VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1790961
Sex: M
Age:
State: NC

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: sudden, generalize, red, raised, itchy, splotchy rash from head to toe; This is a spontaneous report from a contactable nurse (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Sep2021 13:15 at the age of 51-years-old (Lot Number: 30130BA) as single dose for COVID-19 immunization. Medical history included Kidney stones, COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Right arm on 09Sep2021 08:00 PM at the age of 51-years-old (Lot Number: FL3182) for COVID-19 immunization. Concomitant medications included indapamide; potassium; influenza vaccine taken for immunization on 09Sep2021; tetanus vaccine taken for immunization on 09Sep2021. It was reported "Two hours following the shot, I developed a sudden, generalize, red, raised, itchy, splotchy rash from head to toe - most concentrated at wrists and hands, armpits, chest, lower back, waist, groin, knees, and ankles but scattered in between." Adverse event start date was 30Sep2021 14:00. No treatment was for AE. No Covid tested post vaccination. The outcome of event was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event rash and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: INDAPAMIDE; POTASSIUM

Current Illness:

ID: 1790962
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Glaucoma; Frog in Throat/ Lump feeling in throat; eye problems/ saw two figures instead of one when driving and watching television/ double vision; Started Leaking Liquid/ Wound secretion; Bruised Leg/ Bruising of leg; Arthritis; This is a solicited report based on the information received by Pfizer Mfr. Control No.: 21K-163-4087842-00). A contactable consumer (patient) reported that a 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced events of non-serious frog in throat/ lump feeling in throat, verge of glaucoma, eye problems/ saw two figures instead of one when driving and watching television/ double vision, Bruised Leg/ Bruising of leg/ Started Leaking Liquid/ Wound secretion and Arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter causality for bnt162b2 with events Lump feeling in throat, Glaucoma, Double vision, Wound secretion, Bruising of leg, Arthritis was possible. The action taken in response to the events for adalimumab was unknown.The outcome of the events Glaucoma and Wound secretion was unknown, other events was not recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: HUMIRA

Current Illness:

ID: 1790963
Sex: M
Age:
State: CA

Vax Date: 05/14/2021
Onset Date: 05/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: neurological work up; Result Unstructured Data: Test Result:blepharospasm- ataxia of the eyelids

Allergies:

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

Symptoms: blepharospasm- ataxia of the eyelids; apraxia of the eyelid; This is a spontaneous report from a contactable consumer (patient's father). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EWO185), via an unspecified route of administration on 14May2021 (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER8737), on 03Apr2021 (at the age of 17-year-old) as single dose for COVID-19 immunization. The reporter stated that 1 to 2 weeks after the second dose his son began having a side effect diagnosed as blepharospasm- ataxia of the eyelids in May2021. Both eye lids were involved. He stated that it had not gotten any better since it began at the end of May. He stated that his son (patient) had to physically hold his eyelids open with his hands or apply pressure or physical stimulation to the side of the area to cause the muscle to stop contracting. He recently had Botox injected to cause the muscles to relax and provide some relief but he stated that this was temporary. He stated that they had been back and forth to the doctor and he had had a neurological work up which provided so answers. He had seen an optical surgeon as well. The reporter stated he had gone through all the doctors and neurologists and no one could make sense of it. He stated that it was unmanageable. The patient started process a month ago to get labs and went through doctor, his eyes would close and if he pushed his knuckle to side of head it would trigger them to open. The reporter stated that when looking at the CDC website he saw there were around 400 reports of this occurring. He would like to know if there was any data on this or anything that may be related to helpful to his sons case. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1790964
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:103.8

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: temperature of 103.8/running low fever; body aches/pain all over; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 37-year-old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she got the Pfizer COVID 19 vaccine on Tuesday and ever since that evening, she had been running low fever and body aches. Now she had a temperature of 103.8. It had been two days since vaccine and stated she had had severe body aches, chills and pain all over. She was wondering if she should go to the hospital or should she continue to take Ibuprofen rotating with Tylenol. She was taking 1000mg of Tylenol and 800mg of ibuprofen, every 4 to 5 hours, clarifying it would help for only three hours maybe. The outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790965
Sex: F
Age:
State: IL

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
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: Shortly after she developed tingling sensation; This is a spontaneous report from a contactable consumer (mother/caregiver). A 38-years-old female patient (daughter) received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration in left arm on 30Sep2021 at 12:15 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Medical history included eye disorder and sinus disorder. Patient previously took Novocaine and experienced numbness and tingling (Shortly after she developed tingling sensation (similar to when Novocain wears off; like when you had novocaine, there's feeling of numbness). Concomitant medications were not reported. The patient previously received bnt162 (COMIRNATY, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On 30Sep2021, shortly after the administration of vaccine, the patient experienced tingling sensation under her left eye left sinus. It was reported that the tingling sensation (similar to when Novocain wears off; was like when you had novocaine, there's feeling of numbness) under her left eye left sinus after her second vaccine. Outcome of the event was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790966
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Thyroglobulin antibody; Result Unstructured Data: Test Result:3.4 IU/ml; Test Name: Thyroid peroxidase antibody; Result Unstructured Data: Test Result:less than 0.5 IU/ml; Test Name: Thyrotropin receptor antibody; Result Unstructured Data: Test Result:less than 1.10 IU/l; Test Name: Thyrotropin; Result Unstructured Data: Test Result:0.009 uiU/mL; Test Name: Thyrotropin; Result Unstructured Data: Test Result:less than 0.008 uiU/mL; Test Name: Temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: febrile; Test Name: Pulse; Result Unstructured Data: Test Result:137; Comments: beats/min; Test Name: Examination; Result Unstructured Data: Test Result:revealed right thyroid gland enlargement with diff; Comments: revealed right thyroid gland enlargement with diffuse tenderness, and no proptosis, lid lag, or periorbital edema; Test Name: Thyroid stimulating immunoglobulin; Result Unstructured Data: Test Result:less than 0.10 IU/l; Test Name: T4 total; Result Unstructured Data: Test Result:17.4 ug/dL; Test Name: thyroxine (T4) free; Result Unstructured Data: Test Result:2.6 ng/dL; Test Name: thyroxine (T4) free; Result Unstructured Data: Test Result:1.92 ng/dL; Test Name: Triiodothyronine; Result Unstructured Data: Test Result:137 ng/dL; Test Name: Thyroid ultrasound; Result Unstructured Data: Test Result:showed an asymmetrically enlarged hypervascular he; Comments: showed an asymmetrically enlarged hypervascular heterogeneous right thyroid lobe suggestive of thyroiditis

Allergies:

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

Symptoms: thyrotoxicosis; Thyroiditis; Myalgia; Fatigue; Nausea; Chills; new progressive anterior neck pain and swelling; new progressive anterior neck pain and swelling; This is a literature report entitled Letter to the Editor: Thyroiditis and Thyrotoxicosis After the SARS-CoV-2 mRNA Vaccine. The full publication has been requested. Rapid COVID-19 vaccine development and uptake are critical to mitigating the ongoing epidemic. Current vaccine candidates are at various stages of development and regulatory approval. These vaccines are broadly considered safe, though adverse effects have not yet been fully characterized. In this study we present the first description of thyroiditis linked to SARS-CoV-2 vaccination. A 57-year-old woman with no medical history received the first dose of the Pfizer-BioNTech SARS-CoV-2 vaccine 34 days before presentation, with associated fatigue, nausea, chills, and myalgias lasting 1.5 days. She received the second dose 13 days before presentation, and within 24 hours had recurrence of her symptoms associated with new progressive anterior neck pain and swelling. She was referred to the hospital by her outpatient provider for thyrotropin (TSH) 0.009 uU/mL, thyroxine (T4) free 2.6 ng/dL, and T4 total 17.4 mcg/dL (outpatient normal ranges [NRs] unavailable). On hospital arrival, she was febrile to 38.3 Centigrade with a pulse of 137 beats/min. Examination revealed right thyroid gland enlargement with diffuse tenderness, and no proptosis, lid lag, or periorbital edema. Laboratories showed TSH <0.008 uU/mL (NR: 0.4-4.2), free T4 1.92 ng/dL (NR: 0.8-1.5), triiodothyronine (T3) total 137 ng/dL (NR: 87-178) with thyrotropin receptor antibody <1.10 U/L (NR: 0-1.75), thyroid stimulating immunoglobulin <0.10 U/L (NR: 0-0.55), thyroid peroxidase antibody <0.5 U/mL (NR: 0-5.6), and thyroglobulin antibody 3.4 U/mL (NR: 0-4.1). Thyroid ultrasound showed an asymmetrically enlarged hypervascular heterogeneous right thyroid lobe suggestive of thyroiditis. She was treated with propranolol and ibuprofen and later started on prednisone as an outpatient.; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported event, 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: 1790967
Sex: F
Age:
State: CA

