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**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1681916
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Arm soreness; low fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiration date were not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the caller stated with first dose of the Pfizer covid vaccine she and her mother had similar reaction like arm soreness and low fever then it went away and wanted to know about how long mRNA stays in the body. The outcome of the events was recovered on an unspecified date. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681917
Sex: F
Age:
State: NC

Vax Date: 05/13/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210601; Test Name: COVID-19 nasal swab; Test Result: Negative ; Test Date: 2021; Test Name: Weight; Result Unstructured Data: Test Result:Lost 18 lbs

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: 18 pounds weight lost; Complete loss of taste and smell and then only partial of taste and smell; Complete loss of taste and smell and then only partial of taste and smell; Taste buds have changed drastically as everything tastes bad; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 13May2021 at 12:00 PM (at the age of 17 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination). There were no concomitant medications. The patient had no known allergies. No other vaccine was administered in four weeks. The vaccine was administered in a public health clinic or administration facility. In 2021 (reported as 13Apr2021 at 04:00 PM; pending clarification), the patient experienced complete loss of taste and smell for 3 weeks and then only partial of taste and smell. Taste buds have changed drastically as everything tastes bad (2021). In 2021, the patient also experienced 18 pounds weight lost (lost 18 lbs). The events resulted in doctor or other healthcare professional office or clinic visit. No treatment was administered for the events. The patient underwent COVID-19 nasal swab test that was negative on 01Jun2021. The patient had not recovered from the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681918
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Numbness in face; diagnosed initially as potential bell's palsy then later updated to psychosomatic reaction; This is a spontaneous report from a contactable consumer (Pfizer Colleague). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 23Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes COVID-19 from unknown date and unknown if ongoing (reported as if covid prior vaccination Yes). There were no concomitant medications. It was unknown if other vaccine in four weeks and if other medications in two weeks. It was reported that the patient experienced numbness in face, diagnosed initially as potential bell's palsy then later updated to psychosomatic reaction on 23Aug2021. The event resulted in Emergency room/department or urgent care and hospitalization. It was unknown if treatment was initiated. The patient was not covid tested post vaccination. The outcome of the events was recovered. No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1681919
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Body aches; This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hyperthyroidism. The patient's concomitant medication included methimazole. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and she and her mother had similar reaction like arm soreness and low fever then it went away. On an unspecified date, the patient experienced body aches. Caller stated body aches comes and goes and they are not getting any less. Caller wanted to know if its normal. The outcome was recovered. The lot number for the vaccine was not provided and will be requested during follow up.

Other Meds: Methimazole

Current Illness:

ID: 1681920
Sex: F
Age:
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210119; Test Name: Blood pressure; Result Unstructured Data: Test Result:60/32

Allergies:

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

Symptoms: Nose bleed; Blood pressure was 60/32; Headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 71-year-old via an unspecified route of administration on 15Jan2021 (Lot Number: EL8982) as dose 1, single for covid-19 immunisation. Medical history included ongoing hereditary haemorrhagic telangiectasia (she has a rare blood vessel disease called HHT - Hereditary Hemorrhagic Telangiectasia) and on ongoing nosebleed suppression. The patient family history included hereditary hemorrhagic telangiectasia which his father also has. Concomitant medication included tamoxifen (TAMOXIFEN) for nosebleed suppression from an unspecified start date and ongoing (reported as for having been on the medications for 4 years) and a thyroid pill (does not believe that is relevant to these events). The patient did not have prior vaccinations within 4 weeks. The patient reported that she was reporting severe epistaxis after receiving a dose of the Pfizer BioNTech Covid-19 Vaccine. She mentioned that she had to go to the hospital after the first dose due to severe epistaxis resulting in the loss of "a couple liters of blood". The patient mentioned that she gets periodically anyway as she has a history of Hereditary Hemorrhagic Telangiectasia (HHT). She added that HHT causes nosebleed because the blood vessels in the nose are deformed so they break and bleed. She stated that after each vaccine she had nosebleeds and since she gets them (nosebleed) all the time, she did not think anything of it. She inquired if her nosebleeds after the doses of the Pfizer BioNTech Covid-19 Vaccine could have been caused by the vaccine. She was told by an organization that there is specialist in that organization that monitor people with HHT diagnosis, and they told her the nosebleeds were just a coincidence. She also had sore arm and headache. She also stated that she had a sore arm for a couple of hours (15Jan2021) after each of the three doses of the vaccine. She stated that it was no big deal and was gone after those couple of hours and it's to be expected after a vaccine. As for her headache, she experienced it the day after her first dose of the vaccine (16Jan2021), she had a headache for about 2 hours (16Jan2021). She discussed that after the first dose of the vaccine on that Tuesday (19Jan2021), the patient got a nosebleed. She added that she lost about 2 units of blood and she had to go to the hospital by ambulance. She could not get it to stop bleeding. She stated that she looked up at one point and her blood pressure was 60/32. She further added that she was not admitted into the hospital. They stopped the bleeding and then sent her back home. She denied any labs, testing, or treatments relevant to events. She mentioned that she has an appointment with her hematologist tomorrow and they will check her hemoglobin. The event nosebleed required emergency room and physician's office visit. The outcome of the event nose bleed was recovered on Jan2021, for the pain in arm was recovered on 15Jan2021, as for the event headache was recovered on 16Jan2021, while the outcome of the other event was unknown. Follow-up attempts completed. No further information expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100936 Same patient, different vaccine dose, similar events

Other Meds: TAMOXIFEN

Current Illness: Hereditary hemorrhagic telangiectasia (she has a rare blood vessel disease called HHT - Hereditary Hemorrhagic Telangiectasia.); Nose bleed

ID: 1681921
Sex: F
Age:
State: TN

Vax Date: 06/15/2021
Onset Date: 06/27/2021
Rec V Date: 09/08/2021
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: Nasal Swab; Test Result: Negative ; Comments: caller had a negative Covid swab before she got her vaccine

Allergies:

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

Symptoms: Upper respiratory infection; Fever; The caller still doesn't have her voice; When she coughs its crazy; Common cold; Getting sick; This is a spontaneous report from a contactable consumer. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 15Jun2021 19:00 (Batch/Lot Number: EW0168) as dose 1, single for covid-19 immunisation. Medical history included gastric bypass, the caller doesn't have a spleen and doesn't have an immune system, abdominal hernia, the caller has a mesh implant for this. There were no concomitant medications. The patient experienced upper respiratory infection on 27Jun2021 with outcome of not recovered, common cold on 2021 with outcome of unknown, getting sick on 2021 with outcome of unknown, fever on 27Jun2021 with outcome of recovering, when she coughs its crazy on 2021 with outcome of unknown, the caller still doesn't have her voice on 27Jun2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: caller had a negative Covid swab before she got her vaccine. Therapeutic measures were taken as a result of upper respiratory infection (upper respiratory tract infection), when she coughs its crazy (cough). Caller states she received her 1st shot of the Pfizer COVID vaccine on 15Jun2021 and she was scheduled for a second shot but she ended up getting sick and has been sick ever since. Caller would like to know if anyone else has had anything like her before? Caller states she went two and half weeks with a fever and upper respiratory infection and the upper respiratory infection never went away. Caller states she has went through three different times of antibiotics and they didn't work at all. Caller states no medications help her out. Caller would like to know if anyone has experienced a fever for two weeks or had an upper respiratory infection that will not go away? Caller states she can't explain any other cause for her side effects because she works from home and she hasn't been anywhere. Caller states she doesn't have anything in her body to fight off the infection and when it rains she can't go outside and a common cold lasts two to three weeks for her and this has lasted two months. Caller states the only thing she can think of that could be causing her side effects is the shot and she doesn't know where to to turn and she doesn't want to get the second one and die. Caller states even if her doctor recommended she get the second one she wouldn't because she got sick from the first one and she is not going to test the waters. Caller states she wants to get her reaction documented that this happened to her because this is trial and error and people that call in are in guinea pigs and she was one and wants it it be documented. The caller still doesn't have her voice and she has an upper respiratory infection. The caller started feeling kind of crappy towards the end of the work day at 5 pm. The caller works from home and her voice is her job. The fever lasted 2.5 weeks but she has had an upper respiratory thing going on and when she coughs its crazy. They say its an upper respiratory infection but they never say its Covid or anything but its not going away. Nothing is helping the caller- she has tried things over the counter, three rounds of different antibiotics and nothing works. The caller does not know the names of the antibiotics that she was given, nor the lot, NDC, and expiration date of the products. The caller not having her voice is persisting and gets worse. Towards the middle of the day the caller has to force her voice to come out. The caller went to a # and they said she had an upper respiratory infection and put her on antibiotics. The caller later clarifies and confirms that the doctors did not think the patient had Covid and they did not swab the caller for Covid. The caller had a negative Covid swab before she got her vaccine. The fever went away for a day or two and came back that Sunday and so the caller went to the doctor and they gave her a cough syrup that didn't help. The caller does not know the name of the cough syrup or the lot, NDC, and expiration date. The caller took all of the cough syrup and then threw the bottle away. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681922
Sex: F
Age:
State:

