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jun2020. The outcome for all 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: 1645867
Sex: F
Age:
State: VA

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; Itchy feeling and throat and tongue; Also had bad headaches for 2 days; This is a spontaneous report from a contactable consumer (patient). A 48-Years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 23Jul2021 13:15 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. Patient had no known allergies. On 23Jul2021 13:15, the patient experienced Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; and also had bad headaches for 2 days. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received 2 types of medication to help with the hives as a treatment for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1645868
Sex: F
Age:
State: NY

Vax Date: 07/23/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headaches; Diarrhea; dizziness/when I am sleeping if I move my head I get dizzy; This is a spontaneous report from a contactable consumer. This 85-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jul2021 (Batch/Lot Number: EW0179; Expiration Date: 30Aug2021) as DOSE 1, SINGLE for covid-19 immunisation.(85 years old at the age of vaccination). Medical history included salivary gland neoplasm from an unknown date and unknown if ongoing , ankle fracture from an unknown date and unknown if ongoing , hernia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced dizziness/when i am sleeping if i move my head i get dizzy on Jul2021 with , diarrhea on 23Jul2021, headaches on 26Jul2021. She states that she went home, ate dinner, and had diarrhea. The diarrhea cleared up on Friday but she started to get headaches and dizziness. She states that the headaches are all the time, morning, noon, and night. She is wondering if she is doing something wrong, and she is looking for guidance on the second vaccine as well. She states that she was leery to receive the first vaccine but has a very ill brother with cancer and she wants to visit him. So she felt like it was important to get the vaccine. She mentioned that she talked to someone from Pfizer earlier but they hung up on her and were very rude. She states she does not have an interaction number. Caller wants to know what does she take for these headaches and dizziness? She states she thought there was something wrong with her. She said she gets headaches but she takes an aspirin, take Tylenol, an Excedrin and boom its gone, but this is constant morning, noon, night. She gets up to go to the bathroom in the middle of the night and headache. She said what's going on? She states is she taking something wrong? So all she does is take her excedrin and her aspirin and then after a little while it goes away but then later on it comes back again so. She states she will have to call her doctor. Therapeutic measures were taken as a result of headaches. The outcome of the event Diarrhea was resolved on 23Jul2021 and other events was unknown.

Other Meds:

Current Illness:

ID: 1645869
Sex: F
Age:
State: CA

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: passed out in car and went into an accident; passed out in car and went into an accident; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the right arm on 21Jun2021 16:00 (batch/lot number and expiry date unknown) at 36 years of age as dose 1, single for covid-19 immunization in a doctor's office/urgent care facility. Medical history included malignant melanoma. The patient had no covid prior vaccination. There were no concomitant medications. The patient had no other medications in two weeks. The patient had no other vaccine in four weeks. The patient informed that on 21Jun2021 16:30, she passed out in car and went into an accident. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit. The patient has no covid tested post vaccination. The patient did not received treatment due to the events. The outcome of the events was recovered. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645870
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Myocarditis; This is a spontaneous report from a contactable consumer reported for a patient that a patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced myocarditis after mRNA vaccine. The reporter stated that they know of this one additional report of a single cardiac biopsy, but nothing particularly informative beyond the absence of cellular infiltrates. This paper mentions the recommendation to avoid excessive physical activity for several months after an episode of myocarditis. I think it was clear that we are vigorously seeking info to inform about rare risk of cardiac findings after mRNA vaccines. I will be eager to learn about any outcomes from further discussion with Doctor. Please find attached a report in follow up to our discussion about any biopsies obtained in setting of suspected myocarditis after mRNA vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645871
Sex: F
Age:
State: TX

Vax Date: 05/26/2021
Onset Date: 05/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: extreme fatigue; weird top of head feeling; headaches on sides; neck pain; mild numbness on left side of face with random twitching/numbness on left hand with random pinching feeling; left side of face with random twitching; heart palpitations; cold & clammy hands; hot & sweaty feet; hot & sweaty feet; back pain; boils; pain leg with a bump; pain leg with a bump; itchy face; jaw tightness; Paramedics said blood pressure is 211 and took me to ER/Ever since I've being suffering of BP spikes; chest pain; blurred vision; confusion; 2 min after vaccine felt heat waves; nausea; dizziness/felt faint; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26May2021 11:30 (Batch/Lot Number: EW0178) as DOSE 1, SINGLE (age at vaccination 53-years-old) for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient did not have allergies. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 25 ug taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Facility type Vaccine was Pharmacy or Drug Store.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 11:32, the patient experienced 2 min after vaccine felt heat waves, nausea, dizziness, felt faint but did not. On 26May2021 11:45, Paramedics said blood pressure was 211 and took her to ER. The consumer reported ever since she had been suffering of BP spikes, nausea, dizziness, extreme fatigue, confusion, blurred vision, weird top of head feeling, headaches on sides, neck pain, mild numbness on left side face with random twitching, numbness on left hand with random pinching feeling, chest pain, heart palpitations, cold & clammy hands, hot & sweaty feet, back pain, boils, pain leg with a bump, itchy face, and jaw tightness. Being in ER 5 times and haven't work in 2 months. AE's resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment was received for the events. Outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. .

Other Meds: LEVOTHYROXINE; MAGNESIUM; VIT C; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1645872
Sex: M
Age:
State: TX

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/28/2021
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 Date: 20210722; Test Name: PCR; Result Unstructured Data: Test Result:Unknown result; Comments: Nasal Swab; Test Date: 20200123; Test Name: Covid-19 infection; Test Result: Positive ; Comments: Covid-19 infection 23Jan2020

Allergies:

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

Symptoms: Blindness in Right Eye; Dizzyness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 24Feb2021 15:00 (at the age of 65-years-old) as dose 1, single; and then received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 24Feb2021 (at the age of 65-years-old) as dose 2, single both for covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included TLIF; kidney pain in Aug2020; inguinal hernia and Covid-19 infection both on 23Jan2020. There were no concomitant medications. On 18May2021, the patient experienced blindness in right eye and dizzyness. The patient was hospitalized for the reported events for 3 days. The patient underwent lab tests and procedures which included polymerase chain reaction (nasal swab): unknown result on 22Jul2021; and sars-cov-1 test: positive on 23Jan2020. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment was unknown. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1645873
Sex: M
Age:
State: NC