Vax Date: 09/10/2021
Onset Date: 09/23/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:additional elevated D-Dimer; Test Name: SARS-CoV-2, NAA; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: extreme sore throat; body on fire; flu symptoms; chest pain; heart rate was 140-150; D-Dimer was elevated/additional elevated D-Dimer (.69).; This is a spontaneous report from a contactable consumer. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: fc3184), via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Age at Vaccination 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. On 23Sep2021 15:00 the patient experienced extreme sore throat, body on fire, flu symptoms, chest pain, heart rate was 140-150 (heart rate increased), d-dimer was elevated/additional elevated d-dimer (.69). Therapeutic measures were taken as a result of extreme sore throat, body on fire, flu symptoms, chest pain, heart rate was 140-150, d-dimer was elevated/additional elevated d-dimer (.69) Patient received treatment for the event Liquid IV for one hour + Antibiotics. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The patient does not visit any healthcare professional or any emergency room. Device Date: 30Sep2021. The patient underwent lab tests and procedures which included blood test: additional elevated d-dimer he tested negative 2X , sars-cov-2 Nasal Swab antibody test negative: negative on unspecified date. The clinical outcome of the event was not recovered. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1790968
Sex: M
Age:
State: IN

Vax Date: 09/20/2021
Onset Date: 09/23/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: had weird suicidal thoughts; panic attack; brain fog; depression; anxiety; stress; This is a spontaneous report from a contactable consumer (patient). This 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FF2589) via an unspecified route of administration in the left arm on 20Sep2021 at 07:00 PM at age of 27 years old as single dose for COVID-19 immunization. Medical history was none. The patient had no Covid prior vaccination, no Covid tested post vaccination, no known allergies. Concomitant medications were unknown. No other vaccine in four weeks. The patient received the first Pfizer Vaccine dose on Monday, Three days later he experienced a panic attack. The patient had never had any anxiety or panic attacks before. He experienced 4 more attacks the next day. He had had brain fog ever since 23Sep2021 (7 days). He had had weird suicidal thoughts. Again, he had never experienced depression or anxiety before. He had read blogs of others having the same side effects from this vaccine. Adverse event start date and time were reported as 23Sep2021 07:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received. The patient was treated for stress with Hydroxyzine. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790969
Sex: F
Age:
State: TX

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: I ended up with shingles; it is herpes zoster; for over 5 months now; pains in my stomach; I have had pain like a electric shock, electric current going through my stomach; burning sensations and a tightness in my chest; on the right side of my body, front and back around my rib cage; burning sensations and a tightness in my chest; on the right side of my body, front and back around my rib cage; It started out with a rash around my ribs and a lot of pain; I had burning, pain, I had blisters; It started out with a rash around my ribs and a lot of pain; I had burning, pain, I had blisters; I am having a lot of itching; a rash around my ribs and a lot of pain; She cannot go to work, she cannot do anything.; pains in my stomach; I have had pain like a electric shock, electric current going through my stomach; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), Unspecified route of administration, on 15Apr2021 (at the age of 74-year-old) (Batch/Lot Number: ER8737) as dose 2, Single for COVID-19 immunization. No patient medical history was reported. No medical history of hypertension issues and diabetes. Concomitant medication included Vitamin B Complex, magnesium, acetylsalicylic acid (BABY ASPIRIN), acetylsalicylic acid (ASPIRIN 81), losartan pills. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), on 17Mar2021 (at the age of 74-year-old) (Batch/Lot Number: EN6207) as dose 1, Single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. She was not diagnosed had not had any blood work done. The patient had not received any other vaccine prior to vaccination. On an unknown date in Apr2021, she had a really bad reaction with Pfizer vaccine for the COVID. She ended up with herpes zoster or the shingles and she had it on Apr2021 and she had the shingles for over 5 months now. She was having hard time. She cannot go to work, she cannot do anything. On Apr2021, She mentioned that "Yes have had all source of pains in her stomach and then she have had pain like an electric shock, electric current going through her stomach. She have had burning sensations and a tightness around her, underneath her, in her chest. All of this was on the right side of her body, front and back around her rib cage." (She confirmed that these are the events experienced after shot). The patient mentioned that she have not had any blood work done. No investigation assessment was reported. The patient went to see her doctor and the urgent care center to confirm if she didn't know that she had a reaction of shingles. It started out with a rash around her ribs and a lot of pain. She had burning, pain, she had blisters and what else she had, and the doctor confirmed that it was shingles. she mentioned that she definitely need a follow up, she cannot get a booster shot if the CBC was saying that she would experience the similar reaction to the second Pfizer shot. She stated, she had a lot of itching. She had shingles before she know what she was talking about, shingles are very very painful. she cannot receive a shingle vaccine until she was completely well. She mentioned that Pfizer should provide awareness about people over the age of 60 getting the vaccine should get the shingle vaccine first before they get Covid-19 vaccine. She could have avoided this problem; she cannot go to work. She had concern, she stated, let her go ahead and report her problems to Pfizer. The reporter was informed to reach medical information department for further information of her concern. The outcome of events was unknown. Follow-up (11Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN B COMPLEX; MAGNESIUM; BABY ASPIRIN; LOSARTAN; ASPIRIN 81

Current Illness:

ID: 1790970
Sex: M
Age:
State: MA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result:99.7

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: entire body rash; itching; Chills; Nausea; Severe Headache; Fever 99.7; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301308A), via an unspecified route of administration in left arm on 28Sep2021 at 09:45 (at the age of 69-years-old) at dose 3 (booster), single for COVID-19 immunization. Medical history included penicillin allergy. He has no COVID prior to vaccination. Concomitant medications included vitamin B complex, ubidecarenone (COQ 10), omeprazole (PRILOSEC), fish oil, and ascorbic acid (VITAMIN C). The patient previously took aspirin and TYLENOL and experienced allergies. He also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy/ drug store. The patient was not tested for COVID post vaccination. On 28Sep2021 at 21:45, 12 hours after the booster dose, the patient experienced fever at 99.7 that lasted for 15 hours. He also experienced chills, nausea, and severe headache on 28Sep2021 at 22:00. On 29Sep2021 at 21:45, 36 hours after the shot, the patient experienced rash on his entire body and itching. He did not receive any treatment in response to the events. The outcome of the event "fever 99.7" was recovered on 29Sep2021 at 12:45 and recovering for all other events. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN B COMPLEX; COQ 10; PRILOSEC [OMEPRAZOLE]; FISH OIL; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1790971
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: episode of bell's palsy; This is a spontaneous case received from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), 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. On an unspecified date, the patient experienced Bell's palsy. The patient reported that her vaccine doses were finished in Jan2021 and after that was the first episode of Bell's palsy. She had a second episode in less than 7 months in August. The clinical outcome of the event 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) : US-PFIZER INC-202101295584 Same reporter/vaccine/event, different patient/COI

Other Meds:

Current Illness:

ID: 1790972
Sex: F
Age:
State: AZ

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 10/16/2021
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: labs; Result Unstructured Data: Test Result:Normal; Comments: look good. All normal but don't have COVID-19 antibodies for some reason

Allergies:

Symptom List: Rash, Urticaria

Symptoms: fatigue; have some weirdness; had trouble sleeping.; vagina is doing "spasms"; urinate I also have a little bit of poop.; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Batch/Lot Number: EL9767) as dose 1, single for covid-19 immunisation. Our family physician, dermatologist, gynecologist, and vulva specialist have all diagnosed this as lichen planus or a variation thereof. Here is thread with DR. 01Feb2021. Medical history included left leg muscle issues at night and Known allergies: penicillin. COVID prior vaccination. Concomitant medications included Lisinopril taken from 2011 (reported as for 10 Years). No other vaccine in four weeks. Labs of the patient look good. All normal but don't have COVID-19 antibodies for some reason. We'll assume your fatigue is from COVID-19 so give it some time and keep me updated. (No symptoms as of this date). The patient had some weirdness going on and have had trouble sleeping. vagina is doing "spasms" for hours on end, keeping the patient awake at night and driving crazy during the day. It has come and gone over the past 3 weeks but has been here for the past 2 days. The other odd thing is that every time the patient urinate the patient also have a little bit of poop. Like 4 times a day. Adverse events start date was 18Feb2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No COVID tested post vaccination. Ae treatment: 4 physicians 16 medications. Outcome of the events was not recovered.

Other Meds: LISINOPRIL

Current Illness:

ID: 1790973
Sex: F
Age:
State:

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: unknown tests; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: Fever; Flu like symptoms; could not sleep/insomnia probably gotten worse; could not get comfortable; inflamed; Abscess; infection in rear end area; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4002485-00). A contactable consumer (patient) reported a 63-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), second dose, intramuscularly on 23Mar2021 (Lot Number: EP6955; Expiration Date: 30Jun2021) at the age of 63 years old, as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneously from 2017 and ongoing, at 40 mg [(40 mg,1 in 2 wk) for moderate to severe adult crohn's disease. Medical history included insomnia from 1997, Crohn's disease from 1997, non smoker, abstains from alcohol, six surgeries in the same area, unknown medication for nausea allergy manifested by skin crawling and uncomfortable. The patient's concomitant medications were not reported. The patient previously took prednisone, She was on and off with the high dose of Prednisone for 15 to 18 years and it did not work anymore before she was put on Humira. The patent previous took BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), first dose, intramuscularly on 02Mar2021 (Lot Number: EP6198; Expiration Date: 30Jun2021) at the age of 63 years old, for covid-19 immunisation and experienced sore arm. In Mar2021, the patient experienced inflamed, abscess and infection in rear end area. These events inflamed, abscess and infection in rear end area were reported as serious with hospitalization and other medically important condition. On 28Mar2021, the patient experienced fever, flu like symptoms, could not sleep and could not get comfortable. On 29Mar2021, the fever, flu like symptoms, could not sleep and could not get comfortable resolved. In Apr2021, the inflamed, abscess and infection in rear end area resolved. The patient's insomnia probably gotten worse. On 28Mar2021, after the second dose of Covid 19 vaccine, the infection was really bad. On 29Mar2021, morning she went to the emergency room. She had a surgery to drain the abscess and two stents placed in the rear end of the rectum. It took two to three weeks for it to be healed and the stent locked already through a fistula. She was anesthetized for the surgery and had unknown tests. She mentioned that the combination of the second dose of Covid 19 vaccine and Humira shot caused her to get fever and flu like symptoms for a day and a half. Two days later, she ended up having the infection. The alternative etiology for the event of Infection in rear end area and inflamed was reported as abscess and infection. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was dose not changed. The patient was treated with Ambien. The outcome of the events inflamed, abscess and infection in rear end area was recovered in Apr2021, of the other events was recovered on 29Sep2021. The reporter's causality for the events of inflamed, abscess, infection in rear end area, fever, flu like symptoms, could not sleep and could not get comfortable with Humira 40MG/0.4ML (Adalimumab) was a reasonable possibility. The reporter's causality for the events of insomnia was not provided. Opinion is that there is no reasonable possibility that the events of inflamed, abscess, infection in rear end area, insomnia, fever, flu like symptoms, could not sleep, could not get comfortable and sore arm are related to Humira 40MG/0.4ML (Adalimumab). The reporter's causality for the events of inflamed, abscess, infection in rear end area, fever, flu like symptoms, could not sleep and could not get comfortable with BNT162b2 was probable. The reporter's causality for the events of insomnia was not provided. The reporter's assessment of the causal relationship of the event insomnia with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the events inflammation, abscess, localized inflammation, pyrexia, influenza like illness, insomnia, discomfort and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: HUMIRA

Current Illness:

ID: 1790974
Sex: F
Age:
State: MD

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

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

Lab Data: Test Name: Scheimfplug imaging left eye; Result Unstructured Data: Test Result:751; Comments: um (at the pupil center); Test Name: Scheimfplug imaging right eye; Result Unstructured Data: Test Result:788; Comments: um (at the pupil center); Test Name: intraocular pressure in the left eye; Result Unstructured Data: Test Result:9 mmHg; Test Name: intraocular pressure in the right eye; Result Unstructured Data: Test Result:8 mmHg; Test Name: Slit-lamp biomicroscopy; Result Unstructured Data: Test Result:revealed quiet conjunctiva and sclera but was sign; Comments: revealed quiet conjunctiva and sclera but was significant for thickened corneas with Descemet folds in both eyes. No keratic precipitates were present, and no anterior chamber cell was visible, although the view was limited through the cornea; Test Name: Slit-lamp examination; Result Unstructured Data: Test Result:revealed edema in the right cornea; Test Name: Central corneal thickness as measured by ultrasound; Result Unstructured Data: Test Result:825; Comments: um Central corneal thickness as measure by ultrasound; Test Name: Central corneal thickness as measured by ultrasound; Result Unstructured Data: Test Result:809; Comments: um Central corneal thickness as measure by ultrasound; Test Name: Uncorrected visual acuity; Result Unstructured Data: Test Result:20/70; Test Name: Uncorrected visual acuity; Result Unstructured Data: Test Result:20/40; Comments: By day 28; Test Name: visual acuity; Result Unstructured Data: Test Result:20/200; Comments: On day 11, in the right eye; Test Name: visual acuity; Result Unstructured Data: Test Result:20/40; Comments: On day 11, in the left eye; Test Name: visual acuity; Result Unstructured Data: Test Result:20/50; Comments: in the right eye; Test Name: visual acuity; Result Unstructured Data: Test Result:20/25; Comments: in the left eye; Test Name: visual acuity; Result Unstructured Data: Test Result:bilateral decreased; Test Name: visual acuity; Result Unstructured Data: Test Result:improved; Test Name: visual acuity; Result Unstructured Data: Test Result:20/150; Comments: By day 28, in the right eye; Test Name: visual acuity; Result Unstructured Data: Test Result:20/80; Comments: By day 28, in the left eye

Allergies:

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

Symptoms: corneal endothelial graft rejection; decrease in visual acuity in the right eye/By day 9, she noticed a decrease in the visual acuity in her left eye; By day 8 postadministration of the vaccine, her symptoms progressed to pain in the right eye; By day 8 postadministration of the vaccine, her symptoms progressed to photophobia in the right eye; the patient felt her driving was now limited by the decrease in vision in both eyes; mild arm soreness Owing to its rapid development, short-term and long-term effects of the COVID-19 vaccine are still not well understood. This case report highlights bilateral corneal endothelial graft rejection after administration of the Pfizer COVID-19 vaccine. A 73-year-old woman with bilateral Descemet stripping endothelial keratoplasty presented with bilateral decreased visual acuity, ocular pain, and photophobia after her second dose of the Pfizer-BioNTech COVID-19 vaccine. Two weeks after vaccine administration, the uncorrected visual acuity was 20/70 and 20/40. Central corneal thickness as measured by ultrasound was 809 and 825 um and by Scheimfplug imaging was 788 and 751 um at the pupil center. Slit lamp biomicroscopy revealed quiet conjunctiva and sclera but was significant for thickened corneas with Descemet folds in both eyes. The patient was instructed to use prednisolone acetate 1% every 1 to 2 hours with Muro ointment at bedtime. Follow-up (30Sep2021): This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. A 73-year-old woman presented with bilateral decreased visual acuity, ocular pain, and photophobia after her second dose of the Pfizer-BioNTech COVID-19 vaccine. The patient's first dose of the COVID-19 vaccine was similarly the Pfizer-BioNTech vaccine. She denied any known history of infection with SARS-CoV-2. Eight years before presentation, she underwent DSEK in both eyes for Fuchs dystrophy. Postoperatively, the patient followed a topical prednisolone taper that improved her visual acuity within the first year and resolved any postoperative corneal edema. There were no known episodes of rejection in the interim period, although 2 years ago she experienced burning and blurred vision that improved with TobraDex ointment three times a day. Both administrations of the Pfizer-BioNTech COVID-19 vaccine were unremarkable during injection, and the patient reported no immediate symptoms with either dose except for mild arm soreness. Four days after her second dose of the vaccine, she first noted a decrease in visual acuity in the right eye. By day 8 post administration of the vaccine, her symptoms progressed to pain and photophobia in the right eye. By day 9, she noticed a decrease in the visual acuity in her left eye. She initially presented to our practice on day 11 after the vaccine, at which point the visual acuity was 20/200 in the right eye and 20/40 in the left. Slit-lamp examination revealed edema in the right cornea. By day 13, the patient felt her driving was now limited by the decrease in vision in both eyes. Uncorrected visual acuity was 20/ 70 and 20/40, and intraocular pressure was 8- and 9-mm Hg in the right and left eyes, respectively. Central corneal thickness as measured by ultrasound was 809 and 825 mm and by Scheimfplug imaging was 788 and 751 mm at the pupil center. Slit lamp biomicroscopy revealed quiet conjunctiva and sclera but was significant for thickened corneas with Descemet folds in both eyes. No keratic precipitates were present, and no anterior chamber cell was visible, although the view was limited through the cornea. The patient was instructed to use prednisolone acetate 1% four times per day in both eyes for 1 month to address the edema. By day 28, the eyes had become more painful. The visual acuity was 20/150 in the right and 20/80 in the left. Both eyes had 1+ cell in the anterior chamber with mild folds. Prednisolone was increased to every 1 to 2 hours daily, and Muro ointment was added at bedtime. On day 36, the patient reported that her symptoms had greatly improved, although she continued to experience morning vision blurriness in her right eye. Steroid drop frequency was reduced to 4 times per day. Approximately 2 months after graft rejection, visually significant posterior capsular opacification was noted bilaterally (2+ right and 1+ left). The right cornea had areas of superficial punctate keratitis and edema with few folds, although the left cornea had markedly decreased edema. However, the visual acuity was improved bilaterally, with 20/50 in the right eye and 20/ 25 in the left eye. In this case report, the authors present a case of bilateral corneal endothelial rejection in a 73-year-old woman after she received the second dose of the Pfizer-BioNTech SARS-CoV-2 vaccine. Association with the vaccine is suggested by three factors: the temporal association with onset after vaccine administration, the progressive worsening during this time period, and the bilateral nature of the edema. Although the widespread distribution of vaccines implies that some independent cases of graft failure will appear around the same time that patients receive the vaccine, the bilateral nature of this case raises suspicion that a common cause likely precipitated the decline of the grafts, given how infrequently bilateral rejection occurs in practice. The patient in this case report underwent DSEK 8 years before vaccine administration, making the patient's grafts the longest standing to have experienced rejection after COVID-19 vaccine administration. Notably, the patient began to experience symptoms only 4 days after the second dose of the vaccine.; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported event 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: 1790975
Sex: F
Age:
State:

Vax Date: 05/15/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COVID-19; COVID-19; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from (Control No: 21K-163-4088938-00). A 38-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular on 15May2021 (at the age of 38-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 intramuscular on 20Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. HUMIRA, subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 (Drug ineffective) (medically significant) on an unspecified date in Sep2021 with. The action taken in response to the events for HUMIRA was unknown. Outcome of events was unknown. The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was reported as possible and causality of events with HUMIRA was not provided. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug Ineffective and Suspected COVID-19 and the suspect drug bnt162b2 .