Vax Date: 08/06/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: every joint on her body has been hurting/joint issues and her fingers also hurt; hurt pretty bad; hurt pretty bad/injection site that hurt pretty bad; fibromyalgia; retaining water; she also had a bruise on that same arm; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 50-years-old). The patient Medical history, family history and concomitant medications were none. It was reported that, patient still needs to get the 2nd shot of the Comirnaty vaccine but she was concerned if she should get it because the 1st shot hurt pretty bad and every joint on her body has been hurting for the last week and a half and was reported as worsened. As per caller, she clarified that it was the arm where she got the injection site that hurt pretty bad later afternoon. She added that she felt the injection go in and then she screamed because it hurt. She felt that for 2 and a half to 3 days and she also had a bruise on that same arm which was her left arm. Those symptoms went away and now she has body joint issues and her fingers also hurt. Caller received her 1st dose on 06Aug2021 and was set to receive the 2nd one this Friday. She was told that the 1st shot would not bother her and would only feel the side effects after the 2nd shot. She called to know if these are normal side effects of the vaccine because she was nervous to get the 2nd shot. She mentioned that she would be calling her doctor after the call as well. She stated that she felt comfortable knowing that these are normal side effects. She was nervous on day 6 it hurt pretty bad, she had pain when it happen and two and a half to three days later it hurt and bruising. For about a week and a half now every joint in her body hurts. Her husband said it did not hurt him. She hated needles, and she talked to her daughter and she said she also had pain in her joints. Hurt pretty bad: The pain stopped where she got the injection. It went away. The patient experienced hurt pretty bad/injection site that hurt pretty bad on 06Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt on 09Aug2021, she also had a bruise on that same arm, fibromyalgia and retaining water on an unspecified date in Aug2021. Her mother has fibromyalgia and she was thinking that was what she has. She was double checking with us and the doctor before the second shot. The patient did not receive any treatment. The patient not required to visit emergency room and physician office. There were no prior vaccinations (within 4 weeks). There were no relevant tests performed. Outcome of the events hurt pretty bad/injection site that hurt pretty bad was recovered on 09Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt was not recovered and unknown for other events.

Other Meds:

Current Illness:

ID: 1681923
Sex: F
Age:
State: TX

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: heart rate; Result Unstructured Data: Test Result:increased

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: could feel I was about to faint any second/lightheaded; felt a wave of uneasiness come over me; felt confused & scared,everything sounded far away; felt confused & scared,everything sounded far away; my heart was beating rapidly & was sweating; my heart was beating rapidly & was sweating; began to feel terrified; got cold & clammy; got cold & clammy; face was pale; I was too weak; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 14:45 (Batch/Lot Number: FC3182) as single dose for COVID-19 immunisation. Patient age at vaccination was 33-year-old. Medical history was none. Patient did not experienced COVID prior vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clarithromycin (CLARITON) and women's daily vitamins (VITAMINS NOS), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Tetanus Vaccine for immunization and experienced allergic to the Tetanus Vaccine. Patient got her vaccine and was feeling completely fine at first. While patient wait the"15 minutes," all of a sudden, she felt a wave of uneasiness come over her. It felt like slow motion and patient felt as if something just hit her body into shock. SHE felt confused & scared, everything sounded far away and she was too weak to yell for help. She was lightheaded and knew something was wrong. Her heart was beating rapidly and was sweating. She could feel she was about to faint any second and was fighting it as hard as she could not to faint b.c. She began to feel terrified. Her husband ran to her and then ran yelled to pharm for help. He said her body felt like lava when he reached to her and her body was covered in sweat. Patient then got cold and clammy. Her face was pale. The events onset on 17Aug2021 at 14:45. The events resulted in doctor or other healthcare professional office/clinic visit. The pharmacist gave her treatment which included cold rags, water, laid down. Outcome of the events was resolved in Aug2021. Patient did not test COVID post vaccination. Follow-up attempts are completed. No further information is expected.

Other Meds: ADDERALL; CLARITON; VITAMINS NOS

Current Illness:

ID: 1681924
Sex: F
Age:
State: IA

Vax Date: 02/08/2021
Onset Date: 03/09/2021
Rec V Date: 09/08/2021
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: pruritus; Broke out in a rash on the top of both hands; left these hard raised bumps and dry skin from scratching; left these hard raised bumps and dry skin from scratching; left these hard raised bumps and dry skin from scratching; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 08Feb2021 09:45 (Batch/Lot Number: EL3302) (at age 29-years-old) as dose 2, single for covid-19 immunisation. Patient received the first dose on 18Jan2021 09:4 (lot number: EL3246) (at age 29-years-old) on the left arm. Medical history included gallbladder removal. There were no concomitant medications. Patient broke out in a rash on the top of both hands on 09Mar2021. The left side has recovered a lot a better than the right (it left these hard raised bumps and dry skin from scratching), but patient still get bouts of pruritus that affects her right hand more often on 09Mar2021. It can also extend to areas of her face but she does not feel the urge to scratch those areas. She was not prescribed treatment was use Aquaphor for the events. Outcome of the events was recovered with sequel. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.

Other Meds:

Current Illness:

ID: 1681925
Sex: F
Age:
State:

Vax Date: 07/24/2021
Onset Date: 07/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: severe joint pain; dizziness; nausea; This is a spontaneous report from a contactable consumer (other Non-Hcp) reported for herself. A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0176) via unspecified route of administration, administered in Arm Left (left shoulder) on 24Jul2021 (age at the time of vaccination was 67-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Jul2021, the patient experienced severe joint pain. On 28-JUL-2021, the patient experienced severe joint pain. Dizziness and in nausea in Jul2021. Caller states she received her first dose of the Pfizer BioNTech Covid-19 Vaccine on 24Jul2021 and sub subsequently experienced severe joint pain, dizziness, and nausea. Caller states she got through it, but by the time I did it was time for the second dose. For severe joint pain Treatment - None, nothing made it go away she took Tylenol, ibuprofen, rubbed asper cream and be-gay . The clinical outcome of all the events was recovered on unspecified date. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681926
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 07/25/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210725; Test Name: Nasal swas; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: body aches; fatigue; dry cough/Cough has continued to worsen; This is a spontaneous report received from a contactable consumer(patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 22Jul2021,14:00, at age of 37-year-old into left arm, at dose1, single then via an unspecified route of administration, on an unspecified date at dose 2,single for covid-19 immunisation in a pharmacy or drug store. The patient medical history includes Kiwi allergy. The patient's concomitant medications include Ibuprofen (ADVIL), creatine, protein supplement. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and tested post vaccination. The patient tested Nasal Swab on 25Jul2021 and had negative result. The patient experienced body aches, fatigue, and dry cough on 25Jul2021 16:00 about 3 or 4 days after injection after the first dose. Most side effects went away but cough persisted. Day after second dose, the patient had extreme fatigue and body aches, cough increased. Cough has continued to worsen. Still have minor fatigue, but body aches are gone. The patient did not receive treatment in response to the events. The outcome of the events was not recovered for cough, while it was recovered for body ache and fatigue for the first episode and only recovered for body ache for second episode and not recovered for fatigue. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: CREATINE; ADVIL [IBUPROFEN]

Current Illness:

ID: 1681927
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: chest flutters / still experiencing the flutters; runny nose; sweating / sweating on her forehead; staying hot; when the flutters happen there's a little pain/ very painful, extended into neck, armpit and lower arm that kept her up at night.; a little tightening that comes and goes; arm was swollen; couldn't lift the shoulder or arm up; it was red where the needle went in; it was red where the needle went in at the injection site, very painful; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; kept her up at night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer BioNTech Covid 19 vaccine on 07Aug2021 and is due for her second dose on 28Aug2021. About a week after in Aug2021 she developed a runny nose and developed flutters, chest flutters. Her nose was starting to dry out but was still experiencing the flutters and has been sweating on her forehead and staying hot. She said it didn't feel like a fever and hadn't taken her temperature but she did sweat and that she got hot. She had the flutters throughout the day, not constant, it came and went. She got the shot in the left arm. Sometimes when the flutters happen there was a little pain with it, a little tightening that came and went. However, there's not always pain that's associated with it. The sweating happened first and then she got the flutters. Her husband got the vaccine and had no problems. She had a TDaP shot in her left arm back on 15Oct2012 for immunization and had a severe reaction. She had done fine with other tetanus shots in the past but she said she was told that after age 40 you receive a combination and that's the one she had this reaction with. Her arm was swollen, couldn't lift the shoulder or arm up, it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm that kept her up at night. The outcome of chest flutters was not resolved, the outcome of other 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: 1681928
Sex: F
Age:
State:

Vax Date: 08/23/2021
Onset Date: 08/24/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Just very bad headaches; This is a spontaneous report received from a non-contactable consumer(patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration into left arm, on 23Aug2021,11:00, at age of 27-year-old at dose 1,single for covid-19 immunisation in a school or student health clinic. The patient did not have any medical history and concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. The patient experienced just very bad headaches on 24Aug2021 12:00. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1681929
Sex: M
Age:
State: TX

Vax Date: 03/13/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high

Allergies:

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

Symptoms: embolism; This is a spontaneous report from a contactable consumer (patient himself). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 13Mar2021 at the age of 63 years old (Batch/Lot Number: EN6206, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy/drug store. Relevant medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin D3, amlodipine, losartan, and ubidecarenone (CO Q10); all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccination in the past months other than COVID 19 vaccine. It was confirmed that the product was Pfizer COVID-19 vaccine. After the 1st shot, the patient's reaction was embolism on an unspecified date in Mar2021. The patient went to the hospital and emergency room for embolism, and was there for about 4 days, 3 to 4 days. It was further reported that the patient was at the emergency room and they (the doctors) didn't report it; the doctors in the hospital didn't report it. The patient's general practitioner that sent him there (as reported) didn't report it. The patient spoke to the general practitioner and said that he had three other patients who had the same circumstance; they took it and within a day or afterwards, also had embolisms (further information not clarified). The patient stated that it was very surprising to him when he had his doctor telling him, and the doctors were saying they were not required to report and were expecting the people who get sick to report it. It was shocking to the patient and he was very, very irritated about the fact that the doctors were not reporting. The patient received the 2nd dose of COVID-19 vaccine on 05Apr2021 (Batch/Lot Number: ER8734, Expiration date: unknown), but the event "embolism" only occurred after the 1st shot. That time, the patient was already on blood thinner. They put him on apixaban (ELIQUIS); he would have couple of Eliquis. It was further clarified that he was on Eliquis only after the embolism, which happened after the 1st shot. But because he had the embolism, they put him on Eliquis for the 2nd shot. The episode happened after the 1st shot. The patient had no investigation assessment. Therapeutic measures were taken as a result of embolism, which included apixaban (ELIQUIS). The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN D3; AMLODIPINE; LOSARTAN; CO Q10

Current Illness:

ID: 1681930
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Hearing loss; This is a spontaneous report from a non-contactable consumer (patient) received from a Pfizer sponsored program, regulatory authority support. A female patient of unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 1 hour after the vaccination, the patient experienced hearing loss. The patient went to the website to look up the side effects of the vaccine but the side effect that she experienced was not listed there. It says that the side effect was not related to the vaccine but other people has also reported it. When the patient went to the pharmacy, they blew the patient off and said that the hearing loss was not related to the vaccine. The patient got her hearing back within a few days but was perturbed that it was not being acknowledged as a side effect. The patient was nervous about getting the second dose of the vaccine and asked if she can possibly get a permanent hearing loss from the second dose. Outcome of the event was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1681931
Sex: F
Age:
State: AZ

Vax Date: 04/25/2021
Onset Date: 08/14/2021
Rec V Date: 09/08/2021
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: 20210814; Test Name: Covid-19 Test; Test Result: Positive

Allergies:

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

Symptoms: She tested positive for Covid-19 after receiving the second dose in Apr2021; She tested positive for Covid-19 after receiving the second dose in Apr2021; This is a spontaneous report from Pfizer-sponsored program. This report was also received from Product Quality Complaint. A contactable consumer (patient) reported that a 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Apr2021 (Batch/Lot Number: ER8732) as dose 1, single; then via an unspecified route of administration, administered in left arm on 25Apr2021 (Batch/Lot Number: EW0169) as dose 2, single for COVID-19 immunisation. The patient has no medical history and no concomitant medications. Family history included her dad had heart attack at age 41. There were no additional vaccines administered on the same date of the Pfizer vaccine. No other vaccines were given within four weeks prior to the first administration date of the suspect vaccine. The patient tested positive for COVID-19 on 14Aug2021 after receiving the second dose. She believes it is because of her grandkids. She is on her 10th day of quarantine. The events did not require a visit to emergency room and physician office. The outcome of the events was unknown. The Product Quality Complaints Group concluded that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0169 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0169, fill lot EP8700, and the bulk formulated drug product EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.

Other Meds:

Current Illness:

ID: 1681932
Sex: F
Age:
State: AZ

Vax Date: 03/02/2021
Onset Date: 08/23/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: Inappropriate schedule of vaccine administered; I received a positive COVID test on 23Aug; I received a positive COVID test on 23Aug; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer reported for herself that she received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 57 years) as dose 2, single and first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Mar2021 at 15:00 (at the age of 57 years) as dose 1, single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that patient received Dose 1 and Dose 2 on 02Mar2021. The patient experienced Covid on 21Aug2021. No treatment received for AE. The patient underwent lab tests and procedures which included Nasal Swab (COVID-19 Antigen rapid test): positive on 23Aug2021. The outcome of event was recovering. Device Date: 27Aug2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1681933
Sex: F
Age:
State: IA

Vax Date: 03/15/2021
Onset Date: 04/15/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data: Test Name: Covid test; Result Unstructured Data: Test Result:Unknown; Comments: Nasal Swab

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: AFIB; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included valsartan (DIOVAN) taken for an unspecified indication, start and stop date were not reported; clonidine (CLONIDINE) taken for an unspecified indication, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced afib (resulting in hospitalization) on 15Apr2021 with outcome of unknown. The patient was hospitalized for afib for 3 days. The adverse event resulted in Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on Nasal Swab. Therapeutic measures were taken as a result of event (Medication blood thinners, BP meds). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: DIOVAN; CLONIDINE; CARVEDILOL

Current Illness:

ID: 1681934
Sex: F
Age:
State: MS

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: feeling small shock like pain in my thighs; feeling small shock like pain in my thighs. Ever since it's moved to random places all over my body; Like piercing stabbing pain in muscles; feels sometimes like in my veins; This is a spontaneous report from a contactable consumer (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (Batch/Lot number unknown due to unable to locate or read the details) via an unspecified route of administration, administered in Arm Left on 14Aug2021 15:45 at age of 52-year-old at single dose for COVID-19 immunisation. Medical history included Sjogrens, penicillin allergy and sulfa drugs allergy. The patient had no COVID-19 prior vaccination. No COVID tested post vaccination. Concomitant medications included unspecified drugs. It reported the patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As she walked out she began feeling small shock like pain in her thighs. Ever since it's moved to random places all over her body. Like piercing stabbing pain in muscles and felt sometimes like in her veins. The events onset date was reported as 14Aug2021 15:45. No treatment received for the events. The outcome of the events was not recovered. The lot number for BNT162B was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681935
Sex: F
Age:
State: CA

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/08/2021
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: Total body numbness; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Fave and tongue numb and tingly; Severe left sided head pain; Low oxygen; This is a spontaneous report from a contactable other hcp (patient). A 47-years-old female non-pregnant patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 23Aug2021 10:30 (at the age of 48 years), (Batch/Lot Number: Fc3183) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took sulfonamides and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Aug2021 10:45, the patient experienced total body numbness, fave and tongue numb and tingly, severe left sided head pain, low oxygen. The events resulted in visit to Emergency room/department or urgent care. The treatment received for the events was unknown. Device Date was 24Aug2021. The clinical outcome of the events was not recovered at the time of report.