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: swelling in the arm at the injection site/swelling in arm has been there since and it has been almost 3 months; This is a spontaneous report from a contactable consumer or other non-healthcare professional.A 66-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 09Apr2021 10:20 (Batch/Lot Number: EW0150) as Dose 1, SINGLE and dose 2 via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: ER8731) as DOSE 2, SINGLE (at the age of 66-years-old) for covid-19 immunization. Medical history included high blood pressure and pre-diabetes (The patient clarified that he has pre-diabetes and not full. He hopes it doesn't get any worse than that). Concomitant medications included amlodipine (10 mg, once a day) taken for blood pressure measurement, start and stop date were not reported; candesartan (32 mg, daily, oral) taken for blood pressure measurement; metformin (500 mg, daily, Metformin is in the pharmacy bottle and caller doesn't have lot number) taken for glucose tolerance impaired. Start and stop dates of all concomitant medications were not reported. He takes blood pressure medications and is on diabetes pill. He has been taking those prior to getting the vaccine. The patient did not take any vaccines within 4 weeks prior to covid-19 vaccine and no vaccine was received on the same date as Pfizer covid-19 vaccine. On 10Apr2021, the patient experienced swelling in the arm at the injection site/swelling in arm has been there since and it has been almost 3 months. It was reported that after receiving the first dose of the Pfizer COVID 19 vaccine on 09Apr2021 and possibly a week later developed swelling in the arm at the injection site. The patient then received the second dose on 30Apr2021 in the same arm, right. He stated that swelling in arm has been there since and it has been almost 3 months. He reported that it was only a little swelling and not too bad. He could still feel it and when he reaches his arm over to scratch his back, he cannot do it. The patient has appointment on Thursday with his new HCP. He just wanted to know if this is normal, he was concerned that it has stayed swollen this long. clarified that he received the second dose on 30Apr2021. Three weeks before that was when he had the first dose. His arm was swollen a little after the first dose and it never went down completely. Both doses were given in the right arm. The swelling of right arm started the next morning after his first dose, so it was on 10Apr2021. He was not sure if it was the next morning after the first dose. It might have been the next week. He noticed it when he was taking a bath. Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. The clinical outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: AMLODIPINE; CANDESARTAN; METFORMIN

Current Illness:

ID: 1645874
Sex: F
Age:
State: NE

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizziness; Bodyaches; Ringing in ears; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 28Jul2021 at 11:45 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 28Jul2021 at 22:00, the patient experienced dizziness, ringing in ears, fever, headache, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, ringing in ears, fever, headache, body aches was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1645875
Sex: M
Age:
State:

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Caller had the first dose of the Pfizer vaccine today, July 28 2021 and has sinus ear infection; This is a spontaneous report from a Pfizer- sponsored program. A contactable male consumer reported for himself. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration on 28Jul2021 as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included amoxicillin and Antibiotics (unspecified) taken for an unspecified indication, start and stop date were not reported. It was reported that, caller had the first dose of the Pfizer vaccine today, 28Jul2021 and has sinus ear infection, patient was on antibiotics for a while. Patient got a steroid shot 2-3 weeks ago (further clarification unknown). Later Transferring agent stated Caller had the first dose of the Pfizer vaccine today (28Jul2021), 28Jul2021 and has sinus ear infection and he wanted to know if he can get Amoxicillin or Steroids in between the doses because his second dose will be on 18Aug2021. It was reported that When paraphrased, consumer stated, it was not from the shot. Patient had this before patient got the shot. (Further clarification unknown). When probed since when consumer had the sinus ear infection, consumer stated, patient have been having sinus problem for a while. So, patient was on antibiotics for a while. Patient got a steroid shot 2-3 weeks ago (Further clarification unknown). Consumer stated, question was patient need to get more antibiotics for the ear infection, but the question was because patient have to take the second shot can patient take the antibiotics between the first dosage and second dosage, does it have to be out of his system like week before the shot How does it work. Therapeutic measures were taken as a result of event. The outcome of event was unknown.

Other Meds: AMOXICILLIN

Current Illness:

ID: 1645876
Sex: F
Age:
State: AR

Vax Date: 07/26/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: Test Result:102 Units:[degF]; Comments: 102 F Intermittent fever as high as 102 F

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Severe fatigue; Intermittent fever as high as 102 F; Chills; Muscle aches; This is a spontaneous report from a contactable healthcare professional. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E W0173) via an unspecified route of administration in the right arm on 26Jul2021 at 16:15 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Jul2021 at 04:00, the patient experienced severe fatigue, intermittent fever as high as 102 F, chills and muscle aches still occurring from 12 hours post vaccination (lasting 3 days so far). The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. On 27Jul2021 at 04:00, the patient underwent lab test and procedure which included body temperature and the result was shown as 102 F. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fatigue, intermittent fever as high as 102 F, chills and muscle aches were not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1645877
Sex: F
Age:
State: NY

Vax Date: 01/29/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Biopsy of hives; Result Unstructured Data: Test Result:Nothing unusual; Comments: biopsy of the hives found nothing unusual.

Allergies:

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

Symptoms: developed hives; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 86 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration on 29Jan2021 14:00 (at the age of 85 years) as SINGLE for covid-19 immunization, Followed by patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Pfizer 6198 and expiration date were not reported), second dose on deltoid left via an unspecified route of administration on 19Feb2021 14:00 as single for covid-19 immunization. Medical history included colonoscopy from an unknown date and unknown if ongoing 15 years ago, she was preparing for a colonoscopy and took MiraLax and experienced drug hypersensitivity. The patient concomitant medications were not reported. On 09Feb2021 exactly 11 days later the patient experienced developed hives. The patient underwent lab tests and procedures which included biopsy founded nothing unusual on 2021 biopsy of the hives found nothing unusual. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1645878
Sex: M
Age:
State: MD

Vax Date: 06/08/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210705; Test Name: COVID Test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Pain all over body; Mouth pain; Very pale complexion; Headaches; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 08Jun2021 at 19:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, the patient experienced pain all over body, exhaustion, headaches, mouth pain and very pale complexion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. On 05Jul2021, the patient underwent COVID test and the result was negative. The clinical outcome of the events pain all over body, exhaustion, headaches, mouth pain and very pale complexion was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1645879
Sex: F
Age:
State: NJ

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Antibody test; Result Unstructured Data: Test Result:no antibody's; Test Name: IGG; Result Unstructured Data: Test Result:Low

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: her IGG area showed low; she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case; she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 17Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing pre-existing infection that went bonkers, severe emphysema, lupus, Chronic obstructive pulmonary disease and tooth extraction at the very end of Dec2020 (patients tooth broke at the gum line and they had to wiggle and bounce it and when it came out it was blackish). States it was from the gum down into the tooth and they had to fight to get it out and she had ongoing pain her in jaw and didn't pay it attention she thought about the extraction. The patient was on steroids for years and years and got into emphysema and on more steroids. She has been on steroids so long taking them and her body is falling apart and it's affecting her teeth. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9262, Expiration Date: 31May2021), via an unspecified route of administration on 28Jan2021 as dose 1, single for covid-19 immunisation and experienced face was swollen and it made her nose go crooked with pain in her mouth that was terrible, cellulitis in her face, white blood count was 20 and should have been 10, jaw pain. States she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case. She stated the 2nd shot was no big deal, you hear people complaining about being tired and chills and she didn't have that and her arm didn't hurt. She stated the worst part is the opposite side of the top of her jaw bone, the 1st time it was the right side, and right now it's the tooth on the left side, the same tooth opposite side. States it broke away from the gum and it's the exact same thing. States when she does go get it done, she is a little leery of going to get that half tooth or if it comes out and fight to get the bottom that is in the jaw and this is probably black with her staying on steroids for years and years and got into emphysema and on more steroids. After the second dose, patients Immune was low and IGG area showed low, so the patient wanted the test and was waiting for the result. She states that her immunity in general has been in a question for a while. Patient had an antibody test and no antibodies even though she got 2 shots. Patient wanted to know under the circumstances will it be in vain and get the 3rd dose. The outcome of the events was unknown.