Other Meds: HUMIRA

Current Illness:

ID: 1790976
Sex: M
Age:
State: OH

Vax Date: 09/23/2021
Onset Date: 09/24/2021
Rec V Date: 10/16/2021
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: 202109; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 20210924; Test Name: heart rate; Result Unstructured Data: Test Result:49 point increase; Test Date: 202109; Test Name: lab work; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: SOB; chest pain; vomited; tachycardia/ 49 point increase in heart rate; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Sep2021 (at the age of 15 years old) (Lot Number: FC3180) as dose 1, single for covid-19 immunisation. Medical history included autism, visceral hyperalgesia, and Tourette's syndrome from an unknown date and unknown if ongoing. Concomitant medications included guanfacine hydrochloride (TENEX); lamotrigine (LAMICTAL); magnesium; and sertraline hydrochloride (ZOLOFT); Probiotic; and Vitamins; all were taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took OMNICEF [cefdinir] and experienced drug hypersensitivity and flu vaccine VII and experienced allergy to vaccine. The patient experienced SOB, chest pain, vomited, and tachycardia/ 49 point increase in heart rate on 24Sep2021. SOB and chest pain getting out of shower 24Sep, then vomited. Woke with chest pain two nights in a row (morning of 27Sep, 28Sep), worsening. Normal EKG and lab work, but advised to push fluids and check pulse. Noticed tachycardia on standing. 49 point increase in heart rate from laying down to standing. Patient took betablocker (Propanolol) for his treatment received. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient underwent lab tests and procedures which included electrocardiogram: normal in Sep2021, heart rate: 49 point increase on 24Sep2021, lab work: normal in Sep2021. Treatment was received for the events included PRN Medication. The outcome of the events was not recovered.

Other Meds: TENEX; LAMICTAL; MAGNESIUM; ZOLOFT

Current Illness:

ID: 1790977
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date:
Rec V Date: 10/16/2021
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: Covid-19; COVID-19; Stress; Colitis ulcerative aggravated/ulcerative colitis flare ups; This is a solicited report based on information received by Pfizer (Manufacturer Control Number 21K-163-3988258-00). A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular at age of 63 years on 08Apr2021 (Batch/Lot number was not reported) as single dose, dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for Moderate to Severe ulcerative Colitis. Medical history was not reported. No Known Allergies. Concomitant medications were none. On unknown dates, the patient experienced Humira Completely Stopped Working, Covid-19 and Stressed. In 2021, the patient experienced ulcerative colitis flare ups/ colitis ulcerative aggravated. The events reported as non-serious and treated with prednisone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality as per reporter for colitis ulcerative aggravated with bnt162b2 was possible. The action taken in response to the events for adalimumab was permanently withdrawn on an unspecified date (as reported). The outcome of event colitis ulcerative aggravated was recovering, other events was unknown. The reporter's assessment of the causal relationship of the events (except Colitis ulcerative aggravated) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the events colitis ulcerative aggravated, stressed and the suspect drug BNT162B2 cannot be ruled out. The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out. 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: HUMIRA

Current Illness:

ID: 1790978
Sex: F
Age:
State: IL

Vax Date: 09/27/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: uric acid; Result Unstructured Data: Test Result:elevated

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in her neck, around the clavicle. It is tender to the touch and the inside feels soft around the whole big thing; She thinks it is probably a lymph node she is feeling inside. It is probably inflamed around it.; elevated uric acid; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 341458A, Expiration date not reported), via an unspecified route of administration, in left arm on 27Sep2021 14:45 (at the age of 65) as dose 3 (booster), single for COVID-19 immunization. Medical history included arthritis, was on supplement and had eye disorder, all from an unknown date and unknown if ongoing. Patient had no family history. Patient previously took flu shot and shingles shot, experienced body aches and low grade fever. Patient previously received first dose of bnt162b2 (Lot number: EJ1685) via an unspecified route of administration, administered in left arm on 22Dec2020 as dose 1, single, and second dose bnt162b2 (Lot number: EL1283) via an unspecified route of administration on 12Jan2021 as dose 2, single, both for COVID-19 immunization and experienced did not have a problem with the other 2 doses (dose 1 and dose 2). No prior vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS, once daily) taken for supplementation therapy, eye disorder, start and stop date were not reported; colecalciferol (D3, once daily) taken for supplementation therapy from an unspecified start date and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA], once daily) taken for supplementation therapy, start and stop date were not reported (all taken for a couple of years). On 29Sep2021, in the afternoon, the patient experienced lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node. She thought it was probably a lymph node she is feeling inside. It was probably inflamed around it. It was reported that, the lump was tender to the touch and the inside feels soft around the whole big thing. She did not think it is anything to worry about. She had no fever, and no shortness of breath. She did put a little ice on it for about 2 minutes. On an unknown date in 2021, patient experienced elevated uric acid. Events did not require a visit to Emergency Room and Physician Office. The patient underwent lab tests and procedures which included blood uric acid: elevated on an unknown date in 2021. The outcome of elevated uric acid was unknown, and the other events were not recovered. Follow-up attempts completed. No further information expected.

Other Meds: AREDS; D3; TURMERIC [CURCUMA LONGA]

Current Illness:

ID: 1790979
Sex: F
Age:
State: OH

Vax Date: 06/13/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital: Y

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: anaphylactic reaction; sore arm; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jun2021 (Lot Number: EW0217) at age of 61 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and arthritis and she take medication for both. She took inhaler for her arthritis. The patient took a flu shot every year but she did not take it this year. She is worried about the Flu vaccine now. She never had any bad reaction to the flu vaccine but only this one. After the first shot when the patient initially got the shot there was just normal reaction like sore arm and all that but nothing traumatic. Twelve hours later she experienced anaphylactic reaction and all those things described is what happened to her consumer thought she was dead. The patient had the anaphylactic reaction which sent her to the hospital for five days. The patient took the second shot of the Pfizer and she had the anaphylactic reaction to it really severely. She had exactly all the symptoms like fainting she had the fainting she fainted she passed out actually and she had a tongue swell. She had mental confusion. She had really bad breathing and she had impaired voice and her eyes rolled back in her head and she had a feeling of doom. The consumer had call the EMS and she was totally unaware what was going on for about two hours. Then she was in ambulance and then she came to and she was in hospital for five days and what they did they just said that her oxygen count was low and that was major come to the hospital at that time and then just right under three months she had the very same thing happened to her again. She was in the bathroom and she just passed out dead on the floor and she had all the symptoms you know the fast heart rate, tongue swelling, the eyes falling back into the head, mental confusion not aware what was going around did not know consumer was there didn't know EMS was there, breathing bad, feeling sub doom eyes falling back in her head, and impaired voice. She went to the hospital this time they said that she had a bacterial infection, and then they just gave her some antibiotics and send her home. She almost died twice from the shot. The first time they didn't gave her anything for treatment. The outcome was unknown. Follow-Up (04Oct2021) attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790980
Sex: F
Age:
State: TN

Vax Date: 03/15/2021
Onset Date: 03/19/2021
Rec V Date: 10/16/2021
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: pain; whole elbow pain; whole right arm had pain; losing sensation; I have lost use of my right arm where I was injected; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration in Arm Right on 15Mar2021 (at the age of 64-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications reported as unspecified. The patient stated she was having very difficult time in understanding you, is there somebody that, she can be able to speak with, she didn't need medical guidance, she needed to speak with someone regarding Pfizer vaccine side effect that she had, since she received Pfizer Covid19 vaccine. She had no questions, she needed to report side effect (very bad side effects) that she has already been diagnose by three doctors. Patient added she was not comfortable, it was that they were not able to communicate because she cannot understand what you are saying, so she needed anybody else to speak with. Patient stated she was not at this time although she received a Norfloxacin because of the pain for the side effect that she had, no, she just had whole elbow pain, her whole right arm had pain, she was losing sensation, it was very detailed and very, patient did not know how to describe it to you but basically she had lost use of her right arm (confirmed as anatomical site of administration), where she was injected. Start date of adverse events was 19Mar2021. Patient stated that she did not need for help unless she spoke with someone that can help her with the side effects and help in find that what she was able to deal with her right arm since the vaccine. Outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790981
Sex: F
Age:
State: FL