Other Meds:

Current Illness:

ID: 1681936
Sex: M
Age:
State: CA

Vax Date: 06/01/2021
Onset Date: 07/01/2021
Rec V Date: 09/08/2021
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: Test Date: 202108; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%; Was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES. A 53-year-old male patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on Jun2021 (Batch/Lot number was not reported) (at the age of 53-years-old) as dose 2, single; and via an unspecified route of administration, administered in right arm on Apr2021 (Batch/Lot number was not reported) (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered in a school or student health clinic. Medical history included low platelet count Immune thrombocytopenic purpura (ITP). The patient has no relevant past drug history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. In Jul2021, the patient was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. There was no hospitalization prolonged and no treatment received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab test with result: negative in Aug2021. The outcome of the event was not recovered/not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1681937
Sex: M
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/17/2021
Rec V Date: 09/08/2021
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: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Unevaluable event

Symptoms: obstructing my breathing at night; upper respiratory/severe nasal problems; upper respiratory/severe nasal problems; has progressively worsened to the point that it is now obstructing my breathing at night; restricting my day to day activities; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (BNT162B2, also reported Product=COVID 19 vaccine, lot unknown), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for Covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Two weeks after receiving the 2nd dose (17Mar2021), the patient started having upper respiratory/severe nasal problems. It has progressively worsened to the point that it was obstructing breathing at night and restricting the day to day activities. At this point nothing has helped. The patient still tried to do nasal rinses every hour to gain very minimal relief but this cannot be a long term solution. The event, obstructing breathing at night, was reported serious medically significant. The patient had to do clinic visit to a Doctor or other healthcare professional office. The patient underwent laboratory test which included Sars-cov-2 test: negative on unspecified date. The outcome of events was not recovered. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681938
Sex: M
Age:
State:

Vax Date: 05/12/2021
Onset Date: 06/02/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data: Test Date: 20210604; Test Name: Lactate; Result Unstructured Data: Test Result:3.8; Test Date: 20210604; Test Name: Lactate; Result Unstructured Data: Test Result:4.6; Test Date: 20210604; Test Name: CRp; Result Unstructured Data: Test Result:20; Test Date: 20210604; Test Name: EKG; Result Unstructured Data: Test Result:sinus tachycardia; Comments: ST elevation suggests acute pericarditis; Test Name: D-Dimer; Result Unstructured Data: Test Result:unknown results; Test Date: 20210604; Test Name: D-Dimer; Result Unstructured Data: Test Result:3618; Test Date: 20210604; Test Name: INR; Result Unstructured Data: Test Result:1.2; Test Date: 20210604; Test Name: PT; Result Unstructured Data: Test Result:13.2; Test Date: 20210604; Test Name: Sars COV2-PCR; Test Result: Negative ; Test Date: 20210604; Test Name: Troponin; Result Unstructured Data: Test Result:0.30

Allergies:

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

Symptoms: pancytopenia; pericarditis; myocarditis; left axillary adenopathy; fevers; Rash; chest pain; electrocardiogram ST segment elevation; chills; sore throat; shortness of breath; erythematous rash on trunk and limbs; arthralgia in the ankle; tachycardic / sinus tachycardia; mildly tachypneic; C-reactive protein increased; electrocardiogram abnormal; international normalised ratio increased; Troponin: 0.30; prothrombin time prolonged; Blood lactic acid/Lactate: 3.8; 2nd time-4.6; Fibrin d dimer/D-Dimer: 3618; This is a spontaneous report from a non-contactable consumer received from the FDA. The regulatory authority report number is not reported. An 18-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Arm Left on 12May2021 (lot number: EW0182) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications provided as none. No history of allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0165), via intramuscular on 21Apr2021 as single dose for COVID-19 immunization. On 02Jun2021, the patient experienced chest pain, myocarditis, pancytopenia, pericarditis, pyrexia, rash, left axillary adenopathy, chills, sore throat, shortness of breath, erythematous rash on trunk and limbs, arthralgia in the ankle, tachycardic / sinus tachycardia, mildly tachypneic, C-reactive protein increased, electrocardiogram abnormal, electrocardiogram ST segment elevation, international normalised ratio increased, Troponin/ Troponin: 0.30, prothrombin time prolonged, Blood lactic acid (Lactate: 3.8; 2nd time-4.6), Fibrin D dimer (D-Dimer: 3618). Events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, chest pain reported as hospitalized from 04Jun2021, three days in hospital. Events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, tachycardic and mildly tachypneic resulted in emergency room visit. The patient with intensive care on 02Jun2021. The clinical course was reported as follows: Few hours after vaccine developed fevers for 2 days which resolved. Then 02Jun2021 developed fevers, rash, chest pain, admitted to hospital; 04Jun2021 with fevers, rash, pancytopenia, pericarditis, myocarditis. Patient was in usual state of health until 02Jun2021 and experienced fevers, chills, sore throat, shortness of breath, chest pain, erythematous rash on trunk and limbs, arthralgia in the ankle. Presented to ED on 04Jun -febrile, tachycardic and mildly tachypneic. Patient was still currently admitted in unit. left axillary adenopathy. Lab data included on 04Jun2021 (all lab results) Lactate: 3.8; Lactate: 4.6 (2nd time); CRP: 20; EKG: sinus tachycardia, ST elevation suggests acute pericarditis; INR:1.2; D-Dimer: 3618; PT: 13.2; Sars COV2-PCR: negative; Troponin: 0.30. Fibrin d dimer with unknown results on unspecified date. Outcome of the event fevers was recovered on unspecified date. Outcome of events myocarditis, pancytopenia, pericarditis, fevers, rash, left axillary adenopathy, chest pain was not recovered, while of the other events was unknown. This report was assessed by reporting consumer as serious. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681939
Sex: F
Age:
State: VA

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

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:156/107; Test Name: CT Scan; Result Unstructured Data: Test Result:unknown; Test Name: heart scan; Result Unstructured Data: Test Result:unknown; Test Name: heart rate; Result Unstructured Data: Test Result:95 beats per minutes; Test Name: lung scan; Result Unstructured Data: Test Result:unknown

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Symptoms of a heart attack after first vaccine; Palpitations after first vaccine; Shortness of breath, after first vaccine; Chest tightness after first vaccine; Blood pressure elevated, after first vaccine; Heart rate elevated, unspecified, after first vaccine; Very weak and fatigued after first vaccine/Laboring, after first vaccine; Very weak and fatigued after first vaccine; feels like she is going to die; not feeling well; This is a spontaneous report from a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced symptoms of a heart attack after first vaccine, palpitations after first vaccine, shortness of breath, after first vaccine, chest tightness after first vaccine, blood pressure elevated, after first vaccine, heart rate elevated, unspecified, after first vaccine, very weak and fatigued after first vaccine/laboring, after first vaccine, feels like she is going to die, not feeling well. The patient underwent lab tests and procedures which included blood pressure measurement: 156/107, computerised tomogram: unknown, computerised tomogram aorta: unknown, heart rate: 95 beats per minutes, ventilation/perfusion scan: unknown. Consumer had the first dose of the Pfizer Covid vaccine and has been in the hospital 3 times. Outcome of events was unknown. information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681940
Sex: U
Age:
State:

Vax Date: 03/31/2021
Onset Date: 08/02/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210802; Test Name: Covid; Result Unstructured Data: Test Result:contracted Covid; Comments: contracted Covid on 02Aug2021 (COVID positive status).