Other Meds:

Current Illness: Infection (a pre-existing infection that went bonkers)

ID: 1645880
Sex: M
Age:
State: MN

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fainted maybe 20-30 seconds post injection; convulsive vasovagal; Fainted maybe 20-30 seconds post injection. Then had what looked like a short seizure.; This is a spontaneous report from a contactable pharmacist (patient's mother). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 28Jul2021 16:15 (Batch/Lot Number: FA7485), at the age of 12 years old, as dose 2, single for covid-19 immunization in a pharmacy of drug store. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen, cetirizine hydrochloride (ZYRTEC), and mupirocin, all taken for unspecified indications, start and stop date were not reported. No other vaccines were given within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 on 05Jul2021 13:00 (lot no: FA6780), at the age of 12 years old, intramuscular in left arm for COVID-19 immunisation; previously fainted once 2-3 years ago with influenza vaccination. On 28Jul2021 16:15, the patient fainted maybe 20-30 seconds post injection. Then had what looked like a short seizure. He threw himself back in his chair, went totally straight and stiff then threw himself back again. Probably convulsive vasovagal but mom will have him checked out. As treatment, patient was laid on back and was given Gatorade. The events were reported as non-serious. The patient recovered from the events on 28Jul2021.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events syncope and seizure cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.

Other Meds: IBUPROFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MUPIROCIN

Current Illness:

ID: 1645881
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 05/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:Unknown; Test Date: 202106; Test Name: endoscopy; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Nausea

Symptoms: little dots appeared on her hands, as if they were bites/ dots kept on growing and now they appear on her arms, shoulders, chest, and back/ hives are small, but after that they got swollen, grew, and turned red; allergic reaction; The welts are small, swell, grow, turn red,dry up and turn brown, like skin burns; heart has been racing; skin is sensitive; pain; Itching; very depressing; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 49-years-old via an unspecified route of administration on 11May2021 (Batch/Lot Number: EW0173) as DOSE 2, SINGLE for covid-19 immunisation; pantoprazole via an unspecified route of administration from Feb2021 to 12May2021 taken for reflux in her stomach. Medical history included gastritis and hernia from an unknown date. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-years-old on 20Apr2021 (lot: EW0164) for covid-19 immunisation. The patient reported that she received the second dose of Pfizer Covid19 vaccine on 11May2021. The day after on 12May2021, little dots appeared on her hands, as if they were bites. Those dots grew and so she called the hospital, but they gave her an appointment five days later. Doctor told her that was an allergic reaction but it was not associated with the vaccine. Doctor gave her treatment, but she did not specify what the treatment was. The dots kept on growing and now they appear on her arms, shoulders, chest, and back. She mentioned the hives are small, but after that they got swollen, grew, and turned red. After that, they dried and turned brown. They seem like skin burns. She has gone twice to the emergency room and had treatment but it has not been successful. She already reported the reaction online on VAERS. A nurse in the hospital also was going to report the situation. The nurse told her it was a reaction to the vaccine. She has been with these symptoms for the last few months. The spots have been increasing. The patient further clarified that first of all, it wasn't days after. It was the next day after getting the Pfizer COVID19 Vaccine. Those spots during the day grow. The same day they appear they start growing and swell. It is very extensive. Two to three days later they dry up and then appear in other areas of the body. It is on her chest, shoulders, arms, and also in her legs. That has been gradually. The transfer agent didn't mention her legs and they are horrible and it is on her face. She has taken pictures of everything. She has been two times to urgent care, two times to emergency room, has had five appointments with her primary care doctor, and one appointment with her dermatologist. Her back is full of that. It is entirely full. She has been having pain since an unspecified date in 2021. Her heart has been racing on an unspecified date in 2021. She has also had an EKG done, electrocardiogram. The first time she went to the doctor they gave her Benadryl and it didn't do anything, absolutely nothing. Then she went to urgent care and they administered some injection and nothing else. When she went to Urgent Care the second time they administered injections. The doctor was going to prescribe Benadryl, but she told them the Benadryl didn't help so he gave her Loratadine. When she went to ER, they prescribed her Pepcid. When she went to another ER they prescribed her with Triamcinolone, no pills just ointment. The ointment was Triamcinolone Acetonide Cream UTC 0.1%. This thing is her entire body. It is not only itching it is causing her pain. Her skin is sensitive. She has a 2 year old to take care of and she is not able to take care of him. Her entire body. The dermatologist wanted to do a biopsy when it is swollen and red. When she went unfortunately it was drying up. It has increased. It is even more. It is very depressing. No one gives her a solution. She has been on here and not been taking care of myself. He needs her help. Emotionally this has been hard. She doesn't see a solution. She has called the dermatologist so he can see how it is in now, but they said they won't have a dermatologist appointment until October. She has to keep bearing with this pain and it burns through her whole body. In Jun2021, she had an endoscopy done. She had asked the doctor because she had the spots and they said it was separate and she could do her endoscopy. They said the spots were completely separate. She was taking Pantoprazole for reflux for her stomach. She stopped that when she started the spots. She had been taking the medication since February. In May when the spots appeared she stopped it thinking it may be that. She stopped all chemicals and all that thinking it was allergies. The patient underwent lab tests and procedures which included EKG: unknown on an unspecified date and endoscopy: unknown in Jun2021. Therapeutic measures were taken as a result of urticaria generalized, allergic reaction and skin discoloration which included hydrocortisone, Pepcid, Benadryl, Loratadine and triamcinolone acetonide cream. The action taken in response to the events for pantoprazole was permanently withdrawn on 12May2021. The patient did not recover from urticaria generalized and pain while the outcome of the other events was unknown. Pfizer is a marketing authorization holder of pantoprazole in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pantoprazole has submitted the same report to the regulatory authorities. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645882
Sex: U
Age:
State:

Vax Date: 07/22/2021
Onset Date:
Rec V Date: 08/28/2021
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: Headache; Diarrhea; My headache and my eyes are killing me; Chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 22Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient stated that, got the Pfizer shot then patient had the side effects and got it on Thursday. Patient believe it was 22nd. Patient got headache, diarrhea, little bit of chills. Headache and eyes are killing patient. So, sounds like all the symptoms here, the side effects since Thursday. Patient want to report it. Patient asked that, do need to go to a doctor. Consumer was unwilling to complete the report. Hence limited information available over the call. The outcome of the events were unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645883
Sex: F
Age:
State: AL