Vax Date: 08/25/2021
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Severe allergic reaction; Skin allergy: in the inside of her elbows where you bend your elbow on both arms she still has skin allergy; All her skin got allergic reaction like dermatitis; itchy; Her eyes got swollen; Face got very swollen; Coughing; Chills; Congested; Got like shortened in her breath, she couldn't breathe well; Extreme fatigue; Body feels so heavy; She is very active, she likes to go to the gym every day but she has not had the energy to do that; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC3182, Expiration date: unknown) via an unspecified route of administration, administered in right arm (right upper arm) on 25Aug2021 in the evening (age at vaccination was 43 years) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma from an unknown date (she had asthma as a kid, but that was all). The patient did not have any family history. The patient's concomitant medications were not reported. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Aug2021, the patient experienced severe allergic reaction, skin allergy: in the inside of her elbows where you bend your elbow on both arms she still had skin allergy, all her skin got allergic reaction like dermatitis, itchy, her eyes got swollen and face got very swollen. Severe allergic reaction onset time was unknown other than in the evening. She further described as she got all her skin got allergic reaction like dermatitis and it was itchy. Her eyes got swollen, face got very swollen. This allergic reaction lasted for 2-3 weeks in the skin and her eyes. She had lasting effects of skin allergy. Skin allergy in the inside of her elbows where you bend your elbow on both arms she still had skin allergy that was persistent that had been ongoing since the night of 25Aug2021. On an unspecified date in Aug2021, the patient experienced the symptoms which she clarified as being coughing, chills, congested, got like shortened in her breath, she couldn't breathe well. Those symptoms lasted like 3-4 days. Initially she reported time and date of onset as the night of 25Aug2021, but then clarified that onset was not 25Aug2021, the other 2 days after the Pfizer Covid Vaccine, when the physical symptoms started, but then she clarified that onset was not 27Aug2021, that it was the other day, the second day everything got worse, she was unable to clarify specific date or time of onset further. On an unspecified date in Aug2021, she just had this extreme fatigue after the Pfizer COVID Shot vaccination that she hasn't recovered from it. Her body felt so heavy, she hasn't recovered since the Pfizer COVID Shot vaccination. She was very active, she liked to go to the gym every day but she has not had the energy to do that since having the Pfizer COVID Shot. She had not recovered completely, but whether improved, worsened or persisting was unknown. She could not herself take any vaccination, she could not get additional doses of the product. They were mandating her to get the product but she couldn't, it was not going into her body. The patient asked for information regarding these events and recommendations. She needed information to verify that she cannot have any more doses. The patient was not hospitalized. The adverse event did not require a visit to Emergency Room or Physician Office. She didn't know it was necessary because she thought would recover but now they were pushing her to have the second shot and she thought she needed to see the doctor so she made an appointment for that date. No relevant tests were done. The outcome of events severe allergic reaction, all her skin got allergic reaction like dermatitis, itchy, her eyes got swollen and face got very swollen was resolved with sequel on an unspecified date in Sep2021. The outcome of events coughing, chills, congested and got like shortened in her breath, she couldn't breathe well were resolved on an unspecified date in 2021. The outcome of the events body feels so heavy, extreme fatigue, skin allergy: in the inside of her elbows where you bend your elbow on both arms she still has skin allergy and she is very active, she likes to go to the gym every day but she has not had the energy to do that was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790982
Sex: F
Age:
State: MA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
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: vision got a little fuzzy; heart started racing really fast; breathing fast; anxiety; metallic taste in my mouth; tongue felt a little funny; tired; severe dry mouth; soreness/pain in my joints; soreness/pain in fingers; soreness/pain in neck; soreness/pain in back; soreness/pain in whole body; feeling chilly; inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Sep2021 (at the of 44 years old) (Batch/Lot Number: Ff8841) as dose 1, single for covid-19 immunisation. Medical history included neutropenia, plaquepsoriasis, and endometriosis from an unknown date and unknown if ongoing, covid-19 from Feb2021 to an unknown date. The patient was not pregnant at time of vaccination. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced vision got a little fuzzy, heart started racing really fast, breathing fast, anxiety, metallic taste in mouth, tongue felt a little funny, tired, severe dry mouth, soreness/pain in joints, soreness/pain in joints, fingers, neck, back, whole body, feeling chilly, and inflammation on 29Sep2021. Within mins of dose, patient's vision got a little fuzzy but quickly resolved and heart started racing really fast. She was also breathing fast. About 5-10 mins it got better. She was not sure if it was anxiety or related to the medication. She was calm during injection so it was strange this happened. She also had a metallic taste in her mouth and her tongue felt a little funny. She was tired for the rest of the day. Overnight she woke up with severe dry mouth which has never happened to her. She soreness/pain in her joints, her fingers, neck, back, her whole body. She was feeling chilly but no fever as of now. She had Covid in Feb2021 and felt the same inflammation, pain/soreness in her body but not as severe. Since the vaccination, the patient has not yet been tested for COVID-19. The events were reported as non-serious. No treatment was received for the events. The outcome of a little fuzzy, heart started racing really fast, breathing fast, and anxiety was recovered in Sep2021 while the rest of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790983
Sex: F
Age:
State: OH

Vax Date: 07/13/2021
Onset Date:
Rec V Date: 10/16/2021
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 Name: Height; Result Unstructured Data: Test Result:5(feet) 6 (inches); Test Name: heart rate; Result Unstructured Data: Test Result:fast; Test Name: oxygen count; Result Unstructured Data: Test Result:Low; Test Name: weight; Result Unstructured Data: Test Result:like 180 (pounds)

Allergies:

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

Symptoms: Anaphylactic reaction; she fainted; passed out; she almost died twice; tongue swell; Mental confusion; She had really bad breathing; she had impaired voice; her eyes rolled back in her head; eyes falling back into the head; she had a feeling of doom; her oxygen count was low; she is on oxygen 24/7; fast heart rate; Bacterial infection; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient (5(feet) 6 (inches) like 180 (pounds)) received bnt162b2 (BNT162B2 Lot Number: EW0217) via an unspecified route of administration, administered in Arm Right on 13Jul2021 (at 61-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma and arthritis and she take medication for both (further clarification unknown). She took inhaler for her arthritis. The patient previously received the first single dose of bnt162b2 (Lot# EW0217) on 13Jun2021 for covid-19 immunisation and had sore arm then 12 hours later she had the anaphylactic reaction which sent her to the hospital for five days. The patient received a flu shot every year but she did not take it this year. She is worried about the Flu vaccine now. She never had any bad reaction to the flu vaccine but only this one. The consumer reported that his wife got reaction to the COVID vaccine. The patient took the second shot of the Pfizer and she had the anaphylactic reaction to it really severely. She had exactly all the symptoms like fainting she had the fainting she fainted she passed out actually and she had a tongue swell. She had mental confusion. She had really bad breathing and she had impaired voice and her eyes rolled back in her head and she had a feeling of doom. The consumer had called the EMS and she was totally unaware what was going on for about two hours then she was in ambulance and then she came to and she was in hospital for five days and what they did they just said that her oxygen count was low and that was major come to the hospital at that time and then just right under three months she had the very same thing happened to her again. She was in the bathroom and she just passed out dead on the floor and she had all the symptoms you know the fast heart rate, tongue swelling and the eyes falling back into the head, mental confusion not aware what was going around did not know consumer was there didn't know EMS was there breathing bad, feeling sub doom, impaired voice so she went to the hospital this time they said that she had a bacterial infection which the consumer didn't know how that could be and then they just gave her some antibiotics for weaker cells and send her home. So the consumer just want to report that on your website it's said that out of two million people that only 21 had the anaphylactic reaction. So he just want to let your company know that now it's 22. The patient almost died twice from the shot. What is so funny about this whole thing is that after the first time when she came home that was five days she just normal like herself and the second time when exact same thing turned in the reporter thought she was dead, again she came home and she just like nothing happened like fine it could be but he was worried about if this happen twice it could happen again. The reporter knew totally 100 percent from the vaccine because she didn't have any reaction she didn't have any problem like this before she took the and now vaccine she almost died twice in three month common this is not alright and he think it was from the vaccine so. The outcome of the events was unknown. Follow-Up (05Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790984
Sex: M
Age:
State: FL

Vax Date: 08/19/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Guillain-Barre Syndrome; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient (Height: 183 cm, Weight: 300 pounds) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: FC3181) via an unspecified route of administration, administered in Arm Left on 19Aug2021 (at 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated that he developed guillain-barre syndrome two weeks after the first vaccine (hospitalization) on 01Sep2021. The patient was hospitalized from 02Sep2021 to 07Sep2021. Caller clarifies that he was admitted to the hospital and then discharged to a Rehabilitation Facility. Caller states he was readmitted to the hospital briefly on 12Sep2021, and then released back to the Rehabilitation Facility on 13Sep2021. Caller took first vaccine on 19Aug2021, and has not taken second vaccine. Caller states that the symptoms initially worsened and now that he is in a Rehabilitation Facility, the symptoms are getting better. The outcome of the event was recovering. Follow-Up (04Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790985
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: received two doses of the Pfizer COVID vaccine and ended up getting COVID; received two doses of the Pfizer COVID vaccine and ended up getting COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included immunocompromised, arthritic condition. The patient's concomitant medications were not reported. Consumer mentioned her friend who was immunocompromised had received two doses of the Pfizer COVID vaccine and ended up getting COVID. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790986
Sex: M
Age:
State: PA

Vax Date: 02/26/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: 202109; Test Name: Covid test; Test Result: Positive.