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: contracted Covid; contracted Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single, and received first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 03Mar2021 as dose 1, single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. for COVID-19 immunization. On 02Aug2021, Patient contracted COVID. Patient stated, that patient unblinded in order to know vaccine status (placebo) and subsequently received the Pfizer vaccine. Lab test included sars-cov-2 test reported as contracted COVID (COVID positive status). The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681941
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: sore arm that she couldn't lift above her head for a day or so; This is a spontaneous report from a contactable consumer reported for a patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned that someone he knew had their first dose of the vaccine and had no side effects other than a sore arm that she couldn't lift above her head for a day or so on an unspecified date. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681942
Sex: F
Age:
State:

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Lupus; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 19Aug2021 at 15:01 as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Previously on an unspecified date, patient had the first dose of the vaccine for covid-19 immunisation.Patient had a booster shot on 19Aug2021 at 15:01. The patient experienced lupus on an unspecified date in 2021 with outcome of unknown.The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1681943
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: A lot of blood clots in his left leg; This is a spontaneous report from a Pfizer Sponsored Program via Regulatory Authority Support from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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 the patient's concomitant medications were not reported. on unknown date the patient had blood clots, a lot of blood clots in his left leg. He had surgery before second dose was scheduled. The outcome of the evens was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681944
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: become a diabetic/ raise your sugar level; This is a spontaneous report from a non-contactable consumer (patient). A patient 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 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I just have one question for you. I don't wanna give my information. I received Pfizer injection about a week ago and I have a question." Consumer was informed about the Pfizer Medical information department and consumer stated, "No, it is nothing like that. I want to know if taking the second part of the Pfizer injection. Do you get, if you are not diabetic become a diabetic with this injection? Does it raise your sugar level?" Consumer hung up the call abruptly. The outcome 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: 1681945
Sex: M
Age:
State:

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: almost passed out after vaccination/Still feels like he has to pass out; sick; throw uppy/feeling like he has to throw up but he can't/feeling like have to vomit; He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night; wakes up feels nauseous; achy; he feels this bad; heart racing; headachy; he is pale; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FC 3180) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jul2021 for Covid-19 Immunisation and experienced got really sick, heart racing, feeling like have to vomit, nauseous and headache. And He spent 3 to 4 days in nursing quarters, sleeping. After the second dose got even sicker. heart racing, feeling like have to vomit, she is concerned that he is having an adverse event. After his 2nd dose he is still sick, almost passed out after vaccination, the pharmacist thought they would have to call an ambulance, but did not call the ambulance. "He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night, wakes up feels nauseous, achy and headachy and throw uppy, not just being teenage lazy, feeling like he has to throw up but he can't he is pale and still aches. Still feels like he has to pass out, he asks to sleep with us, because he feels this bad.She called the Doctor "can't get us in until Thursday. The nurse said he probably had covid when he got his vaccine. They want to test his white, red blood cell hemoglobin and something else and another covid test. "Call back 24Aug2021 at 2:54PM - Left voice mail with telephone number and extension due to call disconnected while on hold.Outcome of achy was not recovered, of others was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100909916 same pt, different dose/event

Other Meds:

Current Illness:

ID: 1681946
Sex: F
Age:
State: NM

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Comments: couldn't figure out; Test Date: 2021; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results; Comments: both heart and lungs didn't seem to have anything wrong with them.; Test Date: 2021; Test Name: 14 days of constant heart monitor; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Injection site pain

Symptoms: Pain in the heart; Flutters, felt like butterflies in chest; Heart would pound; Pressure, feels like someone has a fist around her heart and the heart is trying to pump while being clenched; Heart skips a beat or a few beats; Weak and fatigued; Weak and fatigued; Couldn't wake up, couldn't keep eyes open; dizzy to the point of a headache; dizzy to the point of a headache; Heart was pumping hard and slower than like she would think would be norma; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route in upper left arm on 29Apr2021 2PM at 30-year-old for Covid-19 immunization. Medical history and concomitant drug were not provided. She steered clear of pain meds during her vaccinations. Dad's side of the family has history with heart trouble. Her dad had an adrenal gland tumor removed that was causing heart issues. Her paternal grandpa had to have a stent put in through the vein in his leg to his heart. She did not know exact details, but all on the paternal side of the family. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unknown route in upper left arm on 07Apr2021 for Covid-19 immunization. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. She didn't notice anything between the two doses. Patient reported events began after the second dose on an unknown date in 2021. She didn't track the dates. She wanted to say the events had been going on for 2-3 months (as of 24Aug2021). Patient could not tell exactly how long after the second dose the heart issues started happening. When the pain and severity she was brought her to the ER. Heart issues clarified as started off with flutters, butterflies in chest and that was it. It started getting to where felt like somebody had a fist around her heart and was squeezing it. Heart would pound. Patient could not say heart was racing, it's not fast. She felt like somebody has a fist around the heart and her heart was trying to pump while being clenched. Heart was pumping hard and slower than like she would think would be normal. Other times it flutters and skips a beat or a few beats and feel like it's tickling and stuff. After a few days of pressure, pressure became a pain got to the point where in bed it would hit out of nowhere. She would be incredibly weak and fatigued, couldn't keep eyes open. Couldn't wake up. Compared this to the first trimester of pregnancy where the woman can't keep her eyes open, that's how tired she felt. She was dizzy to the point of a headache. It's still happening as of 24Aug2021.First ER visit was a month ago (as of 24Aug2021) and finally got really really bad and was scaring her. Had gone to ER twice within that same week and finally kept her sitting and waiting for six hours so she didn't go back. During first time in ER, she ran quite a few blood tests and couldn't figure out. She did an X-ray where both heart and lungs didn't seem to have anything wrong with them. During second time in ER, she went back within the same week, they did not repeat any blood work or anything. She wasn't until last couple of days that this even was a side effect she should be reporting. She noticed it after the vaccine, but didn't start paying attention to it until it started hurting. She clarified it was more of a pressure. This was all ongoing and about the same. It flares up occasionally and almost always had the fluttering more times a day than she could count. Pressure comes out of nowhere and the pain, doesn't matter if she was sitting at work, laying n bed, or doing laundry. The AE(s) require a visit to Emergency Room, discharged both times. She was not admitted to hospital. She was referred to cardiologist, was put on 14 days of constant heart monitor and was able to take it off yesterday (as 0f 24Aug2021). Outcome of the events was not resolved.

Other Meds:

Current Illness:

ID: 1681947
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Blood work; Result Unstructured Data: Test Result: Normal; Test Name: CT; Result Unstructured Data: Test Result:Normal; Test Name: MRI; Result Unstructured Data: Test Result: Normal; Test Name: Nerve conduction test; Result Unstructured Data: Test Result: Normal.

Allergies:

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

Symptoms: This is a spontaneous report received from a noncontactable consumer (patient). A 54-year-old female (non-pregnant) patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection; batch/lot# EW0173 or EW0158; expiry date not reported), at the age of 54, via an unspecified route of administration, on unknown date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient did not have COVID-19 prior to vaccination and was not tested post vaccination. The patient experienced tinnitus, numbness and tingling in all extremities. She felt like electricity pulsing through her body. She got headaches and ringing in ears for months after shot. The patient had bloodwork, CT, MRI and nerve conduction test (all normal). The patient did not receive treatment in response to the events. All events lead to emergency room visit and physician office visit. The outcome of the events: not recovered (at the time of the report). No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1681948
Sex: F
Age:
State: NJ

Vax Date: 08/14/2021
Onset Date: 08/15/2021
Rec V Date: 09/08/2021
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 Date: 202108; Test Name: Kidney and Bladder Ultrasound; Result Unstructured Data: Test Result:normal; Test Date: 202108; Test Name: Kidney and Bladder Ultrasound; Result Unstructured Data: Test Result:normal; Comments: no hydro nephrosis or shadowing renal stones. The bilateral ureter jets were visualized. The kidneys are normal in echo texture. No evidence of hydro nephrosis or shadowing calculus

Allergies:

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

Symptoms: urinating blood. It progressed to clots; Hematuria; urinary tract infection; acute cystitis with hematuria; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2, via an unspecified route of administration, administered in Arm Left on 14Aug2021 11:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization/Covid Prevention. Medical history included microhematuria from an unknown date and unknown if ongoing and developed a keloid from getting the small pox vaccine on an unknown date. There were no concomitant medications. On 15Aug2021, the patient experienced urinating blood. it progressed to clots, hematuria, urinary tract infection and acute cystitis with hematuria. The events were assessed as serious (medically significant). The events resulted in Emergency Room visit and Physician Office visit. There were no prior vaccinations (within 4 weeks). The clinical course was reported as follows: Patient went to the emergency room. She was told her she had a urinary tract infection and was put on an antibiotic. She was convinced it was caused by the vaccine. She will be seeing a urologist for testing. She asked if she should get she get the second dose. The urologist told her to wait until she was scoped to see if anything was going on in bladder. Patient's height as 5 feet 2 and 7/8th inches. She had the shot on Saturday 14Aug2021 at 1130 am. The following morning she woke up feeling like she had a urinary tract infection. She started urinating blood. It progressed to clots. She went to the urgent care. They saw that the level was significant. After 36 hours she went to the urgent care. She was told to contact the doctors office. The office told her to go to the emergency room. She went to the hospital. They did the same test as the urgent care and had the same conclusion. Since age 21 she has had microhematuria. She sees a urologist every 6 months for testing. At the urgent care and hospital she had a kidney and bladder ultrasound. At the hospital they said she had acute cystitis with hematuria. The impression from the Kidney Renal Ultrasound was no hydro nephrosis or shadowing renal stones. The bilateral ureter jets were visualized. The kidneys are normal in echo texture. No evidence of hydro nephrosis or shadowing calculus. She was unable to find any information about someone having gross hematuria and if they should get the second dose. Her doctor will see if there is an underlying cause. This is not a normal reaction and should not have happened. The patient is apprehensive about getting the second dose. She found reports of other people having it from a creditable website. She does not have any details to provide. The patient underwent lab tests and procedures which included Kidney and Bladder Ultrasound: both normal in Aug2021. Therapeutic measures were taken as a result of urinary tract infection. The outcome of the event 'hematuria' was recovered in Aug2021 and outcome of the other 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: 1681949
Sex: F
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: sore arm for a couple of hours; Nosebleed; This is a spontaneous report from a 71 years old contactable consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 (lot number EL9269), at 71 years old, as the second single dose, for COVID-19 immunization. No other vaccine was administered on the same date or within 4 weeks. Medical history included ongoing hereditary hemorrhagic telangiectasia (this was a life-long condition, she was born with it, her father also had it). The patient previously received the first dose of BNT162B2 vaccine on 15Jan2021 (lot number EL8982) experiencing epistaxis, sore arm, headache and blood pressure was 60/32. Concomitant medications included tamoxifen ongoing for about 4 years, at 20 mg twice a day for nosebleed suppression and an unspecified thyroid pill. On an unspecified date in Feb2021, 2-3 days after the second dose, the patient experienced epistaxis and on 05Feb2021 she experienced sore arm (no big deal). The nosebleed occurred after the second vaccination was a bad nosebleed, but she was able to stop it. The patient received also a third dose of vaccine on 19Aug2021. After each vaccine dose the patient experienced a nosebleed a couple of days after and sore arm for a couple of hours. She got nosebleeds periodically anyway. She had a history of hereditary hemorrhagic telangiectasia (HHT) and she stated that it caused nosebleed because the blood vessels in the nose were deformed so they break and bled. Nosebleed required ER visit and physician office visit. Nosebleed resolved on an unspecified date in Feb2021. Sore arm resolved on 05Feb2021. She denied any labs, testing, or treatments relevant to events. She had an appointment with her hematologist and they will check her hemoglobin.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098025 Same patient, different vaccine dose, similar events;US-PFIZER INC-202101100937 Same patient, different vaccine dose, similar events

Other Meds: TAMOXIFEN

Current Illness: Hereditary hemorrhagic telangiectasia (this was a life-long condition, she was born with it, her father also had it)

ID: 1681950
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: terrible tinnitus after receiving your vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event in two patients. This is the first of two reports. A male patient of an unspecified age reported that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknow date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving the vaccine the patient experienced terrible tinnitus in 2021. The patient has been to the doctor 3 times including an ENT visit. The reporter told CDC and they don't care. The doctors just shrug. It's now been 5 months with no improvement. Actually the event has worsened. The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101102283 Same drug/AE, different patient

Other Meds:

Current Illness:

ID: 1681951
Sex: F
Age:
State: NJ

Vax Date: 03/12/2021
Onset Date: 03/18/2021
Rec V Date: 09/08/2021
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: Test Name: Biopsy; Result Unstructured Data: Test Result: lymphocytic colitis; Test Name: colonoscopy; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210608; Test Name: Saliva test by PCR - Accurate Diagnostic Labs; Test Result: Negative.

Allergies:

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

Symptoms: developed diarrhea, stomach cramps, and bloating/diagnosed with lymphocytic colitis; This is spontaneous report from a contactable consume (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:30 (Lot Number: EN6206) as dose 1, single (at age of 43-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included Idiopathic hypersomnia, irritable bowel syndrome (IBS), subclinical hypothyroidism. No known allergies. No COVID prior vaccination. Concomitant medications included levothyroxine sodium; melatonin; DHEA; docosahexaenoic acid (DHA); ubidecarenone (COQ10); vitamin D NOS (VIT D); acetylcysteine (NAC). On 18Mar2021 07:00 (also reported as 6 days after the first dose of the Pfizer Covid19 vaccine), she developed diarrhea, stomach cramps, and bloating. These symptoms worsened and became chronic for 12+ weeks, at which time she finally underwent a colonoscopy. A biopsy was taken during the procedure through which she was diagnosed with lymphocytic colitis. Although she has a history of IBS, which is effectively managed with dietary restrictions, she has never had episodes of colitis prior to this time. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment (prescribed a 5 week regimen of Budesonide). The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 02Apr2021 10:30 (Lot Number: ER8733) as dose 2, single for covid-19 immunisation. The patient underwent lab tests and procedures which included biopsy: lymphocytic colitis, colonoscopy: unknown results, Saliva test by PCR - Accurate Diagnostic Labs: negative on 08Jun2021. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: Levothyroxine Sodium; Melatonin; DHEA; DHA; Coq10 [Ubidecarenone]; Vitamin D [Vitamin D NOS]; NAC [Acetylcysteine]

Current Illness:

ID: 1681952
Sex: M
Age:
State: CT

Vax Date: 04/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Covid-19; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab

Allergies:

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

Symptoms: Typical signs of infection, individual tested positive for Covid with a rapid test.; Typical signs of infection, individual tested positive for Covid with a rapid test; Breakthrough infection 4 months after second dose.; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination was yes. On an unspecified date in Aug2021, breakthrough infection 4 months after second dose. Typical signs of infection, individual tested positive for Covid with a rapid test. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with REGEN-COV. The patient underwent lab tests and procedures which included sars-cov-2 test positive (nasal swab): positive on an unspecified date in Aug2021. The outcome of events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681953
Sex: F
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 07/06/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: New onset seizure activity diagnosed in month of July while patient at home with family.; EEG demonstrated "focal" seizure activity.; This is a spontaneous report from a contactable physician. A 85-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: IR8731)via intramuscular, route of administration, administered in left arm on 01Apr2021 at 10:00 as Dose 1,Single for COVID-19 immunization. Medical history included high blood pressure, a fib (Atrial fibrillation), high cholesterol, TVAR (Transcatheter aortic valve implantation), hx CHF (cardiac failure congestive), seizures and anxiety from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL), diltiazem hydrochloride (CARDIAZEM (AVENTIS)), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), furosemide (LASIX [FUROSEMIDE]), potassium chloride (POTASSIUM CHLORIDE) and apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrim and flourecin contrast and experienced known allergies for bactrim and flourecin contrast. The patient experienced new onset seizure activity diagnosed in month of july while patient at home with family and EEG demonstrated focal seizure activity on 06Jul2021 at 19:00. The patient received treatment for the events. The patient was hospitalized for eeg demonstrated focal seizure activity (partial seizures) for 5 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the events was unknown.