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: AFIB episodes; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0198), via an unspecified route of administration, administered in arm right on 12Jul2021 at 10:15 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, asthma, COVID-19 and AFIB (atrial fibrillation) from an unknown date; and heart ablation from 22Jun2020 (I had a heart Ablation due to AFIB on 22Jun) to an unknown date. The patient 9 AFIB episodes and heart palpitations on 12Jul2021 at 11:15. The clinical course was as follows: The patient had a heart ablation due to AFIB on 22Jun. Approximately 1 hour after receiving her 1st dose, she begun having the same level of heart palpitations as i did prior to her surgery. She had to take additional doses of Flacenide that she uses to regulate her heart. She has had at least 9 AFIB episodes daily since then when they had all but stopped after her surgery. Therapeutic measures were taken as a result of both events. The outcome of the events was recovered with sequelae on an unspecified date. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645884
Sex: F
Age:
State:

Vax Date: 07/28/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: started losing her voice; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on 28Jul2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced that she started losing her voice on 29Jul2021.Patient was the first person at the phone but could not speak clearly as she was losing her voice.The patient didn't receive any treatment for the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645885
Sex: M
Age:
State: AR

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Very weak; Very disjointed thought processes and motor function that day; Very disjointed thought processes and motor function that day; feeling like my knees were going to collapse; Passed out; I began to feel pain radiating from the center of my torso.; I became nauseated,; I fell to the floor; Dizzy and disoriented; disoriented; Began violent vomiting; Worst diarrhea I?ve ever had; Exhausted/tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 19Jul2021 at 18:15 (62-years-old at the time of vaccination) (Batch/Lot Number: FA7484) single, for COVID-19 immunization. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had concomitant medications (unspecified; reported as medications that the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jul2021, about 1 hour and 15 minutes after receiving the vaccine, at 19:30, the patient began to feel pain radiating from the center of his torso. The pain intensified rapidly to severe. He became nauseated and tried to walk to the bathroom but he fell to the floor. Dizzy and disoriented, he started crawling, passed out, and started again. He began violent vomiting, passed out, woke up, and dragged himself up on the commode. Stated that it was the worst diarrhea he'd ever had. Stated that everything in his digestive system left his body. He then passed out on the commode, woke up, crawled back to the living room, and went to sleep. He woke up in a few minutes feeling better but exhausted. The patient woke up the next morning, very weak, and was still somewhat disoriented. He had a very disjointed thought processes and motor function that day. He kept feeling like his knees were going to collapse. The next day, he was still weak but almost clear headed. Next day, he was tired but ok. The initial severe sequence of events lasted maybe an hour or a little more. Since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment for the events. Outcome of the events was recovered in Jul2021. The case was reported as non-serious. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645886
Sex: F
Age:
State: GA

Vax Date: 02/25/2021
Onset Date: 03/02/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210401; Test Name: biopsy polyp; Result Unstructured Data: Test Result:Normal; Test Date: 20210401; Test Name: Hemoglobin; Result Unstructured Data: Test Result:Normal; Test Date: 20210401; Test Name: Post OC-light; Result Unstructured Data: Test Result:Normal; Test Date: 20210401; Test Name: Thin prep; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: vaginal bleeding; cramps; bloating; This is a spontaneous report from a contactable consumer (patient) in response to consumer letter sent via follow-up letter which included that a 60-years-old female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6198, patient was 60-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Right on 25Feb2021 at 08:00 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included post menopause (I am 15 years post menopause, Do not need increase in oestrogen. Onset of period in my 60s), breast cancer (Concerned due to family history of breast cancer), High blood pressure. Concomitant medication(s) included ongoing metoprolol succinate (TOPROL XL, 50 mg, via oral route) taken for High blood pressure; biotin; colecalciferol (VIT D [COLECALCIFEROL]). On 02Mar2021, the patient experienced vaginal bleeding, cramps, bloating. No treatment was received for events. On 01Apr2021, the patient underwent lab tests and procedures which included biopsy polyp, Hemoglobin, Post OC-light, Thin prep which all resulted as normal. The outcomes of events were recovered on 07Mar2021. Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: TOPROL XL; BIOTIN; VIT D [COLECALCIFEROL]

Current Illness:

ID: 1645887
Sex: F
Age:
State: CT

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
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: MRSA; Her left arm was swollen by 3 inch in diameter; has a sight pain when lifting or moving her arm; The vaccination site is very painful and hot to touch; The vaccination site is very painful and hot to touch; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FA7484), via an unspecified route of administration, administered in Arm Left on 28Jul2021 12:40 (received at the age of 55-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The vaccine was administered at a grocery store pharmacy. Medical history included MRSA (Methicillin-resistant Staphylococcus aureus) from 2012 to an unknown date. The patient's concomitant medications were none. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0198), administered in Arm Right, on 01Jul2021 (at the age of 55-years-old), as DOSE 1, SINGLE for COVID-19 IMMUNISATION; anthrax vaccine (first dose on 03May2004, 2nd dose on 17May2004, and 3rd dose on 01Jun2004) and experienced swelling in her arm. The patient stated that at one point she had MRSA in 2012 and she also had an adverse effect from Anthrax shot; she had swelling in her arm from those and also the 3rd shot she had really bad swelling from it in her right arm. She stated that with the 1st one (first dose of Anthrax) she had swelling slightly, with the 2nd one the swelling was a little more and the 3rd one she had a lot. She did not have NDC, lots or expiry dates. She stated the dose was 0.5cc for all of them. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient reported that her left arm was swollen by 3 inch in diameter post Pfizer covid-19 vaccination. She has a sight pain when lifting or moving her arm. The vaccination site is very painful and hot to touch. She stated that she is having swelling and it's about 3 inches in diameter on her left arm and it's hot to the touch. She has slight pain when lifting and moving her arm and it is very painful when she presses on the site. The patient stated her symptoms started on 28Jul2021 after the vaccine and the swelling has gotten worse at the day of report on 29Jul2021. The symptoms started maybe 3-4 hours after and got worse and worse as night came on, and this morning (29Jul2021) it was hot, yesterday (28Jul2021) it was just raised and progressively got more raised and hot to the touch. She is aware people can experience pain and swelling post vaccination, but she is not heard of warmth around injection site. She wants to know if this symptom is associated with the vaccine. She is also concerned as she had MRSA in the past. She explained if you had MRSA once in your lifetime you can get it again. She wants to know if other individuals with MRSA have experienced similar symptoms post vaccination. Outcome of the events was unknown. The adverse events did not require a visit to the emergency room or physician office. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645888
Sex: F
Age:
State: NC

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 2 weeks later still have pain; Vaccine was given very high on arm - Dr. says it was too high; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 14Jul2021 at 10:00 (age at vaccination 69 years) (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia and arthritis. The patient previously took steroids and experienced drug hypersensitivity. Concomitant medication included celecoxib (List of medication patient received within 2 weeks of vaccination). Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jul2021 at 06:00, patient experienced pain and it was mentioned that vaccine was given very high on arm, doctor said it was too high. Patient did not receive any treatment for adverse events. At the time of this report, the outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: CELECOXIB

Current Illness:

ID: 1645889
Sex: M
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 05/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Migraines; brain fog/Just felt awful on a number of fronts.; fatigue; insomnia; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo, concussion in Feb2020, and appendectomy in 2013. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not take any other medication within two weeks of taking COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 16:00, the patient experienced migraines, brain fog, fatigue, insomnia, just felt awful on a number of fronts. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with anti-migraine medication (Names unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraines, brain fog, fatigue, insomnia, just felt awful on a number of fronts was not recovered at the time of this report.