Allergies:

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

Symptoms: Had the delta-variant; Had the delta-variant; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for three patients. This is the second of three reports. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm on 05Feb2021 (at the age of 76-year-old, Lot number: EL9269) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 26Feb2021 (Lot number: EL9266) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing diabetic. Prior vaccinations (within 4 weeks) and additional vaccines administered on same date of the Pfizer suspect were none. Concomitant medication included ongoing metformin for diabetic. The patient had the delta-variant in Sep2021. Patient had both doses of the Pfizer-Covid 19 Vaccine. However, he had the delta-variant. He had the same symptoms as the reporting consumer 2-3 days after she did. The reporting consumer explained she started to have covid symptoms on 08Sep2021. She had a stuffy nose, stuffy ears, slight fever, drainage, and sore throat. At first she thought it was just sinus issues, but her covid test had come back positive. She had tiredness, loose stools, headache, stuffiness, stuffiness in nose and ears really bad. She was assuming she had the delta variant. She explained her husband, the patient, had these same symptoms. Patient started to experience these events 2-3 days after she did. Events did not require a visit to emergency room or physician office, but had a tele-medicine appointment. Lab data included Covid test was positive in Sep2021. Outcome of events was unknown. This report was assessed by the reporting consumer as non-serious. Follow-up attempts are completed. No further information is expected. Linked Report(s): US-PFIZER INC-202101294617 same reporter/drug/AE, different patient; US-PFIZER INC-202101299154 same reporter/drug/AE, different patient.

Other Meds: METFORMIN

Current Illness: Diabetic

ID: 1790987
Sex: F
Age:
State: PA

Vax Date: 02/26/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: 202109; Test Name: Covid test; Test Result: Positive ; Comments: delta-variant

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Had the delta-variant; Had the delta-variant; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A 69-year-old female patient (reporter's sister) received the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at left arm on 26Feb2021 (Lot Number: EL9266) at the age of 68 years as single dose and dose 1 via an unspecified route of administration at left arm on 05Feb2021 (Lot Number: EL9269) at the age of 68 years as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer explained her sister (patient) who also got the Covid-19 vaccine the same days she did have the same symptoms she did. Her sister (patient) had the delta-variant from Sep2021. Consumer started to have covid symptoms on 08Sep2021 she had a stuffy nose, stuffy ears, slight fever, drainage, and sore throat. At first she thought it was just sinus issues, but the covid test had come back positive. She had tiredness, loose stools, headache, stuffiness, stuffiness in nose and ears really bad. Her twin sister (patient) had all these covid symptoms along with a lost of taste. Outcome of events were unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294617 same reporter/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1790988
Sex: M
Age:
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: This is a spontaneous report from a contactable consumer. A 66-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (vaccinated at 66-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cataracts. Patient received first dose on an unspecified date. The patient's concomitant medications were not reported. The patient experienced cataracts got worse after second dose. Unknown if treatment received. The outcome of 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: 1790989
Sex: M
Age:
State: NY

Vax Date: 04/23/2021
Onset Date: 04/26/2021
Rec V Date: 10/16/2021
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: This is a spontaneous report from a contactable consumer (patient). This consumer reported for two patients. This is the first of two reports. A 55-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0170), at the age of 55, via an unspecified route of administration, in right arm, on Apr 23, 2021, at 15:45, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine , solution for injection, batch/lot# EW8377), at the age of 55, in right arm, on Apr 2, 2021, 16:00, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had erectile dysfunction on Apr 26, 2021, at 08:00, with outcome of not recovered. Patient never had an issue like this ever in his life. Patient was physically fit, in great health, and do not smoke or drink. This also happened to his son 2-3 days after receiving his second Pfizer shot. This was not a mental issue or coincidence. It was a physical issue, and would be nice if someone in would start investigating what the vaccine did. This was causing extreme mental distress for his family. It has been 4 months and it is not resolved. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event: not recovered. No treatment used for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts needed. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202101300543 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1790990
Sex: M
Age:
State: NY

Vax Date: 06/01/2021
Onset Date: 06/03/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Erectile dysfunction and very low libido. My father is experiencing the exact same problem after his 2nd Pfizer shot. I am 19, in great physical shape, work out every day, in perfect health. This i; extreme depression.; very low libido.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 01Jun2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no previous COVID-19 prior to vaccination and not COVID-19 tested post vaccination. The patient received the first dose of bnt162b2 on 11May2021 16:00 in the right arm for COVID-19 immunization. The patient reported of Erectile dysfunction and very low libido on 03Jun2021, 08:00 AM. The patient added that: "My father is experiencing the exact same problem after his 2nd Pfizer shot. I am 19, in great physical shape, work out every day, in perfect health. This issue has been ongoing for 4 months now and is causing extreme depression (as reported). Please start investigating what the vaccine is doing to cause this. I keep hearing that the vaccine doesn't cause ED, but it did for both me and my father. This is not being caused by any mental duress. It is a physical problem. " Treatment includes Viagra, Cialis (both did not work). The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790991
Sex: U
Age:
State:

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

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

Lab Data: Test Name: allergy testing; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Injection site pain

Symptoms: symptoms consistent with anaphylaxis; This is a literature report. A health-care system experience. The full publication has been requested. This author reported different events for five patients. This is the first of five reports. A subject of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. The subject experienced symptoms consistent with anaphylaxis on an unspecified date with outcome of unknown. The subject underwent lab tests and procedures which included allergy test with unknown results. Background: Adverse reactions, including anaphylaxis, to messenger RNA coronavirus disease 2019 (COVID-19) vaccines rarely occur. Because of the need to administer a timely second dose in subjects who reported a reaction to their first dose, a panel of health-care professionals developed a safe triage of the employees and health care providers (EHCP) at a large health-care system to consider administration of future dosing. Methods: There were 28,544 EHCPs who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The HCPs self-reported adverse reactions to a regulatory authority. A regulatory authority screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to a regulatory authority, 113 were identified as requiring consideration by a panel of three-certified allergists for future dosing or formal in-person assessment. Of the 113 EHCPs, 94 (83.2%) were recommended to get their second dose. Eighty of 94 received their second planned dose without a severe or immediate reaction. Of the 14 of 113 identified as needing further evaluation, 6 were evaluated by a physician and subsequently received their second dose without a serious adverse reaction. Eight of 14 did not receive their second dose. Only 5 of the 113 HCPs reported reactions (4.4%) were recommended to not take the second dose: 3 (2.6%) because of symptoms consistent with anaphylaxis, and 2 because of neurologic complications (seizure, stroke). Conclusion: The panel demonstrated that, by consideration of reaction history alone, the HCPs could be appropriately triaged to receive scheduled second dosing of COVID-19 vaccines without delays for in-person evaluation and allergy testing.; Sender's Comments: A contributory role of BNT162B2 in triggering the onset of Anaphylaxis cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine,Linked Report(s) : US-PFIZER INC-202101300161 Same article/drug; Different patient/event;US-PFIZER INC-202101300162 Same article/drug; Different patient/event;US-PFIZER INC-202101301646 Same article/drug/event; Different patient;US-PFIZER INC-202101301645 Same article/drug/event; Different patient

Other Meds:

Current Illness:

ID: 1790992
Sex: F
Age:
State: TX

Vax Date: 09/17/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: neurological test; Result Unstructured Data: Test Result:Unknown Results

Allergies:

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

Symptoms: She was like having mini stroke; her left jaw was tighten up where could not sleep; her left jaw was tighten up where could not sleep; left lymph node was swollen; the left side of my tongue was numb; had burning feeling in back of head; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received bnt162b2 (BNT162B2), vaccinated at the same age, via an unspecified route of administration, administered in left arm on 17Sep2021 (Batch/Lot Number: 301130BA) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Relevant medical history included lymphedema, vitamin b1 deficiency (take Vitamin B for low deficiency). Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for lymphoedema; vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]) taken for low deficiency; anastrozole (ANASTROL). On an unspecified date, patient got the shot on the left side, her left jaw was tighten up where could not sleep, her left lymph node was swollen, the left side of tongue was numb. She was like having mini stroke and then had burning feeling in back of head like its burning in the middle of head. Patient received lab test at the hospital since Monday (unspecified date) due to neurological issues with unknown results (Further not clarified). The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: HYDROCHLOROTHIAZIDE; VITAMIN B [VITAMIN B NOS]; ANASTROL

Current Illness:

ID: 1790993
Sex: U
Age:
State:

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

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

Lab Data: Test Name: allergy testing; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: 2 because of neurologic complications (seizure, stroke).; This is a literature report from the Allergy & Asthma Proceedings, 2021, vol 42(5); pp 395-399 (DOI: 10.2500/aap.2021.42.210069) entitled Allergic reactions and adverse events associated with administration of mRNA-based vaccines. A health-care system experience. The full publication has been requested. This author reported different events for five patients. This is the second of five reports. A subject of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. The subject experienced seizure on an unspecified date with outcome of unknown. The subject underwent lab tests and procedures which included allergy test with unknown results. Background: Adverse reactions, including anaphylaxis, to messenger RNA coronavirus disease 2019 (COVID-19) vaccines rarely occur. Because of the need to administer a timely second dose in subjects who reported a reaction to their first dose, a panel of health-care professionals developed a safe triage of the employees and health care providers (EHCP) at a large health-care system to consider administration of future dosing. Methods: There were 28,544 EHCPs who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The EHCPs self-reported adverse reactions to a centralized COVID-19 command center (CCC). The CCC screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to the CCC, 113 were identified as requiring consideration by a panel of three (American Board of Allergy and Immunology) ABAI-certified allergists for future dosing or formal in-person assessment. Of the 113 EHCPs, 94 (83.2%) were recommended to get their second dose. Eighty of 94 received their second planned dose without a severe or immediate reaction. Of the 14 of 113 identified as needing further evaluation, 6 were evaluated by a physician and subsequently received their second dose without a serious adverse reaction. Eight of 14 did not receive their second dose. Only 5 of the 113 EHCPs reported reactions (4.4%) were recommended to not take the second dose: 3 (2.6%) because of symptoms consistent with anaphylaxis, and 2 because of neurologic complications (seizure, stroke). Conclusion: The panel demonstrated that, by consideration of reaction history alone, the ECHPs could be appropriately triaged to receive scheduled second dosing of COVID-19 vaccines without delays for in-person evaluation and allergy testing.; Sender's Comments: A contributory role of BNT162B2 in triggering the onset of seizure might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101300055 Same article/drug; Different patient/event