Other Meds: METOPROLOL; CARDIAZEM (AVENTIS); CRESTOR; CELEXA [CELECOXIB]; LASIX [FUROSEMIDE]; POTASSIUM CHLORIDE; ELIQUIS

Current Illness:

ID: 1681954
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Blood work; Result Unstructured Data: Test Result:Normal; Test Name: ultrasound; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: loss of control of legs; trouble walking; numbness in my abdomen and legs; muscle spasms in legs; knee and ankle pain; loss of bladder control; cannot walk up steps/stairs or on uneven ground/grass; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced trouble walking, numbness in abdomen and legs, muscle spasms in legs, knee and ankle pain, loss of bladder control, cannot walk up steps/stairs or on uneven ground/grass, loss of control of legs. Patient also informed that MDs ordered a lot of lab test, including ultrasound, nerve induction study, blood work, but nothing was abnormal. At the time of the reporting events outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681955
Sex: U
Age:
State:

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

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: Someone right now that is in the hospital with heart conditions with the shot; This is a spontaneous report from a non-contactable consumer via Medical Information Team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she was concerned about the safety of the vaccine when there had not be a 5-6 year review/study and that it was approved so quickly by the FDA. She was just wondering. She heard yesterday that the Pfizer shot was not FDA approved yet just which was an emergency basis, based on the fact that it hasn't done enough reviews, for a long enough time. She knew a lot of people who have serious side effects to this shot. People are having terrible side effects to it. These are people's lives they are messing with. These are people who want to live, they don't want to have serious consequences. For something to be FDA approved in such a short time was very scary to parents and comprehension. That's not long enough to said something was going into her body that had been reviewed to 6 months. That just doesn't seem logical. She know someone right now that was in the hospital with heart conditions with the shot, so she questioned it. She remain anonymous and declined to share any information about herself. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1681956
Sex: F
Age:
State: NC

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210821; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Pain in extremity

Symptoms: possible stroke; Seizure; Fever; chest pain; headache; extreme fatigue.; This is a spontaneous report from a contactable consumer. This 54-year-old non-pregnant female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO168, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 16Aug2021 at 10:15 AM (at the age of 54 years) as dose 2, single for covid-19 immunisation. Medical history included known allergies (unspecified). Concomitant medications in two weeks included Fluvoxamine, Estradiol, Trazadone, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO168, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 26Jul2021 at 12:15 PM (at the age of 54 years) as dose 1, single for covid-19 immunisation. No other vaccine in four weeks. No covid test prior vaccination. Facility type vaccine was public health clinic/veterans administration facility. Covid test performed post vaccination. The patient experienced fever, chest pain, headache. Seizure, possible stroke, extreme fatigue on 16Aug2021 at 13:00. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. The patient underwent lab tests and procedures which included Nasal swab: negative on 21Aug2021. The outcome of event was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds: FLUVOXAMINE; ESTRADIOL; TRAZODONE; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1681957
Sex: F
Age:
State: IL

Vax Date: 03/01/2021
Onset Date: 08/24/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210824; Test Name: rapid Covid test; Test Result: Positive

Allergies:

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

Symptoms: 5 months after their 2nd dose, they both tested positive for Covid; 5 months after their 2nd dose, they both tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program regulatory authority Support via contactable nurse (patient) via medical information team . A 61-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61 years old, Batch/lot number, NDC number, Expiry Date: Not provided) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61 years old, Batch/lot number, NDC number, Expiry Date: Not provided) as dose 2, single both taken for COVID-19 immunisation. The patient medical history and other products were not provided. The patient stated yesterday, 5 months after their 2nd dose, they both; she and her husband tested positive for COVID (24Aug2021), she was a nurse, and spent some years in research and data collection, she went to get a rapid COVID test, her doctor told her that the only information they report to the county was a positive test, they do not report a person's vaccination status, she questioned how was Pfizer gathering data in terms of immune response, and efficacy of the vaccine, if none of this information was being collected on the local level, how can the vaccine be improved to further benefit the patient, they were not testing for variants on the local level, how Pfizer was approaching new variants that are developing, on a local level, they were not doing genomic type testing to differentiate the variants, how Pfizer was getting the information on the variants and she explained information about the flu vaccine for each season. She wanted to know how Pfizer was getting information about the different variants coming out, how Pfizer was following breakthrough cases, how they are gathering information about it, and how Pfizer was keeping the vaccine up to date moving forward. The patient further stated that if local health professionals are not capturing data, how can the pharmaceutical companies move forward with improving their vaccines, she had no adverse events with the vaccine, she wanted to know if there was a 2nd breakthrough susceptibility even after people have been fully vaccinated and are COVID positive and they forward her question to someone from their team so that they can research about it further. The patient underwent lab tests and procedures which included rapid COVID test: positive on 24Aug2021. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available in the case, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.

Other Meds:

Current Illness:

ID: 1681958
Sex: M
Age:
State: NY

Vax Date: 06/01/2021
Onset Date: 06/03/2021
Rec V Date: 09/08/2021
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: Erectile dysfunction. Inability to gain a full erection; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 01Jun2021 at 15:45 (at the age of 19 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 11May2021 at 15:45 (at the age of 19 years) as dose 1, single for covid-19 immunisation. The patient experienced erectile dysfunction and inability to gain a full erection on 03Jun2021. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101103163 similar report from same reporter

Other Meds:

Current Illness:

ID: 1681959
Sex: M
Age:
State: NY

Vax Date: 04/23/2021
Onset Date: 04/28/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Issues with getting a full penile erection. Erectile Dysfunction.My 19-year-old son experienced the same thing 2 days after receiving the Pfizer vaccine 2nd does.; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection via an unspecified route of administration, administered in Arm Left on 23Apr2021 16:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Apr2021 16:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. On 28Apr2021, the patient experienced issues with getting a full penile erection. Erectile dysfunction. His 19-year-old son experienced the same thing 2 days after receiving the pfizer vaccine 2nd dose. No treatment was received to treat this adverse event. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-202101103077 similar report from same reporter

Other Meds:

Current Illness:

ID: 1681960
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: The rectal bleeding is not that much; Bleeding with a lot of clots; she started to bleed vaginally; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 50 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the rectal bleeding on an unspecified date with outcome of unknown, bleeding with a lot of clots leading to thrombosis on an unspecified date with outcome of unknown also she started to bleed vaginally leading to vaginal haemorrhage on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1681961
Sex: F
Age:
State: FL

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

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Unknown; Test Name: CAT scan; Result Unstructured Data: Test Result:cancer has moved to her lymph nodes; Comments: showed the area in her lower left lobe had doubled in size from her CAT scan a year ago.; Test Name: CAT scan; Result Unstructured Data: Test Result:Unknown; Test Name: PET scan; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: cancer has moved to her lymph nodes/ cancer went into the lymph system in her chest; lung tumor doubled in size/tumor was measured at 3.8 and then it went to 8 so that doubled in size; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received BNT162B2 (Pfizer Covid 19 mRNA vaccine, solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Right on 29Mar2021 (age at vaccination 73-years-old), as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing small cell lung cancer, allergy to penicillin when she was very young. Her mother told her never to take the penicillin because she was allergic to it. NDC/Lot/Expiry not known, that was probably 65 years ago. She also had a few surgeries. The patient's concomitant medications were not reported. No additional vaccines was administered on same date of the Pfizer suspect. List of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. On 08Mar2021, patient received BNT162B2 (Pfizer Covid 19 vaccine, solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Right as DOSE 1, SINGLE for covid-19 immunisation. He reported that he and his wife both got their Covid 19 vaccines, the second dose on 29Mar2021. He stated his wife had small cell carcinoma of the lung, lung cancer and she had a CAT scan done recently and the CAT scan showed that the cancer had moved to her lymph nodes and she will be doing chemotherapy treatments. He stated her doctor will be using a "smart drug", Keytruda. He stated her lung tumor actually doubled in size and went into the lymph system in her chest. His concern was, his wife would like to get her Covid 19 booster but because she had to do the chemotherapy he didn't know if their was any information on chemotherapy and the Covid 19 vaccine. He stated the chemotherapy was designed to target his wife's immune system and from what he understood, the Covid 19 vaccine also targets the immune system. After the second Covid 19 vaccine, on an unspecified date the cancer moved to her lymph nodes and the lung tumor doubled in size. He did not said that the Covid 19 vaccine caused this. The Patient was taken to physician office as her lung tumor doubled in size. It was reported that he talked to his wife's oncologist and because the cancer had moved into her lymph system the doctor wanted to begin treatment right away. The doctor stated to the caller that he didn't believe that the Covid 19 booster would affect her taking the chemotherapy but he really didn't know. He would like someone at Pfizer to say the Covid 19 vaccine has been given out for a year and some of those people who have received the Covid 19 vaccine might have ongoing immunotherapy. He stated it didn't seem that those people have problems. He wanted to be safe and his wife will have to have the chemotherapy treatment starting in the next 2 to 3 days (unspecified date). He clarified that his wife had not begun her chemotherapy treatment yet. He provided the names of the chemotherapy medications that his wife will receive as Keytruda, Carboplatin, and Alimta. He reported that his wife had some blood work, CAT scan, and PET scan done on unspecified date. He stated that his wife put off doing any CAT scans right away because they were withheld and everyone was sick with the Covid 19 virus right now. The CAT scan showed the area in her lower left lobe had doubled in size from her CAT scan a year ago. He thought the tumor was measured at 3.8 and then it went to 8 so that doubled in size. It was reported that he doesn't know the measurement specifics. At the time of this report, the outcome of event lung tumor doubled in size/tumor was measured at 3.8 and then it went to 8 so that doubled in size and cancer has moved to her lymph nodes/ cancer went into the lymph system in her chest was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Small cell carcinoma of the lung