Other Meds:

Current Illness: Vitiligo

ID: 1645890
Sex: M
Age:
State: PA

Vax Date: 05/03/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
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 Name: cholesterol; Result Unstructured Data: Test Result:high; Test Name: Blood glucose; Result Unstructured Data: Test Result:sugar is at 105; Test Name: Fasting sugar; Result Unstructured Data: Test Result:HIgh; Comments: but it was always high; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown; Test Date: 20210708; Test Name: Stress test; Result Unstructured Data: Test Result:Unknown; Test Date: 20210708; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown; Test Date: 20210708; Test Name: EKG; Result Unstructured Data: Test Result:Unknown; Test Date: 20210708; Test Name: halter monitor; Result Unstructured Data: Test Result:AFib all the time; Test Name: Hemoglobin A1C; Result Unstructured Data: Test Result:under 5; Comments: Hemoglobin A1C was under 5; Test Date: 202106; Test Name: Heartbeat; Result Unstructured Data: Test Result:Funny

Allergies:

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

Symptoms: Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 51-year-old via an unspecified route of administration, administered in left arm on 03May2021 (Lot Number: ER8736) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to an unknown date (he "had COVID-19 at the end of Dec2020"), high cholesterol and fasting sugar was high, and it was always high. Concomitant medications include the patient was on other medications (unspecified) but has been on them a long time. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EP7533) on 12Apr2021 (15:00-15:45) at the age of 51-year-old administered at the right arm for COVID-19 Immunization. The patient also previously had yellow fever, typhoid, and MMR re-boosted because the titers were not high enough to leave country. The patient had both injections and about a month later from the second dose (Jun2021) started to have his heart beat funny. He was only 51 years old and has been monitored and never had any issues. He was diagnosed with AFib on 08Jul2021. He feels he was a little too young for that. He eats right and exercises. He does not know if it was nature or if it came from the vaccine. He has been in the pharmaceutical industry but confirmed he does not work for Pfizer. He understands there may not be enough data, but he would like to know if there have been any other reports of AFib reported. He worked with a company that sold rare disease and cancer drugs. They used to get drugs approved for Phase 1 and 2 trials for 60 patient trial size. He said the cardiologist picked it up. He had to wear heart monitor for 2 weeks. His cardiologist picked it up when he listened to his heart. He put a heart monitor on him for 10 days and got report that he needs to go in for ablation therapy and cut scars in heart to get electrical activity in heart back to normal. He knew he had a little AFib and did not know it was as bad as it was. They just listen to your heart and that was the first time ever when the doctor listened to his heart and after the halter monitor, he told him he was in it all the time and said he had to fix it so he would not have a stroke. They put him on blood thinners. He had a Stress test, EKG, Echocardiogram, all unknown results and related to his going to the cardiologist. He does not know if it was the vaccine or not. All tests were done when he saw him on 08Jul2021. They put the halter monitor on 08Jul2021 for 7-10 days and he put it in the mail and physician called back yesterday and said he was in AFib all the time. The event resulted in physician office visit since he felt like heart was not beating right and made appointment with cardiologist. The patient underwent lab test and procedures which included routine blood work: unknown results, cholesterol: high, fasting sugar: high but it was always high, hemoglobin A1C: under 5, blood glucose: 105, all on an unspecified date. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645891
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:low grade fever; Comments: low grade fever

Allergies:

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

Symptoms: low grade fever; vomiting; dull headache; exhaustion; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose2, single for Covid-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 30July2021 as dose1, single for Covid-19 immunization and experienced Sore arm. Patient was not diagnosed with Covid-19 Prior to vaccination. It was reported as after second shot had a low grade fever and vomiting. For whole next day had a dull headache and exhaustion. Since the vaccination patient was not tested for Covid-19. The patient underwent lab tests and procedures which included body temperature: low grade fever. The outcome for the events was reported as resolved on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645892
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Pain in extremity

Symptoms: Husband had both doses of the vaccine and has immune issues; This is a spontaneous report from contactable consumer received from Pfizer sponsored program (patient's wife). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number, Expiry date: Unknown), via an unspecified route of administration, administered on unspecified date, dose 1 and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number, Expiry date: Unknown), via an unspecified route of administration, administered on unspecified date, dose 2, single dose for COVID-19 immunisation. The patients Medical history and Concomitant medications were not reported. On an unspecified date, reporter stated that her husband had both doses of the vaccine and had immune issues. Caller called in to know if we have a list of places that do protein antibody tests. She wanted her husband to do the test to check if the vaccine is still effective. His husband had both doses of the vaccine and has immune issues. Caller clarified that his husband is okay and was only worried because of the delta variant that is why she wanted him to do the antibody test. Escalate as NME. Referred to the health department. Created manual AE form for Precautionary as caller mentioned that her husband who got both doses of the vaccine has some immune issues and she is concerned if the vaccine works. Medical Information was not applicable, Customer's questions addressed by CEP Program or no medical questions asked. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645893
Sex: F
Age:
State: SD

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
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: 20210728; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: Chest pain; Lightheaded and dizzy; threw-up once; whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well; couldn't move her hands due to being stiff and tense; tingling sensation as if asleep; Dry cough/the cough was on and off; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 28Jul2021 15:00 (Batch/lot number unknown), at age 36 years old, as dose 1, single, for COVID-19 immunisation, at an urgent care center. The patient was not pregnant at the time of vaccination. Relevant medical history included narcolepsy, hypothyroidism, anxiety, anemia, G.E.R.D. (gastrooesophageal reflux disease), vitamins D deficiency, and allergies to metal, soap, laundry detergent, lotions, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jul2021 15:00 (also reported as "about a minute or two after received the vaccine"), the patient became lightheaded and dizzy, threw-up once, her whole body tensed up to where she couldn't move her hands due to being stiff and tense, her legs tensed up as well and had tingling sensation as if asleep. On the same day, 28Jul2021, the patient had dry cough, the cough was on and off. The events resulted to emergency room and physician's office visits. The patient received oral BENADRYL and most of the tenseness released. The patient received more BENADRYL through an IV and sodium chloride. The patient underwent blood tests on 28Jul2021 with unknown results. "Chest drag" (as reported) was done. Most symptoms resolved except for dizziness, lightheadedness and on and off dry cough. The patient was then released home. The patient was not hospitalized. On 29Jul2021, the next day, the patient had on and off chest pain, the other events resolved. The patient recovered from the events threw-up once, whole body tensed up/couldn't move her hands due to being stiff and tense/legs tensed up as well, couldn't move her hands due to being stiff and tense, and tingling sensation as if asleep on 28Jul2021; from lightheaded and dizzy and dry cough/the cough was on and off on 29Jul2021. The outcome of chest pain was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645894
Sex: F
Age:
State: NV

Vax Date: 04/30/2021
Onset Date: 05/06/2021
Rec V Date: 08/28/2021
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: dry tickle type cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 30Apr2021 13:30 (at the age of 52 years old) (Lot Number: ER8737) as dose 2, single for COVID-19 immunisation. Medical history included arrhythmia and penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included esomeprazole magnesium (NEXIUM); metoprolol, Vitamin D; cyanocobalamin (VIT B12); glucosamine; all taken for an unspecified indication, start and stop date were not reported. The patient took the first dose of BNT2B2 on 09Apr2021, administration time: 04:00 PM, anatomical Location: Arm Right, Batch/lot number: ER8737 (at the age of 52 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06May2021, the patient experienced dry tickle type cough. Patient felt like it comes from the middle of her chest. The event was reported as non-serious. The patient was not hospitalized. No treatment was given for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are need. No further information is expected.