Other Meds:

Current Illness:

ID: 1790994
Sex: U
Age:
State:

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

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

Lab Data: Test Name: allergy testing; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Tremor

Symptoms: 2 because of neurologic complications (seizure, stroke); This is a literature report. A health-care system experience. The full publication has been requested. This author reported different events for five patients. This is the third of five reports. A subject of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. The subject experienced stroke on an unspecified date with outcome of unknown. The subject underwent lab tests and procedures which included allergy test with unknown results. Background: Adverse reactions, including anaphylaxis, to messenger RNA coronavirus disease 2019 (COVID-19) vaccines rarely occur. Because of the need to administer a timely second dose in subjects who reported a reaction to their first dose, a panel of health-care professionals developed a safe triage of the employees and health care providers (HCP) at a large health-care system to consider administration of future dosing. Methods: There were 28,544 HCPs who received their first dose of COVID-19 vaccines between December 15, 2020, and March 8, 2021. The HCPs self-reported adverse reactions to a regulatory authority. A regulatory authority screened and collected information on the quality of reaction, symptoms, and timing of the onset of the reaction. Results: Of 1253 calls to a regulatory authority, 113 were identified as requiring consideration by a panel of three-certified allergists for future dosing or formal in-person assessment. Of the 113 EHCPs, 94 (83.2%) were recommended to get their second dose. Eighty of 94 received their second planned dose without a severe or immediate reaction. Of the 14 of 113 identified as needing further evaluation, 6 were evaluated by a physician and subsequently received their second dose without a serious adverse reaction. Eight of 14 did not receive their second dose. Only 5 of the 113 EHCPs reported reactions (4.4%) were recommended to not take the second dose: 3 (2.6%) because of symptoms consistent with anaphylaxis, and 2 because of neurologic complications (seizure, stroke). Conclusion: The panel demonstrated that, by consideration of reaction history alone, the ECHPs could be appropriately triaged to receive scheduled second dosing of COVID-19 vaccines without delays for in-person evaluation and allergy testing.; Sender's Comments: A contributory role of BNT162B2 in triggering the onset of the neurological complication presented as stroke might not be fully excluded, considering the plausible temporal relationship. More information such as medical history and demographic data are needed for fully meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101300055 Same article/drug; Different patient/event

Other Meds:

Current Illness:

ID: 1790995
Sex: M
Age:
State: FL

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Moderna shot on February 5th. Because we had 4 weeks of travel planned we got a Pfizer shot on September 1st; Moderna shot on February 5th. Because we had 4 weeks of travel planned we got a Pfizer shot on September 1st; Small reaction; This is a spontaneous report from a contactable consumer. A contactable male consumer (patient) reported for himself that who received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 (Lot number and expiry date was not reported) via an unspecified route of administration on 01Sep2021 as dose 3 booster single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine dose 1 Moderna formulation solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunisation, historical Vaccine dose 2 formulation solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration on 05Feb2021 as second dose single dose for COVID-19 immunisation. His wife and he received our 2nd Moderna shot on 05Feb. Because they had 4 weeks of travel planned, we got a Pfizer shot on 01Sep. They had very small reaction. He feels that the mixture may give more immunity, (Interchange of vaccine products, Off label use). Outcome of the events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101300168 Different patient, same drug and event

Other Meds:

Current Illness:

ID: 1790996
Sex: F
Age:
State: FL

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: we got a Pfizer shot on 01Sep. We had very small reaction; received our 2nd Moderna shot on 05Feb. Because we had 4 weeks of travel planned we got a Pfizer shot on 01Sep; received our 2nd Moderna shot on 05Feb. Because we had 4 weeks of travel planned we got a Pfizer shot on 01Sep; This is a spontaneous report from a contactable consumer reporter for wife via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), third dose via an unspecified route of administration on 01Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was MODERNA (MODERNA COVID-19 VACCINE Batch/Lot number was not reported), second dose via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunization; MODERNA (MODERNA COVID-19 VACCINE Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient's wife and patient received their 2nd Moderna shot on 05Feb2021. Because they had 4 weeks of travel planned, they got a Pfizer shot on 01Sep2021. They had very small reaction. The patient feels that the mixture may give more immunity. The outcome of adverse event NOS was reported as unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101300166 Different patient, same drug and event

Other Meds:

Current Illness:

ID: 1790997
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Erectile dysfunction; very low libido; This is a spontaneous report from a contactable consumer (patient's son). The consumer reported similar events for two patients. This is the second of two reports. A male patient of unspecified age received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced erectile dysfunction and very low libido on an unspecified date. He was experiencing the exact same problem after his 2nd Pfizer shot. The outcome of the events was unknown. Information about the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101299845 Same reporter/vaccine, similar events, different patient

Other Meds:

Current Illness:

ID: 1790998
Sex: F
Age:
State:

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

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

Lab Data: Test Name: COVID-19 Test; Test Result: Positive.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: had the 2 doses of the vaccine/tested positive; had the 2 doses of the vaccine/tested positive; This is a spontaneous report from a Program from a Non-contactable Female consumer (patient). A female patient of unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via Unspecified route of administration, on unspecified date (Batch/Lot Number: Not provided) as dose 2, Single and first dose of (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via Unspecified route of administration, on unspecified date (Batch/Lot Number: Not provided) as dose 1, Single for COVID-19 immunization. Reporter, had the 2 doses of the vaccine, she is wondering about the booster shot. Her friend also had the 1st 2 doses and was tested positive, also tested positive. Would like to ask if she got the booster shot, would it be different from the 1st doses, and how soon can she get it. She asked if the booster is the same medication as the first 2 doses. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790999
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Tested positive; Test Result: Positive.

Allergies:

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

Symptoms: Her friend also had the 1st 2 doses and was tested positive; Her friend also had the 1st 2 doses and was tested positive; This is a spontaneous report from a non-contactable consumer or other non hcp via a program. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date a consumer friend experienced that friend also had the 1st 2 doses and was tested positive. She wanted to know ask if she got the booster shot, would it be different from the 1st doses, and how soon can she get it. Consumer asked In the original statement the protection of the vaccine was for at least 6 months, asked if it was true, and asked if the booster was the same medication as the first 2 doses. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The outcome of 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: 1791000
Sex: M
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 04/26/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Erectile dysfunction; This is a spontaneous report from a contactable consumer (parent). This consumer reported for two patients. This is the second of the two reports. A 19-year-old male patient received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced erectile dysfunction on 26Apr2021 08:00 (2-3 days after receiving his second Pfizer shot). This caused extreme mental distress for his family and it has been 4 months and it was not resolved. Had a doctor or other healthcare professional office/clinic visit and no treatment for event. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101299769 Same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1791001
Sex: U
Age:
State:

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

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

Lab Data: Test Name: tested positive; Test Result: Positive.

Allergies:

Symptom List: Pain in extremity

Symptoms: tested positive; tested positive; This is a spontaneous report from a Program from a non-contactable consumer, reported similar events for two patients. This is the first of two reports. A patient (consumer) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's friend was tested positive even after having the 2 doses of the vaccine. Patient was just calling to ask about the booster shot if it was the same as the 1st 2 doses as patient was also tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unspecified date. Outcome of events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101300598 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1791002
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Tested positive; Test Result: Positive.