ID: 1681962
Sex: M
Age:
State: KS

Vax Date: 05/13/2021
Onset Date: 06/17/2021
Rec V Date: 09/08/2021
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: 2021; Test Name: Sperm count; Result Unstructured Data: Test Result: averaged 78 million, concentration 23 million/ml; Comments: Before vaccination 2 semen analysis; Test Date: 2021; Test Name: Sperm count; Result Unstructured Data: Test Result: averaged 16 million, concentration 6 million/ml; Comments: After vaccination 4 semen analysis.

Allergies:

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

Symptoms: Since vaccination, sperm count has dropped approximately 80 percent; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182), via an unspecified route of administration on arm right on 13May2021 10:30 AM (age at vaccination: 39 years) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and known allergies was reported as none. Device Date was reported as 25Aug2021.The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Zinc Glycinate taken for unspecified indication from an unknown date and Multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170), via an unspecified route of administration on arm left on 22Apr2021 11:00 AM (at the age: 39 years) as dose 1, single for COVID-19 immunization. On 17Jun2021, the patient experienced Since vaccination, sperm count has dropped approximately 80%. It was reported that Sperm count before vaccination averaged 78 million, concentration 23 million/mL. Sperm count after vaccination has averaged 16 million, concentration 6 million/mL. This was across 6 semen analyses over 5 months, 2 before vaccination, 4 after vaccination. The adverse event resulted in Doctor or other healthcare professional office/clinic visit/ Disability or permanent damage. The lab test included Sperm concentration: averaged 78 million, concentration 23 million/ml (Before vaccination 2 semen analysis) and Sperm concentration: averaged 16 million, concentration 6 million/ml (After vaccination 4 semen analysis) on an unknown date in 2021. The treatment received for the events was reported as no. The outcome of event was unknown. Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: Zinc Glycinate

Current Illness:

ID: 1681963
Sex: M
Age:
State: SC

Vax Date: 08/07/2021
Onset Date: 08/07/2021
Rec V Date: 09/08/2021
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: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:unknown; Comments: but it is not back yet

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: loss of vision 15 minutes; experienced severe allergic reaction after the first dose of the Pfizer BioNTech Covid-19 Vaccine.; elbow pain; shortness of breath; chest pain; This is a spontaneous report from a contactable other hcp via medical information team. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 07Aug2021 (age at vaccination was 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination was not administered at military facility. Medical history included diabetes mellitus from Jan2020 to an unknown date, chronic obstructive pulmonary disease (COPD) from Feb2019 to an unknown date and hypertension from 15Jan2015 to an unknown date. Concomitant medication was not reported. On 07Aug2021, 15 minutes after the getting the shot, the patient experienced severe allergic reaction after first dose of bnt162b2 vaccine, elbow pain, shortness of breath, chest pain and loss of vision. It all lasted 35-40 minutes. All were simultaneous after the injection. The patient underwent lab tests and procedures which included blood test: unknown, but it is not back yet on an unspecified date in 2021. The event of elbow pain and shortness of breath was related to bnt162b2. No additional vaccines were administered on same date of bnt162b2 vaccine. Prior vaccination, no other vaccines were received within four weeks prior to the administration of bnt162b2. The symptoms subsided and was sent home with no medical treatment. Outcome of the events was resolved on 07Aug2021. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - blindness, hypersensitivity, arthralgia, dyspnoea, chest pain, and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 1681964
Sex: F
Age:
State: TX

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Name: Endoscopy; Result Unstructured Data: Test Result:unknown; Test Name: MRI; Result Unstructured Data: Test Result:unknown

Allergies:

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

Symptoms: Loose stool; numbness in her legs; slight angina in her upper abdomen/she still had some heart pain/pain around her heart; she was tired; Stomach ache/stomach pain that was moving around; some pain under her breast bone; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number EN5318), via an unspecified route of administration on 30Jan2021 (68-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient's medical history and concurrent conditions included, had abdominal stomach pain, weird blood pressure was high, cramping, nauseated, chills, shaking, all from Dec2020 to an un-known date and some off and on numbness of her face, she was born with an irregular heartbeat, Rash, heart pounding, Memory issue from unspecified date. However back in Dec2020 she was starting to have not really bad heart pounding but an occasional heart pounding to where she would make a note of it, but she was not worried about that. Also, this may or may not have an effect, but she had a bat land on her in the summer and she took a rabies shot, it was a strong vaccine, maybe that had something to do with this (Lot number, Expiry date were not provided). She stated well she needed to check her blood pressure log because she had a weird Dec2020. In Dec2020 she was having abdominal stomach pain, blood pressure was high, cramping and in early Dec2020 she was nauseated with chills and shaking. This all kind of started when she had an MRI, it was not 2 weeks before, but this all kind of started a pattern of weird health issues though Dec2020 and Jan2021. She had the MRI and got a rash, weirdly enough it was on her abdomen. Then she started having some heart pounding then, but it was not as bad as it was with her COVID vaccine, but she did make a note of it. She had an endoscopy because her doctor thought that maybe it was worse than just a colon impaction which was what it turned out to be. She went to see a neurologist on 22Jan2021, and the neurologist tapped on the side of her head as she was checking for things. She had gone to her with memory issues before and for other things that have happened. she had car accident years back and had some off and on numbness of her face since then, this was earlier to this time, but when the neurologist tapped on her head it kind of triggered that and also, she had numbness in her legs and the bottoms of her feet following that. She made note also of having heart palpitations. Then in Jan2021 she had her 1st COVID vaccine, 30Jan2021. Now this was important she thought, she used to take her blood pressure every day but for the past few years she hasn't. She asked a doctor or a pharmacist about this and her blood pressure has never been really bad, but she asked if it was okay for her to take only half of her blood pressure medication and whoever she had asked said yes. When she later told her cardiologist, he said that she should had never done that. The morning before she had went to get her first COVID vaccine she had a high blood pressure and so she took half of her Bystolic, so that would had been 5 mg, and she didn't have any side effects except she did have some pain under her breast bone. She added that she doesn't know if that was before or after the COVID vaccine, maybe it was before the COVID vaccine. She made note also of having heart palpitations. It was unknown if the patient received concomitant medications. She had some kind of weird things going on, too she was wondering if maybe she just had these all even before she got the 1st COVID vaccine, now that she was thought in retrospect. Then on 02Feb2021 she still had pain around her heart, she was tired, had stomach aches, loose stools and she still had some heart pain and her stomach hurt on that Wednesday and Thursday. Then that continued for the next few days, the tiredness did, and she was still having the stomach pain and numbness in her legs, that was around 07Feb2021 and then on 12Feb2021 she noted that she was having stomach pain that was moving around and she had fatigue. On 25Feb2021 she noted slight angina in her upper abdomen. She said that she had to get like 5 to 6 shots and waited in the emergency room and only their emergency room was giving them, and she had to wait like 6 hours during COVID. The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1681965
Sex: F
Age:
State: NJ

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 09/08/2021
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: Cancer; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself. An unknown age female patient received her 2nd dose of the Pfizer BioNtech Covid 19 Vaccine BNT162B2 in Jun2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. She later noticed she developed something on her breast, and after testing she was diagnosed with cancer. Outcome of the event was unknown. The lot number for the vaccine was not provided and will be requested during follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am