Other Meds: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; METOPROLOL; VIT D [VITAMIN D NOS]; VIT B12; GLUCOSAMINE

Current Illness:

ID: 1645895
Sex: F
Age:
State: NC

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
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 Date: 202103; Test Name: Barium test; Result Unstructured Data: Test Result:only saw a little problem with reflux; Test Date: 2021; Test Name: cholesterol; Result Unstructured Data: Test Result:Excellent; Test Date: 20210303; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown; Test Date: 202103; Test Name: Heart monitor; Result Unstructured Data: Test Result:Nothing wrong; Test Date: 2021; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:Unknown result; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:fine

Allergies:

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

Symptoms: heart racing and pounding; glands in neck were swollen; having acid problems with gas; tightness in her chest; Little problem with reflux; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 10Mar2021 at 13:10 (Batch/Lot Number: EN6207) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing Discoid lupus, ongoing Blood pressure high, ongoing Spondylosis, ongoing Allergies, ongoing diverticulitis, ongoing Pre-diabetic (In 2019 she became diabetic, but when she went back to her doctor it had gone down so she is now back to pre-diabetes), ongoing Collapsed mitral valve and Diabetic (from 2019 to an unknown date In 2019 she became diabetic, but when she went back to her doctor it had gone down so she is now back to pre-diabetes). Had a yearly physical on 3Mar2021, and is unsure whether or not she received a Flu shot at that appointment. AEs following prior vaccinations includes nothing other than pains or a slight headache when she gets the Flu shot; really makes her feel bad. She thinks she took a Tylenol when she got home on 03Mar2021. No Lot/NDC/Expiry to provide for any of the Flu shots she has had. For some people it makes them sick, but she normally takes just a Tylenol and goes to bed and feels better when she wakes up. Concomitant medication includes cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient experienced heart racing and pounding on 15Mar2021 (reported as 5 days later), glands in neck were swollen on 14Mar2021 (reported as 4 days later) and having acid problems with gas, tightness in her chest and little problem with reflux on Mar2021 (unspecified date). It was reported that on 10Mar2021, she had her 1st dose of the Covid 19 Vaccine. 4 days later, that afternoon, her glands in her neck were swollen. She rubbed them down with alcohol, and took Tylenol. The next morning, which was day 5 after the shot, her heart was racing and pounding when she woke up. She didn't do anything about it at that time because she thought maybe it would go away, but eventually she went to the ER and was checked out. The doctor in the ER said it was not from Covid 19 vaccine. States that she was also having acid problems with gas and tightness in her chest. She went back to the ER; they checked her out again and sent her home. They wanted her to stay so they could do an upper GI, but she wasn't fully vaccinated yet. She called FDA, and was told it sounded like side effects from the vaccine and to go back to ER, so she went back and and took the paper with her that she got from the FDA, but she was told the same thing. So, she decided to let them admit her to see if they could find out what the problem was. She wore a heart monitor for 2 days, but they didn't see anything, and she had a barium test but they only saw a little problem with reflux. When she was discharged, she went to her primary doctor's office and was explaining to them what was going on, and also went to a cardiologist who gave her a heart monitor which she wore for about 7 days, but nothing was seen on the heart monitor. States that she saw a Neurologist on 03Mar2021 before she got the 1st dose of the vaccine. They took blood work, and she was on B12, and they told her that could affect her nervous system. Caller clarifies that the doctor called her during that time and told her to start taking the B12, she doesn't really remember if she was on the B12 or not when got the 1st dose, but she thinks she was. The patient was hospitalized for heart racing and pounding for 2 days. The patient underwent lab tests and procedures which included Barium test (Barium swallow): only saw a little problem with reflux on Mar2021, Cholesterol (blood cholesterol): excellent on 2021, Blood work (blood test): unknown on 03Mar2021, Heart monitor (cardiac monitoring): nothing wrong on Mar2021, chest x-ray: unknown result on 2021, EKG (electrocardiogram): fine on 2021. Therapeutic measures were taken as a result of glands in neck were swollen. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: B12 [CYANOCOBALAMIN]

Current Illness: Allergy NOS; Blood pressure high; Discoid lupus erythematosis; Diverticulitis; Mitral valve disease; Pre-diabetic; Spondylosis

ID: 1645896
Sex: F
Age:
State: NV

Vax Date: 07/09/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: CP of her heart pericarditis; Result Unstructured Data: Test Result:Unknown; Test Name: ultrasound of her gall bladder; Result Unstructured Data: Test Result:Inflammed; Comments: it was inflamed and it was full of sludge

Allergies:

Symptom List: Vomiting

Symptoms: gall bladder issues/gall bladder was inflamed and it was full of sludge; pericarditis; gall bladder inflammation; extreme stomach pain; This is a spontaneous report from a contactable consumer via Medical information team. A 42 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included autoimmune issue and lupus from an unknown date and unknown if ongoing. The patient previously had BNT162B2 dose 1 for COVID-19 immunization. The patient's concomitant medications were not reported. The patient started experiencing some pains turned out to be gall bladder issues and she is in the hospital right now to get her gall bladder removed. The patient's husband was aware about the usual side effect, the pericarditis and also the inflammation of the gall bladder. The patient's husband concern was, is it possible that the spike protein invalidated into her gall bladder, that caused the autoimmune reaction or the inflammation to the gall bladder. He wants to know if we are doing tests on gall bladders that have been removed, and if his wife body is continuing to manufacture the spike protein and with her autoimmune condition related, will it be transmitted to another organ, or will it cause pericarditis. He is asking if we have procedure or testing spike protein concentration and other organs. The patient had gall bladder inflammation and pericarditis issue. The patient went through gall bladder surgery and had her gall bladder removed. The patient woke with extreme stomach pain and went to the emergency room that was last two days in Jul2021. The patient had CP of her heart pericarditis and they did an ultrasound of her gall bladder and told it was inflamed and it was full of sludge and then they sent her home and told her to schedule with a surgeon because he said it was a (Distorted voice). When probed if the result of test were normal: Reporter stated, No, the ultrasounds showed that her gall bladder had sludge in it and it was inflamed. It progressively got that worse over the next couple of days until the patient had surgery this morning to have her gall bladder removed. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645897
Sex: M
Age:
State: FL

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210727; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:No Antibodies/Negative