Allergies:

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

Symptoms: had mentioned that her friend was tested positive even after having the 2 doses of the vaccine.; had mentioned that her friend was tested positive even after having the 2 doses of the vaccine.; This is a spontaneous report from a Program. A non-contactable consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer had mentioned that her friend (patient) was tested positive even after having the 2 doses of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unspecified date. Outcome of events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101300582 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1791003
Sex: F
Age:
State: AK

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: I did have reaction that wasn''t so pleasant; make me little concern; It was more extreme than panic attack; I couldn''t for a second bare what I looked out; when I looked basically all I thought was white.; I felt sick; where I was gonna throw up twice; and then I thought I was gonna passed out and faint.; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 31-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 30155BA; Expiration Date: 31Dec2021), via an unspecified route of administration, administered in right deltoid on an unspecified date (at the age of 31-years) as dose 1, single for covid-19 immunization. The patient medical history included Psoriatic arthritis. The patient's concomitant medications were not reported. On an unspecified date after vaccination, the patient stated that she had a reaction that was not so pleasant and did make her little concerned. The patient also stated that was more extreme than panic attack and she could not for a second bare what she looked out and when she looked basically all she thought was white. The patient also felt sick, was going to throw up twice and also was then going to pass out and faint. The patient queried if that happened to anyone else and why was that happening to her. Also stated that seeing white for a good two minutes had cured and was enquiring whether she had to visit emergency room as she was feeling fine that time. The patient had not received any treatment for the events. The outcome of the events was recovered on an unspecified date at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1791004
Sex: U
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
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: 2021; Test Name: Pneumonia; Test Result: Positive ; Test Date: 2021; Test Name: Covid-19 Test; Test Result: Positive

Allergies:

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

Symptoms: one month and 4 weeks after the second shot i contracted covid and pneumonia; pneumonia; one month and 4 weeks after the second shot i contracted covid and pneumonia; This is a spontaneous report from a contactable consumer (patient) from epsilon escalation team. A patient of unspecified age and gender received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Mar2021 ad dose 1 single and second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Aug2021 (one month and 4 weeks after the second shot), patient contracted covid and pneumonia and patient wondering how it is that this happened in such a short time after the vaccinations. Patient still on oxygen. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1791005
Sex: F
Age:
State: OH

Vax Date: 09/26/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: received her booster shot of the covid-19 vaccine; received her booster shot of the covid-19 vaccine; injured on her foot; This is a spontaneous report from a contactable consumer (patient) from the Pfizer sponsored program. A female patient of an unknown age received 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Sep2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. She received her booster shot of the covid-19 vaccine on 26Sep2021. She got injured on her foot on an unknown date in Sep2021 and her doctor put her on a 6-day regimen for Prednisone. 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: 1791006
Sex: F
Age:
State: NJ

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Nausea within 48 hours - subsided; Nosebleed x 1 at 48 hours (5 in my lifetime 3 related to injury); Right knee swelling and discomfort at 5 days subsided 3 days; Right knee swelling and discomfort at 5 days subsided 3 days; new symptom Lethargy; exhaustion; muscle weakness; sedation/I felt like I was drugged.; She said I might have had Covid and not known it.; muscle ache; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 17Sep2021 10:00AM (at the age of 58 years old) (Lot Number: FC3183) as dose 1, single for covid-19 immunisation. Medical history included allergies to poppy seeds, mushrooms, sarcoidosis, thyroid nodule (benign), nosebleed at 48 hours. Concomitant medications included VITAMIN C; VITAMIN D3; ZINC; CoQ10; VITAMIN C, VITAMIN D3, VITAMIN B, Zinc, Reservatrol, CoQ10, Hair Skin Nails, all were taken for an unspecified indication, start and stop date were not reported. The patient previously took CODEINE and CIPRO, and experienced allergies. The patient was not pregnant at time of vaccination. The patient experienced nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days, new symptom lethargy, exhaustion, muscle weakness, sedation/ felt like she was drugged, she said she might have had covid, and not known it, and muscle ache, all on 18Sep2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported events were nausea within 48 hours - subsided, nosebleed at 48 hours, right knee swelling, and discomfort at 5 days subsided 3 days - new symptom, lethargy, exhaustion, muscle weakness, and sedation started 24 hours after 14 days. Patient felt like she was drugged. She called the pharmacist at RA. She said she might have had Covid and not known it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The patient said she received the 1st dose of the Pfizer- BioNTech Covid-19 Vaccine on 17Sep2021. Afterwards, she experienced severe lethargy, exhaustion, muscle ache, and muscle weakness. She said she felt like she was drugged. She said there was a "sedated feeling." She also said she had a nose bleed, right knee pain which lasted for a couple of days, and nausea which has already subsided. HCP said she is more concerned with the lethargy, and wants to know how long it lasts. She also wants to know if the 2nd dose would be worse or better. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN C; D3; ZINC; CoQ10

Current Illness:

ID: 1791007
Sex: M
Age:
State: OH

Vax Date: 03/01/2021
Onset Date: 03/15/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210921; Test Name: Molecular Nasal Swab; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Terrible arthritis flare up in knees and back.; having bad arthritic pain; This is a spontaneous report from a contactable consumer (reported for himself). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date in Mar2021 (seven months prior at the time of report; also reported on "08Feb2021"; pending clarification) (at the age of 71-year-old) (Lot Number: En6201) as dose 2, single for COVID-19 immunization. Medical history included diabetes. No known allergies. The patient's concomitant medications were not reported. The patient previously administered BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 08Feb2021 at 03:30 PM (at the age of 71-year-old) (Lot Number: EI9265) as dose 1, single for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient no COVID prior to vaccination and was tested for COVID post vaccination with molecular nasal swab on 21Sep2021: unknown results. On 15Mar2021 at 12:00 PM, the patient experienced terrible arthritis flare up in knees and back. Still not able to walk or stand more than 5 minutes. Seven months after the second shot (Mar2021) and still having bad arthritic pain. These events resulted in Doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment was received with prednisone, gabapentin, and spinal physical therapy. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1791008
Sex: F
Age:
State: NY

Vax Date: 09/05/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 202109; Test Name: Heart monitor; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210928; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 202109; Test Name: Heart rhythm (heart beat); Result Unstructured Data: Test Result:Irregular

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Swollen lymph nodes in both sides of her neck and both armpits; Rash on her neck; Lymph nodes are aching more; Irregular heart rhythm; irregular heart beat; weird racing feeling in her heart; Fluttering; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PF2588 or PF2558), via an unspecified route of administration in left arm, on 05Sep2021 at 10:30 AM (at the age of 55 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient's first dose of the vaccine was on 05Sep2021 and the pharmacist was not willing to give her the second until she calls Pfizer. Around 14Sep2021 (about 2 weeks before the reporting), the patient got swollen lymph nodes in both sides of her neck and both armpits, a rash on her neck, and an irregular heart rhythm (Sep2021; 1-2 days after vaccination). The patient went in and her lymph nodes on both sides of her neck and both armpits are swollen, and her primary checked that. The patient has a rash on her neck and an irregular heart rhythm and had to wear a heart monitor for 24 hours (Sep2021) but does not have results yet. Symptoms started around 14Sep2021 and over the last week and a half, her lymph nodes are aching more (Sep2021) and as they got more sore the rash appeared on her neck. The patient clarified that the irregular heart beat started almost instantaneously after about 1-2 days (Sep2021) and her boss was strong holding her and harassing her to get it (second dose). It was like a weird racing feeling in her heart and she now notices fluttering and irregular beats at least once a day (Sep2021). The symptoms are staying the same, but the lymph nodes are aching more. The patient was being referred to cardiology and pulmonology and is scheduled for an ultrasound of her neck and armpits and a chest X-ray. The patient had her first one and for the last 2 weeks, she has seen her primary too and was told it's too new and she can't speak to this and can't advise her. The patient went to get her second injection and asked about the Pfizer vaccine, but the pharmacist won't give it until she calls the company about the side effects she is having. The patient's doctor doesn't know what to tell her and the pharmacist won't give it to her until she calls the company, and that she was told she only has a 42-day window for her second dose, but she won't have her test results before then. The patient was instructed to call the company by her pharmacy and hopefully, the company can give direction. The pharmacist refused to give the patient her second dose and her primary care won't answer, and she doesn't want to exacerbate the symptoms. The patient was informed she has a 42-day window to get the second dose and her company is mandating that she get it. The ultrasound of her lymph nodes and the chest X-ray are scheduled for 12Oct2021 and that is getting close to the 42 days and she will have to get results and follow up and let her work know. The events resulted in physician office visit. The patient also underwent electrocardiogram (EKG) that was normal on 28Sep2021. The patient had not recovered from the events. The lot number for the vaccine, BNT162B2, was not clarified and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1791009
Sex: F
Age:
State:

Vax Date: 09/13/2021
Onset Date: 09/17/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210920; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: had MRI with contrast- had severe allergic reaction; Red huge welt at injection site/Rash and hives developed on torso; Red huge welt at injection site.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy.; Red, hot, swollen, itchy/right upper leg- very itchy; Couldn't move arm; Rash and hives developed on torso; right upper leg- very itchy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in Arm Left on 13Sep2021 12:15 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunization. Medical history included multiple sclerosis. Concomitant medications included levothyroxine sodium (SYNTHROID); estradiol (ESTROGEN); progesterone; vaccinium macrocarpon (ELLURA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Copaxone and clarithromycin (KETEK) and experienced allergies to both. The patient had no other vaccine in four weeks. No COVID prior vaccination and was not tested post vaccination. On 17Sep2021, the patient had a red huge welt at injection site. It was red, hot, swollen, itchy. She could not move an arm, rash and hives developed on torso; right upper leg was very itchy. Days later she had MRI with contrast and had a severe allergic reaction. Never in 20 years she had a reaction to MRI dye before. It was believed that the vaccine caused the allergy. She had a reaction twice, once after first dose and again on 20Sep2021 the day of her MRI. The patient took high dose Benadryl as treatment. The outcome of the events was recovering.

Other Meds: SYNTHROID; ESTROGEN; PROGESTERONE; ELLURA

Current Illness:

ID: 1791010
Sex: F
Age:
State:

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
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: significant nodular swelling up to 4-5cm; Axillary pain; tenderness; This is a spontaneous report from a Non-contactable Other HCP (Patient). A 26-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot Number: Ff8841), via an unspecified route of administration, administered in Arm Left on 30Sep2021 at 08:00 (at the age of 26-years-old) as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Sep2021 at 20:00, patient experienced axillary pain, tenderness, and significant nodular swelling up to 4-5cm. Therapeutic measures were not taken due to the events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am