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Having issues with his left arm and could not lift it above his shoulder; His shoulder was achy like a flu shot; The placement of the vaccine was wrong/he was given the vaccine in the Sub acromial/ Subdeltoid location; This is a spontaneous report from a contactable consumer or other non-health care professional (pa-tient) from a Pfizer sponsored program. A male patient of an unspecified age re-ceived first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injec-tion, Lot number: EL9261), via an unspecified route of administration (at the age of 47-years), adminis-tered in arm left on 13Feb2021 at 08:00 as dose 1, single for COVID-19 immunization. Medical history included ongoing type 2 diabetes mellitus and it is under control. The patient concomitant medications were not reported. The patient historical vaccine include flu shot and experienced Arm irritation (Get the arm irritation from teh flu shot but it goes away in a day or 2), and His shoulder was achy like a flu shot. No other medications took by patient except for his prescribed medications. On 14Feb2021, the patient experienced having issues with his left arm and could not lift it above his shoulder, his shoulder was achy like a flu shot. On an unspecified date in 2021, the patient stated that the placement of the vaccine was wrong/he was given the vaccine in the sub acromial/ subdeltoid location. The adverse events did not resulted in emergency room and physician office visit. Patient stated that he received his first dose of the Pfizer COVID-19 vaccine on13Feb2021 and his second dose on 08Mar2021. Howev-er he feels as though he never received the first dose because after the first dose he started having issues with his left arm and could not lift it above his shoulder and he has also received a negative anti-body test after receiving both doses of the vaccine. He is looking for information if it would be safe about receiving a second round, meaning a third and fourth dose of the vaccine since he thinks he never received the fist dose and his immune system never recognized it because the placement of the vaccine was wrong. He states after looking on the internet he found that he was given the vaccine in the Sub acromial/ Subdeltoid location. He found an article with pictures about the Sub acromi-al/Subdeltoid COVID-19 shot.After having the first dose, he was having issues with the left shoulder and can not lift his left arm up. He said that the vaccine went into the joint and not into the left arm muscle. The caller also reported that he had a test for antibodies, but it is showing no antibodies. He is asking is it safe to get a second round of the vaccine? He said that he thinks the vaccine works, but said that he thinks they placed it in the wrong place. He thinks it went into the joint instead of the muscle. After the second dose he never got sick and stated that everyone else he knows got like mild flu like symptoms for a few hours and got a little sick that went away after a day or so. He never got those known side effects. No further details provided. His physician would not know about his symptoms.He had his shots in withheld. He said that his shoulder was achy like a flu shot. The ache was constantly there. He could not lift his arm over the shoulder level when he went to the gym with any kind of weight and that put up a red flag for him. He also received the second dose, Lot: EL9266, Expiry un-known , Location: Right arm. Description of Product Complaint Description of complaint: Caller on the line that was calling about the Covid-19 Vaccine and reported that he had the first and 2nd dose, first dose was 13Feb2021 and the second dose was 08Mar2021. The caller also reported that he had a test for antibodies, but it is showing no antibodies. After the second dose he never got sick and stated that everyone else he knows got like mild flu like symptoms for a few hours and got a little sick that went away after a day or so. He never got those known side effects. No further details provided. Product strength and count size dispensed: Covid-19 Vaccine. Additional lot numbers: EL9266. The sample of the product was not available to be returned. Packaging sealed and intact? Not provided. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: no antibodies/negative on 27Jul2021. The vaccination facility type was reported as hospital. The culture was not performed and there was no positive result, no seroptyping done. The culture source was not specified. There are no predisposing factors. The clinical outcome for the events having issues with his left arm and could not lift it above his shoul-der, his shoulder was achy like a flu shot was reported as not recovered while for the event the placement of the vaccine was wrong/he was given the vaccine in the sub acromial/ subdeltoid location was reported as unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Type 2 diabetes mellitus (it is under control.)

ID: 1645898
Sex: M
Age:
State:

Vax Date: 07/22/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: dizziness; sweating/sweating profusely; bad cough; diarrhea; losing his voice; he never experienced being this sick before./has been feeling very sick since he received it last Thursday, 22Jul2021; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: PA9484), via an unspecified route of administration on 22Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Jul2021, the patient experienced dizziness, sweating/ sweating profusely, bad cough, diarrhea, losing his voice, he never experienced being this sick before. /has been feeling very sick since he received it last thursday, 22jul2021. Caller wanted to know what to do regarding his adverse events after getting the Pfizer BioNTech Covid-19 Vaccine shot because he was never sick like this before. The outcomes of all reported events were unknown.

Other Meds:

Current Illness:

ID: 1645899
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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 Name: Covid test; Result Unstructured Data: Test Result:positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: tested positive for COVID; sore arm; This is a spontaneous report from Pfizer. This consumer (patient) reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid and sore arm on an unspecified date. Patient received her first does and the next day her husband tested positive for Covid-19. Five days after receiving her vaccine she tested positive as well. She is recovering and is scheduled to receive her second dose August 9th. She wants to know is there any guidance of her receiving the second dose and if she needs to get revaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the event tested positive for covid was recovering and sore arm was unknown. Product Quality Complaint: Reporter Subtype: Patient, PQC Present: No, AE Present: Yes, CEP/PSP: 159558(Pfizer COVID-19 Vaccine Call Center) PQC Details: Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller wants to know if you stretch the interval between the two doses longer than than the three weeks will there be a problem. Response: Caller was provided the following information from the attached document: o The second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, o But if it is not possible to give the second dose at 3-weeks and a delay cannot be avoided, it may be given up to 6 weeks (42 days) after the first dose. 3 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller is a consumer who was transferred by COVAX US Support; CEP 159558. Transfer agent states that the caller has received her first dose of the Pfizer COVID-19 vaccine and the next day her husband had COVID. She states that five days after receiving the vaccine the caller tested positive for COVID as well. The caller is now recovering. The caller is due to get her second dose on 9 AUG 2021 and is looking for guidance on receiving the second dose, and is she going to be immune to COVID, and does she need to start the process over again or is she fine with just getting the second dose? The caller states that her actual question is this, prior to 19 JUL 2021, Her husband went back to work, almost 99 percent sure that Wednesday he got exposed to someone at work, who had no symptoms. She states that the person was unvaccinated and her husband was unvaccinated. She states that her husband had a mask and the person had no mask. He believes that is the person who gave it to him because after he had a meeting with that person in his office., three hours later he heard that person coughing and he literally knew it was the bad news. From that point on everything that went on was text book. Five days later on 19 JUL 2021, we were all still good showed no symptoms what so ever, me, my daughter, and my husband. Her daughter and herself had an appointment to get the first shot of the Pfizer COVID-19 vaccine at 1 o'clock. That same day her husband went to work, he had a dentist appointment, he got home and was fine. She states that at 7 o'clock it hits him like a brick. He was not feeling good, he had a 101.7 fever, high blood pressure which he doesn't run , and the doctor told him to go to the emergency room. They did the rapid test which came back as negative but they also sent out a PCR and sent him home, by Tuesday morning the PCR test became positive for COVID. So they have been in quarantine since 20 JUL 2021. She states that her and her daughter and her husband have been separated and wear masks when they can because they thought that they had COVID. They were still treating each other to be safe but her husband had been locked in his bedroom since the 20 JUL 2021, he hasn't come out. She states that she and her daughter were fine, but states her daughter had a 99.2 pyretic little thing going on, and she is thinking oh great she has COVID even though she had no symptoms until Saturday 24 JUL 2021 it hit the caller that evening. She states she got a few symptoms nothing drastic. She states she got a cold pretty much. She states that today is the first day that she is fever free. She states that she can pretty much state that she will be fine in the next couple of days. She states she contacted her doctor and asked them what are they doing, and on 26 JUL 2021 he sent the caller and her daughter to do a PCR test. She says that her daughter has no symptoms, she doesn't have any fevers for three days now, her symptoms are not showing. She states that they did the PCR test and the callers came back as positive and hers came back as negative. How hers was negative she states she does not know, but what ever is happening with her she did not get COVID. So she is now separated in another room because she needs to protect her daughter because she is the only one who didn't get sick. So the doctor said to keep the 9 AUG 2021 appointment, the callers daughter should repeat the PCR test as close to the appointment as possible, if she is negative she can take the vaccine, and if she is positive call them and let them know and they will tell her what to do. The caller states that the doctor told her that she does not need to take another PCR test which she thought was strange, but the doctor said that she will be shedding the virus for the next three months and if you continue to do the PCR test it will continue to become positive even though you are no longer contagious but there are particles still there that will show up on the PCR test as positive. He told the caller if she is fever free for 24-48 hours and showing no symptoms then she can go an take the vaccine on 9 AUG 2021. She states that she knows people who have been treated with plasma and clonal cocktails they should wait three months before they take the vaccine. She states that she did not have any of that she got over it by her self. She states that someone in her family who had COVID after doing what she was told to do go the second dose of the vaccine and she was sick as a dog. She states that she is really worried it is going to happen to her. She states she needs advice, what does she do? Does she postpone for her and her daughter for another week? She states that her daughter needs to be vaccinated for college before 6 SEP 2021 and we need to make sure she is fully vaccinated with the two week time afterwards. What is your advise knowing what I am telling you. She states that you read me out of the paper but now she wants the agent to tell her without the paper as nurse, what you read is what I read. She doesn't want that. She states she wants a professional person to tell her. She states that she is assuming that she has already been exposed to COVID prior to taking the vaccine because her husband had that contact with that person in his office on Wednesday. He showed symptoms on Tuesday, could he already been exposed or not, she doesn't know. She states that the vaccine didn't do much to them except her daughter had a sore arm right away, and the caller had a sore arm the next day other than that they were fine, but now but with the second one I know you read that its not going to do anything but I do know that there are people who have been sick, how do I know for sure, and can Pfizer be stretched longer than the 28 days or 21 days like they do in Europe because she heard that even given 28 days apart because the longer it is given apart the longer the vaccine has a chance to start working. Rather than just doing it 21 days apart. Caller wants to know what is the recommendation about all of this. Caller states in her case what is the recommendation for her to do just to take it? She states that different doctors will give different information. Her husbands doctor tells her one thing and my doctor tells me another thing that is why she is calling the manufacturer the people who develop the vaccine, and she i

Other Meds:

Current Illness:

ID: 1645900
Sex: M
Age:
State:

Vax Date: 06/25/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a lot of pain in the joints, the shoulder and the neck; a lot of pain in the joints, the shoulder and the neck; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 57-year-old), via an unspecified route of administration on 25Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced a lot of pain in the joints, the shoulder and the neck. 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: Linked Report(s) : PFIZER INC-202100973686 Same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1645901
Sex: F
Age:
State: NV

Vax Date: 07/26/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: Her blood rushed up into her neck and her neck and face went numb/ She continues with stiffness and numbness in her neck/ It was numb up into her chest; shook and had been shaking for 5 hours after the vaccine; Her blood rushed up into her neck; Her blood rushed up into her neck and her neck and face went numb/ She continues with stiffness and numbness in her neck; the heat feeling resolved probably like a half hour later it started going away; The Emergency Room doctor didn't know, but he did diagnose her with an anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A 39-year-old female patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the right arm on 26Jul2021 at 20:00 (at the age of 39-years-old) (Batch/Lot Number: FA7485) single, for COVID-19 immunization. Medical history included a diagnosis of Prothrombin Factor II clotting disorder gene in 2009, ongoing (Prothrombin Factor II gene clotting disorder). The patient had no other vaccines administered on the same date as the Pfizer suspect vaccine and had no prior vaccinations (within 4 weeks). The patient's concomitant medications were not reported. The patient experienced 'anaphylactic reaction' in 2021, 'hypoaesthesia', 'tremor', 'sensation of blood flow', 'musculoskeletal stiffness' on 26Jul2021; and 'feeling hot' in Jul2021. It was reported that the patient received her first dose of the Pfizer Covid-19 Vaccine on 26Jul2021 and experienced a reaction. Her blood rushed up into her neck and her neck and face went numb. It was numb up into her chest and it felt like a rope was wrapped around her neck. She shook for 5 hours after the vaccine. She continued with stiffness and numbness in her neck. She was observed at the vaccine facility sitting for an hour and then was sent to the emergency room where she was given steroids; stated she still has the stiffness and numbness in her neck and was calling to see if she should take the 2nd dose of the vaccine or not. The pharmacist that did her vaccine advised her that he didn't think she should get the second dose. The events required a visit to the emergency rom. The Emergency Room doctor didn't know, but he did diagnose her with an anaphylactic reaction. Her Health Insurance nurse didn't recommend getting the second dose either. She will see her primary care physician the day after at 1PM in a follow-up. The patient further stated that it was like a rush of heat straight up her chest and neck and she started shaking and could not stop and her kids sat on her legs and she was shaking like crazy and then it happened right away. Also stated that they gave her the first dose of the Pfizer COVID vaccine and she thought that was the best shot. She didn't feel like anything and right away after a minute or a minute after she got the shot, the heat rushed up her neck and chest and a really numb feeling and it was still numb on the right side of her face but not where her face was but also on her neck and chest. Reported that she was still numb currently and her neck was stiff from that. According to her, the symptoms were the same and she did not have the rope feeling of it tying around her neck and did not feel like someone was choking her. Stated the heat felt resolved probably like a half hour later, it started going away and then she was super, super really numb and felt her neck lifted up and her neck was so tight. The shaking began a minute after the vaccine was administered and was not ongoing and resolved she knows for sure she had it for 5 hours and then like went to bed and did not know what time she woke up in the morning and she was not shaking anymore. They gave her three prednisone while she was in the emergency room and gave her Benadryl. She was also taking prednisone 50mg tablets and had one more day left of those and takes it once per day by mouth. Her patient vaccine card had no expiry date or NDC written on it. The patient had no relevant tests done. Outcome of the events 'anaphylactic reaction' and 'sensation of blood flow' was unknown; for 'hypoaesthesia' and 'musculoskeletal stiffness' was not recovered; while for 'tremor' and 'feeling hot' was recovered in Jul2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Prothrombin (Prothrombin Factor II gene clotting disorder)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am